The Universal Prosthesis - Report February - November 2005

Feasibility of Written by:

Boudewijn Wisse

the Universal Below-knee Prosthesis

Mentors:
Johan Molenbroek
a Hands-Off PTB/TCB-Hybrid Prosthesis Marc Tassoul
Just Herder
with a Low-Expertise Fitting Method.
Delft University of Technology
Faculty of Industrial Design Engineering
The Netherlands
 Preface
This report is about a quest to improve pros-
thesis for lower-limb amputees and is a result
of my graduation project.
Although estimations vary wildly, it is cer-
tain that there are millions of limbless people
in the world. In 2002 I went to Sri Lanka to
see if my expertise (product design) could
help at least some of them. All my tries, trials
and adventures led to my graduation, of
which this first report is lying in front of you.
I hope you will find the report informative
and inspiring.
It all started with a contest by Johan
Molenbroek and Henk Kooistra, who asked
several groups of industrial design engineers
to think about the land mine-victims in Sri
Lanka. I entered the “Design for All” com-
petition and was able to continue with an
internship in Sri Lanka. Now, two years and
much thinking later, I started this graduation
project.
II
In practice, this project is about the design
of a universal transtibial prosthesis. Imagine
a comfortable, adaptable and adjustable leg
prosthesis, suitable for people with different
residual limb shapes and sizes! It could reach
at least some of the millions limbless, who
now cannot receive the health care and prod-
uct they need. I hope my graduation project
will prove the universal prosthesis is feasible,
so production can be started and amputees
can be reached and benefit from this work.
This report came into being from February
to May 2005, at the faculty of Industrial
Design Engineering, at the Delft University
of Technology in the Netherlands. I would
like to thank Just Herder, Marc Tassoul and
Johan Molenbroek for their kind assistance
and Wouter van Dorsser for his never ending
support. Every day I work on this project , I
think about all the knowledge the people in
Sri Lanka taught me. Thanks again.

Summary
The universal transtibial prosthesis is a below-
knee prosthesis that can be fitted to the
amputees residual limb by an inexperienced
person. Due to the lack of (time of) prosthetist
in many countries, amputees world-wide can
profit from better health care because of the
Universal Prosthesis. Nowadays, still one mil-
lion people are in need of an artificial limb.
The Universal Prosthesis primarily consists
of a socket-pylon frame, a connective compo-
nent to the foot and a “liner” that will func-
tion as the inner and outer layer of the socket,
and an injector.
During the fitting procedure the frame
transfers half the weight of the body of the
amputee to the residual limb’s pressure-toler-
ant areas. Then, a total contact fit is achieved
by filling the inner and outer layer of the
socket with rigid Poly-Urethane foam. The
injector, that provides the foam, is basically
a high-pressure aerosol spray with a special
nozzle.
Because the frame loads the pressure toler-
ant areas (in particular the patellar tendon)
and the injector pressurizes the inner space
of the socket during fabrication, the socket
is a patellar-tendon-bearing / total-contact-
bearing hybrid. (PTB-TCS-hybrid). This way,
maximal comfort is achieved. The precise,
volume-matching fit provides good control
over the prosthesis to the user.
The socket-pylon frame forms an exoskeletal
design, with good stiffness and strength. The
pylon is connected to the foot by a connec-
tive component with a pivot point. In this
way, dynamic alignment or alignment adjust-
ments stay possible after the fabrication of
the socket, though limited in respect to state-
of-the-art modular endoskeletal designs.
Suspension
is achieved by supracondy-
lar brims. In cases where this suspension
is insufficient, a suspension sleeve can be
added.
The fitting procedure results in a prosthesis
that can be used daily, in the same way as
currently available designs.
Apart from the injector, which is part of the
distribution kit containing all components,
no tools are needed that can not be found
in local hardware stores to fit the prosthe-
sis (basically, a saw and a screwdriver). The
Universal Prosthesis is independent of local
infrastructure which enables a broad and
easy distribution.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Markets for the Universal Prosthesis include
temporal, spare prostheses, and definite pros-
Approach
theses, especially for elder and still growing
children. When fully developed and opti-
mized, the Universal Prosthesis can be used
for amputees worldwide in all circumstances.
Because of variations in residual limb shape,
length and health, the Universal Prosthesis
Users
is suitable for about 70% of the transtibial
amputees in the target groups.
Prostheses
Price of the Universal Prosthesis can vary
widely and is dependent on the amount of
pieces produced a year. Market exploitation
in developed countries becomes commercially
Usage
feasible at a price for the distribution kit that
is lower than 700 USD. Worldwide market
exploitation of the Universal Prosthesis
becomes commercially feasible at prices of
Stragegy
the 100-200 USD, dependent on the situation
of the users and the support of NGOs and
aid-funds. To reach these prices, development
and organisation of the Universal Prosthesis
from this report to European distribution
Criteria
and from that to worldwide distribution both
have to stay under 1,000,000 USD.
Page: III
 Field studies have to prove the effectiveness
of the Universal Prosthesis and will provide
feedback for further improvements. These
field studies are the next big step towards
implementation. However, literature shows
that one prefabricated socket can already be
successfully used for 50% of the transtibial
amputees. Outcome is expected to indicate
that the Universal Prosthesis is suitable for
70-80% of the transtibial amputees.

Concluding, the development and implemen-

tation of the Universal Prosthesis is feasible.

IV

Table of Contents
1 Introduction___________________
2 Project Background and
Approach_ _____________________ 2
2.1 Time Line of Project and Design
Philosophy_ ___________________ 2
2.2 The Need for More 3.3.3. Component and fitting prices_____ 23
Prosthetists___________________ 3
2.3 Recommendation: The Universal
Prosthesis_____________________ 4
2.4 Design Objective_______________ 5
2.5 Project Approach______________ 5
3 Actors and Users______________
3.1 The Patient____________________
3.1.1 Anatomy of the Lower Limb_______ 7
3.1.2 Transtibial Amputations_ _________ 8
3.1.3 Residual Limbs_ _________________ 9
3.1.4 Patients Posture and Principles 4.2.2 Endoskeletal Structure___________ 32
for Alignment___________________ 13
3.1.5 Basic Biomechanics of Gait _______ 16
3.1.6 Gait Deviations_ ________________ 19
3.1.7 Special User Groups; children and
patients with a reduced activity level
20
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
1 3.2 The Prosthetist and other 4.3 Components_ _________________ 33
Team Members in a 4.3.1 Basic Components: Socket________ 33
Approach
Prosthetic Clinic_____________ 21 4.3.2 Basic Components: Pylon ________ 36
3.3 Producer of Prostheses_______ 22 4.3.3 Basic Components: Foot/Ankle
System ________________________ 37
3.3.1 Dutch Industry_ ________________ 22
4.3.4 Basic Components: Suspension ___ 40
3.3.2 Worldwide Industry_____________ 22
4.3.5 Additional Components__________ 43
Users
4.3.6 Materials & Tools_ ______________ 44
4.4 Biomechanics of
4 Transtibial Prostheses________ 24
Transtibial Prostheses________ 45
Prostheses
4.1 Types According to the Patients
Rehabilitation Stage__________ 25 4.5 Financial Issues &
Distribution_ _________________ 49
4.1.1 Removable Rigid Dressing - RRD__ 26
4.1.2 Immediate Post Operative 4.5.1 To the Patient___________________ 49
Prosthesis - IPOP_ ______________ 27 4.5.2 To the Practitioner______________ 50
Usage
6 4.1.3 Removable Protective Socket - RPS 28 4.5.3 To the Producer_________________ 50
4.1.4 Temporary Prosthesis_ __________ 29 4.5.4 To Governmental Institutions_____ 50
7
4.1.5 Definite Prosthesis______________ 30 4.6 Repair and Life-time_____________ 50
Stragegy
4.2 Structural Designs ___________ 31
4.2.1 Exoskeletal Structure____________ 31
Criteria
Page: 
 5 Life with a prosthesis - the
amputee’s perspective_______ 51
5.1 Preprosthetic care____________ 52
5.2 Selecting the aid _____________ 53
5.3 Alignment and rehabilitation 54
5.4 Daily routine: donning, 6.1.4 Production_____________________ 62
doffing and gait_ _____________ 55
5.5 Statistics on functional Lankan test designs___________
outcome and use______________ 58
5.6 Aftercare and concerns_______ 58
VI
6 Ethics, Marketing and Design 7 Design criteria and requirements
Vision_________________________ 60 71
6.1 Ethics________________________ 60 7.1 Ten Design Criteria __________ 71
6.1.1 A World-wide Smart-tech product 60 7.2 Requirements for cycle 0:
6.1.2 Social-political consequences 60 6.1.3 The preparatory design
A product for the world__________ 61
trajectory____________________ 72
7.3 Criteria for cycle 1:
6.2 Conclusions from the Sri
Market exploitation in
62
developed countries___________ 73
6.3 Marketing ___________________ 63
7.4 Criteria for cycle 2:
6.4 Substitute products and World market exploitation___ 75
competitive fitting methods___ 65
7.5 Additional goals______________ 76
6.4.1 Fabrication and fitting methods___ 65
6.4.2 Substitute products______________ 66
8 Discussion and conclusion
6.5 Vision of the fitting procedure
of part 1_ ____________________ 77
and usage_____________________ 67
6.5.1 Cycle 1 – for developed countries 67
9 Synthesis -
6.5.2 Cycle 2 – for developing countries 69
from idea to prosthesis_ ______ 79

10 Ideas__________________________ 80
10.1 Idea generation_______________ 80
10.2 Idea discussion________________ 81
10.3 Idea selection and integration 89
10.4 Evaluation of the integrated
design and conclusion_________ 90
11 Concept_______________________ 92
11.1 The hard socket_ _____________ 92
11.1.1 Selection of loadable and avoidable
area’s based on anatomy_________ 92
11.1.2 Determining the rough frame
shape._________________________ 93
11.1.3 Optimizing the frame shape in
regards to the anatomy.__________ 94
11.1.4 Back to 3D_____________________ 95
11.1.5 Material choice_________________ 96
11.1.6 Mechanical properties___________ 97
11.2 The soft socket _ _____________ 98
11.2.1 Fitting liner_ ___________________ 98
11.2.2 The Filler Material_ _____________ 99
11.2.3 Adding pressure_______________ 101
11.3 The connector_______________ 101
11.4 Resulting fitting procedure__ 104
11.5 Daily usage & Suspension_____ 105
11.6 Production and price_________ 106
11.6.1 Production costs per part_______ 106
11.6.2 Development costs_ ____________ 107
11.6.3 Marketing and Distribution costs 107
11.6.4 Conclusion____________________ 108
12 Evaluation___________________ 109
12.1 Scoring criteria in comparison
with other prosthetic systems.___
109
12.2 Evaluation the concept against
the requirements.____________ 115
12.3 Model and Fit of the Frame__117
12.4 Project evaluation___________ 119
12.5 Conclusions
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
13 Recommandation_____________ 120
13.1 Fundamental research in
Approach
prosthetics.__________________ 120
13.2 Improving the Universal
Prosthesis___________________ 121
13.3 Project continuation_ _______ 122
Users
14 Conclusion___________________ 124
14.1 Strengths____________________ 124
Prostheses
14.2 Project progression__________ 125
14.3 Final word___________________ 125
R References___________________ 126
Usage
F Figures & Tables List________ 127
Stragegy
Criteria
Page: VII

1 Introduction
During previous projects [Wisse et al. 2002,
2003] it became clear that making, fitting and
aligning prostheses for patients can be a time
consuming activity. A universal prosthetic
design for daily use could improve prosthetic
health care, but is not yet available. Chapter 2
explains the source of this problem.
This is the first report of a project aiming to
design such a prostheses. It exists of three
parts:
I Analysis
II Synthesis
III Feasibility evaluation
I Analysis
In the first part of this report, the analysis
and preconditions for this project can be
found. It concludes with the possibilities and
the design requirements for a universal pros-
thesis. This part will provide the information
needed for the next phases in this research
project. Those with some background in
prosthetics and who are primary interested
in the design requirements of the universal
prosthesis are referred to chapter 6 and 7.
The patient as well as the practitioner have
to use and feel comfortable with the univer-
sal prosthesis and are therefore the focus of
the design process. In chapter 3 you will find
a description of the actors and their relation-
ships.
The design of the universal prosthesis will
be based on existing knowledge, especially
from current designs. Chapter 4 discusses
current prostheses, existing types and their
fabrication.
The prosthetist needs to fit and align the
prosthesis, but the patient needs to wear it
daily. Chapter 5 discusses the daily use of
current designs.
These analysis, combined with the strategic
principles from chapter 6, result in chapter
7 in the requirements as will be used for the
design of the universal transtibial prosthe-
ses.
Finally, in chapter 8, the conclusion states
what needs to be done in the next phases of
the project.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
II Synthesis
In this part the development of a proof-of-
Approach
principle concept of a universal socket is
described. Chapter 9 describes the followed
process to reach this result.
It all starts with the right ideas. Altough a
Users
strong vision and general idea about how the
prosthesis should look like and function was
generated in Part I, a new set of ideas is for-
mulated to be sure that no good alternatives
Prostheses
were overlooked (chapter 10).
This ideas need to be integrated into a new
fitting method and the components of which
the universal prosthesis is constructed. The
Usage
parts are optimized to ensure one integral
system in chapter 11.
III Feasibility Study
Strategy
The concept has to be evaluated (chapter 12).
Will an universal prosthetic system become
reality in the future? Chapter 13 gives some
recommendations and an overview about
Criteria
what still needs to be done. Chapter 14 con-
cludes with the answer to this question and
gives a notion about what the future might
bring.

 2 Project Background and Approach

This chapter will describe how the need
for a universal prosthesis was recognised.
It explains the underlying problem and the
process that uncovered this problem.
Those who understand the need for a uni-
versal prosthesis and are merely interested in
the design analysis can skip to section 2.4.
2.1 Time Line of Project and
Design Philosophy
While the project now focuses on a tech-
nologically advanced product, it started out
focusing on low cost, easy producible and
repairable prosthesis for use in developing
countries (see TABLE 2-1 and Appendix C for
an overview).
In April 2002, Johan Molenbroek and Henk
Kooistra started a “Design-for-All” contest in
which several groups designed a prosthesis
for Sri Lanka. Of course, I was part of a team
that participated in this contest and the result
was the report: “Prostheses for Sri-Lanka,
prostheses for tibial amputees focused on the
3rd world “[Wisse et al. 2002] (See appendix
A for a summary of the design for all project).
Mainly because of our force analyses and
international approach, we won the contest
and were able to continue our work in an
internship in Sri Lanka. During the intern-
ship, we worked at the Colombo Friends in
Need Society (CFINS), a non-governmental
organization (NGO). The CFINS provides pros-
thetic services all over Sri Lanka and uses
mainly the Jaipur Foot technology [Wisse et
al. 2003, p13]. Here we were able to build
and test some of our ideas from the contest.
This resulted in a new design philosophy and
new designs, which we were able to present
at a World Congress of Alternative Medicine
[Wisse et al. 2003]. Our results can be read in
the report: “The Alternative Prosthesis, final
report internship Sri Lanka 2002” [Wisse et
al. 2003] (See appendix B for a summary of
the internship).

(pre-) Sri Lanka This project

Time span Till December 2002 December 2004 till August 2005
Problem per- Number of produced prosthesis too Number of professionals too low
ceived low
Goal Prosthesis easy to manufacture from Universal prosthesis from plastics
basic materials
Target group Third world amputees Patients worldwide
Costs Extremely low costs Cost reducing through time

 Table 2-1: Project targets before and after the Sri Lanka internship [Adjusted from Wisse et al. 2003,
Chapter 5] (For a complete timeline see appendix C).

At the start of the internship, the design
ideas were based on three basic forms,
namely our redesign of the prosthesis by Inne
ten Have, the design by Michelle Kriesels and
conventional prostheses. The prosthesis by
Inne consists of a long strap of metal, which
can be folded to form a patellar bearing pros-
thesis [Wisse et al. 2002 for more informa-
tion]. We initially improved it by adding some
parts. Michelle Kriesels also participated in
the “Design-for-All” contest and her design
was based on (re)using bicycle parts to man-
ufacture the prosthesis [Kriesels et al. 2002].
Of modern conventional prosthesis, the mod-
ular build-up (See section 4.2) and the patel-
lar tendon bearing principle (See section
4.3.1), were adopted to our designs.
However, during the internship, we found
out that instead of producing prosthesis from
aluminium, the advantages of using plastics
were needed. Plastics offer a lot of design
freedom for a decent final product price (only
at higher quantities, so the product needs to
be distributed to al least several countries).
This design freedom is not only needed to
provide a comfortable and stiff prosthesis,
but moreover to assist the user in fitting and
alignment. With plastics, primary functions,
alignment functions and an adjustable shape
can be integrated in one product. Costs are
less an issue, as we see that US-Aid and other
foundations have a “magical” 100$ border,
which they are ready to pay for in case of
humanitarian distribution of a prosthesis
[Wisse et al. 2003].
For a flowchart of the socket designs till now,
see Appendix D.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
2.2 The Need for More
Prosthetists
Approach
The “Design-for-All” contest’s goal was
improving help for land-mine victims in Sri
Lanka. However, because land mines are used
in specific zones only, and Sri Lanka doesn’t
Users
suffer from sliding landmasses, civilian cau-
salities are few. Still, the amount of amputees
is Worldwide an problem.
Worldwide
Prostheses
there are about 15 million
amputees (also see appendix F). With 39 per-
cent of them living in the Asia’s, this area
deserves special attention. In some coun-
tries land mines are a problem, though most
Usage
common causes are accidents, diabetics,
cancer, infections and congenital deformities.
Health care for the amputees is in many
Stragegy
cases insufficient. The production capacity is
low and there is a lack of experts (prosthetist)
to fit the prostheses. “It has been estimated
that it would require training up to 100,000
new prosthetists if conventional production
Criteria
methods are to meet the worldwide need”
[Michael 1994]. This results in a lack in
health care and aftercare. Although different
groups are thinking about (and working on)
this problem and developing alternatives, no
alternatives are available yet.

 In general a better use of the prosthetists‘
time will result in better overall care, more
patients helped, better aftercare and more
attention to difficult amputations and special
patients (such as children).
There is a worldwide need for the
prosthetist’s valuable time.

2.3 Recommendation: The
Universal Prosthesis
As concluded in section 2.2, there is a need
for more prosthetists.
Given a certain amount of amputees and
the amount of care they need, the lack of
prosthetists can be solved in three ways:
1 Increasing the amount of prosthetists.
2 Lowering the level of experience (knowl-
edge) needed to be a prosthetist.
3 Reducing the time asked per patient of the
prosthetists, which implies:
- Reducing the need for replacement.
- Reducing the time per adjustment
The design and manufacturing of the pros-
thesis is a time-consuming event for the
prosthetist. Research trails and prototypes
strongly suggest that the prosthetist’s work
can be more time-efficient with an alternative
design for transtibial prostheses, the univer-
sal prosthesis.
For developing countries, the philosophy for
the universal prosthesis design could be as
follows:
“A new concept for a everyday prostheses
could improve the situation of amputees.
Evidence shows possibilities for an adjust-
able, easy-to-fit but comfortable socket. The
more the patient can do himself, the fewer
prosthetists are needed, thus reducing the
lack of prosthetists. The higher quantities
needed for the newly reached amputees
enable mass production. Costs are reduced.
Distribution will speed up, because the need
for the patient to travel to distribution points
is cancelled. This prosthesis can be produced
in developing countries, but has market
potential all over the world. It is especially
better suitable for children [Red: because it
is adjustable and children and their residual
limb keep growing].
Ideally, the end users are capable of adjust-
ing the prostheses themselves. The product’s
use should be self-explaining (e.g. by clues
integrated in the product on how to use it).”
[Adapted from Wisse et al. 2003].
N ot only transtibial amputees will benefit
in such a way. The freed production capac-
ity can then be used to produce above knee
prostheses or orthoses.
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

2.4 Design Objective the comfort of the prosthesis’s fit is the most 2.5 Project Approach
important functional outcome factor, this
It is clear that an easy-to-use, comfort- concept will focus on the development of the This project will consist of three phases,

Approach
able, adjustable and durable prosthesis for socket. that are parallel with the three parts of this
daily use could result in better health care report:
for amputees all over. However, the design Concluding, the aim of this project is to
- Analysis
requirements for a daily usable (definite) uni- design a concept of a universal prosthesis.
This concept will be used to assess if the pro- - Concept design
versal prosthesis are quite high. Much devel-

Users
duction of universal prostheses is feasible. - Feasibility assessment
opment is needed before the definite univer-
sal prosthesis is a reality.
In which the major tasks are:
Development of the universal prosthesis in - Analysing the possible markets and target

Prostheses
groups for a universal prosthesis.
stages (each with increasing design criteria)
(this phase)
is a solution. As becomes clear later in the
report, one possible stage is the universal - Formulating a set of requirements.
(this phase)
prosthesis for use as a temporal prosthesis.
Another possibility is developingthe prosthe- - Designing one or more concepts for (the

Usage
socket of) a universal prosthesis.
sis to be an avanced tool for prosthetists in
(second phase)
developed countries.
- Testing the best concept, preferably by testing
To determine which stages or scenarios are a physical model /mock-up of the socket.

Stragegy
(third phase)
beneficial to the project, this project starts
- Assessing the feasibility of universal prosthe-
with finding out what the possibilities are for ses in general and the concept in particular.
a universal prosthesis (solution -> problem) (third phase)
instead of finding the universal prosthesis as
the answer to a specific problem (problem ->

Criteria
solution).

The first step is to evaluate if the universal

prosthesis is a feasible product at all. Such a
feasibility study is most easily conducted at
the hand of a “proof-of-principle” design. As
suggested by the name, such a design proofs 
the concept of a universal prosthesis. Because
 3 Actors and Users

An analysis of the properties and behav- The prosthesis is only part of the total care
iour of the actors is necessary to determine after an amputation and therefore in litera-
the better part of the design requirements. ture a team approach in rehabilitation of the
The user is the most important actor. In the patient is often mentioned [Seymour 2002,
case of prosthetics, the amount of actors is Chapter 3]. The team approach will be shortly
huge (see figure 3-1). The focus on the project discussed in 3.2.
will be on those actors who deal with the
prosthesis most intensively: the patient, the
prosthetist and the producer.
Amputee Revalidation TEAM
Traditionally, prosthetic designs were mainly
based on medical properties of the patient, Family Physician Nurse
especially the anatomy (of the residual limb)
and biomechanics. Only recently more atten- Support network Therapist Dietician
tion has been given to the production (the
modular design as discussed in section 4.2, is Occupation Social Worker
only developed in 1970 by the U.S. Veterans
Administration). Now, high tech (such as
Designer
microprocessor control of joints) solutions
are sought. [Seymour 2002, p7]. However,
till 2002, innovations for the patient or the
prosthetist, were sparse.

In this chapter the three most important Prosthesis

actors will be introduced: The patient (3.1),
the prosthetist (3.2) and the producer of com- Public Prosthetist
ponents (3.3). This chapter focusses on their
properties. Their actions will be discussed Suppliers Counsellor
Governament
later. Everyday use of the prosthesis by the
patient will be discussed in chapter 5. Most Insurances Eduction Component
use by the prosthetist will be discussed in Producer
chapter 4, together with the fabrication,
 alignment and fit of the prosthesis.
Figure 3-1: The prosthesis and its total context.
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

3.1 The Patient 3.1.1 Anatomy of the

Lower Limb
Prosthetic design, selection and use starts Femur Illium

Approach
with a person who needs an artificial leg. Knowledge of the anatomy of Muscles

Some are born without limb (congenital defi- the lower limb is the basic: it Patella

ciency), others are amputated by trauma or provides insight in which func- Tendons
(Patella T)
disease. In case of the latter, the choice of tions are lost by the amputa-
amputation-level (3.1.2) is the most important Ischium
tion and is a major inspira-

Users
Tibia
for the eventual type of prosthesis and the tion in how to reintroduce
functional outcome of use. Transtibial ampu- them by means of a prosthesis. Fibula
tations are in about 70 percent of the cases Figure 3-2 shows the most men-
Femur
the best solution, resulting in a below-knee tioned bones and tissues. Calf

Prostheses
Muscle
stump -or better – a transtibial residual limb
(3.1.3). Scar

Of course, the primary purpose of a pros-

thesis is to improve the performance of func-

Usage
Patella
tional activities and mobility, including ambu-
lation. Some basic biomechanics of gait and Tubercle
of posture should be known (3.1.4 to 3.1.6).

Stragegy
Special user groups, children and patients
Gatroc-
Tibia
with a reduced activity level, have their own nemius Fibula
design requirements. They are introduced in
Peroneus
section 3.1.7 Tibialis tertius

Criteria
anterior
Tibials
Soleus posterior
Tarsal bones

Metatarsal bones
Figure 3-2: Bones of the lower limb (most right), mus-
cles (middle) and anatomy of the residual Phalanges
limb (below) [Adapted from IMT-Baghdad
and Wisse et al. 2002]. 
 3.1.2 Transtibial Amputations
The term trans is used when an amputation
extends across the axis of a long bone. When
two bones are involved, such as the tibia
and fibula, the primary bone is identified.
Transtibial is the proper term for a below-
the-knee amputation. Amputations between
bones or through a joint are referred to as
disarticulations.
Levels
There are different levels of transtibial ampu-
tations (different types), namely short, stand-
ard and long (figure 3-4). During amputation
in a standard procedure, bone is cut shorter
than skin and muscle, so that the skin and
muscles can be folded over and the wound
can be closed well (figure 3-3).
most proximal to the transtibial are the knee-
disarticulation and the Syme amputation.
The Syme amputation is an ankle disarticula-
tion in which the heel pad is kept for good
weight bearing. See figure 3-4. Transfemoral
(above-the-knee or thigh) amputations will
be mentioned as well, because biomechanics
and solutions for transfemoral prostheses are
often comparable to transtibial amputations.
Requirements: The universal prosthesis
should fit most transtibial amputations, which
implies a residual tibia length of at least 80
mm to 50% of the original length.

S tandard transtibial amputation occurs

when between 20 and 50% of the total tibial
length is preserved. An elective amputation
in the middle third of the tibia, regardless of
measured length provides a well-padded and
biomechanical sufficient lever arm. An ampu-
tation shorter than 80 mm is not advised
because of the resulting small-moment arm,
ill-fitting of the prosthesis and the fact that
it makes knee extensions difficult. Long Figure 3-3: Amputation procedure [Seymour Figure 3-4: Different levels of transtibial amputa-
transtibial amputations result in poor blood 2002]. tion [Seymour 2002].
 supply in the distal leg. The two amputations
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Prevalence Because transtibial is the most common 3.1.3 Residual Limbs

Amputation is a common medical treatment level of amputation, the worldwide amount
of transtibial amputees is quite high. Where possible, the physicians will try to

Approach
all around the world. In most developed coun-
Unfortunately, reliable figures on the amount save the original limb of the patient. However,
tries the amputee point prevalence (amount of
of limbless (without a prosthesis) patients when tissue-saving techniques are no longer
amputees in one thousand residents) is about
aren’t available. However, our research in holding out, the practitioners will decide to
1.55 permillage and leg amputees make up
Sri Lanka shows that from the 40-160K amputate the patients leg. This results in a
about 1.33 permillage of the population (see
amputees (assume 80k) there, only about 10k residual limb, also called residua or stump.

Users
Appendix F for sources).
were provided a prosthesis. At least a million During the operation, the fibula is cut 20 mm
shorter than the tibia, so the calf muscle has
However, worldwide prevalence is much
limbless worldwide is very realistic assump-
tion. enough space to form a good stump. Compare
higher, about 2.44 permillage. figures 3-2 and 3-4.

In all zones, transtibial amputees form about
53% of the total amputees and about 65% of
all leg amputees. Calculations with these fig-
ures result in table 3-1.
Prostheses
Project: The universal prosthesis can be
used to provide European and US amputees
Residual limbs differ from patient to patient,
with an addition to their healthcare program.
not only in dimension, but also in skin condi-
However, to reach full potential, the project
tion, flexibility and strength. [Seymour 2002,
should aim to reach 1 million limbless world-
p38]. All these properties can change over

Usage
wide.
time.
Yearly figures from the UK show that the
percentage of lower limb amputations stay
constant in the next few years. Data from the

Stragegy
National Health Service shows that transtibial
amputations account for about 50% of all
6000 yearly amputations and congenital
deficiencies [UK NHS, 2005]. More figures of
prevalence can be found in Appendix F.

Criteria
Zone Population Transtibial
Amputees
Europe 450 M 370 K
U.S. 250 M 210 K
Worldwide 6,1 G 9,7 M

Table 3-1: Amount of amputees worldwide.
 Development
During the first 4 weeks, the residual limb
will significantly change in shape and prop-
erties, mainly due to tissue-healing. Then, up
to 6 months after the operation, the limb will
shrink to its final size.
Other changes in size may occur after
first 6 months. Some patients experience
changes during use (every day). Also, limbs
will change due to training and body-weight
increase or decrease.
Finally, skin conditions such as tissue
damage, scar-forming, onset of callous spots
and oedema can change the shape of the
skin.
Project: The universal properties of the pros-
thesis can be especially useful direct after
the operation (during the first 6 months).
If the prosthesis can (also) be fine-tuned by
the patient, it can be used to adjust for small
daily shape-changes during day-to-day use
(after 6 months). These adjustments should be
very easy to do (few user actions). Slow, long
term changes (taking weeks/months) (e.g.
patient increases in weight) may be adjusted
for using a tool.
10
Measurement and Shape Requirements: The universal prosthesis
should fit all three basic residual limb shapes.
Measurements of the residual limb can Residual limb lengths of 80 to 250 mm
be taken in many ways. In practice, only should be fitted comfortably. Circumferences
basic measurements are taken, because in around the patellar tendon should be varied
most cases a plaster cast from the residual from 250 to 350 mm.
limb itself is used to shape interfaces of the
limb with prosthetic devices (see chapter 4).
Measurements are important to keep track
of the changes in the stump over time, espe-
cially during the first 6 months.
Common measurements are:
- Length from the tibial tubercle (or from the
middle of the patellar tendon) to the end of
the bone.
- Length from the tibial tubercle (or from the
middle of the patellar tendon) to the end of
the soft tissue.
- Circumferential measurements from 0 mm
(at the tibial tubercle or at the middle of the
patellar tendon) and than at every 40 mm
(downwards).
These circumferential measurements are
also an indication for the shape of the resid-
ual limb (figure 3-5). In appendix G statistics
are presented that show the measurements of
residual limbs in Sri Lanka. These measure-
ments give an indication of in which range
the prosthesis should be adjustable. A range
of 80-250 mm covers most of the amputa- Figure 3-5: Residual limb shapes: conical (a),
tions. cylindrical (b) and bulbous (c).
[Seymour 2002]
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Skin and Tissue Conditions Skin areas where these complications or Requirements: In situations were pressure
or friction on certain areas will cause pain
After the healing of the residual limb, most conditions occur, are often very sensitive to
pressure or friction. These areas should not or further complications, the universal pros-

patients are left with a scar. Also skin con-
ditions may vary. Patient may have several
area’s and combination of the conditions
mentionel in table 3-2:
Other skin complications that can occur are:
be loaded (to much) by the prosthesis.
There are more factors that indicate possible
problems. A low temperature may indicate
arterial insufficiency, abnormal warmth may
Approach
thesis must be able to avoid loading these
areas. The universal prosthesis should allow
or stimulate blood flow in the residual limb.
The socket has to make total contact with the
residual limb to avoid oedema and invagina-

abrasions (areas of skin breakdown), blisters
(mostly caused by friction), contact dermatitis
(inflammation), distal oedema (swelling) and
Users
tion.
indicate infection.
Impaired sensitivity can lead to skin damage Preconditions: The patient has a reasonable
due to the lack of feedback to the patient. On

skin ulcerations.
the other hand, the patient may report phan-
tom pain in stead of pain with a evident phys-
ical cause.
Prostheses
amount of loadable areas. The patient has a
reasonable healthy residual limb. T

code condition explanation If the physician suspects blood flow problems,

Usage
t) tenderness over sensitivity, blood flow tests of the remaining extremity
NL: overgevoeligheid may indicate general health of blood flow.
a) adherence NL: aankleving Patients with blood flow problems cannot be
ignored, because most elderly amputations

Stragegy
i) invagina- to fold in so that an
tion outer becomes an are the result of reduced blood flow in the
inner surface, extremities (often due to diabetics).
NL: kloofvorming
“By the year 2005, the five countries with
c) callus a thickening of or a the highest incedence of diabetes will be

Criteria
hard thickened area India, China, the United States, Pakistan and
on skin, NL: eelt
Indonesia.” [ACA 2001, p79]
d) discolora- reduction of health
tion skincolor, NL: verk-
leuring
(nh) nonheal- NL: niet helend
ing
11
Table 3-2: Skin conditions.
 Areas of Weight Bearing and Areas of Requirements: The universal prosthesis
should offer areas of pressure and areas of
Relief
relief according to the anatomy of the resid-
The tissue in the residual limb is more or less ual limb. In any case, load should be trans-
suitable for transferring load in certain areas. ferred to the patellar tendon.
The loadable areas can be seen in figure 3-6 . Preconditions: The patellar tendon, tissue
medial and lateral to the tibial crest, and
Areas of weight bearing include: tissue on the posterior is loadable.
- Patellar tendon
- Flare of the medial tibial condyle and the
anteriomedial aspect of the tibial shaft
- Anteriolateral aspect (pretibial group) of the
residual limb
- Midshaft of the fibula
- Gentle end-bearing if tolerated

Areas of relief include:

- Anterior and lateral edges of the lateral tibial
condyle
- Head and distal end of the fibula
- Crest and tubercle of the tibia
- Anterior distal end of the tibia

In general, relief areas include bony promi-

nences, areas of poor blood supply, or areas
that are near prominent nerves such as the
common peroneal nerve.

