2. Contents
Appendix
1. Preface........................................................1 A. Problem definitions ...................................... 1
1. Preface........................................................1 A.1. Summary start ................................ 1
2. Contents .....................................................2 A.2. Analysis (NL) .................................. 2
3. Summary ....................................................3 A.3. Research and Development (SL) ... 2
4. Introduction................................................4 B. Figures ........................................................... 3
5. Project history............................................5 B.1. Sri Lanka: ....................................... 3
5.1. Start & Initiation 5 B.2. Properties of Amputees .................. 5
5.2. Analysis (NL) 6 B.3. Worldwide....................................... 8
5.3. Research and Development (SL) 8 C. List of references.......................................... 9
5.4. Finalization (NL) 9 C.1. UN................................................... 9
6. Developing alternatives for developing C.2. Consortium of Humanitarian
countries...................................................10 Agencies......................................... 9
6.1. Process 10 C.3. CFINS - Colombo ........................... 9
6.2. Collecting Information 11 C.4. CFINS - Kandy Branch ................. 10
6.3. Sharing information 12 C.5. Army ............................................. 10
7. Developing Prostheses in Sri Lanka .....13 C.6. CT, the Cambodia Trust ............... 10
7.1. Current designs 13 C.7. ICRC ............................................. 11
7.2. Current production situation 13 C.8. WHO ............................................. 11
8. Recommendations ..................................14 C.9. Medics .......................................... 11
8.1. Final product proposal 14 C.10. Team Design for All ...................... 11
8.2. Optimisation 15 C.11. Experts in NL ................................ 11
8.3. Project continuation 15 D. Current designs .......................................... 12
8.4. New projects 15 E. The Friends in Need Society...................... 13
9. Conclusion ...............................................16 E.1. Departments ................................. 13
10. Evaluation.................................................16 E.2. Internal research........................... 15
F. Contacts and Residences .......................... 16
G. Price estimation .......................................... 17
H. Flowchart – socket designs....................... 17
I. Flowchart – foot design ............................. 17
3. 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 fin
such a way. The freed production capacity can
then be used to produce above knee prostheses
or otheses.
1 2
See appendix A.1 for a summary http://www.xs4all.nl/~inne/ ; See Appendix H.2
3
Appendix A.2 Figure “Inne+”: The total Inne+ can be seen on the left.
4
“Prostheses for Tibial Amputees focused on the 3rd The arrows indicate the places where the forces
World; Introduction Report “Design for All” “ – April (pressure) will be high. Therefore at those places extra
2002 – Dorsser, Wisse and Soleymani. A Summary padding is added. On the right is an impression of the
can be found at www.kladder.nl socket.
5
Prostheses for Tibial Amputees focused on the 3rd
World; Introduction Report “Design for All” “ – April 2002
– Dorsser, Wisse and Soleymani
6 7
Appendix A.3 See Appendix C.10
Presentation
5.4. Finalization (NL)
At the 40th World Congress of Medicina In the Netherlands the project was finalized. Well,
Alternativa, this project was presented. The finalized, continuation would still be preferred9. For
emphasis was on the development of continuation by others new students or a company
alternatives. Therefore the “Beat Tradition” interested in the results need to be found and
presentation8 was divided in two parts: informed. Therefore this report is written in a way
“Alternatives: “Can we beat tradition?” (How to that most vital information is present.
develop alternatives) and “The Alternative
Prosthesis” (case description).
Problem definition and design philosophy
The final problem definition should be broader
than for Sri Lanka only. No solution is anticipated
to encourage different project groups to think
about the same problem:
“Worldwide there are about 15 million
amputees. With 39 percent of them living in
the Asia’s, this area deserves special
attention. In some countries landmines are a
problem, though most common causes are
accidents, diabetics, cancer, infections and
congenital deformities.
Heath care for the amputees is in many cases
insufficient. The production capacity is low and
there is a lack of experts (prosthetist) to fit the
Figure “The flyer”: This flyer was distributed at the
prostheses. Current designs are expensive,
world congress. It promoted our lecture about the
outdated or unsuitable for different
development of alternatives. We wanted to improve
environments (social and geographical)
our network of acquaintances.
worldwide. Aftercare is often forgotten.
Although different groups are thinking about
(and working on) this problem and developing
alternatives, no alternatives are implemented
yet.
