The Development and Strength Reinforcement of Rapid Prototyping Prosthetic

Socket Coated with a Resin Layer for Transtibial Amputee

C.T. Lu1, L.H. Hsu1, G.F. Huang2, C.W. Lai1, H.K. Peng1, T.Y. Hong1
1
Department of Mechanical Engineering, National Cheng Kung University, Tainan, Taiwan
2
Department of Physical Therapy, Fooyin University, Kaohsiung, Taiwan

Abstract — This article proposed a computer-aided engi- prosthetic sockets have been designed and fabricated using
neering process that is to fabricate a prosthetic socket using various types of RP machines that include stereolithography
rapid prototyping technology. Moreover, since current RP (SLA), selective laser sintering (SLS), fused deposition
machines use a layer-based process to manufacture products, modeling (FDM), and droplet/binding [1,2]. Although RP
this result in RP products liable to break along layers once
bending moment is applied. To prevent RP prosthetic socket
technology has been employed to develop prosthetic sockets
from breaking, this study proposes wrapping a layer of un- for almost two decades, no RP prosthetic socket provided
saturated polyester resin (UPR) around the prosthetic socket by prosthesis industry has really ever been used in daily life.
to reinforce its strength. Factors affecting the strength of the That is because any object fabricated by current layer-based
resin-reinforced RP socket include thickness and forming RP machines is liable to break along the forming layer.
orientation of the preliminary RP socket, thickness of the UPR Therefore, a method of wrapping a carbon fiber layer was
layer, and type of material used to make the preliminary RP proposed to reinforce the strength of RP sockets [3]. Fuh et
socket. This study employed Taguchi experimental design al. [4] also suggested that coating a reinforced layer on the
method to design a series of test specimens for use by the 3- RP socket would improve its strength.
point bending test. Based on analysis of the results of the bend-
ing strength test, the design parameters for a resin-reinforced
A project aimed to develop a plaster-free process (Fig. 1)
transtibial socket of appropriate strength can be determined. that employed the contemporary technologies including a
The preliminary RP socket for a specific transtibial amputee is scanner, CAD systems together with RP machines [5]. That
fabricated using an FDM machine and then wrapped with a
reinforcing layer of UPR.
To confirm the applicability of the resin-reinforced socket
developed in this study, the measurement of interface pres-
sures between the residual limb and the socket was imple-
mented. Analysis of the result of this measurement would
assist a prosthetist to realize the distribution of interface pres-
sures at the pressure-tolerant (PT) and pressure-relief (PR)
areas of the residual limb while the resin-reinforced RP socket
is being worn. The result of this study demonstrates that
by integrating a CAD system, reverse engineering and RP
technologies, a qualified resin-reinforced RP socket can be
fabricated that meets the requirements of a transtibial ampu-
tee. The quality uncertainty of sockets can be improved if the
proposed socket and the corresponding production procedure
are adopted to replace the traditional manual method of fabri-
cation.

Keywords — Prosthetic socket, Transtibial amputee, Rapid

prototyping, Resin reinforcement.

I. INTRODUCTION

Introducing the contemporary technologies involving

rapid prototyping (RP) and CAD systems provides an alter-
native means to overcome the shortcomings of the conven-
tional process of fabricating prosthetic sockets. Since the
emergence of rapid prototyping technology, a variety of Fig. 1 Comparison between traditional and computer-aided approaches

