Research On Compass

DESIGN AND DEVELOPMENT OF A MEDICAL DEVICE FOR
TREATMENT OF PROXIMAL INTERPHALANGEAL JOINT

CONTRACTURE
by
MAY MAHMOUD AHMED ABDO YOUSSEF
A thesis submitted to
University of Birmingham
for the degree of
DOCTOR OF PHILOSOPHY
School of Mechanical Engineering

University of Birmingham
December 2015
University of Birmingham Research Archive
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ABSTRACT
The proximal Interphalangeal (PIP) joint is vital for hand function. It is frequently affected
by contractures as a result of injury or disease. Dynamic external fixators are one of the
useful treatment methods of these contractures, enabling the ability to exercise adjacent
joints during healing. The aim of this study was a development of the Compass hinge device
to present a new design device for the digit PIP joint.
A failed Compass hinge external fixator has been analysed. The device consists of polymer
parts manufactured from polyetherimide (PEI). Finite element analysis (FEA) was used to
investigate the principal stresses in the device under different loading conditions. Scanning
electron microscopy (SEM) was used to investigate the fracture surfaces. The FEA showed
that the maximum principal stress was greater than the fatigue strength of PEI. The SEM
fractographs confirm that failure was by brittle fatigue.
A new finger fixator named the PIP joint protractor hinge device comprises 17 parts which
are assembled together. The proposed device materials consist of Poly-ether -ether-ketone
(PEEK) and stainless steel 316LS. The design was subjected to FEA and a working model
was manufactured and subjected to cyclic mechanical testing. The FEA showed that the
maximum stress was 242.9 MPa and this was less than the yield strength and the fatigue
endurance limits for the selected materials. Mechanical testing showed that testing reached
run-out of 170,000 cycles with no cracks or damage visible in the device parts.
i
ACKNOWLEDEMENTS
There are so many people to acknowledge in this thesis, without who I could not have
achieved what I have.
I should begin with my academic supervisor, Prof. Duncan Shepherd without his support,
knowledge, guidance and advice I could not have completed this thesis.
I would like to thank Mr. Garth Titley for his believe in this project and support throughout
my PhD.
My thanks are also due to Mr Simon Rowan for his technical support which made the
experimental aspects of this thesis possible.
From the bottom of my heart, I would like to thank my mother, my father and my brother
who have always supported me in so many ways, they always believe in me and been there
whenever I have needed them. Their being let me strong, compassionate and motivated.
My fiancé has been there for me through the stress of my PhD and our engagement and
never once doubted me or shown me anything but support and motivation. Thank you for
your unconditional love, strength, kindness and never giving up.
Finally, I would like to thank the Egyptian government for the provision of the financial
support that made this research work possible.
ii
Table of Contents
ABSTRACT........................................................................................................................... i
LIST OF FIGURES ...........................................................................................................vii
LIST OF TABLES ............................................................................................................xiii
CHAPTER 1 ......................................................................................................................... 1
1 INTRODUCTION ....................................................................................................... 2
CHAPTER 2 ......................................................................................................................... 4
2 BACKGROUND .......................................................................................................... 5
2.1 Chapter overview ................................................................................................... 5

2.2 The human hand anatomy ...................................................................................... 5
2.3 Hand biomechanics ................................................................................................ 7
2.4 Proximal interphalangeal (PIP) joint ................................................................... 14
2.4.1 Anatomy........................................................................................................... 14
2.4.2 Contractures ..................................................................................................... 15
2.5 Dupuytren’s disease ............................................................................................. 16
2.5.1 Clinical Presentation ........................................................................................ 21
2.5.2 Treatment ......................................................................................................... 23
2.6 External finger fixators ........................................................................................ 23
2.7 Medical device design process ............................................................................ 40
2.8 Summary .............................................................................................................. 44
CHAPTER 3 ....................................................................................................................... 45
3 ENGINEERING ANALYSIS OF A FAILED COMPASS HINGE ...................... 46
3.1 Chapter overview ................................................................................................. 46
iii
3.2 Compass hinge device ......................................................................................... 46
3.2.1 Introduction ...................................................................................................... 46
3.2.2 Components and surgical technique ................................................................ 47
3.2.3 Review of clinical studies ................................................................................ 49
3.2.4 Model ............................................................................................................... 55
3.2.5 Results.............................................................................................................. 62
3.3 Scanning electron microscopy ............................................................................. 68
3.3.1 Results.............................................................................................................. 71
3.4 Discussion ............................................................................................................ 73
3.5 Summary .............................................................................................................. 75
CHAPTER 4 ....................................................................................................................... 77
4 NEW DEVICE DESIGN ........................................................................................... 78
4.1 Chapter overview ................................................................................................. 78

4.2 Introduction .......................................................................................................... 78
4.3 Design requirements ............................................................................................ 79
4.4 Concept designs ................................................................................................... 81
4.4.1 Design strategy ................................................................................................ 81
4.4.2 Concept Design 1 – (Screw drive hinge movement) ....................................... 83
4.4.3 Concept Design 2 – (Worm and worm wheel hinge movement) .................... 94
4.5 Detailed design .................................................................................................. 100
4.5.1 Materials ........................................................................................................ 101
4.5.2 The PIP joint protractor hinge device ............................................................ 104
Table 4-2. Gear general nomenclature and design formula (Designatronics, 1999). 113
4.6 Discussion .......................................................................................................... 139
4.7 Summary ............................................................................................................ 142
CHAPTER 5 ..................................................................................................................... 143
5 ENGINEERING ANALYSIS OF THE NEW DEVICE DESIGN ...................... 144
5.1 Chapter overview ............................................................................................... 144

5.2 Finite element analysis....................................................................................... 144
5.2.1 Results............................................................................................................ 147
5.3 Risk analysis ...................................................................................................... 152
iv
5.3.1 Undertaking risk analysis............................................................................... 152
5.3.2 Risk analysis of the PIP joint protractor hinge device ................................... 154
5.3.3 Design description and characteristics ........................................................... 154
5.3.4 Identification of hazards and estimation of risks ........................................... 154
5.4 Manufacturing .................................................................................................... 158
5.4.1 Techniques ..................................................................................................... 158
5.4.2 Models ........................................................................................................... 161
5.5 Mechanical testing ............................................................................................. 170
5.5.1 Testing equipment.......................................................................................... 170
5.5.2 Testing setup .................................................................................................. 171
5.5.3 Methods ......................................................................................................... 173
5.5.4 Results............................................................................................................ 173
5.6 Discussion .......................................................................................................... 175
5.7 Summary ............................................................................................................ 178
CHAPTER 6 ..................................................................................................................... 180
6 OVERALL DISCUSSION AND CONCLUSIONS .............................................. 181
6.1 Chapter overview ............................................................................................... 181

6.2 Project objectives ............................................................................................... 181
6.3 Discussion .......................................................................................................... 182
6.3.1 Analysis of failed Compass hinge device ...................................................... 183
6.3.2 The PIP joint protractor hinge device design................................................. 184
6.3.3 Finite element modelling ............................................................................... 185
6.3.4 Prototyping..................................................................................................... 186
6.3.5 Mechanical testing ......................................................................................... 188
6.4 The PIP joint protractor hinge surgical technique ............................................. 189
6.4.1 Further development ...................................................................................... 190
6.5 Comparison of the new proposed device with other external finger fixators .... 193
6.6 Conclusions........................................................................................................ 197
APPENDICES .................................................................................................................. 198
Appendix A ....................................................................................................................... 199
Appendix B ....................................................................................................................... 201
v
Appendix C ....................................................................................................................... 215
Appendix D ....................................................................................................................... 225
Appendix E ....................................................................................................................... 226
Appendix F ....................................................................................................................... 228
REFERENCES................................................................................................................. 229
vi
LIST OF FIGURES
Figure 2-1. Hand bones and joints diagram (Tate, 2011). .................................................... 6
Figure 2-2. The different couplings of fingers (a) poke; (b) 90-degree distal pad pull; (c)
180-degree distal pad press; (d) lateral pinch; (e) palmar pinch; (f) three-jaw chuck pinch;
(g) power grasp (author's own drawing, adapted from Astin and Nussbaum, 2003). ........... 9
Figure 2-3. Schematic drawing of proximal interphalengeal (PIP) joint (Ng and Oliver,
2009). ................................................................................................................................... 14
Figure 2-4. Grades of Dupuytren’s disease (Murphey et al., 2009). .................................. 18
Figure 2-5. (a) Normal digital fascia and (b) Dupuytren’s disease diseased fascia
(http://bonefix.co.nz) ........................................................................................................... 19
Figure 2-6. The presence of Dupuytren’s disease of a PIP joint (Lahiri et al., 2007). ....... 22
Figure 2-7. The Hueston’s tabletop test finger joint contractures diagnosis
(http://dupuytrens.biz/dupuytrens_1.html). ......................................................................... 22
Figure 2-8. Mini external fixator (Houshian and Schrøder, 2004) ..................................... 24
Figure 2-9. Hoffmann II Micro External Fixation System (Asche et al., 2009)................. 25
Figure 2-10. Mini external fixator (pins and elastic bands) (White et al., 2012). .............. 26
Figure 2-11. Pins and dental rubber bands fixator (Ruland et al., 2008). ........................... 26
Figure 2-12. A Digit Widget device (Slater et al., 2003). .................................................. 27
Figure 2-13. The different types of treatment techniques (a) Robertson Banjo splint; (b)
Extension-block splinting; (c) The Suzuki frame; (d) Allison device; (e) The force couple
splint; (f) The Schenk device facilitating mobilization; (g) The Hynes and Giddings device
(author’s own drawing, adapted from Ng and Oliver, 2009)............................................... 28
Figure 2-14. The Stockport serpentine spring system “S-Quattro” a flexible mini external
fixator (Bostock et al., 1993a). ............................................................................................. 29
Figure 2-15. JESS (Joshi external stabilising system) device (Salafia and Chauhan, 1997).
............................................................................................................................................. 30
Figure 2-16. The Continuous Extension Technique (TEC) device (Citron and Messina,
1998). ................................................................................................................................... 31
Figure 2-17. Verona device (Citron and Messina, 1998).................................................... 32
vii
Figure 2-18. PIPSTER (Proximal Interphalangeal Skeletal Traction Extender) device
(Hodgkinson, 1994). ............................................................................................................ 32
Figure 2-19. Small dynamic external finger fixator (Inanami et al., 1993). ....................... 33
Figure 2-20. Multiplanar distractor (Kasabian et al., 1998). .............................................. 34
Figure 2-21. The medical device design process flowchart (Aitchison et al., 2009). ........ 43
Figure 3-1. Compass hinge external fixator. ....................................................................... 47
Figure 3-2. Surgical technique for the Compass hinge fixator (a) axis K-wire insertion (b)
proximal and distal K-wires insertion (c) dorsal view for the implanted fixator ................ 48
Figure 3-3. Compass hinge device supported on patient finger (a) Position A and (b)
Position B (adapted from (Lahiri et al., 2007)). .................................................................. 49
Figure 3-4. Mechanical failure at distal arcuate hinge (adapted from (Lahiri et al., 2007)).
............................................................................................................................................. 50
Figure 3-5. Pin-track infections (adapted from (Lahiri et al., 2007)). ................................ 50
Figure 3-6. Compass hinge disassembled components....................................................... 56
Figure 3-7. An example of measurements made on the distal arcuate hinge member. ...... 56
Figure 3-8. Solid model of the distal arcuate hinge member. ............................................. 57
Figure 3-9. Solid model of the proximal and distal arcuate hinge assembled members. ... 57
Figure 3-10. Meshed finite element model Ӏ with the load and constrains applied. ........... 59
Figure 3-11. Four different positions of engagement with the worm gear (a) position 1 (15-
30°); (b) position 2 (30-45°); (c) position 3 (65-80°); (d) position 4 (90-105°) .................. 60
Figure 3-12. Meshed finite element model II with the load and constrains applied. .......... 61
Figure 3-13. Two different positions of engagement with the worm gear (a) position 1 (15
- 30°) (b) position 4 (90-105°). ............................................................................................ 62
Figure 3-14. Distribution of maximum Principal stress for model I for four different
positions of gear teeth fixed at (a) position 1 (15-30°); (b) position 2 (30-45°); (c) position
3 (65-80°); (d) position 4 (90-105°)..................................................................................... 64
Figure 3-15. Maximum principal stress against force for the gear teeth fixed at 15 - 30°. 65
Figure 3-16. Maximum principal stress distribution around the distraction screw hole. ... 65
viii
Figure 3-17. Finite element analysis stress distribution results for Model II for position
1gear teeth fixed at (15 - 30°). ............................................................................................. 67
Figure 3-18. Maximum principal stress distribution around the left distraction screw hole.
............................................................................................................................................. 67
Figure 3-19. Fracture surfaces examined using scanning electron microscopy. ................ 68
Figure 3-20. Emscope SC500 sputter coater....................................................................... 69
Figure 3-21. Fracture surface samples (a) before (b) after gold spray coating. .................. 69
Figure 3-22. Joel JSM-6060 LV microscope with computer. ............................................. 70
Figure 3-23. SEM fractography images of the distal block fracture surfaces (a) fracture
surface 1 (b) fracture surface 2 (c) fracture surface 3. ......................................................... 72
Figure 4-1. 3D assembly design of the screw drive hinge movement concept design 1 .... 83
Figure 4-2. 3D design of the proximal protractor part design -1. ....................................... 84
Figure 4-3. 3D design of the proximal protractor part design -1, idea1. ............................ 85
Figure 4-4. 3D design of the distal protractor part design -1, idea2. .................................. 87
Figure 4-5. Distribution of stresses for the distal protractor part design -1, idea2. ............ 88
Figure 4-10. 3D design of the distal protractor part design -1, idea5. ................................ 92
Figure 4-11. Distribution of stresses for the distal protractor part design -1, idea5. .......... 93
Figure 4-12. 3D assembly design of the worm and worm wheel hinge movement concept
design 2 ................................................................................................................................ 94
Figure 4-13. 3D design of the distal protractor part design -2, idea1. ................................ 95
Figure 4-14. 3D assembly design of the proximal and distal protractor parts design -2,
idea1. .................................................................................................................................... 96
ix
idea2. .................................................................................................................................... 97
Figure 4-16. 3D design of concept selection 2, idea2. ...................................................... 101
Figure 4-17. 3D exploded view of the assembly of the PIP joint protractor hinge. ......... 105
Figure 4-18. 3D design assembly of the PIP joint protractor hinge final design. ............. 105
Figure 4-19. 3D design of the proximal protractor hinge part. ......................................... 107
Figure 4-20. Drawing of the proximal protractor hinge part. ........................................... 108
Figure 4-21. 3D design of the distal protractor part.......................................................... 109
Figure 4-22. Drawing of the distal protractor hinge part. ................................................. 110
Figure 4-23. The pressure angle at mating gear teeth (Designatronics, 1999) ................ 112
Figure 4-24. Involute curve derivation of the worm wheel tooth ..................................... 115
Figure 4-25. The gear involute (Buckingham, 1949). ...................................................... 116
Figure 4-26. The gear tooth profile (Buckingham, 1949). ................................................ 118
Figure 4-27. Engineering drawing of the worm wheel tooth profile. ............................... 120
Figure 4-28. 3D design of the worm wheel part. .............................................................. 121
Figure 4-29. Drawing of the worm wheel part. ................................................................ 122
Figure 4-30. 3D design of the worm gear part. ................................................................. 123
Figure 4-31. Engineering drawing of the worm part. ....................................................... 124
Figure 4-32. 3D design of the rod part. ............................................................................. 125
Figure 4-33. Drawing of the rod part. ............................................................................... 126
Figure 4-34. 3D design of the solid clamping blocks. ...................................................... 128
Figure 4-35. 3D design of the slotted clamping blocks. ................................................... 128
Figure 4-36. Drawing of the solid clamping block part. ................................................... 129
Figure 4-37. Drawing of the slotted clamping block part. ................................................ 130
Figure 4-38. 3D design of the assembly of the screw 1 (left) and nut 2 (right). ............... 131
x
Figure 4-39. Drawing of the screw 1 part. ........................................................................ 132
Figure 4-40. Drawing of the nut 2 part. ............................................................................ 133
Figure 4-41. The screw. .................................................................................................... 134
Figure 4-42. Drawing of the screw. .................................................................................. 135
Figure 4-43. A guide Jig for inserting the K-Wires (a) Isometric view and (b) Rear view of
the proposed design. .......................................................................................................... 137
Figure 4-44. A 3D assembling design of the Jig with the PIP joint protractor hinge device.
........................................................................................................................................... 137
Figure 4-45. Drawing of the jig. ....................................................................................... 138
Figure 4-46. 3D design of the Compass hinge device (left) and the PIP joint protractor
hinge device (right). ........................................................................................................... 141
Figure 5-1. Meshed finite element model with the load of 210 N applied and constrains
applied at position 1 with the gear teeth fixed at 15 - 30°. ................................................ 145
Figure 5-2. Two different positions of engagement with the worm gear (a) position 1 gear
teeth fixed at 15 - 30° (b) position 2 gear teeth fixed at 90 - 105°. ................................... 146
Figure 5-3. Distribution of stresses in the model for position 1 gear teeth fixed at 15 - 30°.
........................................................................................................................................... 148
Figure 5-4. Distribution of stresses in the model for position 2 gear teeth fixed at 90 -
105°. ................................................................................................................................... 148
Figure 5-5. FEA Iso Clipping at 110 MPa with the gear teeth fixed at 15 - 30°. ............. 150
Figure 5-6. FEA Iso Clipping at 65 MPa with the gear teeth fixed at 15 - 30°. ............... 151
Figure 5-7. FEA Iso Clipping at 65 MPa with gear teeth fixed at 90 - 105°. ................... 152
Figure 5-8. Rapid prototyping model of the PIP joint protractor hinge device. ............... 162
Figure 5-9. Disassembled rapid prototyping model of the PIP joint protractor hinge device.
........................................................................................................................................... 162
Figure 5-10. Worm and worm wheel teeth meshing......................................................... 167
Figure 5-11. External dynamic protractor hinge fixator working model. ......................... 169
Figure 5-12. A manufactured worm gear by stainless steel 17-4PH composition, Solid
Concepts Inc. ..................................................................................................................... 169
xi
Figure 5-13. The mechanical test model ........................................................................... 169
Figure 5-14. The Bose ElectroForce® 3330 Series II Test Instrument. ........................... 171
Figure 5-15. The designed mechanical test rig. ............................................................... 172
Figure 5-16. The device model after the cyclic bending mechanical test ......................... 174
Figure 5-17. Applying cyclic load on the new designed device using a Bose
ElectroForce® 3330 Series II Test Instrument .................................................................. 175
Figure 5-18. The maximum stress location for both models of the Compass hinge device
(left) and the PIP joint protractor hinge device (right) at position 1 with the gear teeth fixed
at 15 - 30° with a load of 210 N......................................................................................... 176
Figure 6-1. A new feature design for the proximal protractor hinge part. ........................ 190
xii
LIST OF TABLES
Table 2-1. Finger couplings and grip strength summary. ................................................... 10
Table 2-2. Pulp pinch strength average maximum (N) ....................................................... 11
Table 2-3. Classification of Dupuytren’s disease according to Tubiana (1986) ................. 18
Table 2-4. Summary of the main features of the different PIP joint fixators...................... 36
Table 3-1. The previous clinical studies summary.............................................................. 51
Table 4-1. Pugh matrix to concept design selection. .......................................................... 98
Table 4-2. Gear general nomenclature and design formula (Designatronics, 1999). ....... 113
Table 4-3. The Formulas of gear tooth profile (Buckingham, 1949). ............................... 117
Table 4-4. The protractor hinge device size guide. ........................................................... 140
Table 5-1. Rating of occurrence, severity and detection for potential hazards. ................ 153
Table 5-2. Results of risk analysis. ................................................................................... 155
Table 5-3. Comparison between the designed and measured dimensions. ....................... 164
Table 6-1. A predicted timeline of the design process required for the PIP joint protractor
hinge device. ...................................................................................................................... 192
xiii
CHAPTER 1
INTRODUCTION
Chapter 1 Introduction
1 INTRODUCTION
Flexion contracture of the proximal Interphalangeal (PIP) joint is a common clinical problem
that can occur as a result of injury or disease, such as Dupuytren’s disease. Movement of
this joint is responsible for 85% of the total motion of the digit and severe flexion deformity
can lead to marked loss of global hand function that hinders activities of daily living
(Houshian et al., 2013). PIP external dynamic fixators are medical devices that are used for
patients with the case of contractures of a skeletal PIP joint such as Dupuytren's disease and
unstable fracture subluxation of the PIP joint. One type of fixator is the Compass proximal
interphalangeal (PIP) joint hinge (Smith & Nephew, Memphis, TN, USA) (Hotchkiss et al.,
1994) and this device has been used by Mr. Garth Titley (Consultant Plastics and Burns
Surgeon at the Queen Elizabeth Hospital, Birmingham). He has found the device to fail
following attachment to patients and believed that an improved design would have many
clinical benefits.
The aim of this thesis was to investigate, design and develop a new fixator, based on analysis
of a failed Compass hinge device. The specific objectives were to:
 Determine the main cause of Compass hinge failure;
 Generate a new design of fixator device;
 Evaluate the proposed design using finite element analysis;
 Manufacture a prototype model of the new designed fixator;
 Mechanically test the prototype.
2
Chapter 1 Introduction
Chapter 2 presents the background information. The chapter begins with a description and
explanation of the anatomical and biomechanical terms used for the human fingers.
Dupuytren’s disease and its treatment methods then follow. The chapter continues by
describing the different dynamic external fixators available for the human hand with the
advantages and disadvantages associated with their use. The design process for a new
medical device is explained in detail in this chapter.
Chapter 3 starts by introducing the Compass hinge device, followed by an engineering
analysis of a failed device. The predicted stress levels and distributions in the Compass hinge
device, subjected to bending loads, were investigated using Finite Element Analysis and
Scanning Electron Microscopy. The chapter concludes with recommendations for an
improved design.
Chapter 4 describes the development of a new fixator to treat PIP joint contractures. In this
chapter the development and evaluation of various concept designs are presented and
discussed. The final design is presented.
In Chapter 5, the prototype device and the engineering analysis for the final design are
presented. The new design is verified by Finite Element Analysis and the working prototype
is mechanically tested.
Chapter 6 presents the overall discussion of the study and the thesis is summarised by
presenting the general conclusions with regards to the original aim of the research.
3
CHAPTER 2
BACKGROUND
Chapter 2 Background
2 BACKGROUND
2.1 Chapter overview
This chapter aims to provide the general information required to understand the subsequent
chapters. Section 2.2 presents the human hand anatomy. The biomechanics of the hand is
described in § 2.3. The proximal interphalangeal joint anatomy and contractures are
provided in § 2.4. Dupuytren’s disease and its treatment methods are presented in § 2.5,
followed by a description of the different dynamic external fixators available to treat
proximal interphalangeal (PIP) joint contractures in § 2.6. Section 2.7 presents a brief
description of the process used for the design of medical devices. Detailed background
information on each specific part of the study is given in the relevant chapter.
2.2 The human hand anatomy
The human hand consists of five digits, with four fingers and a thumb. The fingers comprise
three intercalated bony segments: the proximal, intermediate and distal phalanges. The
thumb lacks the intermediate phalanx and is made up of only the proximal and distal
phalanges (Bundhoo and Park, 2005).
The bones of the hand, naturally group themselves into the carpus; the base of the hand is
formed by eight carpal bones. The carpal bones are united into two rows of bones. The
5
proximal row contains (from lateral to medial) the scaphoid, lunate, triquetrum, and pisiform
bones. The scaphoid, lunate, and triquetrum bones contribute to the formation of the
radiocarpal joint. The distal row of carpal bones contains (from medial to lateral) the hamate,
capitate, trapezoid, and trapezium bones. The anterior hamate has a prominent bony hook
(Taylor and Schwarz, 1955). The proximal and distal carpal rows articulate with each other
at the midcarpal joint. The five metacarpal bones form the palm of the hand. The metacarpal
bones are numbered 1–5, starting with the thumb side. The first metacarpal bone is freely
mobile, but the other bones are united as a group. The digits are also numbered 1–5, with
the thumb being number 1. The fingers and thumb contain a total of 14 phalanges (phalanx
bones) (Betts et al., 2013). A diagram of the hand bones and joints are illustrated in Figure
2-1 (Tate, 2011).
Figure 2-1. Hand bones and joints diagram (Tate, 2011).
6
The joints between the metacarpals and the proximal phalange are “condyloid” synovial
joints, which allow movement in two planes due to the shape of the bones against each other.
These are the metacarpal (MCP) joints (Joyce, 2004). The fingers can flex and straighten or
abduct and adduct; move apart and together sideways, spreading the fingers. This provides
the mobility and versatility of the hand. The interphalangeal joints, those between each
phalanx and the next are simple hinge shaped joints, which allow only flexion and extension
(Abrahams et al., 2003) with a normal range of motion being 0°/100° extension/flexion
(Reese and Bandy, 2013). The index finger is found to have the greatest range of
extension/flexion amongst the five fingers: 90° at the MCP joint, 100° to 110° at the PIP
joint and 80° at the distal interphalangeal (DIP) joint. In addition, adduction and abduction
angles of 20° have been measured in the MCP joint of the fingers (Bundhoo and Park, 2005).
2.3 Hand biomechanics

