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Table of Contents Boudewijn Wisse - The Universal Prosthesis - Appedixes

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Contents
A Design for All Summary__________________________________ 2
B Internship Summary_______________________________________ 3
C Project Timeline__________________________________________ 4
D Socket Designs Timeline___________________________________ 5
E History of Prosthetics_ __________________________________ 6
F Calculations on Prevelance_ ______________________________7
G Residual Limb Dimensions_________________________________ 8
H Customer Organizations and Resources__________________ 10
I Producers of Components________________________________ 12
K Available Feet___________________________________________ 14
L Connective Components & Pylons_______________________ 15
N ICEX Manual___________________________________________ 16
Q Idea Sketches_____________________________________________17
R Frame Overlays - 1 to 12_______________________________ 25
S Mechanical Analysis - FBD&FEM_______________________ 37
T Total Concept Presentation_ ____________________________ 39
U Fitting Procedure________________________________________ 40
V Price Estimation_________________________________________ 41
X J. Foort - Innovation in Prosthetics_ ____________________ 44
Y Comparison Table________________________________________ 56
Z Technical Drawing of the Frame_________________________ 57
 A Design for All Summary Boudewijn Wisse - The Universal Prosthesis - Appedixes
A
Prosthesis for Tibial Amputees focused on the 3rd World
2002 - TU Delft

By : Boudewijn Wisse, Wouter van Dorsser, Farshad Soleymani

Summary:
For the subject ‘Design for All’ at The Faculty of Industrial Design Engineering
of Delft University of Technology in The Netherlands we designed a prosthesis
for mine victims in Sri Lanka.

After thoroughly doing different analyses, like a medical analysis for

which we made two visits to orthopedic specialists in the Dijkzigt hospital
in Rotterdam, a social analysis and an analysis of existing prostheses, we
could make a list of the most important requirements for our design of the
prosthesis.

We have developed one concept for the prosthesis foot (Rocker foot) and 3
concepts for the socket of the prosthesis (Leather concept, Polymer concept
and a Redesign of a concept which was made years ago by another Industrial
Designer Inne ten Have). The three concepts will be discussed with our
teacher Johan Molenbroek and two specialists Henk Kooistra and Inne ten
Have whom are connected to this project, to eventually choose / combine the
best solutions.

O ur design philosophy is that our design will be made at a prosthetic

workshop in Sri Lanka, by the local prosthetists using local means. The
prosthesis is standardized and has a ‘Western look’ to it and the owner of
the prosthesis can manage to use this design for the rest of his life. The
design of our prosthesis is self explaining. The owner or his/ her supervisors
can easily figure out how the prosthesis is made and if necessary they can
repair or adjust the prosthesis themselves.
 B Internship Summary Boudewijn Wisse - The Universal Prosthesis - Appedixes
B
The alternative prosthesis
2002 - Sri Lanka, Colombo

2003 - TU Delft, The Netherlands

By: Boudewijn Wisse, Wouter van Dorsser

Summary:
These are the results of a project in which a new concept for prostheses for
the trans-tibial (below-knee) amputees of Sri Lanka was developed.

Although civilian landmine victims are a minor cause, Sri Lanka copes with
a shortage of care for amputees. The lack of prosthetists is the bottleneck,
resulting in a low production capacity of prostheses and little aftercare.

Other problems include: Price, locating amputees, difficulties distributing

prostheses and the long time needed to fit, produce and adjust prostheses.

Research trails and prototypes strongly suggest that the situation could
be improved with an alternative for trans-tibial prostheses, in this report
presented as the “DFU” (Designed For You)..

Though the design philosophy is very strong, the actual design is not
optimised and could still be altered. Therefore this project needs to be
continued, so the design will be implemented and much more trans-tibial
amputees can be helped.

Not only trans-tibial amputees will benefit in such a way. The freed
production capacity can then be used to produce above knee prostheses or
otheses.
 F Calculations on Prevelance Boudewijn Wisse - The Universal Prosthesis - Appedixes
F
The following data is collected from the World Health Organisation (WHO). 1 2 3 4 5
Total Amputated % of pop. % of all
Columns: Population Arm
1. Area or criterion Africa 655.477.000 1.041.000 0,1588 19
2. Total amount of persons in that area America’s 837.966.000 662.000 0,0790 12
3. Total amount of amputees in that area Europe 874.178.000 614.000 0,0702 11
4. Total amount of amputees divided by the total amount of persons = the SE Asia’s 1.559.810.000 1.692.000 0,1085 30
percentage of that area which has an amputation
Western Pacific 1.701.689.000 899 0,0001 16
5. Total amount of amputees of the area divided by the total amount of amputees
of the world = percentage of world figure of amputees living in that area. Eastern 493.091.000 644 0,0001 12
Mediterranean
Males 3.083.884.000 3.623.000 0,1175 65
1 2 3 4 5
Females 3.038.327.000 1.930.000 0,0635 35
Total Population Amputated % of pop. % of all
TOTAL 6.122.211.000 5.552.000 0,0907
Foot/leg
Africa 655.477.000 3.235.000 0,4935 22 Table “F-2: Figures about the estimated amount of arm amputees by point
America’s 837.966.000 1.115.000 0,1331 7 prevalence according to the World Health Organisation.
Europe 874.178.000 1.416.000 0,1620 9
SE Asia’s 1.559.810.000 5.769.000 0,3699 39
Western Pacific 1.701.689.000 1.591.000 0,0935 11
Our own data [The Alternative Prosthesis, Appendix B.2] suggests 65% of
Eastern 493.091.000 1.833.000 0,3717 12 the amputations being transtibial in developing countries. The following
Mediterranean picture from internet (source unkown) indicates 55% transtibial amputations
Males 3.083.884.000 8.025.000 0,2602 54 in Western countries.
Females 3.038.327.000 6.934.000 0,2282 46
TOTAL 6.122.211.000 14.959.000 0,2443 100

Table F-1: Figures about the estimated amount of foot or leg amputees by point
prevalence according to the World Health Organisation
 G Residual Limb Dimensions Boudewijn Wisse - The Universal Prosthesis - Appedixes
G
Statistics Length
The following data is derived from population patient cards studied in Sri M easurements of below knee stump lengths. Important data, derived from
Lanka [source: Report – appendix B.2 and data files]. 139 patient cards in Sri Lanka:
stump Foot Leg P.T.
lengths sizes length circumference
(mm) (Jaipur) (mm) (mm)
Mean 166 7,56 433,9 304
Standard 4,4 0,08 11,5 2,77
Error
Median 160 7 45 305
Mode 140 7 45 320
Standard 52 0,88 53 28,7
Deviation
Minimum 0 6 325 155
Maximum 381 9 500 368
Sum 2312,145 885 91122 32623
Population (n) 139 117 21 107
P5 166 - 1,65 X 6,1 (6) 345 258
52=80
P95 166 + 1,65 X 9,0 (9) 520 352
52=250
In Western countries we may expect some less variation because of better
standardized procedures in the hospitals. Maybe the mean length is a little
higher because of a longer mean total body length. Notice that the P5 is equal
to the minimal length due to biomechanical considerations [see section 3.1.2].
A P5 to P95 tibial length seems acceptable.
 Boudewijn Wisse - The Universal Prosthesis - Appedixes
G
Foot sizes Circumferences
Feet are applied to the prosthesis in several sizes, varying from 6 to 10 with From the same data circumferences where obtained at several distances
half a steps in between (6, 6½, 7, etc). The need for several foot sizes needs to from the patellar tendon. This data adds up to the following figure:
be considered while discussing the distribution of the universal prosthesis.

