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Prosthesis for Tibial Amputees

focused on the 3rd World


Introduction Report “Design for All” – April 2002

I'm going to Graceland


Poor boys and Pilgrims with families
And we are going to Graceland
And my traveling companions
Are ghosts and empty sockets
I'm looking at ghosts and empties
But I've reason to believe
We will all be received
In Graceland

Paul Simon - Graceland

Written by:
Boudewijn Wisse IO9964426
Wouter van Dorsser IO9195386
Farshad Soleymani IO9784809

Mentors: Johan Molenbroek


Henk Kooijstra
Inne ten Have
Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Preface
This is a paper which is made in the context of Design for All. Design for all is an optional
subject that is taught at the Faculty of Industrial Design Engineering of Delft University of
Technology in The Netherlands. The assignment for this subject has been given to us by
Mister J. Molenbroek (Associate Professor who teaches Design for All) and Mister H.
Kooistra (Dutch surgeon, who independently works in Sri Lanka as a surgeon and helps
victims of landmines). There are different groups working on this assignment and there is
a price (3 roundtrip tickets to Sri Lanka to implement the solution) to be won for the
group which comes up with the best solution or design for the assignment. According to
us the succes of the solution is dependent of the people (their culture and good will) in
Sri Lanka. We therefore see a decent analysis as the first and most important
requirement to be able to implement designs in Sri Lanka.

The purpose of this paper is to inform everybody who is interested in our solutions for a
prosthesis which can be produced and used in the third world. This paper is written in
March till May 2002. It will (hopefully) be the introduction for a project in Sri Lanka with
local disabled, for which will be tried to implement the design and/or to make necessary
improvements.

In Appendix I we will give individual motivations why we follow this optional subject and
why we choose this design project.

Boudewijn, Wouter & Farshad

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Table of contents
Summary.......................................................................................................................... 3
Introduction ..................................................................................................................... 4
Analysis ………………………………………………………………………………………… 5
Social Analysis of Sri Lanka.......................................................................................... 5
Medical analysis.......................................................................................................... 11
Lower leg................................................................................................................. 11
Amputation .............................................................................................................. 11
Gait Analysis ............................................................................................................... 14
Force Diagram ............................................................................................................ 15
Prostheses .................................................................................................................. 16
History ..................................................................................................................... 16
Sockets.................................................................................................................... 17
Shanks .................................................................................................................... 20
Foot-ankle systems ................................................................................................. 21
Conclusion Prostheses Analysis ............................................................................. 25
Production ................................................................................................................... 27
Available Materials .................................................................................................. 27
Available production methods ................................................................................. 28
Standardization ....................................................................................................... 29
Life Cycle Analysis ...................................................................................................... 31
Synthesis ....................................................................................................................... 33
Design Philosophy ...................................................................................................... 33
List of Design Requirements ....................................................................................... 34
Common.................................................................................................................. 34
Shank ...................................................................................................................... 34
Foot-ankle system ................................................................................................... 34
Socket ..................................................................................................................... 35
Production and implementation............................................................................... 36
Experiments and evaluation........................................................................................ 37
Concepts ..................................................................................................................... 40
Concept 1: The rocker-foot...................................................................................... 40
Concept 2: The socket by Inne redesigned............................................................. 41
Concept 3: The textile / leather socket .................................................................... 44
Concept 4: The polymer socket............................................................................... 46
Concept 5: Knowledge transfer ............................................................................... 47
Concept 6: Implementation plan.............................................................................. 49
Conclusion .................................................................................................................. 52
References..................................................................................................................... 53
Appendix........................................................................................................................ 54
Appendix I: Individual motivations ............................................................................... 54
Appendix II: Exercises................................................................................................. 58
Appendix III: Manual – Producing prostheses............................................................. 60
Appendix IV: Manual - How to design prostheses ...................................................... 65
Appendix V: The measurement prosthesis ................................................................. 70
Appendix VI: Tempur .................................................................................................. 71
Appendix VII: Patents.................................................................................................. 72

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, 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. Our design philosophy is that our design will be made at a prostheses
workshop in Sri Lanka, by the local prostheses builders 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.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Introduction
The problem
Many third world countries are or were a “playground” for civil wars. Millions of mines,
left-over weapons of these wars, but still potentially lethal, are scattered over 70
countries in Africa, Asia, Europe, the Middle East and the Americas. Landmines strike
thousands of innocent victims every year, shattering lives and destroying futures.
According to estimates made by the International Committee of the Red Cross, every
month at least 2,000 people, usually innocent civilians, are killed or injured by land
mines; the equivalent of a new victim every 20 minutes. Sri Lanka is one of the countries
where landmines are still used resulting in many landmine victims, which usually lose a
lower leg….

It is necessarily to come up with a good solution to provide everybody with a hard


needed prosthesis.

Question to answer
According to Henk Kooistra the most urgent problems to be solved can be formulated as
follows:
• How is it possible to produce cheap prostheses?
• Which applicable materials are resistant to wear?
• How can an acceptable walk pattern be created without the use of an ankle joint?
• How can prostheses be produced in third world countries using only materials
and manufacture knowledge of that country?
• Can a manufacture method be invented which doesn’t need technicians (with two
years of training) but can be executed by the local bicycle shop?
• Is it possible to produce a socket for growing children, without having to replace
the prosthesis (too often)?

In this report, first an analysis of the problem is presented. The questions above are
addressed and evaluated, resulting in criteria and eventually a list of requirements. Next
we will develop some solutions for these problems based on the criteria. These can be
tested in Sri Lanka with the included implementation plan.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Analysis
Social Analysis of Sri Lanka

Geography
Sr_ Lank_ Praj_t_ntrika Camajaváti Janarajya (as the
Democratic Socialistic Republic of Sri Lanka is officially
named) is with its area of 65610 km² about 1.6 times bigger
than the Netherlands. It’s easily found on the world map by
looking just below the tip of India. Because of the mountains
in the middle of the country the landscape differs quite a bit
from place to place (0 m (sea level) to 2524 m
(Pidurutalagala)). This combined with the climate (tropical
monsoon- (north) & tropical forest (south)) makes Sri Lanka
an ideal place for many different plants and animals to live. Picture “map”: Sometimes
Among the rubber trees other important trees can be found Sri Lanka is referred to as
like ebony, mangrove, orchids, palm trees, panda wood, “Paradise Island”
rhododendron and satinwood. The capital Colombo, with its
1 300 000 (1995) inhabitants is the biggest city.

Criteria:
• The prosthesis must be resistant to tropical weather.
o The prosthesis should be resistant to heat.
o The prosthesis should be resistant to water and moisture.
• If wood is used in the prosthesis, then
ebony, mangrove, palm trees, panda
wood, rhododendron and satinwood are Singhalese (74)

possibilities.
Tam ils (18)

Inhabitants
Moors (7)
Sri Lanka has 19.500.000 inhabitants (in 2000
(www.lanka.net)). Sri Lankan inhabitants have
other (1)
different ethnic backgrounds and different
religions (see the pie charts). While religion is
not a major issue in Sri Lanka, ethnic Pie Chart “Ethics”: Ethnic groups in Sri
background is, resulting in a war between the Lanka (% of population)
Tamils and the Singhalese (see the paragraph
“war”).

Another important difference between people in


Buddhist
Sri Lanka to be mentioned is the difference
between man and women. Although most Christians
women work, they are socially unequal to men,
but they have great influences in there own Muslim s
families. In most cases they manage the cash
flow of the family. Hindus

Pie Chart “Religion”: Religion in Sri


Lanka (% of population)

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

The official languages of Sri Lanka are Singhalese and Tamil. English is recently added
to these and is understood by many in the big cities (and the tourist areas). Combined
with the knowledge that 90% of the country is educated (between 5 and 10 years of
age), almost every body can read and understand Singhalese. Tamil is understood only
by the Tamils (thus about 20% of the population) and English by about 10%. Although
Sri Lanka was under Dutch colonial rule many years ago, no-one speaks Dutch.

Criteria:
• A manual can contain text.
o First language for local use should be Singhalese.
o International papers can be written in English.
• The prosthesis or the manual should not offend any ethnic or religious group.