The hand is one of the most important parts of the human body. It is the structure that allows
for a number of tasks: adaptation, exploration, prehension, perception and manipulation. The
prehensile movements of the human hand can be divided into power grip and precision grip
(Napier, 1956).
A thorough understanding of the biomechanical principles of the human hand is useful for
medical device design engineers. Medical device design ought to account either the forces
which will be exerted by the human due to daily tasks or the direction of these forces to
avoid any possible failure of the devices. Failure to consider biomechanics in design can
result in non-physiological loads being applied to the device.
7
To verify the proposed design, the digit maximum exerted load for the healthy human will
be considered as the first study parameter. Load direction is measured as the second
parameter. Finally, the finger joint angles during exerting this load are the third parameter
in this study for designing a new external medical fixator. This is to confirm that the new
device design is a safe design from an engineering point of view.
Astin and Nussbaum (2003) compiled and examined the maximum forces exerted by the
fingers in a variety of couplings to both enhance and supplement available data across 100
subjects. The seven couplings investigated in this research were divided into prehensile
(wrapping around with the whole hand and the power grasp) and non-prehensile couplings
(lateral pinch, palmar pinch, three-jaw chuck pinch, poke, 90-degree distal pad pull and 180-
degree distal pad press) (Figure 2-2).
8
(a) (b) (c)
(d) (e) (f)
(g)
Figure 2-2. The different couplings of fingers (a) poke; (b) 90-degree distal pad pull; (c)
180-degree distal pad press; (d) lateral pinch; (e) palmar pinch; (f) three-jaw chuck pinch;
(g) power grasp (author's own drawing, adapted from Astin and Nussbaum, 2003).
A summary of the strength and variability in each of the finger couplings and for simple
grips are given in table 2-1.
9
Table 2-1. Finger couplings and grip strength summary.
Coupling Mean (N) Standard deviation Relevant coupling to
(N) the current study
Poke 46.0 17.8 Not relevant (axial
force not a parameter)
Press 43.1 18.4
Pull 60.1 25.2
Lateral 80.9 28.2
Chuck 79.8 29.0
Palmar 54.2 18.8
Grip 370.7 117.7
Swanson et al. (1974) recorded the strength of the normal hand as applied in basic hand
patterns: grip, chuck pinch (three-digit pinch), pulp (fingertip) pinch with separate fingers,
and lateral pinch. Measurements were reported as an average maximum strength grip force
of 466.8 N for males, and 241.2 N for females. The average maximum strength of a chuck
pinch force was 77.5 N for males, and 51 N for females and an average maximum strength
lateral pinch force of 73.5 N for males, and 48 N for females. The average maximum strength
of pulp pinch measured force compared with the average maximum strength of pulp pinch
in the study of Walker and Erkman (1977) is shown in (Table 2-2). An et al. (1978) also
measured the pulp pinch strengths but for two fingers only (index and long) for 18 males
and 22 females. They reported that the strengths of the two fingers were equal and the
10
strength was the same for tip and pulp pinch actions. The average maximum strength was
63 N (SD=14 N) for male subjects and female subjects had 46 N (SD=10 N).
Table 2-2. Pulp pinch strength average maximum (N)
Swanson et al. (1974) Walker and Erkman (1977)
Hand Digit Male Female Male Female
patterns
index 52 35.3 74
middle 55 37.2 65 56
Pulp pinch ring 37.2 24.5 47 (index digit
small 22.5 16.6 37 only)
Berme et al. (1977) measured the strength of four normal female subjects pinching a 45 mm
diameter cylinder, and reported a mean strength of only 19 N. Weightman and Amis (1982)
showed that the maximal isometric pinch mean strength external force was 35 N of the index
finger by squeezing a strain-gauged instrument for eleven female subjects.
The tip, key, and palmar pinch grip strength were measured for a sample of 310 male and
328 female adults, ages 20 to 94 years using a dynamometer. The results showed that the
maximum grip strength was 463.9 N, tip pinch was 75.6 N, key pinch 108.9 N and palmar
pinch was 104.1 N (Mathiowetz et al., 1985). In pinch strength, men were 40 percent
stronger than women, but in grip strength men were twice as strong (Walker et al., 1978).
Radwin et al. (1992) used a small conductive polymer force sensor to measure the individual
finger forces exerted during submaximal static pinch. Sensors were attached to the distal
11
phalangeal pads. The average maximum five finger pinch strength for the study subjects was
100 N (SD=26 N) where the average finger strength was 61 N (SD=15 N) for index, 58 N
(SD=21 N) for middle, 36 N (SD=13 N) for ring and 28 N (SD=11 N) for small. Lee and
Rim (1990) developed a biomechanical model to predict maximum isometric, finger-grip
forces for plane motion of the middle finger for different cylinder sizes. The maximum force
of 210 N occurred at the joint angles of -40° at the wrist, 80° at the MCP joint, and 70° at
the PIP joint.
The cylindrical type finger-force measuring system with a five-axis force/moment sensor
was designed and manufactured using digital signal processing (DSP), which can measure
the grasping finger-force (Kim et al., 2010). It was found that the average force of men’s
right hands was about 218 N, and that of the left hands was 199 N.
A three-dimensional static biomechanical model was presented by Vigourouxa et al. (2006)
to estimate finger muscle tendon, pulley forces and external fingertip during the ‘‘slope’’
and the ‘‘crimp’’ grip. The results of the model showed that the mean external fingertip force
was 95.6 N (SD=26.4 N) in the crimp grip and 97 N (SD=21.8 N) in the slope grip.
Schweizer (2001) investigated bowstringing and forces during crimp grip position. Two
devices were built to measure the force and the distance of bowstringing and one device to
measure forces at the fingertip. All measurements of 16 fingers (only middle and ring
fingers) of 4 subjects (one woman and three men) were made in vivo. The maximum forces
at one fingertip were determined in two positions; parallel slope grip (maximum force at
fingertip for middle and ring while all other fingers were acting at the horizontal grip) and
isolated crimp grip (the long finger had contact with the grip, the other fingers being in a
12
flexed and unloaded position). The maximum force at one fingertip (middle and ring) while
all other long fingers were acting at the same horizontal grip (parallel grip) and at the same
finger was performed while only this finger had contact with the grip, the other long fingers
being in a flexed and unloaded position (isolated grip) were determined. The maximum
forces at one fingertip for an isolated crimp grip was 96 N (SD=21 N), parallel crimp grip
was 82 N (SD=19 N), isolated slope grip was 116 N (SD=30 N) and for parallel slope grip
was 78 N (SD=22 N). The maximum crimp grip fingertip forces were 100 N (SD=46 N) for
index, 90 N (SD=35 N) for long and 45 N (SD=24 N) for ring in a study by Marco et al.
(1998) where the force at the fingertip (external force) of a closed traumatic rupture of the
flexor tendon pulleys in rock climbers were measured. The individual fingers were tested
separately under simulated in vivo loading conditions. Olandersson et al. (2005) developed
an extension finger force measurement device, and investigated the intra individual
repeatability. The design of the measuring device allows single finger force and whole hand
measurements. The results are shown that the average whole hand force is 170 N (SD=10
N) and for individual fingers; 30.2 N (SD=3.30 N) for the index, 33.9 N (SD=3.63 N) for
long, 28.3 N (SD=3.05 N) ring and the little is 19.5 N (SD=2.24 N).
The conclusions of the previous studies of the human hand biomechanics are as follows:
 The different types of the hand tasks aspect (prehensile and non-prehensile) and the
ergonomic aspect (gender, age and which hand is dominant) were the main causes
for the variety of the force magnitudes. All previous studies take into account these
two aspects during their studies,
13
 The middle digit exerted the maximum finger-grip force of 210 N (Lee and Rim,
1990) and this magnitude force will be used as a loading condition in the finite
element analysis sections to analysis the existing device (Compass hinge) and to
verify the new proposed design (chapters 3 and 5, respectively in this study).
 The range of forces which can be exerted by the healthy human hand was from 10 N
to 210 N by the little and middle fingers, respectively.
 Prehensile coupling as a grip action had a larger magnitude force than non-
prehensile couplings for single and multi-digits tasks (poke, press, pull, lateral,
chuck and palmar). The magnitude force of the poke task will be excluded from
this current study as the axial force is not a parameter for the external fixator
device.
2.4 Proximal interphalangeal (PIP) joint
2.4.1 Anatomy
The PIP joint is a pure hinge joint in function (Figure 2-3). Its stability results from the
articular congruence and the surrounding soft-tissue structures (Ng and Oliver, 2009).
Figure 2-3. Schematic drawing of proximal interphalengeal (PIP) joint (Ng and Oliver,
2009).
14
Ligaments are tough bands of tissue that connect bones or joints together. In the PIP joint,
the strongest ligament is the volar plate which connects the proximal phalanx to the middle
phalanx on the palm side of the joint. There is also a collateral ligament on each side of the
PIP joint which tightens when the joint is bent sideways and keeps the joint stable from side
to side (Bailie et al., 1996). The collateral ligament consists of the collateral ligament proper
(taut in flexion) and an accessory collateral ligament (taut in extension). The volar plate is a
thick fibrocartilaginous structure that constitutes the palmar aspect of the PIP joint capsule.
Distally, it is attached to the volar lip of the base of the middle phalanx. Proximally, the
attachment of the volar plate to the proximal phalanx is more elastic and is U-shaped due to
two lateral bands, known as the checkrein ligaments. Dorsally, the PIP joint is stabilized by
the dorsal extensor apparatus, which consists of a central slip that inserts on the dorsal
tubercle of the middle phalanx and lateral slips that are connected by retinacular ligaments
(Clavero et al., 2002).
2.4.2 Contractures
Contractures of the PIP joints are vexing problems for patient and surgeon alike. Pain,
stiffness, degenerative arthritis and chronic instability are common outcomes of PIP joint
contractures (Feldscher and Blank, 2002).
Most PIP joint injuries are caused by high velocity, such as in sports injuries. The low-
velocity injuries are less common and are usually caused by twisting; this often causes
15
disruption of the thin volar plate origin. The simple injury classification for PIP joints
according to Freiberg (2007) are:
• Dislocations (volar, dorsal);
• Subluxations (volar, dorsal, ulnar, radial);
• Avulsion or ‘chip’ fractures (associated with ligamentous injuries);
• Intra-articular fractures or fracture dislocations:
oUnipolar:
o proximal phalanx: one condyle, two condyles or comminuted;
o middle phalanx: comminuted
oBipolar: complete joint destruction.
Salafia and Chauhan (1997) classified the PIP contracture considering the treatment
strategies to be as follows: (1) mild; the PIP can be extended by stretching the skin, (2)
moderate; maximum extension 50o-60o and surgical intervention is required, and (3) severe;
the PIP contracture 90o or more correction is possible only by surgical methods.
2.5 Dupuytren’s disease

Palmar fibromatosis was originally described in 1831 by the French physician Dupuytren and is
often referred to as Dupuytren’s disease or contracture. It is the most common of the superficial
fibromatosis, affecting 1%–2% of the general population. The disease most commonly occurs
in patients over 65 years of age, with a frequency of 20% in this age group. Men are three to
four times more likely to be affected by the disease than women, and lesions are bilateral in
40%–60% of patients (Murphey et al., 2009). Dupuytren contracture depends on genetic (family
16
history) and environmental factors namely; alcohol consumption, tobacco exposure and,
possibly, manual activities (athletes specially rock climbers), diabetes, smoking, human
immunodeficiency virus (HIV) infection and seizures have been suggested as associated factors
(Balakrishnan et al., 2008; Riester et al., 2014). Palmar fibromatosis is confined to Caucasians
of north western European origin (Gudmundsson et al., 1999). Dupuytren’s disease develops in
both hands regardless of hand dominance. The ring and small finger are the predominately
affected digits which are followed by the index, middle fingers and the thumb. Both severity
and the impact of the disease are different for every individual, but Dupuytren’s disease is
considered more aggressive in younger people when it occurs (Mafi et al., 2012).
Dupuytren’s disease is a benign condition that can present with varying severity. It results in
abnormal “scar-like” tissue in the palmar fascia leading to irreversible, permanent, and
progressive contracture of the injured digits. The decision to carry out surgical correction is
dependent on the surgeon’s evaluation of clinical severity of the disease, where a goniometer is
used to measure the severity of the flexion deformity (Hindocha et al., 2007). The propagation
of Dupuytren’s disease was summarized by Murphey et al. (2009) in three grades (Figure 2-4):
 Grade 1 - presents as a thickened nodule and a band in the palmar aponeurosis
that may progress to skin tethering, puckering, or pitting;
 Grade 2 - presents as a peritendinous band that limits extension of the affected
finger;
 Grade 3 - presents as flexion contracture.
17
Figure 2-4. Grades of Dupuytren’s disease (Murphey et al., 2009).
Tubiana (1986) classified Dupuytren’s disease into four grades (Table 2-3) according to the
range of PIP flexion angle where grade III and IV are the most serious cases (Citron and
Messina, 1998).
Table 2-3. Classification of Dupuytren’s disease according to Tubiana (1986)
Grade Total fixed deformity (degrees)
I 0 to 45
II 45 to 90
III 90 to 135
IV Over 135
Dupuytren’s disease can be explained in terms of a distortion of the normal palmar fascia.
The anatomical diagram for the normal elements of the digital fascia and the diseased fascia
of Dupuytren’s disease (Figure 2-5).
18
(a) (b)
Figure 2-5. (a) Normal digital fascia and (b) Dupuytren’s disease diseased fascia
(http://bonefix.co.nz)
In the normal hand, the palmar aponeurosis runs longitudinally from the wrist, crosses over
the superficial transverse palmar ligament, and splits into pretendinous bands to each digit.
The insertion of the pretendinous bands to the skin distal to the distal palmar crease is by
means of a bifurcate insertion into the side of the finger dorsal to the neurovascular bundle.
A natatory ligament runs transversely across each web space distal to the MCP joint, giving
fibers that blend with each lateral digital sheet and to the superficial aspect of the flexor
tendon sheath. The superficial transverse ligament lies deep to the pretendinous bands,
proximal to the MCP joints and the natatory ligament (Trojian and Chu, 2007).
19
Diseased bands were referred to as cords. The bands and cords are characterized as follows:
 The pretendinous cord is formed from pretendinous bands.
 The spiral cord is made up of the pretendinous band, spiral band, lateral digital sheet,
and Grayson ligament; this cord takes an encircling path around the neurovascular
bundle that often occurs in the ring and small fingers. The spiral cord runs dorsal to
the neurovascular bundle proximally and volar to it distally.
 The lateral cord is formed from the lateral digital band and is rarely observed, except
on the ulnar aspect of the small finger.
 The central cord has no defined fascial precursor; it is the most common cause of
proximal PIP contracture.
 The natatory cord contributes to web space contractures and passes superficially to
the neurovascular bundles (McFarlane, 1984).
Skin pitting is a result of involvement of small vertical fibers (Grapow fibers) that connect
the dermis to the palmar fascia. Nodules develop from the superficial fibers of the palmo-
digital fascia, adhere to the overlying skin, and usually precede cords. The affected bands of
the digital fascia are referred to as cords. Contraction of cords results in predictable
deformity as they cross joints—the pretendinous cord causes flexion contracture at the
metacarpophalangeal joint. The lateral digital sheet becomes the lateral cord and causes
flexion of the proximal interphalangeal joint through its attachment to the Grayson’s
ligament. The spiral cord is responsible for both proximal interphalangeal joint contracture
and superficial displacement of the neurovascular bundle, making it more susceptible to
accidental division at surgery (Townley et al., 2006).
20
2.5.1 Clinical Presentation
In its early stages, Dupuytren disease can be difficult to diagnose where skin changes are the
earliest manifestation. Changes on the dorsum of the hand consist of either garrod nodes or
knuckle pads (common) which are fibrosing lesions over the proximal interphalangeal joints
(Rayan, 2007). Dupuytren’s disease can be notable from other causes of hand contracture
because it begins as a nodule and slowly progresses to contracture of the fingers. During the
physical examination, the following features should be noted by physicians:
 the site of the nodule (tender/non-tender) and the presence of contractures;
 bands;
 skin pitting, tenderness, and dimpling in the palm and digits.
If contractures are present, the angles should be distinguished at the PIP and MCP joints
where patients can do that by themselves. A functional history and rate of progression also
should be noted (Trojian and Chu, 2007). Figure 2-6 shows a patient with Dupuytren’s
disease (Lahiri et al., 2007). The typical findings are the presence of a nodule followed by
the formation of a cord. The contracture usually starts in the palm and then progresses
distally. The palmar skin and underlying tissue thicken, and the subcutaneous fat becomes
more fibrotic, leading to the skin becoming more attached to the under lying fascial
structures. Skin pits are usually seen in the palm distal to the distal palmar crease. They result
from the contraction of the longitudinal fibers of the palmar aponeurosis that insert into the
dermis. (Shaw at al., 2007).
21
Figure 2-6. The presence of Dupuytren’s disease of a PIP joint (Lahiri et al., 2007).
The Hueston’s tabletop test is a useful, quick and simple test to diagnose the disease. The
patient is asked to put his hand and fingers prone on a table (Figure 2-7). The test is positive
when the hand will not go flat and surgery or other treatment may be indicated. Additionally,
finger joints may become fixed and rigid. If the hand lies completely flat on the table, the
test is considered negative (Bayat and McGrouther, 2006).
Figure 2-7. The Hueston’s tabletop test finger joint contractures diagnosis
(http://dupuytrens.biz/dupuytrens_1.html).
22
2.5.2 Treatment
The treatment for Dupuytren’s disease is to correct the deformities which are causing
functional limitations for the patient. The treatment of the disease was subdivided by Jose
and Bainbridge (2010) into: non-surgical treatments and surgical treatment; needle
aponeurotomy, segmental fasciectomy, limited fasciectomy, dermofasciectomy, other
surgical treatments (skeletal distraction, arthrodeses, and amputation). Surgical release or
excision of the affected palmodigital tissue is the mainstay of treatment, however, symptoms
often recur. Although surgeons apply the long-term safety and recurrence rate of the
nonsurgical correction procedure, it needs further assessment (Shih and Bayat, 2010).
Surgical intervention is usually considered when there is a MCP contracture of at least 30
degrees or any degree of PIP joint contracture (Shaw at al., 2007). Preoperative and
postoperative skeletal traction with an external fixation device has been utilized to improve
correction of severe contractures of the PIP joint.
2.6 External finger fixators
The treatment of PIP joint contractures by external fixators is a useful method enabling the
ability to exercise adjacent joints during healing (Halliwell, 1998). Distractors were first
used in 1897 by Clayton (USA) and they have gone through various modifications (Salafia
and Chauhan, 1997). The main feature of external fixators is their ability to stretch finger
tissues. Each device has a specific mechanical mechanism that allows the passive motion of
the injured digit. Different material combinations have been used in the manufacture of PIP
joint fixators. Typical fixators are either manufactured totally from a metal, or a combination
23
of a metal and a polymer. The metal is generally medical grade stainless steel or medical
grade aluminum alloy. The polymers as polyetherimide (PEI) and rubber.
In 1938 Hoffman introduced his mini-hand fixator, used mainly in cases of fractures, and
this was modified by Mantero (Italy) in 1976 (Salafia and Chauhan, 1997). The fixator was
manufactured from aluminum alloy and stainless steel. It consists of 6 components: proximal
and distal blocks, two 2 mm threaded pins, a lengthening bar and a distraction nut, as shown
in Figure 2-8. Houshian and Schrøder were interested in using this type of fixator and they
stated that the fixator was easy to apply and effective in reducing contractures of the PIP
joint by soft tissue distraction. The complications included superficial pin-track infection in
17% of cases and 30% of patients had slight pain at the beginning of distraction (Houshian
and Schrøder, 2004; Houshian et al., 2007).
Figure 2-8. Mini external fixator (Houshian and Schrøder, 2004)
24
In the late 1990s, a group of renowned design surgeons and Stryker engineers developed the
innovative Hoffmann II Micro External Fixation System (Figure 2-9). The Hoffmann II
fixator is manufactured from stainless steel and carbon composite materials to provide an
optimal low profile high resistance features, and was designed to answer the growing needs
of small bone injuries by ensuring ease of use, versatility and patient comfort (Asche et al.,
2009).
Figure 2-9. Hoffmann II Micro External Fixation System (Asche et al., 2009).
Ruland et al. (2008) and White et al. (2012) applied the design mini fixator idea of 1.4 – 1.6
mm diameter K-wires and rubber bands (Figure 2-10 and Figure 2-11). The difference
between these two studies was the position of the inserted pins in the finger phalanx. The
pins were implemented dorsally during treatment of severe Dupuytren’s contracture of the
PIP joint in 38 fingers (27 patients) between 1999 and 2004 (White et al., 2012). On the
other hand, Ruland et al. (2008) inserted the pins laterally in the injured digit to correct 34
PIP joint contractures. Both studies reported that the pin and bands idea achieved fair results
towards their patients especially in the study of White et al. (2012) where the fixator can be
25
attached to any digit, because of its size and position. The common complication was pin
site infections and more complications were listed by White et al. (2012) as: loose pins,
osteoarthritis at the PIP joint, reflex sympathetic dystrophy, and disease recurrence needing
PIPJ fusion.
Figure 2-10. Mini external fixator (pins and elastic bands) (White et al., 2012).
Figure 2-11. Pins and dental rubber bands fixator (Ruland et al., 2008).
26
The dorsal aspect of pin implementation in the involved finger was also presented and
described by Slater et al. (2003), who believed in the advantage of this technique where the
device can be applied to more than one digit simultaneously. Their new device, A Digit
Widget device (Figure 2-12) employs the principle that a gentle extension torque, applied
continuously, simulates the growth and elongation of contracted soft tissues. No
complications were reported in their study.
Figure 2-12. A Digit Widget device (Slater et al., 2003).

