SmartSphincter

Lukas Brgger, Philippe Bchler, Christian Gingert, Franc Hetzer,

Urs Sennhauser, and Bert Mller
Mid-term Evaluation Meeting, Lausanne, 27 April 2016

SmartSphincter a device to treat fecal incontinence

Fecal incontinence (FI) means loss of control of defecation process.

Overall prevalence of FI in adults is between 11 % and 15 %. It

increases with age.

Approximately one third of people living in retirement homes or similar

institutions are affected - about 45 % in U.S. and Europe.

Due to the underreported nature of FI, it is likely that its true

prevalence is even higher.

Diapers can palliate but in severe cases the patient needs an

appropriate device/implant.

Bert Mller, 03/22/2016

University of Basel

Natural anal sphincter and currently used devices

Annals of Biomedical Engineering, Vol. 44, No. 5, May 2016, pp. 13551369
DOI: 10.1007/s10439-016-1572-z
Bert Mller, 03/22/2016

University of Basel

Need for a biomimetic device with sensory feedback

Annals of Biomedical Engineering, Vol. 44, No. 5, May 2016, pp. 13551369
DOI: 10.1007/s10439-016-1572-z
Bert Mller, 03/22/2016

University of Basel

Actuation principles for artificial sphincters

Annals of Biomedical Engineering,

Vol. 44, No. 5, 2016, pp. 13551369
DOI: 10.1007/s10439-016-1572-z
Bert Mller, 03/22/2016

University of Basel

Roadmap of approaches toward breakthrough in nonbiological artificial sphincter development

Annals of Biomedical Engineering, Vol. 44, No. 5, May 2016, pp. 13551369
DOI: 10.1007/s10439-016-1572-z
Bert Mller, 03/22/2016

University of Basel

SmartSphincter project overview

Clinical studies

Biomechanical model

II Smart nanostructures

Biomimetic actuator

III Electronics

Autonomous system

Bert Mller, 03/22/2016

University of Basel

Clinical studies
Anatomy and morphology of the anal canal for the determination of geometry
(length, thickness) and mechanics (E-modulus) as well as functional
parameters such as closing pressure.
Anatomy via MRI and US
Mechanical properties via functional luminal imaging probe (FLIP) and highresolution anal manometry (HRAM)
Clinical study on healthy volunteers (finished)
Clinical study on patients (recruitment and start)
Tobia Brusa, Daniel Abler, Radu Tutuian, Peter Studer, Elisa Fattorini, Christian Gingert, Lukas E.
Brgger and Philippe Bchler
Combining FLIP with anatomical information A novel method to assess the compliance of the anal
sphincter muscles
Neurogastroenterology & Motility (2016) with the authors for final approval
Bert Mller, 03/22/2016

University of Basel

Anal sphincter properties Guideline

FLIP volume: 10 ml

20 ml

30 ml

50 ml

40 ml

FLIP
IAS
EAS

Passive parameters (male / female):

Length, outer radius: (29 4) mm, (18 1) mm / (24 5) mm, (14 2) mm
E modulus several 10 kPa
Active parameters:
Pressure at rest: 52 mmHg / 47 mmHg
Pressure at squeeze: 156 mmHg / 77 mmHg
Bert Mller, 03/22/2016

University of Basel

Artificial muscles based on dielectric elastomer

actuators
+ Self-supporting structure
+ Adequate length change
+ Very low electrical power consumption
+ Materials available
Large actuation voltage (kV)
Scientific challenge: 10,000-layer
sub-micrometer-thin sandwich-structure
1 m
thickness

U = 30V

U = 30V
10000
layers
Bert Mller, 03/22/2016

University of Basel 10

Molecular beam deposition with in situ ellipsometry

T. Tpper et al., Tailoring the mass distribution

and functional group density of dimethylsiloxanebased films by thermal evaporation, APL
Materials, revision submitted (2016)

In-situ ellipsometry allows monitoring

film growth
refractive index
surface roughness
porosity
F. M. Weiss et al., Molecular beam deposition of high-permittivity
polydimethylsiloxane for nanometer-thin elastomer films in dielectric
actuators, Materials and Design, revision submitted (2016)
Bert Mller, 03/22/2016