War
There is a civil war raging
for over 18 years now in
Sri Lanka between the Peace
Liberation Tigers of Tamil breakthrough in
Eelam (LTTE) and their
adversaries, the Sri Lanka
authorities. The war zone
COLOMBO, Sri Lanka --
in the north is cluttered
Peace efforts in war-torn
with landmines, planted Sri Lanka have been given
by both parties to injure a further boost, with the
the enemy and to national government and
slowdown traffic and Ranil Wickremesinghe (center) was the first Tamil Tiger rebels agreeing
support. Unfortunately, Sri Lankan prime minister in 20 years to to conduct talks in May.
both civilians and military visit the epicenter of the island's rambling
ethnic war
are victims of these
landmines. The amount The government announced on Wednesday it would conduct face-
of victims of these to-face discussions with the rebels in an effort to end the 18-year
(amputees) is 10.000 to civil war, which has ravaged the country.
20.000 (confidential
numbers are difficult to
Figure “News”“: Recent news gives hope for oncoming
find).
peace. - CNN - March 27, 2002 Posted: 1255 GMT
Fortunately, peace negotiations give hope for a stop of the war (see the article on the
right). While the use of landmines could be banned in the near future, old landmines will
still be active for years. Add a possible “boom” of victims due to the migration of
refugees back to their home grounds. 500.000 people will “go home” when the ongoing
peace discussions are successful.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Economy
6 million inhabitants are registered as
employed (this amount seems to be Year Source Total No. As % of Labour
low, but that’s because the government (Excluding North & ('000) force by sex
East Provinces)
does not count the northern and the Male Female
East provinces and there are many 2000 Quarterly 6343 94.1 89.0
people not reporting work) Labour Force
While the majority of the income of Sri Survey
Lanka is due to tourism, there is also
some industry. Important occupations Table “Economy”: Occupation and Labour in Sri
are farming, selling goods in the city Lanka (% of population)
market, rubber tapping (see picture),
weaving, fishing and tea leaves picking.
Major (export) products are jewels,
Agriculture, Hunting &
phosphate, graphite, wood, plaster, Forestry
rubber and tea Manufacturing

Although proud on their free-market Mining & Quarrrying


economic system, the economic
situation of Sri Lanka has not been Construction
improved by it. While the poor
inhabitants were getting poorer by the Services
day, the more rich people started to buy
luxurious goods (like car, bikes and Hifi)
from western countries. This influenced Pie Chart “Economy”: Different occupations in Sri
the import/export balance negatively. Lanka (% of population)
According to the government of Sri
Lanka, this situation is slowly improving
since 1993. The growth of the national income is now between
5 and 7 percent per year. But Sri Lanka is still in great
international debts and full with poor people.

The currency is the Rupee. 1 Euro is about 83 Rupees (March


2002).

As can be seen in the table, almost every body who can work
is working, as well men (94%) as women (89%). This is a good
sign. It tells us the people maybe are poor, but not unwilling to
work or to help. Prostheses could enable many to work
normally. Also, we can expect effort from the ones who work in
the production factory. It’s not unthinkable some amputees are
willing to help (work) if they are helped with a good prosthesis.
If we can encourage amputees to build their own prosthesis,
we find cheap labour and he of she learns to build and fix
prosthesis (for himself and the neighbourhood).
Criteria: Picture “rubber tapping”
• A prosthesis should assist people in their work.
• Both “normal people” and amputees should be able to
work in a factory.
• Amputees are willing to work for their prosthesis. If its possible, let amputees
build their own prosthesis.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Social welfare and developmental help


As everybody can understand, social welfare is not as advanced in a developing country
such as Sri Lanka, as it is in European countries such as the Netherlands. First of all not
enough money can be collected for good hospitals and different kinds of developments.
Also, not enough qualified personnel is present. The army hospitals (instead of the civil
hospitals) are the main place where landmine victims are amputated. The army also
buys and distributes prostheses (but mainly for the military).
These circumstances are the reason that little prostheses are made in Sri Lanka. Current
designs are very costly and time consuming to produce. They require qualified personnel
(medical to fit the prosthesis and technical due to the difficult production process) and
sometimes expensive machines.
Therefore humanitarian help is given by some parties in Sri Lanka (Friends in need,
white pigeon and poor attempts from bigger organizations) to reduce the amount of
amputees without a proper prosthesis. Unfortunately some devices distributed by these
organizations are cultural or even physical inappropriate for them. Recently, some
organizations have withdrawn their financial support for prostheses.
Currently, 1800 prostheses are being built each year in Sri Lanka, while a production of
5000 is needed. This results in long waiting lists (up to 15 years) and no possibility to
repair or change a prosthesis (if you get one, you get one for your entire life).

A big amount of the amputees are children (60% of all who are amputated each year),
who search wood for cooking in landmine infected areas. Their number is expected to
increase rapidly. The Red Cross says a child injured at the age of 10 will need about 25
artificial limbs during their lifetime, but in many countries crutches are all people can
afford. But, because of the long waiting list (and of course the aging of the children),
almost all prosthesis have to be fitted on adult amputees. Because the long duration of
the war, only a small percentage of all the current amputees is a child. If the waiting list
can be reduced (eliminated) than children can be helped.

Criteria:
• First focus on reducing the waiting list (prostheses for adults) then start producing
prostheses for children.
• The prosthesis should be cheap.
o The factories should become independent from (financial) charity in the
future.
• The prosthesis can be made in large quantities.
o 3000 prostheses can eventually be produced each year)
(also see the chapter “production and implementation”, page 38)

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Customs, Aesthetics
A prosthesis is culturally
appropriate if it allows users
to engage in everyday
physical activities in rural Sri
Lanka, such as squatting (an
important body posture in Sri
Lanka and India for resting,
sitting, eating and using
toilets), walking barefoot or
with thongs (flip-flops) over
rough terrain, and
submersing the prosthesis in
water (for washing feet or
walking in farm fields during
rainy season). People wear
thongs, shirts and sarongs.
Another custom is wearing
no shoes or sandals in
house.

Although Sri Lankan people Picture “shoes”: The local Picture “Squatting”: This
won’t confront they are poor, custom is to remove shoes labourer, which makes a
an inferiority complex is not when entering buildings camera cover from camel
uncommon. This results in leather, clearly illustrates the
the wish for luxurious goods and also high tech production way people squat while
methods (“Import products are cool”). Therefore an interesting working.
aspect of the production of third world prostheses (like the
Jaipur limb) is that it is locally manufactured, which has great
social impact on the local society. It supports a feeling of
equality.

The aesthetics of the design is also important. Some of the


currently used prostheses can be described as "like something
from the Dark Ages," with a look and manufacturing and fitting
processes at least 20 years out of date.

Important is to realise that people of Sri Lanka don’t do things


our way, but the results are as good. If a good prosthesis will
be the result of the cooperation between western and local
people, trust on both sides is needed.

Criteria:
• The factory should encourage social integration.
• The aesthetics are important. The prostheses must be
a wanted item.
• The prosthesis can be submersed in water or mud.
Picture “cowboy boot”: This
• The prosthesis allows squatting.
cowboy boot could be a
• The prosthesis can easily be taken off and put on. prosthesis…… Who wouldn’t
• The prosthesis can be fitted with a flip-flip. This flip-flop want one?
can be replaced / taken off.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Travel
Especially people with one leg have difficulties to make a
long trip. If the factory where they receive their prosthesis
is far away, the trip to and back from this factory is an
expensive event, which maybe occurs once in their lives. It
is important that these people are being welcomed at the
service centre with great care and hospitality. The
residence should be decent. After the long trip back to their
homes, people are deprived from medical attention. They
cannot be expected to make the trip again when the
prosthesis is broken.

Ways to get around the country are train, bus, taxi, bike
and rental car, although the roads are not that good. The
main speed of travel is about 30 km/hour.

Bikes, Mopeds and Bicycles (and things like them as


Rickshaw’s are together with carts (driven by animals) the
main way of travel in many third world countries. Even
transportation of goods is done in ways not imaginable to Picture “bicycle”: This
us (see the picture to the right). A bicycle repair shop can transporter in Delhi shows the
be found literally on every corner in a city. If you have a flat creative use of bikes in Third
tire, rescue is always near. World countries.

Criteria:
• The factories should be spread around the country.
• The service centres should be hospitable.
• The design should be easily repaired in the local village (home, carpenter, local
bike shop, etc)

Picture “bikes”: This collection of bikes shows how people


think about aesthetics and how they “upgrade” normal bikes
to a kind of carts.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Medical analysis
Lower leg
There are different kinds of prostheses required
for different amputations. At the right the different
kinds of prostheses are featured in a drawing.

The most common leg amputation in Sri Lanka is


below the knee. In Sri Lanka 78% of the
amputees has a “tibial” (lower leg) amputation. A
leg that has been amputated halfway between the
knee and ankle works best for walking with an
artificial limb.

The cause of this ratio is the “design philosophy”


of the Pakistan Ordnance Factories (which make Picture “anatomy”: Different kinds of
the cheap landmines that are used in the Sri prostheses are used for different
Lankan war), which is that: “It is better to disable amputations
man than to kill him. A wounded man requires
attention, conveyance and evacuation to the rear, thus causing disturbances in the traffic
lines of the combat area. Also a wounded person has a detrimental psychological effect
on his fellow soldiers.” It’s because of this that the landmine is designed to destroy only a
part of the victim’s body. Because tibial prostheses are the most needed type of
prostheses, we will focus our design on these.

Criteria:
• The prosthesis must be a tibial prosthesis

Amputation
The amputation of the patients’ lower leg takes
place in a hospital. The leg is amputated halfway
the lower leg. The fibula is cut 2 cm shorter than
the Tibia, so the calf muscle (sural muscle) has
enough space to form a good stump.