A review article of a complete study of the wide spectrum of PIP joint injuries and the
Different types of treatment techniques was presented in 2009 by Ng and Oliver and
reviewed by the British Editorial Society of Bone and Joint Surgery Journal (Ng and Oliver,
2009). Devices (Figure 2-13) included the dynamic traction device, the Robertson Banjo
splint 1946, extension-block splinting 1972, the Suzuki frame 1994, the Allison device 1996,
the force couple splint 2000, the Schenk device facilitating mobilisation 2000 and the Hynes
and Giddings device 2001. The review study concluded that the surgical treatment of
fractures of the PIP joint is still mainly based on the experience and personal preference of
individual surgeons. For the dorsal fracture-dislocation with a volar lip, if the volar fragment
is less than 30% of the articular surface the extension-block splinting with a wire was a
favorable technique. For those with more extensive articular involvement or with complex
27
unstable fractures, including Pilon fracture, the ‘S’ Quattro is the preferred fixator because
of its relative ease of application.
(a) (b) (c) (d)
(g)
(e) (f)
Figure 2-13. The different types of treatment techniques (a) Robertson Banjo splint; (b)
Extension-block splinting; (c) The Suzuki frame; (d) Allison device; (e) The force couple
splint; (f) The Schenk device facilitating mobilization; (g) The Hynes and Giddings device
(author’s own drawing, adapted from Ng and Oliver, 2009).
The Stockport Serpentine Spring System or “S-Quattro” is a flexible mini external fixator.
The device was devised by Fahmy in 1990 (Fahmy, 1990) and designed to treat comminuted
unstable intra-articular phalangeal fractures. It contains a unique, dual, parallel, but opposing
action, spring column system. It consists of two modified unthreaded notched K-wires and
two serpentine springs (Figure 2-14) (Bostock et al., 1993a). The advantages of the S-Quattro
are: low mass; a reduced operative time; distraction of joints in different degrees of flexion,
extension and radial-ulnar deviation; allowing movement in intra-articular fractures; its use
in some compound fractures and in cases of mal-union (Bhamra et al., 2012). The S-Quattro
28
was used in 224 cases (Fahmy, 1990; Fahmy and Harvey, 1992; Bostock et al., 1993b; Mullet
et al., 1999; Khan and Fahmy, 2006a; Khan and Fahmy, 2006b; Byrne et al., 2008) with good
overall results. Some complications were reported in a few cases such as devices dislodging,
pin site infections and pin loosening.
Figure 2-14. The Stockport serpentine spring system “S-Quattro” a flexible mini external
fixator (Bostock et al., 1993a).
The Joshi external stabilising system (JESS) is considered one of the most comprehensively
used systems where many previous clinical studies from 1991 to 2013 have referred to it
(Figure 2-15). A wide range of complex problems in the management of fracture of the
humerus and hand were corrected using the JESS fixator. In 1991 Dr Joshi (Bombay, India)
introduced the external fixator JESS which is economical, reliable, reusable and low mass.
This system has a high safety profile and unparalleled ease of implantation. It can be applied
easily by any surgeon with minimal instrumentation (Ghosh et al., 2013). It uses transfixing
K-wires which are bridged together via ‘link joints’. JESS allows frames of varying rigidity
to be readily constructed depending upon the clinical need. Malleable connecting rods
obviate the need for complex joints with multiplanar freedom. The construction of standard
29
hand positioning frames allows proper positioning of crushed hands. Subsequent
mobilization of the hand with the help of slings and rubber bands is also possible. With the
addition of hinges and distractors the system is able to cope with complex problems as well
such as stiff contracted joints and clubfoot (Joshi, 1997). The JESS device was applied for
correction of PIP Joint contracture deformities in 68 fingers between 1991 and 1997 by
Salafia and Chauhan (1997). The study results were compared with other distractors at that
time which were made in the USA and Europe and it was concluded that the JESS was easy
to apply, economical, reliable, re-usable and will be accepted by the patient. The device
complications included mechanical malalignment of the K-wire and infection. In another
study, 25 patients with hand injuries, fractures and a mangled hand used the JESS device
and it was evaluated by x-ray (Sathishchandra et al., 2011). The study reported that all cases
recovered from the injuries with rod migration and rotational instability the complications.
Figure 2-15. JESS (Joshi external stabilising system) device (Salafia and Chauhan, 1997).
In 1998 a comparison study was undertaken between one of the most widely used devices
for a continuous elongation treatment for severe Duputren’s disease, The Continuous
30
Extension Technique (TEC) device (Figure 2-16) and a new designed device by Neil Citron,
the Verona device (Figure 2-17). The TEC device was constructed in 1986 by A. Messina
(Messina and Messina, 1993). The TEC was used widely between 1991 and 1996. Citron
and Messina (1998) used the TEC and the Verona for the preoperative correction of the
deformities of severe Dupuytren’s disease in 13 patients (18 fingers) with 7 cases using the
Verona and 11 cases using the TEC. The conclusions of the study were that the TEC is a
large device which can apply longitudinal traction to several fingers simultaneously and to
the various joints in that finger independently with the possibility of varying the direction of
traction from a straight pull. The Verona fixator is less bulky and it can apply an angular
corrective force as well as distraction if required. It can be used on only one joint at a time
and was employed only for the PIP joint.
Figure 2-16. The Continuous Extension Technique (TEC) device (Citron and Messina,
1998).
31
Figure 2-17. Verona device (Citron and Messina, 1998).
The PIPSTER (Proximal Interphalangeal Skeletal Traction Extender) device (Figure 2-18)
was designed by Hodgkinson in 1994 (Hodgkinson, 1994) in order to develop the TEC. The
PIPSTER is described as a very simple device and small in size in which two fixation points
are separated as a nut is turned. One of them is transversely across the base of the proximal
phalanx and the other across the head of the middle phalanx. A silicone gel spacer separates
the device from the skin of the finger. The PIPSTER device was applied in five patients with
seven affected fingers and two complications were found to occur with a skin ulcer in the
web of the K-wires.
Figure 2-18. PIPSTER (Proximal Interphalangeal Skeletal Traction Extender) device

(Hodgkinson, 1994).
32
Between 1993 and 1998 two more external fixators were designed and presented. By 1993
a small dynamic external finger fixator (Inanami et al., 1993) was designed to maintain the
reduced position of the dislocated PIP joint (Figure 2-19). In 1998 the “Multiplanar”
distractor (Figure 2-20) was designed for three-dimensional distraction of the mandible by
Kasabian et al. (1998). Inanami et al. (1993) fixator consists of a pair of rhomboid
apparatuses that have two pulleys at both ends and a pair of arm apparatuses that have one
pulley in the middle. The Multiplanar was placed in the proximal phalanx and two pins were
placed in the middle phalanx and the angle of distracter performed by simple rotation of a
screw on the device. The small fixator was attached to 7 male patients (5 ring and 2 index
digits) and the Multiplanar was attached only in one patient. All patients were satisfied with
the final results of the treatment in both studies. In only one case did a patient suffer from
pain (Inanami et al., 1993) with no complications reported by Kasabian et al. (1998).
Figure 2-19. Small dynamic external finger fixator (Inanami et al., 1993).
33
Figure 2-20. Multiplanar distractor (Kasabian et al., 1998).
A unique unilateral external device was designed by Hotchkiss et al. (1994), which is the
Compass PIP joint hinge. The Compass hinge differs from other devices in that there is
easier access for fasciectomy, less technically demanding fasciectomy, the device corrects
contracture prior to fasciectomy and maintains an active and passive range of movement. In
contrast to the other distraction devices, only the Compass hinge allows and maintains active
extension. Mechanical failures are the most common problems associated with the use of the
Compass device (Bonaspetti et al., 1999; Bain et al., 1998; Houshian et al., 2002; Feldscher
and Blank, 2002; Lahiri et al., 2007; Youssef et al., 2015). Full details about the Compass
hinge will be addressed in the next chapter.
By the end of this section, there are some design considerations that can be picked from the
background study of the different PIP joint fixators and these key points helped in generating
some of the new design device requirements (see chapter 4 in this study). These
considerations can be summarized as:
34
 There were two possible fixation positions for the fixators in the digits, laterally and
dorsally. But the surgeon feedback from Mr. Titley confirmed that the lateral position
is most sufficient than dorsal one,
 The fixator’s mechanical working mechanisms are classified mainly into two; lock
mechanism (screw and nut) and gear mechanism (worm and worm wheel) supporting
in the fixators widely used. They will be the basis of the two concept designs for the
mechanisms of the new device design.
 A low profile fixator was recommended from the previous studies and had a positive
feedback from surgeons and patients as well. They can be attached to the central
digits easily and the patients feel comfort due to the small space between the fingers,
 Surgeons considered the polymer in the device as important as it is light weight and
natural in color so it close to the skin color. That makes patients motivated to implant
it in their injured digits.
35
Table 2-4 shows a summary from the available data about the main features of the different external fixators used to treat PIP joint
contractures.
Table 2-4. Summary of the main features of the different PIP joint fixators.
Number
Fixator of Working Device Size Weight Material Applicability Complications References
patients/ mechanism implanted / usability (fractures, infections, and
digits position loosening)
Mini external 42 Lock Lateral side Not Not Aluminum Easy to apply Pin-track infection, Houshian and
fixator patients mechanism available available alloy and pain Schrøder,
(screw and data data stainless 2004;
nut) steel Houshian et
al., 2007.
36
Hoffmann II Not Lock Lateral side Low Not Stainless Ease of use Not available data Asche et al.,
Micro available mechanism profile available steel and 2009.
External data (screw and data carbon
Fixation nut) composite
materials
Pins and 38 digits Pins and Dorsal side Small Low Stainless Not available Pin site infections, loose White et al.,
elastic bands elastic size mass steel and data pins. 2012.
bands rubber
Pins and 34 digits Pins and Lateral side Small Light Stainless Not available Pin site infections. Ruland et al.,
dental rubber rubber size weight steel and data 2008
bands fixator bands rubber
37
S-Quattro 224 Unthreaded Lateral side Small Low Stainless Easy to apply Devices dislodging, pin Fahmy, 1990;
fixator patients notched K- mass steel site infections, pin Fahmy and
wires and loosening. Harvey, 1992;
two Bostock et al.,
serpentine 1993b; Mullet
springs et al., 1999;
Khan and
Fahmy,
2006a; Khan
and Fahmy,
2006b; Byrne
et al., 2008.
JESS device 93 digits Lock Lateral side High Low Not Reusable, Mechanical malalignment Joshi, 1997;
mechanism safety mass available applied easily of the K-wire, infection. Salafia and
profile data Chauhan,1997
38
(screw and ; Ghosh et al.,
nut) 2013;
Sathishchandr
a et al., 2011.
TEC device 11 digits Lock Lateral side Large Heavy Not Not easy to No complications recorded Messina and
mechanism device available use due to the use of TEC Messina,
(screw and data device. 1993.
nut)
Verona 7 digits Worm and Lateral side Less Not Not Easy to use, No complications recorded Citron and
device worm wheel bulky available available easy to apply due to the use of Verona Messina,
mechanism data data device. 1998.
PIPSTER 7 digits Lock Lateral side Small in Not Not Easy to apply Skin ulcer in the web of the Hodgkinson,
device mechanism size available available K-wires 1994.
data data
39
(screw and
nut)
40
2.7 Medical device design process
The design process for implantable orthopedic medical devices can be divided into six stages
(Aitchison et al., 2009): market research, design specification, development of concept
designs, detail design, manufacturing and sales. The detailed structure to the design process,
shown in Figure 2-21, presents the sequence of procedures which should be followed to
implement a new device design into the market.
In order to ensure the safety of patients and healthcare workers, the design process of medical
devices is highly regulated. The design of the device has to meet certain requirements
directed by legislations such as the Medical Device Directive for Europe and the Food and
Drug Administration for the USA. A Design History File which describes the design history
of the product should keep the record of the design process, which needs to be maintained
after the product is released to include any subsequent modifications.
For the design aspects, where the conceptual design creates many solutions to meet the
design requirements. A conceptual idea is chosen and developed until a detail design has
been produced.
The design is verified using finite element analysis which is a method that has been used
widely to analyse medical devices. A major advantage of this method is allowing the
different designs to be assessed and optimized without the need to build unnecessary and
expensive prototypes. Finite element model parameters can be changed repeatedly and
40
quickly to evaluate the effect and influence of each single component before the final design
is manufactured.
An important step in the design of a medical device is to carry out a risk assessment. Any
risk associated with the device must be eliminated or reduced as far as possible so that the
safety of patients and healthcare workers is not compromised. Since June 1998 it has been
law that no new medical device can be sold in the European Union without the device being
European Conformity (CE) marked. Every medical device prior to approval with CE
marking needs to have completed a risk analysis procedure. It is a legal procedure which is
very useful to evaluate the design during the development stages. To gain a CE mark a
medical device must comply with the Medical Device Directive (MDD) (1993). The MDD
(1993) has been developed as a means to regulate medical devices in Europe (Crisp, 1996).
This regulation covers any instruments, apparatus, appliance, material or other article
intended for use or in the human body.
The MDD is now well established and is used by medical device manufacturers as a
benchmark for the minimum standard of quality required (EN14971; MDD). During
manufacture faults can occur and these faults are described by the MDD as risks. A risk is
the probability of a hazard causing harm to a patient or healthcare worker. Therefore, the
device also requires documented evidence that the device is fit for the purpose for which it
was intended and that packaging, sterilization, transportation and storage must not adversely
affect it.
A repeatable and reliable manufacturing process should be chosen before transferring the
final design to the production stage and the final design is verified using validation processes
(e.g. mechanical testing) to ensure that the medical device meets the user requirements and
41
the intended use. All documents and training associated with the device should all be stored
in the Design History File. Finally, there is the launch of the new device in the market and
post-market surveillance.
A design review is required, at each stage of the design process, to formally document
complete and systematic examination of a design (Aitchison et al., 2009).
42
Figure 2-21. The medical device design process flowchart (Aitchison et al., 2009).
43
2.8 Summary
Contracture of the proximal interphalangeal (PIP) joint is a common clinical problem and a
number of skeletal fixation devices have been used to correct flexion contractures of the PIP
joint. The TEC, PIPSTER, JESS, Verona, Multiplaner distractor, S Quattro, Ortho fix, Digit
Widget device and Compass hinge device are examples of the fixators. Of these devices, the
Compass hinge has received the most investigation regarding its effect on contractures
associated with Dupuytren’s disease. The Compass hinge is characterised by allowing active
extension movement. Mechanical failures and pin infection are the most common problems
associated with the use of the Compass device. A complete engineering analysis for a failed
Compass hinge device was required to understand the main causes of mechanical failure and
this will be presented in the next chapter.
44
CHAPTER 3
ENGINEERING ANALYSIS OF A FAILED
COMPASS HINGE
Chapter 3 Engineering analysis of a failed Compass hinge
3 ENGINEERING ANALYSIS OF A FAILED