The design philosophy is concentrating around the
development of a new concept for prostheses:
“A new (design) concept for prostheses could
improve the situation of amputees.
Evidence shows possibilities for an adjustable
but comfortable socket. This enables mass
production. Distribution will speed up, among
others because the need to travel to
distribution points is cancelled. Costs will
reduce. Children amputees can use the
prostheses longer.
The prostheses should be easy to fit and
adjust, thus reducing the lack of prosthetists.
Ideally, the end users are capable of adjusting
the prostheses themselves.
9
In the first place we can think of continuation by
8
See Chapter 6.1 & 8.1 for a summary and ourselves. Probably one of us will graduate on this
www.kladder.nl for the complete download. project.
rewarding to think about groups without access problem definition changed several time because
to money or other requirements (like time or new (other) information was collected. Secondly in
transport). If you find an application where there the conceptualisation specific information needs to
are none yet, than that’s your way to realize you be collected. Another type of information needed,
ideas, because you’ll be the alternative to especially in developing countries, is daily
nothing! information,
Produce enough confidence
Problem definition. The first information needed
How will you convince your surrounding to is related to the problem definition. Important
accept your idea and to help you? Most questions to be answered are:
important is to start with yourself. If you think of
(easy) ways to validate some advantages of What are the (main) problems? For who do we
your idea, validate them! Don’t try to convince need a solution? Do we really need a product to
every sceptic, especially when (they think) solve the problem? Why is the problem not solved
money or jobs are on stake. Better find a few, yet? What will happen if the problem will not be
reliable contacts. Also, don’t get lost in solved or what will happen if the problem will be
searching for or producing statistical data and solved, does this imply new problems?
figures. These are always difficult, because
there is always room for objections. Instead, rely The subject. Before starting drawing and
on the smile of the customer. systematically thinking about solutions a proper
knowledge of the subject is required. The main
Act different part of this type of information related to this
While fine-tuning your alternative, it’s time to project can be found in the first report13. In
start thinking about the implementation. Be developing countries it’s important to collect
generous with your knowledge (were possible), information about social aspects specifically. While
you’ll earn trust. When the situation allows it, developing alternatives information on new
grow gradually. This enables development while developments and existing products is very
deploying your alternative and is less risky. important as well.
Speaking of risk, expect to rise and fall. Few
developments where a first time success! You
Specific Information. This information is needed
will encounter new problems and will have to
in a later stage of the project. In this case we can
adjust. Last of all, don’t focus on money. Where
think of information about stump measurements,
the focus is on money, little room is left for
specific material data or specific production
innovation or development.
methods.
Adapt information
It will often happen that the information you seek
is not available. The most difficult information to
collect is statistical data. First of all ask around if
someone can help you. If not, you can conduct
your own research. But be aware, this will take a
lot of energy. Make sure you really need the
(specific) information.
Don’t focus too much on the data. Use available
data, adjust it and apply a safety margin. For
15
More about this on the website www.kladder.nl at
“zinvolle stage”.
Especially we are confident about our final Nowadays most of the prostheses in developing
design philosophy. It offers a total new approach countries like Sri Lanka are custom made. If we
opening new possibilities. The DFU is just one want to produce them in mass production, it will be
possible solution. Using the design philosophy, even more difficult; besides a comfortable
other good solutions could be found. prosthesis we now also need an adjustable and
re-alignable one. If you know there is a great
difference in stump measurements and
In this report a lot of figures can be found. It was
contractures you can imagine it’s a difficult job to
very hard and it took us a long time to collect
design a prosthesis suitable for mass production.
and rightly interpret all these figures. The figures
It took us a long time to understand all the
about the amount and properties of amputees
problems and to come up with a good design
are extremely useful to understand the scale of
philosophy. We also made a product proposal but
the problem and not to be misled by people or
unfortunately we did not have time enough to
(non governmental) organisations with second
implement our ideas.
agenda’s. Besides these figures, the figures
about stump measurements can be very useful
to design (adjustable) prostheses. There is need for people who can combine
medical knowledge with technical (especially
industrial designing and developing) knowledge.