University of Basel 11

Alternating current electro-spray deposition

F. Weiss et al. Electrospraying nanometer-thin elastomer films for low-voltage dielectric actuators, Adv. Electron. Mater.
1500476, online (2016) doi:10.1002/aelm.201500476
F. Weiss et al. Thin film formation and morphology of electro-sprayed polydimethylsiloxane, Langmuir 32 (2016) 3276
F. Weiss et al. Electro-spraying and ultra-violet light curing of polydimethylsiloxane to fabricate thin films for low-voltage
dielectric elastomer actuators, Proc. SPIE 9798 (2016) 97983C
Bert Mller, 03/22/2016

University of Basel 12

Nanometer-thin PDMS deposition by electrospray

F. Weiss et al., Electrospraying nanometer-thin

elastomer films for low-voltage dielectric actuators,
Adv. Electron. Mater. 1500476, online (2016)
doi:10.1002/aelm.201500476
F. Weiss et al., Thin film formation and morphology of
electro-sprayed polydimethylsiloxane, Langmuir 32
(2016) 3276-3283

Bert Mller, 03/22/2016

University of Basel 13

Multi-stack actuators

4
3
2
1

Identify optimal adhesion layers and

photo-initiators
Engineer oligomers with
advantageous functional groups
Use of mechanical processing steps,
e.g. pre-straining

C u r v a tu r e (m -1 )

0 .1

0 .0

L a y e rs
L a y e rs
L a y e rs
L aye r

100
V o lt a g e ( V )

Optimize process reliability and

scalability

B. Osmani et al., Stress measurements of planar

dielectric elastomer actuators, Rev. Sci. Instrum.
revision submitted (2016)

Multi-stacked actuators with MBD and

electrospray deposition

M. Karapetkova, Masters thesis Biomedical

Engineering, ETH Zrich (2016)

Bert Mller, 03/22/2016

University of Basel 14

A
Charger
Data transfer
A
Bert Mller, 03/22/2016

Receiver coil

Transmitter coil

System overview

BMS

Energy storage
A
and control electronics

A
D

Dielectric elastomer
A
actuator/sensor
University of Basel 15

Battery selection and testing as well as transcutaneous

energy transfer inductive power transfer
Experiments to estimate power
consumption, selection on
appropriate batteries
Greatbatch 2793, capacity 220 mAh,
nominal voltage 3.7 V
Battery endurance stress test at body
temperature (37 C) considering
standby and actuator use
Cycle time compression factor: 28.8,
i.e. # actuator cycles in 10 years
tested within 4.1 months
Efficiency measurements as the
function of tissue thickness from 5 to
25 mm

Bert Mller, 03/22/2016

University of Basel 16

Energy harvesting experiments designed

Human
energy
harvesting

Kinetic energy

active
passive

Thermal energy

Study with 20 healthy volunteers to measure the amount of energy gained by

body activities like movement and breathing as well as from temperature
differences
Kinetic energy via magnetic induction, piezoelectric and electrostatic
approaches using active and passive movement
Thermal energy via temperature gradients between body and environment
Devices selection, probably combination
Review article pending, only first draft available (postponed)
Results important beyond the current project
Bert Mller, 03/22/2016

University of Basel 17

Conclusions

Clinical studies with volunteers have yielded experimental data to

select geometry and mechanics of the actuator. Devices for male and
female will differ. Device for females have priority.

Electrospraying (monitored with ellipsometry) and combined with ultraviolet light curing allows for the preparation of ultra-flat nanometer-thin
films with rates at least one order of magnitude faster than MBD.

Power supply and electronics are designed, should be improved, and

complemented by energy harvesting.

Much attention has been given to the scientific papers (cp. News, Uni
Basel 6 April 2016), but prototype development is focus of activities.

The financial support of the nano-tera.ch initiative is gratefully acknowledged.

Bert Mller, 03/22/2016

University of Basel 18