In this figure it becomes clear that circumferences vary much less around
the patter tendon than about 160 mm below it. Also note that almost half of
the amputees have their stumps ending at this level.
 H Customer Organizations and Resources Boudewijn Wisse - The Universal Prosthesis - Appedixes
H
Organizations NL - VRIN Landelijke samenwerkingsverband van
revalidatie-instellingen
3rd W - Adopt-A- Raising awareness and funds to clear landmines NL - VRA Nederlandse Vereniging van Revalidatie Artsen,
Minefield and help survivors website met veel resources.
3th W - POF Prosthetics Outreach Foundation UK - BAPO British Association of Prosthetists and Orthotists
International - CIR The CIR is a worldwide humanitarian network of UK - Limbless Information for Amputees in the UK
individuals and organizations that promote the Association
full potential of people with disabilities through USA - ACA Amputee Coalition of America
education, innovation, and advocacy. USA - amputee-online. Resource and forum for amputees
International - IAOP International Association of Orthotics & com
Prosthetics USA - AOPA American Orthotic & Prosthetic Association
International - Interbor International dome association of national O&P USA - ISPO United States Member Society of the International
trade associations Society for Prosthetics and Orthotics
International – IPRLS International Institute for Prosthetic USA - NAAOP US National Association for the Advancement of
Rehabilitation of Landmine Survivors is a Tufts- Orthotics and Prosthetics
affiliated non-profit organization, which strives
to help landmine survivors to regain the quality USA – NARIC US National Rehabilitation Information Center.
of life. Also developers of the Rolling Joint Ankle USA - NRAF US National rehabilitation awareness foundation
aka Free-flow foot. USA - OPAF Orthotic and Prosthetic Assistance Fund
International - ISPO International Society for Prosthetics and USA – U.S. DVA US Government - Department of Veterans Affairs
Orthotics
USA - UASA United Amputee Services Association
NL - CVZ Het College voor zorgverzekeringen (CVZ)
coördineert en financiert de uitvoering van de
Ziekenfondswet en de Algemene Wet Bijzondere
Ziektekosten (AWBZ).
NL – I-S-P-O ISPO Nederland is de Nederlandse vereniging
van de International Society for Prosthetics and
Orthotics
NL - LVvG Landelijke Vereniging van Geamputeerden
NL - NPI Het Nederlands Paramedisch Instituut is het
paramedisch kenniscentrum in Nederland
en voor alle paramedische beroepen actief
op de volgende drie terreinen: Documentaire
informatievoorziening, Onderzoek &
ontwikkeling, Deskundigheidsbevordering.
 Boudewijn Wisse - The Universal Prosthesis - Appedixes
H
Web-resources and Journals Important Prosthetic Workshops and revalidation centres in the
netherlands
International - oandp. The leading Internet information resource for
com - the global professionals and consumers with an interest in the
resource for Orthotics orthotics and prosthetics field. Also publishes the
& Prosthetics Journal of Prosthetics & Orthotics. LIVIT Region Den Haag
information. Jongenengel
NL - Orthobode Orthobode is een tijdschrift dat informatie en opinie Roessingh Twente
biedt over ontwikkelingen in de orthopedische
OIM Groep North of Netherlands
branche.
Sophia Revalidatie Den Haag
International - CIRRIE The database from the Center for International
database (2) Rehabilitation Research Information and Exchange.
Contains only research conducted OUTSIDE of the
US Design and Research in Prosthetics in the Netherlands
POI Prosthetics and Orthotics International
Physical Medicine and Official Journal of the American Congress of
Rehabilitation Rehabilitation Medicine and the American Academy Movi Bewegingstechnologisch ontwerpbureau
of Physical Medicine and Rehabilitation [Elsevier /
WB Saunders], also see Science Direct database
TU Delft Library Electronic Journals available on multiple subjects
AbleDATA ABLEDATA provides objective information on
assistive technology and rehabilitation equipment
available from domestic and international sources
to consumers, organizations, professionals, and
caregivers within the United States.
REHAB-Data From NARIC. Contains only research conducted
INSIDE of the US
 I Producers of Components Boudewijn Wisse - The Universal Prosthesis - Appedixes
I
Most important for the project / big players: Medium importance

Bauerfeind.nl www.bauerfeind.nl, Components and accessory Airlimb www.medwing.com Air-limb, inflatable IPOP
www.bauerfeind.de, Ambroise www.ambroise.n The Wilmer and UTX
www.bauerfeind.co.uk, [Enschede] orthoses
www.bauerfeindusa.com
Amputee www.amputee-center. Pump-It-UP! Socket
Blatchford www.blatchford.co.uk, Endolite (ESK knee, DR2 foot, treatment center com
(Endolite) www.endolite.com Mercury foot, Multiflex, SACH,
ATF) Atlas International www.atlasortho.com Components and materials

Fillauer www.fillauer.com Durashock pylon, EAS Alignment Basko www.basko.com Silicone-kits and components.
systems, 3S, Hosmer, [Amsterdam,
international]
Hanger www.hanger.com ComfortFlex, springlite
Orthopedics Cascade www.cascade-usa.com Components and materials
Group Flo-Tech Orthotics www.1800flo-tech.com APOPPS (Adjustable
Kingsley www.kingsleymfg.com SACH (strider) foot, Steplite, B.O.A. and Prosthetics. Postoperative, Protective and
Alignable BK System - (Built- Preparatory System)
In-One Point Alignment), Also Orthomedics www.orthomedics.com Prefabricated Adjustable AK
distributor, etc [currently not working] Socket, Redi-Lite
Ortho Europe www.ortho-europe.com, Ohio Willow Wood (import), Alpha Simbex www.simbex.com Active Contact System (fluid
[Utrecht] / www.owwco.com Liners, pump) IC-110
Ohio Willow USMC www.usmc.com Components
Wood [currently not working]
Össur Total www.ossur.com Flex-Foot, Icelock, Iceross, Mauch,
Solutions The Pin, Total Concept, Total Knee,
Total Shock, Ices
Otto-Bock www.ottobock.de, www. Components (C-Leg, Harmony,
Healthcare ottobockus.com Springlite feet) and materials
Seattle www.seattlesystems. Seattle Foot, Voyager Foot/ankle
Systems com
Streifeneder www.streifeneder.de, Components, materials
www.eurointl.com
 Boudewijn Wisse - The Universal Prosthesis - Appedixes
I
Less important: No information about: Alblas, Tehlin, Nordic, O&P Enterprises Inc,
Remarks:
Acor Prosthetic cones, materials
Freedom-Innovations Sports feet and liners
AEGIS Liners, sleeves, locks Orthotic/Prosthetic Laboratories acquired by Otto-bock.
Jim Smith Sales Distributor
ALPS South Corp. Euro International represents FG Streifener, but offers also some other
products.
Knit-Rite Prosthetic Socks
American Plastics materials Hosmer & Centri are Fillauer companies.
MICA Genesis II foot series, Evolution foot
American Prosthetic Components APCI, components Resources at: http://www.oandp.com/, http://www.oandpbiznews.com/, and
Inc obtained from LIVIT Den Haag, obtained from literature.
Practitioner’s Support Laboratory Fabrication techniques/support
Aulie Prosthetic Devices water sports components This results in a slightly America orientated list of companies.
Prosthetic Research Specialists Shrinkable U-Fleet Skin Sleeves
Bolt Systems Inc liners
Rampro Activankle and Swimankle Sports components
College Park Industries CPI, TruStep foot, TruPer foot
Royal-knit Socks
Coyote Design locks, liners, materials, integrators
RX textiles Materials
ESP (Engineered Silicone Products) liners, valves
Silipos Gel liners
Engineered Silicone Products (ESP)
Victhom Human bionics
Fabtech Systems materials
Farablock Fanthom pain relief
Ferrier Coupler Inc couplers
ForeSee Orthopedic Products 4C: Custom, Carbon, Composite,
Creation components
N ICEX Manual - 1 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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N ICEX Manual - 2 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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N ICEX Manual - 3 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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N ICEX Manual - 4 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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N ICEX Manual - 5 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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N ICEX Manual - 5 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(1) - How can you adjust the size (length and circumference) of a socket/cyclinder?