According to specialists in the Dijkzigt Hospital in


The Netherlands, it’s not recommended to put
pressure on the limb during the first two weeks
after the operation. After this period the patient
here in The Netherlands gets a temporary
prosthesis for a period of 5 months. Such a
temporary prosthesis is necessary because the
stump shrinks if it is not subjected to forces. The
patient needs to keep moving the limb, because
otherwise it will become deformed and finally
because the patient needs to get used to a
prosthesis. The picture on the next page shows a Picture “amputed leg”
temporary prosthesis that we saw at the Dijkzigt
Hospital in The Netherlands.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

In Sri Lanka the reasons for having a temporary


prosthesis will be the same as in The Netherlands, but
it’s too costly to buy a temporary prosthesis.
From the time a leg has been amputated until a limb is
fitted, daily exercises are needed to keep the hip and
knee muscles strong and to avoid contractures. If
weakness and contractures already exist, these should
be corrected as much as possible before a limb is fitted
(see picture “fitting a limb”). It can also help to (for
example while sleeping) strap on a wooden splint on
the leg, in such a way that the amputated leg is forced
to be straight. (See also Appendix II–exercises for
preventing contractures).

Criteria:
• It’s better to wait with getting a prosthesis in the
first 6 months after the amputation.
• Do exercises during the untill you get a
prosthesis after the operation to avoid
contractures.
• The stump has to be vertical in the prosthesis. Picture “temporarily leg”: A
The knee has to be stretched. temporarily leg as currently used in
the Netherlands

Picture “Fitting a limb”: The knee joint should almost be stretched while standing on a
prosthesis. 2-5 degrees angles are normal.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

During our second visit to the Dijkzigt Hospital we were told which areas on the stump
we could put under pressure and which areas on the stump we should avoid putting
pressure on.
We were given a foam model by the Hospital, which had all these critical points drawn
on it. We put an epoxy layer around this model and marked all the critical points with
colours.
In the picture below you see this model (of the right leg). The red parts are the areas
where pressure should be avoided, because these are bony bumps and bony areas
(shin bone). The blue hatched areas are suitable to be put under pressure and the fully
coloured area (patellar tendon) is capable of carrying a lot of pressure.
The areas which are not coloured are not capable of carrying a lot of pressure.

The blue hatched area above the knee prevents the prosthesis from sliding down the leg
through the prosthesis.
The better the prosthesis fits around the stump, the less friction there is between the
prosthesis and the stump (while under stress or without).
The tip of the stump is slightly put under pressure to avoid sliding downwards in the
prosthesis and to have a good positioning of the pressure on the kneecap tendon.
Furthermore it’s important to divide the pressure on an as big as possible contact
surface.

Criteria:
• The stump needs to be put under pressure according to the picture “foam model”.
• Sliding and friction should be avoided.
• The force on the patellar tendon has to be positioned properly.
• The prosthesis needs a big contact area to help the distribution of the force. The
maximum pressure should be low (except for on the patellar tendon, which can
handle the pressure).

Picture “foam model”: The blue areas can be loaded. Red areas should be avoided

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Gait Analysis
Normal walking creates the need for dorsiflexion (toes up)
and plantarflexion (toes down) of the ankle joint. The whole
angle changes during motion of the ankle joint in the
sagittal plane (see picture “planes in a human body”) about
45°. 10 to 20 degrees angle change is dorsiflexion. The
remaining 25° to 35° is plantarflexion. (see picture ”ankle
angles in gait”)

When the heel touches the surface, the ankle undergoes


some degree of plantar flexion. This plantarflexion holds on Figure 1
until the total foot is flat on the ground. The motion changes
into dorsilflexion when the body moves over the supporting
foot. Plantarflexion appears again while the heel lifts from Picture “planes in the human
the ground at the end of the stance phase. When the toes body”: The gray area is the
push off, at the beginning of the swing phase, the ankle sagittal plane
bends further into plantarflexion, then changes shortly into
dorsilflexion and back again into
a low degree of plantarflexion
when the heel touches the
surface.

If we use an ankle joint we can


also have some dorsiflexion and
plantarflexion. Without an ankle
joint this is not possible. We than
have to improve gait another
way (see paragraph “foot-ankle
systems, B, III”)

Criteria:
• The prosthesis should
simulate a normal gait.
• The angle between the
normal foot and the
prosthetic foot should be two
times 15 degrees. Picture “ankle angles in gait”: The angle of the ankle
changes about 45 degrees while in normal gait.

Picture “degrees”: The angle between the two feet should be two
times 15 degrees.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Force Diagram

The diagram to the right shows one of the major


principles in prosthesis design. It shows how
biomechanics can explain the places that are most
loaded (mostly put under pressure) by the prosthesis.
How a prosthesis can be evaluated this way is
illustrated in chapter “The socket by Inne
redesigned”.

The red arrow indicates the force created by the


mass of the body. We can estimate its magnitude by
taking the mass of the total body. For a person with
two legs we would have to multiply this by 94 %
(because we have to subtract one lower leg and foot)
and then again by the gravitational acceleration
(9.81). Of course, with amputees, the weight of the
leg is already “subtracted”. 600 Newton is an
average. 800 can be used for “heavy” persons.
Diagram “forces in the stump”: This
Fg = Mbody * 9.81 = …. N picture shows the major forces which a
socket applies to the stump.
The black arrow (Ft) is the force loaded on the knee
(patellar) tendon by the prosthesis. This force is mainly used to support the bodyweight
of the person. Because the body can only resists perpendicular (normal) forces and no
shear forces on the skin and this is the only part which is not totally vertical, we can
assume that this force is the only one which supports bodyweight.
The blue force upward (Fry) is this reaction force on the gravitational force (Fg). The
horizontal blue arrow (Frx) is the force needed to achieve the angle (α) that the black
arrow makes. The angle (α) between this force and the Ft (the black arrow), has to as big
as possible, but you can not influence it, because it is dictated by the angle the patellar
tendon makes. Here it is drawn about 60o, but later experiments proved that 30o to 45o is
more likely (see concept 2 and the experiments). We can now calculate the Ft and Frx:

Fry = Fg Frx = Fg / tan (α) Ft = Fg / sin (30o)

Because of the Frx, now translation (the leg moves to the right) will occur if we don’t add
a force to the right. Force Fx1 (the purple arrow pointed to the left) is born. This force
could be exactly the same as Frx if no turning would exist. Unfortunately Force Fx1 will
make the leg turn clock wards. To counteract this movement we need Force Fx2 (the
lowest force). With the right formulas we can find their magnitudes:

No turning: Fx1 * b = Fx2 * a Solve for Fx2: Frx + Fx2 = Fx2 * a / b


No translation: Fx1 = Frx + Fx2 Fx2 = Frx / (a/b - 1)

The example with concept 2 shows that force Fx1 is almost 3 times the weight of the
person!
Criteria:
• Distance “a” should be as big as possible, while distance “b” is as small as
possible.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Prostheses
History
Biomechanics, Biology, Medical Science, all have had interests in the design of
prostheses for a long time (especially since world war two, because lots of people lost a
body part during that war). In the beginning these prostheses where cheap and easily
fabricated (just like the prostheses we want to design). The big difference is the social
context and the fact that people in the western world are able to “upgrade” or replace
their prosthesis at least once every year. Years later, prostheses became more
advanced, using high-tech solutions and parts. This development was possible due to
the integration of mechanics and medical science (which became biomechanics and
ergonomics) and the increasing welfare.

The basic components


The basic components of lower leg prosthesis
are the socket, the shank and the foot-ankle
system. It’s important to realize that the design
has to be a synthesis. All the problems have to
be addressed equally and at the same time. Socket
The weight of a prosthesis is an important
factor. Because the prosthesis is “dead
material” it has to be as light as possible. If the
prosthesis is very light, it can be blown away Shank
and new difficulties arise. A good weight seems
to be around 1.5 kg.

The socket is the part of an artificial limb that Foot-ankle system


fits onto the patient's residual limb.
A good fit of the socket on the stump is one of
the most important -and difficult- parts of limb Picture “basic components”: The basic
making. A shank is a structural component of a components of a below-knee prosthesis are the
prosthesis which connects the socket to the socket, the shank and the foot-ankle system.
foot-ankle system and transfers the load of
body weight to the foot and the floor. It can be designed to be adjustable to allow growth
of the amputee.
Next is the foot-ankle system. This lower part of the prosthesis has to provide a decent
winding of the foot and enough support. Also, this is the visible part of the prosthesis,
making its aesthetics important.

Sometimes the patient wears a prosthetic sock which is generally worn with an artificial
limb to provide additional padding for bony surfaces. Sometimes people even wear a
“Soft Socket”, which is a soft liner within a socket to provide cushioning.

Hereafter we describe different kinds of solutions and designs of sockets and feet.

Criteria:
• The weight of the prosthesis should be above 0.5 and below 2 kg.

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Sockets
Suction Sockets
For active amputees with good blood circulation, a close fit between the stump and the
socket can create a suction that holds the prosthesis in place. In this kind of socket,
called a suction socket, nothing is worn on the stump. When blood circulation is poor, a
sock is worn over the stump and the socket is held in place by a belt around the pelvic
area.
The shape of the socket is crucial for comfort and functionality. The socket should allow
blood circulation without being loose.

Quadrilateral sockets
Quadrilateral sockets are nearly rectangular in shape when viewed from the top. They
are among the most commonly used sockets in third world countries, as they provide
almost total contact with the limb.

Inflatable sockets
Sometimes Inflatable sockets can be used. These sockets are quite big, but can expand
by adding air, thus leading to a tight fit. In richer countries, these prostheses are
sometimes used as a temporarily solution. Strong inflatable parts are needed to
withstand the high pressures. Also, there is a risk for a “flat” prosthesis.