In this report also an idea how to develop
With this combination good solutions can be found
alternatives (in developing countries) is given.
to help al lot of different patients (not only
Thinking about the process can be very helpful
amputees). We think the technical university of
to develop and implement alternatives. Also the
Delft has to take a leading role in this.
words said about collecting and sharing
information can be helpful while designing
alternatives, especially in foreign counties. Sri Lanka inspired us to look to the medical world
at a different approach. We met people who made
us think in a different way, who inspired us. You
As said before, with this report we hope to
can’t, and do not have to, think in high-tech
encourage the reader to find ways to improve.
materials only to help people. Not only patients
To improve prostheses, to improve the world, to
who can effort this need to be helped. There is a
improve your and our experiences. Most of all
need to think in global solutions.
we want to inspire all the fantastic people we
met. People who inspired us in the first place.
Appendix ..............................................................0
A. Problem definitions ......................................1
A.1. Summary start ................................1
A.2. Analysis (NL) ..................................2
A.3. Research and Development (SL) ...2
B. Figures ...........................................................3
B.1. Sri Lanka:........................................3
B.2. Properties of Amputees ..................5
B.3. Worldwide .......................................8
C. List of references ..........................................9
C.1. UN...................................................9
C.2. Consortium of Humanitarian
Agencies .........................................9
C.3. CFINS - Colombo ...........................9
C.4. CFINS - Kandy Branch .................10
C.5. Army .............................................10
C.6. CT, the Cambodia Trust ...............10
C.7. ICRC .............................................11
C.8. WHO .............................................11
C.9. Medics ..........................................11
C.10. Team Design for All ......................11
C.11. Experts in NL ................................11
D. Current designs ..........................................12
E. The Friends in Need Society......................13
E.1. Departments .................................13
E.2. Internal research...........................15
F. Contacts and Residences ..........................16
G. Price estimation ..........................................17
H. Flowchart – socket designs.......................17
I. Flowchart – foot design..............................17
The Alternative Prosthesis TU-Delft 2002-2003 Wisse & v Dorsser
16
Redaction: In 2001/2002
17
Redaction: read the figures section in the appendix
about the reliability of these figures
18 19
Redaction: Excluding reparation Redaction: Actually 100 USD
20
See appendix “figures”
21
In blue this minimal calculation is given.
22
This estimation is given in a normal font colour.
Needed
With a replacement rate of three years B.2. Properties of Amputees
(according to Dr. Gratzl (C.7) a prosthesis has
an average life expectancy of 3 years or less
depending on the income generation of the Measurements of below knee amputees
amputee) at least 7000 a year need to be
produced for the currently registered amputees Important data, derived from 139 patient cards:
• 20.000 patients known get 1 prosthesis (*1) Column1 stump lengths
per 3 years (/ 3) ≈ 7000 a year.
For all the estimated amputees a production of Mean 166 mm
at least 17.000 prostheses a year is needed. It is
Standard Error 4,4 mm
probable 32.000 prostheses are needed.
Median 160 mm
• 96.000 patients estimated get 1 prosthesis
(*1) per 3 years (/ 3) ≈ 32.000 a year. Mode 140 mm
[At least 50.000/3 ≈ 17.000 a year are Standard Deviation 52 mm
needed] Minimum 0 mm
• Of which trans tibial civilian amputees are: Maximum 381 mm
48.000/3 ≈ 16.000 Sum 2312,145
[At least 23.000/3 ≈ 8.000] Population (n) 139
• And trans femoral civilian amputees are:
23.000/3≈ 8.000
[At least 12.000/3 ≈ 4.000] 1
Amount of prosthetists (needed) 0,9
We believe there are about 10 prosthetists in Sri 0,8
Lanka (2002). In three years (2005) there will be 40
about 15-20 prosthetists in Sri Lanka. For a 0,7
proper care Sri Lanka needs at least 125 0,6 actual
prosthetists. counts
0,5
• For proper care one prosthetist is needed for expected
400 patients. 0,4 spread
20
• 20.000 / 400 = 50 prosthetist needed for the 0,3
current situation.
0,2
• For the minimal estimated amputees a total
of 50.000 / 400 = 125 prosthetists. 0,1
• For the estimated amount of amputees a 0 0
total of 96.000 / 400 = 240 prosthetists. 0 20 40
• Prosthetists needed for patients with
ortheses are not even taken in account in
this figures.
Graph “stump lengths”: In this figure the spread of the
stump lengths is found to be nearly a standard
deviation.
