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Proceedings of the 2018 Design of Medical Devices Conference

DMD2018
April 9-12, 2018, Minneapolis, MN, USA

when AIS becomes a chronic condition, surgery may be


Design of a Thumb Strength Testing necessary to correct or release the AIN.
Device
Christian Fry
James Mardula
Brandon Lee
Davide Piovesan

Biomedical Engineering Program


Gannon University

1 Abstract
The scope of the project was to design a pneumatic
cylinder for measuring the resistive and applied force of the
flexor pollicis longus (FPL) after anterior interosseous nerve
(AIN) surgery. The patient’s distal section of the first
phalange, of the thumb, is the area of evaluation. The device
is intended for assessing both the quality of the surgery results
as well as physical therapy progression. Criteria such as
mobility, compact design, accuracy, repeatability, and ease of AIN
operation are some of the major requirements. The initial
prototype is intended to collect FPL strength data to establish
operating conditions.

1 Background
Anterior interosseous syndrome (AIS) is classified as the
impairment of the anterior interosseous nerve (AIN) (Fig. 1) Figure 1: Anterior Interosseous Nerve [4].
[1]. Typically, sufferers experience numbness, tingling, and
localized discomfort. Also, individuals can experience After surgeries, physical therapy is required. During
weakness of the flexor pollicis longus (FPL), flexor digitorum physical therapy it is valuable to assess the patient’s abilities
profundus (FDP), and/or pronator quadratus (PQ). The post-surgery and incrementally reassess their progression. By
condition is commonly the result of transient neuritis doing so, the patient’s quality of recovery is tracked. Also, the
(temporary inflammation of the nerve), compression, patient’s FPL strength can be compared to pre/post-op
entrapment, or direct trauma of the AIN. AIS is quite rare readings. Potentially, such readings can be used to determine
(~1%) when compared to other upper-limb nerve the quality of the surgery. In cases of compressive
impairments. However, Carpal Tunnel Syndrome (CTS) entrapment, the median nerve may not be completely
demonstrates similar symptoms like AIS. This is because the released. It would be ideal to obtain a direct measurement of
AIN is a branch of the median nerve and occurs within the the AIN’s Action Potential. We know that the FPL is solely
palmar region. Compressive of the median nerve within the innervated by the AIN. Thus, an estimation of the FPL’s
carpal tunnel is the source of CTS. Depending on the strength would give a direct estimate of the AIN’s status. The
population, the prevalence can be 2-150 cases per 1000 FPL is responsible for the rotation/flexion of the first
subjects [2]. phalange of the thumb (Fig. 2). On the other hand, it is
Inflammation can result from an immunological response challenging to solely rotate the distal portion of the thumb’s
against the nerve cells. Another potential factor is AIN’s phalange (P1) while rigidly holding the middle portion
demyelination or damages to its axon and/or dendrites [3]. In stationary (fix the metacarpophalangeal joint (MP)). This
cases of compression, a temporary or constant compressive maneuver tends to be accurate for all the digits but the thumb.
load is applied, weakening the transmission of an AIN’s Individuals can more easily rotate the proximal section of the
action potential (AP) thus producing an overall weakening of thumb (i.e. the base of the thumb attached to the palm). Thus,
FLP strength. Constant compression of the nerve may be due to isolate and measure the thumb’s force during the rotation of
to a lesion, growth mass, adjacent to the nerve. Entrapment of P1 becomes an area of interest for strength evaluation.
the AIN can occur as the forearm undergoes motion. During
contraction muscle groups can “roll-over” one another.
During such cases, the AIN can become entrapped and
impinged by the muscle sheets or tendons. Degradation by
direct trauma occurs when the nerve is lacerated. In cases
Proceedings of the 2018 Design of Medical Devices Conference
DMD2018
April 9-12, 2018, Minneapolis, MN, USA

Figure 2: FPL Origin and Insertion Anatomy [5].