Figure 3-6: Pressure tolerant and sensitive areas. Most left: A scematic of sensitive (light red)
and tolerant (dark red) areas [Seymour 2002]. 4 Right: anterior, lateral, anterior
and medial view of a positive (cast), with pressure sensitive (red) and tolerant areas
(blue).
12
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

R ange of Motion 3.1.4 Patients Posture and Principles Static alignment is the alignment of the
The knee joint should allow enough move- for Alignment socket and foot. The physician uses a plumb
line from the centre of the posterior wall of

ment to properly use the prosthesis (range
of motion or ROM). Additionally, the patient
needs at least the strength to move the pros-
thesis. Before fitting a prosthesis, the knee is
normally tested for:
Posture is the alignment of the body seg-
ments in space. To maintain upright posture
(to stand), the body must counteract the
effects of gravity or other forces acting on
it. This involves muscles, ligaments, capsules
Approach
the socket to a location about 10 mm lat-
eral to the centre of the heel. This alignment
maintains a fairly normal base of support
and loads the more-pressure-tolerant areas
on the medial residual limb rather than the

- Anterior and posterior drawer
- Medial and lateral (valgus and varus) stability
- Crepitus (a peculiar crackling, crinkly, or grat-
ing feeling or sound under the skin or in the
and other soft tissue, bone and the nervous
system.
In the case of an amputee wearing a pros-
Users
fibular head region. In the sagittal plane, a
plumb line should fall from the centre of the
lateral wall of the socket to just anterior to
the front edge of the heel (figure 3-8).

joints)
- Recurvatum (hyper extension of the knee)
Preconditions: The range of motion of the
patient allows walking with conventional
prosthesis.
Prostheses
thesis that weighs less than the original limb,
the centre of gravity will shift proximally and
away from the prosthesis. The amputee may
lean the trunk towards the uninvolved side to
compensate. For the best stability the line of

Usage
gravity should pass through the base of the
support (see figure 3-7).
Requirements: The prosthesis should not be

Stragegy
too light (<0.5 kg). Distal weight has more
inpact on the energy consumption and expe-
rienced comfort.
center of
gravity Prosthetic alignment is the position of a

Figure 3-7: Base of support. The size of the base
of support varies with a change in
foot position. [Seymour 2002]
Criteria
prosthetic socket in relation to foot and
knee. Alignment is performed in two phases,
a bench or static alignment based on estab-
lished guidelines and a dynamic alignment
based on the patient’s gait patterns to fine- Figure 3-8: Static alignment for a transtibial pros-
tune the device to achieve an optimal gait thesis.
A) In the frontal plane,
pattern.
B) In the sagittal plane. 13
[Seymour 2002]
 Static alignment of the transtibial socket Subjects seem to find a PTB socket omst Gravitational Force
usually includes 5 to 10 degrees of flexion of comfortable with a PTB-bar at 4 mm depth of Body-Weight
the socket. A residual limb in a socket with [kim 2003]. Furhtermore, according to Besser
vertical walls would easily slide up and down. [1992] 45% of the total body weight can be
Also, flexion allows greater exposure of the carried by the Patellar Tendon.
patellar tendon for weight bearing (figure 3-9
and figure 3-10).
Requirements: Alignment of the prosthesis
should allow more load to the medial resid-
ual limb rather than the fibular head region.
Alignment allows 5 to 10 degrees of flexion of
the knee (and the socket).The patellar tendon
should be loaded most.

A well dynamic aligned prosthesis will not

rotate while standing, due to the equilib-
rium between the ground forces and the
forces from the residual limb on the prosthe-
sis. However, during gait the forces are not
along the same line and the fit of the socket
becomes crucial to resist the rotation during
gait.

Figure 3-9: Inclination of the bulge of the PTB
(see section 4.2) socket. The bulge
provides more surface for weight
bearing than the wall of the socket.
Note the relatively longer horizontal
component of the vector. [Seymour
14 2002]
Figure 3-10: Forces on the patellar tendon
increase because of the need to
compensate moments due to distance
a and b and because the inclination of
the force factor on the patellar tendon
[Wisse et al .2002]
14
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Also, the line of gravity of the prosthetic

limb should run near or through the (knee)
joint, because otherwise the body must com-

Approach
pensate the resulting moments with muscle
activity. This is mostly achieved by linear
alignment. Figures 3-11 to 3-14 show linear
alignment (in contrast to angular alignment)
problems and their resulting forces.

Users
Requirements. Rotational alignment of the
prosthesis should result in a minimum of
rotational forces while standing, while pro-

Prostheses
viding enough rotational support during gait.
The line of gravity of the prosthetic limb
should run through the knee joint. This might
imply the need for linear alignment.

Usage
Figure 3-11: Alignment of the transtibial pros-
thesis in the sagittal plane, placing

the foot medial to the socket. This
placement tends to cause a rota-
tion of the socket that then places
pressure on the proximal medial
and distal lateral residual limb.
Stragegy
Figure 3-13: Alignment in the frontal plane.
Left: normal. Right: Foot placed to
far backward, causing pressure on

[Seymour 2002]
Figure 3-12: Alignment in the sagittal plane
placing the foot lateral to the
socket, resulting in pressure on
the fibular head and distal medial
residual limb. [Seymour 2002]
Criteria
the distal anterior part and proxi-
mal posterior part of the limb.
Figure 3-14: Alignment in the frontal plane.
Left: normal. Right: Foot placed to
far forward. If the force though the
spocket fell posterior to the ground
reaction force vector, the prosthesis
15
would tend to rotate.
 3.1.5 Basic Biomechanics of Gait
Terms
For an explanation of the terms used to
describe the type of motion, rotary motions
(such as flexion/extension, abduction/adduc-
tion, etc), the planes in the body (frontal or
coronal, horizontal or transverse and sagittal)
and biomechanical concepts (such as axes
of joint motion, instant axis of rotation, kin-
ematic chain, degrees of freedom), etc, I refer
to standard reference books and figure 3-15.
16 Figure 3-15: Planes of the body. [Seymour 2002]
Gait or ambulation can be defined as the
translation of the body from one point to
another by way of bipedal motion (NL: gang,
pas, loop). In both walking and running there
is a rhythmic displacement of body parts that
maintains the person in constant forward
progression.
Normal gait is not easily defined. Therefore, Figure 3-16: Distance variables of giat. a) left step
literature sometimes speaks of accept-
length, b) left stride length, c) right
able gait. From a mechanical perspective, it
stride length, d) right step length, e)
would seem logical to take energy efficiency width of base support f) Right toe-out,
and force transmission as main criteria, but g) left toe-out [Seymour 2002]
in practise a naturally looking gait is most
important. Overall the amputee should
exhibit even step length, step timing and arm
swing. Walking speed is less important (also
see section 5.5).
Requirements: The prosthesis should allow
acceptable gait.
Period Phase Description
Stance Initial contact When the foot hits the ground
Loading Until the opposite foot leaves the ground
Midstance Until the body is over and just ahead of the support
Terminal stance To toe-off
Preswing Just after heel-off to toe-off
Swing Initial swing Until maximum knee flexion occurs
Midswing Until the tibia is vertical
Terminal swing Until initial contact
Table 3-3. Phases in gait. [Seymour 2002]
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Gait can be described from both a kinematic

and kinetic standpoint.

Approach
Kinematics
Kinematics is the classification and compari-
son of motions. In gait, the feet are moved in

Users
different phases (table 3-3).

In figure 3-16 the different distance vari-

ables, occurring during the gait phases, can

Prostheses
be seen.

To provide adequate weight acceptance, initial

contact
loading
response
mid-
stance
terminal
stance
prewsing initial
swing
mid-
swing
terminal
swing
single-limb support and limb advancement,
% of gait 0-2 0-10 10-30 30-50 50-60 60-73 73-87 87-100
the hip, knee, ankle and subtalar joints need cylce

Usage
to flex and rotate. Their range of motion rocker Heel Ankle Ankle Forefoot
(excursions) accompanying the phases of gait phase rocker rocker rocker rocker
can be found in table 3-4. knee extension; flexion; flexion to extension extension gravity gravity gravity
moment valgus valgus extension to flexion extend- linear flexing;
Apart from joint mobility other factors can ing; distract- decelera-

Stragegy
accelra- ing tion
affect normal gait. Among these are age, tion
strength, cardiovascular status, habit, cloth- knee 0 0-15 15-5 5-0 0-30 to 60 to 30 0
ing, psychological status (including fear of angle flexion flexion flexion flexion flexion flexion
falling) and factors that affect the location of ankle plantar- plantar- plantar- dorsiflex- dorsiflex- gravity gravity gravity

Criteria
the centre of gravity (COG) of the total body. moment flexion; flexion; flexion ion ion plantar- plantar- plantar-
valgus valgus todiorsi- flexing flexing flexing
Preconditions: The joint excursions during flexion
normal gait are the minimum required range ankle neutral 0-15 15 0-5 0-20 10 neutral neutral
angle plantar- planter- dorsiflex- planter- plantar-
of motion that is also needed for proper gait
flexion flexion to ion flexion flexion
with the prosthesis. 10 dorsi-
flexion

Table 3-4: Phases of the gait cycle of the right leg. [Adjusted from Seymour 2002] 17
 Kinetics
Kinetics is the branch of mechanics that
is concerned with the forces that cause
motions. The primary external forces acting
on the body in normal gait are gravity and
the ground reaction force. Muscles function
to counteract these forces and to accomplish
the forward progression of the body.
During gait the COG moves side-to-side.
Placing the feet further apart, thus creating
a wider base of support increases stability,
but results in an increase in the side-to-side
excursion of the COG and thus an increase in
energy cost.
knee passively extends with relaxation of the
knee flexors.
Requirements: The prosthesis should allow
enough stability with a lateral feet placement
which resembles normal gait.
Requirements: The energy-cost of use of the
universal prosthesis should be comparable to
current prostheses. The ankle-foot complex
should decrease the vertical excursion of the
centre of gravity. The prosthesis should be
light.
Requirements: During swing, the toes may
not hit the ground.

The ankle/foot complex plays a very impor-

tant role in limiting the vertical excursion of
the COG. A greater excursion will increase
the energy required for gait.

At initial contact (see table 3-3), the critical

event for normal gait is that the heel should
contact the floor first. Once the foot hits the
ground, loading response occurs. In this
phase knee flexion and plantarflexion occur
for shock absorption. Hereafter, stability is
of utmost importance. Especially during ter-
minal stance, the gastrocsoleus contracts to
stabilize the advancing tibial and to raise the
heel (heel-off phase). During swing the mus-
cles of the anterior compartment prevent the Figure 3-17: Gait deviations to accommodate a long limb. A) Hip hiking, B) Lateral trunk lean, C)
18 toes to drag on the ground. In midswing, the Circumduction, D) Vaulting, E) Excessive hip and knee flexion. [Seymour 2002]

3.1.6 Gait Deviations
Gait deviations are often the result of a ill-
fitted or poorly aligned prosthesis. Other
common and often related causes include:
muscle weakness, deformity (of bone or soft
tissue), impaired control including sensory
loss, pain, fear or anxiety.
Weakness of the residual limb with poor
muscle tone can result in rotation of the soft
tissue and of the prosthesis itself over the
underlying bone. It can also increase pres-
sure.
A common deformity is a leg length differ-
ence. Either the leg consisting of a residual
limb and prosthesis or the other side is to
long. This can be caused by the prosthesis
itself (pylon to long), or by insufficient flexion
in the knee (or in the hip). Whatever the cause,
it is more difficult to clear the ground during
swing. An individual has several options to
accommodate the long limb (Figure 3-17). An
additional option to accommodate is a wide
walking base, but walking this way is very
energy inefficient.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
With impaired sensory control in transtibial Requirements: The length of the universal
prosthesis should be adjustable. The pros-
amputees, the ability to know when the feet
are in contact with the floor and to know thesis must provide enough and direct sen-
Approach
where the joints are in space is lost. A person sory information to the residual limb. The
with an amputation must rely on the sensory prosthesis should be easily trusted (win the
input from the residual limb, a factor that patients confidence), especially during gait.
may affect the individual’s confidence in gait. Pain, especially from to much stress or strain
As a result, the walking speed (cadence) of in the tissues of the residual limb, should be
Users
individuals with amputations is lower than avoided.
normal.
Fear and anxiety are particular pertinent
Prostheses
contributors to gait deviations among those
with amputations. Vaulting may occur if
there is a fear of stubbing the toe of the pros-
thesis during swing. If there is a lack of con-
fidence in the prosthesis, the individual may
Usage
try to get off the limb quickly, resulting in an
uneven step length.
Pain can develop from the stress and strain
Stragegy
of the device on the tissues of the body and
can cause major gait deviations. The natu-
ral response to pain is to try to move away
from it, to take the weight or pressure off the
painful area. For example, an individual with
Criteria
pain of the distal residual limb may bend the
trunk laterally to get more weight of the area.
[Seymour 2002, p109-13]
19
 3.1.7 Special User Groups; children
and patients with a reduced
activity level
There are several special patient groups, that
can benefit from a universal prosthesis.
Project: These special user groups are being
reviewed to see later on if the specific require-
ments they have for the prosthesis can give
the Universal Prosthesis an edge over current
existing systems for these groups
20
Children
Children need a new prosthesis every six
months. The universal prosthesis could
improve their comfort, because changes in
stump size are more often adjusted for. While
the load during stance is lower (lower body
weight) their life-style if often very active
(many loading cycles). Children are very
demanding and impatient users, the prosthe-
sis should be even more easy to use than in
the case of adult patients. The standard range
of sizes the universal prosthesis would be
usable for might not be sufficient. A smaller
version may be needed.
Patients with a Reduced Activity
Level
Inactive, often elder patients are sometimes
bound to their beds. If their prognosis is not
bright, the practitioners might decide not
to make a prosthesis (due to costs). These
people could benefit from the universal pros-
thesis. The load during stance is standard,
but the load cycles and total usage time are
much less.
With these patients, the donning and doff-
ing should be very easy. Also, extra attention
to the blood flow in the residual limb should
be given.
Requirements: Design requirements may
vary for these special target groups.
20

3.2 The Prosthetist and
other Team Members in
a Prosthetic Clinic
Team Approach
Considering
the amputation as an accom-
plished fact, a whole team of experts is
needed to provide optimal rehabilitation of a
patient. The team should include the physi-
cian, prosthetist, orthotist, physical and occu-
pational therapist, vocational rehabilitation
counsellor, social worker, psychologist, rec-
reation therapist, dietician, nurse, the patient
and the patient’s family or support network.
The key to any team is communication. The
patient should be regarded as the team leader
and have clear expectations of the rehabilita-
tion process.
Procedures of a Prosthetic Clinic
The procedures of a prosthetic clinic are out-
lined in figure 3-18. The better the prosthesis
assists several of these procedures, the more
successful it will be.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The Prosthetist Pre-Prescription Examination
In this project, the prosthetist receives spe-
Approach
cial attention, because he or she is the team
member who is most in contact with prosthe-
Prescription
ses. In general, the prosthetist’s function is to
design, fabricate and fit prostheses.
Pre-Fitting Intervention
Knowledge
Users
and Education: To select, fit or
train an individual in the use of a prosthe- Prosthetic Fabrication
sis, a practitioner must posses a basic under-
standing of biomechanical principles, normal
Prostheses
alignment, movement and forces acting on Initial Check-out / Examination
the body or body segment. In addition, an
understanding of normal gait and common
gait deviations is important. Prosthetics is a Prosthetic Training
profession that combines specialized clinical
Usage
and technical skills.
Final Check-out or Examination
Professionals are educated in these subjects
and may be certified as either an orthotist, a
Stragegy
prosthetist, or both. Return to Existing Employment
or
Prosthetist may own their own business as
a sole proprietor or work as an employee in a Vocational Training
hospital, rehabilitation centre, research facil-
Criteria
ity, or private business. or
On the Job Training
Placement
Figure 3-18: Procedures of a prostetic clinic 21
[Adapted from Seymour 2002]
 3.3 Producer of Prostheses
In contrast with e.g. shoe manufacturers,
who sell a complete product direct to the
end-user, the manufacturers of prostheses
sell system components and materials to the
prosthetist, who fabricates the final product
for the patient.
Big producers of prosthetic components
include Össur, Otto-bock and Endolite. A
(more) complete list of producers can be
found in appendix I.
3.3.1 Dutch Industry
Industry figures show a healthy grow in the
Dutch medical equipment industry (Table 3-
5). Also, specific figures about the revenues
show a healthy industry (Table 3-5).
import/export centre [IEEE 1998].
3.3.2 Worldwide Industry
In 1996, the World market for medical
devices was estimated at US$ 94340 Million,
of which 15.5% is within the orthopedic and
prosthetic product sector (= 14717 Million)
[IEE 1998]
Over 90% of the world market for medi-
cal devices and supplies consists of the
regions USA (42%), Europe (28%), Japan and
Australia.
Sells of prosthetic devices in
Netherlands
(Million Euros)
Table 3-6: Market for prostheitc devices in the Netherlands [CBS 2005].
In the Western European market (1996), big
players are France (17%), Germany (32%), Italy
(10%) and The UK (11%). The Netherlands
only make up for 4,7% of the market. In the
European market, the orthopedic and pros-
thetic product category is a bit bigger: 18.5%
[IEE 1998]
Total import to Western European countries
of other artificial body parts than artificial
teeth (dentistry) and orthopedic implants was
worth about 600 million US$.
2001 2002 2003
57 85 80

Industry statistics about the production of The sales of the industry 2000 2002 2003 2004
medical equipment and instruments, ortho- National 100 106 110 112
pedic devices, prosthesis and precision
Foreign 100 102 103 104
instruments. Dutch product price industry
index figures can be found in table 3-6 [CBS Total 100 103 105 106
2005]. The use of resources and
half-fabricates From National 100 103 105 108
The Dutch industry is a relatively big importer Foreign (import) 100 97 93 94
of medical devices: 2015 million US$ in 1996.
Total 100 99 97 99
The Netherlands only imported 30% from the
EU, but this is most likely due to the status Table 3-5: Grow indexes of the sales in the medical equipment industry in the Netherlands [CBS
22
of the Netherlands as a leading European 2005].
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

3.3.3. Component and fitting prices They calculated the following costs (in With an more realistic man/machine hour
Euros): pice of 100 Euros this would lead to the fol-
lowing costs:

Approach
COSTS FACTOR ICEX PTB
The costs for fitting a prosthesis to a user Prosthesists salary 27 39 COSTS FACTOR ICEX PTB
can vary wide and is dependent of many fac- Technicians salary 7 49 Prosthesists salary 125 175
tors such as: Transportation of the 44 88 Technicians salary 42 300

Users
- currency rates, patient Transportation of the 44 88
- place / country, Component costs 1100 300 patient
- hour costs /salary TOTAL 1180 476 Component costs 1100 300
- machnines and tools needed TOTAL 1311 863
However, it has to be noted that they calcu-

Prostheses
- facility needed
- etc, etc lated with an hour price for the technicians And the price-difference is much less.
and the prosthetists of 22 Euros. It is clear
that this calculation is without machine costs,
facilitation costs, etc etc.
To give some indication, the numbers from

Usage
the study by D. Datta et al [2004] are used. The needed times where as follows (min-
They compared the cost, tima and functional utes):
outcome implications for changing from

Stragegy
TIME NEEDED ICEX PTB
PTB to ICEX sockets. These commonly used
socket systems are described in chapter 4. Prosthesists 75 105
Technicians 25 180
TOTAL 100 285

Criteria
23
 4 Transtibial Prostheses

The prosthesis is a device with perhaps the Components come into existence in the fac-
most important function in the total care tory and are assembled into a prosthesis
after an amputation. It restores some of the by the prosthetists. Because of wear and
lost functions of the amputated limb. To do changes in the patients situation, the pros-
so, it will (1) suspend the limb (weight bear- thesis sometimes need to be repaired (4.6).
ing), (2) give the patient stability (balance),
(3) allow an acceptable gait (ambulation), (4)
prevent further deformations of the body
and (5) provide some sociopsychological
support (cosmetics) for the patient. The
choice of prosthetic design is therefore very
dependent on the patient’s rehabilitation
stage and prognosis (section 4.1).

Almost all current prostheses are build-

up from pre-fabricated components and a
custom-made socket (4.2). The fabrication
supplies, in orthopaedics often called mate-
rials, and the components are bought from
prosthetic device manufacturers and assem-
bled by the prosthetist. Generally, compo-
nents (4.3) offered by different manufactur-
ers don’t differ much, because their shape,
function and properties are dictated by
biomechanics(4.4) and the anatomy of their
users. Components and professional care
are not cheap, but social services enable
most Western patients to acquire the right
prosthesis (4.5).

24 24

4.1 Types According to the
Patients Rehabilitation
Stage
There are three types of prostheses (interim,
temporary and definite) each appropriate
for different stages after amputation. These
stages can be determined by the health of
the wound and the dressing that the wound
needs to heal. A clear definition is difficult.
In practise, the period in which a certain
prosthetic type can be used overlaps several
rehabilitation stages. Table 4-1 gives an over-
view.
In
this section descriptions of these pros-
thesic types are given. While many terms
are employed, the designs that are used in
the early stages following amputation (in this
report referred to as interim prostheses) are
very similar in function.
Other terms used for Interim Prosthesis
include (common abbreviations are added in
brackets):
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
-
-
Immediate Postoperative Prosthesis (IPOP)
Early Postoperative Prosthesis (EPOP)
The prosthesis that is used for gait training
is in almost all literature referred to as the
- Immediate postoperative prosthetic fittings temporary prosthesis. Terms which also refer
Approach
-
(IPPF)
Custom Removable IPOP
to temporary prostheses are:
- Universal Prosthesis
- Weight Bearing Rigid Dressing (WRD)
- Prefabricated Prosthesis (PFP)
- Removable Rigid Dressing (RRD)
- Preparatory Prosthesis
- Post Surgical Prosthesis (PSP)
Users
- Removable Protective Socket (RPS) The prosthesis that the patient will use finally
- Protective Prosthesis is called the definite or permanent prosthesis.
- Early Fitting Prosthetic Socket
Prostheses
- Early Ambulatory Prosthesis
- Early Rehabilitation Prosthesis
- Adjustable Postoperative Protective and
Preparatory System (APOPPS) – FLO-Tech.
- Initial Prosthesis
Usage
Start use after sur- Used till (after surgery) Prosthesis type / Compression
Direct 1 months (wounds heal) Soft and semi-rigid dressings
Stragegy
0 to 1 weeks 1 months (incision heals) Rigid dressing interim, partial
load possible
5 to 21 days 3 months (incision and sutures Rigid dressing interim, complete
healed) loading possible
Criteria
10 to 21 days 6 months (residual shape almost Removable Protective interim,
stable) compression needed during use
1 to 3 months 6 months (residual shape stabilizes) Temporary, compression during
night
3 to 6 months Prosthesis wears out Definitive
Table 4-1: An overview of clinical patient stage and applicable prosthesis type. In practise, the choice is
less time dependent, but is determined by the healing rate and activity level of the amputee. 25
 4.1.1 Removable Rigid Dressing - Advantages: Very early load on the residual
limb, while wound inspection is still possible.
There are no commercial packages that offer
RRD a complete solution including a rigid dressing
It offers protection and access. Pre-ambula- and ambulation components.
The removable rigid dressing is a form of a tory training is possible (limited load), An
early start with patient education can be
dressing (also see section 5.1 for prepros-
made.
thetic care), which can be used very soon after
the operation. The problem with rigid dress- Disadvantage: Time consuming to make and
ings is that the wounds cannot be inspected fit and highly skilled personnel needed.
and attended to. A removable setup solves
this problem. The Removable Rigid Dressing
with integrated components for amublation is
called an custom removable IPOP. In contrast
with a conventional IPOP, it can be applied
before the patients’ incisions are closed (and
the sutures healed). Full load on the risidual
limb is not possible till the wound is closed
fully. Removable rigid dressings are always
made by the prosthetist. The procedure
includes making a rigid dressing, cutting it
open along specific lines and applying Velcro
bands (See figure 4-1). The materials needed
are standard and easily available.

Figure 4-1: Fabrication of a RRD and Custom Removable IPOP. Left: 3 spandex socks, pads and an
attachment plate, 3 velcro straps and attachment base plates. Middle: fiberglass cast with
cut lines and base plate attachment points and the result. Inset: anterior and posterior sec-
26 tions of the cast with gel pads. Right: Ambulation is possible, with weightbearing limited to
10-20 kg. [Walsh 2003]
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.1.2 Immediate Post Operative Disadvantage: High skilled personnel needed. These inflatable IPOPs are far less time
Prosthesis - IPOP Wound inspection is difficult. consuming to apply to the patient and are
used in many Dutch revalidation hospitals.
Some companies sell universal IPOPs based

An IPOP (see figure 4-2) is a combination
of a rigid dressing, a pylon and a foot. It was
developed in the late 60s. An IPOP is used
while the residual limb still changes shape
fast, but the incision of the operation is
on air compression. These prostheses exist of
a universal outer socket and insertable air-
cells. An example can be seen in figure 4-3.
Approach
However, the residual limb must be healed
fully, the inflatable IPOP cannot be used
too long and the weight distribution cannot
be controlled. Therefore the inflatable IPOP
cannot be applied to all patients.

Users
healed and the sutures removed.

In the first place, an IPOP can provide the

psychological and physiologic benefits attrib-

Prostheses
uted to walking soon after the amputation.
The early use of an IPOP is attributed many
other advantages to the patient (although
not by all researchers), but (because fabri-
cation is time consuming and not easy), the

Usage
IPOP is little used. IPOPs are made by the
prosthetists in the hospital. While the orig-
inal design is based on a plaster cast (rigid
dressing), a fibreglass cast can also be used

Stragegy
to reduce weight.
Advantages: Control and shaping of the
residual limb, protection of the surgical site,
improving healing time, maintenance of resid-

Criteria
ual and sound limb and upper body strength,
reduction of contracture development, main-
tenance of cardiovascular status, early return
to balance and ambulation, social and emo-
tional support, shorter hospital stay, shorter
overall recovery time, quicker identifications Figure 4-2: A complete IPOP (without pylon). Figure 4-3: The universal IPOP (Aircast Air-limb)
of the patients functional levels [Seymour [Source: Seattle Rehab Research, US is inflatable to accomodate differ-
2002, p128]. Veteran Affairs] ent stump sizes. [source: ACA 2001, 27
 4.1.3 Removable Protective Flo-tech also provides pre-fabricated protec-
Socket - RPS tive sockets (APPOP-system). Their system
exists of a flexible outer socket which allows
If a (rigid) dressing is no longer needed, gentle reduction of the socket’s overall cir-
but the residual limb still needs to be cumference. The mid-thigh design prevents
formed through compression, a com- knee flexion contractures. The Velcro bands
pression device (see section 5.1) can be help to shape the residual limb (see figure 4-
used in conjuncture with a removable 4).
protective socket. This socket is used
for patients with very easily damaged The Flow-Tech UFOS (Universal Frame Outer
residual limbs. Weight bearing toler- Socket ), also fits over the VCSPS (Variable
ance is gradually build, to enable the Circumference Supra Patellar Preparatory
patient to wear a firm definite prosthe- Socket), together forming a complete pre-
sis later [Seymour 2002, p138]. Over this paratory system to fit 80% of the transtibial
custom-fitted device a Universal Frame amputations. [Source: flow-tech brochures]
Outer Socket (UFOS) can be put to enable Disadvantage: Many sizes needed, expensive.
weight bearing (See figure 4-4).
Advantages: The residual limb is well
protected to additional trauma. The pres-
Figure 4-4: The Flow-tech Adjustable Postoperative sure and weight bearing tolerance of the
Protective and Preparatory System (APPOPS) provides a residual limb is gradually improved. The
prefabricated prosthetic system offering protection, con- socket and the Universal Frame Outer
trolled shaping of the residuum and early rehabilitation. Socket can be easily adjusted to accom-
The TOR (top left) is a prefabricated socket (available in modate each patient. Easy access for
22 sizes) that fits over elastic wrapping and bandages. hygiene.
The socket prevents knee contraction and provides pro-
tection for the residual limb. When fitted with a UFOS Disadvantage: Sockets custom made,
(universal frame outer socket, middle) it functions as an expensive.
interim prosthesis (top right). Full load and knee flexion
becomes possible with the VCSPS (bottom). Fitted with a
UFOS the VCSPS (available in 34 sizes) can be used as a
temporary prosthesis. [Source: Flow-tech Brochures]

28

4.1.4 Temporary Prosthesis
The temporary prosthesis is a socket, pylon
and foot system which is used when the
patient wounds are fully healed, while the
residual limb still changes its shape fast and
the socket needs to be replaced several times
as the volume of the residual limb stabilizes.
The temporary prosthesis came into exist-
ence in the 1970s, together with the develop-
ment of the endoskeletal design (See section
4.2), which made the use of adjustable align-
ment components possible. It provides the
same functions as a definite prosthesis, but
the alignment can be adjusted more easily by
the prosthetist to improve the patient’s gait.
The patient can use the temporary prosthesis
at home. However, in most cases the tempo-
rary prosthesis is not yet fitted with an opti-
mal foot and additions such as a rotator or
shock-absorber (see section 4.3.5). Also, aes-
thetically the prosthesis is not finished yet
(e.g. no cosmetic cover) and the temporary
prosthesis could be heavier than a definite.
Advantages: Better control over the align-
ment for the prosthetists, the socket needs to
be fabricated several times.
Disadvantage: The system might be heavier,
not all components can be fitted, the prosthe-
sis lacks cosmetics.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The preparatory socket is normally created Some systems are said to be usable as
by using a plaster mould of the residual limb interim and temporary prosthesis, such as
as a template ( just as with definite prostheses, the Maramed components (figure 4-5).
Approach
compare figure 4-8). The other components,
such as the pylon and the foot, are stand-
ard available. In most cases, a SACH foot is
used (see section 4.3.3). The connective com-
ponents, such as the interface between the
Users
socket and the pylon, can be easily rotated.
The alignment of the prosthesis is deter-
mined by the angle between the socket, pylon
and foot.
Prostheses
Most companies offer a wide range of
temporary components, because after the
dynamic gait training the temporary parts
will be replaced by definite components (of
Usage
the same company). Also, many definite com-
ponents can be adjusted quick enough to be
suitable for a temporary prosthesis, such as
the connective devices from Endolite (see
Stragegy
figure 4-4 and section 4.3.5).
Criteria
Figure 4-6: Components of Maramed orho-
pedic Systems. Left: X-tender
system can be used as a temporary
prosthesis(middle). At the right a
Figure 4-5: Connective part between socket and retainer is shown, in which a custum-
pylon, which can be used in tempo- made socket can be attached. [Source:
rary and definite prostheses. [Source: Maramed website]
Endolite brochure] 29
 4.1.5 Definite Prosthesis Normally, a plaster cast is made from the
residual limb, of which in turn a positive cast
The definite prosthesis is the prosthesis that is formed. This cast is then adjusted (see sec-
the patient will use in daily life. In most cases, tion 4.3.1) and the final socket is then fabri-
it highly resembles the temporary prosthesis, cated by either vacuum thermoforming or
now finished with a cosmetic cover or pros- applying epoxy resins (plastic lamination).
thetic skin (see section 4.3.5). The definite (See figure 4-8).
socket is difficult to adjust. When the residual
limb changes in shape or pressure sensitivity,
a new socket is needed.
Advantages: Firm fit and therefore the
best gait and control over the prosthesis.
Cosmetics are pleasing.
Disadvantage: Difficult to adjust.