Chwee Teck Lim, James C.H. Goh (Eds.): ICBME 2008, Proceedings 23, pp. 1128–1131, 2009
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The Development and Strength Reinforcement of Rapid Prototyping Prosthetic Socket Coated with a Resin Layer …
project concluded that prosthetic sockets fabricated by RP
machine are liable to break along forming layer during the
implementation of testing RP prosthetic socket. To prevent
RP prosthetic socket from breaking, wrapping a layer of
unsaturated polyester resin (UPR, a widely adopted material
in conventional socket manufacturing process) around the
prosthetic socket to reinforce its strength is then proposed.
This idea also raised the problem of determination of factors
affecting the strength of the resin-reinforced RP socket. The
bending strength of this proposed socket might need to be
validated by a testing process such as the three-point testing
method. An experiment reported in this paper is to deter-
mine the appropriate parameters including RP material,
thickness of the RP layer, forming orientation of the pre-
liminary RP socket, thickness of the UPR layer coating for
building resin-reinforced RP prosthetic sockets of proper
flexural strength.
II. METHOD
A. Three-point bending test and Taguchi experiment method
To confirm the parameters that affect the strength of RP
socket a series of bending strength tests are implemented.
We apply the Taguchi method to data analysis of the bend-
ing test in order to find out the best parameters of the RP
prosthetic socket, including thickness of the RP layer,
thickness of the UPR layer, the RP material and RP fabri-
cating orientation, and the relationship illustration is shown
in Fig. 2. Based on the ASTM D790 [6], a standard method
for testing the flexural properties of reinforced plastics, the
specification of a testing specimen is designed and an MTS
universal tensile testing system is used (Fig. 3). To simplify
the experiment, the Taguchi method [7] helps to compare all
the parameters.
Fig. 2 The relationship of the parameters
Based on the expertise of a prosthetist and RP techniques,
the level values of the parameters are determined as follows:
RP materials selected in this study including ABS, PC and
gypsum; the thickness of specimen made by RP machine
designated as 1.5 mm, 2.0 mm and 2.5 mm; the thickness of
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Fig. 3 The layout and a MTS machine used for three-point bending test
UPR layer coated onto RP specimen 2.0 mm, 2.25 mm and
2.5 mm; the forming orientation of RP specimen. Taguchi
method provided the appropriate orthogonal array (L9 in
this study) is selected to carry the reasonable number of
experiments. According to the calculation values of the
flexural strength and flexural modulus from the MTS testing
data, the ratio of signal and noise can be estimated the best
performance parameters as shown in Table 1.
Table 1 Best collocation of the prosthetic socket fabricated by FDM and
3D printing
RP type FDM 3D printing
RP Thickness 1.50 mm 2.00 mm
UPR Thickness 2.50 mm 2.50 mm
RP Material ABS Gypsum
Forming orientation Horizontal Lie down
The results shown in Table 1 are then used to design
socket, two kinds of sockets will be fabricated. The first one
is fabricated by FDM, and the other is fabricated by 3D-
printer.
B. Design and fabrication of a resin-reinforced socket
Based on the principles of designing a prosthetic socket
to achieve the criteria of a qualified prosthesis in terms of
comfort, sufficient strength, and good performance, the
sensitive (or pressure-relief, PR) areas on a residual limb
should not bear too much load either at standing or during
the stance phase of the prosthesis. The weight should be
supported on pressure-tolerant (PT) areas while the amputee
is walking and standing. The PR areas are moved outward
and PT areas indented inward according to the expertise of
the prosthetist so that the interface pressures between stump
and socket can be properly distributed. The shape modifica-
tion will be proceeded iteratively until biomechanical as-
sessment of the interface pressures on all PT/PR areas meets
the load-bearing ability of the amputee. The modified stump
shape (Fig. 4) will then be used to design a socket for the
specific amputee. With the parameters illustrated in Table 1
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to achieve better flexural strength and flexural modulus, the
designed socket model with a thickness of 1.5 mm (Fig. 5a)
is then acquired and its data in STL format transferred to an
FDM machine. A preliminary RP socket with ABS material
is fabricated as shown in Fig. 5b.
To reinforce the bending strength of a socket made by
RP, covering the preliminary RP socket with six layers of
cotton socks, the liquid UPR mixed with hardener was then
filled and uniformly squeezed by hand around the socket to
allow UPR to infiltrate into the socks' fiber layers (Fig. 5c).
The thickness of the resin-reinforced layer is approximate
2.5 mm according to the three-point test specimen. The
proximal brim of that resin-reinforced socket is manually
trimmed to fit the shape of the stump (Fig. 6).
(a) (b)
Fig. 4 Shape modification during socket design