Bamboo socket
This socket is made by putting two layers of cotton
stocking (with in between the two stockings a plastic bag)
over the stump and knee and to wrap the stump and knee
with plaster bandage. Then a bamboo is split at one end
into a few strips and the plaster socket is then put between
the bamboo strips. This same socket can be used for a
PVC plastic pipe prosthesis.

Advantages:
• Simple to make.
• Low cost.
• Easily available.

Disadvantages:
• It doesn’t last long.
• It looks primitive.
Picture “bamboo socket”:
This picture shows a very
cheap and easy made
prosthesis.

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Leather socket
Advantages:
• The socket is open at the bottom of the stump,
which makes it cooler, and also allows for growth.
• Leather is available almost everywhere.
• It’s comfortable in hot weather.
• It can easily be adjusted to the stump as it
becomes smaller or bigger.
• It’s soft and easily takes the shape of the stump,
and therefore self-corrects moulding mistakes.
Disadvantages:
• You have to “use” animals for their pelts.
• Leather has to be treated to be resistant to water.
When wearing a wet, leather prosthesis, blisters
can arise. Wet leather dries very slowly
Picture “leather socket”:
Jaipur (aluminium) socket This is one basic and useful
The foot, itself, is probably the better known component of design.
the Jaipur limb, but the socket is just as important.
Originally made of aluminium and PVC irrigation pipes and (now also aluminium in
tandem with polypropylene in various versions). Most versions are open ended plug
sockets which bear the amputee's weight on a popliteal shelf and patellar tendon bar
(the upper calf muscle and just below the kneecap). The most common suspension
system, or method of affixing the prosthesis, is a leather cuff above the knee.

Here the socket is part of the shank and is made/ shaped


directly on the stump.
Advantages:
• Low cost.
• Quickly fitted.
• Low/light weight.
• Easy to fit stumps of non-optimal size in the socket,
because the socket is open on both ends.
• The socket is easy to produce.

Disadvantages:
• It requires a lot of skill as well as special equipment
to make the limb.
• It can brake easily.
• Less suitable for wet climates where water and
moisture can enter through the open end of the
socket.
• Physically less attractive than most other
prostheses. Picture “Jaipur limb”: Jaipur
• The aluminium absorbs heat in a hot climate and sockets as well as Jaipur
can become uncomfortable. foots exist.
• The fact that it is produced manually makes
alignment difficult.

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Mukti limb
First a negative cast mould of the stump is made. Then a
positive cast mould is made for the whole artificial leg, with the
help of the negative mould. After that, plastic pipe is stretched
over the leg mould, the leg mould inside the plastic is broken
and removed and a rubber foot is fitted to the leg.

Advantages:
• Quickly made.
• Low-cost.
• Easier to mould than PVC pipe.
• Light weight. Picture “a mukti limb”

Polypropylene prostheses
The sockets of these prosthesis’s are also made with the help of
negative and positive cast moulds.

Advantages:
• It’s lightweight yet strong PP.
• It’s flexible and easy to shape.
• It’s more user friendly compared to for example metal.
• It’s easy and comfortable to fit.
• It’s water resistant and easy to clean.

Disadvantages:
• The plaster bandage is expensive.
• In warm weather it can become uncomfortable and skin
irritation can be a result of that.

There are of course other materials that are used for the Picture “Polypropylene
production of sockets, like wood, fibreglass, carbon fibre, etc… prostheses”: One
“naked” and one
More information can be found on the videotape “Phnom Penh’s “aesthetical” prosthesis
Component factory and Battambang’s Prosthetic Workshop” are shown here. .
(1998).

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Shanks
There are two types of
prostheses: exoskeletal (or
crustacean) and endoskeletal.
The shanks of exoskeletal
prostheses are on the outside,
typically made of wood,
thermoplastic or polyester resin.
The inside is usually filled with
wood. These shanks are
heavier, but more durable than
endoskeletal prostheses.
The Jaipur prosthesis, a type of
exoskeletal prosthesis, can also
be made using high-density
polyethylene (HDPE) to make
Picture “exoskeletal Picture “exoskeletal
both the socket and the shank
wooden prosthesis”: an below-knee resin
(see the picture below). The
easy and robust solution for prosthesis”: Also notice
HDPE is available in the form of
the shank. the bilateral below-knee
pipes designed for irrigating rice
amputation.
fields. It is thus easily available
in many developing countries like for example Sri Lanka. Endoskeletal prostheses have
the most lifelike appearance, but require careful maintenance. Their shank is on the
inside. It is a central tube, called the pylon, which is usually made of aluminum. It is
covered in foam or polypropylene and encased in a latex or fabric stocking for cosmetic
purposes. These shanks are generally more attractive than those of the exoskeletal
prostheses.

Criteria:
• It has to be easy to adjust the length of the shank or to replace it.

Picture “the Jaipur limb”: A Picture “endoskeletal prosthesis”: here you can see
famous exoskeletal prosthesis. the lifelike appearance of the endoskeletal prosthesis and
the aluminum pylon which fits inside.

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Foot-ankle systems
According to us there are two main principles to simulate normal walking with a tibial
prosthesis. The first principle is one with an ankle joint and the second is one without an
ankle joint. In case of the latter we must simulate
the motion of the ankle in another way, which we
will discuss at a later stage.

A: Prosthesis with an ankle joint

I A rubber joint
In Sri Lanka there is a lot of rubber available. So it
seems to be a good idea to make a rubber ankle
joint. However we didn’t find an example of a
rubber ankle joint in the literature. Nevertheless in
other applications rubber joints are frequently used
Picture “windsurf joints”: Windsurf
(see the pictures at the right, here a rubber joint is
joints can resist sun and water.
used for connecting a windsurf board and its sail.)

II A metal joint
Another way to simulate an ankle joint in a
prosthesis is the use of a metal joint. In
the literature we found different kinds of
metal ankle joints. Most of them are using
a high standard of technology which
usually makes them very (see the pictures
at the right).
In other applications we also found metal
joints usable for ankle joints.

Picture “metal joints”: This design by Otto-


Bock contains metal a joint..

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B: Prosthesis without an ankle joint

If we do not use an ankle joint, another way to simulate the motion of the ankle must be
found. There are several broadly used solutions.

I Springs
There are two different materials (spring steel and laminated wood) to use for this
solution. Most examples below are from existing patents that we found on the internet.
Spring steel is difficult to manufacture. Laminated wood has a bigger chance of breaking
when subjected to loading for a large amount of time, because of its fibre structure.
Otto Bock, the biggest producer of prostheses in Europe uses these solutions only in
very specific situations, because there are easier solutions like for example the foam
rubber foot (see next page).

Picture “springs”: Here a few solutions for spring feet are shown. These are
from the patents found in Appendix VII

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II (Foam) rubber
The solution for the feet
which is used the most is the
foam rubber foot. These feet
have heels that are pressed
inwards (like a rubber
sponge) at heel contact and
the fingers of the feet bend a
little at the ’roll over’ at the
end of a step. In third world
countries this method is used
somewhat more primitive, but
with the same principles.
For example the Jaipur Foot.
The Jaipur foot has an
opening between the “thumb”
and the rest of the toes (see
the picture at the right),
which causes a better
unwinding of the foot, with Picture “foam solutions”: Most famous as a third world
the toes bending outward a solution for the foot is the Jaipur foot. The picture is a foot as
little. used in Netherlands (and in our experiments).

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III A curved sole (Rocker-foot)


Another way to simulate the way of walking without an ankle joint
is with a curved sole. With a sole which is curve shaped, it still is
possible to obtain a decent gait.

The working principle of the Rocker-foot is that the back slopes in


at an angle of 30 degrees with the floor for a softer heel strike and
roll-up of the heel delays plantar-flexion of the ankle joint enabling
the accelerating tibia to maintain a constant angle to the foot.
The middle section is flat for firm standing on the flour. The front of
the rocker-foot is rounded in at an angle of 25 degrees with the
floor for easy ’roll over’ at the end of a step.
With the help of the curved sole it’s possible to have a correct
unwinding of the foot.
Picture “curved
A rocker sole delays forefoot contact until the leg can catch up. sole”: this is not a bad
Then it advances heel lift to catch up with the leg as it moves over solution. Good gait is
the foot. possible with this
In Europe the rocker-foot is used for people who broke an ankle design. Of course,
and have them in plaster to heal. nobody would call it
beautiful.
In this example the rocker-foot is used as an orthesis, but we can
also use it for prostheses. The rocker-foot can easily be made from
wood (see the picture at the right).

Picture “rocker-
foot”: we tried this
solution….it worked
even better than
expected!

Picture “rocker-foot principle”: due to the curved Picture “rocker-foot”: the


shape of the rocker-foot the angle of the ankle can be 90 solution. Look at the flat parts for
degrees all the time in spite of plantar and dorsiflexion. relaxed standing.

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Conclusion Prostheses Analysis


Sockets
In table “comparing the sockets” the sockets as just described are compared on a few
points. The score we have given is meant for the sockets which will be made in Sri
Lanka. The table shows two strong solutions.

The first high-scoring socket is the leather socket. This socket seems to have little
disadvantages, except that animal pelts are required for its production. The two
strongest advantages of this socket are the facts that leather is a cheap, easy available
material in Sri Lanka and that leather is comfortable in hot/ wet surroundings, if treated
right. Later we shall try to design a solution which combines leather and denim.