COMPASS HINGE
This chapter aims to provide an engineering analysis of a failed Compass hinge device.
Section 3.2 introduces the Compass hinge device. The engineering analysis of a failed device
is presented in § 3.3. The chapter concludes with recommendations for an improved design
which is described in § 3.4. A peer reviewed journal paper based on this chapter has been
published (Youssef et al., 2015).
3.2 Compass hinge device
3.2.1 Introduction
The Compass hinge (Smith & Nephew, Memphis, TN, USA) is an example of a dynamic
external fixation device (Figure 3-1) which is used by surgeons for correcting the PIP joint
for conditions such as fractures and diseases. Dupuytren's disease is one of the diseases
which the Compass hinge is commonly used to treat it. (Krakauer and Stern, 1996; Bain et
al., 1998; Houshian et al., 2002; Feldscher and Blank, 2002). The Compass hinge is used to
46
stretch tissues prior to corrective surgery (Bonaspetti et al., 1999). The Compass hinge
fixator is a unilateral external hinge that attaches with skeletal fixation to either side of the
joint with stainless steel Kirschner wires (K-wires) (Feldscher and Blank, 2002).
Two K-
wires will
be inserted Two K-wires will
between be inserted
the blocks between the
One K-wire (at PIP center) blocks
Figure 3-1. Compass hinge external fixator.
3.2.2 Components and surgical technique
The Compass hinge consists of eight main parts: proximal arcuate hinge member; distal
arcuate hinge member; worm gear; 2 superior clamping blocks; 2 inferior clamping blocks;
a radiopaque axle (Hotchkiss et al., 1994). The device is surgically attached under
fluoroscopic guidance (Krakauer and Stern, 1996). The first step is placement of a K-wire
through the approximate axis of rotation of the PIP joint; this becomes the mechanical axis
of the Compass hinge. Two K-wires are then inserted into both the proximal and middle
phalanges and the proximal and distal clamping blocks are clamped around the two K-wires.
47
These K-wires should be placed parallel to the first inserted K-wire. The original K-wire,
which marks the axis of rotation, is then removed at the end of the procedure (Figure 3-2).
Distraction may be applied by tightening a screw in the distal block. The device is equipped
with a worm gear (Houshian et al., 2002). When the worm gear is disengaged, active
movement of the finger is possible by the patient (Bain et al., 1998). With the gear engaged
only passive motion is possible. The Compass hinge differs from other devices in that it can
provide distraction, stabilisation and controlled passive mobilisation, whilst allowing
disengagement for active motion (Krakauer and Stern, 1996).
(a) (b)
(c)
Figure 3-2. Surgical technique for the Compass hinge fixator (a) axis K-wire insertion (b)
proximal and distal K-wires insertion (c) dorsal view for the implanted fixator
(author’s own drawing, adapted from Hotchkiss et al., 1994).
48
The Compass hinge device can be attached to the fingers in two positions depending on
which finger is injured in which hand (Figure 3-3). Position A is where the distal arcuate
hinge member is supported in the middle phalanx of the patient injured finger and the
proximal arcuate hinge member in the proximal phalanx. Position B is where the proximal
arcuate hinge member is supported in the middle phalanx and the distal arcuate hinge
member in the proximal phalanx (Lahiri et al., 2007).
(a) (b)
Figure 3-3. Compass hinge device supported on patient finger (a) Position A and (b)
3.2.3 Review Position B (adapted
of clinical from (Lahiri et al., 2007)).
studies
Previous clinical case studies have reported different time periods for use of the Compass
hinge device for each patient depending on the severity of injury; the maximum period the
device was attached to a patient was 64 days (Bain et al., 1998). Pin-track infections and
mechanical failures (Krakauer and Stern, 1996; Bain et al., 1998; Bonaspetti et al., 1999;
Houshian et al., 2002; Feldscher and Blank, 2002; Lahiri et al., 2007) are the most common
problems associated with the use of the device (Figure 3-4 and Figure 3-5).
49
Figure 3-4. Mechanical failure at distal arcuate hinge (adapted from (Lahiri et al., 2007)).
Figure 3-5. Pin-track infections (adapted from (Lahiri et al., 2007)).
The Compass hinge device was applied between 1994 and 2007 in 88 patients with PIP joint
contractures; fracture dislocations, dorsal dislocation, fracture subluxation and Dupuytren’s
disease affected 54 border digits (index and small) and 43 central digits (middle and ring).
The compliance of the patients was high and they responded well to the fixator. The overall
results of the device were acceptable for surgeons. The advantages of the devices were
reported as: low profile; easy to apply; easy to use; allows for active and passive mobility.
Table 3-1 is a summary of the previous clinical studies where the Compass hinge device was
used in them.
50
Table 3-1. The previous clinical studies summary
Year of PIP contractures Number Injured Complications References
study of digits
Patients
3 index mild pain was rated in 4 cases and moderate
Fractures of the 3 middle to severe in 2 cases, recurrent subluxation in 3
1993 -1994 PIP joint 20 4 ring cases, fixator reduction was lost in 1 case, 2 Krakauer and Stern,1996
10 small cases of pin track infection, and the device
worked its way off the digit in 1 case.
Fracture 3 index
dislocations of the 11 ring
PIP, a dorsal 1 middle
dislocation of the 20 5 little four pin-track infections and two fractured pin
1994 -1996 PIP joint, a PIP blocks Bain et al., 1998
51
joint contracture,
fractures of the
base of the
middle phalanx, a
fracture of the
head of the
proximal phalanx,
swan-neck
deformities after
longstanding
avulsions of the
volar plate
Dupuytren’s 6 small one case the clamp broke and was replaced;
1999 disease 6 another patient had skin infection in his palm Bonaspetti et al., 1999
which was treated with antibiotics for 10 days
52
Device developed 2 index pin-track infections occurred in 11 cases and
after tendon 6 middle 2 cases of them led to pin loosening, aseptic
1997 - 2000 surgery, severe 21 7 ring pin loosening occurred in 2 cases and the pin Houshian et al., 2002
hand injuries, 12 little support block of the Compass hinge broke in
replantation 5 cases (in 2 cases it happened twice)
surgery,
Dupuytren
surgery ,
dislocation of PIP
joint and fracture
surgery
A chronic PIP 1 ring
2002 joint fracture 1 1 small frame cracked after 35 days from use Feldscher and Blank,
dislocation 2002
53
Dupuytren’s, 12 border
flexion digits, 10 the distal arcuate hinge polymer part fractured
2007 contractures, 20 central in all cases, Pin-tract infection in 7 patients Lahiri et al., 2007
fracture digits
subluxation
54
From the previous clinical studies using the Compass hinge device it was concluded that the
device was applied to 88 patients with 97 digits where some patients had more than one
injured digit with PIP joint contractures. Fracture happened in 22 devices; 14 in the device
frame and 8 in the clamping blocks. There has been no recorded causes of these failures. Pin
track infection occurred in 25 cases; surgeons confirmed that infection might happen due to
the different response from the human body with the K-wire and also patients should keep
the area around the inserted K-wires clean as possible to avoid any infection.
3.2.4 Model
A Compass hinge device was provided by Mr. Garth Titley (Consultant Plastics and Burns
Surgeon at the Queen Elizabeth Hospital, Birmingham). The device was disassembled
(Figure 3-6) by using a standard hexagonal head driver and the dimensions of its parts were
measured using a digital vernier caliper (Hilka Tools (UK) Ltd, Surrey, UK). Figure 3-7
shows an example of these measurements. The width was in a range from 49.5 to 58.5 mm,
height was 35 mm and thickness was 11.5 mm. The Compass hinge had a range of motion
from 0° extension to 105° flexion as written on the device frame. Its mass was 15 g (with a
standard deviation of 0.02 g) that was measured using a digital laboratory scale (GA200D,
OHAUS ®, European Instruments Ltd, Oxford, UK). The gear part nomenclature (module,
worm gear teeth pitch and the outer diameter) in the device was measured using the gear
tooth pitch gauge. From the measured dimensions two solid models of the Compass hinge
device were created using SolidWorks 2011® premium 2011x 64 Edition © 1995-2010
(Dassault Systèmes SolidWorks Corporation, Waltham, USA).
55
Figure 3-6. Compass hinge disassembled components.
Figure 3-7. An example of measurements made on the distal arcuate hinge member.
The first model (Model I) consisted of the distal arcuate hinge member and this was used to
model the Compass hinge on the middle phalanx (Figure 3-8). The second model (Model
II) consisted of the assembly of the proximal arcuate hinge member and the distal arcuate
hinge member which were used to model the Compass hinge on the proximal and middle
phalanges (Figure 3-9). For both models SolidWorks Simulation (SolidWorks 2011®
56
premium 2011x 64 Edition © 1995-2010 (Dassault Systèmes SolidWorks Corporation,
Waltham, USA) was used for the finite element analysis.
Figure 3-8. Solid model of the distal arcuate hinge member.
Figure 3-9. Solid model of the proximal and distal arcuate hinge assembled members.
The proximal and distal arcuate hinge members are manufactured from the material Ultem®
which is a polyetherimide with a Young’s modulus of 3.3 GPa and a Poisson’s ratio of 0.44
(Kirby, 1992). Model Ӏ was meshed with a total of 75,023 parabolic tetrahedral elements (it
57
is second-order element which is defined by four corner nodes, six mid-side nodes, and six
edges). They represent curved boundaries which means more accurate and better
mathematical approximations of the results. This number was determined following mesh
convergence testing and the convergence criteria was the peak stress. The parts material to
be an input to the SolidWorks simulation model was selected from the data base library list
which was installed in the SolidWorks program.
Constraints were then applied to the model as follows (Figure 3-10):
 The pivoting joint hole was constrained to allow only rotation;
 Four gear teeth were fixed in all directions to simulate the gear teeth in engagement
with the worm gear;
 A range of forces from 10 N to 210 N were applied to the model to simulate the likely
forces a patient could apply to the device, based on values of force previously
determined from the literature (see chapter 2 section 2.3). Forces were applied either
vertically downwards or upwards through the threaded hole of the distraction screw
or perpendicular to the middle phalanx of the finger.
58
Figure 3-10. Meshed finite element model Ӏ with the load and constrains applied.
Four different positions of engagement with the worm gear were investigated: position (1)
teeth between 15 and 30°; position (2) 30-45°; position (3) 65-80°; position (4) 90-105°
(Figure 3-11).
59
(a) (b)
(c) (d)
Figure 3-11. Four different positions of engagement with the worm gear (a) position 1
(15-30°); (b) position 2 (30-45°); (c) position 3 (65-80°); (d) position 4 (90-105°)
Maximum normal stress theory was selected for analysing the stresses in the distal arcuate
hinge member rather than Von Mises stress theory due to the constrains were applied in the
PEI material parts (Collins, 1993; Woods and Nimmer, 2001; Hamrock et al., 2007).
60
Model II was meshed with a total of 30,000 tetrahedral elements, which depended on the
gear teeth fixation positions. Constraints were applied to the model as follows (Figure 3-
12):
 The pivoting joint hole of the proximal arcuate hinge part was constrained to allow
only rotation;
 A fixed geometry constraint was selected to the pivoting hole of the distal arcuate
hinge member;
with the worm gear;
 Forces were applied to the model either vertically downwards through the threaded
hole of the proximal arcuate hinge member distraction screw or perpendicular to the
middle phalanx of the finger.
Figure 3-12. Meshed finite element model II with the load and constrains applied.
61
The model was analysed with the gear teeth engaged in just two of the positions used for
Model I, as there has been no recorded failure case at the proximal arcuate hinge member:
position (1) teeth between 15 and 30° and position (4) 90-105° (Figure 3-13).
(a) (b)
Figure 3-13. Two different positions of engagement with the worm gear (a) position 1 (15
- 30°) (b) position 4 (90-105°).
3.2.5 Results
The results from the simulation analysis for Model Ӏ showed that stress patterns were similar
for all four positions of the fixed gear teeth. For all cases the maximum value of the principal
stress was located between the gear teeth at a point of fixation and the high stresses were
distributed at the right side of the distal arcuate hinge member. Figure 3-14 shows the stress
distribution pattern at the four different fixation positions at a load of 210 N. The maximum
principal stress was 285.3 MPa in position (1) of 15 - 30°.
62
(a)
(b)
63
(c)
(d)
Figure 3-14. Distribution of maximum Principal stress for model I for four different
positions of gear teeth fixed at (a) position 1 (15-30°); (b) position 2 (30-45°); (c) position
3 (65-80°); (d) position 4 (90-105°).
64
A linear relationship was found between the applied force in the finite element model and
the corresponding maximum principal stress. This relationship was found for all four
positions of the fixed gear teeth; the results for position (1) of 15 - 30° are shown in (Figure
3-15). In this position the maximum principal stress was 285.3 MPa.
Figure 3-15. Maximum principal stress against force for the gear teeth fixed at 15 - 30°.
High stresses of up to 200 MPa were also found on both sides of the right threaded
distraction screw hole, as shown in Figure 3-16.
Figure 3-16. Maximum principal stress distribution around the distraction screw hole.
65
For Model II, the results from the simulation analysis showed that the stress patterns were
similar for the two positions of the fixed gear teeth. For these cases the maximum value of
the principal stress was located between the gear teeth at a point of fixation for the closest
tooth to the applied load. Additionally, most of the high stresses were distributed at the left
side of the proximal arcuate hinge member. Figure 3-17 shows the stress distribution pattern
for position (1) of 15 - 30° and position (4) 90-105° at a load of 210 N. The maximum
principal stress was 122.3 MPa which occurred in position (1) of 15 - 30°. High stresses of
up to 90 MPa were also found on both sides of the left thread distraction screw hole as shown
in Figure 3-18.
(a)
66
(b)
Figure 3-17. Finite element analysis stress distribution results for Model II for position
1gear teeth fixed at (15 - 30°).
Figure 3-18. Maximum principal stress distribution around the left distraction screw hole.
67
3.3 Scanning electron microscopy
Scanning electron microscopy (SEM) can be very useful for many different types of material
and project. It has the advantages of being able to examine fairly large samples (up to around
25 mm diameter) and has a large depth of focus (Engel et al., 1981; John, 1992). SEM
examination has been well documented in the use of polymers, for both characterisation and
examination of damage or faults (Campbell and White, 1989). A Compass hinge that had
fractured through the distal arcuate hinge member was provided by the surgeon Mr. Garth
Titley and three fracture surfaces (Figure 3-19) were analysed:
 fracture surface (1) at the distraction threaded hole in the right side of the distal
arcuate hinge member;
 fracture surface (2) at the detached part from the distal arcuate part;
 fracture surface (3) at the angles side in the distal arcuate hinge part.
2 1
Figure 3-19. Fracture surfaces examined using scanning electron microscopy.
68
Prior to examination, the samples were cut from the fractured surfaces to size using a scalpel
blade and mounted onto SEM stubs (AGAR Scientific, Standard, UK). These are metal discs
measuring approximately 30 mm in diameter and 10 mm in height. The sample length and
width cannot be larger than the disc and the height of the sample must be as small as possible
to ensure it does not make contact with the camera in the microscope chamber. The samples
were sputter coated with a thin layer of gold using a gold sputter coater (Emscope SC500;
Emitech Ltd., Ashford, Kent, Great Britain) (Figure 3-20). Parts before and after coating are
shown in Figure 3-21.
Figure 3-20. Emscope SC500 sputter coater.
(a) (b)
Figure 3-21. Fracture surface samples (a) before (b) after gold spray coating.
69
SEM was performed in the School of Metallurgy and Materials (University of Birmingham)
on a Joel JSM-6060 scanning electron microscope (JEOL Ltd, Tokyo, Japan), which is
shown in Figure 3-22. The accelerating voltage was 10 kV and the working distance (WD)
was 11 mm. The working distance is the distance between the objective lens and the
specimen. A short WD results in a higher resolution and decreased depth of field, whereas a
longer WD results in less resolution, but an increased depth of field. The optimum WD is 11
mm for the energy dispersive x-ray spectrometry analysis on the 6060 microscope as
recommended by the University of Birmingham SEM technician.
Figure 3-22. Joel JSM-6060 LV microscope with computer.
70
3.3.1 Results
The SEM images were reviewed and compared with known types of failure published in the
literature. The most useful piece of literature was a journal paper entitled “SEM Analysis of
Polymeric Mechanical Failures in Polyetherimide” (Zimmerman and Jones, 1994).
The scanning electron microscopy fractographs from the three fracture surfaces investigated
from a failed Compass hinge are presented in Figure 3-23. Fracture surface 1 (Figure 3-23a)
showed mirror, mist and rough regions, with brittle failure bands. This is consistent with a
fracture caused by bending. Fracture surface 2 (Figure 3-23b) and fracture surface 3 (Figure
3-23c) were similar with crazes, shears bands and small indentations or voids. This failure
is consistent with a brittle fracture caused by fatigue.
71
(a)
(b)
(c)
Figure 3-23. SEM fractography images of the distal block fracture surfaces (a) fracture
surface 1 (b) fracture surface 2 (c) fracture surface 3.
72
3.4 Discussion
An engineering analysis of a failed Compass hinge device using FEA and SEM was
undertaken to investigate the potential failure modes. The FEA for Model Ӏ which consisted
of the distal arcuate hinge member shows that the highest stresses were located on the right
side of the distal arcuate hinge member, usually between the gear teeth. The maximum
principal stress was found to be 285.3 MPa. Model II which consisted of the assembly of the
proximal arcuate hinge member and the distal arcuate hinge member showed that the highest
stresses were located on the left side of the proximal arcuate hinge member, usually between
the gear teeth. The maximum principal stress was found to be 122.3 MPa. These values of
stress are well in excess of the fatigue strength of the polyetherimide that the parts are
manufactured from which has a value of 24 MPa at 5 Hz, 20°C and >107 cycles (Trotignon
et al., 1993).
Even if low forces are applied to the Compass hinge as a result of daily patient finger
activities, the stresses are still likely to exceed the fatigue strength of the material. It is
assumed that around 1 million finger motions per year occur (Joyce and Unsworth, 2000),
so that would be an average of around 2,700 motions per day. The results also show high
stress around the screw hole, which is the distal arcuate member for Model Ӏ and in the
proximal arcuate member for Model II.
The SEM results were compared with published work (Zimmerman and Jones, 1994) and
show that fracture surfaces 1, 2 and 3 (Figure 3-19) were caused by cyclic bending stresses.
This information, together with the results of the finite element analysis for Model Ӏ confirms
that the likely sequence of events for failure is as follows:
73
 Firstly, with the worm gear locked in position, the patient may try and move their PIP
joint, thus causing high stresses between the gear teeth when in position (1) with the gear
teeth between 15 and 30°;
 Then, if the loads are high enough, the stress between the gear teeth will exceed the
fatigue strength of the polyetherimide material and a crack will be initiated;
 As the patient carries on loading the device the crack will propagate through the device
into the slot;
 Finally, the fragment of polyetherimide will bend, fracture and detach from the device.
A number of studies have detailed failure of the polyetherimide distal arcuate hinge member
(refer to section 3.2.3 in this chapter) so it does seem to be a reasonably common failure
mode. On the other hand, no study has recorded any failure case at the proximal arcuate
hinge member.
The difference between the failures in the two positions (A and B) (Figure 3-3) is likely due
to where the stresses are distributed. In Model I the fatigue cyclic stresses were located and
distributed in the same part which is the distal arcuate member; this means that cracks are
likely to propagate rapidly. However, in Model II the stresses are distributed in two different
areas; the distal arcuate member and in the proximal arcuate hinge member.
74
The results from the two models also showed that whatever the position of fixation, the high
values of stresses usually appeared when the worm gear was engaged at position (1) with
the teeth between 15 and 30° which means that the finger is in the fully extended position.
The Compass hinge is a reliable and safe system for patients affected by Dupuytren’s disease
with flexion deformity. It has clinical advantages that are not available in other external
distraction fixators which makes it easy to apply (Bonaspetti et al., 1999), namely the ability
to disengage the device to allow active flexion from an extended position. The development
plan towards implementing a new design device will firstly, give consideration to other
polymers that have a higher fatigue strength than polyetherimide. PEEK (Poly-ether-ether-
ketone) is a potential candidate material as it is a polymer that is used increasingly in medical
devices (Xin et al., 2013) and it has fatigue strength at >107 cycles and 5 Hz of around 65
MPa (Trotignon et al., 1993) and a range from 99.4 to 107.4 MPa for heat treated PEEK
(Xin et al., 2013). Secondly, work on evolving new design features to overcome the
complications in other devices will be undertaken. Finally, an evaluation of the proposed
design will be undertaken using FEA and then mechanical testing to validate the design.
3.5 Summary
A failed Compass hinge external fixator for fingers has been analysed. The polymer parts
were manufactured from a polyetherimide (PEI) and the metal parts from an aluminum alloy.
The Compass hinge differs from other devices in that it can maintain an active and a passive
range of movement. Pin-track infections and mechanical failures are the most common
problems associated with the use of this device. Finite element analysis (FEA) was used to
75
investigate the principal stresses in the device under different loading conditions. Scanning
electron microscopy (SEM) was used to investigate the fracture surfaces. The FEA showed
that the maximum principal stress was greater than the fatigue strength of polyetherimide.
The SEM fractographs confirm that failure by cyclic bending stress was the main cause of
the device distal arcuate hinge member part fracture. A modified design and the use of a
polymer with greater fatigue strength are considered as potential solutions to overcome this
problem. The next chapter will present the design and development of a new device.
76
CHAPTER 4
NEW DEVICE DESIGN
Chapter 4 New device design
4 NEW DEVICE DESIGN
This chapter describes the design and development of a new finger fixator for treatment of
PIP joint contracture. Section 4.2 presents the introduction to the design of medical devices.
The new device design requirements are described in §4.3 and the different concept designs
in §4.4. The detailed design and the device engineering drawings are presented in §4.5,
followed by the discussion in §4.6. Section 4.7 presents a brief summary of the chapter.
4.2 Introduction
Dynamic external finger fixators are designed to correct and prevent finger joint
contractures, improve the flexion appearance of the injured finger, restore the functional
range of motion, provide stability of the joint and adequate strength to carry out daily
activities (Houshian and Schrøder, 2004; Houshian et al., 2007; Ng and Oliver, 2009). Ideas
to improve the Compass hinge device (chapter 3 section 3.2.1) came from working on the
reported complications in the previous clinical studies of the Compass hinge device (chapter
3 section 3.2.3) and other finger fixators (chapter 2 section 2.6). Towards presenting a new
designed device, the detailed structure of the medical device design process which was
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presented by Aitchison et al. (2009) was followed and each aspect of this design process
(chapter 2 section 2.7) will be applied in this chapter.
4.3 Design requirements
For a successful design of a fixator to be used on the PIP joint it has been suggested that it
should be small enough to be of use on central fingers (Hodgkinson, 1994). More
considerations were adapted from the conclusions of the previous clinical studies advantages
of implementing different external fixators to patients (see chapter 2 section 2.6). These
considerations included easy to apply, low profile, easy to use, reliable and allows for active
and passive mobility (Krakauer and Stern, 1996; Salafia and Chauhan, 1997; Bain et al.,
1998; Bonaspetti et al., 1999; Houshian et al., 2002; Feldscher and Blank, 2002; Houshian
and Schrøder, 2004; Lahiri et al., 2007; Houshian et al., 2007; Asche et al., 2009).
The standard BS EN ISO 14630 (2005) and the element of the product design specification
(PDS) design core diagram presented by Pugh (1991) have been used to list the requirements
of the new device. The PDS is a document that contains all the criteria relating to the product
outcome. It defines the elements, factors and boundaries of the object to be designed. The
PDS thus acts as the control for the total design activity (Pugh, 1991).The PDS has been
formulated based on the literature review (given in chapter 2), surgeon feedback throughout
the design process (Mr. Titley) and the analysis of the existing device (given in chapter 3).
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The new device should have the following design requirements:
a) Be able to withstand a dynamically applied axial force of up to 13 N (Walker and
Erkman, 1975) and a quasi-static force of up to 210 N (Lee and Rim, 1990);
b) Have a range of motion from 0° extension to 100° flexion (Reese and Bandy, 2013);
c) Be manufactured from biocompatible materials, including a radiolucent polymer to
enable the wires to be visible on radiographs;
d) Have good fatigue resistance and be able to withstand 170,000 cycles at 2 Hz (this is
based on the assumption that 1 million finger motions per year occur (Joyce and
Unsworth, 2000) and the device would be attached to a patient for a maximum of 64
days (Bain et al., 1998);
e) Have a mass of less than 15 g to be comparable with the Compass hinge device;
f) Have smaller dimensions than the Compass hinge device (the dimensions of the parts of
a Compass hinge were found to be 49.5 to 58.5 mm for the width, 35 mm for the height
and 11.5 mm for the thickness;
g) Have a mechanism to allow active and passive movements;
h) Provide a continuous movement working mechanism;
i) Be able to fit a range of human hands based on anthropometric data (Peebles and Norris,
1998; Alexander and Viktor, 2010);
j) Natural in color (close to skin color) to motivate patients to use it;
k) Be simple to assemble;
l) Manufacturing processes should be considered to do not affect the quality of the device
(functionality and surface finish);
m) Cost of the device should not exceed other market available fixators where their cost
ranged from 400 to 600 British Pound Sterling.
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4.4 Concept designs
4.4.1 Design strategy
The concept design stage involved generating all the possible designs that meet the product
design specification. The initial drawings and a brief description of the various concept
designs are presented. The process of selecting one of the concepts to develop and to be the
final design will be described. The SolidWorks Computer Aided Design software 2011®
premium 2011x 64 Edition © 1995-2010 (Dassault Systèmes SolidWorks Corporation,
Waltham, USA) was used for the design of the new PIP joint dynamic external fixator.
In order to generate concept designs for the new device the anatomical description of the
PIP joint was studied to consider the nature motion of this joint. The different available
patents of the joint fixators also were studied to understand the ideas of the working
mechanisms. The Compass hinge geometry, advantages and complications were considered
a key points in generating the new concept designs. The steps toward generating ideas to
present a new device were as follows:
 Firstly, patents of external joint fixators were studied aiming to generate ideas of
working mechanical mechanisms to give the required dynamic movements (US
Patent 5376091, US Patent 5100403, US Patent 0097944 A1 and US Patent
4604997). The fixation device in US Patent 0097944 A1 helped in the development
of the feature of the clamping blocks which are used to support the inserted K-wires
(see section 4.4.3 concept design 2). The dynamic finger support in US Patent
5376091 provided a detailed description of each device component, helping to
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understand the working idea of that fixator and specifically the worm and worm
wheel mechanism in it, which assisted to develop the working mechanism of the new
design (see section 4.4.3 concept design 2).
 Secondly, according to the anatomical description of the PIP joint, which acts as a
pure hinge in the finger (Ng and Oliver, 2009) the development process of the new
device should also have this concept. The device will act as a hinge and the center of
the PIP finger joint will be the pivoting point of the device.
 Finally, the device should be symmetrical so that it can be applied to any digit on the
left or right hand.
The development plan was divided into three stages:
 working on the design of the proximal hinge member;
 working on the design of the distal hinge member;
 development of the clamping block parts.
There are 2 main concept designs for the device assembly which will be described in detail
later, with concept design 1 being based on the screw drive working mechanism. The second
concept design was based on the worm and worm wheel as the working mechanism for the
device. For each concept design of the two assemblies there are a series of concept designs
for the distal and proximal parts.
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4.4.2 Concept Design 1 – (Screw drive hinge movement)
According to the PIP joint working mechanism, a rotation movement is required in
designing the new device by the surgeon. The main two parts, the proximal and the distal
parts were developed to be as a protractor. Figure 4-1 is a 3D assembly of concept design
1.
Screw placemat
M2 x 0.4 screw
The proximal part
Screw thread hole
The distal part
Figure 4-1. 3D assembly design of the screw drive hinge movement concept design 1
The proximal part (Figure 4-2) is considered the main frame of the device which has a
circular middle body cavity to allow fitting of the distal part. This idea depends on the
movement mechanism of the screw where a 2 mm diameter threaded hole (in the top right
side of the proximal part) tapped with 1.6 mm twist drill was designed to fit with a metric
standard M2 x 0.4 screw thread (Oberg, 2012). Mechanically when the screw thread was
83
untightened the active motions for the distal part (Figure 4-1) can occur. For keeping the
distal part in a selected position the screw would be tightened.
M2 x 0.4 screw
A curved slot
Thread hole
Middle cavity
Figure 4-2. 3D design of the proximal protractor part design -1.
The Compass hinge proximal side clamping blocks, which clamp to the K-wires were
replaced here by many small holes in the frame of the proximal part. The position of these
holes is designed to be located at the same level as the lateral line of the PIP joint to work as
a guide for surgeons to insert the K-wires during surgery to attach the device to the patient’s
fingers. These holes have a diameter of 1.4 mm and were designed to fit with the skeletal
inserted K-wires diameter (1.15 mm) and the 0.25 mm difference between the diameter of
the hole and the K-wire diameter, was a tolerance for each hole to allow for the drilling
insertion technique of the K-wire to be used by the surgeon without damaging the device.
More than 10 holes were designed along the proximal part to cover a large range of the
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human digits proximal phalanges sizes (Alexander and Viktor, 2010) and for individual
patient the surgeon would need to select the two most suitable holes to insert the K-wires in
them. The range of movement of the PIP joint will be controlled by the angle guide on the
distal part and that can be monitored during the curvature slot in the front view of the
proximal part.
4.4.2.1 Concept distal part idea 1
A protractor feature new distal part (Figure 4-3) was designed to insert in the middle cavity
of the proximal part. The guide to the angle of the device was designed as engraved marks
on the distal part at both the front and the rear. This angle guide is to help the device users
attain the required PIP joint position movements which started from 0ᵒ (the PIP joint at fully
extension position) to 105ᵒ (the PIP joint at the maximum flexion position).
Engraved
marks
Screw placemat
Figure 4-3. 3D design of the proximal protractor part design -1, idea1.
85
The Compass hinge distal side clamping blocks were replaced here by a series of small holes
in the frame of the distal part. These 1.4 mm diameter holes were designed to fit with the
skeletal inserted K-wire diameter. The numbers of holes were designed to cover a large range
(from 18 mm to 26 mm) of finger middle phalanges sizes (Alexander and Viktor, 2010). For
individual patients the surgeon would need to select the two most suitable holes to insert the
K-wires in them according to the length of their middle phalanges which can be measured
using x-ray. Wear may be a problem on the distal part during screw movement and for that
reason a small metal part was added between the distal part and the screw to act as a placemat
to avoid that action.
The advantages of the distal part, concept idea 1 were:
 The device consists only of 4 main assembled parts: proximal part, distal part, screw
and placemat;
 A simple screw thread working mechanism was used in this design idea;
 No surgical assistant would be required for surgeons during the device attachment
process where the holes will work as a guide for the K-wires.
The disadvantages were:
 The surgeon should select the most suitable holes for each patient’s finger phalanx
so that more time may be required during the attachment process;
 During the screw loosening action, the placemat part may be de-attached from the
device;
 K-wire loosening may occur where the mechanism to clamp the wires is not
sufficient to secure the wires.
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The series of holes suggested in concept distal idea 1 (section 4.4.2.1) were merged into one
slot to provide a wide range of options for the insertion of the K-wires into the finger. This
idea will let the device fit with a large number of different finger middle phalange sizes
(from 18 mm to 26 mm) (Alexander and Viktor, 2010) (Figure 4-4).
Slot feature
Figure 4-4. 3D design of the distal protractor part design -1, idea2.
From an engineering point of view because there is a long length of the slot through the
distal part (Figure 4-4), a large deflection may occur under the slot during loading which
makes this idea not desirable. A finite element analysis result for this idea is shown in Figure
4-5 and the maximum stress was 330.9 MPa, overall the evaluation of the design was that it
was weak to resist stresses. A surgeon feedback towards this idea was negative, he not
recommended slot feature idea he preferred the holes.
87
Figure 4-5. Distribution of stresses for the distal protractor part design -1, idea2.
To overcome the disadvantage of idea 2, the small holes design (concept distal idea 1, section
4.4.2.1) is a more acceptable idea than the slot design (concept distal idea 2, section 4.4.2.2)
to avoid any deflection in the area underneath the slot. To make sure the distal part
withstands the applied loads a slight change in dimensions from idea 1 (section 4.4.2.1) was
made by increasing the length of the distal part under the holes by 2 mm (Figure 4-6).
88
Stresses distributed at
areas around holes
due to sharp edges
2 mm increased
length
The sharp end edges (90ᵒ) of the holes (zero fillets) in both sides (front and rear views) could
potentially be a cause of localized stresses around the holes, which surgeons select to insert
the K-wires through. A finite element analysis result for this idea is shown in Figure 4-7 and
the maximum stress was 516.6 MPa. The maximum stresses were located around the holes,
which the K-wires were inserted in them.
89
The holes (concept distal idea 3, section 4.4.2.3) were developed to have a filleted feature
so that it will help to reduce stresses around the edges of the holes due to loading through
these holes (Figure 4-8). A finite element analysis result for this idea is shown in Figure 4-9
and the maximum stress was 292.9 MPa. The maximum stresses were located around the
holes, which the K-wires were inserted in them.
90
Fillet feature was