Fold Multilink WC-roll (rotate Insert piece Like a poster Fill (foam or Inflate or fill Distal end cup
and pull) (roll) coating)

Make ellips with Diaphragm Flower principle Bend inwards or Roll Roll (length) Harmonica Bamboo Patellar tendon
belts outwards (circumference) (straw principle) flap
(2) - Or a pylon?

Bolt Telescope Screw it Bend/Stretch Saw it Add length two plates _ two plates_ rotate and move
(perpendicular) (parallel) up
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(3) - How to make a frame (that can carry the body weight) deformable?

Pivots and locks two shells Increase Deformation Ti-rap - Ski-Shoe Self-locking
(detach, deform, deformation only one way lock force
(4) - How to attach a deformable part to a rigid skeletal frame?

Melt

Weld

Glue Dip and coat Plait / Weave Add bag Wrap Inject
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(5) How to align a loadable frame/pylon?

Bend Movement in _ Pivots Standard Slide Standard Pivot Shorten one side Two cut
horizontal plane solution cylinders

Clasp with Angle by lever Multi holes Angle by _ Multi Angle cube
screws deformation
(6) How can one prosthesis make total contact with a wide range of different shaped residual limbs? How can a tight fit be assured?

Suck / vacuum Follow (De)form soft _ Inflate/fill

tissues
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(7) - How to improve weightbearing properties and pressure destribution of the socket?

Partly loaded Turn to increase Distal End gel Extra dampening Multi 4-bar
distal end pad stiffness pad mechanisms

Force redirect _ Force analysis Tensile strap _ 4 bar Vertical

with pulleys with pylon in (front to back) mechanism dampening
(8) - How can the fitting and alignment procedure become easier? How to communicate the angle?
High feedback
Make the Simplify speed During the fit
Incorporate procedure the patient can Talk
Less steps
use-cues Adjust the
For length and Fit, production fitting
for angle and alignment

Standerdize the Use easy

actions to identify
Always 5 Knee-hight
degree flexion while sitting
3D compensated
view
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(9) - How can a tight fit of the socket be accented during load (stance) and a comfortable fit during rest (sitting, swing-phase)?

Change load_ Tranfer forces Remove _ Strangle-fitting Leave space

area’s compensation (worg-fitting)
(10) - How to improve vertical dampening while keeping control and direct sensory feedback during use?

Dampening as Restricted _ System only

low as possible dampening reacts to high
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(11) - How to don and dof prosthesis?

Fix it with a _ Roll (condom/_ Klick Shove Tie Wrap Deform/bend Zip it Use Belts
elastic ring liner principle)
(12) - How to don and dof a prosthesis when the patient has a bulbous residual limb shape?

Two parts Stay below_ Bend/Deform Screw last part

tangents
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(13) - How to increase weight bearing properties of bendable pylon?

attach surface Attach surface Rotate

below (1) above perpendicular to
(14) - Principles for the pylon:

Basic shapes Below (standard) Front Side Back (incl. 4 bar

mechanism)
 Q Idea Sketches Boudewijn Wisse - The Universal Prosthesis - Appedixes
Q
(15) - How does the soft part contribute to the stiffness of the whole?

Fill Harden it
Add tensile
force
Make it elastic
Add springs

see

(16) - How to make a deformable socket solid/force resistent within 10 minutes?

Freeze it Remove Inflate

something
Remove Add pressure
Warm it, then compensation
cool it Add something
UV (light)- _ Fill Wrap it
trigger Electro- trigger Lock it
Concrete Glue
Chemical Deform it
reaction Epoxy / Resins
Thermal- _ Screw tight
Chemical- _ Deform forces
trigger trigger Burn it! much bigger Increase
tension_

(17) - How to integrate a suspension system and connective components in the universal prosthesis?

Condyle part Knee cuff Suction bag Multi pylon ends

R Frame Overlay - 1 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

The leg and the knee; impressions of the

view from outside. Also the common pero-
neal nerve is shown. If the peroneal nerve is
damaged, the patient will suffer from drop-
foot. For the amputee, damage and pressure
on the peroneal nerve can result in pain and
dis-comfort.

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 2 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

Impressions of the muscles and some bones.

The big muscles such as the gastronemicus
are pressure tolerant. Muscle-bone conbina-
tion is especially presure tolerant, such as the
borders of the tibia (where the muscle over-
laps the tibia. The tibial crest, without mus-
cle protection is very sensitive. The patellar
tendon is very pressure tolerant.

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 3 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

The bones in the (residual) limb can transfer

load best. however, in amputees, the distal
end of the bone is very sensitive. Distal load-
ing is therefore not recommanded. Because
the gatrocnemicus (kuitspier) takes a lot of
space, it will easily deform while loaded (no
bones to transer the load to!)

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 4 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

Sensitivity and pressure tolerance:

Summarizing, the (residual) limb is
extremely pressure tolerant in the blue area’s,
tolerant in the green area’s,
neutral in the yellow area’s,
sensity in the orange area’s and
pressure intolerant in the red area’s

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 5 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

352 mm

circumferences
304 mm
258 mm

80 mm
166 mm
mean total leg lenght 434 mm

250 mm

Impressions of different residual limb sizes:

black P05 circumference and P05 length.
green P50 circumference and P50 length.
orange P95 circumference and P95 length.
underlay: Pressure sensitivity ± 15%

Variation in length is much bigger (mean ±

50% for P5 & P95) than in circumference
(mean ± 15%).
Note: Residual limb shapes can differ from
shown.

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 6 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

1 1

1 1

2 3 4 2 4

surface max pressure area

green 230 + 30 kPa 700 mm2
blue 1+2+3 60 + 30 kPa 6500 mm2
red 1 0 + 30 kPa 2700 mm2
+20 kPa is hydrostatic pressure after fabrica-
tion.

From the pressure tolerance of the differ-

ent residual limb area’s and the data about
the variance in length and circumference for
P5-P95, suitable area’s (blue) for the hard
parts of the universal prosthesis are selected.
Area’s to avoid pressure are shown in red.

Note: the area’s are selected on tissue proper-

ties and anatomy only, not on biomechanics.

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 7 Boudewijn Wisse - The Universal Prosthesis - Appedixes
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scale approx. 1 : 3.8
y-axis

x-axis

surface max F angle Fy Fxz

green 160 N 60 140 81
blue 1 60 N 18 20 57
blue 2 180 N 19 60 170
blue 3 150 N 14 35 146
blue 4 570 N 20 195 536

Force vectors should be normal to the tis-
sue/skin and can be devided in a Fx, Fy, Fz
component. Free Body Diagrams per plane
are shown. Forces for hard parts only, so with
-30 kPa per area for hydrostatic pressures.
Hydrostatic pressure over the total area of the
residual limb (green border line) of 30 kPA
Total Fx when all blue&green surfaces are
will result in an additional upwards force of
used at maximum pressure is 450N, which is
about 310 N.
50% of the body weight of an 90 kg (heavy)
user. Optimal use for all blue and green sur-
Warning: as shown above, the FBD is not in
faces is needed for hard socket parts.
equilibrium in plane x and z!

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 8 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

Blue : Pressure area’s

(medium stiffness)

These area’s transfer the highest loads to the

risidual limb.

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

R Frame Overlay - 9 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

Hard socket:

Blue : Pressure area’s

(medium stiffness)
Red: Connective part of hard socket
(high stiffness)
Green: Connective but movable part
(high tensile strength)

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

 R Frame Overlay - 10 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8
Velcro with
big area The connective textile
Dubble layer to the other part is
glass fiber in integrated in one frame
between the and attached with Velcro
frame parts on the other.

A tighening The strip is

mechanism to completely
increase tensile Long, thin
fastened to the
forces when extentions of the
frame parts on
needed during the interface frame
this side
fitting procedure. (blue) help to
shape the final
prosthesis and
to support the
residual limb.

In height adjustable. If
needed the extruding
frame parts can be sawn
and discarded.