The definite prosthesis is always fabricated

by the prosthetists. However, there is a wide
range of available materials and production
methods. The choice of these have a great
impact on weight (composites are very light),
adjustability (thermoforming plastics can still
be somewhat adjusted after fabrication by
applying local heat) and comfort. An interest-
ing commercial material is ICEX from Össur
which consists of carbon fibre enhanced
sheets that harden when mixed with water Figure 4-8: Standard fabrication starts with
(see figure 4-7). The ICEX is one of the few taking a negative mold. Then plas-
systems which can be fabricated directly onto ter is poured into the negative mold
the residual limb. to create a positive mold. At last,
the positive mold is shaped by the
prosthetist to emphasis the shape.
The final socket is made by laminat-
30 Figure 4-7: The ICEX toolbox and component box. ing or thermoforming it around the
[Source: Ossur website] positive. [Seymour 2002, p179]

4.2 Structural Designs
There are two solutions for the structural
build-up of a prosthesis: the exoskeletal
design, which is around for a long time and
the endoskeletal or modular design, invented
in 1970 (compare Appendix E). Nowadays,
the endoskeletal design is by far the most
common.
Figure 4-9: The exoskeletal prosthesis (depicting
socket, plastic exterior and foot) is
one, integrated product. [Seymour
2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
4.2.1 Exoskeletal Structure
An exoskeletal structure has a hard outer
Approach
cover made of plastic laminate (figure 4-9).
Socket and pylon are integrated into one
product. Sometimes, the foot is a standard
component, such as in the case of the Jaipur
prosthesis (see figure 4-10), but it can also be
Users
integrated (figure 4-9).
The structure consists of soft foam con-
toured to match the other limb with a hard
Prostheses
laminated shell.
Advantages: High strength, better suited
for occupations that require great durability,
such as farming or construction work. Better
Usage
resistant against dirt. Sometimes also better
heat resistant.
Disadvantages: Alignment and replacement
are difficult. Difficult to fabricate. Flexion,
Stragegy
shock-absorption and rotation is absent in
the rigid prosthesis.
Vision: An integration of the socket and the
pylon, while allowing for adjustability, could
result in a highly durable and resistant pros-
Criteria
thesis.
Figure 4-10: The Jaipur prosthesis, here
drying from paint finish, consists
of a exoskeletal structure with
a separate manufactured foot.
[Source: FINS- Sri Lanka]
31
 4.2.2 Endoskeletal Structure
In an endoskeletal design, a pylon is used to
transfer forces from the residual limb to the
floor. The endoskeletal or modular prosthesis
is build from components. The basic compo-
nents of an endoskeletal prosthesis (figure 4-
11) are the socket (4.3.1), the pylon (4.3.2) and
the terminal device (4.3.3) (almost always
referred to as the foot). Every prostetic design
needs suspension (4.3.4) to stay put when the
leg is lifted. Sometimes additional compo-
nents (4.3.5) are included such as a rotator,
shock-absorbers, a sock or (gel-) liner, a cover
or a prosthetic skin.
Figure 4-11: The endoskeletal prosthesis always
contains a pylon. Very seldom the
other parts are integrated. Normally,
the socket and foot are modular com-
32
ponents. [Seymour 2002]
Advantages: Being adjustable, being light-
weight, this setup is cost efficient when com-
ponents need to be replaced, the (mass-pro-
duced) components are of relatively low costs.
The total system is highly customizable to the
patient’s needs.
Disadvantages: Not so strong, components
may be expensive, custom-made socket
needed.
Vision: The universal prosthesis will be really
successful when the socket and the pylon
can be used together with a wide range of
(already available) feet.
A combination of socket and pylon, while
maintaining the endoskeletal principles is
called a monolithic socket and pylon combi-
nation and may be attached to commercially
available prosthetic feet. One thermoplastic
design is the Endoflex [Valenti, 1991]. See
figure 4-12 for an example without cosmetic
cover. It is suitable for a majority of amputees
and its advantages include increased flex-
ibility, absorption of stress and shear and
reduced cost.
Vision: An integration of the socket and the
pylon, while allowing for adjustability, could Figure 4-12: The 4C Air Lite Monolithic (above 2
result in a highly durable and resistant pros- pictures show manufacturing steps.
thesis. A carbon-fibre sock is one of the
important materials) and the Endoflex
(lower pictures) are two of the few
designs in which the pylon and socket
are integrated. [4C Air-Lite Tech
Manual, Valenti 1991]

4.3 Components
Components for the endoskeletal prosthesis
are widely available. This section offers an
overview.
4.3.1 Basic Components: Socket
The socket is the connection between the
residual limb and the prosthesis. It must not
only protect the residual limb but also trans-
mit the forces associated with standing and
ambulation.
Sockets are generally created by using a
plaster mould of the residual limb as a tem-
plate. Some prosthetic manufacturing facili-
ties use computer-assisted technology to
“map” the residual limb and then manufacture
a socket directly from that data (CAD-CAM
fabrication).
There are primarily two socket designs
used for transtibial amputations, the patellar
tendon bearing (PTB) and the total surface
bearing (TSB). Since the late 50’s, the PTB
socket has been the design of choice for most
traumatic transtibial amputees [VHI 2002].
Project: The definite socket is in practically
every case custom made and therefore the
most challenging part for a complete univer-
sal prosthesis. Therefore this project must
focus on the socket and its effects on the
patient and the prosthetist.
Vision: The universal prosthesis will be really
successful when the interface with the body
is as comfortable as current sockets.
Rigidity
There are different types of hardness for the
socket. Again, there is a multitude of terms in
use and definitions are unclear:
- liner
- soft socket or softsocket
- semi-rigid socket
- Flexible socket
- Hard outer, soft inner socket system
- Hard socket
Figure 4-13: ISNY Components [Source: Website
Otto-Bock]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Traditionally, the socket is constructed as
hard as possible, because this rigid type of
sockets transfer the forces well to the pylon
Approach
and gives control to the patient. However,
since the invention of the liner, a new devel-
opment is the hard outer, soft inner socket
(semi-rigid sockets). These sockets consist
of a shell and a liner that are both formed
Users
to the residual limb. The outer sockets func-
tion is protection of the residual limb and
the transfer of forces. The outer socket sur-
rounds the liner, made of a flexible material
Prostheses
(in most cases Pelite, a poly-ethylene foam).
This socket helps with the better distribu-
tion of forces. The difference between a soft
socket and a conventional liner [see section
4.3.5] is that the liner is a hollow, stretch-
Usage
able, standard tube, while the soft socket is
fabricated to the shape of the residual limb
of the patient. Soft sockets are more often
used for transfemoral amputees than for
Stragegy
transtibial amputees. Also, for transfemoral
amputees there is a system that integrates
hard elements (ISNY concept, figure 4-13 and
4-14) with flexible (polyurethane) parts into
one socket. However, this socket type is only
Criteria
recently developed at Össur [2002] and infor-
mation about development of a transtibial
type is limited [COTA 2002].
Project: Recent developments in softsockets
for transfemoral amputees, seem to suggest
that a flexible socket could be well adapted to
transtibial prosthetics. 33
 Rectification
There are two principles for force distribu-
tions between the residual limb and the pros-
thetic socket. The first, “Rectified” takes in
account which areas and tissues are less sen-
sitive to pressure and the socket puts more
pressure there. The second, “Unrectified” does
not take the difference in tissue in account
and the socket is fabricated such that it dis-
tributes the forces of the residual limb best
distributed as possible (in most cases except
the distal end). Interesting, there is little liter-
ature that compares these two types of pres-
sure distribution. However, recent studies do
suggest that unrectified sockets perform just
as well as rectified sockets. Rectified sock-
ets tend to be evaluated better in less active
situations, while unrectified sockets are more
comfortable during heavy use. [Weeks 2003]
Patellar Tendon Bearing (PTB)
Socket
The PTB socket is the best known rectified
socket design. The PTB socket offers areas
of pressure and areas of relief in accordance
with figure 3-6 from section 3.1.3. As can be
seen, important pressure bearing areas are
the patellar tendon, the medial tibial flare
(next to the tibial crest) and the posterior of
the residual limb. The socket makes contact
with the residual limb even in areas where no
pressure is transferred, including the distal
end, to avoid pockets of oedema.
Requirements: The universal socket should
make contact with all areas of the residual
limb, to avoid pockets of oedema.

O n the other hand, prosthetists at LIVIT

(Den Haag) suggested that unrectified sockets
tend to rotate around the residual limb and
thus offer problems when subjected to tor-
sion. Also, they mentioned that rectification
(while years ago being quite exaggerated) is
Figure 4-14: Flexible ischial-containment practically not so strongly emphasized any-
socket for transfemoral amputees
more in the socket fabrication.
(this one from Otto-Bock, inset
from Hanger) consist of a flexible
inside and a frame. Other names
include Total Flexible Brim, the
ISNY and SFS (Scandinavian
34 Flexible Socket)[Seymour 2002].

Total Surface Bearing (TSB) Socket
The TSB socket design is an unrectified
design, that was developed in the mid 1980’s.
It provides complete contact of the prosthetic
socket to the residual limb with no built-in
pockets for relief of bones and other sensi-
tive tissue. By allowing total surface contact,
all tissue of the residual limb is in contact
with the prosthetic socket, thus reducing the
loading on the medial tibial flare and patel-
lar tendon. When using this type of design it
is usually necessary to use a roll-on type of
liner made of silicone, mineral gel or similar
material. The thickness of these liners is usu-
ally three, six or nine millimetres. This design
is fast becoming the socket design of choice
for traumatic amputees. [VHI 2002]
Requirements: The socket can either transfer
pressure equally or rectified, as long as the
total area over which the pressure is distrib-
uted is optimized.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Plug Fit Socket Hydrostatic Socket
The plug fit prosthesis, mostly used for trans- The Hydrostatic socket is a socket that is
Approach
femoral amputations, was very popular from unrectified, but in stead of determining its
WWI to mid 1950’s, but is seldom used today. shape from the shape of the unloaded resid-
The socket shape is a simple cone (figure 4- ual limb, it is formed around the (hydrostatic)
15). Transtibially, this socket design provided loaded limb. This socket type is very com-
weight bearing at the patellar tendon and fortable while standing, because pressure
Users
was used in conjunction with a thigh lacer for distribution is optimal [SOURCE]. However,
suspension (see section 4.3.4). Additionally by when soft tissue is hydrostatically loaded, it
tightening the thigh lacer additional weight becomes more round shap round shaped.
bearing was transferred to the thigh. The This may cause friction and instability when
Prostheses
distal end of the the prosthesis is subject to rotation or torque.
prosthesis is usu-
ally left open with
no distal wieght
bearing. [VHI
Usage
2002]
Stragegy
Criteria
Figure 4-15: Plug fit socket. The first prosthetic
socket without weight-bearing at the
distal end by Verduin 1696 [Wetz
35
2000]
 The before mentioned ICEX socket (figure 4-7,
figure 4-16) is produced on the residual limb.
It is cast under pressure with a pressure-cast-
ing device. Due to this production method, it
is a hydrostatic socket design. All pressure is
distributed equally, but areas still be relieved
from pressure by applying pressure pads.
Figure 4-16: Icex finished socket (left). Pressure
pads are added to compensate for
weight intolerant areas (cutt-through
36 right) [Source: Ossur Icex brochures.]
4.3.2 Basic Components: Pylon
The pylon is a tube or shell that attaches the
socket to the terminal device. The main func-
tion of the pylon, is to transfer force from the
socket to the ground. Pylons have progressed
from simple static shells to dynamic devices
that allow axial rotation and absorb, store
and release energy.
Because of the high forces involved, most
pylons are made from titanium. For geriatric
purposes (less use and low weight) some-
times aluminium is needed. Plastic pylons
are used in designs meant for the third world,
such as the ICRC-limb (figure 4-17) (polypro-
pylene) and monolithic prostheses (see figure
4-12). In these cases, an addition exoskeletal
can be applied after alignment, to enhance
the durability of the prosthesis.
Figure 4-17: The ICRC-limb makes use of a poly-
propylene pylon.. Its cross-section is
H-shaped.
Also, there are low cost systems with mul-
tiple pylons, however these seem to be only
used in Argentina (about 2000 produced in
1989, see figure 4-18).
New types of pylons are slightly flexible
and
take-over some of the functions of the ankle
(figure 4-19).
Pylons can be orderd in standard sizes
or sawn into the needed length by the
prosthetist.
Figure 4-18: (left) Trimodular Pylon as used in
the sauer-bruck trimodular physi-
ological prosthesis [Angarami 1989]
Figure 4-19: (right) Springlite Advantage DP flex-
ible pylon and dynamic response foot
by Hanger Orthopedic Group. [Source:
website]

4.3.3 Basic Components: Foot/Ankle
System
The foot is the typical form of the terminal
device, but it may take other forms for water
or sports activities, or for use as an interim-
prosthesis. The main function of the foot is
to aid in gait and provide aesthetics.
Better defined the functions of the prosthetic
foot are (1) to provide a stable weight-bearing
surface, (2) to absorb shock, (3) to replace lost
muscle function, (4) to replicate the anatomic
joint, and (5) to restore cosmetic appearance.
The ankle function usually is incorporated
into the terminal device. Separate ankle
joints can be beneficial in heavy-duty indus-
trial work or in sports such as mountain
climbing, swimming, and rowing. However,
the additional weight requires
more energy expenditure and
more limb strength to control
the additional motion.
Figure 4-20: Left: Principle of Rocker foot or sole.
[Adapted from: www.customfootware.
com] Right: Low cost prosthesis with
cane pylon and rocker foot
Because of the biomechanical and anatomi-
cal parallel, designers often speak of the
foot-ankle system. Prosthetic feet are broadly
classified as energy-storing feet and non–
energy-storing feet.
Non-Energy-Storing Feet
Rocker “foot”: The rocker is the most simple
terminal device. It does not try to resemble a
normal foot, but is a stump end, which allows
a very nice ambulation. This terminal device
is most useful in interim prostheses.
SACH foot: Solid Ankle Cushion Heel –
Developed in the 1950s, the SACH foot is the
simplest foot. It mimics ankle plantar flexion,
which allows for a smooth gait. There are no
moving parts, which makes this design very
durable and ideal for children and for individ-
uals whose ambulation is limited to walking
(sedentary patients).
Figure 4-21: SACH foot (Adapted from Seymour
2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The SACH foot designs allow compression
of the foam heel at heel-strike to simulate
planter-flexion. A wooden internal keel pro-
Approach
vides stability in mid-stance and allows for
a relatively easy rollover in late stance. [VHI
2002]
SAFE foot: Solid Ankle Flexible Endoskeleton
Users
– This in 1980s developed foot is more flex-
ible than the SACH foot. This design had an
elastic keel, which enabled a smoother and
easier rollover, which is more preferable than
Prostheses
the rigid keel of the SACH foot. Some disad-
vantages include limited push-off, increased
cost and added weight. [VHI 2002].
Usage
Stragegy
Criteria
Figure 4-22: SAFE II foot. (Original manufacturer
is Campbell Childs Inc, now bought by
4C (Foresee Orthopeadic Products)).
37
 Single-Axis foot: Predating the 1860s, single Multiple-Axis foot: The multiaxial foot adds Simple Energy Storing
axis feet contain an ankle joint that adds pas-
sive plantar flexion and dorsiflexion, which
inversion-eversion and transverse rotation
capabilities to the function of the single-axis
STEN foot: The STored ENergy foot is a
simple energy storing foot that has a keel that
increase stability during stance phase. Single- foot and is often recommended to accommo- compresses in the loading response to mid-
Axis feet pre-date the American Civil War and date uneven terrain. Its weight and mainte- stance of gait, thereby storing energy. The
still are used today on a limited basis. The nance requirements are similar to that of the energy is released in the terminal stance to
main advantage is that the foot will allow for single-axis foot and is a good choice for the the preswing phase of gait. [Seymour 2002]
a quick foot-flat, which increases knee stabil- individual with a minimal-to-moderate activ-
ity in an above-knee prosthetic wearer or in ity level. [VHI 2002]
a below-knee prosthetic wearer who uses a
thigh corset with knee joints in early stance.
This feature is important in the individual
who has knee instability. Disadvantages
include weight, maintenance, abrupt dorsi-
flexion stop, noise and cost. [VHI 2002]

Figure 4-25: STEN foot. [Source: Kinsley

38 Figure 4-23: Single-axis foot. [Seymour 2002] Figure 4-24: Multiple axis foot. [Seymour 2002] Manufacturing Co brochure]
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Dynamic Response:
Dynamic Response (formerly known as

Approach
advanced Energy Storing) feet have a plastic
spring keel that provide a dynamic respon-
siveness during stance. There are numerous
dynamic response feet available, such as the
Carbon Copy, Seattle, Flex-foot, Springlite,etc

Users
(figure 4-26, 4-27). The more aggressive
ambulator can use these designs, including
runners and those participating in recrea-
tional or competitive sports who can load the

forefoot for these activities. Disadvantages
include increased fabrication time and
increased cost for some designs. [VHI 2002]
Hybrid Design feet (figure 4-28) are avail-
Prostheses
Figure 4-26: (Above) Though from the outside
not visible, energy storing feet differ
from the inside [Impulse foot, OHIO
Willow Wood] Various energy-stor-
ing feet. Earch foot is composed of a

Usage
able that combine multiaxial ankle mecha- compressible heel and a flexible keel
nism with dynamic response, such as the spring.
College Park foot/ankle and the Phoenix foot. A) Seattle foot, B) Dynamic foot,
These designs can be used for recreational C) STEN foot, D) SAFE foot,

Stragegy
and competitive sports, as well as for uneven E) Carbon Copy II foot.
terrain. Disadvantages would include mainte- [Hafner et al. 2002]
nance and cost. [VHI 2002]

Criteria
Figure 4-28: Two hybrids: The Seattle Cadence
Figure 4-27: Advanced energy-storing prostheses: HP [Source: Seattle website] and the
A) Modular III, B) Reflex VSP, MICA Genisis II+. [Source: MICA web-
C) Advanced DP, D) Pathfinder. site]
[Hafner et al. 2002] 39
 4.3.4 Basic Components: Suspension
Prostheses can be attached to the residual
limb by a variety of belts, wedges, straps, suc-
tion, or a combination of the above. Designs
include differential pressure suspension sys-
tems, anatomical suspension systems, strap
suspension, thigh corset with mechanical
hinges, Silesian Belt and pelvic joint with belt.
Most important transtibial suspension meth-
ods:
Figure 4-29: (right) Anatomical Suspension. The
supracondylar suspension is in this
case removable due to the brim.
(right, middle) The supracondylar
suprapattelar system is fixed.
40 [Seymour 2002]
1) Supracondylar Cuff – A supracondylar
cuff, affixed to a socket, allows the prosthesis
to hang from the top of the knee (Anatomical
suspension). In Dutch often referred to as the
KBM design.
2) Joint and thigh corset – This suspension
method bears much of the patient’s weight on
the thigh. (corset suspension)
3) Waist belt suspension – In this design,
much of the weight of the prosthesis is dis-
tributed around the waist (corset suspension).
4) Sleeve suspension – An elastic or neo-
prene sleeve is pulled over both the prosthe-
sis and a large area of skin, thereby suspend-
ing the prosthesis by partial suction (suction
suspension).
5) Gel liner with shuttle-lock – One of the
more advanced designs, this pin, incorporated
at the end of the liner, fits into a shuttle-lock-
ing mechanism fabricated into the bottom
of the socket. (suction suspension). The liner
is equipted with a pin or plunger threaded
into the distal end. This pin can lock into the
socket. to remove the prostesis, a button on
the locking mechanism is depressed.
Anatomical Suspension
Anatomical suspension designs (figure 29)
are the second most desirable option for
suspension of the prosthesis. Suspension is
achieved by careful contouring of the socket
walls over and proximal to the femoral epi-
condyles to lock the condyles in place. This
method of suspension is known as supra-
condylar (SC, In Dutch often referred to as
the Kondyl Bettung Munster, KBM) and can
be very effective in suspending the prosthe-
sis and in providing enhanced mediolateral
stability in individuals with a shorter residual
limb.
A variant to this design allows for moulding
of the socket anteriorly above the patella for
added suspension and to control hyperexten-
sion in the shorter residual limb. This design
is known as supracondylar/suprapatellar
(SC/SP), sometimes referred to as the Patellar
Tendon Suspension (PTS). [VHI, 2002]
Advantages: Are increased medial-lateral sta-
bility with the SC and increased anterior-pos-
terior stability with the SP feature.
Disadvantages: include localized pressure
over condyles and restriction of full flexion.

Straps
When it is not feasible to use differential
pressure or anatomical modes of suspen-
sion, a strap (figure 4-30) can be used to sus-
pend the prosthesis. A popular strap, called a
PTB or supracondylar cuff, is attached to the
medial and lateral walls of the prosthesis at
their posterior-proximal juncture and is then
angled proximally over the patella. The lower
border of the cuff touches the superior border
of the patella to achieve suspension. In addi-
tion to the cuff, a waist belt with extension
assist can be attached to the proximal border
of the cuff to increase suspension and to
assist the individual in extending
the prosthesis. [VHI, 2002]
Advantages: This design can
accommodate changes in
volume and is relatively simple
to adjust.
Disadvantages: Include slight
pistoning and belt irritation.
Figure 4-30: The PTB cuff or supracondylar cuff.
[Seymour 2002]
Corsets
The thigh corset (figure 4-31) with mechani-
cal hinges was the design of choice up until
the early 1960’s. [VHI, 2002] Also, a corset
can be worn around the waist.
Nowadays, there are to much disadvantages
in comparison to the other suspension meth-
ods to use corsets for definite prostheses,
but they are still used in conjuncture with a
interim or temporary prosthesis.
Advantages: In using the thigh lacer with
joints include the reduction of weight bearing
on the residual limb and can greatly increase
the medial-lateral stability.
Disadvantages: Include pistoning, added
weight and bulk, difficul-
ties in donning and exces-
sive wear and tear on
clothing.
Figure 4-31: The thigh corset can be used in
conjuncture with a waist belt and an
elastic strap. [Seymour 2002]. The
suspension sleeve has a similar work-
ing principle (left) [Otto Bock].
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Suction Suspension
Suction suspension uses an atmospheric
Approach
pressure (vacuum) or suction to maintain
the prosthesis onto the residuum. Suction
suspension is broken down into 2 categories:
standard suction and silicon suspension suc-
tion. A standard suction is simply a form-fit-
Users
ting rigid or semi-rigid socket into which the
residual limb is fitted. The silicon suction
uses a silicon-based sock, liner or sleeve (also
see section 4.3.5) that slips onto the residual
Prostheses
limb, which is then inserted into the socket.
The silicon helps to form an airtight seal that
stabilizes the prosthesis. [VHI 2002]
Advantages: These designs tend to provide
the amputee with enhanced function, great-
Usage
est range of motion, added sense of security,
greater control of prosthesis and no piston
action when fitted properly. Of all suspension
modes, suction designs tend to be the most
Stragegy
desirable because of the enhanced retention
of the prosthesis to the residual limb created
by the vacuum.
Criteria
41
 S everal suction suspension designs are used
[VHI, 2002]:
1) One design incorporates an overall snug fit
with a valve placed distally into the prosthetic
socket. The skin is in direct contact with the
socket interface. In order to use this type of
suspension, the residual limb has to be stable
with no fluctuations in volume and generally
free of scars that could prevent vacuum from
being achieved
2) Another system includes the use of elas-
tomer sleeves made of silicone, urethane or
mineral gel. (Figure 4-32) These sleeves are
rolled onto the residual and have a distal
pin attachment (plunger) that anchors dis-
tally into the socket locking the prosthesis.
in place. These systems allow
for moderate volume changes by
placing socks of varying plies
on the outside of the sleeve to
achieve a snug fit. Also, applica-
tion for residual limbs that may
have some scarring or grafts is
possible.
Figure 4-32: Pin/Shuttle suspension. [Seymour
42
2002]
3 ) Variants to these methods include the 5) The simplest design of achieving suc-
“hypobaric” design, which has a valve dis- tion suspension could be to use a rubber-
tally in the socket to expel air and a silicone ized sleeve over the outer socket surface and
rubber band (gasket) moulded into standard onto the mid-thigh, thus preventing air from
textile stump liners at the proximal socket. entering into the socket. This design allows
This gasket is positioned slightly distal to for stump socks and/or soft insert to be used.
the socket edge, which creates a seal and
maintains vacuum or suction. This silicone
band is moulded into prosthetic sheaths and
stump socks of varying plies to accommodate
volume changes. Sometimes, to enhance the
seal, a skin lotion is used for a wet fit.
4) Another design allows a mineral gel sleeve
to be rolled onto the residual limb, with a
fabric backing and no distal pin. (Figure 4-
33) Once the sleeve has been placed onto the
residua, the residua is placed into the socket,
where a distal valve expels the air. With all
the air expelled, a second sleeve is placed over
the inner mineral gel sleeve and outer socket,
sealing any air from entering the socket, thus
creating a suction or vacuum. This design
can accommodate some volume changes by
use of a thicker sleeve.
Figure 4-33: Mineral gel sleeve suction suspen-
sion. [www.customprosthetics.com].
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.3.5 Additional Components Rotators and Shock-Absorbing Couplers, Locks, Valves and Grace
Systems Plates
Liners and Socks The All basic components are connected by spe-

Liners (figure 4-34) fit inside prosthetic
sockets and are used to cushion and protect
fragile limbs and to accommodate volume
changes. They can be used to suspend pros-
Torque Absorber (figure 4-35) allows
the leg to rotate with reference to the socket
during stance phase, automatically returning
the leg to the normal position during swing
phase. The torque absorber is excellent in
Approach
cific components. These connective compon-
vents (figure 4-36) often exist of a “male”and
a “female”part, that can be attached in a
range of angles. These angles determine the

theses by rolling them onto a residual limb
to provide suction suspension or they can
have wedges built into them to provide supra-
condylar suspension. They can be made of
activities where rotation is important: golfing,
dancing, bowling, base-ball, standing and
working at a bench for considerable periods
of time. Generally, the shorter the residual
Users
alignment. The connective component that is
integrated with the socket is called the grace
plate.
In case of suction suspension, valves need to

silicone, urethane, and mineral gel, rubbers
and expanded polyethylene foam. The thick-
ness of liners is usually three, six or nine mil-
limetres and this thickness is referred to as a
ply. [VHI 2002]
Prostheses
limb, the greater the loss of natural torsional
capabilities. A torsion absorber would restore be added. Locks are needed for above-knee
the loss of torsion. prostheses.
Shock absorbing pylons allow for telescoping

Usage
of the pylon to absorb shock to the residual
- Stockinet (tubular open ended cotton of nylon
limb that occurs in jumping and running
material)
activities, as well as aggressive walking.
- Sleeves

Stragegy
- Compressors
- Shrinkers (Elastic Wraps or compression sock)
- Socks (not only for the feet!, wool of cotton)
- Liners
- Gel sheath

Criteria
Figure 4-36: Some examples of connective com-
Figure 4-34: Double/Single Socket Gel Liner Figure 4-35: Demountable Torque absorber and ponents [adapted from www.atlas- 43
[Silipos]. its effects. [adapted from endolite] ti.com]
 Covers and Prosthetic Skins 4.3.6 Materials & Tools
Most endoskeletal setups are finished with Plastics, supplies, tools, alignment systems,
a cosmetic cover. This cover usually exists of
they are the resource for the prosthetist
a foam inner part and is finished with a very
(figure 4-38).
flexible “sock”. In very expensive prostheses,
the outer sock can resemble the remain-
ing limb, including hairs, veins, etc. then the
cover is called a prosthetic skin. Some manu-
factures speak of skin coatings. (figure 4-37)

Figure 4-38: Examples of supplies (above): Rivits,

Polyester Resin-Laminae, box of
stockinettes, pneumatic cast cutter,
Figure 4-37: Prosthetic skins can have a high
carbon tape [Fillauer Supplies bro-
life-like appearance [left, dorset and
chure]. Static alignment is done on an
orthopeadic]. Uflate sleeve skin covers
alignment table [otto bock[. Supplies
44 shrinks to fit the prosthesis when
enable prosthetists to make custom
treated with a heat-gun.
liners [otto bock].

4.4 Biomechanics of
Transtibial Prostheses
Now the structure of prostheses and the
used components are discussed, a applica-
tion of biomechanics on the residual-limb-
prosthesis system is useful. From this analy-
ses important criteria and insight why the
endoskeletal structure is so popular can
be derived. Again kinematics and kinetics
are considered (compare sections 3.1.5 and
3.1.6). Both have implications for the selec-
tion, fit, use and design of prosthetic devices.
Generally, kinematic considerations provide
insight into the alignment of the prosthe-
sis, while kinetic considerations will provide
insight in the design requirements.
Kinematics
Orientation of axes of motion: For the total
limb to move in its normal path of motion
(figure 4-39), the axes of the human joint and
the prosthetic orientation must be aligned
similarly. The choice of the type and location
of the axes will affect the movement and sta-
bility of the prosthetic limb. [Seymour 2002,
p78]. For example, a dynamic ankle joint can
improve ambulation on rough terrain, but
reduces the stability of the prosthetic limb.
Requirements: The universal prosthesis
should be normally aligned similar to the
axis of motion of the knee. Enhanced flex-
ibility and additional joints (such as a flexible
pylon) could be applied, but stability is more
important.
Figure 4-39: Pathway of the instant axis of rota-
tion for the knee joint. [Seymour
2002]
Figure 4-40: Limited dorsiflexion at the ankle. If
the ankle can not dorsiflex normally,
either A) the individual will weight
bear on the toe or B) the knee must
hyperextend to get the foot flat on the
ground. [Seymour 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Range of motion: The prosthetic device
should allow normal range of motion in
any plane, which for a transtibial prosthesis
Approach
involves primarily the rotation of the knee
and ankle in the sagittal plane.
However, because of the closed kinematic
chain (the foot stands on the ground), adja-
Users
cent joints are likely to be effected. For
example, when a prosthetic foot is locked in
plantarflexion it will result in an abnormal
knee angle (FIG 4-40). [Seymour 2002, p79].
Prostheses
This is an important observation, because for
example an abnormal knee angle could result
from a problem in the foot/ankle system.
Requirements: The universal prosthetic
Usage
system should include hints when it is aligned
well.
Stragegy
Criteria
45
 Degrees of freedom: If the prosthesis has
a different number of degrees of freedom as
the normal joint, the function of the joint will
be affected. For example, some prosthetic feet,
such as SACH feet, allow plantar- and dorsi-
flexion, but do not allow pronation/supination.
This will affect the interface of the foot with
the ground. Adaptation to uneven terrain is
diminished and forces may be transferred to
the residual limb. [Seymour 2002, p79]
Kinetics
Stress: Stress or pressure considerations
lead to a preference of a large surface to bear
forces. A typical application of this principle
is the use of a total surface-bearing (TSB)
socket [See section 4.3.1]. High pressure on
the tissue of the residual limb could occlude
the vessels, creating ischemia (oxygen short-
age) and tissue damage. Also, nerves are
pressure sensitive, resulting in pain or nerve
damage. [Seymour 2002, p80]
Deformation: Tissues of the residual limb
as well as materials used in prosthetics,
vary in their stiffness (their ability to resist
deformation). In the residual limb, the stiffer
bone bears the brunt of the load, but is also
more pain-sensitive to pressure. These con-
siderations lead to designs such as the patel-
lar tendon bearing (PTB) socket [See section
46 4.3.1] as shown in figure 4-41. All considera-
tions for the size and location of suspensions
should take in account the relationship of
force area, stress toleration and deformation.
[Seymour 2002, p80]. Deformation of the
tissue also occurs while the residual stump
is loaded. Therefore, the shape during load
can be different from the unloaded shape.
Especially in hydrostatic socket, semi-rigid
and softsocket designs this can be a problem.
Under evenly distributed pressure, the soft
tissues tend form a cylinder or cone. If this
happens, the system will find it difficult to
transfer torque (cylinder in cylinder). A solu-
tion is using a somewhat triangular socket.
Requirements: the socket design should con-
sider rotational forces, while the residual limb
Stress
is loaded.
Equal stess Increased stess Relief (pressure) Relief
(pressure) equilized
throughout throughout
A B C D
Decreased stress
Build up Build up
Figure 4-41: Stress on the residual limb from the prosthesis. A) The hypothetical situation in which the
residual limb is of uniform firmness and the socket matches the circular shape of the limb. B)
A residual limb of nonuniform firmness and a socket that matches the circular shape of the
limb. This would result in increased stress on the firm areas of the residual limb. C) The same
residual limb with a socket designed to equalize the pressures over the firm and soft areas.
D) The same socket design used to accommodate pressure-sensitive areas and pressure-toler-
ant areas. [Adapted from Seymour 2002]
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Elasticity: Tissue should not be loaded Area and Problem Effect

beyond the yield point, which would result - foot rotation
in permanent deformity. The same principle too hard

Approach
- execssive knee flexion
applies to materials used in the prosthetic heel cushion
- foot-slap
design. The material characteristics such too soft
- absent or insufficient knee flexion
as yield strength and ductility affect their
usage in the fabrication of prosthetic devices. posterior - early knee flexion (drop-off)
Displacement of the keel
[Seymour 2002, p82] anterior - delayed knee flexion

Users
- excessive knee flexion
The materials used in the components of the dorsiflexion
- early knee flexion (drop-off)
prosthesis may cause or solve gait deviations. Excessive flexion of the pros-
- absent or insufficient knee flexion
They will affect deformation and the energy thetic foot

Prostheses
plantarflexion - delayed knee flexion
deformed of returned, wit a result impact on
gait. In transtibial conventional prosthesis, - circumduction
this principle is mostly used in shock-absorb- medial - excessive lateral thrust of prosthesis
ing feet (compare table 4-2, first row). The - absent or insufficient knee flexion
Excessive placement of the anterior
socket and pylon are generally designed as

Usage
- delayed knee flexion
foot in relation to the socket
stiff as possible. - excessive knee flexion
posterior
- early knee flexion (drop-off)
posterior - delayed knee flexion

Stragegy
Excessive tilt of the socket - early knee flexion (drop-off)
anterior
- excessive knee flexion
- foot rotation
too loosely
Socket fits - pistoning

Criteria
too tightly - reduced knee flexion/exention

Table 4-2: Gait deviations due to materials and the alignment [Seymour 2002]. Note that many align-
ment choices can have the same effect. If the effect is unwanted, all can be adjusted, but
47
some will cause other problems (because one alignment choice will have multiple effects).
 Strain: Some materials exhibit a differ-
ent stress/strain curve for increasing and
decreasing stress, called hysteresis. Materials
which can dissipate a lot of energy, such as
vulcanised rubber, can be used to absorb
energy. These materials will be selected for
either their return energy or absorption of
energy. Important here is that one material
would not work for all individuals, because
the load or stress placed on the material
would be different from, for example a light
individual and a heavy individual. A case in
point would be the firmer heel of a SACH (see
section 4.3.3) prosthetic foot for a heavier
individual. [Seymour 2002, p83]
Tension, compression and torsion forces
play an important part in the design of the
pylon.
Shear forces: The application of a shear or
tangential force can cause shear stress and
strain on weight-bearing surfaces, for exam-
ple, in a poorly fitted prosthetic device. Soft
tissue in general should not be loaded with
shear force. [Seymour 2002, p84]
48
Bending forces: The patellar tendon bear-
ing prosthesis is in principle a three-point
system, resulting in bigger forces than one
would expect purely from the patients weight
(see figure 4-42).
Figure 4-42: Bending forces on the residual limb
while standing. [Wisse et al. 2002]
Viscoelasticity: Viscoelastic materials,
such as the connective tissues of the body,
exhibit some of the characteristics of both
elasticity and viscosity. Viscous substances
have the ability to resist loads that produce
shear. Viscoelastic materials may be used in
prosthetics to reduce shear and pressure, as
can be seen in liners (often containing ure-
thane) (see section 4.3.5). Viscoelastic mate-
rials demonstrate the characteristic of creep,
the increase in strain with time under a con-
stant load. Constant loading, subjects joints,
surrounding structures and the prosthesis
itself to the effects of creep. Deformation of
the residual limb or of the prosthesis will be
the result. [Seymour 2002, p88]
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.5 Financial Issues & 4.5.1 To the Patient In developing countries, the patient will
have to pay for the prosthesis themselves, or
Distribution Most prostheses are reimbursed by in assur- their “social insurance” will be provided by

Of course, the prosthesis and its components
are not fabricated freely. For every prosthetic
design that becomes a success, benefits to the
patient (such as improved comfort), the prac-
ances, but reimbursement rates may vary
widely. Usually an insurance company will
pay for a new prosthesis every 3-5 years or
sooner in cases of ill-fitting caused, for exam-
ple, by weight gain or loss.
Approach
humanitarian aid organisations, such as US-
Aid. Normally, a transtibial prosthesis can be
provided between $60 and $100. $100 seems
to be the “magic border” for the amount most
NGO’s are willing to pay for prosthetic help.

titioner (such as reduced fabrication time), the
producer (higher revenues or bigger market
share) and to governmental institutions such
as assurances (a clear solution with a good
The cost of a prosthesis varies widely depend-
ing on the degree of disability, activity needs
of the wearer, and the types of components
Users
These costs include components, materials,
labour, office visits and adjustments in the
first weeks. However, long-term aftercare is
generally unavailable until the time a patient

prognosis for a fair price) should be out-
weighing the costs.
All transtibial components are part of a com-
plex value chain (figure 4-43).
Prostheses
and materials used. The cost of a transtibial really needs a new prosthesis.
prosthesis ranges from $4,000 to $16,000
Project: The universal could cut back total
[Seymour 2002, p49], including components,
materials, labour, office visits and adjust-
cost, because of the reduced need of office
visits and adjustments.
ments (in the first 90 days).