added for each
hole
91
The idea 5 mainly works on the development of the screw placemat part feature (concept
distal idea 1 section 4.4.2.1). To avoid the placemat part de-attachment from the device
during the device movement, a guide and guide way concept mechanism was applied to this
concept idea. The curvature feature of the distal part works as a guide way to the guide
placemat which was developed to be “U” shaped, moving along the distal part curve (Figure
4-10). A finite element analysis result for this idea is shown in Figure 4-11 and the maximum
stress was 78.4 MPa. The maximum stresses were located around the holes, which the K-
wires were inserted in them and around the both sides of the guide placemat.
Guide way curve
U shape guide
placemat
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The design ideas were reviewed with Mr. Garth Titley (Consultant Plastics and Burns
Surgeon at the Queen Elizabeth Hospital, Birmingham) where the meetings with him
provided feedback about the concept designs from a surgical point of view. Although the
outside feature of the idea 5 design was acceptable to him he was concerned that there was
a lack of continuous movement of the patient’s PIP joint which the treatment procedure
requires.
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4.4.3 Concept Design 2 – (Worm and worm wheel hinge

movement)
To provide the proposed design with a continuous movement mechanism, gears are one of
the mechanisms considered to be able to do that. A worm and worm wheel for driving the
distal part to the proximal part was considered as a suitable idea (Figure 4-12).
Figure 4-12. 3D assembly design of the worm and worm wheel hinge movement concept
design 2
4.4.3.1 Concept clamping block idea 1
The design works on the development of dimensions and features of the Compass hinge
device worm and worm wheel parts. The aim was to reduce the stress distribution along the
worm wheel part which was the main cause of failure in the Compass hinge (see chapter 3
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section 3.3 and section 3.4). It was, therefore, proposed that the worm and worm wheel
should be manufactured from a metal as opposed to a polymer, as with the Compass hinge.
Posterior and interior Compass hinge blocks (see chapter 3 section 3.2.1) were developed to
be 6 assembled blocks (four metals and two polymers) where 3 of them (2 metal and 1
polymer) were for the proximal side and others for the distal side. For each side the blocks
were connected together by 2 screws (Figure 4-13).
Worm wheel
2 metal blocks
Polymer block
Threaded holes
The four metal blocks were responsible for clamping the inserted K-wires and they were
chosen to be metal to resist stresses which will be generated in this area during exerting
loads. One metal block was designed to assemble with the distal part, one with the proximal
part, one with the polymer block on the distal side and the last one with another polymer
block on the proximal side. A polymer was selected for the two polymer blocks for two
95
reasons; firstly, these blocks did not directly affect and were not close to the exerting load
area, so high mechanical property materials were not required to manufacture them.
Secondly, to keep the mass of the device low.
The difficulty to apply this concept design idea appeared after the assembly process was
completed when allowing the distal part to rotate around the proximal part (from full
extension position to any flexion angle). It was found that the distal part could not move as
there was no space for this movement and the interference action would happen between the
proximal and distal parts (Figure 4-14).
Proximal protractor
hinge part
Distal protractor hinge

part
Rotate for Rotate for

flexion An interference problem area flexion
idea1.
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4.4.3.2 Concept clamping block idea 2
Four metal solid clamping blocks were designed where 2 of them were on the proximal side
and the others on the distal side (Figure 4-15). These blocks will act as jaws to keep the
inserted K-wires in position. A metal was selected to resist the stresses generated during
active movement of the device by the patient. The four solid blocks will be inserted into the
4 fitted slots, where there is one slot in the body of the proximal protractor hinge part, one
slot in the body of the distal protractor hinge part and two in the slotted polymer clamping
blocks.
2 Solid clamping
blocks
2 Solid clamping
blocks
2 Slotted
clamping blocks
idea2.
Towards selecting the most describable concept design, a positive/negative score system
by the Pugh matrix (Table 4-1) was used to select the concept design which will be worked
on as a detailed design.
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Table 4-1. Pugh matrix to concept design selection.
Concept design 1 – (Screw drive) Concept design 2 – (Worm and worm wheel)
Proximal
Baseline part Distal part Clamping blocks
Idea Idea Idea Idea Idea Idea 1 Idea 2
1 2 3 4 5
Easy to 0 - - - - - - - 0
assemble
Easy to 0 0 0 + 0 0 0 0 +
apply
Easy to use 0 - - - - - - + +
Safe design - - 0 - + + 0 +
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Symmetrical 0 + + + + + + + +
features
Profile 0 + + + + + + 0 +
Weight 0 + + + + + + - +
Flexible to 0 - - - - - - - +
develop
Surgeon 0 - - - - - - - +
feedback
Reliable 0 - - - - - - + +
Net score -3 -3 -3 -1 -3 -1 -1 +9
Rank 3 3 3 2 3 2 2 1
Continue? No No No No No No No Yes
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4.5 Detailed design
During the concept design selection, concept design 2, idea 2 was chosen to be developed,
as shown in Figure 4-16. This design was selected after a design review meeting with Mr.
Garth Titley (Consultant Plastics and Burns Surgeon at the Queen Elizabeth Hospital,
Birmingham), who provided feedback. From the surgical point of view, the device looked
small in size compared to other devices, the symmetrical design enabled it to be applied to
any digits on both hands and the most important advantage is that it allows both active and
passive continuous motion. From an engineering point of view, the device parts which were
predicted to have high stresses, referring to the previous study of the Compass hinge device
(see chapter 3 section 3.3) were now designed from a metal. A metal was chosen for the
areas around the applied load and the area where the working mechanism was locked (worm
and worm wheel teeth were meshed together). For the other device parts, they were designed
to be manufactured from a radiolucent polymer. This would enable the device to be low in
mass, seen under x-ray and its working mechanism achieved the required motion without
any interference between the device parts.
Concept 2, idea 2 will be worked up to a final design. Each part will be designed to optimize
the size and materials, then the final geometry and materials for the whole design will be
presented. The final design presented here can be used on any PIP joint on any digit.
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The proximal Worm and worm wheel

protractor hinge part
4 Metal solid blocks
The distal
protractor
hinge part
2 Polymer slotted blocks
Figure 4-16. 3D design of concept selection 2, idea2.
4.5.1 Materials
The materials for the parts of the new device should provide high mechanical strength. Poly-
ether-ether-ketone (PEEK) and Polyetheremide (PEI) were suggested to manufacture the
new designed polymer parts where these two advanced polymers are biocompatible with
high mechanical properties: PEI has a yield strength of 105 MPa and PEEK has a yield
strength of 110 MPa (GE Plastics; VICTREX®). The finite element analysis results for the
failed Compass hinge (see chapter 3 section 3.3) concluded that the Compass hinge fixator
was affected by the cyclic bending stress due to the natural motion of the PIP joint which
acts as hinge (Ng and Oliver, 2009). For that reason, PEEK was chosen for the new designed
parts where its fatigue strength endurance limit (65 MPa at 5 Hz, >107 cycles) is significantly
101
higher than the fatigue strength endurance limit of PEI (24 MPa at 5Hz, >10 7 cycles)
(Trotignon et al., 1993).
PEEK was selected as the main polymer part material for the new device for its mechanical,
chemical and thermal properties which helped to develop the Compass hinge device. PEEK
is a highly biocompatible, non-toxic, non resorbable polymer (Cho et al., 2002; Abu Bakar
et al., 2003). PEEK has a Young’s modulus of 3.6 GPa (Chou et al., 2008; Hee and
Kundnani, 2010) and has good sterilization resistance (using steam, gamma irradiation and
ethylene oxide processes) and can be fabricated using extrusion, injection molding,
machining and 3D printing (Ferguson et al., 2006; Toth et al., 2006; Sagomonyants et al.,
2008). It is also radiolucent where this material can see under X-ray (Cho et al., 2002;
Ferguson et al., 2006; Hee and Kundnani, 2010; Kurtz et al., 2007). Recently, PEEK is the
most common and favoured material for orthopedic medical devices (Kurtz, 2011). Two
different grades of PEEK were considered: PEEK 90G and PEEK 450G according to the
VICTREX® material properties guide sheet; 90G is a very easy flow grade for thin sections
and complex parts manufactured using injection molding and 450G is a standard flow grade
for general injection molding purposes. Finally, PEEK VICTREX® 90G was selected for
the new designed polymer parts due to their complex features and thin wall thicknesses (0.7
mm). Each engineering drawing of the polymer parts is presented in detail (section 5.4.2) in
this chapter.
A medical grade stainless steel was selected to manufacture the new parts which were
selected to be metal. These parts will directly be affected with the applied load (see section
5.2.1) so the material strength for these parts should be high to be able to withstand the cyclic
102
stresses. Alternative materials rather than stainless steel to manufacture the new device metal
parts were nonferrous alloys (such as aluminum alloys), cobalt-chromium (Co-Cr) alloys or
titanium (Ti) alloys. The density of stainless steel (8.0 g/cm3) is almost three times greater
than the density of aluminum alloys (2.7 g/cm3). Stainless steel has a high Young’s modulus
of 200 GPa that is approximately three times that of aluminum alloys (70 GPa) (Davis,
1994). Ti alloys and Co-Cr alloys are the most commonly used metals in total joint
arthroplasty (TJA) devices and the stainless steel is used in non-active surgical medical
devices (Long, 2008). Another issue that made the stainless steel the best manufacturing
choice is that titanium costs five to ten times as much as stainless steel (Budinski, 1991).
Co-Cr and Ti alloys are used mainly for applications where high thermal and corrosion
resistance, rather than specific strength requirements, are of greater importance (Elshennawy
and Weheba, 2015)
A surgical stainless steel material compliant to ASTM F138 – 13a and ASTM F899 - 12b
was selected for manufacture of the designed metal parts. The 316, 420 and 440 stainless
steel grades were the three options which are used in biomedical applications. Biomedical
cutting instruments are often made from 440 or 420 stainless according to ASTM F899 - 12b
which were high-carbon steel with a minimum chromium content of 12%. The 316L series
was most suitable for the medical device parts (ASTM F138 standard). The fatigue strength
of stainless steel grade 316L ranges from 180 MPa to 520 MPa at 6 Hz and N > 10 7 cycle
(Huang et al., 2006). 316LS grade was selected to be the metal material to manufacture the
new designed parts. This grade is the low carbon version of 316 stainless steel with a
maximum carbon content of 0.03%, low silicon with a maximum content of 0.75%, a sulfur
content of 0.010% and with a yield strength range from 190 to 690 MPa (annealed/cold
103
worked conditions) (ASTM F138 - UNS S31673). Finally, 316LS medical grade stainless
steel, 90% cold worked condition was selected to manufacture all metal parts because its
high mechanical properties where the yield strength is 946 MPa (MatWeb, material property
data).
4.5.2 The PIP joint protractor hinge device
The seventeen parts of the assembly are shown in the exploded view of the design (Figure
4-17) and all the parts are assembled together in Figure 4-18. The proximal protractor hinge
part was designed as the housing for the distal protractor hinge part. The four polymer
slotted proximal and distal blocks are assembled with the four stainless steel solid blocks
and are used for securing the wires which will support the device in the human phalanges.
Four hexagonal head standard screws (M2 x 0.4) are used to compress the blocks together
around the K-wires. The function of the screw and nut are to hold the proximal and the distal
protractor hinge parts together and allowing them to rotate.
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1. Proximal protractor part

2. Distal protractor part
3. Screw 1
4. Nut 2
5. Slotted clamping block (2)
6. Rod
7. Worm gear
8. Worm wheel
9. Solid clamping block (4)
10. Screws for connection (4)
Figure 4-17. 3D exploded view of the assembly of the PIP joint protractor hinge.
Fine marks
user guide
Screw 1
Figure 4-18. 3D design assembly of the PIP joint protractor hinge final design.
105
In the beginning, the whole concept design was divided into the individual parts that need
further research for their design aspects and also separate evaluation. The complete design
can be disassembled during the detailed design process into: proximal protractor hinge part,
distal protractor hinge part, worm gear, worm wheel, screw 1, nut 2, rod, 2 slotted clamping
blocks, and 4 solid blocks.
4.5.2.1 Proximal protractor hinge part
The proximal protractor hinge part is considered the main frame for the new device. In
Figure 4-19 the 3D design of the proximal protractor hinge part is shown and the engineering
drawing of the proximal protractor hinge part is shown in Figure 4-20 with the dimensions
of the final design. The proximal protractor part is attached by 2 K-wires which are
embedded in the skeletal elements of the digit proximal phalanx. Its key design idea is to be
a house for the distal protractor hinge part; consequently the middle slot dimensions in the
proximal protractor part fit the distal protractor part. Another slot (from engineering drawing
bottom view, Figure 4-20) was designed to assemble with a part named solid clamping block.
A worm gear will be placed on the top right designed housing and the four end small clips
were provided in the side walls to keep the worm in its selected position. Four marks were
engraved on the frame (two on the front frame view and two on the rear frame view) to aid
the patient in how many turns should be performed. A medical grade plastic VICTREX®
PEEK 90G was chosen to manufacture this part (see section 4.5.1 from this chapter). The
previous engineering study of the Compass hinge which had its parts manufactured from the
PEI material confirms that PEI cannot withstand the cyclic bending stresses and this causes
106
device failure (see chapter 3 section 3.3 and section 3.4). For that reason PEEK was chosen
for the proximal protractor part.
Front markers
Side wall clips
Worm housing
Middle slot for
distal part
Slot for the solid

clamping part
Figure 4-19. 3D design of the proximal protractor hinge part.
107
Figure 4-20. Drawing of the proximal protractor hinge part.
108
4.5.2.2 Distal protractor hinge part
The distal protractor part will be inserted inside the cavity of the proximal protractor hinge
part. The distal protractor hinge part is attached by 2 K-wires embedded in the skeletal distal
phalanx of the finger. A semi-circular cavity on the top of the distal part body was designed
so that the worm wheel component could fit inside the cavity. Also, it has a slot so that the
solid clamping block can be fitted. The range of movement is guided by the engraved angles
marked on both sides (front and rear) of the distal protractor hinge part. The material that
has been chosen for the distal protractor hinge part is the medical grade plastic VICTREX®
PEEK 90G, the same as the proximal protractor hinge part (see section 4.5.1 for this chapter).
In Figure 4-21 the 3D design of the distal protractor part is presented and in Figure 4-22 the
engineering drawing of the distal protractor part is shown.
Cavity for worm wheel part

Engraved
marked angles
Slot for the solid

clamping part
Figure 4-21. 3D design of the distal protractor part.
109
Figure 4-22. Drawing of the distal protractor hinge part.
110
4.5.2.3 Worm wheel
The worm wheel part was designed and its dimensions were calculated from the gear design
formula (Designatronics, 1999). The worm wheel gear tooth nomenclature was defined from
Radzevich (2012) and ANSI/AGMA 1012-G05. At the beginning, the outer circle diameter
(which coincides with the tops of the teeth of a gear) was selected in the range 32 mm to
33.5 mm where the chosen gear outer diameter should be within this range to match with the
overall height of the distal protractor part (section 4.5.2.2) and the proximal protractor part
height (section 4.5.2.1). Then, the standard worm wheel with the outer circle diameter of
32.80 mm was selected from the catalogue (Catalogue C14) which listed the pressure angle
as 20ᵒ (it is formed by the radial line and the line tangent to the profile at the pitch point
(Figure 4-23). It describes the direction of the force created by the driving gear acting upon
its mate), the module was 0.4 (is the ratio of the pitch diameter to the number of teeth in the
metric system used to determine tooth size, for gears to mesh, their modules must be equal)
and the number of teeth for that gear was 80. After that the worm wheel design formula
(Designatronics, 1999) was used to calculate all other required data for designing the worm
wheel teeth and for drawing the involute curve of the tooth. These data are summarised with
each term definition and equation in table 4-2. In this gear it was found that, the root circle
diameter (which coincides with the bottom of the tooth spaces) was equal to 31 mm and this
was greater than the base circle diameter (the circle from which involute tooth profiles are
derived) which was equal to 30.07 mm (Figure 4-24). Therefore, theoretically the involute
has already started before the root circle. Thus, correction formulas were used to produce
the final design (Buckingham, 1949).
111
Figure 4-23. The pressure angle at mating gear teeth (Designatronics, 1999)
112
Table 4-2. Gear general nomenclature and design formula (Designatronics, 1999).
To obtain Term definition From known Use this formula
Pitch diameter The curve of intersection of Module (m), D=mN
(D) a pitch surface of revolution teeth number(N)
and a plane of rotation
Addendum (a) The radial distance between Module (m) a=m
the pitch diameter and the
outside diameter
Dedendum (b) The radial distance between Module (m) b = 1.25 m
the pitch diameter and the
root diameter
Root diameter Coincides with the bottoms Pitch diameter DR = D – 2.5 m
(DR) of the tooth spaces (D),
Module (m)
Base circle The circle from Pitch diameter Db = D cos (φ)
diameter (Db) which involute (D),
tooth profiles are derived pressure angle (φ)
Tooth thickness Thickness of tooth Module (m) Tstd = π/2 m
Tstd (at standard pitch
diameter)
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The following were previously decided:
Module (m) = 0.4, Number of Teeth (N) = 80 and Pressure Angle (φ) = 20ᵒ
The worm wheel design formulae, given in Table 4-1 were then used to calculate all the
required dimensions:
Pitch Diameter (D) = mN = 0.4 × 80 =32 mm
Circular Pitch (Pc) = mπ = 0.4 × π = 1.257 mm
Addendum (a) = m = 0.4 mm
Dedendum (b) = 1.25m = 1.25 × 0.4 = 0.5 mm
Outside Diameter (Do) = D + 2m = m (N + 2) = 32 + 2 × 0.4 = 32.80 mm
Root Diameter (DR) = D - 2.5m = 32 -2.5 × 0.4 = 31 mm
Base Circle Diameter (Db) = D cos φ = 32 cos 20ᵒ =30.070 mm
Base Pitch (Pb) = m π cos φ = 0.4 × π × cos 20ᵒ = 1.181 mm
Tooth Thickness at Standard Pitch Diameter (Tstd) = π/2 × m = π/2 × 0.4 = 0.628
mm
114
Figure 4-24. Involute curve derivation of the worm wheel tooth
115
The worm wheel gear formulae (Buckingham, 1949) were used to draw the involute curve
of the gear teeth (Table 4-3) as shown in Figure 4-25 and the teeth profile as shown in Figure
4-26, where the root circle diameter was greater than the base circle diameter case. Units for
these formulas in the Buckingham (1949) reference book were in English imperial
measurements. The engineering drawing of the worm wheel tooth profile is shown in Figure
4-27.
Figure 4-25. The gear involute (Buckingham, 1949).
116
Table 4-3. The Formulas of gear tooth profile (Buckingham, 1949).
To obtain From known Use this formula
r pressure angle (φ), r = Rb / cos φ
any radius to involute form, in radius of base circle
(Rb)
φ any radius to involute

𝑡𝑎𝑛 𝜑 = √(√𝑟 2 − 𝑅𝑏)2 / Rb
pressure angle at radius, r form (r),
radius of base circle
(Rb)
θ any radius to involute