The connective component is

empty inside. It is not round, but
elliptical to transfer torque

The connection with the foot is

compatible with standard foot
components. Complete design of the hard socket and con-
nective components.
anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)
R Frame Overlay - 11 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
R Frame Overlay - 12 Boudewijn Wisse - The Universal Prosthesis - Appedixes
R
scale approx. 1 : 3.8

anterior (frontal plane) lateral (saggital plane) posterior (frontal plane)

 S Mechanical Analysis - FBD Boudewijn Wisse - The Universal Prosthesis - Appedixes
S
Niet op schaal
BODY
40 40

400 N

400 N

1030 N 400 N 1030 N 400 N

PT
70

400 N
1030 N 1030 N
MP
70

630 N 630 N
END
260

Fixed CONNECTOR Fixed

(72 Nm) (88 Nm)

Static Analysis that will be used for the FEM-analyssis. First the FBD of the residual limb is drawn (middle). The situation is simplified to 100% Patellar Tendon
Bearing of (half of the) body weight (80 KG). The needed bulge inclination (see figure 3-9) varies between 45 and 60 degrees, of which the first statically
results in higher forces and is used in the calculations. The 400 N (BODY) which needs to be beared results in two 400 N components at the PT. The resulting
moment and translational forces are compensated at Mid-Posterior (MP) and the distal END. All these forces (expect the body weight) are applied on the
risidual limb by the frame parts (left: posterior, right: anterior). The frame parts are fixed in the connector which for the FEM-analysis can be taken as fixed in
space.
 S Mechanical Analysis - FEM Boudewijn Wisse - The Universal Prosthesis - Appedixes
S

Deformation map

Side view of load Back view of load 3D-view of load Displacement overlays

The loads from the FBM are transfered to: Strain map
Place of act load name height colour
the most proximal edge of the model the PT-load at PT=0 in yellow
the two end vertexes of the proximal edge the band-pull at PT=0 in dark green
A intersection curve the distal end load at PT=140 in purple
Start of straight frame shape constraint at PT=260 in light green

In general, we can see that:

- Under the load presented here the shape stays roughly the same,
- The pattellar tendon dent (edge) wants to press harder in the residual limb (the depicted displacement cannot occur during use,
because then the knee/ PT is “in the way”).
- Before production, the frame shape has to be optimized to reduce stresses in the material, especially more distally. Stress map
U Fitting Procedure Boudewijn Wisse - The Universal Prosthesis - Appedixes
U
1 2 3 6
5

7 6 17
18

10 12
9

14
16
13 15
11
8
 V Price Estimation Boudewijn Wisse - The Universal Prosthesis - Appedixes
V
Rough price estimation. All prices in Euro’s. The machining, assembly, etc is calculated from man/machine hour prices. This keeps the chose of producting in own facilities
or out-sourced open.

Amount of kits: 1000,00 10000,00 Comment

Produced parts: Pieces Material Production Price per Material Production Price per
costs tools piece costs tools piece
Interface frame L 1000 1,25 4000,00 5,25 10000 1,25 8000,00 2,05 20 out of 1 m2, ABS
Ant+Post
Interface frame R 1000 1,25 4000,00 5,25 10000 1,25 8000,00 2,05 20 out of 1 m2, ABS
Ant+Post
Weight-bearing 1000 1,75 4000,00 5,75 10000 1,75 6000,00 2,35 20 out of 1 m2, Hylite
frame L Ant+Post
Weight-bearing 1000 1,75 4000,00 5,75 10000 1,75 6000,00 2,35 20 out of 1 m2, Hylite
frame R Ant+ Post
Liner inside 1000 0,15 6000,00 6,15 10000 0,15 6000,00 0,75 3E/kg raw material, The
inside and the outside are
extruded together
Liner outside 1000 0,15 1,00 0,15 10000 0,15 1,00 0,15 3E/kg raw material
Pad 1000 0,30 2000,00 2,30 10000 0,30 2000,00 0,50 6E/kg raw material
Connector L 500 2,78 90,00 2,96 5000 1,99 90,00 2,01
Connector R 500 2,78 91,00 2,96 5000 1,99 91,00 2,01
Inner Seal L 1000 0,15 3000,00 3,15 10000 0,15 3000,00 0,45
Inners Seal R 1000 0,15 3000,00 3,15 10000 0,15 3000,00 0,45
V Price Estimation Boudewijn Wisse - The Universal Prosthesis - Appedixes
V
Machinecosts: Cost per Amount per Cost per Amount
hour hour hour per hour
cut+draw 4000 150,00 240,00 0,63 150,00 480,00 0,31 Cutting and deepdrawing or
injection moulding
Double extruder 1000 1500,00 2000,00 0,75 500,00 2000,00 0,25
Cutting 1000 100,00 600,00 0,17 100,00 600,00 0,17
Welding 1000 100,00 240,00 0,42 100,00 240,00 0,42
Moulding (pad) 1000 100,00 240,00 0,42 100,00 240,00 0,42
cut+draw 1000 150,00 20,00 7,50 150,00 30,00 5,00 CNC machining.
moulding 1000 100,00 360,00 0,28 100,00 360,00 0,28

Bought in : Pieces Price per Price per

piece piece
Screws 6000 0,01 60000 0,01
Straws 3000 0,01 30000 0,01
Minivalve 1000 1,50 10000 1,00
Outer Seal (elastic 1000 0,10 10000 0,08
band)
Pyramid 1000 0,50 10000 0,50
connection core
Spray with foam 1000 12,00 10000 10,00
Special nozzle 1000 2,00 10000 0,50
Velcro 1000 0,03 10000 0,03
Kit extra’s
Paper box 1000 4,00 10000 2,00
Manual 1 1000 4,00 10000 2,00
Manual 2 1000 4,00 10000 2,00
Protective foam 1000 3,00 10000 2,00
Gel pads 4000 1,00 40000 0,80
Sock 1000 1,00 10000 1,00
V Price Estimation Boudewijn Wisse - The Universal Prosthesis - Appedixes
V
Assembly: Pieces Cost per Amount per Price per Pieces Cost per Amount Price per
hour hour piece hour per hour piece
1000 150,00 6,00 25,00 10000 150,00 15,00 10,00

Price overview:
material 54,05 24,73
machining 12,03 6,53
assembly 25,00 10,00
kit 20,00 12,20