Usage
Project: In the value chain, the universal In Western countries the assurances will
prosthetic system can be regarded as a spe- reimburse the more cheaper prostheses
cific component. ($4000). The fight for reimbursement of

Stragegy
more expensive components can be difficult
and the improvement in functionality for the
patient should be very clear.

Criteria
Party Raw Materials Components Distributor
Resources producer producer
Product Carbon, Oil Sheets Feet System
example
Company Shell GE Otto-Bock Otto-Bock LIVIT Jan
example Plastics Klaas

Figure 4-43: A Simple model of the value chain of prostheses. Value is increased from left to right. Note
that some companies have multiple roles. 49
 4.5.2 To the Practitioner the patient and how they will develop in time. 4.6 Repair and Life-time
Then they select the most price efficient solu-
The most valuable resource to the prosthetist tion over a longer period. Just as shoes, a prosthesis has a limited life-
is time. He needs this time not only to fit and Project: Even a more expensive universal time. A study done in the United Kingdom
fabricate the prosthesis, but also for meetings prosthesis could in many cases be selected found that on average, a new prosthesis was
with other members of the team and to adjust by the social insurances, because it will still needed every two years.
prosthesis for patients in their rehabilitation. function when the residual limb changes
Project: The universal prosthesis could allow shape. Costs of maintenance and adjustments In some cases, the prosthesis can be repaired.
the prosthetist to cut back costs (time) or to are decreased, especially when the patient In the same UK study, one major repair was
improve his service to the patients. can adjust (some aspects of) the prosthesis needed every 5 years and two minor repairs
himself. were needed per year.
Requirements. The Universal Prosthesis has
4.5.3 To the Producer a lifetime comparable with normal shoes, 1 a
Because of the high requirements to the
2 years.
components (light, durability, etc), they
can be quite expensive. The customer (the
prosthetist) will suggest them to the insur-
ance company or the patient as long as the
benefit to the end user is clear (and that
depends highly on the patients level of activ-
ity).
Project: The producer could improve his
market share, while maintaining his profit-
revenue ratio, especially in the niche for
products between temporary and definite
prosthesis.

4.5.4 To Governmental Institutions

Insurances primarily look for solutions, not
for the final price of the product. That is ,
50
they assess what the functional needs are of
 The Universal Prosthesis
5 Life with a prosthesis - the amputee’s perspective Boudewijn Martin Wisse
TU Delft, 2005

For a succesful design, insight into the expe- Phase Discription See Section
riences of the recently amputated is needed.
From a patient’s perspective, the news that

a leg or arm needs to be amputated can be
shocking and comes with a lot of emotions
and questions. In this chapter an overview
of actions that a (new) amputee has to take
is given.
Approach
The accident In a case of trauma the patient has to deal with the
or the disease accident. Treatment is acute.
In case of disease, such as diabetics (vascular), the
patient has time to prepare for the amputation. He
consults a practisioner and makes the decision
(or hearing the annoucement that he needs) to be

Users
amputed.
Recommended reading: For additional Hospitalization During the period of surgery to provide the patient
information, the First Step guide from the with a clean and useable residual limb.
Amputee Coalition of America is very useful.

[ACA 2001]
The patient will experience a sequence of
happenings as mentioned in table 5.1.
Prostheses
Preprosthetic care Shrinking of the residual limb with compressive wrap- section 5.1
and rehabilitation pings. Physiotherapy to prevent contractures. Fit of a
temporal prosthesis as a training to use and life with a
prosthesis. The residual limb reaches final shape.
Definite prosthesis The choice and fit of the prosthesis is based on the section 5.2
assessed functionality and the amputees life-style.

Usage
All these situations will require sociopsy- Dynamic alignment Further rehabilitation and adjusting the alignment of section 5.3
chological adjustment of the patient and a the prosthesis.
lot of effort to learn how to use the prosthe- Learning (daily Learning to maintain, don, dof and use the prosthesis. section 5.4
sis. However, life is not care-free. Some major

Stragegy
routine).
concerns of users of prostheses are summa-
Rebuilding life Rebuiling his or hers life after a long period of rehabili- section 5.5
rized in section 5.6. tation. Best results with the help of a rehabilitation and
aftercare team .

Criteria
51
 5.1 Preprosthetic care
After the surgery (the incision is healed and
the sutures removed), a patient will need a
compression device to contain residual limb
oedema and to accomodate the shaping of the
residual limb. Learning the patient to apply
the compression device themselves is an
important part of early rehabilitation. Most
patients will need to wear a compression
device during the night indefinitely because
of oedema fluctuations. In the preprosthetic
phase, compression devices should be worn
24 hours a day and reapplied about every 4
hours. Several types of compression devices
are possible such as:
- Elastic wraps (Bandages): Elastic wraps are
strips of elastic fabric, which are wrapped
around the residual limb. 50% of the patients
will be able to wrap the elastic bandages
themselves, but this is a difficult practice.
Wraps are readily available and inexpensive,
they promote a tapered shape to the residual
limb (see figure 5-1).
- Shrinkers: Shrinkers are preformed elastic
“socks”. Shrinkers are easier to use, but are
also more expensive. Because of the difficulty
of applying wraps around the hip, shrinkers
are very often used for transfemoral ampu-
tations. Shrinkers can only be used after
sutures are removed.
- Removable protective socket: This socket is
often used with elastic wraps or shrinkers.
52 The socket is a custom-fitted device made of
thermoplastics. It protects the wound from
traumatic impact, shapes the residual limb
During the first weeks after an amputation,
and adjusts to volume changes in the residual the psychological effect is the most severe.
limb (see also chapter 4.1.2). The patient will become conscious of the con-
sequences of his amputation and the changes
that will become evident in his life. To
emphasize the fact that the patient can stay
highly independent with the use of a pros-
thesis, an interim prosthesis is very useful.
Also rehabilitation will start very soon.
Pysiotherapy will prefend contractures and
muscles need to be used to stay in shape. The
sooner a patient is out of hospitalization, the
cheaper his treatment becomes.
Figure 5-1: Figure-8 wrap for the transtibial
amputation: [Seymour 2002]
A. First wrap max extend from proxi-
mal medial to distal lateral.
B. Second wrap may extend from
proximal lateral to distal medial.
C. Thrid wrap may overlie first wrap.
D. Bandage is looslely wrapped
approximately 60 milimeter to the
knee.
E. Completed wrap.
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

5.2 Selecting the aid Success criteria in clinical decision Considerations for prosthetic type

Having seen the huge amount of available

making Once these basic requirements are met, a
When

prostheses, it is clear that the choice of pros-
thesis is vital to the successrate of prosthetic
use. However, the patient is not aquintanced
with all the available brands and systems. He
will partly have to trust the prosthetist with
the amputation is a fact, the first
decision to make is to fit the patient with a
prosthesis at all, or if his functioning will be
better by providing other solutions (such as
a wheelchair). This is an important decision
Approach
prosthesis can be provided to the patient.
Stability, ease of movement, energy efficiency,
and the appearance of a natural gait are
key elements to achieve with prosthetic use.
Considerations that influence the choice of

his selection of the type of prosthesis. But,
because of differnt finances (the approval of
reimbursement of more expensive prosthe-
ses by social insurances can take months)
Users
made by the prosthetic team in close col- type of prosthesis are:
laboration with the patient and has to take - What is the amputation level?
many factors on account, including available - What is the expected function of the prosthe-
finances. Most important functional require- sis?

patients will have to make some decisions
themselves. The first decision for the patient
is to buy a temporal prosthesis or a definite.
(Temporal can cost more, but can also save
money, because adjustments are easier). The
ments of the patient to fit a prosthesis are
sufficient trunk control, good upper body
strength, static and dynamic balance and
adequate posture. Once these basic require-
ments are met, then
Prostheses
- What is the cognitive function of the patient?
- What is the patient’s vocation (desk job vs.
manual labour)?
- What are the patient’s avocational interests
(e.g., hobbies)?

Usage
second most imporant choice is which type of - What is the cosmetic importance of the pros-
socket and in the third place comes the com- thesis?
ponents, most important being the foot. Most - What are the patient’s financial resources (e.g.,
patients will start with a decent but relatively medical insurance, worker’s compensation)?

Stragegy
simple temporal prosthesis. Later, especially
when the patient’s prosthesis is not perform-
ing to expectations, he will look for other
solutions himself.

Criteria
53
 Factors in outcome of prosthetic use
If the chosen prosthesis is provided, the
patient has, from a functional perspective, a
proper prosthesis. However, there are more
criteria for a successful outcome of prosthetic
use:
- motivation individual
- team approach
- comfortable to wear
- easy to don (put on) and doff (take off)
- lightweight and durable
-
-
cosmetically pleasing
low maintenance requirements
- function mechanically satisfactory
As will become evident in section 5.4, in
many cases, the factors don’t add up, and the
prosthesis is not used properly or not used at
all.
54
5.3 Alignment and
rehabilitation
Now the type of prosthesis is chosen, a tem-
porary prosthesis can be provided to begin
gait training and to determine the right fit
and alignment.
Static alignment (see 3.1.4) is done on fore-
hand and is primary dependent on the
patient’s atonomy and posture.
Dynamic alignment needs to be done in gait.
However, the patient needs to learn how to
walk properly with the prosthesis (e.g. with
enough confidence). His muscles need to
be trained to accommodate for the higher
energy requirements of ambulation with a
prosthesis.
Adjustment of the dynamic alignment and
the patient learning how to ambulate is a
cyclic process and can take months. For the
patient, who’s energy is already used to heal
the wounds of the trauma and the amputa-
tion, the rehabilitation is very tiring. That
constricts the available time per day the
patient can practise. Also, the forming resid-
ual limb is still sensitive and needs to get
used to the high pressures of prosthetic gait
(again constricting practise time). And the
shape of the residual limb is not optimal yet.
For example, oedema could make the residual
limb more round, therefore rotational resist-
ance is reduced, while the alignment and fit
are right in principle. It is the experience of
the prosthetist to determine where the prob-
lem lies (in the prosthesis or in the patient)
and what can be done about it.

5.4 Daily routine: donning,
doffing and gait
After the hospitalization and rehabilitation
period, the patient will go home. His level of
functional ability, will determine the things
he can do with his prosthesis and thus his
“daily routine”. Most actions however, will be
comparable for the majority of patients. In
a way, it is very comparable with wearing
shoes:
- Daily care for the residual limb
- Daily care for the prosthesis
- Donning: inner sockets, liners and socks, then
outer sockets (and components)
- Wearing the prosthesis during activities
(ambulation, work, sitting, etc)
- Changing the prosthesis?
- Doffing: removing the prosthesis
- Applying a compression device (see section
5.1).
Daily care for the residual limb and
the prosthesis
The
wet environment in the sockets com-
bined with socks, inserts, and shrinkers may
cause fungi and bacteria. Proper, daily care
is needed. If there are problems, it might be
necessary to temporarily pause using the
prosthesis. Daily healthcare, such as washing
and drying of the residual limb, the socket
and socks or liners, will prevent most trou-
bles. Shrinkers and socks should be changed
more frequently during the day in humid, hot
weather. If needed, a 2-liter bottle may be
inserted to restore the shape.
The inside of the socket should be cleansed
weekly, washed with warm water and mild
soap and dried thoroughly [Seymour 2002,
p141]. It needs to be inspected daily for cracks
or rough areas.
Amputees don’t need to shave their residual
limb. Shaving can cause ingrown hairs, and
often leads to infected hair follicles.
Requirements: The socket should be wash-
able.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Donning and doffing
It is important that the residual limb and the
Approach
interfaces are clean, before the prosthesis is
donned, because hairs and other small par-
ticles can cause pressure concentration and
become a source of skin problems.
Prosthetic
Users
socks are often worn over the
residual limb, because they add cushioning,
reduce friction and replace lost volume in the
socket due to shrinking of the residual limb.
Prostheses
As the residual limb size changes socks can
be added and removed. Prosthetic socks are
available in various thicknesses often called
ply.
Wearing
Usage
the fewest number of socks to
achieve the desired ply will help reduce
bunching and wrinkling of the socks.
Liners
Stragegy
in most cases are rolled onto the
residual limb, just like a condom is. This
method prevents pre-stretching of skin by
donning and ensures a tight fit between the
liner and the residual limb. Applying a liner
Criteria
can sometimes be difficult. The liner needs to
have the right orientation and the application
of the liner requires some force.
55
 Sockets are donned in different matters,
often dependent on the suspension system
(see section 4.3). In some cases, the amputee
wears only the hard socket and the prosthe-
sis can be shoved right on the residual limb.
In most cases however, users use a donning
sock. A donning sock is a stockinette, without
a end (a long tube). It is protruded through
a hole at the distal end of the prosthesis. By
pulling that sock, the residual limb is pulled
in the prosthesis. In case of an amputee using
a liner with a pin/shuttle lock, or a liner with
suction suspension, the donning sock often
can not be used (of course, there are systems
in which the patient can pull the end of the
donning sock through the valve). Also, the
donning of (hard) sockets can be a problem
with patients with a very bulbous residual
limb shape.
Changing the prosthesis for special
activities
Some special activities, such as shower-
ing and all kind of sportsactivities (biking,
skiing, swimming), require specialized
prostheses, specifically made for that
purpose. An example is the shower-limb
(figure 5-2). In these cases, the requirements
for the prosthetic design differ.
And for some activities the prosthesis is not
needed at all. Many amputees, especially kids,
like to move in-house without their prosthe-
sis (instead using a wheelchair or nothing).
Exercise is the key
The prosthesis is (has to become) part of
everyday life. All successful use of prosthe-
ses starts with the amputee. As Jon Holmes
states it [ACA 2001, p84]: “The most impor-
tant part of the prosthesis is the motor’’. And
the motor is the amputee. Good functionality
and control over the prosthesis is obtained by
daily exercise. Keeping the muscles and joints
in shape and keeping confidence by practic-
ing and using the prosthesis. Use it or lose it!

Shoes are often changeable. Of course, most

persons wearing a prosthesis, also wear
shoes, so that the artificial and the unaf-
fected limb are harmonically clad.

Figure 5-2: LEFT: The endolite Aqualimb with

anto-slip tread patterm on the sole
for extra grip on wet surfaces. [www.
endolite.com].
RIGHT: The rampro activankle swim-
56 ming prosthesis [www.rampro.net].

Ambulation during everday life
A very important factor in functional out-
come and use of the prosthesis is the amount
of energy it takes to use it.
People with amputations tend to walk slower,
to bring the power needed to walk to normal
levels. Since the disabled person, like the
normal subject, tends to choose his most effi-
cient speed of ambulation, it seems appro-
priate to let the subject pick his own speed,
instead of imposing an unnatural speed of
walking for the researcher’s convenience.
[Seymour 2002, p.166]. Some general proper-
ties of ambulation with a prosthesis can be
drawn from the averaging of the results of
studies in which the subjects did choose their
own speed. However, the results given should
be taken as approximations and generaliza-
tions: [Fisher 1978]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
1. The normal person walks 83 m/min and
expends 0.063 kcal/min/kg and 0.000764
Many prosthetist use the thumb rule that
kcal/m/kg. using a unilateral transtibial prosthesis
takes about 50% more energy than normal.
Approach
2. The average transtibial amputee walks 43%
slower, and expends five% less kcal/min and Especially for elderly, this can be very signifi-
89% more kcal/m than the normal person. cant.
3. Normal and disabled persons naturally
Another difficulty can be a limited range
attempt to walk at a speed which is most effi-
cient in terms of Ee /kcal/min. of motion in the joints. This can prevent
Users
4. Disabled persons decrease their speed of the amputee from climbing and descending
walking, so that their Ee /kcal/min decreases stairs, sidewalks, etc. Also, it can slow down
toward the normal range. the amputee when turning.
Prostheses
5. The more disabled a person, the more deter-
minants of gait are lost; therefore, the more Ee
/unit distance is used in ambulating and the
Standing and sitting
Requirement: The prosthesis must enable
less efficient is the gait.
the patient to stand up fully (else it takes a lot
of energy to stand) and to sit (allow enough
Usage
movement and avoid painful brims).
Stragegy
Criteria
57
 5.5 Statistics on functional
outcome and use
Practically, how often and intensive the pros-
thesis is used, is dependent on a lot of factors,
most important being age.
Elderly
Functional outcome of elderly is partly pre-
dictable by age at amputation, one-leg balance
on the unaffected limb and cognitive impair-
ment [Schoppen, 2001]. One study found that
of 50+ US amputates only 44% wore their
prostheses every day [Seymour 2002, p71]. A
Canadian study [Bilodeau et al, 2000] shows
different statistics: over 70% of amputees 60
years or older used their prosthesis every day.
It concludes: “A multiple regression analysis
showed that satisfaction, not possessing a
wheelchair and cognitive integrity explained
46% of the variance in prosthesis use”. It is
safe to conclude that the comfort level of the
prosthesis and its easy of use is a major factor
determining functional outcome.
Young
Younger people are much more forgiv-
ing to the design. A study of 88 children of
transtibial amputation in the Netherlands
found high use rates. 90% of them attended a
regular school. This increased use is a result
of various factors. These include early fitting,
decrease in pain and home and work modifi-
cations. [Seymour 2002]
Project: Comfort of fit and use are the most
important criteria of the prosthesis
5.6 Aftercare and concerns
Amputation results in social losses due to
amputation involve loss of function, loss of
sensation and loss of body image [Seymour
2002, p63]. Successful adaptation to the disa-
bility results in change of behaviour, such as:
- Increased confidence
- Taken charge of life rather than allowing
-
external factors to control one’s life.
Return to work or hobbies,
- Focus on new activities and skills
- Renewal of friendships
- Increased feelings of independence

58
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

The patient himself is responsible for finding

the right support in his neighbourhood, but
the rehabilitation team will help him on his

Approach
way. However, life after an amputation is chal-
lenging. The amount of concerns of patients
show this [Seymour 2002, p70]:
- Health-care access and expense

Users
- Financial concerns
- Coordination of social services benefits
- Disability rights and advocacy
- Lack of knowledge of new prosthetic compo-

Prostheses
nents
- Fit of the prosthetic socket
- Functioning of the prosthesis
- Adaptation to life with the prosthesis
- Lack of available information on new tech-

Usage
nologies
- Accessibility to Commercial Services

Stragegy
Criteria
59
 6 Ethics, Marketing and Design Vision
6.1 Ethics
To determine the design target, apart from
function and practical requirements, a dis-
cussion of ethical implications is needed. It
provides insight in the social requirements of
the product.
The Universal Prosthesis is a healthcare
product. Its benefits for the user are clear.
It is evident that there are also benefits for
the society. How to optimize these bene-
fits? By assessing the positive and negative
impact of the product and building on the
strengths. The following sections discuss
these strengths, especially in the Universal
Prosthesis’s final form, as a worldwide avail-
able product.
6.1.1 A World-wide Smart-tech
product
The Universal Prosthesis is a product that
improves the live of the limbless that it is
provided to. It is clear that a wide distribution
of prostheses is wanted. In developed coun-
tries, the amputees are generally provided
good healthcare. The wealth is available to
improve these person’s welfare and Quality of
Life. However, in developing countries, there
is still a high unattended need for healthcare.
A low-cost universal prosthesis can reach a
60
big group of customers. Future requirements: The Universal prosthe-
sis should consist of few parts. The price of
However, low-cost products generally are the product (in higher production volumes)
quite stigmatizing. Even people in need want should fall in time. The Universal prosthesis
the best. High-end “Western” products are should have a high-tech or modern look.
better accepted. The universal prosthesis
could acquire a good reputation by beginning
as a high-end product for developed areas.
6.1.2 Social-political consequences
Later, it can become cheaper and available
everywhere. In the controlled environment
An important factor to predict the social-
political consequences of a product is to look
of orthopaedic clinics, the design can be per-
to the influence of the production and use of
fected and later translated to a design that is
the product to the distribution of wealth in
better suitable for the “stand alone” distribu-
the society. Will the product contribute to an
tion in developing areas.
egalitarian or an in-egalitarian society?
How can this evolution from high to low-
The Universal Prosthesis is a product that
cost product already be incorporated into
helps the users to better fulfil their daily
the design now? The key is the use of smart-
tasks, needs and functioning. This makes
tech and developing a smart-product. A smart
them more interdependent of their envi-
product is a product, which development is
ronment. There social integration is eased,
dependent on high input levels of knowledge.
improving their social, educational and voca-
Often, also high-end production facilities and
tional chances.
technologies are needed. However, the need
for resources and parts in the final product is
low. Smart products generally consist of high- The differences between the transtibial
amputees and other people become smaller,
end materials. While being expensive at the
start-up, the price of a smart product reduces also there economical differences. We can
say that a prosthesis is a product that advo-
when the investments are turned over, the
product can be produced in higher volumes cates an egalitatian society by its function.
(mass-production) and the price of the used
materials and technologies drop as well.
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Politically, there is a need for high knowl- 6.1.3 A product for the world The second limiting factor is economics.
edge and production technologies to produce There must be enough interest to produce and
the prosthesis. High investments are needed In the long term, the Universal Prosthesis distribute the Universal Prosthesis worldwide.

at the start-up of the implementation process.
The resources for these investments need to
be collected by a small group of people, who
gain power by their possibilities. To accommo-
date such power/money concentrations, an in-
will become available to a wide public. It is
favourable to integrate this development in
the current design.
As seen in chapter two, the distribution and
Approach
Even while in this cases humanitarian NGO’s
and funds, and social insurance play an enor-
mous role, costs will always be an issue.
Demand for the Universal Prosthesis is

egalitarian society is needed. The differences
between the rich and the poor become bigger.
However, the improvement in social function-
ing of the owners of a Universal Prosthesis
Users
use of the Universal Prosthesis is the limiting highly dependent on its comfort level during
factor in the feasibility. Economics comes in use.
the second place.
To combine price, adjustability (to reach new

has a more powerful egalitarian impact on
society. Especially, when the investments are
returned and the prosthesis becomes avail-
able to the masses for a low price.
Important for its distribution is the easy of
use. The product must be understandable for
a wide range of people, from different cul-
tures and languages.
Prostheses
markets) and a high comfort level in one
product, a lot of knowledge is needed. Again,
the smart-tech approach seems to be appro-
priate.

Usage
We can conclude that on the long run, the Requirements: use-cues should be multi-lan-
Universal Prosthesis will advocate an egalitar- guage
ian society. General healthcare will improve.
The effect of the product will be most notice- Another distribution factor is the

able in developing countries.
Stragegy
(in)dependency of the product on the local
infrastructure of resources. For example, it
can be assumed that water and electricity are
available everywhere but helium-gas is not.
The same story goes for dependency on the

Criteria
local infrastructure of knowledge. For exam-
ple, electrical-engineers are not available eve-
rywhere.

61
 6.1.4 Production
To ensure better distribution the Universal
Prosthesis is adjustable. But more is needed.
While designed as a total concept, the
Universal Prosthesis will still have a modu-
lar setup. Especially the foot, because of the
need for different sizes, left-and-right models
and varying requirements will have to be
produced separately. It could be possible to
use existing designs for the feet (produced by
now operating companies), but the feet could
also be locally produced, in accordance with
the local culture and needs.
On the other hand, the socket needs high
input of skills and knowledge. It is better to
produce it centrally.
A good option to combine these different
production places is to offer the product as
an assembly kit. The socket is build centrally
and imported. Locally, (in the country of
distribution) feet and other component are
added to complete the kit. Final assembly can
be done by the user or the local specialist.
This strategy is very similar to current dis-
tribution strategies, where components and
assembly kits are sold to the prosthetists.
62
It is well possible (and probably smart) too
include many locally made parts in the kit,
such as manuals or components. That gives
the local production facility the possibility to
give the product a local character. People and
the local society will feel more involved with
the product.
In the world of tomorrow, environmental
considerations can’t be ignored. In the case
of smart products, when the applied produc-
tion methods are reasonable, the product can
have a low impact on the environment. Smart
products are produced in mass and often effi-
ciency of resources is needed. Also, they exist
of fewer parts.
6.2 Conclusions from the Sri
Lankan test designs
Apart from identifying the lack of
prosthetists as the mean problem in devel-
oping countries, additional lessons where
learned from the design made there and the
tests conducted.
Trials of amputees walking in open-frame
sockets (see appendix D for some designs)
indicate that open-frame sockets can be
used to stand in. During ambulation the test-
models in Sri Lanka buckled within a few
steps.
WATCH THE VIDEO
ON THE CD
Figure 6-1: A movie, in which an amputee
walks several steps in a frame
socket. [Wisse et al. 2002]

These results indicate that open-frame sock-
ets can be used to stand in and might be
developed further, so that even ambulation is
possible.
The open-frame design was never reported
as being comfortable. One problem was the
connection between the back and front part
of the open-frame (usually a leather belt). The
system had to be very precisely dimensioned
and stiff connected; otherwise the amputee
would slip downwards into the prosthesis
(pistoning).
To achieve a comfortable fit (a level of com-
fort comparable to current sockets) as many
areas as possible must assist in weight-bear-
ing and control (up to their maximum pres-
sure tolerance).
This is an important find. If an open-frame
socket can be used to stand in during the fit-
ting procedure, the prosthesis can be fitted
while the residual limb is under load. A total
contact socket can than be formed in respect
to the loaded limb. The resulting unique fit-
ting procedure will result in:
- higher pressures on the interface between the
limb and the open-frame on pressure-tolerant
area’s (see section 3.1.3)
- less tissue deformation during load (prosthe-
sis will be formed to the situation when the
highest pressures find place). This results in
more comfort during stance and probably to a
higher overall comfort.
These intermediate finds strongly suggest
that the universal prosthesis should exist of
a hard open-frame part and an easily deform-
able soft part.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
6.3 Marketing
In chapter four we have seen that current
Approach
prosthetic design vary widely in quality (com-
fort level) and price. The market in developing
countries is completely different than that in
western markets. This results in different cri-
teria, a different maximum price and a differ-
Users
ent value the users will give to the universal
prosthesis.
Because the current state of prosthetics in
Prostheses
developing countries has to be improved (and
the amputees won’t accept else!), compromis-
ing comfort is not an option.
Given the high requirements on comfort
Usage
level, it is challenging to offer the universal
prosthesis for a low price (for a better fit,
more or better adjustable parts are needed).
This leads to a multi-step approach to the
Stragegy
world market. Because each step requires a
new design (optimization), the phases in this
approach are referred to as cycles:
Criteria
63
 - Cycle 0 - The preparatory design trajectory:
In this phase, the feasibility of the universal
prosthesis is shown by developing a proof-of-
principle design (this graduation project) and
testing it with users (continuation).
- Cycle 1- Market exploitation in developed
countries:
A high quality (medium-high costs) design is
made. In this phase, the design is tested on a
broader scale, while production quantities can
stay low. It will be used by many experienced
prosthetists, whose feedback is invaluable.
- Cycle 2 – World market exploitation: ited use of the prosthesis leads to low struc-
A high quality, low coast design is made.
The product can be low in costs because
the product is produced in large quantities
(>10,000 a year). This high volume production
is supported by a well organized distribution
around the world (compare 6.1.4).
64
Each cycle will have a different target group. - Cycles 2: - Standard group”,
“Kids” and “Inactive”. The final design has to
Most users of the universal prosthesis will be combine all the positive sides of the universal
part of these groups: prosthesis. If feasible, multiple versions will
- Cycle 0 – “Standard group”: improve the comfort for the target groups.
Healthy man and women with a unilateral The “UP Kids” can be smaller and the “UP
transtibial amputation. The age group for Senior” can be lighter than the “UP Standard
which the universal prosthesis is designed, edition”.
will be around 20-60, because (anatomical
and statistical) data is used from this age-
group (see appendix G).
- Cycle 1 – “Inactive amputees”:
such as bed-bound people, because the lim-
tural/mechanical demands. In this case, the
universal prosthesis can be designed lighter
(and more easily adjustable if deformation
forces are needed). The quickly fitted prosthe-
sis results in more elders that are fitted.
- Cycle 1 – “Kids”:
The lower body weights leads to low struc-
tural/mechanical demands. Also, because of
the growth of the younger, more frequently
new prostheses have to be fitted. The univer-
sal prosthesis can lead to a higher replace-
ment rate. The design can be smaller, or
issued in multiple sizes.

6.4 Substitute products to alleviate the same problem as the universal
prosthesis does, namely, the lack of experts
and competitive fitting and the difficulty of making new prosthetic
(sockets). They compare as follows:
methods
Most direct competitive products for the Basic procedures:
universal prosthesis are mentioned in chap- Standard: make a negative of the residual limb
with plaster of Paris, make a positive with
ter 4, during the discussion of the different
plaster of Paris, rectify for pressure distribu-
prosthetic types. However, the most distinc-
tion, laminate with fibre and resin.
tive property, the fabrication method, is only
discussed very briefly in section 4.1.5.
Sand-cast: put residual limb in plastic bag, Put
the limb in a container, fill the container with
sand, suck air out of container (negative shape
For the acceptance in developing countries, forms), fill the negative with sand and evacu-
the prosthesis has to be more wanted than ate air (positive sand form), rectify, vacuum
two important substitute products, the wheel-
form or laminate socket.
chair and the cane.
6.4.1 Fabrication and fitting methods
In section 4.1.5 the standard fabrication
method is shown (figure 4-9) and the ICEX-
system is introduced, which is an example of Product Rectification? Expertise level
a pressure-cast method (see 4.3.1). Its fabrica- needed?
tion manual can be found in appendix N. The Standard Yes (PTB) High
sand-cast-method is developed for use in the
Sand-cast Yes (PTB) Medium-High
third world as another pressure-cast method
Water-cast No Low
(fabrication details in appendix O). Finally,
the water-cast-method, currently in develop- Icex No (but pads) Medium-High
ment at orthopaedic centre “de Hoogstraat” Uni. Pros Yes (PTB) Low
in Utrecht and the University of Strathclyde,
is developed with the same target group in
Table 6-1: Several fitting methods and their properties.
mind. These last three, all pressure casts, aim
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Water-cast: wrap residual limb in plaster of Paris,
put limb in pressure-tank, add pressure while
hardening, make a positive with plaster of
Approach
Paris, laminate with fibre and resin.
Icex: Fit liner with silicone pads to protect bones,
prepare Icecast component, calibrate, wrap
limb, shove on residual limb, harden (plaster
of Paris or directly laminated), finish.
Universal prosthesis: For an impression see sec-
Users
tion 6.5.
A scan of the advantages of the systems can
be found in table 6-1. Concluding from it, if
Prostheses
the universal prosthesis can keep its promise,
it will be a good alternative (also see evalua-
tion chapters).
Usage
Stragegy
Tools needed
often vacuum forming
Criteria
Pressure device + air-tight container
Pressure device + water-tight fitting-tank
Icecast compact component
None other than for do-it-yourself (saw,
screwdriver, etc)
65
 6.4.2 Substitute products
The wheelchair and the cane are widely
spread and used in developing countries.
They compare as presented in table 6-2.

The universal prosthesis can alleviate the

problem with the quality of currently pro-
duced prosthetics in developing countries.
It will stay more expensive than a cane, and
100 USD will stay a high amount for a large
part of the world population. The wheelchair
has to be available, especially for people
with other amputations or disorders than a
transtibial amputation.