The second socket with a good prospectus is the one designed by Inne ten Have. The
strongest advantages of this socket are the facts that it’s simple to produce, low cost and
that it uses easily available materials. Another reason to experiment with this prosthesis
is that it is never take in production. It would be a pity if a good design would not be
implemented. While experimenting, we try to examine if adjustments to the design are
needed.

Socket Simple Easy to Low cost Easily Durable Aesthetical Low weight Comfortable in hot/ Adjustable
Sri Lanka to make repair available wet surroundings

Bamboo ++ ++ ++ + -- -- +/- - ++
Jaipur (Al.) + - + + - - + -- -
Leather + + + ++ + + + +/- ++
Mukti + - + + + ++ ++ ++ --
Polypropylene +/- -- -- - ++ ++ ++ + --
Inne ++ + ++ ++ + + + +/- +/-

Table “comparing the socket”: The scores of the different sockets. Especially the
leather and Inne’s solution score well

Shanks
The shank can be chosen depending on the solutions selected for the socket. Both
exoskeletal and endoskeletal shanks have their advantages. In most cases, we can
choose the shank that’s most easily produced (in combination with the socket and the
foot). A shank which is adjustable in length is recommended.

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Feet
The same comparison procedure as with the socket has been applied to the different
solutions for the foot (see table “comparing the feet”). Again, two designs are very good.

The first very good solution is the foam-rubber foot. This one has (especially the version
from Otto-Bock and the one from Jaipur) the big advantage that it is aesthetically very
appealing. The disadvantage is that is doesn’t improve the unwinding of the foot.

The second solution is the use of a simple and cheap version of the rocker-foot (for
example by using wood). This solution can provide a decent unwinding of the foot. A
disadvantage is the (probably) high weight of the foot. Solutions using springs are much
lighter, but other disadvantages do not justify their use (in third world countries).

In the experimental phase we shall examine if we are able to combine the two solutions.
The result has to be a foot which is easy to repair and produce, simulates the unwinding
of the foot and has nice aesthetics.

Foot Simple Easy to low cost Easily Durable Aesthetical Low weight good gait
Sri Lanka to make repair available simulation
Metal -- - -- -- ++ ++ +/- ++
Springs +/- -- +/- - - -- + +
Foam-Rubber + + + + + ++ +/- -
Rocker-foot (wooden solution) ++ ++ ++ ++ ++ + - +

Table “comparing the feet”: Especially the foam-rubber and the rocker-foot solutions
score well.

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Production

Available Materials
• Aluminium, titanium, steel and alloys
Three different materials are most commonly used (in European countries) in the
making of below-knee (lower leg) prostheses: aluminium alloys, titanium and
polypropylene (see below). Titanium is extensively used in China for making
expensive high-quality pylons, which are attached to the prosthetic foot and
socket through an attachment plate. This considerably increases the strength and
reduces the weight of prostheses. Fabrication of titanium parts is difficult,
however, as special equipment is required to process the metal in an oxygen-free
atmosphere. Aluminium is light weighting (weight), but brittle. Steel is strong and
easy to deform and produce, but heavy. Metals are easy to produce and last for
a long time. Attaching other parts of the prosthesis to the metal part causes more
work and costs.
• Polypropylene, Thermoplastic or Polyester resin
Polypropylene has three advantages over aluminium: it is much lighter; it is
cheaper and setting up production facilities may be easier for PP than for
aluminum
• Foams,
Tempur (see Appendix VI) and Polyfoam
Foams are easy to shape.
• FiberGlass
Fiberglass if used wisely can be a lot cheaper in a third world country than in a
first world country
• Leather
Leather is available almost everywhere, also in Sri Lanka. Leather is comfortable
in warm weather; it adjusts its shape easily to the person who’s wearing it.
• Wood, Bamboo
Wood is available almost everywhere
• Clay, Plaster
Plaster of Paris or another high accuracy plaster is needed if you want to produce
negative limb moulds.
• Useful products
Using recycled products
could greatly decrease the
costs of the prosthesis
o Car Tires
o Bicycles / Mopeds
o Ropes, Strings,
o Fabric and textile,

Picture “materials”: A picture of a market in India


shows all kinds of materials daily used in third world
(households). Some of these materials are ideal for
use in prostheses.

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Available production methods


Industry
Not intended as a factory for prostheses, in industry area’s large factories can be found
which can produce almost everything we can produce in European countries (at a lower
price and often with a lower quality). If needed, large quantities of parts can be obtained
from these factories. The use of large quantities of parts requires difficult logistics (if you
want to distribute them over the whole country and is therefore not recommended).

Funded prostheses workshops


The prostheses are now often made specifically for one person. The production method
is standard and the prostheses builders of the workshop are craftsmen who are very
good in reproducing prostheses. The craftsmen know how to make moulds of the stump
of the residual limb with plaster and are experienced fitting prostheses on patients.
These craftsmen usually don’t develop any new solutions or designs and if they do, they
would hardly draw it on paper. Instead they will start producing the new design
immediately, learning from trial and error.
Often there is one person in charge of the workshop and maybe he is also the one
taking care of all the financial matters.
These workshops in third world countries like Sri Lanka have the following equipments,
which are mostly in bad condition:
Grinding machine, bending bench, hand power drill, column power drill, electrode
welding machine, halogen welding machine, a small belt sanding machine, a sewing
machine, moulds for making a Jaipur foot, a heating oven and all kinds of hand tools.
Such a workshop also often functions as a village repair shop, because it could be the
only place which has such equipment.
Sri Lanka’s electricity net uses 220 Volts, so the same tools can be used there as are
used in European countries.

Bicycle repair shops


If we want to estimate what can be done at these often mentioned bicycle repair shops
we can use the following slogan: “the shopkeeper there can do the same, as we can do
here at home”. Of course, not only bicycle shops can repair or manufacture prostheses,
also carpenters or maybe even local sewing shops or other local industry.

Homes
People can always make little adjustments themselves, like adding buttons or adjusting a
screw. We can not ask too much from “home improvements”, because these people do
not have the same tools as we do at home.

Combined
A large amount of prostheses needs to be produced every year. This way a production
of 3000 pieces a year could be realised. For example: “1000 at 3 small factories, 1000 at
local blacksmiths, bicycle shops etc, 1000 by repairing the prostheses at home”.

Criteria:
• The prosthesis can be manufactured in a prostheses workshop
• The prosthesis can be repaired in a bicycle repair shop.
• It would be better if the prosthesis can be manufactured in a bicycle repair shop.

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Standardization
When you would be asked to build one prosthesis, for only one patient, how would you
undertake this? Probably, you want to know a lot about the patient’s needs and
measurements, and then design a good solution for this particular patient. When you,
after this, would be asked to build ten prostheses for ten different people, how would you
undertake that? Probably, for building the first few prostheses, you would follow the
same process each time, as you did for making the one single prosthesis. After a while,
however, you would notice that all prostheses you designed and built show similarities in
some way. Noticing this, you would realize that you are making duplicated efforts when
designing the whole prosthesis again for each child. Also, on that moment you would
start thinking about the use of similar parts in every prosthesis. Thus, before you
continue the building of the ten prostheses, you design some parts, which you can make
easily and which you can use for every prosthesis.

Cheaper
The process of ´standardization´ has started. Standardization means, that all parts,
assemblies or even whole products, that don’t need to be different, are made equal. On
a low, but very important level, some parts are already standardized. Think of the bolts
or the screws that have been made in a particular standard. On a higher level, the foot
can be completely standardized. Without these standard parts (and even assemblies),
the costs of a prosthesis might become too enormous.
So, the answer to the question 'why standardization?' is: because it makes things
cheaper. And cheaper things have two advantages: They are for more people available
and in the same time they can provide more income for the people who make them. The
following example shows how that is possible.

The quality of the prostheses


Many people have the idea that 'standardization' and meeting peoples particular needs'
are in conflict with one another. However, this is anything but true. In fact, the modern
sense of the industrial term ‘standardization’ is based on the principle 'meeting the
particular needs of many people’. The particular needs are met by 'building' a product as
a sort of modular system, out of standardized and changeable parts. Because of this
modularity, a great variety of 'particular needs' can be realized. Besides, because of the
low costs of standard parts, such a product will be available for many people. So, the
quality of the prosthesis for the particular patient is not in danger, and can even be
improved by using the principles of standardization.

Different levels of standardization


Different parts of the design and different users either need specific adaptations to the
design or can use standard parts. In this context, we can distinguish between different
levels of standardization (see table: “levels” on the next page).

Of course there are no clear borders drawn between the levels. Different parts (for
example foot and socket) can use different levels.

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Level 1 Every prosthesis designed for a particular user. Except from the standard
buying parts you use to build these prostheses, there is no standardization at
this level.
Level 2 A wide range of particular standard designs. Each design meets the needs of
only a small range of users. Although, at this level, the prostheses can be
highly standardized, the standardization level of your workshop as a whole is
not very high. The wide range of different models will take a lot of time
changing the production, and causes low routine to build the prostheses.
Level 3 A small range of partly standardized designs. Each design meets the needs of
a wide range of users. Some adaptations might be standardized, while others
have to be designed to user’s particular needs.
Level 4 A small range of completely standardized designs. At this level, even the most
particular adaptation needs are met by standardized options. For this
standardization level, either an extensive machinery park, or a very ingenious
design would be required.
Level 5 One completely standardized design for adaptation to all needs of all people
who need a prosthesis. Such a prosthesis would be unnecessary complex and
costly for most of its purposes. However, this level could only exist in mass
production.