Total price: 111,08 53,46

 X J. Foort - Innovation in Prosthetics
THE KNUD JANSEN LECTURE
COPENHAGEN 1986
Innovation in prosthetics and orthotics
J. FOORT
Medical Engineering Resource Unit, University of British Columbia
All correspondence to be addressed to Mr. J. Foort, Medical Engineering Resource
Unit, University of British Columbia, Shaughnessy Hospital, 4500 Oak Street,
Vancouver, B.C. V6H 3N1, Canada.
Introduction
As I look back over my 35 years in the field of prosthetics and orthotics
research, and consider those years from the point of view of the innovations I
have witnessed and participated in, certain insights and influences stand out.
They cluster around specific people and projects. Two years in Toronto with
Fred Hampton and Colin McLaurin led to the establishment of the Canadian
Plastic Syme’s Prosthesis, the Canadian Hip Disarticulation Prosthesis, plastic
reinforcement of wooden prostheses and conception of the SACH Foot.
The products of ten years at Berkeley with Chuck Radcliffe, Leigh Wilson,
Bill Hoskinson, Frank Todd, Jim McKinnon and others, included design of the
SACH Foot, the Quadrilateral above-knee (A.K.) socket, the Patellar Tendon
Bearing below-knee (B.K.) prosthesis; conception of socket standardization,
studies of prosthesis alignment and experiences with modular prosthetics.
Introduction of modular prosthetics to the clinic, development of the
electrical alignment unit, use of semiflexible sockets and work on standard
sockets and standard cosmetic restorations were experiences of my 8 years
in Winnipeg with lan Cochrane, Doug Hobson and Reinhard Daher.
Invention of Shapeable Matrices, development of Tubular orthotics,
development of Computer Aided Socket Design and design of the valgus
varus resist knee orthosis are milestones of my Vancouver experiences with
Boudewijn Wisse - The Universal Prosthesis - Appedixes
X
colleagues Steve Cousins, Richard Hannah, David Cooper, Carl Saunders and
Margaret Bannon over the past 15 years.
I have appreciated experiences in projects outside my work environment
too. The most recent was the cooperation that developed around Computer
Aided Socket Design and Computer Aided Manufacturing between the group
at UBC and the groups at University College London and West Park Research,
Toronto. I am pleased that cooperation is being extended by new initiatives
developing between the original groups and others. I speak of these things
to convey to you the team basis for developments and the positive effect
cooperation between people has on advances in our field.
Those of us who have worked together on various projects functioned best
when we recognized and used each others qualities. Among the qualities I
am thinking of are drive, curiosity, imagination, persistence, patience, trust,
confidence and the ability to share.
To keep sweet reasonableness alive between people, participants have had
to review their motives and consider the needs of their associates. How these
associates functioned varied.
Some were definite and decisive. Some pondered things over and came to
considered views. Some were very competent at the things they were trained
to do. Some inspired new ideas on how to solve the problems we worked on.
Some were able to take risks easily.
Assertiveness born of clarity of view could sometimes be mistaken for
arrogance.
While human relations are never without their problems, all of these people
enlarged my capabilities and enriched my work life.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
There have been things I loved doing. Other things I have compelled myself
to do. My attachment has been to what I believe were keystone projects,
projects that had the potential to generate multiple solutions. Inaddition, they
were projects that suited my natural rhythms, abilities and needs, and were
championed by colleagues who could fill the gaps in my own abilities. For the
most part, the means used to solve problems were traditional engineering
coupled to vigorous artisanship. A great deal of self education was involved.
Now we are at a new intersection of events. Many of the problems have
been defined but new means for problem solving are at hand. Although
engineering and artisan skills are still required, there is a need to reassess
our methods in light of the new means so that smooth and effective advances
can be made. Re-education and new education are involved. Factors affecting
innovation, on the other hand, will not change. Some already alluded to are:
1. A suitable field for inventing.
2. Colleagues who cooperate, lead and support.
3. A mix of skills and temperaments in the team.
4. People willing to take risks.
5. An environment conducive to study and experimentation.
6. A speculative attitude.
7. Tools and techniques for problem solving.
8. A willingness to reassess methods and means periodically.
9. Appreciation of accumulated skills and knowledge.
In order to develop the theme of innovation in prosthetics and orthotics, I
will use a review of the problem of shaping structures that fit against the
body for control of forces and movements. Although the emphasis will be
prosthetic, the problem is common to both prosthetics and orthotics.
I have organized the presentation around eight propositions which have
a bearing on shape management. Factors I have observed as conducive to
innovation are interspersed among them.
First proposition: Tissue density is non-homogeneous (1955)
X
Clinical studies of the quadrilateral socket for trans femoral amputees taught
us that the residuum cannot be treated as a homogeneous mass. I believe
that an examination of derivation of this proposition in relation to design of
the quadrilateral socket will help us to identify some factors associated with
innovation and indicate the need for further innovation.
The quadrilateral socket
The quadrilateral socket for AK amputees was brought to the Biomechanics
Laboratory, University of California, USA from Germany by Eberhart and
his team in 1949. It was assumed to be a suitable solution to prosthetic
socket design for the above-knee amputee. The plan was to examine its
characteristics and to test it clinically at the Laboratory. It was studied
throughout the 1950s for rational factors that could” help to define
it. Simultaneously, suction suspension was used, a factor that imposed
greater demands on socket design, thereby highlighting problems with the
quadrilateral socket.
Difficulties: _
Common difficulties encountered included (a) cysts on the residual limbs
in areas contacting the medial and anterior brims; (b) formation of horny
nodules, or keratin plugs in the ischialgluteal weight-bearing regions and (c)
distal residuum oedema.
Shear forces on tissues where they extended over socket edges were
identified as contributing to cyst formation. Oedema was due to proximal
wedging effects and to insufficient support of distal tissues. Nodules, or
keratin plugs, were traced to high compressive forces which drove small
corns inward, building them into pain-producing nail-like structures.
It was assumed by Radcliffe that if the ischium was stabilized on the seat
of the quadrilateral socket by means of more positive anterior forces, these
difficulties would be overcome. To achieve this, he proposed that soft tissues
over Scarpa’s Triangle be compressed more positively as compared to harder
muscular regions laterally. This led to the inward bulge over Scarpa’s Triangle
characteristic of present day quadrilateral sockets.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
The differential displacement of tissues to effect even loading on the front of
the residuum was a new idea that could be applied to any part of the body
for force transfer and movement control.
In order to convey the requirements, he depicted the concept in biomechanical
terms that practitioners might understand. Thereafterit became common
practice to illustrate biomechanical events in this way, encouraging a more
systematic analysis of fit and alignment. Innovative factors illustrated in this
include:
10. A person able to derive and champion a new concept.
11. Use of engineering principles for socket design.
12. Confident application of the hypothesized solution.
13. Using a clinical environment for testing it.
The solution helped to reduce the incidence of cysts, keratin plugs and
oedema when applied to clinical study amputees.
Practitioners trying to follow the clinical study procedures however, found
the information difficult to interpret because it was essentially descriptive.
Their difficulties were thought to be due to their failure to abide by the
principles. Measurements were made of successful and unsuccessful sockets
in order to identify differences that might be responsible. From these might
come a more definitive set of instructions for socket design. It was soon
apparent however that the dimensions being measured could be the same for
sockets that were obviously different. At the same time, successful sockets
were observed to appear very similar to one another. This led Bill Hoskinson
and I to speculate that it might be possible to standardize quadrilateral
sockets.
This is the next proposition:
X
Second proposition: Socket shapes can be standardized (1957)
Calculations based on hazy ideas and gross assumptions to test the
hypothesis that quadrilateral sockets could be standardized indicated that
it might require approximately 11,000 one piece AK sockets (5,500 for each
side of the body) to provide the range of sizes needed for a system that could
be used with no more than small shape adjustments.
At that time, with no computers, storage, selection and distribution would be
major problems in practical application.
To arrive at a more favourable format, the hypothetical socket was divided
into sections. Attention finally focussed on the brim area alone. If the brims
were one-piece, only 150 would be required for each side of the body. If all
four sides of each brim were adjustable, the number of brims required could
be reduced to 3 for each side of the body.
The innovative impulse in this can be seen to follow out of:
14. A problem in strong focus.
15. The search for objective data.
16. A willingness to make assumptions in the absence of facts.
17. A practical objective.
The results of this hypothesis included:
a) establishment of jigs for fitting quadrilateral sockets, notably the Berkeley
Adjustable Brims,
b) prefabricated temporary sockets,
c) adjustable sockets for the study of socket design parameters.
The jig fitting method facilitated acceptance of quadrilateral sockets by
making the design principles more obvious and the design methods more
simple.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