Fig. 5 A socket CAD model, its preliminary RP socket and infiltration
of the resin-layer
Fig. 6 Trimming the proximal brim, assembling components
and fitting the stump
C. Measurement of interface pressures and results
To verify the applicability of resin-reinforced RP socket
fabricated by following the procedure proposed as shown in
Fig. 1, interface pressures between socket and stump were
measured using socket sensors (Fig. 7). A male volunteer
(whose residual limb is the stump used in this study) weigh-
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IFMBE Proceedings Vol. 23
C.T. Lu, L.H. Hsu, G.F. Huang, C.W. Lai, H.K. Peng, T.Y. Hong
ing 60kg with a left below-knee amputation was selected in
this experiment. A Pliance mobile system® [8] was em-
ployed to measure the local pressure distribution at the
residual limb and socket interface. The procedure of the
measurement for interface pressures is shown in Fig. 7. Due
to the preliminary RP socket made of gypsum was brittle
and avoiding its rough surface harm to stump, the layer of
gypsum was removed. That means the preliminary RP
socket fabricated by using a 3D printing machine was used
as mold for producing a UPR socket. The measurement
results (Fig. 8) showed that the interface pressures either on
main PT areas or PR areas have similar distribution.
Fig. 7 Procedure for the measurement of interface pressures
(a) Patella tendon (b)Medial tibia flare
(c ) Tibia end (d) Fibular head
(e) Fibular end (f) Tibia crest
Fig. 8 The interface pressures measured on some PT/PR areas
III. CONCLUSIONS
Using the Taguchi experimental design method and
ASTM three-point bending test standard, the parameters
that influence the flexural strength of the RP prosthetic
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The Development and Strength Reinforcement of Rapid Prototyping Prosthetic Socket Coated with a Resin Layer …
socket coated with a UPR layer could be determined. Based
on the better parameters, including thickness of the RP
layer, thickness of the UPR layer, the RP material and RP
fabricating orientation, the resin-reinforced RP prosthetic
sockets fabricated by FDM and 3D-printer RP machines can
be normally used by volunteer amputee for walking and
implementing the interface pressure measurement.
Two RP-based sockets have been designed and fabri-
cated based on the computer-aided process proposed in this
study. This process reduced the quality uncertainty and
labor intensity, and also the level of discomfort experienced
by the amputee, which are pitfalls of the conventional man-
ual method. An assistant interface used in the proposed
process also helps to shorten training time for prosthetists
and to modify pressure-tolerant and pressure-relief areas
more precisely.
Although the resin-reinforced RP prosthetic socket pro-
posed in this study has primarily shown the applicability for
the specific amputee, a long period of trial should be con-
ducted for a durability test. Furthermore, investigation on
the trial use of more subjects is needed for testing effective-
ness of using this socket type.
ACKNOWLEDGMENT
The authors would like to thank the National Science
Council Taiwan for its support through grant No. 97-2212-E-
006-105.
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REFERENCES
1. Gibson I, editor. (2005) Advanced manufacturing technology for
medical applications: reverse engineering, software conversion and
rapid prototyping. John Wiley & Sons.
2. Rogers B, Bosker GW, Crawford RH, Faustini MC, Neptune RR,
Walden G, Gitter AJ. (2007) Advanced trans-tibial socket fabrication
using selective laser sintering. Prosthet Orthot Int 31(1):88-100.
3. Herbert N, Simpson D, Spence, W, Ion, W. (2005) A preliminary
investigation into the development of 3-D printing of prosthetic sock-
ets, J Rehabil Res Dev 42(2):141-146.
4. Fuh JYH, Feng W, Wong YS. (2005) Modelling, analysis and fabrica-
tion of below-knee prosthetic sockets using rapid prototyping. In:
Gibson I, editor, Advanced manufacturing technology for medical ap-
plications: reverse engineering, software conversion and rapid proto-
typing. John Wiley & Sons. p. 207-226.
5. Hsu LH, Huang GF, Lu CT, Chen YM, Yu IC, Shih HS. (2008) The
application of rapid prototyping for the design and manufacturing of
transtibial prosthetic socket. Materials science forum. Switzerland:
Trans Tech Publications; 594: 273-280.
6. Taguchi G, Yokoyama T, chief editor, (1993) Taguchi methods
:design of experiments , Yuin Wu, technical editor for the English
edition, Dearborn, MI :ASI Press ; Tokyo, Japan :Japanese Standards
Association.
7. ASTM D790, (2007) Standard Test Methods for Flexural Properties
of Unreinforced and Reinforced Plastics and Electrical Insulating Ma-
terials, American Society of Material Testing.
8. Novel. 2008. Pliance application on prosthesis system. [cited 2008
Aug 15] Available from: http://www.novel.de/productinfo/systems-
pliance-prosthesis.htm.
The address of the corresponding author:
Author: L.H. Hsu
Institute: Department of Mechanical Engineering, National Cheng
Kung University
Street: No. 1, University Street
City: Tainan, 70101
Country: Taiwan
Email: lhhsu@mail.ncku.edu.tw
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