Table “levels”: We can distinguish different levels of standardization. Each level


increases the amount of standardization

How to
To read about a possible way to implement design for standardization in the third world,
look in Appendix IV: “Manual - How to design prostheses”, paragraph “design for
standardization”.

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Life Cycle Analysis


Life Cycle Analysis (LCA) is an approach for the evaluation of the total environmental
impact of the prosthesis. Since the whole life cycle of a product is considered, LCA is
often called 'the analysis from cradle to grave'. In the situation described below however
you will see that the materials of the prosthesis eventually find their grave, but the
prosthesis itself keeps on living.

Here we have tried to describe the life cycle of the prosthesis with the help of a scenario.
We’ll use an example of a young boy of ten years old, who gets the possibility to get a
prosthesis fitted. He will have to take a long journey, probably by bus, with his parents to
the prostheses workshop. At the workshop the family is welcomed and the boy’s
measurements are taken. The prosthesis is then skilfully made by the prostheses
builders. Of course some tests will be done to see if the prostheses fit the boy well and if
it’s comfortable. Quicker then expected, after only one day, the family and the child go
back to their home.
Before the boy had a prosthesis, the family of the boy had to look after him, but of
course they couldn’t always be around and the boy was living in isolation, because he
couldn’t go out to play and to explore the world around him.
With the prosthesis the boy can improve his mobility and so won’t be dependent on
others. His improved mobility gives him the opportunity to live his life as a worthy human
being.
In the beginning the boy will have to get used to his prosthesis and learn to walk on it
and during his journey back home on the bus, he’ll learn how to bend his knees while
sitting in the bus.
On his first night back he’ll have to put off his flip-flops which are attached under his
normal and artificial foot and later on take off his prosthesis before going to sleep.
Standing up in the morning he’ll have to see if his prosthesis is clean and then put it on
himself or (in the beginning) with the help of his parents.
He will then immediately learn to squat down with his prosthesis and sit on the floor to
eat breakfast.
He will walk to school on his prosthesis and during the break be able to play on the
playground with his friends. Of course he’s very enthusiastic.
Later in the day he might have to go with his father to work in the rice fields. During and
after work he’ll see what the possibilities of his prosthesis are. His prosthesis has of
course gotten dirty and he needs to clean it up at home, otherwise his prosthesis might
get damaged, following the instructions that have been given to him by the prosthetic
workshop about “How to clean your prosthesis”.

SQUAT

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After a year the boy has grown and does not feel comfortable any more in his prosthesis.
His father then gets the manual given to them by the prosthesis workshop about “How to
adjust or repair your prosthesis”. They then decide that they have to make a bigger
shank. They measure how big the new shank should be and go to the local repair shop
to order this specific piece of wood or metal if needed. They then themselves or with the
help of a friend or the repair shop, replace the old shank with the new shank. The old
shank can then be used for cooking in their own home.
The design of the whole prosthesis is in such a way that the disabled person itself or
their family can improve and customize their prosthesis themselves, replacing old parts
with new ones and keeping the prosthesis alive.

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Synthesis
Design Philosophy
This is our design philosophy. It is a summary of the most important principles we think
are important for the design of the prosthesis and the implementation in Sri Lanka. This
Design philosophy can be found between the lines all through the synthesis.

• The most important is that the solutions work (strong, robust, comfortable and with
good prospect)
• Standardization of the design of shank and feet. “one design fits all”
• A modular system for the socket. A range of standard sizes is produced. The
combination of these parts fulfils the needs of everybody.
• The design has to give enough information (usecues) about how it could be
produced “at home” (the local bike repair shop or carpenter). This doesn’t imply that
the design could not have a modern look. Example: A pink injection moulded foot
with a wood texture could “communicate” that it also could be made of wood. This
principle implies that the design also shows how it can be repaired at home.
• We give the amputees a cheap, basic prosthesis (which fits better than it looks). The
people improve and customize their prosthesis themselves. Example: The prosthetic
foot given is aesthetically minimal optimized (and thus cheap). This foot is easily
changeable for a homemade one which looks more like the normal foot of the
amputee.
• If we cooperate with a factory that already has a machine park (for example plastic
processing) then you will have to use this “high tech” machinery. The same principle
applies to the design. If you cooperate with people who have years of knowledge
about for example a Jaipur foot, a lesser solution can not be proposed.
• We want to start up a trial when we arrive in Sri Lanka. We aim at an initial
production of 300 pieces a year.
• Because of the many aspects on designing sockets and their production and fitting,
we now present some general solutions. These can be optimized and standardized
in Sri Lanka together with the professionals. Designs can be tried and adjusted
immediately.
• Eventually we will come up with three Designs:
o 1 mechanically and medical correct one: This one does what it has to do,
nothing more. Its producible and comfortable
o 2 an aesthetic design : The idea’s are made in the Netherlands, the final
design in Sri Lanka
o 3 luxurious versions: In the future, if the trials are successful, a new and
improved, more expensive design could be made. Its possible this prosthesis
is designed by a different team

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

List of Design Requirements


Common
An ideal artificial leg/ prosthesis should:
• Functional
o serve its purpose well (help a handicapped person walk or function better)
o be easy to put on and take off
o be long lasting
water-resistant and wear-resistant
o easy to clean
• Forces
o be lightweight yet strong, but have a minimum weight of about 1 kg.
• Social
o be as attractive as possible
o be low cost
• Medical
o be comfortable
o do no harm
o can be aligned without the help of well-trained professionals.
• Production
o be easy and quick to make
o be producible with local tools and limited skills
o use local or easily available materials
o be easy to repair and adjust as a handicapped person grows or develops
Shank
• It has to be easy to adjust the length of the shank or to replace it.

Foot-ankle system
The prosthetic foot should:
• Gait
o allow a gait as normal as possible
o allow for the swing of the pace
o absorb any jolts to the heel
o stabile while standing still
• Functional
o allow squatting
o walking over rough surfaces
o not make any noise
o be resistant to the tropical climate
o be durable
• Social aspects
o be made with the consideration taken of the social structure, cultural and
religious traditions and lifestyle of the person involved
o be appropriate for wear with flip-flops
o be appropriate to wearing no shoe at all, given the custom of taking off
shoes before entering a house.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Socket
A Socket should:
• Fitting
o be comfortable / fit comfortably
o provide a good fit with the stump / provide almost total contact with the
limb
o allow blood circulation without being loose
provide continues pressure on the right places while not using the
leg to prevent sliding. The prosthesis always stays on the same
place. This pressure is as low as possible
while using the leg the normal pressures have to increase enough
to provide stability. There has to be a good balance between the
maximum pressure (this is the biggest force on a small surface
and will probably be found on the patellar tendon) and the total
pressure (sum of al forces * surface)
o allow a straight stump
• Functional
o give an effective overall stability and suspension to the limb.
o allow a “normal” gait
be correctly aligned (angular and linear). The angle between the
upper leg and the shank should be correct.
not falling off while lifting the leg
o allow squatting
o allow to be easily taken off or put on.
• Forces
o provide weight bearing support in the area of patellar tendon right below
the knee and medial tibial flares (popliteal shelf, the upper calf muscle).
o not bear any weight on pressure sensitive areas
o support the shear forces about the stump
• Pain
o not cause any pressure sores
o have enough air ventilation
o not irritate the skin
• Adjustable / Grow
o be adjustable to change according to stump thickness
o be adjustable to support growing children
o be able to support a large quantity of the Sri Lankan amputees
o be adjustable all around the Island, with simple means

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Production and implementation


• Production should involve the amputees.
• The implementation should be low risk
• The required financial investments should be low
• The western input should be low, more input (e.g. time, energy and effort) is
asked from the country (its inhabitants, especially the amputees) itself
• The prosthesis design is allowed to evolve. There is enough time for good
evaluation and feedback

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Experiments and evaluation


From the beginning we we’re very exited to
experiment with all kinds of solutions. We began with
making our own Rocker-foot from wood to walk with
and to test the feel of it. We were very satisfied with
the outcome of this wooden model, which you can
see at the right.

We also made different kinds of sockets and


simulated different ways of suspension, from which
you can see a few examples in the pictures below.

During our first visit to the Dijkzigt hospital we were


given a prosthetic foot, which we later on attached to
a piece of wood that functioned as a shank.

Picture: “rockerfoot”: While in


normal gait the ankle can be held in
the same angle all the time.

Picture: “connecting the


prosthetic foot and the shank”

Picture: “suspension”: We tried different solution for the suspension.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

After a while we had thought of a suspension


method, for which the lower leg had to be on a 30
degree angle with the upper leg, to be able to put
sufficient pressure on the kneecap tendon to bear the
patients weight. Here to the right you can see a
picture of this idea.