Product Comfort Availability / support Price

Prosthesis The prosthesis can be very comfortable, but the user has to A comfortable prosthesis is difficult to make. Because of this, ± 100
have a decent residual limb (health and length). Social accepta- properly functioning prostheses are not wide-spread. On the USD
tion is high. other hand, a robust prosthesis can be used in many situations
(city, farmland, etc)
Wheelchair The comfort level of the wheelchair is high, especially for Wheelchairs are easy to manufacture from blue-prints. ± 100
people with difficult amputation levels. Wheelchairs are wide-spread, but use is limited because the USD
user needs flat roads and other adaptations of the environ-
ment. These adaptations are part of normal life in developed
countries, but not so in developing countries.
Cane The comfort level is low during ambulation. The user needs an With a cane most places are accessible. Also, canes are easily ± 10
arm while walking. However, the cane can easily be put away. produced and distributed USD
Social acceptance is low, but some make use of this (beggars).
Universal High-comfort fit made possible without expertise for a select Better distribution ?
Prosthesis group (of medium-active, healthy, transtibial amputees). USD
66
Table 6-2: Several walking and mobility aids and their properties

6.5 Vision of the fitting
procedure and usage
The results in Sri Lanka (section 6.2), com-
bined with the market possibilities from sec-
tion 6.3 and the project and vision remarks
found all over chapter 3 and 4, lead to one
vision about how the prosthesis and its fitting
procedure should be. This vision is hereafter
presented for both cycle 1 and 2 and follows
the life-cycle of the product (design and pro-
duction, distribution, fitting procedure, use
by patient, disposition).
6.5.1 Cycle 1 – for developed
countries
Design and production
- After the feasibility of the concept is proven,
the product has to be developed into a final
design. This development can be conducted
at universities or at one of the big compa-
nies, such as Otto-Bock or Ossur, that can
finance it. A new team, combining industrial
design engineers, technical engineers and
prosthetists optimizes the design. The exist-
ing requirements list (chapter 7) defines the
design target.
- With a small number prostheses clinical
tests are conducted to answer questions as:
“can the universal prosthesis find its way in
current (orthopaedic) practise?” and “what is
long-term functional outcome?”.
- Now, after evaluation and redesign, produc-
tion can be started. The first batch will exist
of 10,000 pieces. The assembly of the pros-
thetic parts is mostly left to the prosthetists.
They buy assembly kits, so that they have
greater influence on the final shape of the
fitted prosthesis. The kits don’t contain
feet, which are easily available through the
common distribution channels.
- The kit contains: a manual for the prosthetist,
a manual for the user, the parts needed for
the prosthesis, additional parts that can
improve the fit for non-standard residual
limbs (such as gel pads), a brochure that
explains the long term project objective.
The main part of the prosthesis, the socket, is
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
easily visible from the outside of the pack-
age. On the box is basic information about
the range in stump shape, circumference and
Approach
length for which the kit is suitable.
Distribution:
- The kits cost about 500 USD.
- The kits are being advertised as an
Users
(cost)effective, customizable, base from which
a prosthetist can (time)efficiently fit a prosthe-
sis.
- The kits are being sold via existing reselling
Prostheses
companies, from two centralized points, one
in the United States and one in Europe.
- The kit is bought in conjuncture with a serv-
ice contract. This service contract will help
the prosthetists with information and will sell
additional parts when needed. The service
Usage
contract will provide the producer of the uni-
versal prosthesis with addition feedback on
usage and functioning.
Stragegy
Use – fit and alignment procedure:
- The kits are easy to lift, they don’t weigh more
that 5 kilograms. The can be easily stored due
to their form.
- The prosthetist opens the kit, when basic
Criteria
information on the residual limb is known,
before the patient arrives, so he has time to
prepare the parts he will need. The socket
can be connected to a fitting pylon/foot if the
prosthetist doesn’t know yet which type of
foot he will use for his client. If he knows, he
can immediately connect the selected foot.
67
 - When the patient arrives, the basic setup
is ready. The patient has to sit and to stand
during the fitting procedure, so a frame or a
walking aid and a chair are needed. The order
of the parts in the box support the procedure
the prosthetist has to follow.
- SITTING: To protect the residual limb of the
client, a sock is donned. The still (de)formable
socket is being donned over it. The prosthetist
adjusts the total limb length by adjusting the
length of the pylon. The socket is provided
in its biggest shape, the prosthetist can by
deforming it, globally adjust the form to the
shape of the residual limb. If needed, gel pads
or gel stickers are attached on the sock over
wounds or extra-sensitive areas.
- STANDING: The patient can stand now. The
hard part of the socket provides weight bear-
ing. The pylon is aligned in such a way, that
the line of gravity is normal on the axis of
rotation of the knee. The feet of the patient
have a natural distance and angle.
- STANDING: The soft part of the socket now
exactly forms itself around the loaded residual
limb. The prosthetist can aid this formation.
When the soft part has the right shape, the
prosthetist starts the hardening phase. The
soft socket now quickly settles, the complete
hardening doesn’t take longer than 10 min-
utes. Meanwhile, the patient is standing in the
prosthesis (with about half its body weight
supported by the prosthesis).
68
- SITTING: The prosthesis now can be doffed.
The fitting sock and gel stickers can be dis-
posed of. A thin liner or sock (as thick as the
fitting sock) can be worn during the use of
the prosthesis.
- AMBULATION: The client walks. The pros-
thesis now behaves as a PTB-prosthesis.
To improve pressure distribution (more
TCB-behaviour), a thick, but viscous liner is
donned. The user himself can choose the most
comfortable combination.
- The fitting procedure is finished. The fitted
pylon and foot are definitely attached to the
socket. The client can take the result home,
together with the manual. Not-used parts,
which might be used later for repairs or when
a new prosthesis is fitted, can be given to the
client or send back to the factory.
Use- daily use by the client:
- PREPERATIONS: The socket has to be clean,
especially on the inside. The user can, depend-
ent on the type of foot that was provided with
the prosthesis, don socks and shoes over the
prosthesis.
- DONNING: The user dons a liner or sock. The
prosthesis is donned over the liner or sock. If
needed, a suspension belt or sleeve is attached.
- AMBULATION: The client now can do his
normal, daily activities. In the beginning, the
patient has to get used to the prosthesis. He
has to gradually increase the daily period of
use.
- DONNING: The prosthesis is donned. It can be
stored everywhere. Socks need to be washed.
- MAINTENANCE: For reparations and main-
tenance, the client visits the prosthetist. The
prosthesis is checked every half a year.
Disposition
- The prosthesis is returned to the prosthetist,
who will provide a new one.
- The prosthetist detaches the foot.
- The prosthetist sends the prosthesis back to
the factory. The factory will check the pros-
thesis on wear and will evaluate the way it
was used.

6.5.2 Cycle 2 – for developing
countries
If the use of the prosthesis is successful in
the developed countries, the transition to the
use for the developing countries can be made.
Design and production
- After the success on the markets in the
developed countries, the product has to
be improved further. The producers of the
prosthesis, in combination with subsidy and
grants, finance the new development. The new
team, again with multi-disciplinary now also
combines members from all around the world.
- With a small amount of prototypes new clini-
cal tests are conducted. Now, the ability of
the prosthesis to function in area’s such as
farmland and the ease of fitting need to be
assessed.
- After redesign and optimization, mass produc-
tion can be started. At least 10,000 pros-
theses a year are fabricated. The prosthesis
will be as much as possible pre-assembled
in the factory. The result will be distributed
in assembly kits, which consist of the socket
parts, pylon and a foot.
- The kit contains: the parts needed for fabri-
cation, a manual for the one who will help
during the fitting procedure (hereafter called
helper), a manual for the user, a fit-sheet with
feet positions printed on it and gel-stickers
and a liner. The final product (after fitting pro-
cedure) is shown on the outside of the box. On
the box is shown for which residual limb sizes
the prosthesis is suitable and the size and side
of the foot that is in the box.
Distribution:
- The kits cost about 100 USD.
- The kits are being advertised as a good, com-
plete and easily fitted prosthesis..
- The kits are being sold in every country from
centralized spots.
- Additional parts are easily available through
the centralized selling points.
Use – fit and alignment procedure:
- The kits are easy to lift; they don’t weigh more
that 5 kilograms. The can be easily stored due
to their form.
- The user is able to fit the prosthesis himself,
but aid is useful. The helper and the user
together open the kit.
- The order of the parts in the box supports the
procedure the users have to follow. The socket,
the pylon and the foot are connected by them.
The user has to sit and to stand during the
fitting procedure, so a frame or a table and a
chair are needed. For the functioning of the
prosthesis, a right alignment of the feet is
required. The user can easily see this on the
fit-sheet, which is placed on the ground and
has an image of to feet printed on it.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
- SITTING: To protect the residual limb of the
client, a sock is donned. The still (de)formable
socket is being donned over it. The helper
Approach
adjusts the total limb length by adjusting the
length of the pylon. The length can be easily
determined by comparing the resulting knee
heights. The socket is provided in its big-
gest shape, the helper can, by deforming it,
globally adjust the form to the shape of the
Users
residual limb. If needed, gel pads or gel stick-
ers are attached on the sock over wounds or
extra-sensitive areas.
- STANDING: The patient can stand now. The
Prostheses
hard part of the socket provides weight bear-
ing. The pylon is aligned in such a way, that
the line of gravity is normal on the axis of
rotation of the knee. The feet of the patient
have a natural distance and angle.
- STANDING: The soft part of the socket
Usage
now exactly forms itself around the loaded
residual limb. The helper can aid this forma-
tion. When the soft part has the right shape,
the helper starts the hardening phase. The
Stragegy
soft socket now quickly settles, the complete
hardening doesn’t take longer than 10 min-
utes. Meanwhile, the user is standing in the
prosthesis (with about half its body weight
supported by the prosthesis).
Criteria
69
 - SITTING: The prosthesis now can be doffed.
The fitting sock and gel stickers can be dis-
posed of. A thin liner or sock (as thick as the
fitting sock) can be worn during the use of
the prosthesis.
- AMBULATION: The amputee walks. The
prosthesis now behaves as a PTB-prosthe-
sis. To improve pressure distribution (more
TCB-behaviour), a thick, but viscous liner is
donned. The user himself can choose the most
comfortable combination.
- The fitting procedure is finished. The user
take the result home, together with the
manual and unused parts, which might be
used later for small repairs.
70
Use - daily use by the client: Disposition
- PREPERATIONS: The socket has to be clean, - The prosthesis can be send or brought back to
especially on the inside. The user can, depend- the factory, who will issue a new kit against a
ent on the type of foot that was provided with slightly reduced price.
the prosthesis, don socks and shoes over the
prosthesis.
- DONNING: The user dons a liner or sock. The
prosthesis is donned over the liner or sock. If
needed, a suspension belt or sleeve is attached.
- AMBULATION: The client now can do his
normal, daily activities. In the beginning, the
patient has to get used to the prosthesis. He
has to gradually increase the daily period of
use.
- DONNING: The prosthesis is donned. It can be
stored everywhere. Socks need to be washed.
- MAINTENANCE: Small reparations and
adjustments can be done by the user himself.
For bigger defects, a new prosthesis has to
be fitted. The manual will advice the user to
replace the prosthesis every year.

7 Design criteria and requirements
In chapter 3 it became clear that transtibial
amputation is the most prevalent level of
amputation. Therefore, the universal prosthe-
ses should be usable by this group. But what
are other requirements? Ten criteria, which
are constantly used while evaluating ideas,
and the total concept can be found in section
7.1.
The requirements (Dutch: eisen) are depend-
ent on the cycle (see section 6.3) in which the
development of the prosthesis is. However,
requirements for a later cycle, are always
goals (Dutch: wensen) for the preceding cycle.
That’s why the requirements can be found per
cycle (section 7.2 to 7.4). Additional goals can
be found in section 7.5.
A good list of requirements only consists of
requirements for the design and doesn’t con-
tain solution on how to meet these require-
ments. In the list of requirements hereafter,
this principle is not used. This project is a
continuation from the internship in Sri Lanka
and the results of that work determine the
global design and project form.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The list of requirements also isn’t complete. 1. Universal
The prosthesis can be fitted to a big group of
The complete set of requirements relates to transtibial amputees.
the complete service that de producer and the
Approach
2. Comfortable
prosthetist offer to the client (of which the The prosthesis is comfortable during use by
prosthesis is a part). That would be a long list. the amputee.
Here is chosen for a shorter, better usable list, 3. Easily fitted
that suits the purpose of this project, namely The prosthesis can be fitted easily to the
to conduct a feasibility study. Areas which amputee by low educated.
Users
won’t be the bottleneck for the feasibility of 4. Controllable
the project are not worked out. The prosthesis provides the control and feed-
back during use.
Prostheses
5. Usable
7.1 Ten Design Criteria The prosthesis can be easily used (espe-
cially donning, doffing and cleaning) by the
Design criteria follow from what the design amputee.
needs to be successful. The design can 6. Safe
comply with the criteria in a higher or lower The prosthesis is safe in respect to health of
Usage
level (score better or worse). In order of the user and of the planet.
importance the 10 criteria are: 7 Affordable
The price of the prosthesis is low.
8 Cosmetics
Stragegy
The cosmetics of the prosthesis are pleasing.
The amputee blends easily into the society.
9 Quickly fitted
The fitting procedure takes little time.
10 Distributable
Criteria
The distribution is easy and the prosthesis
is complete or well compatible with other
systems. The (fitting of the) prosthesis is inde-
pendent on locale infrastructure.
71
 7.2 Requirements for cycle
0: The preparatory
design trajectory
Corresponding sections are given between
brackets ().
Total distribution kit /prosthesis:
- The prosthesis can be donned seated.
- The prosthesis can be doffed seated.
- The prosthesis has roughly the same shape as
the natural leg.
- The fitting procedure takes little time.
- The prosthesis is suitable for at least 70% of
the transtibial amputees (2.3).
- The prosthesis improves the functional activi-
ties and mobility of the user in a similar way
as existing prostheses. Inclusive ambulation
and body posture.
- The prosthesis provides an acceptable gait
(3.1.5).
- Ambulation is possible without the toes
touching or skimming the ground.
- The prosthesis provides enough stability
(during ambulation that resembles normal
gait).
- The prosthesis provides enough perception
and control.
72
The socket:
- The interface with the residual limb can not
- The socket makes total contact with the
residual limb. Every area of the residual limb,
be poisonous or irritate the skin (for P99). inclusive the distal end, has to make contact
with the socket (so no “holes”) (4.3.1)
- The socket is suitable for more than 70% of
the transtibial amputees (2.3). - The pressure-distribution is optimized to
the PTB or the TCB-model or a hybrid/combi-
- The socket is suitable for residual limbs with
lengths of 80 to 250 mm (3.1.2, 3.1.3).
nation of those. (4.3.1)
- The socket is not uncomfortable (2.3), the
- The socket is suitable for residual limbs with
comfort level is comparable with existing
circumferences of 250 to 350 mm (at patellar
prostheses. (4.3.1)
tendon height) (3.1.3).
- The socket does not hurt.
- The socket is suitable for residual limb
shapes that are conical and cylindrical (3.1.3) - The socket does not obstruct normal
movement.
- During the fitting procedure:
- The socket can not have obtruding or
- The socket is formed while the residual
sharp parts as well on the inside as on the
limb is loaded (while the user stands in it):
outside.
- The socket provides weight-bearing at
beginning of the procedure. The unhardened
socket is enough flexible and deformable, so
that the prosthetist can shape it in the shape
of the residual limb.
- The socket loads the pressure-tolerant
areas of the residual limb.
- The socket has to harden so that the
total area can add up to the transfer of loads
between the socket and the residual limb.
The prosthetist has to be able to decide the
moment of the hardening. The hardening
won’t take longer than ten minutes.
- During daily use:
- The sensitive areas of the residual limb
will not be overloaded. Most of the loading is
on the load tolerant areas (3.1.3 – 3.1.5).

Pylon:
- The pylon can be adjusted in length. The total
height of the prosthesis is the same as that of
the opposing leg.
- The pylon can transfer the forces that act
upon it during stance (maximal 700 N) to the
ground without plastic deformation. The total
elastic bending may not be more than 6 mm
at a length of 240 mm and the total elastic
rotation may not be more than 10 degrees,
when the pylon is loaded with a torque of 60
Nm at a length of 240 mm.
- The pylon can be aligned:
- The pylon can be aligned is such a way,
that the medial side transfers more load than
the fibular head region (3.1.4).
- The alignment is done with 5 to 10
degrees flexed knees (3.1.4).
- The complete prosthesis can be aligned
in such a way, that the rotation-forces on the
residual limb while standing are minimal (no
more than current prostheses) (4.4).
- The pylon can be aligned in such a way
that the line of gravity of the body will be
normal to the rotational axis of the knee
during stance.
Foot:
- A “rocker foot” suffices.
Additional parts:
- SUSPENSION: The comfort level has to be
minimally equal to the comfort level of the
currently used “knee-cuff” solution.
- CONNECTIVE COMPONENTS: The connec-
tion between the socket and the pylon can be
rotated. The connection between the pylon
and the socket can be rotated.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
7.3 Criteria for cycle 1:
Market exploitation in
Approach
developed countries
Corresponding sections are given between brack-
ets ().
Users
Total distribution kit /prosthesis:
- The product is optimized for production quan-
tities over 10,000 pieces. (4.1)
- The prosthesis complies with the current
Prostheses
West-European and American industry stand-
ards. (3.3)
- The final price of the distribution kit is maxi-
mal 700 USD. Using the universal prosthesis
will (in general) reduce the costs of the total
Usage
rehabilitation trajectory. (4.5.1-4.5.5)
- The prosthetist assembles the socket, the
pylon and the foot within 2 minutes, so that it
is ready to be fitted.
Stragegy
- The final prosthesis will weight between
2.2 and 3.5 kilograms (3.1.4, 3.1.5) with the
centre of gravity of the prostheses as proxi-
mal as possible.
- The prosthesis will stay functioning properly
at normal use (average usage of the target
Criteria
group) al least one year. (4.6)
- The prosthesis doesn’t attract attention when
worn under a pair of trousers, socks and
shoes (4.1).
- The donning and doffing of the prosthesis
does not take longer than one minute (5.4).
73
 - The prosthesis aids the prosthetist in finding
the right alignment (use-cues). The prosthetist
has to experience the fitting and alignment
procedure as more natural and intuitive than
the procedures of current prostheses (2.3-4.4).
- The prosthesis is suitable for daily use (2.3).
- The energy expenditure of normal use of the
prosthesis is comparable with that of current
prostheses (maximal 30% more) (3.1.5).
The socket:
- The total production cost of the socket is
maximal 500 USD.
- The socket must be easy to clean (5.4).
Pylon:
- The total production cost of the pylon is maxi-
mal 100 USD.
- The pylon can be fitted with a shock-absorp-
tion component or rotator.
Foot:
- REMARK: In this distribution kit, no foot is
supplied. Standard feet designs can be con-
nected to the universal prosthesis.
74
Additional parts:
- SUSPENSION: The included suspension will
keep the prosthesis connected to the residual
limb during swing-phase.
- CONNECTIVE COMPONENTS: The included
connective components provide connection
with popular feet designs. The connection to
the feet stays adjustable (translation and rota-
tion), even when the prosthesis is hardened.
(4.2)
- FITTING SOCK: The supplied fitting sock can
be donned sitting. The fitting sock protects
(the skin of) the residual limb during the fit-
ting procedure.
- PRESSURE-RELIEVING-PARTS (GEL PADS):
These included parts will diminish the pres-
sure on extra sensitive areas of maximal 600
mm2.
- FITTING PYLON – OPTIONAL FOR CYCLE 1:
The fitting pylon is an extra pylon part that
can be attached to make up for the lacking
foot during the fitting procedure.
Packaging and manuals:
- The manual for the prosthetist contains a (tex-
tual) description of the preferred procedures.
- The manual for the user contains information
about donning and doffing, the maintenance
and cleaning of the prosthesis, how the user
can recognize problems and what actions to
take.
- OPTIONAL FOR CYCLE 1: A brochure that
explains the long term project objective.
- On the outside of the distribution box (pack-
aging) is printed for what range of residual
limb sizes and shapes the prostheses is suit-
able. The socket is visible from the outside of
the packaging.
- The total package is easily displaceable by a
single person. It is not bigger than 0,12 M3)
and it has sides shorter than 800 mm. The
package is not heavier than 5 kg.
- The order in which the parts come out of the
package supports the fitting procedure.

Marketing:
- The distribution kit is being advertised as an
(cost)efficient, customizable, base from which
a prosthetist can (time)efficiently fit a prosthe-
sis.
- The kit is bought in together with a service
contract.
7.4 Criteria for cycle
2: World market
exploitation
Corresponding sections are given between brack-
ets ().
Total distribution kit /prosthesis:
- The final selling price of the distribution kit is
maximal 200 USD.
- The total prosthesis will keep functioning sat-
isfactory for two years when normally used.
- The assembly has to be finished as far as pos-
sible in the factory. Pylon and socket are one
part.
- The prosthesis can be worn without shoes
(without attracting negative attention).
- The prosthesis can be fitted by non-experts.
The socket:
- The total production cost of the socket is
maximal 80 USD.
Pylon:
- The total production cost of the pylon is maxi-
mal 30 USD.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Foot:
- The total production cost of the foot is maxi-
mal 30 USD.
Approach
- The foot has a natural appearance.
- The foot is available in left and right.
- The foot is available in several sizes.
- The foot can be fitted with sandals.
Users
Additional parts:
- CONNECTIVE COMPONENTS: The included
Prostheses
connective components provide connection
to the included foot. The connection to the
foot stays adjustable (translation and rotation),
even when the prosthesis is hardened.
- FITTING SOCK: Included.
- SOCKS FOR DAILY USE: Included in 2 thick-
Usage
nesses. The wearing of these socks increases
the pressure in the socket.
- LINER FOR DAILY USE: Included. Wearing of
the liner results in a more evenly distributed
Stragegy
pressure in the socket.
- PRESSURE-RELIEVING-PARTS (GEL PADS):
Included.
- FEET-SHEET AND OTHER ASSISTIVE
DEVICES: Simple products that can improve
Criteria
the ease of aligning (the residual limb in) the
prosthesis.
75
 Packaging and manuals:
- The manuals are internationally interchange-
able. It uses mainly figures / drawings.
- On the package (distribution kit) the final
product and the included foot-size and foot-
side are printed.
Marketing
- The kits are being advertised as a good, com-
plete and easily fitted prosthesis.
7.5 Additional goals
If possible, the following goals can add value to
the solution:
Total prosthesis:
- The prosthesis is adjustable after the fitting
procedure.
- The prosthesis is as light as possible.
- The prosthesis fits into the locale culture.
(Part of the) production is conducted locally.
Local, social involvement is stimulated
- The prosthesis exists of as few as possible
parts (2.3).
- The prosthesis is accepted by the total reha-
bilitation team (3.2)
Foot:
- The included foot is suitable for multiple
weights, multiple foot sizes and for left and
right use (adjustable foot).
Additional parts:
- SOCK: The sock is transparent. The sock is as
thin as possible. The fitting sock and the sock
for daily use are the same.
- SUSPENSION: The suspension is as easy and
comfortable as current suction suspensions.
Marketing:
- In an early stage, a big organization (pro-
ducer), such as Otto-Bock or Ossur is involved.

Socket:
- The socket is transparent (makes evaluation
of the interface between the socket and the
residual limb easier)
- The socket is adjustable during use (adjust-
ments take place several times a year).
- The socket is adjustable during use (adjust-
ments take place multiple times a day).

Pylon:
- The pylon is adjustable during use (adjust-
ments take place several times a year)
- The pylon is an integral part of the socket and
forms an exoskeletal design (4.2).
76

8 Discussion and conclusion of part 1
The analysis indicates that the design an
implementation of the universal prosthesis is
possible, although with some constraints.
A broad range of market options.
In chapter 2 the benefit for users all around
the world, amputees and prosthetists,
becomes clear. The fact that designing a
prosthesis takes time is recognised and the
project is split into phases. These phases are
design cycles and are “a preparatory design
trajectory”, “market exploitation in developed
countries” and “world market exploitation”
(see section 6.3).
The unique selling point of the Universal
Prosthesis is that it is quickly fitted by low-
educated experts. For the amputee, this
means better access to prosthetics and more
often replaced prostheses. On the other hand,
because the shape of the socket has to be
formable, the strength and stiffness of the
Universal Prosthesis could be limited. These
facts combined indicate that the Universal
Prosthesis is especially suitable for two spe-
cific target groups, namely children and elder
(see section 3.1.7 & 6.3). It also is useful as
a temporal prosthesis (3-6 months after
amputation) or a spare one (see section 2.4,
4.1.4). When, by smart design, stiffness and
strength become less a problem, the Universal
Prosthesis can be used for daily activities.
Focus on fitting procedure
Still unclear in the design objective (see sec-
tion 2.4) is if the adjustability of the design
refers only to the fitting procedure or also
to periodically or even daily adjustments.
However, it became clear that comfort and
control acre the main determines for func-
tional outcome (see section 5.5) and these
requirements are met by a socket with a stiff
fit and an appropriate pressure distribution
(see section 3.1). Current solutions for daily
adjustable sockets are few and only improve
comfort significantly for a very select group
of users. Adjustability of the socket during
use therefore is not a requirement for the
Universal Prosthesis to be successful.
The pylon has to stay adjustable. To allow for
dynamic alignment of the pylon/foot after
socket production is an important factor to
improve gait and will make the Universal
Prosthesis easier accepted by current day
prosthetists (see section 3.1.4).
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
A high comfort level can be reached
A high comfort level of the socket can be
Approach
reached best if pressure tolerant areas are
loaded more than pressure intolerant areas
(PTB-principle, section 3.1.3). The bony prom-
inences (figure 3-6) and the distal end are
the areas of relief and the patellar tendon is
Users
very pressure tolerant. The limited variation
in these areas (except in distal end height)
indicated that a standard socket shape is pos-
sible (appendix F, elaborated on in chapter 11
Prostheses
and appendix R).
J. Foort (appendix X) even concludes that
the use of prefabricated Below-knee sock-
ets “taught us that five sizes for each side
Usage
of the body were sufficient to fit all the new
amputees managed in this way and that one
size alone met 50% of the needs”. However,
the use of prefabricated sockets in current
prosthetic practise is not mainstream. The
Stragegy
adjustability of the universal prosthesis could
improve the trust prosthetists have in the fit
of the prefabricated (universal) socket and
increase it use.
Criteria
77
 A vision of the socket design
User tests in Sri Lanka show that weight-
bearing in a frame is possible, but total con-
tact is necessary for comfort. This leads to a
socket system that consists of a hard, weight-
bearing frame and a flexible total contact
part. The form and properties of these are
determined in part 2 of this report: “synthe-
sis”.

78

9 Synthesis - from idea to prosthesis
Having determined the project target and
design requirements, the materialization of
the design can begin.
The base for the new design is the design
made in Sri Lanka. However, because of
changes in the design philosophy (from
cheap production to easy fitting procedure)
and the preferred production method (from
low-budget to mass-production) a review of
the (sub)problems is needed (section 10.1)
and solutions need to be re-evaluated (sec-
tion 10.2). The real synthesis can now take
place; the chosen ideas are integrated into a
final concept (section 10.3).
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The result exits of rigid and flexible parts. The In part 3 (chapter 12, 13 and 14) of this
form of the rigid parts needs to be refined. A report, the universal prosthesis will be
study of the anatomy of the residual limb and evaluated.
Synthesis
the (expected) biomechanical behaviour is
the basis for their shapes (section 11.1). The
(fabrication of the) flexible parts is another
important design step (section 11.2). The con-
nector, connects these parts with the foot
Ideas
(section 11.3). When the shape of the frame
is determined, the prosthesis is ready to be
optimized for daily use (11.4), the fitting pro-
cedure (11.5) and production (11.6).
Concept
Evaluation
Recomm.
Conclusion
79
 10 Ideas
In Sri Lanka it became clear that weight
bearing can be achieved by making an open-
frame based socket (see section 6.2). However,
made from aluminium and basic production
methods, the open frame socket was not
comfortable enough to be used for ambula-
tion (for a prolonged period of time). Another
problem was that the design was not stiff and
strong enough, which resulted in buckling
(during ambulation).
A better fit and pressure distribution as
well as higher stiffness and strength can be
achieved by new form-giving and new mate-
rial choice.
80
10.1 Idea generation
From the criteria and design requirements,
sub-problems follow:
1 Universal (1) How can one socket vary in
length, circumference or shape (the socket
has to be hollow)? (2) How can one pylon/
total prosthesis vary in those properties (the
pylon can be solid)? (5) How to align a load-
able frame or pylon?
2 Comfortable (6) How can one prosthe-
sis make total contact with different shaped
residual limbs? (7) How to improve weight
bearing properties and pressure distribution
in the socket?
3 Easily fitted (8) How can the fitting procedure
made easier?
4 Controllable (together with 6) How
can a tight fit be assured by a wide range of
residual limb shapes?
5 Usable (11) How can a prosthesis be
donned and doffed? (12) Even when the
patient has a bulbous residual limb shape?
6 Safe (13, 14, 15, 16) How can stiffness and
strength be guarantied?
7 Affordable (Optimization)
8 Social (Optimization)
9 Quickly fitted (Optimization)
10 Distributed (17) How can integration with
existing parts (connective components and
the suspension system) be made easy?
Conflicts in the criteria
Two specific equilibriums need to be found
in opposing criteria which are:
Variable vs. stiff
Stiffness is an important aspect of safety and
control, while variability or adjustability is
an important aspect of the universality. How
can the prosthesis be made stiff enough,
while still being variable? We know that the
prosthesis will incorporate an open-frame
socket design. Therefore this question can be
restated as: (3) “How to make a frame (that
can transfer loads) deformable?” and (4) “How
to attach a deformable part to a rigid skeletal
frame?”.
Comfort vs. control
More control can be achieved by a tighter
fit, which means higher pressures. However,
control is more important during ambula-
tion/stance than during sitting or swing, so
the problem is: (9) “How can a tight fit be
accented during load and a comfortable fit
during rest?”.
Another way to improve comfort is to reduce
pressure-peaks by vertical dampening. The
problem is: (10) “How to improve vertical
dampening while keeping control (and direct
sensory feedback) during use?
The problems are explored in appendix Q.
The presented solutions were obtained by
looking at existing solutions, looking into
other products with similar problems and by
creative thinking.

10.2 Idea discussion
Subproblems and ideas (solutions) can than
be evaluated by rating them against the 10
criteria. However, selected solutions have to
be integrated into one prosthesis. Also, we
know that the socket will exist of hard and
soft parts and that the hard parts will func-
tion as an open-frame socket (see 6.3). It is
therefore important to select idea’s that inte-
grate well into each other and that contribute
to an integrated fitting procedure.
Hereafter follows a short discussion and
some considerations of the subproblems and
the solutions that can be found in appendix
Q.
Each number correspondences with the
number and the figures in the Appendix.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
1 able belts are chosen as part of the final solu-
tion, the user has to be able to determine
The “flower principle” is a very interesting
the length of the belt quite precise. (see 6.2).
Synthesis
The “harmonica” option can also be used in
to use for an adjustable socket. It promotes a
a tapered socket shape, so it can accommo-
pylon at the distal end of the socket and the
date for variable stump sizes and lengths.
“opening of the flower” is the normal response
of shell parts when loaded from the inside
(when you try to stand in it. The flower prin-
Ideas
ciple can be used, but the normal response
should be counteracted, for example, by a belt
all around the socket.
The “multi-link” option is also very interest-
Concept
ing. Theoretically, the more parts an open-
frame socket consists of, the better the fit is
that can be achieved. J. Foort formulated the
Evaluation
potential usefulness of the multi-link option
in 1977 and proposed that “Shapeable matri-
ces can be used to construct biomechanical
structures directly”.
Recomm.
However, elements of which these shapeable
matrices should consist of are not satisfac-
tory developed until now. Cousins proposes
that “hybrid modular-matrix systems may
Conclusion
develop as stepping stones to either matrix
or modular structures” [J Foort, 1986]. The
Universal Prosthesis, with its hard open-
frame and connective soft-frame parts does
in a way resemble a modular-matrix system.
Belts as seen in the “ellipse with belts” option
are suitable to transfer tensile forces between
frame parts over a variable length. If adjust- 81
 2 The “saw it” option for the pylon is
basic and can be integrated well into designs
that can only be fitted once (can only be made
shorter after the fitting procedure). For addi-
tional adjustments during use, a combination
with the “telescope” or “screw it” options can
be chosen.
3 Building the prosthesis from parts
that are deformable of displaceable when
separated, but are that are rigid when con-
nected, is a good option. It compares well to a
modular “Lego” kind of build-up.
”One-way-deformation can be unsafe for the
patient and result in a locked-in residual limb.
On the other hand, it might be a useful tool
during the fitting procedure. In this case, the
“one-way-deformation” has to be reversible or
to be reset.
4 “Gluing parts together” is a good
option in case it can be done during the pro-
duction of the prosthetic components. Glue is
difficult to use during the fitting procedure:
it can get quite messy and results may vary.
These difficulties can partly be removed by
using a bag around the glue and the parts
that need connecting. However, in this last
case it is difficult to add a reaction agent or
to start the reaction otherwise.
82
w
“ raps” can be used, especially in combina-
tion with Velcro (NL: klittenband). “Dip and
coat” is another option that is only usable in
the factory.
”plait/weave” is an option that can lead to
advanced designs with varying stiffness
(or other properties” in direction and place.
However, the production method for woven
components is not easy, especially when the
textile has to be integrated into hard frame
parts. Another limit is that it is not easy to
predetermine the shape of the end-product.
5 A “standard solution” (multi-axis) pivot
at the distal end of the pylon seems a natural
and satisfying solution, especially when mul-
tiple distal ends can be inserted (see subprob-
lem 17). However, the proximal bending point
will differ from location, according to the
length of the residual limb of the amputee.
For this “pivot” point the “angle by deforma-
tion” or “bend” solutions seem to be more
appropriate. These deformations must hen
be easy for the prosthetist to apply, while the
pylon still has to provide weight bearing after
the bending. This is a typical example of the
variable-stiff conflict which makes the design
of the universal prosthesis such a challenge.
6 Total contact is of utmost importance
for the comfort and function of the socket.
”Following the contour” of the (unloaded)
residual limb, in literature sometimes
referred to as surface matching, is currently
the most used method for determining the
stump shape. However, due to the compres-
sive forces, deformation of the soft tissue is
to be expected. Deformation of the soft tissue
is used in the first (3 to 6) months after the
amputation to promote a stiffer residual limb,
with a taper shape (see section 5.1). Also,
deformation of the residual limb will not
stop blood flow up to a internal (skin) pres-
sure of 35 kPA (Sangeorzan et al. 1989). For
posterior soft tissues in the residual limb (the
calf muscle) this implies that load pressures
of up to 70 kPa are allowed (Sangeorzan et
al. 1989). Deformation of the limb will then
be up to 5.4 ± 1.1 mm, dependent on the
amount of soft tissue, it stiffness and other
factors (Sangeorzan et al. 1989).