𝜃 = √(√𝑟 2 − 𝑅𝑏)2 / Rb –
Vectorial angle form (r),
tan-1 (√𝑟 2 − 𝑅𝑏 2 / Rb)
radius of base circle
Or
(Rb)
θ = tan φ – φ = inv φ
117
Figure 4-26. The gear tooth profile (Buckingham, 1949).
The following were previously decided:
Arc tooth thickness (T1) = 0.628 mm, Radius of base circle (Rb) = 15.04 mm,
Pitch Diameter (D1) =32 mm and Pressure Angle (φ1) = 20ᵒ
The worm wheel design tooth profile formulae, given in Table 4-2 were then used to
calculate all the required dimensions:
inv φ2 = (T1 / 2 r1)+ inv φ1
T1 = 0.628 mm = 0.628/25.4 = 0.025 in.
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r1 = 32/2 mm = 16/25.4 = 0.629 in.
inv φ1 = 0.014904 rad = 0.8539ᵒ
inv φ2 = 0.025/(2×0.629) + 0.014904 = 0.0347 rad = 1.988ᵒ
φ2 = 26.168ᵒ
cos φ2 = 0.898
Rb = r1 cos φ1 = 16 × cos 20ᵒ
= 15.035 mm = 0.592 in
r2 = Rb / cos φ2 = 15.035 / 0.898 = 16.70 mm
T1 / 2r1 = 0.628 / 2×16 = 0.0196
119
Figure 4-27. Engineering drawing of the worm wheel tooth profile.
120
The gear feature was improved where the bottom land was modified to be rounded with a
radius R = 0.28 mm aiming to decrease the generated stresses between the gear teeth as a
result of application of the external load. It is designed to match the dimensions of the distal
protractor hinge part top curvature slot. According to the engineering analysis of the failed
Compass hinge device (see chapter 3) the worm wheel component material for this design
has been selected to be metal. The worm wheel is the main component which is exposed to
high stresses that are exerted during loading when its teeth are in a fixed position (see chapter
3 section 3.3.1). A surgical stainless steel 316LS material was selected for the worm wheel
part (section 4.5.1). The 3D design of the worm wheel is shown in Figure 4-28, while the
engineering drawing is shown in Figure 4-29.
Figure 4-28. 3D design of the worm wheel part.
121
Figure 4-29. Drawing of the worm wheel part.
122
4.5.2.4 Worm gear
A worm gear was included in the proximal protractor part. The specifications (0.4 module -
20° Pressure angle- 1.25 pitch) (Catalogue C14) were selected to mesh with the designed
worm wheel and match with the size of the proximal protractor part. A worm is provided to
move the proximal and distal protractor parts by mating with worm wheel teeth on the distal
protractor part. The worm function is to translate rotational motion to the engaged gear teeth
and thus it affects extension and flexion of the finger joint. The worm is adjustable within
the worm housing in the proximal protractor hinge part to be either engaged or disengaged.
A plastic material was suggested for that part as the engineering study of the Compass hinge
device (chapter 3 section 3.3) confirmed that the worm gear was not subjected to high
stresses and it was not the cause of a Compass hinge device failure. Towards keeping the
new device with a low mass and compatible with the proximal protractor part which it will
assemble to, the medical grade plastic VICTREX® PEEK 90G was selected for the worm
gear (see section 4.5.1). The 3D design of the worm gear and its engineering drawing is
shown in Figure 4-30 and Figure 4-31, respectively.
Figure 4-30. 3D design of the worm gear part.
123
Figure 4-31. Engineering drawing of the worm part.
124
4.5.2.5 Rod
The rod was designed as a shaft to include 2 small extra features at both ends of the rod to
facilitate movement of the worm on the engaging surface of the worm housing at the
proximal protractor part. This clutch permits the selected position of the engagement of the
worm and the worm wheel teeth such that force is transferred between them. Also, it restricts
free motion of the skeletal supported protractor parts and permits controlled motion of the
joint. When the gear is disengaged the worm and worm wheel permit the proximal and distal
protractor parts to move freely. Because the rod will be assembled with the worm gear, the
material of manufacturing was chosen to be VICTREX® PEEK 90G (see section 4.5.1.).
Figure 4-32 is the 3D design of the rod and Figure 4-33 is the engineering drawings of it.
Figure 4-32. 3D design of the rod part.
125
Figure 4-33. Drawing of the rod part.
126
4.5.2.6 Slotted and solid clamping blocks
The four solid clamping blocks and the two slotted clamping blocks were designed to be
joined and tightened by vertical screws to engage the K-wires. Two of the solid blocks with
the two slotted blocks were designed to be inserted inside each other. Therefore, the other
two solid blocks will be assembled with the designed cavities where one is for the proximal
part and another is for the distal part (see section 4.5.2.1 and 4.5.2.2). The solid blocks were
chosen to be metal because these parts are directly in contact with the K-wires so the stress
distribution from the load exerted will be minimized. The slotted blocks were selected to be
polymer for that reason; these parts are the solid block houses so they will not affect directly
with any exerting load which means a very high strength material (such as metal) was not
required for these parts. The selected polymer material should be compatible with other
plastic parts in this designed device so the medical grade plastic VICTREX® PEEK 90G
was chosen for the slotted clamping blocks. A 316LS medical grade stainless steel was
selected for the solid clamping blocks and for the main properties of these two materials
refer to section 4.5.1 from this chapter. The 3D design of the slotted and solid clamping
blocks can be seen in Figure 4-34 and Figure 4-35, followed by their engineering drawings
in Figure 4-36 and Figure 4-37.
127
Figure 4-34. 3D design of the solid clamping blocks.
Figure 4-35. 3D design of the slotted clamping blocks.
128
Figure 4-36. Drawing of the solid clamping block part.
129
Figure 4-37. Drawing of the slotted clamping block part.
130
4.5.2.7 Screw 1 and nut 2
The screw 1 and nut 2 connect together to attach to the proximal and distal protractor parts
to each other. This screw axle with nut combination serve as the axis of rotation of the hinge
and aligns the protractor parts with the natural axis of the PIP finger joint. The hole of 1.40
mm diameter along the screw and nut was designed with the diameter slight bigger than the
diameter of the K-wires (1.15 mm diameter) to allow it to pass through the device. In the
aim of overcoming the Compass hinge device complications, with one of them being the
difficulty to see under x-ray the area around the radiopaque axle (see chapter 3 section 3.2.2)
for surgeons to monitor the K-wire insertion process at the digit PIP joint center. A
radiolucent material was selected to manufacture these two parts (screw and nut) and
because the screw and nut will be assembled together the material selected had to be the
same. Also the parts will be assembled with the proximal and distal protractor parts (see
section 4.5.2.1 and 4.5.2.2) so the material of choice for both these parts was VICTREX®
PEEK 90G medical grade polymer (section 4.5.1). PEEK 90G was not only chosen for the
same reasons of previous selection of parts, but also to match all the device parts together.
Figure 4-38 shows the 3D design of the two screw and nut and the engineering drawing of
each one is shown in Figure 4-39 and Figure 4-40.
Figure 4-38. 3D design of the assembly of the screw 1 (left) and nut 2 (right).
131
Figure 4-39. Drawing of the screw 1 part.
132
Figure 4-40. Drawing of the nut 2 part.
133
4.5.2.8 Screws
Four M2 × 0.4 standard metric stainless steel screws were placed in either vertical or
perpendicular positions on the slotted clamping blocks (Figure 4-16). To access the
hexagonal heads of these screws that will be through the bottom of the device. These screws
were selected to secure and keep the clamping blocks with the inserted K- wires in position
by tightening them. The 3D and the engineering drawing of selected type screws are shown
in Figure 4-41 and Figure 4-42, respectively.
Figure 4-41. The screw.
134
Figure 4-42. Drawing of the screw.
135
A guide jig for inserting the K-wires in the digit skeletal is also required to help surgeons
during the surgical technique procedures to attach the fixator in the patient’s finger. A simple
jig was presented as a part from this project (as a concept design) and the 3D design,
assembly 3D design of the jig with the PIP joint protractor hinge device and the engineering
drawing are shown in Figure 4-43, Figure 4-44 and Figure 4-45, respectively. However,
further engineering analysis is still required to finalise the design where more concept
designs are needed to be generated. The concept designs would then be evaluated using
methods such as the Pugh matrix. It was suggested to be manufactured from a radiolucent
medical grade polymer material with a small ellipse holes to fit with inserted K –wires. The
effect of the digit bone drilling technique to insert the K-wires on the jig geometry and
material should be studied. The small material chips (abrasives from jig) can be generated
and inserted inside the human body during the drilling process. That is harmful and not
accepted so this is a key point of a risk analysis and should working on it very well. A hollow
cavity was designed for the purpose of seating the jig in the head of the screw 1 part (see
section 4.5.2.7). A step was provided in the jig to keep it in the correct position during the
surgical procedure by supporting it on the slotted clamping block (section 4.5.2.6).
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(a) (b)
Figure 4-43. A guide Jig for inserting the K-Wires (a) Isometric view and (b) Rear view of
the proposed design.
Figure 4-44. A 3D assembling design of the Jig with the PIP joint protractor hinge device.
137
Figure 4-45. Drawing of the jig.
138
4.6 Discussion
A new external dynamic finger fixator based on development of the Compass hinge was
designed. Areas that have been improved include replacing parts previously manufactured
from a polymer with a metal so that the parts had greater strength. Further, PEEK (65 MPa
at 5 Hz, 20°C and >107 cycles) has been chosen for the remaining polymer parts rather than
polyetherimide (PEI) (24 MPa at 5 Hz, 20°C and >107 cycles) where the fatigue endurance
limit for PEEK is approximately three times higher than PEI (Trotignon et al., 1993).
Another aspect of the design that has been changed is reducing the dimensions of the device
compared to the Compass hinge (see chapter 3 section 3.3.1). With the new design, the
width has been reduced by 4 to 19 percent and the thickness by 26 percent where the design
was based upon the medium (50% percentile) human hand size required. The dimensions
for a medium size device are 47.5 mm width, 35.5 mm height and 8.5 mm thickness. The
dimensions of the device are based on the anthropometry data of the human hand (Tilley and
Associates, 2002; BS EN ISO 7250-1; Peebles and Norris, 1998; Alexander and Viktor,
2010). These dimensions were derived by calculating the overall average dimensions from
the 50% percentile hand data for both men and women which were presented by the study
of Tilley and Associates (2002). BS EN ISO 7250-1 is intended to serve as a guide for hand
anthropometric terms definitions and basic measurements. The new device fixator would be
required to be available in a range of sizes to take into account the different sizes of human
fingers. The study which was presented by Alexander and Viktor (2010) about the human
fingers phalanges lengths measurements was helped in specifying the different sizes of the
new device. Three sizes that relate to different design criteria are suggested for the new
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device as medium (M) designed for average, small (S) and large (L). In order to enable
surgeons to determine which size of device to use, table 4-4 will guide them.
Table 4-4. The protractor hinge device size guide.
Device size Middle phalanx length (mm)
(Alexander and Viktor, 2010)
Small (S) < 20
Medium (M) From 20 to 26.5
Large (L) ≥ 26.5
The proposed guidance depends on the middle phalanx length of the patient. Anatomically
the medial phalanx length for each digit is less than the proximal phalanx length (Alexander
and Viktor, 2010) so the device size which fits the middle phalanx length will cover the
proximal phalanx length as well. X-ray is suggested to help surgeons measure the patient’s
phalanx length to select the suitable size of device. The new device which is presented in
this study was medium in size and for the other sizes, small and large, it was suggested that
the only parts to have different dimensions are the slotted and solid clamping blocks (see
section 4.5.2.6). For the small size (S) device, the length of the slotted part will be 14.6 mm
and the solid part will be 12.9 mm. In the large (L) size, the length of the slotted part will be
20.6 mm and the solid part will be 18.9 mm.
The new device design also helps to overcome some of the disadvantages of the Compass
hinge. The new design avoids slippage between the main device frame and blocks compared
with the Compass hinge design. The part which the PIP Joint center pin is inserted is now
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manufactured from a radio-lucent polymer which can be seen under x-ray rather than the
radio-opaque metal used in the Compass hinge device.
The number of screws used was reduced to four and these are more accessible compared
with those in the Compass hinge. To loosen and tighten the screws will be by the use of a
standard dimension hexagonal head tool.
The worm gear has guide marks in the new finger device to aid the user in the amount of
turns performed which is an advantage not found in the Compass hinge. As the new design
has less parts the assembly during surgery is likely to be quicker.
The new device can be attached to both left and right hands on both the medial and lateral
sides of the phalanx. With the compass hinge device this was not possible. The comparison
between the 3D design of the Compass hinge device and the PIP joint protractor hinge device
is shown in Figure 4-46.
Top plate
Figure 4-46. 3D design of the Compass hinge device (left) and the PIP joint protractor
hinge device (right).
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A top plate was designed to stop the worm gear from totally detaching from the device when
the gear has been disengaged to enable the patient to undertake active motion.
4.7 Summary
A new fixator based on development of the Compass hinge consists of 17 parts where 8 of
them (proximal and distal protractor hinge parts, worm gear, screw 1 and nut 2, rod and 2
slotted clamping blocks) are to be made from a radiolucent medical grade plastic
VICTREX® PEEK 90G. The stainless steel 316LS medical implant alloy, 90% cold worked
was selected for the remaining components (worm wheel, four solid clamping blocks and
four connection screws). A complete engineering analysis of the new designed device was
required to determine its likely performance and this will be presented in the next chapt
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CHAPTER 5
ENGINEERING ANALYSIS OF THE NEW
DEVICE DESIGN
5 ENGINEERING ANALYSIS OF THE NEW

DEVICE DESIGN
In this chapter the engineering analysis of the new finger fixator is presented. In § 5.2 the
finite element analysis for the new device components are presented. The risk assessment
for the proposed design is presented in § 5.3 before the manufacturing method is explained
in § 5.4. The mechanical testing is presented in § 5.5, followed by the discussion of the
engineering analysis in §5.6. Finally, a brief summary of the whole chapter is provided in §
5.7.
5.2 Finite element analysis
Finite element analysis of the device was conducted to verify the proposed design. The finite
element method allows the stress distribution and any deformation of a loaded structure to
be assessed, before an expensive prototype is produced, which reduces the cost of
development.
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SolidWorks Simulation (SolidWorks 2011, Dassault Systèmes SolidWorks Corporation,
Waltham, USA) was used to undertake the finite element analysis. The solid model consisted
of the distal protractor hinge part assembled with the worm wheel, proximal protractor hinge
part and both solid and slotted clamping blocks. The model was meshed with a total of
201,446 tetrahedral elements, which depended on the gear teeth fixation positions; this
number was determined following mesh converge testing. Constraints were then applied to
the model (Figure 5-1) as follows:
 The pivoting joint hole was constrained to allow rotation;
with the worm gear;
 The force was applied to the model either vertically downwards through the metal
solid block part or perpendicular to the middle phalanx of the finger.
Figure 5-1. Meshed finite element model with the load of 210 N applied and constrains
applied at position 1 with the gear teeth fixed at 15 - 30°.
145
Two different positions of engagement with the worm gear were investigated: position (1)
teeth between 15 and 30°; position (2) 90-105° as two extreme gear teeth fixation positions
(Figure 5-2).
(a)
(b)
Figure 5-2. Two different positions of engagement with the worm gear (a) position 1 gear
teeth fixed at 15 - 30° (b) position 2 gear teeth fixed at 90 - 105°.
146
A force of 210 N was applied to the model to simulate the likely force a human could apply
to the device, based on literature values for different finger activities (see chapter 2 section
2.3). Von Mises stress theory was selected for analysing the stresses in the model as the
model materials were metal and PEEK (Semi-crystalline microstructure). Materials are
classified as ductile materials for that reason von Mises failure criterion is appropriate theory
and enables an accurate result (Collins, 1993). In the finite element analysis section for the
Compass hinge device (see chapter 3 section 3.2.4) the maximum principle stress theory was
selected for analysing the stresses in the Compass hinge device’s models as the material was
PEI.
5.2.1 Results
The results from the simulation analysis for the model showed that stress patterns were
similar for the two positions of the fixed gear teeth. For the two cases the maximum value
of the stress was 242.9 MPa and it was located along the screws which connect the blocks
together with the distal protractor hinge part. The stresses in the models in the metal and
polymer parts are less than the yield strength (946 MPa for 316LS stainless steel and 110
MPa for PEEK, respectively) (MatWeb, material property data; GE Plastics VICTREX®)
and the fatigue strength of the selected materials for those parts (< 65 MPa and 270 MPa at
>107, 5 Hz for PEEK and stainless steel, respectively) (Trotignon et al., 1993; BSSA, Fatigue
resistance). Figure 5-3 and Figure 5-4 show the stress distribution patterns at position 1 with
the gear teeth fixed at 15 - 30° and position 2 with the gear teeth fixed at 90 - 105° with a
load of 210 N.
147
Figure 5-3. Distribution of stresses in the model for position 1 gear teeth fixed at 15 - 30°.
Figure 5-4. Distribution of stresses in the model for position 2 gear teeth fixed at 90 -
105°.
148
Further stress distribution patterns were studied by checking the Iso clipping analysis (the
property manager in SolidWorks allows stresses of a specified value to be plotted) at
different stress values with a load of 210 N:
 at the PEEK yield strength value of 110 MPa;
 at the PEEK fatigue stress endurance limit value of 65 MPa.
The high values of the stresses (> 110 MPa) were located along the screws and metal solid
blocks. Figure 5-5 shows the FEA Iso Clipping at 110 MPa with a load of 210 N. FEA Iso
Clipping at 65 MPa at position 1 with the gear teeth fixed at 15 - 30° with a load of 210 N is
shown in Figure 5-6. Figure 5-7 is the FEA Iso Clipping at 65 MPa in position 2 with the
gear teeth fixed at 90 - 105° with a load of 210 N.
149
Figure 5-5. FEA Iso Clipping at 110 MPa with the gear teeth fixed at 15 - 30°.
150
Figure 5-6. FEA Iso Clipping at 65 MPa with the gear teeth fixed at 15 - 30°.
151
Figure 5-7. FEA Iso Clipping at 65 MPa with gear teeth fixed at 90 - 105°.
5.3 Risk analysis
5.3.1 Undertaking risk analysis
Once the characteristics of the medical device have been defined, it is necessary to identify
all the possible hazards associated with the device such as hazards related to the use of the
device (labelling, packaging and instructions for use), biological hazards (bio-
incompatibility) and energy hazards (moving parts and mechanical force). It is important to
152
balance risk against benefit. High level risks must be identified to reduce them to an
acceptable level that may include redesigning parts of the medical device, making the user
instructions clearer or improving the device packaging.
A report on the risk analysis is produced so that a decision can be made towards the risks
associated with the device are within the acceptable levels or are outweighed by the benefits
to the patient. It is important to review the risk analysis at regular intervals during the
development process.
Many techniques, such as Failure Mode Effect Analysis (FMEA) and Fault Tree Analysis
(FTA) can be used in a risk analysis (Viceconti et al., 2009). For each potential hazard
associated with a medical device, there is a frequency of occurrence “O”, a severity of failure
“S” and an ability to detect the failure “D”. Each of these elements was rated on a scale from
1 to 10 (Suresh et al., 2014), for the hazards identified for the PIP joint protractor hinge
device, as shown in table 5-1. A risk priority number was then calculated by multiplying the
three ratings together.
Table 5-1. Rating of occurrence, severity and detection for potential hazards.
Rating Occurrence “O” Severity “S” Detection “D”