We eventually had to put aside this idea because of


what we heard during our second visit to the Dijkzigt
Hospital
The orthopaedic surgeon at the Dijkzigt Hospital told
us that this idea would cause contractures in the
patient’s hip and knee (see picture “fitting a limb” on
page 11).

After our second visit to the Dijkzigt Hospital we were


given a mould of an amputated limb, with which we
could make designs, according to the measurements
of the mould.

Picture: “finding an angle”:


Notice that angle α (see chapter
“force diagram”) is about 65o, which
has great mechanical advantages.

At the same time we thought of a


leather design for the socket.
This leather design is made from
the materials leather and denim,
with special padding for the bony
places on the limb, which should
be protected from any pressure
being put on them. The leather
socket also has two pockets for
two wooden sticks, which
suspend the limb. With
amputees, the two sticks are
attached to the shank.

Picture: “leather prosthesis”: The leather


prosthesis can be worn even with normal legs.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

During the experiments with this


leather design, we saw that the
limb would slip through the socket
after a while. The wooden sticks
were causing the socket to be
stretched out, in such a way that
the suspension wasn’t good
enough. Even without the sticks
the suspension did not improve.
So we decide to wear the socket
upside down. This (to our surprise)
worked like a charm. In this
situation the pressure that is put
on the patellar tendon is along a
wider surface, which causes a
bigger pressure on the patellar
tendon and a better force
distribution (see the pictures to the
right).

Picture: “wrong way”: The leather prosthesis


can be worn even with normal legs, but what
about wearing it upside down?

Picture: “production of the leather / denim socket”: The leather socket can
be produced with simple tools, as is shown in this picture.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Concepts
Hereafter some concepts are shown. These are our results and recommendations for
the design of the foot, shank and socket. Also, our concepts about production,
implementation and knowledge transfer are present.

Concept 1: The rocker-foot


This Rocker-foot concept consists of four parts. The main foot is made of wood and
attached to the shank with the help of a connecting mechanism that is usually used for
connecting kitchen sink components together. With this connecting mechanism there is
no need to screw a hole in the wood, yet the connection remains very strong.

A steel profile is shaped around the sole of the foot. On top of that there is an aesthetic
foot, of which it is clear how it has been made. Our principle is that the person wearing
the prosthesis or its environment can reproduce this aesthetic foot to look like the way
they want it too look.
At the bottom of the foot there is a standard flip-flop, which is removable.

Picture: “production of the rocket foot”: from left above to right under you can see how this foot could be
produced.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Concept 2: The socket by Inne redesigned


Inne ten Have showed us and explained us his design.
These are his results:

Picture: “Inne’s design”: Here you can see the main principle and production method of
Inne’s design. In the upper left corner is shows how the prosthesis only loads the green parts,
which can handle the pressure. At the upper right corner we see how the prosthesis can be
fitted for every amputee. The lower pictures show the prosthesis while in use and their
attachment to the limb.

Advantages:
• Easy Production
• Easy reproduction
• Clear design
• Good pressure points are used – principally right

Disadvantages:
• Not very comfortable
• Not the most efficient force distribution
• Easy to make mistakes while fitting
• If the prosthesis bends through (cycling) loading, the prosthesis needs to be
taken off, tinkered back into the right shape and put on again

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Force Distribution:
As you can see on the right side, this design (as do
all designs) requires an enormous force on the
backside of the leg (see “Force Analysis”). This
amount can be decreased with a bigger angle (now
30 degrees) or by a better a:b ratio (see chapter
“Force diagram”). In this example the a:b ratio is 3.
While the design of Inne takes the great force on the
knee tensor in account, it doesn’t do the reaction
force on the backside of the leg.
Also, some additional attention is needed for the
force on the shin-bone (tibia). In Inne’s design this
force is in reality the resultant of two perpendicular
forces from the vertical metal sheets on to the stump
(see picture “resultant force”).

Figure “MRI scan” shows a MRI scan of the knee. A


MRI scan clearly shows hard and soft parts and
tissue, like bone and cartilage and the ligaments. Soft
tissue obviously deforms more under pressure than
hard tissue. The red part drawn inside the scan
shows the expected deformation if the tensor is
loaded (on a 30 degree angle). Thus, instead of a
straight shape of the prostheses (shown in blue) a
piece with different thickness has a better force
distribution (shown in red outside). Also, the patella is
a moving part, so pressure upwards will cause the Picture: “Force Analysis for Inne’s
patella to move upwards. Therefore it’s required to design”: Here you can see the big
load the patellar tendon (low and perpendicular to the forces which are needed to support an
surface) more than the patella itself (to high or to 80 Kg weighing person. The formula’s
vertically loaded). used are below (Fx1 is the 2100 N
arrow and Fx2 the 700 N arrow)

Horizontal force 1385 = 800 / tan(30)


Ftensor 1600
Solve Fx2: 1385 + Fx2=Fx2 * a / b
Is a/ b= 3 then Fx2 = 692.5 N

Picture: “MRI scan”: The two forces that act from the Picture: “resultant force”: The two
metal sheets on the stump, result in a force forces that act from the metal sheets on
“backwards”. the stump, result in a force “backwards”.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Improvements
• The patellar improvement. With an extra rubber piece on the metal sheet that loads
the patellar tendon, the pressure can be divided better when under load.
• With some padding at the sides (vertical sheets) the pressure can be divided further.
• A broad strip on the backside can be used, instead of using a thin thread
• A western look can be obtained by making a nice aesthetic cover from foam or
polypropylene. The appearance is lifelike, but the underlying skeleton can still be
made by the local carpenter.
• By having different sized inserts (“klickable” solutions) customized prosthesis can be
presented. The measuring time can be reduced to minutes instead of days.

Picture: “add-ons”: With extra Picture: “padding”: The red areas


add-ons a more comfortable are as broad as possible. Padding
prosthesis comes into existence. can be added here to improve
The light blue pockets on the comfort and to divide the pressure.
vertical sheets can be stuffed with
padding according to the needs of
the amputee.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Concept 3: The textile / leather socket


As we shortly described in
chapter ‘Experiments and
evaluation’ we thought of a
leather design for the socket.
This leather design is on the
outside made from the materials
leather and denim. On the inside
special padding is placed for the
places on the limb where the two
wooden sticks will be placed to
suspend the limb. (See Picture:
“the inside” and picture “the
outside”) The padding is meant
to give the prosthesis more
comfort and also for creating a
large surface for contact. The
bony places on the limb should
be avoided from any pressure
being put on them (see chapter
“amputation”). For these places
we made holes/ openings in the
foam. Picture: “the inside” There are several easy available
materials used for the inside

On the outside there are two


pockets placed for the wooden
sticks. The wooden sticks will
be fastened to the shank of the
prosthesis. If you would like to
make the shank longer (for
growing) you only have to
change the length of the sticks.
On the backside of the socket
we made some holes to put a
rope through.

Picture: “The outside”: Picture: “The backward


The wooden sticks are in side”: A rope is holding
special pockets. the socket together.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

During the experiments with


this leather design, we saw
that the limb would slip
through the socket after a
while. The wooden sticks
were causing the socket to
be stretched out, in such a
way that the suspension
wasn’t good enough. Even
without the sticks the
suspension did not improve.
The reason for this is that the
arrow ‘b’ is missing in this
first design (see the right
picture). In the chapter ‘Force
Diagram’ we described why
this arrow is so important.

Picture: “b is missing in this first design”: The cause of its


‘failure’

We decided to wear the socket upside


down. This (to our surprise) worked
like a charm. In this situation the
pressure that is put on the patellar
tendon is along a wider surface, which
causes a bigger pressure on the
patellar tendon and a better force
distribution (see the pictures to the
left).

Unfortunately we did not have enough


time to make a new leather / textile
socket with the sticks on the right side.
Before going to Sri Lanka we’ll do this
to optimize the design.

The great advantage of the leather


socket is that it can be adjusted easily
to a persons stump.

Picture: “upside down”: The leather


prosthesis can even be worn on normal legs,
but what about wearing it upside down?

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Concept 4: The polymer socket


During our second visit to the Dijkzigt hospital we were shown some examples of
temporary prostheses, which had an easy to shape polymer socket. We had already
been thinking about polymers which would mold themselves to the shape of the body
when heated and thought of the following concept.

Under high
pressure
deformable
polymer, is
heated, wound
The back of around and
the stump pressed onto the
stump.

The rest material


at the back and
the bottom of the
stump can be cut
off, while the
polymer is being
fastened around
the stump and
glued to itself.
This is now the
inner socket.

The outer socket The front of


is a standard the stump
shape, which is
quite hard. It is
pushed onto the
inner socket from Attached to the
the bottom of the bottom of the
stump. outer socket is a
part, which is
used to connect
the outer socket
to the shank.

Foams like polyfoam or Tempur (see appendix “Tempur”) could be suitable materials to
use for the inner socket. The outer socket can be made out of carbon fiber, fiberglass,
Polypropylene, wood, etc…

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Concept 5: Knowledge transfer


The transfer of knowledge is important in this project, because the local people should
be able to continue or even extend the production of prostheses in the future.