Also, pressure cast methods deform the
soft tissue, but the volume (is assumed to)
stays constant. This is called volume match-
ing. The “inflate/fill” option is therefore a
deisgn option that promotes volume-match-
ing (and a TSB socket fit). The big difference
between this solution and current pressure
cast solutions is that the currently pressure
is applied by an apparatus that completely
envelops the socket. In the presented solu-
tion, the pressure is added to the socket itself.
The “suck/vacuum” solution is used in the
otto bock Harmony system. In this system
(figure 10-1) every step is used to decrease
the pressure between the socket and a spe-
cial liner, thus improving the connection
between them. The fit is said to be com-
fortable and provides excellent control.
Figure 10-1: Otto-Bock Harmony system
Tissue deformation is therefore not only a
design option, but a tissue reaction to load
that has to be taken into account. Also, tissue
cannot be deformed to much, especially when
the amputee has a bony residual limb.
7 Smart designs can further improve
the weight-bearing and pressure-distributing
properties of the socket.
Most professional prosthetists agree that
in general, the distal end of the residual
limb should not be loaded. The distal end
pad (an idea that came into existence in Sri
Lanka) does exactly that, but in a very con-
trollable manner. It contributes to the total
weight bearing properties of the socket, if
the amputee has some pressure tolerance
in that area. Because there is always some
pistoning of the residual limb in the socket
(or the residual bones in the soft tissue), the
distal end pad has to be designed in such a
way that it will not exceed the tolerance level
during stance and ambulation. In the appen-
dix, a possible solution with springs, one
with elastic band and the commonly used gel
pad are shown. The distal end pads should
be inserted at different distances from the
Pattelar tendon, because of variations in the
residual limb lengths.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Extra dampening can reduce shocks and
therefore decrease the amount of pressure
peaks and promote comfort (also see section
Synthesis
4.3.5). On the other hand, the extra freedom
of movement decreases the direct feedback
and control over the prosthesis. In this light,
vertical freedom of movement is less prob-
lematic than horizontal or rotational move-
Ideas
ments (see subproblem 10).
Increasing the pressure (perpendicular
forces on the residual limb) increases the
Concept
control and can improve weight bearing.
On the other hand, during swing-phase and
other cases in which there is no load on the
prosthesis (e.g. sitting), constant elevated
Evaluation
pressure on the residual limb should be
avoided to avoid tissue damage. Several idea’s
are shown in the appendix that increase the
pressure during load, but keep pressures low
without the load. All these solutions react on
Recomm.
a displacement (that is caused by the loading
of the prosthesis). The “four bar mechanism”
is the most basic solution of which some
other presented solutions are spin-offs. The
Conclusion
“force redirected with pulleys”-option uses the
vertical dampening displacement to increase
the posterior(-anterior) pressure. This way,
control is only limited decreased. However,
these systems introduce moveable parts in
the prosthesis thus decreasing life-time, ease-
of-use and increasing costs.
83
 8 The success of the universal prosthe-
sis is highly dependent on the east of the fit-
ting procedure. Several strategies can be fol-
lowed to keep the fitting method simple.
First of all, use-cues can be added where use
is ambivalent. Examples are the length of the
total prosthesis and the socket-residual limb
angle. Use-cues are tips that are part of the
design. For example, by accenting the patel-
lar tendon and the tibial crest on the out-
side of the socket, users immediately know
what the front side of the socket is. The total
height of the prosthesis can be shown by tag-
ging the height which the prosthesis should
have when the user stands in it (mid-patellar-
tendon is easily comparable with the opposite
leg). Another option is to attach a temporal
part that needs to be level with the top-knee
height of the opposite limb when the amputee
sits (figure 10-2).
Another way to improve the easiness of the
fitting procedure is to standardize it. The uni-
versal prosthesis will standardize it, because
it will incorporate a hands-off fitting proce-
dure for the socket. Further standardization
can be achieved throughout the procedure by
copying the fitting techniques now commonly
used. These are practical and using them will
improve the acceptation rate of the universal
prosthesis for the current prosthetists.
84
Simplifying the fitting and production of 9 The advantages of promoting a tight
the universal prosthesis can be achieved by fit during use have been mentioned while dis-
combining them into one procedure. In this cussing subproblems 6 and 7. Also rotation
respect the “immediate production method” (displacement) can be used to achieve this.
is similar of that of the ICEX (see section 4.3.1 The “strangle-fit” will tighten when rotational
– hydrostatic socket). If this can be achieved, forces are applied. Two springs, one winded
the universal prosthesis not only reduces clockwise and the other counter-clockwise,
the need for skilled prosthetists, but also for will make sure that rotation in both direc-
technicians and machinery. tions will result in this behaviour. An advan-
tage of this system is that a relatively small
Quick feedback of the user will also reduce rotation is needed to increase the pressure.
the time the prosthetist needs per client. A difficulty is that spring hat to be deformed
Especially when feedback can be incorpo- to be used for amputees with variable stump
rated and reacted on immediately. When the circumferences.
patient is loading the residual limb during the
fitting procedure, it becomes directly clear
when the fit is not optimal and the prosthetist
and the amputee can take action by adding
pressure pads, realigning the hard parts of
the socket or realigning the residual limb. If
this direct feedback will reduce the visits of
the amputee to the prosthetist in practise,
clinical tests have to determine.
Another way to increase the feedback is to
make as many parts as possible transparent.
If this is the case, the prosthetist can check if
sensitive area’s are avoided, if all the tissue
makes contact with the socket and how the
tissue reacts to the pressure.
Figure 10-2: Possibilities for adding use-cues
to ease the fitting procedure.
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

A completely other solution is to change the
(transversal) shape of the socket. The rounder
the shape, the more volume it can contain
One basic way to avoid this problem is to use
a flexible socket, that when donned is fas-
The wrapping solution is another idea that
is very suitable for the fitting procedure.
tened or tightened (“fix it with a rubber ring”,
With the wrapping method, a material can

Synthesis
“tightening”, ”zip” and “belt” idea’s). In the
with the same circumference, resulting in be applied around all sorts of residual limb
“bend /deform” idea, the socket is elastic but
lower pressures. On the other hand, the shapes. The same principle is used in the
the force needed for deformation is higher
round shape is not resistant to torque. The ICEX-system see section 4.3.1 – hydrostatic
than the forces during ambulation. This can
triangular shape results in higher pressures sockets), in which carbon fibre reinforced
only be achieved when and additional device
and is far better in transferring rotational wraps are used, that during the fitting proce-

Ideas
or tool is used for donning and doffing, which
forces from the socket to the residual limb. dure are impregnated and hardened.
doesn’t fit the design philosophy.
10 Vertical dampening can increase
The “roll on” idea is now commonly used in 12 Discussed with 11
comfort, but also means less control (also see
the donning and doffing of the liner. If it is

Concept
subproblem 7). Currently, most dampening
applied on the socket itself, this would result
systems are integrated into the foot. In gen-
in a very flexible socket and force transfer
eral, the more distal the dampening system
would be a problem. However, the roll on
is placed, the better the experienced control
principle can be very useful during the fitting

Evaluation
will be.
procedure, because it results in a very pre-
11 Donning and doffing the prosthesis
cise total contact fit. Even while a liner can’t
transfer loads, it will prevent oedema.
is an important factor in how user friendly
the prosthesis will be experienced. Also,

Recomm.
because the socket will be formed directly
on the residual limb, the doffing should get
extra attention. In most cases the residual
limb shape will be taper (see section 3.1.3)

Conclusion
and the socket can just be slipped of the limb
(“shove”-option). However, caution has to be
taken when handling bulbous shaped resid-
ual limbs. In these cases the directly on the
residual limb fabricated socket can get locked
in.

85
 13 The pylon has to deal with the same
stiffness-deformable conflict. Does it have to
change shape? Well, extra leverage acting on
the residual limb should be avoided, because
that implies extra pressure. Normally, that is
solved by connecting the pylon to the socket
at the intersection with the line of gravity
(figure 10-3, compare section 3.1.4).
A nother option is to use multiple pylons
(see section 4.3.2). In function this last solu-
tion resembles an exoskeletal prosthesis
(see section 4.2.1). The exoskeletal setup is
in this regard very suitable for the universal
prosthesis. It provides a very stiff and strong
prosthesis, while it can easily adept to vari-
able residual limb lengths.
Because the universal prosthesis incor-
porates a hard open-frame, the pylon will
have properties of both the multi-pylon and
exoskeletal solution. The basic shape used for
the pylon will than be the round or triangu-
lar shape.
Figure 10-3: Moments around the socket, as a
86 result of diffrent pylon types.
The H-basic shape is also interesting. When
two vertical pylons are connected by an addi-
tional surface, a transversal H-shape will be
formed (figure 10-4)
This increases the stiffness of the total struc-
ture. In the same way, many connections with
a stiff socket can also enhance the stiffness
(“attach-surface-above” idea). This connec-
tive surface can be integrated into one part
by adding surfaces that can be rotated from
parallel (deformable status) to perpendicular
(stiff status).
14 Discussed with 13
Figure 10-4: H-profile.
15 To achieve a light but stiff total con-
cept design, the flexible part of the design has
to contribute to the total stiffness. The fitting
procedure is an important factor in this.
The soft parts can add “tensile forces” to the
open socket frame. Imagine this principle as
elastic bands or springs between the hard
frame parts. The tensile forces increase the
pressure on the residual limb. As long as this
pressure doesn’t exceed the threshold of the
residual limbs tissue tolerance, the total stiff-
ness of the system will improve.
Problematic is the variance in residual limb
circumferences. If the connective bands are
stretched to accommodate for bigger resid-
ual limbs, the elastic bands will exert higher
forces, which can result in higher pressures.
Ideally, the tensile force, or even better, the
extra pressure resulting from the tensile
forces, can be controlled. This implies that
the elastic bands can at least be adjusted
in length. One fundamental problem is that
(elastic) bands will always try to find the
lowest force route, which results in straight
lines and can result in pressure peaks on the
tissue between the hard parts (figure 10-5).
Figure 10-5: Flexible bands
that connect parts
will result in pres-
sure peaks.

That last property of elastic bands is some-
thing that “hardening” the connective flexible
parts can prevent. Of course, the flexible part
than no longer generates tensile forces, but
the hardened part can transfer tensile (and
compressive) forces. The pressure on the
residual limb is now determined by the shape
and circumference of the socket. For satis-
factory results with the “harden”-option, the
shape has to be determined very precisely.
16 There are a few options for hardening
flexible parts. Two fundamental principles
both can lead to a satisfying solution.
First of all, the parts can be hard in normal
circumstances and become deformable when
altered. The most commonly used materi-
als in which this principle is used, are plas-
tics that can be heated, (de)formed and then
cooled again (“freeze it” idea). A current
application of these materials can be found
in ski-shoes, violin supports. This are heated
to approximately 60 degrees Celsius to fit the
user’s body shape. This principle could be
applied to the hard open socket parts, if more
variance in these parts proves to increase the
comfort level of the fit.
Secondly, for the flexible parts, “chemical
reactions” can be used, that harden a mix of
(carbon) fibres and resin, exactly in the same
way currently PTB-sockets are produced.
This solution allows for a high freedom of
shapes that can be given to the socket and
is successfully used in the ICEX-system (com-
pare subproblem 11 and 8). The big disadvan-
tage of the ICEX system is that water has to
be added as the reaction agent. This makes
the fitting procedure a complicated and time-
critical happening. Because the universal
prosthesis eventually has to be fitted by inex-
perienced people, this solution is not optimal.
Better are solutions that can use (UV)-light,
heat or electricity as the reaction trigger or
reaction agent. However, these agents bring
along their own difficulties, sometimes in
regard to the fitting procedure, sometimes in
regard to the safety of the amputee.
Other options, that require the addition (or
removal) of parts or the use of specific tools
or machinery (“deform it”-option), are less
useable for the Universal Prosthesis. The
additional parts or tools have to be included
into the distributed package or kit, thereby
increasing its costs.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
17 The completeness of the UP is in
regard to its distribution options very impor-
tant.
Synthesis
In cycle 1 of the marketing (see section 6.3),
multiple or easily interchangeable pylon ends,
will make sure that the Universal Prosthesis
can be used in conjuncture with existing feet.
Ideas
For cycle 2, a foot has to be part of the distri-
bution kit.
The suspension system (see section 4.3.4)
Concept
is another integral part. Suction suspension
is regarded as the most comfortable option
nowadays. It does demand a highly accurate
fit of the socket.
Evaluation
Knee straps or suspension sleeves are some-
what less comfortable during the donning
and doffing of the prosthesis, but provide
excellent suspension.
Recomm.
Conclusion
Figure 10-6: Suspension sleeve
87
 Problems arise when the suspension is to
loose and the residual limb starts pistoning
in and out the prosthetic socket.

Supra-condylar and supra-patellar sock-

ets (section 4.3.4 – anatomical suspension)
enclose the hard parts of the residual limb
and the knee. This suspension “cups” are
stiffly connected to the socket. In current
condyle suspended sockets, such as the KMB,
the suspension parts are integrated into the
(high) socket.

88

10.3 Idea selection and
integration
Having discussed all these possibilities,
those who integrate well into a total design
have to be selected.
In section 6.2 it became clear that the socket
has to exist of both hard and soft parts and
that it will at least contain an open-frame
socket that can provide weight bearing for
the amputee. This open-frame socket can
at least partly morph into a multi-pylon /
exoskeletal pylon (as discussed in subprob-
lem 13/14). The pylon can end in a multi-pur-
pose connection component (subproblem 17).
Alignment can be improved if this component
can be rotated (subproblem 5). To attach the
frame parts, (elastic) bands or belts can be
used (subproblem 1, compare subproblem
15/16) but it has to be possible to adjust them
precisely in length. More distal the length
of these bands has to vary more, because of
different residual limb shapes. Velcro can be
used to attach these bands. Velcro is com-
monly used in orthopaedic appliances and a
blood pressure meter (sphygmomanometer)
illustrates that the connection can cope with
medium-high pressures (200 mmHg = 26,6
kPa) of the connective area is big enough.
For the fitting procedure of the hard frame,
this results in figure 10-7.
In contrast to the open-frame principle, every
area of the residual limb should make contact
with the socket, to prevent oedema (see sec-
tion 3.1.3). This can most easily be achieved
by rolling a highly flexible and stretchable
textile or material on the residual limb, as is
currently done with liners (subproblem 11). If
we can harden this flexible material (subprob-
lem 15,16) or fill the space behind it (subprob-
lem 15), the total contact surface can become
weight bearing and thereby increasing the
comfort level of the socket. In this case,
pressure has to be applied onto the mate-
rial that will become rigid and the residual
Figure 10-7: Steps for fitting the hard frame
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
limb, because else the socket becomes shape
matched instead of the preferred volume
matched (subproblem 6).
Synthesis
To achieve this pressure casting, the outer
and inner layer of the socket with a material
that will become hard after filling and apply
pressure. The outer layer of the socket can
Ideas
also exist of a roll-on component. To avoid
deformation on the outside, the outside layer
needs to be either very stiff or restricted. For
the Universal prosthesis, this restriction can
be achieved by simply wrapping the outside
Concept
with difficult to expand material or textile.
For the fitting procedure of the soft socket,
Evaluation
this results in figure 10-8.
Recomm.
Conclusion
Figure 10-8: Steps for fitting the soft frame
89
 The two fitting procedures have to be inte- 10.4 Evaluation of the
grated into one, resulting in figure 10-9.
integrated design and
conclusion

If we quickly evaluate the resulting proce-

dure and design, we see that the total has
high potential to achieve that:
- The fitting procedure is a hands-off method
which combines the best of the TCB and PTB
principles.
- The fitting procedure is suitable for a wide
range of residual limb shapes. The range is
primarily dependent on the shape of the open-
frame parts.
- The resulting prosthesis is not too heavy, not
bulky, comfortable and siff.

The distribution kit will contain at least 2 or

3 hard frame parts, several Velcro bands, a
special fabrication liner, an connective com-
ponent, a filler (material), a means to apply
pressure to the inside of the socket while
hardening, wraps. The only tool needed is a
saw, which is widely distributed and accessi-
ble.

Figure 10-9: Steps for fitting the combined

system
90
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Comparison Discussion
This intermediate design can be scored If the currently presented fitting procedure

Synthesis
against the commonly used PTB-procedure can be realised, the Universal Prosthesis
and the ICEX-system (table 10-1): is very comparable with the ICEX-system
in performance. This is not so surprising
because the ICEX-system is also a hands-off
fitting method (and also needs a compres-

Ideas
sive device). However, the ICEX-system is not
to suitable for inexperienced prosthetists,
because pressure-pads have to be applied by
Criterium Universal ICEX Standard Main argument / comments the prosthetists on pressure sensitive area’s
Pros. PTB and the wrapping of the residual limb (and

Concept
1 Universal ++ + + The UP combines the best of two worlds, pads) is difficult.
because it’s a PTB-TCB-hybrid.
2 Comfortable ++ + + (needs clinical test) The Universal prosthesis has some other
advantages. It is fitted with the amputee

Evaluation
3 Easily fitted ++ + - UP has many steps, but ICEX requires
standing and it uses the PTB-principle, thus
knowledge to apply pads, apply wrappings
and steps are time-critical using pressure tolerant area’s to a much
better extend. These two features will very
4 Controllable + + ++ PTB can be adjusted better after the fitting
probably lead to a more comfortable fit (espe-
procedure.
cially during stance). Clinical test will have to

Recomm.
5 Usable 0 0 0 The PTB might not need a cosmethic cover, prove this in practise.
because it is an exoskeletal design.
6 Safe + + ++ There are no problems expected, but PTB is
used for many years by now. PTB normally

Conclusion
produced with toxic resins.
7 Affordable 0 0 0 Dependent on the costs of personel and the
tools needed such as a compressor.
8 Cosmetic 0 + + (needs to be improved)
9 Quick fitted + + - PTB needs many steps.
10 Distribution + + - PTB needs specific tools

Table 10-1 Quick comparison between the Universal Prosthesis and two popular fitting systems.e 91
 11 Concept
Having determined the global design and
fitting procedure, the final shape and the
properties of each part have to be chosen.
The final design evolves over multiple cycles,
because each change in a part influences
other parts. Hereafter the most important
design considerations for each part are dis-
cussed, but not (necessarily) in chronological
order..
The hard open-frame socket parts (section
11.1) are the base of the design. They are
the parts of which the most clear idea about
how they should look exists, because they
evolved out of the designs made in Sri Lanka
and it became clear what improvements were
needed in the analysis.
The best argument against an open-frame
socket design (that total contact is needed to
prevent tissue damage and oedema), is solved
by adding a soft socket (section 11.2).
The pylon (section 11.3) is the connection
between the socket and the foot (and indi-
rectly to the ground). Especially the connec-
tive component at the distal end is important.
It is needs to connect the hard socket to the
foot while providing an air-tight seal for the
soft socket.
92
Having redesigned the parts, the resulting
fitting procedure (section 11.4) needs to be
optimized. Incorporating a low-expertise fit-
ting procedure is the unique selling point of
the universal prosthesis and therefore it has
to be solid (no buyers means no product). The
user-friendliness of the design is discussed
in section 11.5 (no satisfied users means
no buyers). The high-tech design that is the
result has to be produced in such a way that,
in time, the universal prosthesis becomes
affordable for a broad group of users around
the world (section 11.6).
11.1 The hard socket
11.1.1 Selection of loadable and
avoidable area’s based on
anatomy
The open-frame socket has to make contact
with the pressure-tolerant areas of a variation
of residual limbs. The variance in circumfer-
ences and lengths of these residual limbs
can be found in appendix G. As emphasized
in section 3.1.3, these measurements where
taken in Sri Lanka. Amputation procedures
in developed countries are somewhat more
standardized, resulting in a lower standard
deviation. However, residual limb lengths in
developed countries will vary from 100-180
mm, quite comparable with the data gath-
ered in Sri Lanka. It is clear that the first
100 mm from (mid) patellar tendon are the
most important for the open-frame socket.
Luckily, the variance in circumference is also
the smallest around that area. At 50 mm
from mid patellar tendon the P5-95 spread
is 230-340 mm). At 150 mm distance from
mid patellar tendon, the circumference can
vary from 170-320 mm. That apart from the
fact that many amputees will have a shorter
residual limb length (and no circumference at
all).

In appendix R, this data is combined with the
anatomy of the residual limb (overlay 1 to 4).
Overlay 5 shows the resulting spread in pres-
sure sensitive and tolerant areas. The bony
prominences are the most important factor in
determining these areas. These were scaled
in respect to the circumference variance (P5-
P50-P95). It has to be noted here that these
areas are estimations, because in reality
the anatomy of everybody differs. It would
be far better if the data would be obtained
from (scans of) a large amount of residual
limb shapes and measured tissue properties.
However, that information is not available in
literature and time-consuming to generate.
The estimation here is reasonable and makes
use of the same assumptions as prosthetists
do while fitting a prosthesis.
Interpreting the data from appendix R, over-
lay 5, it becomes clear that there are quite
some areas that overlap (mid patellar tendon
taken as a fixed point). The pressure sensi-
tive area’s are shown in red and don’t domi-
nate. The big blue and green area is loadable.
This results in overlay 6, where the loadable
and avoidable areas are selected. The chosen
areas are shown till approximately 130 mm
from patellar tendon, after which they fade
out, in conjuncture with the variable residual
limb length.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
11.1.2 Determining the rough It is concluded that the interface surfaces
of the frame will have to be maximized to
frame shape.
ensure a comfortable fit during the fitting
Synthesis
Having selected the loadable areas, the
procedure.
interface frame that will transfer the load to
the residual limb have to be materialized. The
The preferred area’s of load as presented in
overlay 7, lead to the frame parts as shown
bigger these parts are, the better the pres-
in overlay 8, shown in blue. These parts will
sure distribution will be. The smaller these
Ideas
form the interface to the residual limb and
parts are, the better they will be adaptable
still need to be connected by a stiff frame
to accommodate for the wide range of stump
that is able to transfer the loads between the
sizes and shapes.
interface parts and to the ground (overlay 9,
On overlay 7, an estimation of the maximal shown in red).
Concept
load that can be carried by the soft tissue is
given. Every surface has a maximum pres-
The interface frame can be some what easier
deformable to fit the varying residual limb
sure tolerance, an area (size) and an average
Evaluation
shapes. More distally, the variance is bigger
angle in respect to the gravitation load line of
and therefore the parts have to be better
the total body mass. From these, the maximal
deformable there. To maximize contact, mul-
upward force is calculated.
tiple strips downwards are chosen where
Note that the Free Body Diagram shown
possible. Near the patellar tendon and on
Recomm.
the opposite side (posterior), the variance in
is not in equilibrium. The current forces
residual limb shapes can be compensated by
will coerce the soft-tissue to deform and
translation of the frame.
the residual limb to rotate and trans-
late (if the socket is regarded as fixed in
This stiff frame can be translated because of
Conclusion
space). Also, resulting shear stresses are
two vertical areas where no frame is present.
not taken in account. However, this behav-
This effectively splits the frame into two
iour cannot be predicted without more
parts.
knowledge of the (properties and shape of
the) frame parts. It is assumed that the user
will compensate for pressure overload and
that the maximum upwards force will not
diminish significantly by the relocations. 93
 Tensile forces (that need to be transferred
from the anterior from the anterior to the
posterior to prevent the parts to part and the
residual limb to slip downwards) are trans-
ferred by belts of connective textile, shown in
green in layout 9.
Layout 10 summarizes the tough frame
design. The belts can be fastened by a tight-
ening mechanism or by Velcro. The space in
between the frame parts is filled with carbon
or glass fiber textile, which will help to
strengthen the connection between the parts
after hardening of the soft socket (see section
11.2). The stiff frame parts are lengthened so
that they will function as a pylon. For small
amputees, these frame parts can be short-
ened by sawing the distal end. A connective
part (see section 11.3) is added to connect
the foot.
94
11.1.3 Optimizing the frame shape in
regards to the anatomy.
Having determined the rough shape of the
frame parts, these have to be (re)matched to
the anatomy of the residual limb.
In overlay 11 this process is shown. In the
top row, slices from the “visible human
project” are given at steps of 10mm, from the
patellar tendon, to 130mm distal.
These slices give a good impression of the
bone structure of the residual limb. As a
reminder:
- Bony prominences (with only skin over them)
cannot be loaded.
- Muscle with bone “behind” it can be loaded
well, but perpendicular.
- Large areas of muscle can be loaded well, but
deformation has to be restricted.
The general shape of the bones is shown in
black. Muscle that borders these lines can be
loaded (perpendicular). The green lines indi-
cate where the stiff frame can part. Variation
in residual limb circumference can be com-
pensated by moving the green lines together
or away from each other.
Tensile parts (straight lines between them on
the border) will not result in tissue damage.
In the second row, the cross-sections of the
rough frame design from layout 9 are shown.
These are used as a guide to determine the
optimised shape.
To stabilize the forces resulting from pres-
sure on the inside of the frame, the support-
ive areas and stiff frame parts need to be
divided as good as possible over the circum-
ference.
Having tree strips downwards this means
that midpoints of the strips have to be equal
distance from each other (an isosceles trian-
gle).
In row 3 this has been pursued, without
neglecting the tissue pressure tolerance. The
V-shape of the anterior part is to protect the
tibial crest. The patellar tendon indent can be
easily recognised in blue (at PT-height).
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

To prevent the limb from slipping through 11.1.4 Back to 3D They were connected and a little smoothened.
the frame near the distal end, the anterior This was necessary because the slices from
strip and the medial strip get closer together the “visible human project (see layout 11)

near the end. This is in line with the higher
distal forces during gait in anterior-poste-
rior direction to compensate the then acting
moments and the higher force to compensate
for the moment caused by the load on the
The optimized cross-sections from Appendix
R, layout 11, were stacked together in 3D,
resulting in figure 11-1.
Synthesis
proved not to be well centred.
The result is as seen in figure 11-2 and
appendix R - layout 12,

Ideas
patellar tendon (see section 11.1.5).
for aligning the
cross-sections.

In row four, these strips are connected proxi-

Concept
mally to bridge over and protect the pressure
intolerant areas. Also, the stiffness of the stiff
frame parts is added to maximise the contact

Evaluation
area with the residual limb. Where necessary, supra condylar
direct contact with the hard borders of the brims
stiff frame is countered by overlapping the
some cross-sec-
soft frame with the interface frame.
tion placements

Recomm.
needed to be
adjusted. The
slices from the
In row five, the frame is optimised for the visible human
variance in residual limb circumferences. project where not

Conclusion
The more flexible blue parts that are not sup- aligned before
ported or attached to the stiff frame are given processing.
a curvature that is equal to that of P5. These basic shape of
parts also bend in more distally, to extra sup- the pylon.
port smaller residual limbs. Figure 11-2: Together with the resulting frame
Figure 11-1: 13 stacked layers that where parts. [Top] stiff frame, two views.
derived from the anatomy of the [Below] interface frame.
residual limb. Top view and isomet-
95
ric view.
 Note that the tensile textile (see layout 10
and section 11.1.2) has been replaced by
extensions of the frame parts. These exten-
sions are thinner and more flexible as the rest
of the stiff frame. They are connected to the
opposing frame by Velcro. This improvement
was made to ensure that:
- the frame parts are on the proper height in
respect to each other
- there will be some curvature of a straight line,
improving comfort.
- assembly is quicker because there are less
parts.
The most distal end of the stiff frame strips
has been punctured to enable the connection
of the connective component on the desired
height.
11.1.5 Material choice
To assess the mechanical properties of the
frame, first the material has to be specified.
Material of the interface frame
For the interface frame (blue) a plastic will
be used. It should be possible to deform the
interface frame to fit the varying residual
limbs, but it should also be able to transfer
some forces. Solution to this contradictory is
found in deforming the plastic by heating it,
and then fix it into the desired position while
cooling down. This should be possible with
normal heating equipment, so the soften-
ing temperature should not be higher than
150°C. But it also should not deform at a tem-
perature lower than 50°C, as it might turn
soft during use in the sun on a hot day.
Several, commonly available plastics are
suitable; PP, PVC, PS, ABS, PMMA, POM, PPO.
PVC is toxic for the environment and will
therefore not be used. POM and PPO have
softening temperatures which are quite high,
155°C and 130°C respectively. It would be
possible to use them, but there are other pos-
sibilities with lower softening temperatures
(table 11-1).
ABS was chosen from those four, as it is said
to have good chemical and mechanical prop-
erties. Examples of applications are security
helmets and profiles for skis and surfing
boards.

Technical drawings of the frames can be

found in appendix Z.

PP PS ABS PMMA
Bending strength (Nmm ) 2
40-115 80 55-80 140
Modulus of elasticity (N/mm ) 2
1250-2200 2600-3200 1800-2500 3250
Softening temperature (C) 90 100 90 115

96 Table 11-1: Four material options for the interface frame.

 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Material of the stiff frame 11.1.6 Mechanical properties or in the residual limb were assessed. In this
stage of the development these specific FEM-
For the stiff frame (red) Hylite, a composite The mechanical properties of the frame models are too time-consuming. Instead, a

Synthesis
material developed by Corus) will by used. quick indication of the stresses during stand-
can be assessed in several ways. The best
This is a sandwich material, existing of two ing on the two force conducting frame parts
way is to build the frame and to experiment.
aluminium layers with a plastic layer (poly- (red frame) and on the connective compo-
However, production of several parts of the
propylene) in between. It is a very lightweight nents (strips & Velcro) between these frames
frame is expensive.
and strong material. At a thickness of 1.2 is given. The applied loads were chosen as
With the material properties of Hylite and

Ideas
mm it has the same flexural stiffness as steel shown in appendix S - FBD.
at 0,74mm and aluminium at 1.06mm, while
ABS known and the frame design available
having a much lower mass.
as an 3D model, the behaviour of the parts Appendix S - FBD shows the main resultant
under load can be simulated (finite elements forces when standing with 50% of the body
When the aluminium layers are grinded or weight (100% of the load on the prosthesis)

Concept
methods).
machined, hinges can be formed as is shown supported by the patellar tendon. It again
in figure 11-3. It can also be formed in the
desired shape by deep drawing as shown in
Many studies to socket fit and socket illustrates (as in section 3.1.4) that the PTB-
deformities were conducted in literature. bearing principle increases the loads on the
figure 11-4. anterior distal end and the posterior mid of

Evaluation
These in-depth studies were demanding and
the shear and stress forces in the total socket the residual limb. For people with sensitive
Other options are: distal ends, this can be a problem. In that
- Carbon fibre reinforced resins case, a TCB-approach is more suitable (see
- Aluminium section 11.2).

Recomm.
-
-
Titanium
Glare
The 3D-application of thise forces and the
frame’s displacement behaviour can be found
in appendix S - FEM.

Conclusion
Figure 11-4: Deep drawed car part from Hylite.
Figure 11-3: Applying hinges to Hylite (source: (source: Corus) 97
Corus)
 What we can conclude is that with the cur-
rent thickness (2 mm) and shape, (Hylite and)
aluminium has such a stiffness, that major
deformations can be expected. Solutions can
be found in applying ribs, thickening the
structure or increasing the area of the frame
parts. Also, the residual limb will constrict
the total amount of deformation. And, as
can be seen in figure 11.2, the general shape
that follows the anatomy of the user will not
change much, thus staying comfortable while
deforming.
The socket/pylon in this shape is not suitable
for prolonged ambulation. Because of its free-
dom to move, it will become subject to fatigue
and break. However, the addition of the soft
socket will improve this.
98
11.2 The soft socket
The soft socket exists of a flexible closed tube
or “fitting liner”, that will become the inner
and outer layers of the prosthesis, and the
filler that will harden in between these layers
(also see 10.3).
11.2.1 Fitting liner
The fitting liner is rolled on to the residual
limb and, after placing the frame parts, rolled
down over them again. It will function as the
inner and outer layer of the prosthesis. These
fitting liner will envelop empty space and
the frame parts. The resulting inner space or
chamber will be filled with a filler or foam.
The material choice of the fitting liner deter-
mines most of its properties. In its relaxed
form it has the smallest circumference.
Because it has to fit around the connector
and the frame this minimal circumference is
about 200 mm. While rolled on to the knee
or even higher, it has to be stretched to at
least the p95 maximal circumference (at 25
mm proximal from patellar tendon), which is
about 370 mm (see appendix F) and, when
taking a maximal thickness of 10 mm of the
socket in account is about 430 mm.
Because the fitting liner will be the outside
of the prosthesis, it also makes contact with
the skin and the environment. Resulting in
the following requirements:
- The material has to be able to lengthen more
than 215% in transverse direction.
- The material has to be non toxic / non-irritat-
ing.
- The material has to be smooth and repel dirt.
- The material has to resist impact.
One possible material is a combination
between PP and PU. PU (on the inside) will
stretch easily (up to 500%) and will integrate
with the PU-foam (see later this section). PP
(on the outside) will be smooth and non-irri-
tating. If necessary, for example when the
amputee has work that is very demanding on
the prosthesis, the outer layer can be coated
(with for example epoxy resin) to increase
impact resistance.
The fitting liner can be tube-shaped, but has
to have a padded distal end to overcome high
distal-end pressures. This is common for
most liners.

11.2.2 The Filler Material
Effects of filling
Filling the space inside the prosthesis will
contribute to the stiffness of the whole.
However, to contribute significantly, the foam
has to have stiffness in the same order as
that of the load bearing frame. Foam that will
have this type of stiffness is often very brittle
and in that case, the inside would deteriorate
with use. Filling the inside with foam can best
contribute to compressive forces (in between
the frame parts). However, weight-bearing
will result in the frames wanting to part and
thus in tensile forces.
A completely other advantage of filling the
prosthesis is that it will contribute in weight
bearing. The prosthesis will effectively
become a total contact bearing socket (TCB).
Without pressurizing the foam (0-5 kPa),
this would already prevent oedema. However,
with higher pressures ranging from 30-40
kPa (50% TCB-behaviour) to 60-80 kPa
(100% TCB-behaviour, comparable pressures
as used in the hydro-cast and ICEX methods),
the socket will contribute more and more to
the weight-bearing properties of the total.
Resins
The space within between the layers of the
prosthesis can also be filled with resins.
When combined with fibres, the result can be
very stiff and strong. In the case that resins
are used, a suction method as is commonly
used while fabricating prostheses (resins
applied from above, air sucked out below, so
that the resin will divide through the space)
is preferred. In that case, the inner space of
the prosthesis is minimized and the increase
in weight will be minimal.
Polyurethane
Foams have some special properties that are
useful in prosthetics:
- It has a very good mass-volume ratio
- It can take make shapes
- It is available with a great variation of proper-
ties, including mass, rigidity /stiffness, yield
strength, etc.
Polyurethane is one material that is easy
to foam and is available for a broad range
of applications. Polyurethanes and derived
plastics are used in PUR-foam, but also in
dashboards of cars, for cushions in seats and
chairs, for shoes (soles) and in other flexible,
semi-rigid and rigid applications.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Polyurethane can be used in the universal
prosthesis if a mix can be found that meets
the following requirements.
Synthesis
- It connects to the frame parts and the outer
layer of the prosthesis
- It does not grind to powder (wears) under
dynamic load
Ideas
- It divides itself well within the prosthesis.
- It reacts slow enough, so that the pressure
can be homogenous increased. But within 10
minutes, so that the fitting procedure stays
comfortable
Concept
The application examples, especially the
Evaluation
use in shoes, show that PU can meet these
requirements. Its use in aerosol sprays, such
as PUR, makes it plausible that it also can
be distributed in a spray. It can use water (a
component of air) as the reagent (in a spray
Recomm.
the reacting chemical components of poly-
urethane are prepared in a special way) and
use the air in the chamber in the prosthe-
sis as the filling gas. It is no problem when
Conclusion
the reaction increases the inner pressure,
because this is an effect that is wanted for
weight-bearing anyways.
99
 To optimize the properties of the universal In this example, the (massive) PU layer can
prosthesis, the choice of foam is very impor- be stretched up to 500% of its original length,
tant. Because the application is very specific, where no fibres are integrated and can not be
it is probably a better option to develop a stretched where the fibres are integrated. The
“new” foam in corporation with a producer of two layers can slide along each other. The
PU. foam will “glue” then together and a much
stiffer connection is obtained than when the
foam or PU directly connects the frames.
Fibre reinforcements
Even when instead of resin PU (foam) is
used, glass or carbon fibres can enhance the
stiffness of the prosthesis. Note that the bot-
tleneck is the connection between the fibres.
However when the connective material (foam)
would strain 25% when a certain force is
applied, the distance between the two attach-
ments of the material to the stiffer compo-
nents becomes critical in the stiffness of the
whole, as explained in figure 11-5.

This principle can be used by applying thin

extensions of carbon or glass fibres to the
weight bearing frame parts as shown in
figure 11-6.