1 Remote No harm Almost certain
2
3 Low remote Minor - unnoticed by customer
4
5 Moderate Low - Customer notices Easily spotted
6
7 High High - Customer complains
8
9 Very high Device will not function at all
10 Serious injury Absolute uncertainty
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5.3.2 Risk analysis of the PIP joint protractor hinge device
The risk analysis should be considered for the individual parts of the assembly as well as the
device as a whole. Sterilization, packaging and labelling are important, but are not being
considered during this study, as only design was concerned. The results are presented in
Table 5-2.
5.3.3 Design description and characteristics
The characteristics of the new PIP joint protractor hinge device are:
I. It is intended for external implantation for the diseased or damaged proximal
interphalangeal joint. It is intended to extend the human digits and improve
functionality of the joint.
II. It is intended to be used by surgeons familiar with finger joint contractures.
III. The selected design is a worm and worm wheel mechanism controlled design which
consists of 13 assembled parts (see chapter 4 section 4.5.1).
5.3.4 Identification of hazards and estimation of risks
The identification of the prospective hazards was carried out and the FMEA was used for
the estimation of the risk of any hazards. The results of this procedure are presented in table
5-2. The estimation of the risk was made based on the risk priority number (RPN). As can
be seen in table 5-2, the risk analysis identified that pin infection and the worm wheel part
as a potential source of unacceptable hazards with a RPN of 560 and 300, respectively.
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Chapter 5 Engineering analysis of the new device design
Table 5-2. Results of risk analysis.
Item Function Possible Effect of hazard Causes of hazard or failure O S D RPN Action to reduce or eliminate
hazard or or failure risk
failure mode
Proximal Main frame of the Wear Loose connection Sliding motion of the distal 2 3 2 12 Design tolerances to be
protractor device between the part to enable the required joint considered
hinge proximal and distal range of motion
parts
>> >> Breaks Top plate part de- Patient exerts a high force to 2 4 6 48 Clear instructions for patients
attached disengage the gears
>> >> Wear Loose connection Repeated unnecessary 3 2 3 18 Redesign part geometry
between the engagement /disengagement of
proximal and the the worm gear
rod part
Distal Range of movement Breaks Device non Cyclic bending moment 1 3 1 3 Suitable material & geometry
protractor (ROM) guide functional
hinge
>> >> Breaks Inaccurate ROM Assembly process with worm 1 2 1 2 Assembly process steps should
wheel fault be provided
Worm wheel Transfer the motion Breaks Device non Cyclic bending moment 5 10 6 300 Suitable material & geometry
to the distal part via functional between the gear teeth
meshing with the
worm part
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Worm gear Transmit the high Wear Device non Excessive engagement and 2 8 8 128 Suitable material & Clear
torque to enable functional disengagement actions of instructions for patients
device motion worm with worm wheel
Rod Connect the worm Wear Device non High force exerted by patients 1 8 8 64 Suitable material & design
gear with the functional to engage/disengage the worm
proximal part gear
Solid Clamp the K-wires Wear Loose K-wires tightened /untightened actions 6 4 5 120 Suitable material
clamping of connecting screws
blocks
Slotted Solid blocks housing Breaks Device non Surgeons over torque the 6 5 5 150 Adequate training and
clamping & more support to functional connecting screws instructions for use to be
blocks clamp the K-wires supplied
>> >> Damage >> Manual assembly process fault 3 2 3 18 Assembly process steps should
with the solid blocks be provided
Screw 1 Radiolucent device Wear Inaccurate device Tighten action to assemble 4 2 2 16 Suitable material & instruction
axle function screw1 with nut 2 for use provided
Nut 2 Radiolucent device Wear Inaccurate device Distal part rotational motion 3 2 2 12 Suitable material selection
axle function
The PIP joint Treat the contracture Inadequate Device non Design problem 4 8 5 160 Re-evaluate the design process
protractor of the PIP joint performance functional
hinge device
156
>> >> Pin infection Severe pain/ death Insertion of K-wires 8 10 7 560 Suitable material selection &
Surgeon advice (area around the
wires should be clean /
medicine)
>> >> Breaks Device non Stored and handled in the 2 2 2 8 Safety instructions should be
functional wrong way followed
>> >> Deformations >> Apply wrong Sterilization 2 2 2 8 Sterilization procedure should
in device Technique be followed for each part
parts material
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5.4 Manufacturing
5.4.1 Techniques
A three-dimensional (3D) printing technique, Computer numerical control (CNC)
machining, injection molding process and electrical discharge machining (EDM) were
considered to manufacture the prototypes of the new device parts. With regards to the fine
detail dimensions of the designed components (see chapter 4 section 4.5) the 3D printing
technique was selected rather than other traditional manufacturing techniques (e.g. CNC,
EDM and injection molding). For the metal parts CNC and EDM should be advanced enough
processes to offer the required part resolutions (minimum thickness is 0.7 mm) and complex
geometry. Unfortunately, these machine tools were not available in the University of
Birmingham’s laboratories (technicians at the Mechanical Engineering School, University
of Birmingham confirmed that). The injection molding forming process for polymer parts
would be used in the case of mass production rather than rapid prototypes due to the high
cost of this process where a die design and its manufacturing process were required to get a
pattern to manufacture the parts. At this stage of the study, the communication was started
with a number of manufacturing companies in the United Kingdom, Europe and United
States to discuss with them the alternative techniques to manufacture both metal and polymer
parts. Most of the companies such as Solid Concepts Inc. - A Stratasys Company, Los
Angeles, USA and Proto Labs, Ltd., Shropshire, United Kingdom recommended 3D printing
technology due to the complexity of the parts and the low mass production required.
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3D printing is a methodology using 3D Computer Aided Design data to produce the 3D
model. This process is also referred to as additive manufacturing (AM), rapid prototyping
(RP), or solid free-form technology (SFF) (Ventola, 2014). The principle of rapid
prototyping is to build a 3D physical model from the 3D computer models by the addition
of material layers to check and validate product design (Ahmad et al., 2015). The advantages
presented by 3D printing are (Pîrjan and Petroşanu, 2013):
 The possibility of creating in a short timeframe the complex 3D objects with fine
details from different materials;
 The material waste is almost zero;
 It is easy to print small movable parts.
The type of 3D printer chosen for an application often depends on the materials to be used
and how the layers in the finished product are bonded. The technical type classification
includes Stereolithography (SL), selective laser sintering (SLS), 3D printing (Binder-Jet),
fused deposition modeling (FDM), direct metal laser sintering (DMLS), laminated object
manufacturing (LOM) and electron beam melting (EBM) (Choi and Kim, 2015).
The 3D printers are currently limited to using only a handful of engineered materials, mostly
plastics and a few metals. The plastic materials are generally of low quality and not suitable
for most production products due to their limited strength, toughness, surface quality, and
UV degradation properties. The 3D printing technique can produce visible layer lines on
side walls and tool paths on the top and bottom surfaces. These can be eliminated, but that
requires additional post-processing, such as an automated finishing station or some manual
finishing Solid (Concepts Inc. - A Stratasys Company, Los Angeles, USA).
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A major disadvantage of 3D printing is its high cost and sometimes, the build quality of 3D
printed parts is lower than if it had been traditionally manufactured where the final product
can have flaws that might affect not only the object’s design, but also its functionality. (Pîrjan
and Petroşanu, 2013).
Wu et al. (2015) presented a recent study to investigate the effect of the layer thickness on
mechanical properties of 3D-printed PEEK samples. The experiments confirmed that the
layer thickness had a marked effect on tensile, compressive and three-point bending
properties. The results showed that 3D-printed PEEK had high mechanical properties. They
mentioned that the mechanical properties of 3D-printed PEEK parts may be improved by
increasing the control accuracy and hardware precision of the 3D-printing system. Their
experimental studies and comparative analyses were carried out to study the factors affecting
PEEK 3D print forming quality, hoping to provide reference conditions under which to print
PEEK. Pore formation during the printing process is still required, including further research
to reduce it and to improve interlayer bonding. They believed that PEEK may be a significant
and promising material for industrial applications of 3D-printed components.
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5.4.2 Models
5.4.2.1 Rapid prototype model
Two solid rapid prototype models were manufactured using an Eden 250 3D Printer (Objet,
Billerica, USA) and made out of an acrylic monomer based resin (brand name Fullcure 720)
in the School of Mechanical Engineering, University of Birmingham (Birmingham, UK).
One of these models was a 3D assembled solid model as a single part (Figure 5-8) and
another was manufactured with separate parts which required assembly (Figure 5-9). These
prototypes were manufactured for the purpose of:
 Checking the dimensions of each part;
 Confirming the working mechanism of the device;
 Checking the consistency and fitting together of the assembled parts of the device;
 Approving it from the medical point of view (shape, accessibility and functionality)
according to the surgeon feedback.
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Screw 1
Figure 5-8. Rapid prototyping model of the PIP joint protractor hinge device.
Figure 5-9. Disassembled rapid prototyping model of the PIP joint protractor hinge device.
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The whole printed model (width, length and thickness) and all printed separate parts
dimensions were measured using a digital vernier caliper (Hilka Tools (UK) Ltd, Surrey,
UK) and the measurement results approved the design. An example of the comparison
between the designed dimensions and average measured dimensions (refer to the prototyped
parts in figure 5-9) for each part shown in table 5-3. The thread pitch for worm gear and
screw 1 were checked by the thread gauge and the dimensions were confirmed. Some
dimensions were slightly larger than designed and were adjusted manually using sand paper.
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Table 5-3. Comparison between the designed and measured dimensions.
Designed Average
Part name Symbol dimensions measured
(mm) dimensions
(mm)
a 14.5 14.49
Proximal protractor hinge part
a b 23 23.05
b
c 4.9 4.87
d
d 4.9 5.04
c
e
e 18 18.03
Distal protractor hinge part

f 19.6 19.56
f
g
g 2.5 2.46
h
h 4 4.17
i
i 4.9 4.82
Worm wheel
j 4 3.98
j k k 1.9 1.97
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Worm l 14.3 14.28
m 9.8 9.77
m
n l
n 4.6 4.55
o 2.4 2.37
Solid clamping block
o
p 3.4 3.50
p
q 15.9 15.86
q
r 3.3 3.70
Slotted clamping block
s
s R2 2.10
t
r
t 4 4.13
u u 17.6 17.63
v 6 5.93
Nut 2
w
w D 4.7 4.78
v
x 7.5 7.54
x
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y 6 6.01
Screw 1
z
z 7.9 7.92
y
A M3 3.04
A
B 3.2 3.19
Rod
B
C 3 3.01
C D 21 21.09
D
The teeth meshing between the worm and worm wheel was tested by assembling the two
parts together and the worm was turned manually (Figure 5-10). The worm and worm gear
working mechanism (active and passive movements) was found to be controlled and
confirmed.
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Worm
Worm wheel
Figure 5-10. Worm and worm wheel teeth meshing.
The assembly process was done manually for the printed parts to check the tolerance fit for
all parts which were assembled together.
A review meeting with Mr. Garth Titley (Consultant Plastics and Burns Surgeon at the
Queen Elizabeth Hospital, Birmingham) about the prototype model was undertaken to gain
his feedback; he approved the whole size of the new device and its thickness (8.5 mm) which
allows the device to be implemented in the central digits easily. The worm and worm wheel
mechanism achieves the continuous active and passive movements which is the main idea
of the treatment process. The overall device feature with the marks used to guide to angle
(see chapter 4 Figure 4-16) on the frame was strongly acceptable to be a digit fixator from
the medical point of view.
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5.4.2.2 Working model
To assess the design, a working model of the finger fixator was manufactured (Figure 5-11).
All parts were manufactured by Solid Concepts Inc. (A Stratasys Company, Los Angeles,
USA). Selective Laser Sintering (SLS) was used to manufacture the polymer parts from
NYTEK TM 1200 CF which is carbon filled nylon (Solid Concepts Inc.- A Stratasys
Company, Los Angeles, USA). This material has similar mechanical properties to PEEK
and was used as PEEK was not available for manufacture using SLS. For manufacturing the
metal parts, Direct Metal Laser Sintering (DMLS) was used, and they were manufactured
using stainless steel 17-4PH composition. The worm gear material was replaced from
polymer to stainless steel 17-4PH composition as the Solid Concepts Inc. SLS machine did
not allow to manufacture the dimensions of the worm. After manufacturing, it was found
that the resolution of the DMLS technique was not sufficient to enable the worm gear to
mesh with worm wheel part (Figure 5-12). Subsequently, the worm gear part was
manufactured using an Eden 250 3D Printer (Objet, Billerica, USA) and made out of an
acrylic monomer based resin (brand name Fullcure 720). Figure 5-13 shows the working
model used in the mechanical test to evaluate the new device design.
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Figure 5-11. External dynamic protractor hinge fixator working model.
Thick tooth width

Inaccurate teeth
thickness dimensions
Thin tooth width
Figure 5-12. A manufactured worm gear by stainless steel 17-4PH composition, Solid
Concepts Inc.
Fullcure 720 material

worm gear
Figure 5-13. The mechanical test model
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5.5 Mechanical testing
To validate the new device, the working model was subjected to the cyclic mechanical
testing. The experimental test for the new device was guided by ASTM F1541-02. Section
A4 of ASTM F1541-02, which describes the test procedure for external skeletal fixator joints
was used in selecting the cyclic bend test.
5.5.1 Testing equipment
Mechanical testing of the working model was undertaken using a Bose ElectroForce® 3330
Series II Test Instrument (Bose Corporation, ElectroForce Systems Group, Eden Prairie,
Minnesota, USA) run using Win Test software (Figure 5-14). The testing machine is
designed with an electromagnetically controlled actuator which is able to move vertically up
and down. The top and bottom plates can be manually moved up and down and be fixed at
any desired position within this distance. The machine has a maximum range of motion of
25 mm and can be controlled in two ways: either statically between set displacements or
cyclically with a number of alternating loading waveforms such as sine waves, square,
triangles and ramp loading. Cyclically the machine can operate at a maximum frequency of
100 Hz. According to the manufacturer’s specifications, this equipment has a peak dynamic
force of ± 3000 N (Bose 1010CCH-1K-B) and a static force capacity of ± 2100 N.
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Actuator
Desktop computer
Bottom plate
Load cell
Rig
Figure 5-14. The Bose ElectroForce® 3330 Series II Test Instrument.
5.5.2 Testing setup
A rig was designed to enable the fixator to be held in position and subjected to mechanical
loads. The rig consists of 5 parts: main frame, support frame, cup, load rod and wire. All
these parts were manufactured by Proto Rig workshop (Birmingham, UK) (Figure 5-15).
The rig main frame was designed to be attached to the base of the testing machine and works
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as a bracket to carry other parts. On the main frame there was a cup into which an artificial
bone (a section cut from a fourth-generation Sawbones (Pacific research laboratories Inc.,
Vashon, WA, USA) composite femur (item# 3406) was fixed in position using a fast cure
acrylic denture base bone cement (WHW Plastics, East Yorkshire, UK). The device was then
fixed to the artificial bone using a clamping bracket to keep the new device proximal
protractor hinge part (the device left hand side) in position during the test. The device was
fixed to the rig frame through the support frame. The support frame has a 1.5 mm diameter
wire which acts as the PIP joint center wire for the new device. Loads were then applied to
the fixator using the load rod which connected to the load cell of the Bose machine (Figure
5-14) by the screw thread part of the rod.
Figure 5-15. The designed mechanical test rig.
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5.5.3 Methods
A compressive sinusoidally varying force of between 1.5 and 13 N was applied by the testing
machine to the supported device at the protractor distal part. A preload of 1.5 N was used to
ensure that there was contact between the device and the load cell. The loading was
performed to a maximum of 13 N as this is that maximum force a prosthesis finger joint can
exert (Joyce and Unsworth, 2000); there has been no force recorded for PIP joint contraction
patients. The sine waveform was run at 2 Hz and testing continued until failure or run-out
of 170,000 cycles was reached; this value was based on the assumption that around 1 million
finger motions per year occur (Joyce and Unsworth, 2000) and the maximum period to
support the device on an injured finger of a patient was reported as 64days (Bain et al.,
1998).
5.5.4 Results
Testing reached run-out of 170,000 cycles and was completed after 23 hours and 36 minutes
with no cracks or damage was visible in the device parts. The maximum displacement under
the maximum load applied of 13 N was 1.3 mm. Figure 5-16 shows the model after
completing the test. Two areas were examined before and after running the test: the first one
at the worm wheel teeth and spaces between them where they had been in contact together.
The second area examined, the right side of the distal protractor hinge part, was the area
assumed to have the maximum stresses from the finite element analysis (section 5.2.1).
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Figure 5-16. The device model after the cyclic bending mechanical test
For area 1 (Figure 5-16), no damage was seen at both the stainless steel worm wheel and the
plastic worm gear. A magnification lens was used to check the worm and worm wheel
manually and it was confirmed that no cracks were generated in either gear. On the other
hand, unserious wear had happened at the worm gear; that result was predicted before
running the test where the metal worm wheel material was harder than the polymer worm
gear material (Kato and Adachi, 2001). The hardness of the stainless steel 17-4PH
composition worm wheel in Rockwell scale “C” is 30 HRC (Solid Concepts Inc. - A
Stratasys Company, Los Angeles, USA – DMLS material data sheet) and the hardness of
the Fullcure 720 material in Rockwell scale “M” is 81 HRM (The FullCure® - Object
geometries material data sheet). During the mechanical test, the applied cycling load caused
the stainless steel teeth of the worm wheel to impinge on the polymer worm gear engagement
teeth.
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For the second tested area (Figure 5-16), it was predicted that the scratched line would appear
on the surface of the distal protractor hinge part due to the effect of the applied load shaft
(Figure 5-17). However, this line did not appear because of the rough surface finish of the
new device plastic parts, as shown in Figure 5-16.
New designed device
Applied load shaft
Figure 5-17. Applying cyclic load on the new designed device using a Bose
ElectroForce® 3330 Series II Test Instrument
5.6 Discussion
The new design feature was generated, analysed and a working model manufactured. The
new design was verified using the finite element analysis technique. That technique showed
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that the Compass hinge had a maximum stress of 285.3 MPa (see chapter 3 section 3.3) and
this occurred in a polymer part which was located between the gear teeth in the distal arcuate
hinge member at a fixation position which engaged the gear teeth between 15 and 30°. In
the new device the worm wheel part is now made from a metal and the maximum stress is
now located along the connecting screws with a maximum value of 242.9 MPa (Figure 5-
18).
285.3 242.9
Figure 5-18. The maximum stress location for both models of the Compass hinge device
(left) and the PIP joint protractor hinge device (right) at position 1 with the gear teeth fixed
at 15 - 30° with a load of 210 N.
The gear tooth strength analysis was done by using Lewis bending stress equation (Schmid
et al., 2013) to get the maximum bending stress per worm wheel tooth (see chapter 4 section
4.5.2.3). The tooth bending stress was calculated at two different load values; firstly, at 210
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N as the maximum applied load (see section 5.2). Secondly, at 13 N where the mechanical
test was performed at the new device (see section 5.5.3). The results of the worm wheel tooth
stress analysis were 0.22 MPa at 210 N and 0.014 MPa at 13 N. These stress analysis values
were low compared with the fatigue strength of the stainless steel grade 316L worm wheel
material (180 MPa to 520 MPa at 6 Hz and N > 107 cycle (Huang et al., 2006)).
A 0.7 mm minimum wall thickness dimension and the complex detailed features of the new
designed components device meant that the 3D printing manufacturing technique was
strongly recommended by Mechanical Engineering school technicians at the University of
Birmingham and manufacturing companies (Solid Concepts Inc. - A Stratasys Company,
Los Angeles, USA and Proto Labs, Ltd., Shropshire, United Kingdom) to manufacture them.
On the other hand, the conventional manufacturing techniques such as CNC and EDM would
not enable the required part dimensions since advanced machine tools were not available.
The stainless steel 316LS medical grade (90% cold worked) and PEEK 90G VICTREX®
were selected to be the new materials for manufacturing the metal and polymer parts. These
two materials were picked among other candidate materials for their mechanical properties
which fulfil the new device requirements (chapter 4 section 4.3.2). Although the aluminum
alloys (2.7 g/cm3) are almost one third the density of stainless steel (8.0 g/cm3) (Davis, 1994)
they are typically not as strong as 316LS stainless steel, with a yield strength of 946 MPa
(MatWeb, material property data). Despite PEEK and PEI polymer material being close in
their mechanical properties where the yield strength and Young’s modulus are 110 MPa, 3.6
GPa (Chou et al., 2008; Hee and Kundnani, 2010) and 105 MPa, 3.3 GPa (Kirby, 1992),
respectively, PEEK (65 MPa at 5Hz, >107 cycles) exceeds the PEI (24 MPa at 5Hz, >107
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cycles) in the fatigue stress endurance limit by approximately three times (Trotignon et al.,
1993).
The new design and the 3D printed models were reviewed by Mr. Titley (Consultant Plastics
and Burns Surgeon at the Queen Elizabeth Hospital, Birmingham) and it was concluded that
this new fixator meets the needs of surgeons for a device that is, small, allowing active and
passive motion, like the Compass hinge, but with a reduced chance of mechanical failure. It
can be applied to the radial or ulnar side of any finger and is radiolucent to facilitate accurate
placement.
5.7 Summary
The new fixator based on development of the Compass hinge consists of 17 parts where 8
of them (proximal and distal protractor hinge parts, worm gear, screw 1 and nut 2, rod,
slotted clamping proximal and distal blocks) are to be made from a radiolucent medical grade
plastic VICTREX® PEEK 90G. The stainless steel 316LS Medical Implant Alloy, 90% cold
worked was selected for the remaining parts (worm wheel, four solid blocks and four
connecting screws). The selected materials were not available for manufacturing using 3D
printing so NYTEK TM 1200 CF which is carbon filled nylon and stainless steel 17-4PH
composition were used to manufacture a working model. The new device would be attached
to the patient fingers such that the distal protractor hinge part is attached to the middle
phalanx of the patient’s injured finger and the proximal protractor hinge part is attached to
the proximal phalanx.
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The new design was analysed using finite element analysis which showed that the maximum
stress was 242.9 MPa and this was less than the yield strength and the fatigue endurance
limits for the selected materials. A cyclic bending test was performed using a Bose
ElectroForce® 3330 Series II Test Instrument which was guided by ASTM F1541-02. The
results showed that testing reached run-out of 170,000 cycles with no cracks or damage
visible in the device parts. The next chapter will present an overall discussion of the thesis
and the conclusions which are drawn from the results.
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CHAPTER 6
OVERALL DISCUSSION AND
CONCLUSIONS
Chapter 6 Overall discussion and conclusions
6 OVERALL DISCUSSION AND CONCLUSIONS
This chapter provides an overall discussion of the thesis and brings together the various
individual studies that have been undertaken. A reminder of the aims of the project is
provided in section 6.2. The general discussion of this study is described in § 6.3. The
surgical technique of the proposed device is presented in §6.4, followed by a comparison
between the current and previous fixators together in §6.5. A number of areas worth
exploring in developing this work is detailed in §6.6. A number of conclusions are drawn
from the results and are listed at the end of the chapter.
6.2 Project objectives
The overall aim of this project was to develop and test a prototype of an external PIP joint
finger fixator. The specific objectives of this project were to:
 Analyse a failed Compass hinge device;
 Produce a new design of fixator device;
 Manufacture a prototype model of the new designed fixator;
 Analyse the new design using finite element modelling;
 Mechanically test the prototype of the new designed fixator.
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6.3 Discussion
Following the development and completion of the new external finger fixator which was the
ultimate aim of this research project, there are a number of important points of discussion.
Initially the study of the biomechanics and the different contracture of the PIP joint was
presented. Then, as an example of these contractures, Dupuytren’s disease was described in
detail. A variety of fixators are offered for PIP extension mobilization. One designed
distractor of the PIP for both extension and flexion mobilization is the Compass hinge device
which was analysed and developed in this project.
The study and review of the current and past designs was vital as those can be the base for
inspiration and a way to improve and develop a new design. This is especially important
when complications from previous designs and failure analysis are published that could be
an advantage in the design progress.
The design considerations and requirements take into account the available previous data on
the biomechanics of the joint and the different designs that have been presented. The concept
design procedure followed the design requirements procedure and a detailed design led to
the final design.
Verification and validation methods have been used in this study. Finite element analysis
has been performed for the optimal shape of the suggested design. The finite element
modelling showed that the expected stresses experienced within the new design when the
force of 210 N was applied would not exceed the fatigue strength of the new selected PEEK
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and stainless steel 316LS manufacturing materials. The mechanical test has shown the
device is strong enough and the worm and worm wheel mechanism system is stable enough
to withstand the expected loading conditions in the human digit.
The proposed device, which has been designed and tested in this project, was a medium size,
low mass, easy to use and natural color likely to be required for the attachment of the PIP
joint fixator. It could be possible to design the skeletal external fixator in various sizes to fit
into the different lengths of the human fingers. Small, medium and large are the three
suggested sizes to manufacture the new device. These sizes were guided during the design
stage by the different lengths of the middle phalanges of human digits (Alexander and
Viktor, 2010).
6.3.1 Analysis of failed Compass hinge device
The Compass hinge device engineering analysis study (chapter 3) was undertaken to
investigate the different modes of failure. The finite element modelling and scanning
electron microscopy techniques were used to determine the appropriate types and causes of
the failure, since all the relevant information was not available in the literature. SolidWorks
Simulation (SolidWorks 2011, Dassault Systèmes SolidWorks Corporation, Waltham, USA)
was used for the finite element analysis. A Joel JSM-6060 scanning electron microscope
(JEOL Ltd, Tokyo, Japan) was used to scan the fracture surfaces of the failed device.
The results of this study showed that the cyclic bending stresses are the main cause of the
mechanical failure in the polyetherimide distal arcuate member in the Compass hinge device.
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When the device was attached to the digit of a patient they try and move their PIP joint, thus
causing high stresses to be generated in the weak resistant areas in the device which causes
cracks to be initiated. As the patient carries on loading the device this means that cracks are
likely to propagate rapidly. Lastly, the section of polyetherimide distal arcuate member will
bend, fracture and detach from the device.
The results of the study of the distal arcuate member are given in section 3.3.2 and section
3.4.1 and from these results the features, dimensions and materials for manufacture (chapter
4 section 4.5.1) for the new design prototype were determined.
6.3.2 The PIP joint protractor hinge device design
The PIP joint protractor hinge device design was presented in chapter 4 and the outer
dimensions are 35.5 mm for height, 47.5 mm for width and the thickness is 8.5 mm.
SolidWorks Computer Aided Design (SolidWorks 2011, Dassault Systèmes SolidWorks
Corporation, Waltham, USA) software was used to model the new device design parts. Three
device sizes were suggested to fit with a large range of patient finger sizes as medium (M)
designed for average, small (S) and large (L). In this study, a medium (M) design was
presented that was based upon the medium (50% percentile) human hand anthropometric
data. The protractor hinge device will be attached to the finger bone by inserting 5 K-wires.
One of these wires will inserted in the center point of the PIP joint and will be removed later
after the positioning surgical procedure has ended. The remaining four wires will be
permanently fixed in the proximal and middle digit phalanges, with 2 wires for each phalanx.
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The device depends on the worm and worm wheel mechanism which enables active and
passive (flexion and extension) mobilization for the injured PIP joint.
6.3.3 Finite element modelling
Finite element analysis was used to determine the stresses which would be experienced by
the new device parts (chapter 5 section 5.2). A force of 210 N was applied to this model.
This force magnitude was chosen from previous studies of the biomechanics for the human
finger which predicted forces during daily activities (Chapter 2 section 2.3).
The results of the finite element analysis showed that the predicted stresses are not as high
as the fatigue strength of the PEEK and stainless steel, the proposed materials for the
prototype of the new designed device. The new designed components were modelled with
the constraints at two different PIP joint flexion positions with the worm gear at: position
(1) teeth between 15 and 30° and position (2) 90-105° as two extreme gear teeth fixation
positions. The stress patterns were similar for the two positions, where the maximum value
of the stress was located along the screws which connect the blocks together with the distal
protractor hinge part, with the maximum stress being 242.9 MPa. For the Compass hinge the
maximum stress was 285.3 MPa (see chapter 3 section 3.3) and this occurred in the main
device part of the distal arcute hinge member and was located between the gear teeth in the
distal arcuate hinge member with the gear teeth fixed between 15 and 30°. It was concluded
that the new design would be expected to withstand the likely forces which are exerted by
the human fingers.
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6.3.4 Prototyping
A 3D printing technique was used to manufacture both the metal and the polymer parts of
the new device as high dimensional accuracy was required (0.7 mm minimum thickness).
As there had been no recorded manufacturing techniques for other fixators, the 3D printing
method was chosen among other possible conventional manufacturing techniques such as
CNC and EDM for metal parts and injection molding for polymer parts for many reasons.
These reasons are that firstly, traditional manufacturing techniques, such as CNC and EDM
for metal materials in the School of Mechanical Engineering workshop at University of
Birmingham would fail to get the required dimensional resolution. Although the CNC five
axis machine may get the required dimensions, it will be expensive where a special design
set up will be required to hold the tiny dimension work pieces. Also, an engineer or highly
skilled technician would be required to monitor the cutting process which means a very high
cost toward manufacture of the prototype models for the new device. For manufacturing the
polymer parts by a traditional technique such as injection molding will be expensive where
a die design will be required; this technique will be worth the money in the case of mass
production of the new device, but not for prototype models.
A suggested strategy plan to manufacture mass production for a final device that was being
implanted into patients was as follows. For all metal parts the wire EDM machining process
was selected. That by reason of the advantage of this process as X, Y, and Z machine axes
movements allow for the programming of complex profiles using simple electrode, complex
sections can be produced accurately, fast and low cost to produce a large number of work
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pieces (Dewangan, 2010). For the main polymer parts, proximal and distal protractor hinge
parts and slotted clamping blocks (chapter 4 section 4.5.2.1, 4.5.2.2 and 4.5.2.6) the injection
molding process was suggested to manufacture these parts. Prototype injection molds are
most commonly produced by conventional machining, grinding or electrical discharge
machining (EDM) techniques (Malloy, 1994). The advantages of the injection molding
process are for complex geometries, high production output rates, close tolerances on small
intricate parts and parts have a very finished look (Rosato and Rosato, 2012). The CNC
machining process was suggested for the remaining polymer parts, rather than another
alternative 3D printing technique, where the parts manufactured by CNC have high
accuracy, is fast and it is the best solution when manufacturing a large number of complex
objects. In addition, sometimes, the 3D printed build quality is lower than if it had been
traditionally manufactured (Pîrjan and Petroşanu, 2013).
In this study, three prototypes were manufactured; two of them were made out of an acrylic
monomer based resin (brand name Fullcure 720) to check that the all of the features and the
outer dimensions were acceptable. Since the designed materials were not available for
manufacture by 3D printing another prototype was made from NYTEK TM 1200 CF which
is carbon filled nylon for polymer parts and stainless steel 17-4PH composition for metal
parts. This prototype was manufactured to be subjected to mechanical testing.
Another aspect that should be considered during the design process is the manufacturing
cost. It is the sum of costs of all resources consumed in the process of making a device. The
manufacturing cost is classified into three categories; direct materials cost (the cost of raw
materials), direct labor cost (the cost of workers) and manufacturing overhead (the cost of
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supervisors and material handling, the cost of associated with consumables and any expenses
that keep the factory operating) (Ostwald and McLaren, 2004). The manufacturing cost of
one of the PIP joint protractor hinge device should not exceed the range of 400-600 British
Pound Sterling, which is the price range of other fixators in the current market, as confirmed
by Mr. Titley.
6.3.5 Mechanical testing
ISO and ASTM standards were checked carefully for testing procedures for external finger
fixators, and very few standards were found. Therefore, the general requirements for non-
active surgical implants (BS EN ISO 14630:2005), standard specification and test methods
for external skeletal fixation devices (ASTM F1541-02 2001) were used as guides for the
current study.
The mechanical testing of the prototype PIP joint protractor hinge device was carried out
using a Bose 3330 materials testing machine (Bose Corporation, Minnesota, USA). The test
set-up for the cyclic compression tests was modified so that the force was applied by the top
load cell straight onto the distal protractor hinge part. In the cyclic compression test a
sinusoidal load between 1.5 N and 13 N was applied at a frequency of 2 Hz. The mechanical
testing showed that testing reached run-out of 170,000 cycles with no cracks or damage
visible in the device parts. The prototype of the PIP joint protractor hinge device was strong
enough to withstand the expected forces that it would be subjected to in the fingers. Further,
the worm and worm wheel mechanism system was found to work well in the test.
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The new designed device (13 components and 4 connecting screws) (see chapter 4 § 4.5.1)
had a reduced number of parts compared with the Compass hinge device (16 components
and 8 screws) (see chapter 3 § 3.2.4). The reduction by 7 parts would mean that the new
device was more accessible and easier to manually assemble compared to the Compass
hinge. An assessment method for assembling the new device parts was still required to
confirm that. More solid models should be manufactured to apply this assessment method
and volunteers to assemble the devices should be trained with the device assembly sequence
plan to be sure all used the same sequence. Human factor aspects should be considered in
choosing volunteers as gender and age where male and female with both right and left write
hands should participate in the assessment.
6.4 The PIP joint protractor hinge surgical technique
The axis of the protractor hinge is located at the axis of the PIP joint. To maintain motion
during healing, the device is equipped with a worm gear that allows passive motion through
the worm wheel in the device frame. The gear mechanism may be disengaged by the patient
for active motion to maintain tendon excursion, particularly in the later phases of treatment.
The protractor hinge device attaches with skeletal fixation to either side of the joint with
stainless steel Kirschner (K)-wires, which are inserted along the lateral and mid-axial line of
the finger phalanx. The new device is attached to the patient fingers such that the distal
protractor hinge part is attached to the middle phalanx of the patient’s injured finger and the
proximal protractor hinge part is attached to the proximal phalanx. In order to enable
surgeons to determine which size of device to use, table 4-4 was created (see chapter 4
section 4.6).
189
6.4.1 Further development
Further work supplementary to the current study could be done with the proposed PIP joint
protractor hinge device design.
 Side walls were suggested to be added to the proximal protractor part to avoid any
detachment of the assembled rod part (see section 4.5.2.5) so a rapid prototyping for
the modified part is required to check the dimensions and the function to confirm it.
A 3D design of the modified proposed part is shown in Figure 6-1.
Side walls
Figure 6-1. A new feature design for the proximal protractor hinge part.
190
 A prototype of the final design should be manufactured from the suggested materials
(VICTREX® PEEK 90G, 316LS medical grade stainless steel, 90% cold worked
condition) rather than manufacture with available materials.
 The accommodation of the design to cover the range of sizes that are needed to cover
the different sizes of the human fingers.
 An in vitro clinical evaluation of the final design of a manufactured model is