Muscle force generation is due to two factors, tetanic Figure 4: Initial Prototype
tension capacity and the speed of muscle lengthening (Fig. 3)
[6]. Because of this, the peak force of a muscle contraction
depends on how the force is generated. In general, the distal The cylinder is fabricated using a 2.5 in (63.5 mm)
portion of P1 does not have a relatively max angular velocity polycarbonate tube. The diameter is similar to a coffee cup
(ω) when compared to joints like the elbow or shoulder. which is considered to be a familiar and comfortable hand
Depending on the muscle, the force generated while either orientation. To avoid excessive friction, O-rings were omitted
resisting or applying a force may be largely different. and the working fluid is contained within a balloon (Fig. 5).
Our main goal is to design a device that can isolate the The balloon consists of two polycarbonate endcaps and a
movement of the first thumb’s phalange (P1) and either poly-vinyl sheet wrapped around. The sheet is firmly secured
measure the force applied by the subject or imposed a force to to the side walls of the endcaps by high-strength glue. The
the subject’s thumb until the thumb “gives away”. To this end endcaps provide a rigidly flat surface to transfer the pressure
a custom made cuff equipped with a pneumatic cylinder was to the piston head. To eliminate sliding between these two
utilized. surfaces, one endcap is glued to the base of the piston. At the
opposite end, a tire valve is secured. The one-way switch
within the valve is removed to allow two-way air flow.

Figure 3: Hills Muscle Model curve [6].

2 Methods Figure 5: Air Balloon.


Fabrication
The tire valve provides a flat bottom for securing to an
Figure 4 presents the initial prototype for data collection
endcap but also a shaft to attach an air hose. The air line runs
of FPL strength and ergonomic evaluation. It is presented to
out the cylinder to a brass tee. This is where the pressure
provide the reader with a basic understanding prior to detailed
gauge is attached. Because there is no stopper between the
explanation. Due to no prior strength data found, the pressure
pressure gauge and the air balloon, constant readings are
ceiling was based on strength values for key-pinch
obtained. This is also what allows for the dual actions of
configuration. This configuration was chosen because the
either applying the force or measuring the applied load. The
least number of muscles are activated during performance.
current gauge pressure has a max capability of 15 psi,
Thus, providing a more realistic scenario to the desired FPL
determined by the key-pinch strength values.
innervation. Max key-pinch strengths did not exceed 60 lbf
(~267 N).
Proceedings of the 2018 Design of Medical Devices Conference
DMD2018
April 9-12, 2018, Minneapolis, MN, USA

After the pressure gauge, the air hose leads to a


sphygmomanometer bulb and valve. These parts are
specifically incorporated to allow for one hand operation.
Medical professions are trained to use a sphygmomanometer
and by utilizing the parts, the operators should be familiar
with this portion of the system.

The pneumatic cylinder and associated parts, in itself,


doesn’t isolate the MP joint. Rather than design a feature to
accommodate various thumb lengths, a simpler solution has
been incorporated. A Mueller® reversible thumb stabilizer is
used in parallel with the prototype (Fig. 6). As the name
states, this brace has a metal link that stabilizes the thumb up
to the interphalangeal (IP) joint. The dual straps on the
cylinder casing serve the purpose of orientating and Figure 7: Device/ Hand Interaction
maintaining the hand. This puts the hand in a relatively fixed
orientation, the IP joint approximately lines up along the same Patient generated force, the patient’s hand is orientated in
plane as the U shape cut-out.
a similar fashion. However, the thumb is not to be flex at the
start. Air is inputted to the pneumatic cylinder. The patient
then presses on the piston to their greatest potential. The
pressure difference (Initial input minus max achieved)
represents the force generated.

Calibration
Evaluation of the prototype was done empirically because
initial strength values of the P1 must be obtained first. After
extensive research, such prior data had not been found. The
device was run through multiple operating cycles to test
performance. The balloon appeared to not possess leaks. The
piston head moved smoothly during the length of the stroke.
Multiple individuals used the device with no significant
ergonomic issues. Calibration of the device was performed by
placing steel bar across the top and running steel wire to a
weight scale (Fig. 8). Data recording took place for every 1
full pump. The pressure gage measurement and corresponding
weight were recorded.