Figure 11-6: A Polyurethane layer is partly rein-

forced with fibres. The Hylite is milled
Figure 11-5: Less space in between the frames is to better attach the reinforced PU.
better; it results in a stiffer prosthesis. The two Polyurethane layers can slide
100 along each other

11.2.3 Adding pressure
When the chamber is filled with foam, pres-
sure has to be added before it has taken its
final form. This can be achieved in several
ways:
- Using the pressure from the aerosol spray, at
the same time injecting the foam. Current
sprays have a nozzle that will vaporize the
contained liquid. In this application, the
nozzle is not necessary and the needed pres-
sure can be directly added to the prosthesis.
- A mini hand pump or compressor
- A separate CO2, N or air spray or gas patron.
The volume that needs to be filled when a
residual limb of length 100 mm and a maxi-
mal socket height (430) is fitted is estimated
to 1.5 litres. To apply a pressure of 0.8 bar
(80 kPA) to such a volume, the following gas
patrons can be used: 0.97 litres at 2 bar, 0.36
litres at 4 bar or 0.16 litres at 8 bar.
- A compressor.
Figure 11-7: The airman Panter is an example of
a hand-pump.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Using the spray is the preferred solution in 11.3 The connector
situations where only a few prostheses are
fitted. The spray is easily distributed and The connector has several important func-
Synthesis
relatively cheap. In situations where more tions in the design. It has to:
prostheses are fitted, such as an orthopaedic - connect the weight-bearing frame parts.
workshop, a compressor can be cheaper and
- connect the frame to the foot.
more environment friendly.
- be adjustable in height.
Ideas
- be airtight.
- be stiff.
Concept
Connection to the frame
Because the frame parts will be completely
Evaluation
surrounded by (foam) and the outer layers
they can contain holes. There are two basic
options to connect the frame parts to the
connector. One is with screws and the other
is without.
Recomm.
The use of screws is chosen for safety rea-
sons. A disadvantage of this system is that
it results in that the prosthesis can only be
Conclusion
Figure 11-8: Two ways to connect the frame lengthened or shortened in steps. This can be
parts. Because all mayor forces between the solved by adding an extra lengthening com-
frame and the connector work in vertical direc- ponent between the foot and the frame.
tion, fitting of the frame on just shape is sufficient
(left). However, to be sure the frame parts connect
well, also during ambulation, and the connec-
tion is airtight, screws can be added (right). Both
solutions are cheap, intuitive understandable and
position the posterior and anterior frame parts on 101
the right height from each other.
 Connection to the foot Airtight
The connection to the foot is a standard pyr- The connector has to seal the inner chamber
amid alignment core (see Appendix M) that of the prosthesis, while allowing the frame to
is commonly used. When screwed in tight, it protrude.
can be removed with a tool and replaced with
another alignment core when necessary. To
resist the torque that acts upon it as a result
from turning (the foot), it is better when it is
attached permanently (figure 11-10). In the
latter case, transition extensions to other
systems can be made available, possibly inte-
grated with the extension as shown in figure
11-9.

Figure 11-10: The connection to the foot is

achieved by either screwing a standard pyramid
alignment core into it (changeable) or by integrat-
ing the alignment core in the piece (improved
strength). The dome increases the range in which
the foot can be aligned.

Figure 11-11: (Up and Left) The airlock is

Figure 11-9: An extra component that can fine- achieved by an outer and an inner
tune the length enhances the adjust- seal. NOTE: The dome on the connec-
102
ability of the prosthesis. tor is drawn on the wrong side!
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

The airlock can be made from two seals. The Fill channel and valve
first seal is made from a compressible rubber
or plastic, and will be placed on top of the
Because it is the only place where the outer

Synthesis
layer is interrupted, it is also the perfect spot
connector and between the connector and from where to inject the foam and apply the
the frame parts. The second seal is placed pressure. To achieve this, a channel that con-
over on the outside of the connector and the nects the outside with the inside is drilled in
frame parts. This part is made from an elas- the corner of the component (figure 11-12).
tic and compressive material. Its elasticity is

Ideas
For safety, a Minivalve is added. These valves
used to generate the force that is needed to are mass-produced and very cheap (figure 11-
keep the whole airtight, even when apply- 13).
ing the maximum pressure (80 kPA) and the
compressibility to fill height differences and

Concept
filleted corners.

Note on alignment
In current endo-skeletal prostheses, not only

Evaluation
a distal alignment core, but also a proximal
alignment core is added. The universal pros-
thesis only uses one alignment core (dis-
tally). One would expect that this results in

Recomm.
reduced possibilities for alignment. However,
traditional endoskeletal systems did not
incorporate a proximal alignment core. The
placement of the connection to the pylon
was determined during the fitting proce-

Figure 11-12: The fill channel and the valve in
the connector. To transfer the filler
up to the proximal side of the pros-
thesis, flexible tubes (straws) and
splitters can be used. The entrance of
the channel has to be distally or on
the bottom of the connector, because
else the air seals would be in the way.
Conclusion
dure. In practise, this went wrong so often
that an extra alignment core was added to
the system. In the universal prosthesis, the
socket and pylon are integrated and the
alignment between them cannot go wrong!
The distal alignment core provides sufficient
adjustability.
103
 The placement of the residual limb in the
socket will determine the right alignment.
This placement will only be problematic in
(the few) cases where contractures are a prob-
lem. In those cases, the pylon can be short-
ened (at 260 mm from patellar tendon) and a
normal pylon can be attached with standard
screw connections as seen in appendix M).
104 Figure 11-13: An example of a Minivalve (source:
www.minivalve.com)
11.4 Resulting fitting
procedure
The fitting procedure doesn’t change funda-
mentally (see section 10.3). With optimized
components it adds up to the figure in appen-
dix U and the following steps:
SITTING
1) The foot is connected to the connector.
2) The user rolls the fitting liner that will
become the outer layer of the prosthesis, onto
his residual limb and up to his thigh or knee.
3) The needed length of the prosthesis is meas-
ured with the frame parts and the connector.
The height of the total has to end on top knee
height.
4) The frame parts are attached to the connec-
tor. The connector is already distributed with
the inner air seal and straws attached (see
section 11.3), so the connection is immedi-
ately airtight. The needed screws are included
in the distribution kit (TOOLS NEEDED:
SCREWDRIVER).
5) The frame parts are placed on the residual
limb.
STANDING
6) The frame parts are connected to each other
and the user can stand in the prosthesis. The
Velcro can be detached and reattached until
the user can stand in the prosthesis (50% of
his body-weight on each leg) without sliding
down, while experiencing the most satisfac-
tory fit. If the prosthesis seems too long or
too short, the connector can be re-adjusted.
If specific areas are painful, gel pads can be
added or the interface frame parts can be
adjusted by heating and deforming.
7) It is made sure that the supracondylar brims
press against the knee (see section 11.5).
8) The prosthesis is taken off the residual limb
(doffed) and the distally extending frame
parts are sawn from the prosthesis. (TOOLS
NEEDED: SAW)
9) The straws inside the prosthesis are cut on
to the right length (10-20 mm from the upper
border of the frame parts).
10) The prosthesis is donned again and the fitting
liner is rolled down, over the frame parts.
11) The outer seal is pulled over the connec-
tor and the fitting liner. The extending liner
parts are cut off (TOOLS NEEDED: KNIFE OR
SCISSORS).
12) The prosthesis and the knee are wrapped
(tight) with wrapping bandage.
13) The foam spray is attached to the connector.
14) The foam is injected.
15) The pressure is increased till a comfortable
level is found or the maximal pressure of 60-
80 kPa is reached.
16) Waiting 10 minutes.
17) The wraps can now be taken away.

WALKING
18) The user can now walk around. The align-
ment of the foot can be adjusted when neces-
sary.
11.5 Daily usage & Suspension
The universal will basically be used in the
same way as currently available prostheses
(see section 4.3.4). Most important aspects
of use are donning/doffing, suspension and
cleaning.
Suspension and donning/doffing
Suspension can be achieved in three ways:
1) Standard supracondylar brim suspension.
The integrated brims on the interface socket
make contact with the knee at the broadest
part of the fibular head (see figure 11-14). The
variance in this distance from patellar tendon
is expected to be small, so the brims can be
fabricated on a predetermined length.
2) Shuttle lock suspension.
In this suspension type, a shuttle lock is
added to the standard fitting liner and an
extra liner is rolled on before the fitting pro-
cedure with a pin or plunger threaded into the
distal end of the liner (compare figure 4-32).
The shuttle has to be unlocked before doffing,
so a button needs to be brought to the outside
of the socket. One possible solution is shown
in figure 11-15 (next page).
3) Supracondylar cuff suspension or suspension
sleeve.
A cuff or belt is attached to the finished
prosthesis. A suspension sleeve can also be
attached.
The suspension types result in a different
donning/doffing approach
1) In the standard (supracondylar) solution, the
residual limb slides, while pushing the brims
slightly apart, into the prosthesis. When the
user has to little force to do so (for example
elder), or when the condyles are too sensitive,
a hole can be made in the prosthetic socket
after the fitting procedure. Through this hole,
a sock can be pulled, which assists in the
donning of the prosthesis. The hole has to be
finished to protect the (rigid) foam that will
otherwise wear too fast.
Figure 11-14: Height of supracondylar suspen-
sion.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
2) The second, more expensive solution, provides
an easier to use and in cases where pistoning
is a problem, more comfortable suspension.
Synthesis
This option can be used for people who are
sensitive, have less force, have problems with
pistoning or whose anatomy doesn’t allow for
supracondylar suspension with the integrated
brims. Before the donning of the prosthesis,
the user has to roll on the liner with the pin
Ideas
threaded in. The pin has to be positioned well,
because it has to lock in the shuttle.
3) If the integrated brim solution fails, and
finances are limited, a very functional and
quite comfortable (except in some case where
Concept
knee flexion (sitting) results in high forces in
the popliteal space [Seymour 2002]) solution
is the knee cuff.
Suction
Evaluation
suspension might be integrated in
the system in the future.
Cleaning & Cosmetics
Recomm.
Whether or not the prosthesis is cleanable
is mostly dependent on the outer layer (see
section 11.2). An extra outer layer could be
applied that makes cleaning easier. This extra
Conclusion
layer could also function as a cosmetic transi-
tion from the pylon to the foot (add an ankle
shape) and make the pylon more oval shaped.
105
 11.6 Production and price 11.6.1 Production costs per part Weight-bearing frame

Warning: Keep in mind that the estimations The Hylite, used for both the higher and
Interface frame lower production volume, is relatively expen-
in this section are quite rough.
The interface frame exists of two parts, each sive, but easily processed.

The production price and production method
is dependent on the amount of produced
parts (production volume). Estimations are
made for 1000 and for 10.000 pieces. For
this relatively low amount of pieces produced
(per year) the production can be out-sourced.
The estimated prices can be found in appen-
dix V.
in a left and right version. The frame parts
can be made by cutting and deep drawing.
When higher quantities are produced, the
frame parts can be injection moulded.
Fabrication liner
The basic version of the production liner for
the universal prosthesis (without pin/shut-
tle suspension) uses a simple tube on which
a distal end pad is welded together by sonar
heating. The distal end pad is made of sili-
cones.

Connector
For the lower quantities, the connector is
milled and drilled. For the higher quantities
a redesign might lead to a decent solution
that can be injection moulded (in high qual-
ity plastic, ceramic or aluminium). The inner
air seal has to be produced, other parts are
bought in.

Distribution Kit
In the kit, that protects the parts, extra com-
ponents can be found, such as manuals, gel
pads and a sock (also see section 10.4).

Figure 11-15: The shuttle for the pin/shuttle suspension can perforate the outer layer. The rings will
restore the system to an airtight state. The shuttle can be attached on most heights (with
106
varying circumference). During the fitting procedure the pin is locked in the shuttle.

This results in a production cost price of 110
(at 1000 pieces a year) to respectively 55 (at
10,000 pieces a year.
11.6.2 Development costs
It is clear that the costs of developing the
universal prosthesis will be primarily made of
developing costs. The way to a market-ready
product is long. Among others, to make the
prosthesis ready for the first market (cycle 1
section 6.3), time (FTE’s in brackets) should
be invested in (also see chapter 13):
- (1) researching the pressure tolerance of the
residual limb.
- (2) collecting data about residual limb vari-
ances, including bone-shape and soft tissue
properties.
- (2) development and selection of the right
materials.
- (2) optimizing the design of the components
and parts.
- (4) clinical trials.
- (2) re-evaluate and improve business-setup
and distribution strategy.
- (1) project management.
- (3) project office support.
This would imply that a team consisting
of about 17 full-time workers could launch
the universal prosthesis in one year. With a
FTE price (including accommodation, etc) of
47,000 Euro a year, the first cycle costs would
add up to 800,000 Euro. If 1000 universal
prostheses are sold for a period of 5 years,
this would be a 160 Euro increase of the cost
price of the product. For the next cycle (world
market), another development round of the
same magnitude (800,000 Euro)is expected
to be needed, resulting in an increase of 14.5
Euro a piece (over 11,000 sold prostheses a
year).
This results in a R&D and production cost
price of 370 and 70 Euros respectively.
The R&D prices can be lowered significantly
by intensive collaboration with big orthopae-
dic producers (who have a lot of knowledge
in-house and who can divide the R&D-costs
over multiple products), and by attracting
grants and subsidies.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
11.6.3 Marketing and Distribution
costs
Synthesis
Marketing will make the universal pros-
thesis a well known alternative for the
prosthetist. Sales and services are needed to
distribute the product.
Ideas
Marketing
The marketing, especially for the first cycle,
has to be pro-active and direct. The buyers
Concept
of the universal prosthesis are well known
(prosthetists, orthopaedic workshops, hos-
pitals, etc), so the campaign can be reason-
ably focussed. On the other hand, the end-
Evaluation
users or amputees need to be informed as
well, because they might opt for the universal
prosthesis while choosing the prosthesis that
will be fitted. Also, they have to know the uni-
versal prosthesis is available for them in the
Recomm.
case they need a spare one.
Conclusion
107
 For the second cycle, the initial buyers are
even better known (local workshops and
hospitals) and distribution or collabora-
tion with expert NGO’s, such as the World
Health Organization and the Cambodia
Trust Foundation has to be sought. A budget
for both marketing campaigns has to be
reserved:
Cycle 1: 100,000 Euro, resulting in an increase of
100 Euro and a total price of 470 Euro.
Cycle 2: 100,000 Euro, resulting in an increase
of 9 Euro and a total price of 79 Euro.
Sales and Service
The service has to be good, because this is an
important source for feedback. Feedback will
reduce design cycles and R&D-costs. Also, it
is the most important factor for a good cus-
tomer base.
Cycle 1: 4 FTE at 50,000 Euro a year, resulting
in an increase of 50 Euro and a total price of
520 Euro.
Cycle 2: 6x4 FTE at a mean of 25,000 Euro a
year, resulting in an increase of 55 Euro and a
total price of 134 Euro.
108
11.6.4 Conclusion
Keeping in mind that the estimations in this
section are quite rough, the expected costs
stay well within the requirements. For both
the prices (European/US and World market)
the R&D-costs are significant, but there are
possibilities to lower them by attracting
grants and by choosing the right business-
partners. Delivering a quality product will
result in lower costs on the long term, so cut-
ting down on the input in research is not an
option.
For the world market product, collabora-
tion with NGO’s such as the Red Cross, WHO,
Cambodia Trust Foundation, etc can further
lower the price. Costs of this product are
made up from service and sales for 40% and
from marketing costs for 7%. Collaboration
with well organized NGO’s can reduce both
costs significantly and the costs price of the
Universal Prosthesis could fall under 100
USD.

12 Evaluation
The concept as presented in chapter 11 can
be evaluated in several ways:
1) Review it against the criteria (section 7.1).
2) Review it against the requirements and the
additional goals (section 7.2-7.5).
3) Review it in comparison with other prosthetic
systems for transtibial amputees.
4) Have it reviewed by professionals (experi-
enced prosthetists).
5) Build a model and evaluate the design by
inspections
6) Build a working model (prototype) and try
that out in practise.
In section 12.1 evaluation method 1 and 3
are taken together and a discussion with the
requirements as a guide (method 2) is added
in 12.2.
In section 12.3 a model is presented that
was build. This model can be used for assess-
ing the shape of the frame parts (evaluation
method 5), but it is not able to provide weight-
baring (evaluation method 6). In section 12.4,
a conclusion is given in which remarks of
experts are integrated (evaluation method 4).
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
12.1 Scoring criteria in methods and designs to be compared:
1) PTB-resins (standard PTB)
comparison with other 2) PTB-ICRC
Synthesis
prosthetic systems. 3) PTB-Jaipur
4) The Universal Below-knee Prosthesis
In section 10.4, Table 10-1, a rough com- 5) ICEX-IDC
parison between the Universal Prosthesis, 6) ICEX-resins
the Ossur ICEX-system and a standard PTB-
Ideas
7) Hydro-cast/sand-cast
system was given.
This six can be weighted against the criteria,
However, the ICEX-system can be used with of which some are further specified:
direct fabrication on the residual limb (the
Concept
IDC-Icelandic Direct Casting system) and
without direct fabrication (with plaster of
1) Universal
Paris as shown in appendix N).
2 ) Comfort
Evaluation
Both systems use the Ice-cast Compact pres- A)Socket fit
surizing device as shown in figure 4-7 and B) Prosthesis weight
appendix N. C) Materials used and their effects (such as
perspiration).
Also, the PTB is produced in two ways. The 3) Easy fit
Recomm.
first is the vacuum technique with fibre rein- A) Easy fit Amount of steps needed to fit and
forced resins and the second is a polypro- produce a socket/prosthesis
pylene vacuum-forming technique. The latter B) Specific knowledge needed
fabrication method is used often in develop- 4) Control
Conclusion
ing countries, as a part of the ICRC (red-cross) 5 Usable
design, by the aluminium/wood hand pro-
A) Donning/doffing and suspension
duced Jaipur-system is very commonly used
B) Cleaning
as well (see Wisse et al. 2002,2003 for more
information about these production meth-
ods). Water-cast/sand-cast prostheses are an
important development, not to be neglected.
This adds up to the following production 109
 6 Safe
A) Design toughness
B) Toxicity of the fitting materials and the
interface for user and environment
7 Affordable
A) Material/component price
B) Service
8) Cosmetics
9) Quick fit
10) Distribution
These are all compared with the commonly
used PTB-resin system taken as a 100% refer-
ence-index. The resulting table can be found
in appendix Y, and a discussion per criterion
below.
Note that the final verdict about for example
affordability will be dependent on multiple
points in the table (7,9 and 10) and the situ-
ation that is reviewed (the market cycles as
mentioned in section 6.3).
110
1) Universal
The Universal prosthesis offers a TCB-PTY-
hybrid for amputees with a healthy residual
limb, within a specified range of residual limb
lengths, sizes and shapes. From data (appen-
dix G) this range is expected to be P10-P90.
For most of the amputees in this range it will
provide a comfortable fit, however problems
can be expected with amputees that:
- Have contractures (reduced knee movement)
because of the reduced alignment possibilities
of the prosthesis
- Have a bulbous residual limb shape.
- Have a deviating bone structure (for example
as a result of bone fractures).
- Have too little weight-bearing tolerance on the
interface with the frame (but just enough to
allow total contact weight bearing).
For the latter, a prosthesis could be fitted
without the user initially standing (with half
of his body weight supported) in it fully. All
these exceptions don’t add up to a group of
more than 10% of all transtibial amputees,
resulting in that the Universal Prosthesis is
expected to be suitable for about 70-80% of
all transtibial amputees that will ever find a
comfortable socket.
Of course, this needs to be validated in prac-
tise (see chapter 13).
The PTB-socket is, because all features are
hand made from direct measurements, suit-
able for all residual limb shapes, lengths and
seizes, al long as they result in enough weight-
bearing area’s (residual limb length is more
than 80 mm). In practise, not all amputees
fint the PTB-socket comfortable (because of
pressure concentrations and fabrication mis-
takes made by prosthetists). Probably around
90% of the fitted prosthesis will be experi-
enced as comfortable.
The same reasoning goes for the TCB-socket,
only with less influence of prosthetist-mis-
takes and a suitability of around 95% can be
assumed. The IDC-fabricated TCB-socket can
not be fitted to bulbous residual limbs and
will be confronted with roughly the same
problematic residual limbs as the Universal
Prosthesis.
The PTB-Jaipur system is made from drawing
and measurements and doesn’t have a distal
end pad. This results in higher pressures and
will the system is comfortable for a smaller
group than standard (70-80%).
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

2 A) Socket fit 2 B) Weight Conclusively, the weight-scores (compen-

Socket comfort depends on the users expe- The weight of the socket is highly depend- sated for the distal-weight) will all be close
together.

rience and therefore can not really be pre-
dicted. Also, it has to be mentioned here that
most literature (studies) in which prosthetics
are functionally compared are with only a
few subjects (n < 15) so significant data is
Synthesis
ent on the material used. This results in the
following order from light to heavy: carbon-
resins, glass-resins, either the Universal
Prosthesis or the PP-ICRC-sockets and the
most heavy being the Jaipur-socket. 2 C) Materials used and perspiration

limited. However, standard PTB-sockets are
found to be satisfying in most cases (lets say
80%) and TCB-sockets even perform a bit
better (85%).
The mass of the Universal Prosthesis frame
is nearly nothing (<200 grams), but the
socket will be filled with foam, increasing the
weight. The foam itself is expected to weight
Ideas
All sockets envelop the complete residual
limb. Also in all cases, the prosthesis will
be worn with socks or liners. The Universal
Prosthesis might feel more hot, because of

The Universal Prosthesis will have a combi-
nation of both, resulting in 85-90% comfort.
However, because of less optimal use of pres-
sure tolerant area’s and possibly a pressure
up to 1 kg, but more heavy are the fibre-rein-
forcements as proposed in section 11.2. Still,
the total prosthesis (without foot) is expected
to stay under 2 kg.
Concept
the isolating property of foam, however, after
a few days of wearing a prosthesis (even in
tropical countries) problems with perspira-
tion usually disappear. The Jaipur might feel

differences during the TCB-fitting (pressuriz-
ing the inner chamber of the prosthesis) as
a result of the frames being in the wat, this
percentage will drop to about 75-80%. Other
systems compare, except the Jaipur which
Evaluation
more foreign, because of the cold metal feel
In the endoskeletal prostheses, where the of the aluminium used.
pylon is separate from the socket, the pylon
can be either heavy or expensive. This is

performs a little worse due to the lack of
the distal end pad and due to the fabrication
method. Again, 100% is taken as all amputees
that can find a comfortable design.
Recomm.
important because weight more distally is
experienced more cumbersome (and will take
more energy during ambulation) that weight
more proximal. The Jaipur and the Universal
Prosthesis are the only exoskeletal systems

Conclusion
in this comparison.

The Universal Prosthesis’s connector can be

optimized by either taking by either taking
redundant material away or examining the
possibility to use other materials, resulting
in about the same weight for all connectors
used in the compared prostheses. 111
 3 A) Amounts of steps needed to fit
and produce the prosthesis
The Universal Prosthesis ant the ICEX-IDC
are two systems in which the measurement/
fitting and the fabrication method are inte-
grated. Comparing appendix N and other
sources on www.ossur.com with section 11.4,
they both need about the same amount of
steps to fabricate the sockets.
PTB-sockets have a separated fitting and
fabrication method, which does increase the
amount of steps needed. Because adjustments
are might manually, the socket often has to
be adjusted after fabrication. Even more so
for the Jaipur socket, which is hand-made
and adjusted many times, until a decent fit
has been achieved.
112
3 B) Specific knowledge needed
Specific knowledge is needed for all the sys-
tems to be fitted.
For the Universal Prosthesis, this is basic
knowledge, such as the preferred 5 degree
flexion of the knee and the right foot posi-
tions, can be communicated easily with
manuals with figures or with easy-to-use
measurement tools, such as the proposed fit-
ting-foot-board (see chapter 10). All other sys-
tems require advanced knowledge of biome-
chanics and the residual limb anatomy. Even
the pressure-cast/TCB-systems are produced
after the prosthetist has applied pressure
pads on the specific area’s of the residual
limb that need to be shielded from the pres-
sure. Additionally, the Universal Prosthesis
and the IDC prosthesis do not require knowl-
edge about the fabrication technique used, in
contrast with the other systems.
4) Stiffness
All current socket systems can be assumed
to be almost equally stiff, because the socket
designs are optimized that way. The resins
will be slightly stiffer that the ICRC and the
Jaupir, but not very significantly. The stiffness
of the Universal Prosthesis is for the biggest
part dependent of the function of the foam.
The foam has not been developed yet, so the
stiffness cannot be assessed. However, with
the suggestion from section 11.3, a sufficient
stiffness seems to be feasible. The Universal
Prosthesis can always be made stiffer, by
coating it with fibre reinforced resins, but at
the cost of weight and size. Also, more straps
can be added. Note that the strap at 100 mm
below patellar tendon as shown in appendix
R-12, cannot be found in the final design. It
is expected to be unnecessary, until proven
otherwise.
By mechanical principle, the exoskeletal
designs are more stiff than the endoskel-
etal designs. The Jaipur and the Universal
Prosthesis score well here, but overall stiff-
ness (control) is not expected to improve sig-
nificantly by this.

5 A) Donning, doffing and suspension
The donning/doffing-ease is dependent of
the suspension type. In the comparison table,
all possible suspension types of each system
is shown. Except for the designs made for
developing countries (ICRC, Jaipur), each can
be fitted with all popular suspension systems.
Beside this, no real differences for donning
and doffing can be identified.
5 B) Cleaning
All modular/endoskeletar systems can be
more difficult to clean, because of the attach-
ment points. However, most systems are
finished with a cosmetic cover, eliminating
problems. The Universal Prosthesis does not
really provide a good protection for the tran-
sition between the connector and the foot.
Something that might prove easy to solve,
either by adding a cosmetic cover for the
complete prosthesis or the ankle piece only.
The Jaipur-system consists of many material
(finished with leather and paint) and is most
difficult to clean.
6 A) Toughness
The frame parts of the Universal Prosthesis
can easily be bended in transverse directions.
However, Appendix S shows that they will not
buckle. Performance will improve after the
fitting procedure, because of the filling of the
soft socket. Long term outcome (more than
2 years under dynamic loading) has to be
assessed experimentally. All prostheses can
be assumed to be safe. Some problems with
ICRC prostheses have been observed when
they where produced with recycled PP.
When the prostheses fail, their failure will
probably be tearing of the material (espe-
cially so with the exoskeletal systems), so that
the user will have time to notice and does not
fall.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
6 B) Toxicity of the fitting
materials and the interface for user
Synthesis
and environment
Toxicity of the materials used is an impor-
tant factor during use and during the fit-
ting method, both in respect to the user/
prosthetist as to the environment.
Ideas
The used materials in all prosthetic compo-
nents are generally non-toxic to humans.
However, glass-fibres, epoxy and especially
Concept
polyester resins are difficult and dangerous
to work with.
The
Evaluation
heating and forming of the PP is not
dangerous, when performed well.
Most methods (PTB,ICEX-resin, ICRC, hydro-
cast) use plaster of Paris to cast and fabricate
Recomm.
positive and negative moulds of the residual
limb to form the socket around. The impact
of plaster of Paris on the environment is low.
The Universal Prosthesis uses foam which is
Conclusion
non-toxic. In addition, the prosthetist and the
user cannot come into contact with it.
113
 The Universal Prosthesis doesn’t produce
much residual material and powder, except
for the aerosol spray with probably some
spare foam left in it.
When discarded (end-of-life of the prosthe-
sis), the Universal Prosthesis is difficult to
recycle. After fitting, the socket has become
a mix of glass fibre, foam PP, aluminium, ABS
and PU. Also the resins-based prostheses
cannot be recycled. The Jaipur, made of basic
material can be recycled best. The PP used in
the ICRC-design can be recycled as well.
7 A) Material costs
Material prices are taken from 11.6, 3.3.1
and Wisse et al, 2004. They are summarized
in the comparison table. For the comparison,
the high (first-cycle) Universal Prosthesis
price is taken, in which a budget for research
is taken in account.
114
7B) Service
Except for the ICEX (system from Össur) and
the ICRC (from the International Committee
of the Red Cross, factories in Switzerland and
Ethiopia) the presented systems are widely
available from a broad range of suppliers.
This implies that the prosthetist should
deliver service and guarantees about the
fit and comfort level. Knowledge about and
experience with the fitting procedure is
spread and varies in quality, but the amount
of prosthetists that are known with the sys-
tems is huge.
The Universal Prosthesis and the ICEX-sys-
tems both have a centralized selling strategy,
better enabling feedback and future develop-
ments. Service in respect to material quality
(for example wear resistance) can be consid-
ered equal for all components, except for the
Jaipur system, which is 100% dependent on
the local workshop.
8) Cosmetics that all technicians and prosthetists have
Cosmetics is most important during daily
use (how does the finished product look), but
also before and during the fitting procedure
(trust of the user and the prosthetist in the
system might depend on it).
B asically, all systems can be fitted with a
(foam) aesthetic cover. Only the Jaipur system,
though looks are acceptable because of the
paint and because it is the only affordable
system with a life-like foot under it, scores
worst. It has a make-shift look.
The Universal Prosthesis is thicker than the
average prosthesis, which might show, even
when the prosthesis is worn under a pair of
trousers. The frame does show that it has
been thought about, tough that won’t be vis-
ible anymore after fabrication.
9) Quick fit
The time-consumption of the prosthetist
and technicians is related to the amount of
steps taken to produce the socket (see point
3). Times of standard PTB and ICEX-IDC
are known from literature (see section 3.3).
Estimations for other systems can be found in
the comparison table. It has to be emphasized
to be educated, except in case the Universal
Prosthesis is used. This is also true for the
Jaipur-socket. Its fit is highly dependent on
the skill of the technician.

10) Distribution
How well the system can be distributed is
dependent of:
- the tools needed
- the compatibility with currently used systems
- services (see point 7B)
- life-time/visits needed per year
- and of course the dependency of the system
on the infrastructure (such as water, electric-
ity, etc) and on the availability of prosthetists.
From the list, the tools and service types are
specified in the table.
The life-time of all systems can be taken as
1 to 5 years (dependent on the activity of the
user, with a mean of 2.5 years), which is com-
parable to the use of a pair of shoes.
The current design for the Universal
Prosthesis might have a shorter life-time, but
a decent optimization and the right choice
of foam will result in a lifetime in the same
order.
All systems are well compatible with com-
monly used connection systems (such as the
pyramid connection core) except the ICEX-
IDC (standard distributed with Össur com-
ponents) and the Jaipur (though the used
woodblock can be adapted at will by the tech-
nician).
12.2 Evaluation the concept
against the requirements.
The requirements and design goals as pre-
sented in chapter 7, are divided per cycle.
During this project a concept was developed
(chapter 11) that should comply with cycle
0. All requirements for cycle 1 and 2 where
design goals, but not required as such. Also
the requirements where catagorized by pros-
thetic component or part. Hereafter follow
remarks about the concept where necessary
and which are not discussed in section 12.1
or where the Universal Prosthesis is expected
to perform as well as a PTB-standard design.
The Posterior side of the soft-socket:
The prosthesis can be donned seated, cer-
tainly when only reviewing the hard frame. It
can be that the soft frame will be too long
at the posterior side, because the fabrication
liner can stay in between the brims (figure 12-
1). In that case, some of the fitted and hard-
ened prosthesis might need to be removed.
Or an extra brim has to be developed that
keeps the foam below while hardening and
pressurizing.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The Flexible socket:
The frame parts can be adjusted by the
Synthesis
prosthetist, either by plastic deformation of
the hard frame parts) or by heating the inter-
face frame parts. The small distal ends of the
interface frame parts can easily be adjusted
to provide extra weight-bearing, and no spe-
Ideas
cial knowledge is needed. However, changing
the proximal end of the interface frame parts,
needs experience and insight, and is not rec-
ommended (nor necessary) for the un-expe-
rienced. The flexibility is added to the design
Concept
to facilitate the acceptance of the system by
current prosthetists.
Evaluation
Recomm.
Conclusion
Figure 12-1: A high posterior socket as a result
of the fitting of the soft socket. The
brims will keep the fitting liner high
(dotted lines).
115
 The Advanced fit sock:
The fit sock can be further developed, so
that it is thickened at places where the even-
tual pressure will have to be lower than the
pressure used during the foaming of the soft
socket, especially the distal end. This will
result in a bit more distance between the
residual limb and the fabricated socket. After
fabrication and without wearing the special
sock, the pressure in those area will be lower
than that used during the filling of the soft
socket. This sock is comparable with the gel
pads used during the fabrication of the ICEX-
socket.
The Mechanical properties of the
pylon:
It has to be mentioned here, that analysis
of the mechanical properties of the pylon is
incomplete. A working model has to be build
and tested, to see if the pylon/socket combi-
nation comes up to the requirements.
The whole design of the pylon might have to
be rotated (about 5 degrees) to take the opti-
mal 5 degrees of knee flexion in account. This
is not so in the concept, the frame shapes
have been derived from a stretched leg.
116
Cycle 1 Prices:
Tough the maximal total price for the system
is correct and the concept does complies with
it (see section 11.6), the maximal production
costs of the parts is formulated completely
wrong. For example, the socket mentions a
total production cost price of maximal 500
USD. This has to be either the price inclusive
R&D, or a percentage of the total production
costs price. For example, the production cost
price of the socket should not be higher than
80% of the production cost price of the total.
Market share:
For Cycle 1 a price was calculated with 1000
pieces sold a year for 5 year, resulting in an
break-even price of 700 Euros. For Cycle 2 a
break-even price of 200 was calculated with
10,000+1000 sold a year for 5 years.
These amounts of products sold are huge for
the prosthetic market. For cycle 1 the market
size
1.416.000 Amputees in Europe (see appendix F)
X 54% which have a transtibial amputation (see
appendix F)
X 70% that can be fitted with the UPis (see 12.1-
1)
X 0.4 new prostheses needed a year for each
amputee (see 12.1-10)
= 215.000 prostheses a year (total market size).
This is a market share of 0.47%, which is a lot
considering:
- The current prosthetists have been using the
current system for over 20 years.
- It will be difficult to reach all amputees in
Europe.
- In Lower-income countries such as Rumania
and Poland, the price of 700 Euro is high in
comparison to the hour-price of technicians
and prosthetists.
For cycle 2 the total market size adds up
2,300,000 pieces needed worldwide a year,
with the same calculation:
This is a market share of 0.48%, which is a
lot considering:
- The current prosthetists have been using the
-
current system for over 20 years.
Worldwide a lot of initiatives exist to promote
the education of prosthetists.
- It will be impossible to reach all amputees.
- The price of 200 Euro or even 100 Euros can
be considered high. Development of cheap
systems that work on known systems (PTB-PP
for example), with cheap components is being
conducted and prices of other systems are
expected to drop.
These market shares can only be reached
within the 5 year periods when using exist-
ing distribution channels, such as that of well-
known companies or in this field operating
NGO’s.
 The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

12.3 Model and Fit of the

Frame

Synthesis
Shape
If we evaluate the shape of the interface
frame, two things can be noticed. One, the

Ideas
model is slightly to big. This is an effect of
the slices used of the Visual Human project.
These were bigger than P95, probably
because of conversion mistakes (see appen-

Concept
dix R-10).