X
Factors that influenced acceptance of jig fitting methods included: Adjustable sockets constructed to study design parameters gave information
a) the desire for total contact sockets, which could be made easily by this method on sensitivity of residual limbs to changes in socket dimensions (1962). There
is a need to continue this work 5 in the light of what we now know and need
b) difficulties experienced in defining the quadrilateral socket shape,
to know.
c) the desire to substitute plastic laminates for wood in socket construction, a
feature of the brim fitting method.
The adjustable sockets were suggestive of socket modularization, but did not
In this we see how: lead to it. New fabrication techniques, an appreciation of the value of socket
flexibility as exemplified in the Icelandic Socket and modular shapes in
18. Converging ideas and overlapping experiences bring innovation to focus.
computer aided socket design systems may foster socket modularization.
19. Simplification of methods enhances acceptance.
Data for design could be derived from computer banked shapes and this
in turn could lead to the impedance matching of sockets to residual limbs
proposed by Ben Wilson and Eugene Murphy once the required data on
In spite of these meaningful consequences, the hypothesis on standardization tissue qualities is available.
received a hostile response in general. I doubt if many of you will appreciate
how heretical it was during the 1960s (and perhaps still is) to suggest
that sockets can be standardized. I remember sending a paper based on
Without objective data on tissue qualities to use in design work,
modularization will require that intelligent, workable assumptions be made.
standardization to an American journal approximately 20 years ago. The
Following out of that, however, adjustable modular sockets could help refine
provocative title was “Instant Prostheses for Thigh Level Amputees.” The
these assumptions and ultimately be the basis for defining tissue qualities.
editors reply was that there was no space for the article in the journal at the
Finally, with sufficient data available, standardization could be reconsidered.
time, and it could not be foreseen that there ever would be! My comment is
The computer would be used for shape storage and numerically controlled
this:
machines for production of the shapes.
20. Negative attitudes toward innovations can either hamper their development or
prolong their demise! I can add other innovation factors:
21. Advances may reduce the need for information, reduce its importance, or
facilitate its acquisition.
While I consider the proposition on socket standardization valid, it may be 22. New options precipitate new speculations.
that every successful shape will be computer banked and standardization 23. Oscillation between various options indicates that we have insufficient data.
will be bypassed. Banking all shapes overcomes obstacles to acceptance of
standardization which include:
a) the shape preferences and prejudices that people hold,
b) concern for the population that might be excluded from coverage (i.e. congenital
amputees),
c) the lack of objective data.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
So far, I have indicated how the North American version of the quadrilateral
socket evolved out of the original German design through clinical studies and
how these developments established propositions which I now summarize:
(1) Residual limb tissue density is variable.
(2) Socket shapes can be standardized An appreciation of the role of the skeletal
frame in determining the shape of the quadrilateral socket led to the third
proposition.
Third proposition: The bony frame is the basis for socket design
(1965)
For example, the triangle defined by the tendon of adductor longus, the
ischial tuberosity and the trochanter is the bony frame round which the
proximal shape of the AK socket is designed. Deviations from the triangular
shape come about because of the need to accommodate the tissue-muscle
masses adjacent to the sides of the triangle in a biomechanically compatible
way.
The facts of this are most clearly exemplified in sockets derived from hand
cast impressions. Lean residual limbs tend to give a shape that resembles
the plug fit type of socket. Heavily tissued residual limbs yield a more
quadrilateral shape.
This proposition explains deviations from stereotyped socket shapes for any
level of amputation. It can be taken into account in standardizing shapes and
in adapting standard shapes for shape customization in the computer. It is
relevant also in making biomechanical shapes from sensed topographical
data. It indicates:
a) why there are limitations in the Berkeley jig fitting method, which utilizes jigs of
a single standard form,
b) limitations of standard sockets currently used,
c) what might be done to improve the biomechanical result,
d) why computer aided socket design programs include means for customizing the
standard reference shape
e) why reference shape processing of bone geometry is significant for socket design
X
f) and why we need information on tissue qualities.
The patellar-tendon-bearing BK prosthesis
In my opinion, development of the PTB prosthesis is a good model for
this discussion of innovation in prosthetics and orthotics. I will stress the
process rather than design in order toemphasize the mechanism of study
and motivating factors involved.
Up until the late 1950’s at Berkeley, so much time and effort had gone into
development of AK prosthetics that there was an uneasy feeling that BK
prosthetics had been neglected.
To deal with this, Radcliffe called together a group of knowledgeable
practitioners and educators to lay out a plan of attack on BK prosthetics
with the researchers. It was agreed that in the studies the researchers would
systematize prosthesis design and the educators would disseminate the
information. They would also help format the information to be disseminated.
The Veterans Administration would require prosthetists to take the courses
as a condition for servicing VA clients.
This was a very potent format — one I would recommend for solving
other problems, one 1 wish was being followed in the development and
dissemination of CAD/CAM for prosthetics and orthotics.
No formal evaluation component was included. Each group made its
contribution. That which would normally be done by evaluators was done
directly by the prosthetists who applied the system. In retrospect, I would
say that it was a satisfactory way to do it. In fact, considering the rate at
which knowledge and means now develop, existing scenarios for evaluation
seem more like seaweed around the propeller than a jib full of wind.
I will make another comment. The fascination with statistics on the part of
our major funding agency, Health and Welfare Canada, is restricting Canadian
prosthetics and orthotics research. In Berkeley, and elsewhere where
innovations have advanced our field to a remarkable degree, the sample sizes
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
used in the studies were sub-statistical. Results leading to commitment to
adopt the PTB prosthesis rested on multiple fittings on no more than a dozen
amputees, each different in various ways.
The results were not expressed objectively so much as procedurally. We
knew that our methods were better than existing ones, a fact confirmed by
the rate of dissemination and application of the new information.
Competent judgement was substituted for evaluation — and I would add, at
no loss.
The PTB prosthesis was essentially assembled from information modules.
A modified form of the German practice of using the patellar tendon as a
weight-bearing surface introduced at the original workshop, was adopted.
Total contact was already acceptable at the research level in socket design
tor oedema control and was adopted for use in the BK system. At the same
time, Shindler’s technique for making Kemblo inserts to line sockets made of
hard blocked leather set in wood was adopted. Blocked leather and wood for
the socket were replaced by plastic laminates. The SACH foot, now entering
clinical application, was incorporated.
Simultaneously, Blevins was making prostheses which he suspended by
means of multiple socks with rubber buns stuffed between them and a knee
strap. Galdick in San Francisco was making BK prostheses suspended by
suction. Woodall was trying condylar suspension by 1962.
This gives you an idea of the many influences at work to give rise to the PTB
prosthesis and to stimulate innovation. Much of this information was present
in the field but unintegrated.
Summarizing,
24. Innovation is enhanced by coordinated efforts based on shared motives.
25. Informed judgement can be equivalent to evaluation.
26. Information density affects innovation.
27. Accomplishments in one area affect events in another.
X
28. Practical hypotheses are quickly accepted.
29. Accident also plays a part.
Alignment of trial prostheses at the biomechanics laboratory during
checkout of procedures outlined by the review group was done in two steps.
The socket-foot complex was aligned without the side joint and corset system
in place, and then, upon completion of dynamic alignment of the foot-socket
complex, the joint and corset system was added and aligned.
At that time, it was considered hazardous for an amputee to walk for
prolonged periods on a prosthesis without the corset and side joints in place
to protect the knee. No explanation was given as to why some people were
able to wear jointless Muley prostheses. When one of our test amputees
rebelled at having the corset-joint system added to his prosthesis following
successful trials without, the switch was made to what is now the PTB
below-knee prosthesis. Controversy surrounded the PTB initially. Concerns
remained that the knee would be damaged. Some critics said that only a few
people could be successful PTB users, the majority would require side joints
and corset.
Examination of the role of alignment on forces at the knee and application
of normal locomotion data led researchers to abandon the myth against
jointless prostheses and led to emphasizing the flexed knee gait as an
insurance against knee damage.
Factors pertinent to success of the PTB prosthesis seem to have been:
a) a better understanding of how to shape and construct a socket;
b) a better appreciation of the biomechanics of the prosthesis as exemplified by the
improved definition of alignment;
c) relating fundamental gait data to the practical situation;
d) the experiences of successful wearers of Muley prostheses,
e) development of the SACH foot;
f) a switch to new prosthesis construction methods;