23
From the 2228 (including the second prosthesis of
bilaterals 2246) entries only 1105 civilians and 1020
military are taken into account.
24
Also wounds
25
Diseases of the blood or of the bone.
26
These Accidents are mainly traffic, train and
accidents which occurred during work
27
Gangrenous but also snakebites, etc. Also
"wounds", which could belong to another section
as well.
28
Bomb blasts, shell blast, but also gun shots (of
which the minimal of 23 trap guns are excluded
and transferred to subtotal trauma)
29
Pressure mines or landmines and UXO’s.
30
Military= Army + Air force + Navy + Police
Age spread
On this page the amount of amputees (helped at
the FINS Headquarters 1993-1997) per age can
be found. Red is military (subtotal = 1029), blue
is civilian (subtotal = 1172) adding up to 2200
patients of which the age was recorded.
180
160
140
120
100
Military
Civilian
80
60
40
20
0
10
13
16
19
22
25
28
31
34
37
40
43
46
49
52
55
58
61
64
67
70
73
76
79
82
85
1
B.3. Worldwide
The following data is collected from the World Total Amputated % of % of
Health Organisation (WHO)31 Population Arm pop. all
Columns:
Africa 655.477.000 1.041.000 0,1588 19
1. Area or criterion
America’s 837.966.000 662.000 0,0790 12
2. Total amount of persons in that area
Europe 874.178.000 614.000 0,0702 11
3. Total amount of amputees in that area
SE Asia’s 1.559.810.000 1.692.000 0,1085 30
4. Total amount of amputees divided by the
total amount of persons = the percentage of Western 1.701.689.000 899 0,0001 16
that area which has an amputation Pacific
31
See Appendix C: “References”
Western:
D. Current designs “Western” prostheses (Otto Bock,
At this moment there are several designs Blatchford, etc) simple are the state
available in Sri-Lanka. We will describe their of the art. But the best in Europe or
properties here briefly: America is not always the best in
the Asia’s. The ‘problem’ with these
Jaipur Limb: prostheses is that the materials
The Jaipur limb is the main used are not always suitable for the
technology, which has been climate in the Asia’s. Besides, they
used in Sri Lanka from 1984 often need to be repaired because
till now (2002). It’s easy to they are not made for the work people do in the
produce and low cost. The Asia’s. (Heavy work in rice field, bare feet walking,
amputee who has been etc). And don’t forget the prices.
rehabilitated doesn’t have the
best prosthesis in the world, Mobility Kit:
but he has the means to walk A recently new technology
and work again, to retain his introduced in Sri Lanka by
dignity and get back to a “normal” life. The limb the Kandy branch of the
is traditionally made of local materials (wood, FINS is the so-called
rubber, aluminium) and is produced by local Mobility Kit from India.
production methods. The FINS-technicians also More information can be
make an adjusted version with Poly Propylene obtained by Vinod (C.4).
(PP). The foot is extremely suitable for tropical
climates and can be used without shoes The Mobility kit is produced
because of its lifelike appearance. in Bangalore (as far as the
authors know: Mobility
Mukti limb: India, 515 Base Workshop,
The Mukti system is based on Bangalore)
the same design philosophy It uses a modular system with a custom made
as the Jaipur Foot (Easy to socket (above and below knee prostheses are
produce, low cost, not the both possible). The kit is delivered with sheets for
best there is but suitable) This the socket, the shaft (piston), sheets for the
design is made of a fixating exoskeleton, foot and slippers (to reduce
biocompatible material (High Density Poly wear). The foot is of lower quality than the Jaipur
Ethylene [HDPE]) simply bought as drainpipes. foot.
The foot is (almost) similar to the Jaipur -foot The use of a piston makes fitting easy for a
prosthetist, but the need of a exo-skeleton to
ICRC limb: support the weight makes later adjustments
Also the ICRC (International Committee of the difficult.
Red Cross) has the same principle. (Easy to
produce, low cost, not the best there is but
suitable) The ICRC is made in local mass
production. Unfortunately there are only two
(mass-producing) factories at the moment (in
Geneva and Ethiopia). It was designed to be
made of recycled Poly Propylene. But
unfortunately recycled Poly Propylene does not
have the recommended stiffness and strength.
So now non-recycled Poly Propylene (much
more expensive, no environmental gain) is used.