Secondly, the interface frame performs well

in avoiding the pressure-sensitive areas and

Evaluation
loading the pressure tolerant areas. The
exception to this is the lateral place is the lat-
eral edge of the lateral tibial condyle (figure
12-2). This load is the result of the need to
connect the interface parts as defined in

Recomm.
section 11.1.3. This place should be avoided
better, possibly by increasing the distance
between the interface frame and the residual
limb.

Conclusion
Figure 12-2: Assessing the fit of the interface frame parts. 117
 Flexibility of the weight-bearing
frame

The model that has been build demonstrates

that the first 200 mm from PT, the shape of
the frame parts contributes to the strength
and stiffness. Even when thermoformed, the
frame parts do have enough flexibility to
accommodate for a wide range of circumfer-
ences at patellar tendon height, while staying
in shape, so that the pressure-tolerant areas
are loaded, and the pressure-intolerant areas
are avoided.

However, the posterior weight-bearing

frame is too flexible from 200 mm below PT
and downwards. This can be solved, either
by adjusting the material used, or by adding
a rib. The anterior frame does perform well,
as a result of the shape that it has to follow
the tibial crest. Giving this shape to the two
extensions of the posterior frame is another
good option to improve weight-bearing per-
formance. Additionally, a second connec-
tor can be added, that can be used for long
amputees at PT-260 mm.

Figure 12.3 gives an impression of the

model.

Figure 12-3: Impression of the model build.

118

12.4 Project evaluation
Building from base
Looking back, it becomes clear that at the
beginning of the whole trajectory toward
the Universal Prosthesis (the design-for-all
subject, the internship in Sri Lanka and the
graduation project), all knowledge has been
gathered from base.
Producing aluminium frame sockets in Sri
Lanka, with anvil and hammer, was neces-
sary to learn the properties of the materials
and of the human body.
Being in Sri Lanka was necessary to learn
what the wants and musts are of both
prosthetists and users worldwide. In this
project, the target was not to develop a cheap
but inferior product for developing countries.
Instead, the aim was to develop an excellent
performing product for a good price that an
be used worldwide.
Keeping
the vision of the Universal
Prosthesis clear and keeping trust in the
intuitive notion that this vision is good, in
spite of negative advices of some individu-
als, was needed to keep going on until the
needed technological innovations were con-
ceived. Listening to other people is essential
but never without listening to your own intui-
tion.
Independency
This back-to-base strategy was needed to
come up with a completely new system. In
current day scientific research (also see sec-
tion 13.1) the focus is too much on FEM-anal-
yses and modelling and functional outcome
analyses between PTB and TCB-sockets. This
also explains why this project was done by an
industrial design engineer, and not by a team
of prosthetists. Prosthetists know too much
to even think about making a low-expert
system.
Now the most innovative steps have been
taken, and the system needs to be optimized,
bringing a team together of prosthetists, engi-
neers, market experts, etc is the only way to
ensure a practical and high-quality product.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
The road to innovation
Around 1950 the quadrilateral AK-socket
Synthesis
and the PTB-socket were developed (also
see appendix E). These socket designs were
two of the few fundamental innovations in
prosthetics after WWII. It can be said that
these and other important innovations are
Ideas
the work of a small group of people, one of
them being J. Foort. In appendix X, the story
of his experiences can be found. I found read-
ing them really intriguing, because the devel-
opment methods and processes he describes
Concept
highly resemble the methods and processes
of this graduation project. A few quotes to
give an impression:
Evaluation
Recomm.
Conclusion
119
 13 Recommandation
In the evaluation it has become clear, that
the concept presented in this report needs to
be further improved (better properties) and
further developed (made market ready). In
section 13.1 recommendations for fundamen-
tal research that needs to be conducted can
be found. Section 13.2 offers specific sugges-
tions for improvements of the universal pros-
thesis.
Section 13.3 discusses possibilities on how
to continue the development of the universal
prosthesis.
13.1 Fundamental research in
prosthetics.
All interface design starts with knowledge
about human behaviour and the human body
and its properties. Prosthetists make prod-
ucts for people. The prosthesis replaces a
(lost) body part and restores a function that
is lost and is needed for the participation of
the user in society. Logical, it seems.
120
The lack of knowledge about pressure
tolerances
Now, the amazing part of the story is that
fundamental knowledge about the anatomy
and properties of the human body (needed
to design an interface) in literature is either
extremely out-dated and lacking or not
public available. Ming Zhang concludes in
his overview of FEM-analyses [Zhang 1998],
that mechanical properties of the soft tis-
sues are little known. A bigger question is
the tolerance to load of the tissue. Zheng
in “state-of-the-art methods for geometric
and biomechanical assessments of residual
limbs: A review” states: “While FE analysis
can estimate the stress distribution within
the residual limb and the socket interface, it
cannot tell us whether a stress distribution is
good or not. A good interface stress distribu-
tion should facilitate effective load transfers
during gait and should be well tolerated by
the residuum soft tissues. Such tissue toler-
ance involves tissue damage criteria and
tissue adaptation mechanism in response to
external loading. How residuum tissues react
and adapt to external loading deserve much
further investigation.“ While FEM-analyses
are numerous, nobody actually knows what
pressure distribution they are looking for.
The lack of knowledge about shape
and property variances
For the development of the Universal
Prosthesis, the data that was gathered in Sri
Lanka (appendix G) was of utmost impor-
tance. It was assumed that the bone-structure
for everybody is the same and only propor-
tions (scale) differ. This assumption has to be
validated.
This can be achieved by scanning the limbs
of a range of people (N>100). Scans can be
made with CT or MRI. Other (less preferred)
approaches are the study of corpses and
the study of 2D-X-ray images. These people
don’t have to be amputees, though this would
improve the data.
Better insight in the variance of the bony
structure and the soft tissues of people leads
to a better optimized interface frame fit, and
a better overview of the group for who the
Universal Prosthesis would provide a com-
fortable solution.

The PTB-TCB battle
This lack of knowledge about whether a pres-
sure distribution is good or not results in a
battle between promoters of the PTB and
promoters of the TCB-system. Comparative
studies are being conducted but with a small
population in subject groups.
Worse, the studies that are conducted are
functional outcome studies in which both
sockets are fabricated for the same subject
(in which a slight, but often insignificant
preference for the TCB-sockets can be seen).
However, the PTB-socket is a hands-on socket
design, which means that the experience
and the knowledge of the prosthetist are the
determining factor. The prosthetist will make
“mistakes” which results in a negative outcome
bias for the PTB-socket . The TCB-socket on
the other hand is a hands-off socket design.
There is less chance that the fit will not be
optimal after the fitting procedure.
These two factors should be split and studied
separately:
- A study determining the functional outcome
differences between hands-off and hands-on
systems.
- A study determining the functional outcome
between rectified and unrectified systems
(such as the PTB and the TCB sockets).
Before the development of the Universal
Prosthesis this could be achieved by:
- Comparing hands-on and hands-off produced
TCB’s.
- Comparing hands-on produced PTB’s with
hands-on produced TCB’s.
Now, because the Universal Prosthesis is a
hands-off produced PTB also it can also be
compared with hands-off produced TCB’s.
None of the mentioned comparisons have
been made in literature.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
13.2 Improving the Universal
Prosthesis
Synthesis
The frame
When more data about the variance in
residual limb shapes and tissue structures
Ideas
and more data about the pressure tolerance
of residual limb tissue is obtained, the frame
shapes can be optimized in respect to anat-
omy.
Concept
FEM-analyses can be a valuable tool for the
optimization in mechanical properties. Ribs
on the frame parts, especially the injection
Evaluation
moulded interface frame parts, can improve
their properties significantly. It might be nec-
essary to add more connective belts between
the weight-bearing frame parts.
Other materials might prove more suitable
Recomm.
for the frame. For example, Hylite could also
be used for the interface frame, while glare
or possibly normal aluminium could improve
Conclusion
the performance of the weight-bearing frame
parts.
121
 Improvements would include:
- a better, more comfortable fit
- a wider group that can be fitted with the
Universal Prosthesis (bigger target group)
- a lighter prosthesis
- a stiffer prosthesis (more control)
The soft socket
Absolute priority is the development and
testing of the foam that will fill the prosthe-
sis. Without a proper foam, the complete con-
cept fails. The posterior side of the prosthesis
might prove to be in the way for donning/
doffing and sitting as shown in figure 12-1.
Cosmetics
C osmetics after fabrication of the Universal
Prosthesis can and needs to be further
improved. A prosthetic cover can be put
over the outside, but it can also be put inside
the prosthesis. In that case the fitting liner
is pulled over the frame and the cosmetic
socket. Another option is to integrate it in
the frame (as was the intention). Now, the
problematic shape difference between the
Universal Prosthesis and a natural leg occurs
near the connector, where the frame is too
triangular.
122
Cost reduction
To make the Universal Prosthesis a real suc-
cess in cycle 2, it have to overcome the high
competition during cycle 1 (section 6.3). A
lower price would give the system the edge
over the ICEX-system it needs. Costs can be
reduced by smart use of subsidies and grants.
Also, this project might best be developed in
universities. In that case, initial investments
needed for R&D are lower, but the problem
might be that no companies are willing to
take the risks that come with production,
because the design is not patented or pro-
tected otherwise, as discussed in the next
section.
13.3 Project continuation
There are basically three realistic options to
continue this project:
1) Find an enthusiastic entrepreneur, that is
willing to start a company, bring together
several business-partners, such as a orthopae-
dic workshop, a hospital, a knowledge insti-
tute (university) and try to start independent
production of the Universal Prosthesis. The
success of this enterprise would be highly
dependent on the amount of subsidies and
grants that can be attracted.
2) Find a big player in the current market, such
as Otto-Bock or Össur, and start in-house
development of the Universal Prosthesis as a
new addition to their assortment.
3) Try to encourage America/Canadian
research institutes, such as the US National
Rehabilitation Information Center, to take up
the project and develop it further with help of
the world-wide prosthetic scientific research
community.

O ption two is preferred, because in this
way quality and development speed of the
Universal Prosthesis can be controlled. Also,
when production is started, a company
will benefit most by wide-spread use of the
system and will actively promote it. Contact
has been sought with Össur to discuss this
possibility. However, to make commercial
exploitation feasible on a broad scale, protec-
tion of the intellectual property is a must. A
patent is a way to protect the knowledge. It
has to be emphasized that the development
of the Universal Prosthesis will cost consid-
erately and that the investments for this R&D
will have to return to the entrepreneur to
ensure future developments and continues
production.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
It might well be that the time just is not ripe
for the Universal Prosthesis to appear on
the market. Tough the tendency (trend) of
Synthesis
the branch towards standardized systems,
with customized results has been identified,
prosthetists still keep using their well known
systems, such as the PTB-resin system.
And why not, it does perform well, and the
Ideas
needed knowledge to fabricate them has
been invested in (years of training by exactly
those prosthetists). The negative attitude
towards the new systems by some (and the
Concept
naïve positive attitude to new technologies by
others) can even be read between the lines
in literature publications. It takes time for the
prosthetists to realize that with the Universal
Evaluation
Prosthesis (and other low-expertise systems)
their knowledge doesn’t become obsolete,
but that it can be used better and with more
effect elsewhere.
Recomm.
Conclusion
123
 14 Conclusion

“I urge you to do this – aim for universal solu-
tions “ J. Foort, Appendix X.
Is the development, production and distribu-
tion of an Universal Below-Knee Prosthesis
feasible?
Yes it is.
But the road is long.
14.1 Strengths
The Universal Prosthesis has some unique
features or Unique Selling Points (UPS). Its
strongest point is that the Universal Below-
Knee Prosthesis combines a customized, com-
fortable fit with a low-expertise fitting proce-
dure. This strength fits in the market trend
toward standardized systems that provide a
customized fit.
COMFORT:
The Universal Prosthesis combines the
Total Contact Bearing (TCB) and the Patellar
Tendon Bearing (PTB) weight-bearing prin-
ciples. During the fitting procedure, the
amount of pressure added during the filling
of the soft socket, will determine if the pros-
thesis will behave more like a TCB or more
as a PTB socket. This flexible system ensures
that a wide range of amputees can be fitted
with a comfortable prosthesis.
QUICK:
The Universal Prosthesis can be fitted within
an hour. The efficient use of the prosthetist’s
time, can lead to cost reduction and better
overall healthcare in current orthopaedic
workshops. Patients for which a prosthesis is
now regarded as too expensive or time-con-
suming (for example bed-staying elder, with
a bad prognosis), can be fitted more easily.
Also, the amputee can be a prosthesis more
often, for example during the post-operative
period (1-6 months after amputation) or as a
spare one when the custom-made prosthesis
is being repaired or being replaced.
LOW-EXPERTISE:
The Universal Prosthesis can be fitted by
relatively un-educated people. This unique
features addresses the lack of experienced
prosthetists worldwide. The educated
prosthetists can use their valuable time to
solve orthopaedic problems for people with
non-standard BK-amputations. In the long
run, more people can benefit from proper
prosthetic care.

124

14.2 Project progression
The here-presented concept if far from fin-
ished. A lot of fundamental questions have to
be researched to improve the base of knowl-
edge on which this innovation is build. Apart
from that, the frame parts have to be opti-
mized and the formation of the soft-frame,
by filling the prosthesis with foam, has to be
developed from scratch. When the first series
of prostheses become available clinical/field
test have to make sure the procedure is
indeed understandable and efficient when
performed by non-experts. After that, bring-
ing it to other markets, other cultures and
other environments brings along a complete
new set of challenges.
Commercial feasibility
It is clear that a huge amount of research
and development work has to be done before
the Universal Prosthesis can be a qualita-
tive system, that has an edge over other cur-
rent prosthetic systems. And R&D-work is
an expensive investment that needs to be
returned by the revenues of the product.
With 2 x 800.000 Euros R&D-investments,
the Universal Prosthesis can be developed.
Return of investment is possible when sell-
ing 1000 Universal Prostheses for 5 years at
a price of 700 Euros and then selling 11,000
pieces a year for 5 more years at a price of
100-200 Euros. These market share of 0.47%
will be difficult to reach. Strategies to do so
include:
- Cutting down on R&D-costs by attracting
grants and encouraging many parties to par-
ticipate.
- Get support from existing distribution net-
works, including NGO’s, producers of pros-
thetic components and governments.
- Integrate the Universal Prosthesis into an
assortment of prosthetic systems, components
and methods, so that the R&D costs can be
spread over a group of products.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
14.3 Final word
History learns us that innovation in socket
Synthesis
designs doesn’t occur often. However, innova-
tions that occurred, such as the PTB-socket
and the quadrilateral socket, did become
mainstream. These innovations were not pat-
ented, were not commercialized, but were
Ideas
developed by a relatively small group of
enthusiastic scientists and practitioners.
Because the Universal Prosthesis is a prod-
Concept
uct that will only be economically feasible
when produced in large quantities, for this
new innovation commercial exploitation
might be the best option.
Evaluation
I know that the development of the Universal
Prosthesis is not finished. But I feel that the
here presented concept is a good step towards
the next generation of prostheses. Whether
Recomm.
the concept is freely developed or com-
mercialized, I believe that within 10 years,
many people can benefit from the Universal
Prosthesis or similar innovations. And I hope
Conclusion
that some of the 1,000,000 people that cur-
rently are without proper prosthetic care, will
be able to walk once more.
125
 R References
- Wisse BM, WD van Dorsser, F Soleymani, Prosthesis for Sri Lanka
– Prosthesis for tibial amputees focused on the 3rd World, Delft, 2002
- Wisse BM, WD van Dorsser, The Alternative Prosthesis – final report
internship Sri Lanka 2002, Delft, 2003
- Seymour R, Prosthetics and Orthotics: lower limb and spinal, USA:
Lippincott Williams & Wilkins, 2002
- IMT-Baghdad, Institute of medical technology department of rehabili-
tation, Baghdad, Iraq, Education for orthopedic technician, Part 1
– Symes and partial foot prostheses and below knee prostheses, year
unknown
- CBS, Centraal Bureau voor de statistiek, Statistisch Bulletin, 60e jaar-
gang no. 5 / 3 februari 2005
- CBS, Centraal Bureau voor de statistiek, Statline online database (web-
site): statline.cbs.nl, 2005
- IEE, Medical Equipment Industry-potential for growth, edited by pro-
fessor Alan Murray (Freeman Hospital), 1998
- VHI, Veteran Health Institute, Traumatic Amputation And Prosthetics,
Independent Study Course, May 2002
- Weeks DL, Preliminary Investigation Comparing Rectified and
Unrectified Sockets for Transtibial Amputees, Journal of Prosthetics
and Orthotics 2003; Vol 15, Num 4, p119
- Fisher SV, G Gullickson Jr., Energy cost of ambulation in health and
disability: a literature review, Archives of Physical and Medical
Rehabilitation. 1978 Mar; 59: 124-133.
- Angarami GR, An Efficient Low Cost Prosthetic Structural System,
Journal of Prosthetics and Orthotics 1989; Vol 1, Num 2, p86.
- Valenti TJ, Experience with Endoflex: A Monolithic Thermoplastic
Prosthesis for Below-Knee Amputees, Journal of Prosthetics and
Orthotics 1991, Vol 3, Num 1, p43.
- Schoppen T, Physical, Mental and Social predictors of functional out-
come, Rijks Universiteit Groningen 2001
- ACA, Amputee Coalition of America, FirstStep 2001, www.amputee-coali-
tion.org/aca_first_step.html.
126 - Kriesels M, Protheses voor Sri Lanka uit fietsonderdelen, 2002, please
contact the writers for more information
- UK NHS, 2005 (website): www.pasa.doh.gov.uk/prosthetics/
- Walsh TL, Custom Removable Immediate Postoperative Prostheses,
Journal of Prosthetics and Orthotics 2003; Vol 15, Num 4, p158-161.
- COTA, Centrum voor Orthopedie Techniek Amsterdam, De Softsocket,
2002
- Hafner BJ, JE Sanders, JM Czerniecki, J Fergason, Transtibial energy-
storage-and-return prosthetic devices: A review of energy concepts
and a proposed nomenclature, Journal of Rehabilitation Research and
Development 2002; Vol 39, Num 1, p1-11.
- Michael JW, JH Bowker, Prosthetics/Orthetics Research for the
Twenty-first Century: Summary 1992 Conference Proceedings, Journal
of Prosthetics and Orthotics 1994; Vol 6, Num 4, p100.
- Sangeorzan BJ, Harrington RM, Wyss CR, Czerneicki JM, Matsen FA,
Circulary and Mechanical Response of Skin to Laoding, Journal of
Orthopaedic Research 1989, Vol 7, p425-431
- Foort J, 1986, Innovation in prosthetics and orthotics, The Knud
Jansen Lecture, Copenhagen 1986
- Kim WD, Lim D, Hong KS, An evaluation of the effectiveness of the
patellar tendon bar in the trans-tibial patellar-tendon-bearing
prosthesis socket, Prosthetics and Orthotics International 2003, Vol 27,
p23-35
- Reswick JB, Rogers JE, Experience at Rancho Los Amigos hospital
with devices and techniques to prevent pressure sores, Bedsore
Biomechanics, 1975
- Convery P, Buis AWP, Socket/stump interface dynamic pressure
distributions recorded during the prosthetic stance phase of gait of
a trans-tibial amputee wearing a hydrocast socket, Prosthetics and
Orthotics International, 1999, Vol 23, p107-112
- Zhang M, Mak AFT, Roberts VC, Finite element of a residual lower-
limb in a prosthetic socket: a survey of the development in the first
decade, Medical Engineering & Physics 1998, Vol 20, p360-373
- Datta D, Harris I, Heller B, Howitt J, Martin R, Gait, cost and time
implications for changing from PTB to ICEX sockets, Prosthetics and
Orthotics International 2004, Vol 28, p115-120.

F Figures & Tables List
Tables and figures
Table 2-1: Project targets before and after the Sri Lanka internship
[Adjusted from Wisse et al. 2003, Chapter 5] (For a complete
timeline see appendix C). 2
Figure 3-1: The prosthesis and its total context. 6
Figure 3-2: Bones of the lower limb (most right), muscles (middle) and
anatomy of the residual limb (below) [Adapted from IMT-
Baghdad and Wisse et al. 2002]. 7
Figure 3-3: Amputation procedure [Seymour 2002]. 8
Figure 3-4: Different levels of transtibial amputation [Seymour 2002]. 8
Table 3-1: Amount of amputees worldwide. 9
Figure 3-5: Residual limb shapes: conical (a), cylindrical (b) and bulbous
(c). [Seymour 2002] 10
Table 3-2: Skin conditions. 11
Figure 3-6: Pressure tolerant and sensitive areas. Most left: A scematic
of sensitive (light red) and tolerant (dark red) areas [Seymour
2002]. 4 Right: anterior, lateral, anterior and medial view of
a positive (cast), with pressure sensitive (red) and to 12
Figure 3-7: Base of support. The size of the base of support varies with
a change in foot position. [Seymour 2002] 13
Figure 3-8: Static alignment for a transtibial prosthesis. A) In the fron-
tal plane, B) In the sagittal plane. [Seymour 2002] 13
Figure 3-9: Inclination of the bulge of the PTB (see section 4.2) socket.
The bulge provides more surface for weight bearing than
the wall of the socket. Note the relatively longer horizontal
component of the vector. [Seymour 2002] 14
Figure 3-10: Forces on the patellar tendon increase because of the
need to compensate moments due to distance a and b and
because the inclination of the force factor on the patellar
tendon [Wisse et al .2002] 14
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Figure 3-11: Alignment of the transtibial prosthesis in the sagittal plane,
placing the foot medial to the socket. This placement tends
to cause a rotation of the socket that then places pressure
Synthesis
on the proximal medial and distal lateral residual limb. 15
Figure 3-12: Alignment in the sagittal plane placing the foot lateral to the
socket, resulting in pressure on the fibular head and distal
medial residual limb. [Seymour 2002] 15
Figure 3-13: Alignment in the frontal plane. Left: normal. Right: Foot
placed to far backward, causing pressure on the distal ante-
Ideas
rior part and proximal posterior part of the limb. 15
Figure 3-14: Alignment in the frontal plane. Left: normal. Right: Foot
placed to far forward. If the force though the spocket fell
posterior to the ground reaction force vector, the prosthesis
Concept
would tend to rotate. 15
Figure 3-15: Planes of the body. [Seymour 2002] 16
Table 3-3. Phases in gait. [Seymour 2002] 16
Figure 3-16: Distance variables of giat. a) left step length, b) left stride
Evaluation
length, c) right stride length, d)right step length, e) width
of base support f) Right toe-out, g) left toe-out [Seymour
2002] 16
Table 3-4: Phases of the gait cycle of the right leg. [Adjusted from
Seymour 2002]
Recomm.
Figure 3-17: Gait deviations to accommodate a long limb. A) Hip hiking,
B) Lateral trunk lean, C) Circumduction, D) Vaulting, E)
Excessive hip and knee flexion. [Seymour 2002] 18
Figure 3-18: Procedures of a prostetic clinic [Adapted from Seymour
Conclusion
2002] 21
Table 3-5: Grow indexes of the sales in the medical equipment indus-
try in the Netherlands [CBS 2005]. 22
Table 3-6: Market for prostheitc devices in the Netherlands [CBS
2005]. 22
127
 Table 4-1: An overview of clinical patient stage and applicable prosthe-
sis type. In practise, the choice is less time dependent, but
is determined by the healing rate and activity level of the
amputee. 24
Figure 4-1: Fabrication of a RRD and Custom Removable IPOP. Left: 3
spandex socks, pads and an attachment plate, 3 velcro
straps and attachment base plates. Middle: fiberglass cast
with cut lines and base plate attachment points and the
result. Inset: ant 25
Figure 4-2: A complete IPOP (without pylon). [Source: Seattle Rehab
Research, US Veteran Affairs] 26
Figure 4-3: The universal IPOP (Aircast Air-limb) is inflatable to acco-
modate different stump sizes. [source: ACA 2001, Aircast
brochures] 26
Figure 4-4: The Flow-tech Adjustable Postoperative Protective and
Preparatory System (APPOPS) provides a prefabricated
prosthetic system offering protection, controlled shaping of
the residuum and early rehabilitation.... 27
Figure 4-5: Connective part between socket and pylon, which can be
used in temporary and definite prostheses. [Source: Endolite
brochure] 28
Figure 4-6: Components of Maramed orhopedic Systems. Left: X-tender
system can be used as a temporary prosthesis(middle).
At the right a retainer is shown, in which a custum-made
socket can be attached. [Source: Maramed website] 28
Figure 4-7: The ICEX toolbox and component box. [Source: Ossur web-
site] 29
Figure 4-8: Standard fabrication starts with taking a negative mold.
Then plaster is poured into the negative mold to create a
positive mold. At last, the positive mold is shaped by the
prosthetist to emphasis the shape. The final socket is made
by laminat 29
Figure 4-9: The exoskeletal prosthesis (depicting socket, plastic exterior
and foot) is one, integrated product. [Seymour 2002] 30
128
Figure 4-10: The Jaipur prosthesis, here drying from paint finish,
consists of a exoskeletal structure with a separate
manufactured foot. [Source: FINS- Sri Lanka] 30
Figure 4-11: The endoskeletal prosthesis always contains a pylon. Very
seldom the other parts are integrated. Normally, the socket
and foot are modular components. [Seymour 2002] 31
Figure 4-12: The 4C Air Lite Monolithic (above 2 pictures show manu-
facturing steps. A carbon-fibre sock is one of the important
materials) and the Endoflex (lower pictures) are two of the
few designs in which the pylon and socket are integrated.
[4C Air-Li 31
Figure 4-13: ISNY Components [Source: Website Otto-Bock] 32
Figure 4-14: Flexible ischial-containment socket for transfemoral
amputees (this one from Otto-Bock, inset from Hanger) con-
sist of a flexible inside and a frame. Other names include
Total Flexible Brim, the ISNY and SFS (Scandinavian Flexible
Socket)[Seym 33
Figure 4-15: Plug fit socket. The first prosthetic socket without weight-
bearing at the distal end by Verduin 1696 [Wetz 2000] 34
Figure 4-16: Icex finished socket (left). Pressure pads are added to com-
pensate for weight intolerant areas (cutt-through right)
[Source: Ossur Icex brochures.] 35
Figure 4-17: The ICRC-limb makes use of a polypropylene pylon.. Its
cross-section is H-shaped. 35
Figure 4-18: (left) Trimodular Pylon as used in the sauer-bruck trimodu-
lar physiological prosthesis [Angarami 1989] 35
Figure 4-19: (right) Springlite Advantage DP flexible pylon and dynamic
response foot by Hanger Orthopedic Group. [Source: web-
site] 35
Figure 4-20: Left: Principle of Rocker foot or sole. [Adapted from: www.
customfootware.com] Right: Low cost prosthesis with cane
pylon and rocker foot 36

Figure 4-21: SACH foot (Adapted from Seymour 2002] 36
Figure 4-22: SAFE II foot. (Original manufacturer is Campbell Childs Inc,
now bought by 4C (Foresee Orthopeadic Products)). 36
Figure 4-23: Single-axis foot. [Seymour 2002] 37
Figure 4-24: Multiple axis foot. [Seymour 2002] 37
Figure 4-25: STEN foot. [Source: Kinsley Manufacturing Co brochure] 37
Figure 4-26: (Above) Though from the outside not visible, energy storing
feet differ from the inside [Impulse foot, OHIO Willow Wood]
Various energy-storing feet. Earch foot is composed of a com-
pressible heel and a flexible keel spring. A) Seattle foot, B)
Dynamic foot,C) STEN foot, D) SAFE foot,E) Carbon Copy II
foot.[Hafner et al. 2002] 38
Figure 4-27: Advanced energy-storing prostheses: A) Modular III, B) Reflex
VSP, C) Advanced DP, D) Pathfinder.[Hafner et al. 2002] 38
Figure 4-28: Two hybrids: The Seattle Cadence HP [Source: Seattle web-
site] and the MICA Genisis II+. [Source: MICA website] 38
Figure 4-29: (right) Anatomical Suspension. The supracondylar suspen-
sion is in this case removable due to the brim.(right, middle)
The supracondylar suprapattelar system is fixed. [Seymour
2002] 39
Figure 4-30: The PTB cuff or supracondylar cuff. [Seymour 2002] 40
Figure 4-31: The thigh corset can be used in conjuncture with a waist belt
and an elastic strap. [Seymour 2002]. The suspension sleeve
has a similar working principle (left) [Otto Bock]. 40
Figure 4-32: Pin/Shuttle suspension. [Seymour 2002] 41
Figure 4-33: Mineral gel sleeve suction suspension. [www.customprosthet-
ics.com]. 41
Figure 4-34: Double/Single Socket Gel Liner [Silipos]. 42
Figure 4-35: Demountable Torque absorber and its effects. [adapted from
endolite] 42
Figure 4-36: Some examples of connective components [adapted from
www.atlas-ti.com] 42
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005
Figure 4-37: Prosthetic skins can have a high life-like appearance [left,
dorset and orthopeadic]. Uflate sleeve skin covers shrinks to
fit the prosthesis when treated with a heat-gun. 43
Synthesis
Figure 4-38: Examples of supplies (above): Rivits, Polyester Resin-
Laminae, box of stockinettes, pneumatic cast cutter, carbon
tape [Fillauer Supplies brochure]. Static alignment is done on
an alignment table [otto bock[. Supplies enable prosthetists
to ma 43
Figure 4-39: Pathway of the instant axis of rotation for the knee joint.
Ideas
[Seymour 2002] 44
Figure 4-40: Limited dorsiflexion at the ankle. If the ankle can not dor-
siflex normally, either A) the individual will weight bear on
the toe or B) the knee must hyperextend to get the foot flat
Concept
on the ground. [Seymour 2002] 44
Figure 4-41: Stress on the residual limb from the prosthesis. A) The
hypothetical situation in which the residual limb is of uni-
form firmness and the socket matches the circular shape of
Evaluation
the limb. B) A residual limb of nonuniform firmness and a
socket that 45
Table 4-2: Gait deviations due to materials and the alignment [Seymour
2002]. Note that many alignment choices can have the
same effect. If the effect is unwanted, all can be adjusted,
Recomm.
but some will cause other problems (because one alignment
choice will h 46
Figure 4-42: Bending forces on the residual limb while standing. [Wisse
et al. 2002] 47
Figure 4-43: A Simple model of the value chain of prostheses. Value is
Conclusion
increased from left to right. Note that some companies have
multiple roles. 48
129
 Figure 5-1: Figure-8 wrap for the transtibial amputation: [Seymour
2002] A. First wrap max extend from proximal medial to
distal lateral. B. Second wrap may extend from proximal lat-
eral to distal medial. C. Thrid wrap may overlie first wrap. D.
Bandage is looslely wrapped approximately 60 milimeter to
the knee. E. Completed wrap. 51
Figure 5-2: LEFT: The endolite Aqualimb with anto-slip tread patterm on
the sole for extra grip on wet surfaces. [www.endolite.com].
RIGHT: The rampro activankle swimming prosthesis [www.
rampro.net]. 55
Figure 6-1: Snapshots of a movie, in which an amputee walks several
steps in a frame socket. [Wisse et al. 2002] 61
Table 6-1: Several fitting methods and their properties. 64
Table 6-2: Several walking and mobility aids and their properties 65
Figure 10-1: Otto-Bock Harmony system 82
Figure 10-2: Possibilities for adding use-cues to ease the fitting proce-
dure. 83
Figure 10-3: Moments around the socket, as a result of diffrent pylon
types. 85
Figure 10-4: H-profile. 85
Figure 10-5: Flexible bands that connect parts will result in pressure
peaks. 85
Figure 10-6: Suspension sleeve 86
Figure 10-7: Steps for fitting the hard frame 88
Figure 10-8: Steps for fitting the soft frame 88
Figure 10-9: Steps for fitting the combined system 89
Table 10-1: Quick comparison between the Universal Prosthesis and two
popular fitting systems.e 90
Figure 11-1: 13 stacked layers that where derived from the anatomy of the
residual limb. Top view and isometric view. 94
Figure 11-2: Together with the resulting frame parts. [Top] stiff frame,
two views. [Below] interface frame. 94
130
Table 11-1: Four material options for the interface frame. 95
Figure 11-3: Applying hinges to Hylite (source: Corus) 96
Figure 11-4: Deep drawed car part from Hylite. (source: Corus) 96
Figure 11-5: Less space in between the frames is better; it results in a
stiffer prosthesis. 99
Figure 11-6: A Polyurethane layer is partly reinforced with fibres. The
Hylite is milled to better attach the reinforced PU. The two
Polyurethane layers can slide along each other 99
Figure 11-7: The airman Panter is an example of a hand-pump. 100
Figure 11-8: Two ways to connect the frame. 100
Figure 11-9: An extra component that can fine-tune the length enhances
the adjustability of the prosthesis. 101
Figure 11-10: The connection to the foot is 101
Figure 11-11: (Up and Right)The airlock is achieved by an outer and an
inner seal. 101
Figure 11-12: The fill channel and the valve in the connector. To transfer
the filler up to the proximal side of the prosthesis, flexible
tubes (straws) and splitters can be used. The entrance of
the channel has to be distally or on the bottom of the ... 102
Figure 11-13: An example of a Minivalve (source: www.minivalve.com)
102
Figure 11-14: Height of supracondylar suspension. 104
Figure 11-15: The shuttle for the pin/shuttle suspension can perforate the
outer layer. The rings will restore the system to an airtight
state. The shuttle can be attached on most heights (with
varying circumference). During the fitting .... 105
Figure 12-1: A high posterior socket as a result of the fitting of the soft
socket.
Figure 12-2: Assessing the fit of the interface frame parts.
Figure 12-3: Impression of the model build.