g) significant simplification of the BK system.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
Factors favouring innovation were;
30. The existence of the “Muley” type of prosthesis.
31. Available fundamental information on locomotion.
32. An engineering-artisan approach to solving the problem.
33. Cooperative effort directed toward its implementation.
34. Including the amputees on the team.
35. Using accumulated information.
With regard to the last spur to innovation, I would comment that
technologists who are about to do fundamental design work for the
production of orthopaedic shoes using computer aided design methods would
be wise to take into account what the practitioners can teach them! Much
of the information that designers will need resides in the shoe lasts and
methods of measurement and last modification used by the practitioners.
Innovations spawned by development of the PTB prosthesis included the
air cushion socket, adjustable sockets, transparent sockets, adjustable spring
loaded end-bearing sockets, sockets fabricated directly on residual limbs,
foam-in-place end pads, suspension from the patellar and femoral condyles
and inflatable bladders in sockets.
36. New innovations spawn innovation of variants.
Modular prosthetics
During the 1960s, a major problem, and still a problem to quite an extent in
North American prosthetics, was the degree of immutability in prostheses.
When there were difficulties, the socket was usually the problem. To replace
the socket required major modifications to the prosthesis, even replacement
of the entire prosthesis.
In experimental modular-like prostheses however, the option for quick
exchange of components existed.
X
The need and the obvious solution led to the next proposition:
Fourth proposition: Modular structures optimize prosthetic
management (1955 — )
The modular-like designs in the research laboratories that foreshadowed
modern modular systems did not seem attractive to prosthetists; the
Northwestern University BK pylon with alignment and length adjustability
built-in and the University of California Polycentric Knee for above-knee
amputees are examples.
It was apparent that a comprehensive modular system that overcame
whatever obstacles were inhibiting development was needed if the potential
advantages were to be exploited. This realisation influenced me to adopt
modular prosthetics for clinical use when I went to Winnipeg, Manitoba
in 1963. My conviction was that modularizing prosthetics would speed
up access of amputees to prosthetic care. It would also help people learn
prosthetic practices and would lead to economies.
The emphasis in Winnipeg was on physical rehabilitation in a newly
established hospital designed for that purpose. However, the prosthetics clinic
was bogged down in wooden leg making practices of the times. Geographic
isolation and absence of modern technical resources in prosthetics inhibited
change.
I came as an expert. What I proposed for clinical application in fact was
experimental. I had worked in an environment linked to innovating and
wished to bring the attitudes associated with innovating into the clinic.
The aim was to have a comprehensive and adaptable modular system that
included as many prefabricated elements as possible. The system would be
used to manage patients with any level of amputation through their full
spectrum of care from immediately post surgery to return to community life.
The design process would be evolutionary with the designed system used for
what it was good for at every stage of development. A system with the least
number of parts would be designed and common parts and tools would be
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
used as far as possible.
A key feature would be rapid assembly-disassembly and reassembly for
quick adjustment and socket exchange.
Only a few basic elements had to be designed to manage BK, AK and HD
prostheses. All other parts were available or could be adapted.
We tried to make the system suit a basically rural environment so that a
person who was distant from services might be able to manage repairs using
community resources, including the local hardware store.
This experience illustrates:
37. Integrating what exists in new ways is innovating.
38. Experimentation can be a part of a service system.
39. Problems can be tackled from the users point of view.
The risks that might be involved in adopting a modular system for clinical
use seemed small compared to the advantages to be gained in overcoming
the bottlenecks affecting amputee rehabilitation.
Results were positive. No amputee had to postpone rehabilitation because of
the prosthesis.
In fact, it became common for a training prosthesis to be delivered on the
day prescribed.
The evolutionary design approach allowed defects in design to be overcome
as a means of extending usefulness of the system while it was used for what
it would permit. At first, the objective was to keep people walking until the
definitive prostheses were delivered. Stage by stage, the system was improved
until finally it could be used definitively.
Evaluation proceeded in tandem with design. This circumvented the
X
possibility of incorporating unsatisfactory features into the final design. In
my view reaching objectives in this manner must be one option to consider
in the interest of economizing on time, costs and effort (I must admit that I
would always choose this approach).
Shaped components were a source of problems, especially with the BK
amputees. Although standard cosmetic covers had been designed, and also
standard socket receptacles to link the sockets to distal components, the
sockets themselves were all custom made. This was reasonable for definitive
prostheses, but training prostheses require frequent socket changes.
Successes with the AK prefabricated sockets motivated us to develop
prefabricated BK sockets in response to the bottleneck experienced.
Nineteen sockets were made for each side of the body.
Use of these sockets taught us that five sizes for each side of the body were
sufficient to fit all of the new amputees managed in this way and that one
size alone met 50% of the needs. This illustrates other factors in innovating:
40. Previously successful patterns are followed.
41. Every experience is treated as an information source.
We were acutely aware of limitations imposed by standardization.
Standardizing can mean that someone is left out unless the standardized
item is adaptable. Such implications for the client need to be kept clearly in
mind during innovating. That is:
42. A sense of responsibility must influence what is done.
Shape sensing
At that time, obtaining limb shapes by means of a shape sensing method,
subject of the next proposition, seemed like a possible solution to the
limitations imposed by standardizing.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
Fifth proposition: Shape sensing gives data for interface design
(1961)
When the idea of automating shape management for the fitting of sockets
and cosmetic restorations was first raised in 1960, there was no sympathy
for it at Berkeley. In fact there was strong scepticism toward it in the research
community when I raised it as a proposal at a meeting of the Subcommittee
on Socket Design of CPRD in 1965. Although I was chairman of the
subcommittee, the proposition did not even win a place in the minutes.
43. An innovative idea in its first stages is fragile.
I had discussed shape management by automated means in a letter to Colin
McLaurin in June 1961. In practical terms, Frank Todd and I constructed a left
side shank model from a right side shank model by means of photographic
silhouetting in 1962 and that was all that was attempted until I returned to
the idea in 1969.
When the gap between conception and initiation of work is considered, one
can appreciate 10 that:
44. Innovators must be patient and persistent.
45. A concept has to be suited to its times for acceptance. Our first formal attempt
to sense shape for prosthetic applications involved use of the shadow moire
phenomenon. These studies spanned the period 1972 to 1980. A prosthesis
replicated in Vancouver, using the moire technique for sensing the shape and a
numerical controlled carver for producing the models, was worn by the recipient
for three years.
We were introduced to the shadow moire technique by Dr. Duncan, then
Head of Mechanical Engineering at UBC. He was actively engaged in shape
processing for ocean bottom survey, boat hull design and machine design
purposes.
Using a system that he had built to obtain multiple view photographic
contour maps around objects, Steve Cousins and I produced a number of
maps and models of residual and intact limbs.
On the basis of this work, Tony Staros established a contract with us to
X
quantify shoe last shapes for the USA Veterans Administration, a forward
looking project which we completed in December 1980.
We set up design criteria and had fabricated on principles demonstrated by
Dr. Vickers and Doug Dean at UBC Mechanical Engineering Department, a
machine that gave a single continuous moire shoe last map.
Saunders forced the system to work by putting the data into the computer
point by point. He soon appreciated that quick input of data was necessary if
sensing was to be a part of automating prosthetic procedures.
In later studies of what was being done in Japan where considerable expertise
in shape processing had developed, he identified the flying spot technique as
significant. It offered direct, rapid deposit of data into the computer at an
affordable cost.
These experiences taught us to:
46. Look outside our field for information.
47. Go for information where the information density is greatest.
The light streak technique has been adopted at West Park Research Centre,
Toronto, Canada, where, by agreement between us, sensing shape has become
a central project while we concentrate on manipulating shape.
Because sensed shape is topographical, it must be used in conjunction with
tissue quality data or be subjected to manipulation to derive the required
biomechanical shape. This weakness in topographic mapping methods for
derivation of biomechanical shapes has yet to be overcome.
On the other hand, biomechanical data are inherent in standard shapes and
this fact can be the basis for deriving custom shapes. I proposed this concept
first during the 1SPO course in AK prosthetics held here in Denmark in 1978.
(You may recall, that in Winnipeg 50% of new BK amputees were found to fit
into a single standard socket size).
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
This leads us to the general hypothesis of the next proposition.