This is why some believe the ICRC failed.
Departments
E. The Friends in Need Society Apart from the administrative and financial
The Colombo Friends in Need department, the production floor is divided in
Society is a non-governmental several departments.
organization (NGO) in Sri-
Lanka. The CFINS provides The Foot department
prosthetic services in Sri The Jaipur Foot has wooden and rubber parts
Lanka and is based in inside covered by a several rubber layers. It is
Colombo (headquarters), extremely resistant and has a lot of flexibility,
Kandy, Jaffna and Galle. The main part of this which is very useful for the unpaved areas in Sri
project in Sri Lanka was done at the Colombo Lanka. It has an aesthetic design, which is
Headquarters. The Kandy branch has been preferable for walking bare-feet. It lasts a long time
visited. The FINS-Colombo produces about 100 but the problem is that there is no adjustment and
prostheses and ortheses a month. They provide alignment possible. It is completely fixed. It has a
below knee, above knee and arm prostheses. steel bolt which allows the foot to be connected to
Besides prostheses they provide ortheses. All the Aluminium shank.
prostheses and ortheses are custom-made. The The production capacity of the FINS-C is eight feet
FINS-C uses the famous Jaipur Foot a day. The chief of the feet department is Mr.
Technology. The FINS-K produces the Mukti Francis. He has been the director of the Jaffna
limb and the Mobility kit. The Jaipur Foot branch for many years. There are five employees.
prostheses provided by the FINS-C are funded One is making the wooden parts and the others
by US-AID and if needed the civilian survivors are producing the actual feet. “over”-production is
receive them free-of-charge. “sold” to the other branches.
There is a belt saw, a sander, a drill, a bench-vice
E.1. and a wood file to shape the wood pieces for the
feet. Furthermore there is an oven and there are
aluminium moulds to produce the feet. The rubber-
glue is made of recycled rubber parts and
petroleum.
G. Price estimation
Material costs
Material
Part(sub-) Quantity Material Purchase Productiontech. Price (E)
SOCKET 1
Front p.t.piece 1 pp inject.m. /v.f. 1
klitterband 2 stof purchase - 0,25
padding 2 stof purchase - 0,75
backside 1 cfibre inject.m. /v.f. 4
inferface 2 pp/metaal? inject.molding 4
belts 2 stof purchase - 0,25
tentioner 2 pp purchase - 1
length adjust 2 metaal purchase - 0,25
stumpend cup 1 pp vacuum forming 0,5
padding 1 foam purchase - 0,25
suspention 1 metaal? bending/cold-forming 0,25
bolt and nut 1 metaal purchase - 0,05
LINER 1
liner 1 foam purchase - 0,75
FOOT 1
basis 1 pp inject.m. 1
lid 1 pp inject.m. 0,5
anklerubber 1 rubber casting/inject.m. 1
toes 2 pp inject.nm. 1
interface 1 pp? inject.m. 1
sealing (surface) 1 textiel heat&glue 1
bolt and nut 1 metaal purchase - 0,05
rubbers 3 rubber cut 0,25
Finishing
Tube (shank) 1 metaal purchase - 2
Cosmetic cover 1 foam purchase - 1,5
Box 1 papier purchase - 1
Measurement card 1 papier purchase - 0,05
Manual 1 papier purchase - 0,5
upperlegbelt 1 leather purchase - 2
Rounded: 300.000 85 47 42
Aluminum prostheses
G Plastic prostheses H
G, H, K
The decision to leave the hand-made
principle and to design for mass-
production enables the use of synthetic
materials. “Plastics” are highly
formable.
[G] Features: A patellar tendon flap at
the front; ski shoe bindings; calf muscle
holes at the back; adjustable shank
system.
Description: Holes in the product are
small (else skin gets trapped), but large
enough to adjust the socket for
different stump sizes. The holes at the
side make height adjusting possible,
but stepwise.
[H] Features: A flexible socket; a
(flexible) patellar tendon flap; ski shoe
bindings (not in picture); an above
knee belt.
Description: Difficulties with this design
are adjusting the height, contracture
compensation and pressure
distribution. K
[K] Features: Bearing area on stump
end. Adjustable in height and size. DFU - socket
Description: see the chapter 8 version date: 18-10-2004 Page 19
The Alternative Prosthesis