Bar
Figure 6: Hand Orientation

Operator imposed force, the patient’s hand is fitted into


the device by grasping the cylinder with the palm (Fig. 7). Device
The hand is secured to the device with two straps, one around
the P2-P5 digits and one around the dorsal portion of the P2-
P5 metacarpals. The distal section of the P1 is rested on the
U-shaped recess and fully flexed. Air is introduced into the
cylinder by a sphygmomanometer. The operator increases the
volume, while observing the pressure reading, until the patient Wire
can no longer resist. The max pressure reading is the greatest
pressure obtained during operation. Determining the
associated force is accomplished by dividing the measured
pressure by the area of the piston head. The diameter of this
portion is approximately 2.49” or 63.25 mm. The piston head
Scale
transfers the force from the working fluid (i.e. air) to the tip of
the thumb, thus inducing a rotation of P1. It also aids in
guiding the direction of the force to act solely along the long
axis of the cylinder. This minimizes thumb’s lateral
deviations while the subject is either resisting or applying the Figure 8: Device Calibration Setup
force.
Proceedings of the 2018 Design of Medical Devices Conference
DMD2018
April 9-12, 2018, Minneapolis, MN, USA

3 Results References
The experimental results were then compared to a [1] Pham, M., P. Baumer, H.-M. Meinck, J. Schiefer, M.
theoretical curve based on the area of the top surface of the air Weiler, M. Bendszus, and H. Kele. 2014. "Anterior
balloon (Fig. 9). This is the surface of interest for force Interosseous Nerve Syndrome: Fascicular Motor Lesions of
transfer. Median Nerve Trunk." Neurology 82 (7): 598-606.
doi:10.1212/wnl.0000000000000128.

[2] Nigel L., Ashworth, MBChB, MSc, FRCPC. “Carpal


Tunnel Syndrome: Background, Pathophysiology,
Epidemiology.” Emedicine.medscape.com. https://emedicine-
.medscape.com/article/327330-overview#a6.

[3] "Peripheral Neuropathy Fact Sheet | National Institute of


Neurological Disorders and Stroke." 2017. Ninds.Nih.Gov.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-
Education/Fact-Sheets/Peripheral-Neuropathy-Fact-Sheet.

[4] "Anterior interosseous nerve." 2017. En.wikipedia.org.


https://en.wikipedia.org/wiki/Anterior_interosseous_nerve.

[5] Moore, D. "Flexor Pollicis Longus - Anatomy -


Orthobullets.com." Orthobullets.com. https://www.Ortho -
bullets. com/anatomy/10027/flexor-pollicis-longus.

[6] Lindstedt, S. L. 2016. "Skeletal Muscle Tissue in


Figure 9: Device Calibration
Movement and Health: Positives and Negatives." Journal of
Experimental Biology 219 (2): 183-188.
A bias deviation from the theoretical curve can be
doi:10.1242/jeb.124297.
observed in Fig.9. The average deviation is 2.18 psi. Based on
the area, this equates to 6.8 lbf. This error can be attributed to
[7] "(New) Polycarbonate Material Datasheet | Nationwide
several potential aspects. One such item is unaccounted
Plastics", Nationwideplastics.net https://www.nationwide-
weight. A weight of the steel bar, as well as the piston head
plastics.net/pdfs/Polycarbonate/(New)%20Polycarbonate%20
itself, were unintentionally excluded. Their combined weight
Material%20Datasheet.pdf.
could account for ~1.886 lbf. This equates to approximately
0.6 psi. Another possible source is the friction between the
cylinder and piston head. Both materials are polycarbonate.
Because this is a prototype the materials used to make the
device were mostly composed of light weight “scrap” pieces
within the universities machine shop. The specific type of
polycarbonate is unknown and therefore the coefficient of
friction could range from 0.3 to 0.8 [7]. It was also observed
that the pressure readings were not steady. To elaborate, there
was a slow decrease after each initial input of air. Lastly, an
error can be attributed to the stiffness of the vinyl balloon.

4 Interpretation
The main goal of this work was to design a device to
measure the FPL strength of the distal section of the P1.
Current clinical experiments are using the device to build a
database of FPL strength values. In the process, the
ergonomics of the prototype will be evaluated by both the
therapists and the patients. Upon feedback and data post-
processing, many aspects are expected to be redesigned.
Because the pressure requirements were based on key pinch
configuration, the device is most likely designed for an
excessive force. Thus, in future design iterations, a lower
range pressure gauge will be required. This is just one
potential redesign of the first iteration prototype.

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