Sixth proposition: The shapes of all examples of any
given anatomical feature or its biomechanically matched
representation are sufficiently similar to permit shape matching
on a mathematical basis using a standard shape as the reference
(1978) and Strathclyde Paper #1, 1984.
That is, you can make a standard shape bigger, make it smaller, make it
longer or shorter, make it differentially flatter or deeper in any direction
and add or subtract from a particular point any required amount starting
with a preconceived shape that serves as a biomechanically relevant core or
reference shape.
My UBC colleagues have designed the current CASD (Computer Aided Socket
Design) system on the basis of this proposition. Colleague Dave Cooper has
extended its application to derive the shape of bones in vivo using external
bony landmark measurements.
The hypothesis stems from attempts to standardize sockets and from
attempts to adapt sensed shapes to socket design.
The hypothesis does not discount the significance of shape sensing. Shape
sensing can be used:
a) to deposit shapes in the computer for further processing; and
b) for defining how a shape should be processed.
Reference shape modelling has elegance. It can be used for internal as well as
external anatomical structures and has no adverse effects on the person for
whom the shape is being developed. It can be used for other than anatomical
features. It can be used in conjunction with other techniques, such as shape
sensing. It is, in fact, a concept of general significance.
The next gap to leap is that of constructing the interface with a degree of
elegance comparable to that offered for designing it.
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This leads to the next proposition:
Seventh proposition: Shapeable matrices can be used to construct
biomechanical structures directly (1977)
A shapeable matrix is a structure made up of nodes and links in a format
that permits it to be contoured to match a required shape. You may liken it
to a flexible lattice that can be made rigid once shaped and be returned to
flexibility for re-shaping.
The new emphasis could be on structures that can be assembled in the
shape format required and remain amendable for post fitting adjustment. The
seating systems developed at the Bioengineering Centre University College
London and at MERU are the only examples of shapeable matrices so far.
Design of shapeable matrices grew out of brainstorming sessions led by
Steve Cousins when he worked with the team at the Medical Engineering
Resource Unit, Vancouver in 1977.
With advent of the Shapeable Matrix, shape management is targeted from
two directions:
a) On the one hand, computer graphic techniques for shape management can be
used to define the shape.
b) On the other, mechanical matrices can be used to build up the shaped structures
directly.
Yet to be achieved is the mating of computer and matrix to allow configuration
of the matrix by computer.
The aim should be to develop universal matrix building blocks from which
any shape can be constructed. This may lead to modularization of interfaces,
or modularization may circumvent development of matrices. If the matrix
approach is circumvented, there may be some gains but there will also be
losses. The matrix approach is much more fundamental even though design
is difficult. Hybrid modular-matrix systems, as proposed by Cousins, may
develop as stepping stones to either matrix or modular structures.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
This illustrates other factors in innovating:
47. The path to choose is the more fundamental one if an innovation is to be far
reaching.
48. Concepts can be combined.
Difficulties experienced with hand assembly and adjustment of miniature
shapeable matrices which we have attempted to design for direct use against
the body have led us to the eighth proposition:
Eighth proposition: Shape dependent components will be produced
by robot constructors
To produce sockets directly by computer controlled robots, while difficult, You may well consider the long and arduous course of actions bringing us to
would set the stage for a manufacturing method that precludes the need
for moulds. Such an approach is infinitely compatible with computer aided
design.
It is also compatible with the needs in prosthetics and orthotics which are
now so heavily dependent on custom made moulds for production of shape
determined components.
This view is shared by our colleagues in Toronto at the West Park Research
Center where it is proposed to use a robot constructor to make seats.
The dream is that CAD and CAM will become so intimately meshed that the
design and fabrication of shaped objects will proceed simultaneously. Also, it
will be possible to have raw material managed in a way that will deliver an
interface that varies in stiffness according to the way in which materials are
delivered from the nozzles held by the robot constructor.
Establishment of computer controlled robot constructors would be as
revolutionary in production technology as was the introduction of mass
production.
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Intermediate steps might include (a) the design of programmable moulds, or
(b) design of matrix elements that can be assembled by computer controlled
robots.
When all of this is put together, we can say:
a) Biomechanical shape is determined by bone geometry and tissue quality.
b) Biomechanical shapes can be standardized.
c) Standard shapes can be customized.
d) Shape sensing can capture and classify shapes.
e) Interfaces can be constructed from matrices.
f) Matrices can be constructed by robots.
these possibilities. We can mesh them easily on the basis of hindsight. What
step could have been omitted, what influences of colleagues on one another
done without?
The adoption of matrices, computers, shape sensing, internal and external
reference shapes and robot constructors is equivalent to a new date zero
for design of shaped components for use in prosthetics, orthotics, and
orthopaedics. We come to this as a consequence of the technology that
surrounds us or can be envisioned on the basis of what surrounds us. We
have merely to take note of it, reassess our problems in the light of it and act
innovatively.
An important principle to guide us is to derive solutions that have wide-
spread uses. This will help make what we design available to the disabled
population. Matrices are like this. They could dim the boundary between
prosthetics and orthotics and the boundary between disabled and able bodied
persons. Computer aided design already does this. Robotic constructors
are likely to have the same affect. I urge you to this — aim for universal
solutions.
 X Boudewijn Wisse - The Universal Prosthesis - Appedixes
Epilogue
I have tried to show how, starting with limited information, some propositions
that foster solution of difficult problems have come into focus.
The time and effort and innovative skills of many people, some unknown,
have been involved. That there are such people with the time and resources
to solve problems is a prime requirement. They need to be in environments
that are conducive to original thinking.
Persons within or between groups need to be linked to permit complementary
problem solving paths to develop. Innovating is not the province of a person
or a group but is a flower that grows out of the human garden.
Innovative impulses need to influence not only what and how we design, but
how we organize to do so. The need for cooperation and joint involvement
in large projects is growing. Fortunately, the technical means are available
to foster this. Seemingly separate entities such as standardizing shapes,
designing modular systems, sensing shape, manipulating shape, transmitting
shapes over the telephone, designing matrices and constructing custom
shapes by robots coalesce as lively possibilities for automation of design and
production of shaped components for prostheses, orthoses and orthopaedic
footwear.
I cannot help but wonder how all of these things might have fared had they
been part of an overall strategy fostered by cooperation of all of us engaged
in prosthetics/orthotics research over the past few decades.
The necessity is for designers to overcome indifference to colleagues,
mistrust, greed and jealousy so that field-adoption of comprehensive systems
that can develop from joint efforts will be realized.
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I personally feel that copyrighting and patenting are impediments to the
free flow of information. Researchers would not be corrupted by the impulse
to protect what they innovate in order to derive gain if the social means
were available for the work they wish to do. The political problem is to foster
mechanisms by which such programmes can be funded and the benefits be
directly applied where the needs exist.
As I see it, we must be free of attitudes that keep us bound to our particular
institutions. We must discount nationalism and ideologies to become truly
conscious of our roles in relation to the world’s people. Every person in our
field plays some part in this. Manufacturers do when they make quality the
factor of significance intheir competition. Designers do when they encourage
the best things to be used by the various participants in the rehabilitation
field regardless of origins. Practitioners do when they stay informed and use
what is best in the developing armamentarium. Educators do by trying new
things, selecting the best and disseminating information about them. Funding
agencies do when they are sensitive to grass roots inputs that identify
appropriate objectives for research in support of services. Politicians do when
they transcend political boundaries in response to world-wide needs.
These are the sorts of ideals that thoughtful men have brought to us down
through the years.
An innovative approach to their implementation is to be encouraged.
ISPO is the means by which we keep in touch with each other for furtherance
of our common interests. They are the sorts of interests Knud Jensen held for
ISPO which he saw as an important element in the evolution of a brotherhood
dedicated to the well-being of physically disabled people throughout the
world.
I appreciate the chance I have had to outline a course of events that illustrates
the innovative process, to give you these thoughts through the Knud Jensen
lecture and to wish you an inspiring 5th World Congress of the ISPO.
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Precise measurements can be

found in the solidworks models
accompanying this report.

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