compulsory to be performed.
Approach In 1993, the European Committee for Standardization the international standard
ISO 14155 first requirements for the clinical investigation plan was published. This
International Standard addresses good clinical practice for the design, conduct, recording
and reporting of clinical investigations carried out in human subjects to assess the safety or
performance of medical devices for regulatory purposes. Clinical research studies can be
categorized as either observational or analytical (hypothesis testing trials). Becker and
Whyte (2007) described the clinical evaluation of medical devices and summarized the
clinical investigation plan in 17 elements which should be considered at the validation stage
of the medical design process (Aitchison et al., 2009); device description, study objective,
study design, study population, treatment regimen, control group, endpoints evaluated, trial
success, study procedures and duration, sample size calculations, data analysis plan, risk
analysis, case report forms, informed consent forms, investigational sites, data safety
monitoring board, and monitoring plan.
191
ISO EN 14155-2 details that the individual who participates in a clinical investigation should
be a patient. In addition to articulating the clinical condition of the subjects, investigators
often include demographic criteria specifying patient, age, sex and race also educational
level may be relevant in vitro diagnostics.
For the PIP joint protractor hinge device there are some aspects of the design process still
required to accomplish to present the new device to the market as Aitchison et al. (2009)
detail in their medical design process flow chart. The estimated timeline for the required
design processes was summarized in Table 6-1 and the predictable time period is
approximately 2 years.
Table 6-1. A predicted timeline of the design process required for the PIP joint protractor
hinge device.
Medical design process Approximate period of time
(still required) Process description (month)
Production 5
Manufacture Sterilization 1
Mechanical testing 1
Validation Clinical investigation 12
Sterilization validation 2
Surgical technique 1
Design transfer Packaging & labelling 1
Master device record 1
192
6.5 Comparison of the new proposed device with other

external finger fixators
The developed design presented in this thesis has some similar design features to the Verona
and Compass hinge devices with the design dependent on the gear transmission mechanism
system. A worm and worm wheel gear type were used according to its function which is the
rotation motion which will allow higher torque to be transmitted by the patient due to turning
the worm gear to device parts. Although the screw and nut mechanism in many finger
fixators such as the TEC, JESS and Orthofix devices (Messina and Messina, 1993; Joshi,
1997; Houshian and Schrøder, 2004) offered the same type of motion as the worm and worm
wheel mechanism, but are difficult to implant and turn the nut to give movement in the
patient’s central digits. TEC is an example of the screw and nut mechanism in a working
fixator (Figure 2-16), which is quite big which makes it not accepted by patients especially
to be implemented in the central digits where they do not feel comfort since there is not
enough space between the central digits (Citron and Messina, 1998). Furthermore, the screw
and nut mechanism is not easy to be used by patients during the treatment period where the
force was required to be exerted to turn a nut to move the fixator. The PIP joint protractor
hinge device was designed to be based on development of the Compass hinge device. The
new device idea not only works on overcoming the Compass hinge device complications
(see chapter 3 section 3.2.3), but also the reported claims of other fixators (chapter 2 section
2.6). The new device advantages are mechanical failure of parts were reduced, there is no
slippage between the device parts, it is small in size, it allows active and passive motion,
some parts are manufactured from a radiolucent material and it has low thickness so it can
be used in the central digits.
193
The new device was suggested to be manufactured from both metal and polymer medical
grade materials (316LS stainless steel and VICTREX® PEEK 90G) to enable the advantages
of both materials, namely low mass, radiolucent and natural color for the polymer material
(VICTREX®) and high yield strength and fatigue stress endurance limit for the metal
material (yield strength = 946 MPa) (MatWeb, material property data). The previous
engineering analysis study (section 3.3 and section 3.4) for a failed Compass hinge device
confirms that the bending cyclic stress was the main cause of the failure so a medical grade
316LS stainless steel material, which has a high fatigue strength, was selected to replace the
Compass hinge device in areas of the parts with high stresses. Further, a medical grade
plastic VICTREX® PEEK 90G material has been chosen for the remaining polymer parts
rather than polyetherimide parts (used for the Compass hinge) where the fatigue endurance
limit for the selected material (65 MPa at 5 Hz, 20°C and >107 cycles) is higher by
approximately three times that of the polyetherimide (24 MPa at 5 Hz, 20°C and >107 cycles)
(Trotignon et al., 1993).
The PIP joint protractor device is unique where parts close to the PIP joint center are
manufactured from a radio-lucent PEEK material polymer, which can be seen under x-ray
rather than a radio-opaque metal used in the Compass hinge and Verona devices (Hotchkiss
et al., 1994; Citron and Messina, 1998). The new device has fine guide marks on the device
frame and on the worm gear to aid the user with the amount of turns when using the worm
gear.
The newly design device is small in size compared with the Compass hinge measured
dimensions (the width has been reduced by 4 -19 percent and the thickness by 26 percent),
194
and the device has low thickness compared with other devices (TEC, JESS, Hoffmann II
Micro External Fixation System and Compass hinge). Since the new device will attach in
the lateral direction to the finger phalangeal, the attachment process to a patient’s central
digits is easy and will be accepted by patients, particularly with the advantages of the new
device, namely small size and low thickness. This was concluded from Mr. Titley
(Consultant Plastics and Burns Surgeon at the Queen Elizabeth Hospital, Birmingham)
design meeting feedback. This enabled the new device advantage over other fixators which
have used pins and elastic bands (White et al., 2012) which were implemented in digits in
the dorsal direction.
The new design device finite element analysis and the mechanical tested prototype analysis
results confirmed that the occurrence of mechanical failure was vastly reduced compared
with the results of the compass hinge device engineering analysis. The finite element
simulation analysis (SolidWorks 2011, Dassault Systèmes SolidWorks Corporation,
Waltham, USA) for the Compass hinge device showed that the high stress area was
generated at the main polymer part of the device, which is the part which allows the device
to move (Figure 3-14). The maximum stress value reached was 285.3 MPa. This value was
more than the fatigue endurance limit of the Compass hinge distal part material which was
PEI material (24 MPa at 5 Hz, 20°C and >107 cycles) by eleven times and by 2.7 times of
the yield strength (105 MPa). The conclusion of this analysis was confirmed that the
Compass hinge device could not withstand the cyclic loads due to human daily activity
motion and in the long run failure occurs. On the other hand, the finite element simulation
analysis (SolidWorks 2011, Dassault Systèmes SolidWorks Corporation, Waltham, USA)
for the new designed device showed that generated stresses were located in three areas
(Figure 5-3). These areas were assumed to be high, medium and low stresses. The low stress
195
area were where the value of stresses were less than 60 MPa distributed at the right side of
the PEEK distal protractor hinge part and these values were less than the PEEK fatigue
endurance limit (65 MPa at 5 Hz, 20°C and >107 cycles) and yield strength (110 MPa) by 2
times (Figure 5-6). That confirms that the polymer device parts can withstand the likely load
conditions in the human hand during activities. For the medium and high stresses, values
ranged from 60 MPa to 243 MPa and they were distributed along the distal solid blocks and
the connecting screws (maximum stress 242.9 MPa). These parts were to be manufactured
from a metal (316LS stainless steel) where the maximum generated stress was less than the
316LS yield strength (946 MPa) by 3.8 times. The new device analysis and its calculations
verify theoretically the device from the engineering point of view.
More stages are still required according to the flow chart which was presented by Aitchison
et al. (2009) for the design of new medical devices. The devices should be manufactured
with the suggested manufacturing techniques. A required clinical investigation plan must be
produced in accordance with BS EN ISO 14155-2 as the next required step. The Ethics
Committee should approve the investigation and the manufacturer would be required to
decide on the length of it, the number of patients to be involved and other type of data to be
collected such as patient’s digit flexion angle, PIP joint range of motion (ROM) after
treatment and any complications should be recorded by both patients and surgeons. After
that, the instructions for use of the new device should be prepared with the finalization of
the surgical technique. Then, the design will be ready to transfer to production. The final
stage for a new design is launch into the market and to have a post-market surveillance
procedure in place. The manufacturer should work on the negative feedback and improve
the design and this feedback must be fully documented. Repeating the design verification
196
process such as the finite element analysis and the validation process such as the mechanical
testing may be required upon to the magnitude of the design changes. Also, a risk assessment
should be updated to ensure that the full impact of the changes has been understood.
6.6 Conclusions
The conclusions from this thesis are as follows:
 The cyclic fatigue stresses are the main causes of the Compass PIP joint hinge distal
arcuate hinge member part fracture that were investigated using finite element
analysis and scanning electron microscope techniques.
 A new external fixator device has been designed that has an improved design
compared with previous fixators, through smaller dimensions and the use of a radio-
lucent polymer;
 Finite element analysis showed that the maximum stress was 242.9 MPa and this was
less than the yield strength and the fatigue endurance limits for the selected materials;
 Mechanical testing showed that testing reached run-out of 170,000 cycles with no
cracks or damage visible in the device parts;
 The verification and validation procedures for a new design fixator have shown that
the device is strong and stable enough to withstand the likely loading conditions in
the human digits.
197
APPENDICES
Appendix A
Free hand sketches drawing views of the Compass hinge device parts at measurement stage
see (section 3.2.4).
199
200
Appendix B
The engineering drawings of the Compass hinge device parts (see section 3.2.4)
201
202
203
204
205
206
207
208
209
210
211
212
213
214
Appendix C
The engineering drawings of the designed rig for the mechanical testing (see section 5.5.2)
215
216
217
218
219
220
221
222
223
224
Appendix D
The worm wheel teeth stress calculation (see section 5.6)
Lewis Bending Stress (Schmid et al., 2013)
Where:
Wt is the tangential load (Ibs),

Pd is the diametral pitch (in -1),
F is the face width (in), and
Y is the Lewis form factor (dimensionless)
Tooth bending stress at load W = 210 N (47.21Ibs)
Wt = W cos φ1
= 11.80 cos 20ᵒ = 11.088 Ibs
Pd = 1/m
= 2.5 mm = 0.098 in
F = 2 mm = 0.079 in
σt = (11.088 x 0.098) / (0.079 x 0.43) = 32 Ibs/in2
σt = 0.22 MPa / tooth
σt for four teeth is 0.88 MPa
Tooth bending stress at load W = 13 N (2.92 Ibs)
σt = (0.69 cos 20ᵒ x 0.098) / (0.079 x 0.43) = 1.99 Ibs/in2
σt = 0.014 MPa / tooth
σt for four teeth is 0.056 MPa
225
Appendix E
The engineering drawings of a proposed future design of the proximal protractor hinge part
(see section 6.4.1).
226
227
Appendix F
List of publications for current work
 Youssef, M.M., Shepherd, D.E.T., and Titley, O.G., 2015, “Engineering Analysis
of A Failed Compass Proximal Interphalangeal (PIP) Joint Hinge,” Biomedical
Engineering: Applications, Basis and Communications, 27 (2), 1550013.
 Youssef, M.M., Shepherd, D.E.T., and Titley, O.G., 2015, “Design of an Dynamic
External Finger Fixator,” Under review by Medical Devices Journal.
228
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DESIGN AND DEVELOPMENT OF A MEDICAL DEVICE FOR

TREATMENT OF PROXIMAL INTERPHALANGEAL JOINT

MAY MAHMOUD AHMED ABDO YOUSSEF

School of Mechanical Engineering

This unpublished thesis/dissertation is copyright of the author and/or third

Any use made of information contained in this thesis/dissertation must be in

to present a new design device for the digit PIP joint.

fractographs confirm that failure was by brittle fatigue.

achieved what I have.

experimental aspects of this thesis possible.

your unconditional love, strength, kindness and never giving up.

support that made this research work possible.

LIST OF FIGURES ...........................................................................................................vii

LIST OF TABLES ............................................................................................................xiii

2.1 Chapter overview ................................................................................................... 5

3 ENGINEERING ANALYSIS OF A FAILED COMPASS HINGE ...................... 46

3.1 Chapter overview ................................................................................................. 46

4 NEW DEVICE DESIGN ........................................................................................... 78

4.1 Chapter overview ................................................................................................. 78

CHAPTER 5 ..................................................................................................................... 143

5 ENGINEERING ANALYSIS OF THE NEW DEVICE DESIGN ...................... 144

5.1 Chapter overview ............................................................................................... 144

CHAPTER 6 ..................................................................................................................... 180

6 OVERALL DISCUSSION AND CONCLUSIONS .............................................. 181

6.1 Chapter overview ............................................................................................... 181

APPENDICES .................................................................................................................. 198

Appendix A ....................................................................................................................... 199

Appendix B ....................................................................................................................... 201

Appendix D ....................................................................................................................... 225

Appendix E ....................................................................................................................... 226

Appendix F ....................................................................................................................... 228

Figure 2-4. Grades of Dupuytren’s disease (Murphey et al., 2009). .................................. 18

Figure 2-12. A Digit Widget device (Slater et al., 2003). .................................................. 27

Figure 2-17. Verona device (Citron and Messina, 1998).................................................... 32

Figure 2-20. Multiplanar distractor (Kasabian et al., 1998). .............................................. 34

Figure 3-1. Compass hinge external fixator. ....................................................................... 47

Figure 3-6. Compass hinge disassembled components....................................................... 56

Figure 3-20. Emscope SC500 sputter coater....................................................................... 69

Figure 3-22. Joel JSM-6060 LV microscope with computer. ............................................. 70

Figure 4-16. 3D design of concept selection 2, idea2. ...................................................... 101

Figure 4-21. 3D design of the distal protractor part.......................................................... 109

Figure 4-25. The gear involute (Buckingham, 1949). ...................................................... 116

Figure 4-28. 3D design of the worm wheel part. .............................................................. 121

Figure 4-29. Drawing of the worm wheel part. ................................................................ 122

Figure 4-30. 3D design of the worm gear part. ................................................................. 123

Figure 4-31. Engineering drawing of the worm part. ....................................................... 124

Figure 4-32. 3D design of the rod part. ............................................................................. 125

Figure 4-33. Drawing of the rod part. ............................................................................... 126

Figure 4-34. 3D design of the solid clamping blocks. ...................................................... 128

Figure 4-35. 3D design of the slotted clamping blocks. ................................................... 128

Figure 4-40. Drawing of the nut 2 part. ............................................................................ 133

Figure 4-41. The screw. .................................................................................................... 134

Figure 4-42. Drawing of the screw. .................................................................................. 135

Figure 4-45. Drawing of the jig. ....................................................................................... 138

Figure 5-10. Worm and worm wheel teeth meshing......................................................... 167

Figure 5-15. The designed mechanical test rig. ............................................................... 172

Table 2-1. Finger couplings and grip strength summary. ................................................... 10

Table 2-2. Pulp pinch strength average maximum (N) ....................................................... 11