Information should be shared and applied in a way which provides the disabled person
or the caretakers of that person with the appropriate knowledge.
Books can be very helpful to share knowledge but learning from a book isn’t often the
best way to learn something. A lot of methods, aids, and exercises can be learned more
easily from other persons, through watching and through guided practice. But after a
doctor, a limb maker or a village worker has taught the patient for example how to do
certain exercises, or shown them an example of a home-made aid, printed instruction
sheets with clear drawings can be a big help. Also depending on the interest and reading
ability of the disabled person or its caretakers, it may be helpful to give them a few
written papers of information about their disability. Sometimes they can make the
difference between whether the recommendations are followed at home or not.
For example a person with a artificial limb can get an instruction manual about how
his/her prosthesis is produced and how it can be repaired, so when the prosthesis needs
repairment or a modification, they themselves, a carpenter or a blacksmith in their own
village can do the job.
The Prosthesis workshop can build themselves a database of knowledge by keeping a
big file box of papers and information sheets to give to disabled people, explaining not
only what to do, but also why.
It’s recommended that all the information, for example the exercises or the activities are
adapted to the local situation.
So three steps can be taken to help a disabled person or its family to understand how to
make the prosthesis, how to do exercises that are needed and what kind of exercises to
do:
1. First show and explain.
2. Guide them for a while in doing for example the exercises and to understand
why.
3. Then, give them the instruction sheet and explain the main points.

Next to giving information on rehabilitation and use of a certain aid to disabled people,
also information needs to be shared about how disabilities can be prevented. A lot of
times people aren’t concerned with disability until someone they love becomes disabled.
After their loved one is helped, it’s possible to interest them in ways to prevent disability
of other members of the family and community.
Many of the preventive measures, just like the more general social measures, depend on
increased awareness, community participation, and new ways of looking at things.
These changes do not just happen. They require a process of education, organization,
and struggle led by those who are most deeply concerned. Those who are most
concerned about disability are usually disabled persons themselves and their families.
Based on this concern, they can become leaders and community educators for disability
prevention.
Or disabled children and families can join together to form prevention campaigns.
For example, village people put on short plays to inform the whole community about the
dangers of mines.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Lack of correct information often leads to misunderstanding. For example some people
think that paralysis caused by polio is contagious, so they’re scared to go near a
paralyzed person. A good education leads to a society where the disabled people are
able to be a part of the community. The disabled people and their families can then
maybe begin to organize a community rehabilitation program run by disabled people.

Another way of sharing knowledge is through the radio. When a lot of people in
development countries have a transistor radio, then it’s obvious that this is one of the
simplest ways to reach people in a wide vicinity.

Also, a picture could be with instructions could be printed on the prosthesis itself.
Information about repair or use could then always be at hand. Also a print with which
areas of the limb can de subject to pressure can be added.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Concept 6: Implementation plan

Apart from the list of requirements, this implementation plan is based on some basic
ideas. First of all we have to try to let the system become self-supporting (see picture:
“The Distribution”), as well in finances as in knowledge. We try to find finances by selling
prostheses to the army (so, eventually, the army pays for all the disabled).

Picture: “The Distribution”: Apart of prostheses all the parties in the production
process have their “special” extras. For Example: The environment and the high tech
factory provide money for the smaller less advanced factories. These little factories are
an important source of knowledge for the local carpenter or bicycle shop which wants to
produce prostheses. Of course, the high tech factory also provides knowledge, but in
this schematic only the most important functions are shown”.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

1: “At home” – year 0: preparation


Objective: Collecting necessary data, get an overview over the total problem. Provide a
starting point.
• Developing a decent design which can be used in this implementation
• Collecting a knowledge base
• Find finances
• Develop an implementation plan
• Write temporarily production and consultation documentation and a temporarily
knowledge transfer plan

2: “Sri Lanka” – year 1: setting up an trial


Objective: Learn to cope with the people / situation.
• Discuss and evaluate the designs with the local experts. The manual as
described in Appendix IV “Manual - How to design prostheses” can be used to as
an introduction.
• Start a small factory or approach existing factories
• Build a measuring prosthesis (see Appendix V “The measurement prosthesis” for
a functional description)
• Fabricate some prostheses for “locals” (living in the neighbourhood)
• Document all steps necessarily to teach the factory how to produce the
prostheses and how to consult the patients. Finish the production and
consultation documentation and the knowledge transfer plan. (Also see Appendix
III “Manual - Producing prostheses”)

3: “Sri Lanka” – year 2: evaluation


Objective: Evaluation of the design.
• Retrieve information about the prostheses and their use from the subjects in step
2. Adjust the design according to the findings
• Evaluate the development of the factory over a year (is it grown, did it slow down
production, did it start making other prostheses, etc)
• If the design is really good and the consultation handling too, the spreading of the
design should already have begun. Look for this… it’s a good indication this
implementation is going to work….
• Decide how to go on (worst-case scenario: stop the project, best-case scenario:
speed up the project )

4A: “Sri Lanka” – year 2/3: implementing the redesign


Objective: Spread the design
• Set up some factories and consultation centers spread over the whole country
• Set up coordination / “helpdesk” centre for these factories; be sure all information
is available to all.
• If needed, now new versions can be designed (for example for upper-leg
amputees or a version for bilateral (both legs) amputees). Consultation will than
be more important. Appendix III “Manual - Producing prostheses”, chapter
“consultation” describes this scenario.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

4B: “Sri Lanka” – year 2/3: trail for luxurious design


Objective: Making money
• Design a luxurious version of the prostheses, meant for the Sri Lankan army (and
eventually export)
• Find finances (which should be less difficult, because the design proved itself by
now). Set up an import program and a distribution centre for the first prostheses
(with this design) from Europe. This can be an extra task for the coordination
centre (4A).

5: Sri Lanka – year 4: evaluation and merge


Objective: Close the circle
• Evaluate the success of the luxurious design.
• Set up a factory in Sri Lanka which is able to produce the luxurious design. This
can be an upgrade of the distribution centre (4B).
• Make sure profit and parts are distributed to the smaller factories

Although this implementation plan seems to be a difficult and time consuming thing to
do, it’s important to keep in mind that the main idea is to provide a self-supporting
system. If the design is successful, it’s worth to experiment with this idea. Even if only
steps 1 through 4a are implemented the project is already a success.
In the project for “Design for All” we are focused on step 1 and 2.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Conclusion
We have thought about using one standard solution for the prosthesis foot. This could be
the Rocker-foot (“concept 1”), which consists of three parts. A steel profile shaped to
the shape of the sole of the foot. On top of that there is an aesthetic foot, of which it is
clear how it has been made. At the bottom of the foot there is a standard flip-flop, which
is removable.

Still three different designs/concepts of the socket can be thought of. These are all
reasonably good and worth experimenting with. The first design (called “concept 2” in
the synthesis) is an adjusted and improved design, which was already made years ago
by a designer, named Inne ten Have. We have lots of confidence in this concept
because it’s well designed, having a good socket. We think it’s a shame that it hasn’t
been used all these since it was designed.

The second design (“concept 3”), which is made from leather and textile, has specially
added soft pads and has the same bearing principle (in the socket) as the first design.
This concept is aesthetically nicer than the Inne’s design (concept 2) and looks more
comfortable. The disadvantage of this design could be that it will sweat more.

The third design (“concept 4”) is a plastic prosthesis more based on western ideas and
influenced by a video that we saw about a prosthetic workshop in Cambodia. We still
have to see if the materials are available in Sri Lanka and if it can be produced there.

Next, we presented some ideas about knowledge transfer and how the implementation
could develop “concept 5 & 6”)

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

References
• Ontwerpergonomie (sixth edition), Prof.dr.ir. R. den Buurman et al.
Technische Universiteit Delft, Subfaculteit Industrieel Ontwerpen, March 2000.
• Biomechanica van het spierskeletstelsel, grondslagen en toepassingen (third
edition), Prof.dr.ir. C.J. Snijders, Dr. M. Nordin, Prof.dr. V.H. Frankel
Elsevier gezondheidszorg, Maarsen 2001
• Reader Beweging en Analyse, Haagse Hogeschool, May 1998
• The Tibial Prosthesis (second edition), Handicap International Training centre,
1985.
• Prothesen-Kompendium, Prothesen für die untere Extremität, Otto Bock,
• Prothesenpaßteile-Untere Extremität-, Otto Bock health Care, Germany 2002
• Materialien für die Orthopädie-Technik, Otto Bock health Care, Germany 2001

• Nothing About Us Without Us, Developing Innovative Technologies For, By and


With Disabled Persons, David Werner, Published by HealthWrights, 1998
• Disabled Village Children, A guide for community health workers, rehabilitation
workers, and families, David Werner, Published by HealthWrights, Published by
The Hesperian Foundation, 1987

• Videotape, Phnom Penh’s Component factory and Battambang’s Prosthetic


Workshop, 1998

Picture “information”: A selection from the gathered


information.

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Appendix
Appendix I: Individual motivations
Boudewijn

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Prosthesis for Sri-Lanka TU-Delft 2002 Wisse, v Dorsser, Soleymani

Farshad

Farshad Soleymani, born in Teheran (Iran) on 18 April 1978, fled (from the long lasting
war between Iran and Iraq) with parents in 1986 to The Netherlands.

Leaving home to work or study abroad is an adventurous leap into the great unknown,
especially if your destination is a remote country in the Far East which has been afflicted
by numerous wars in the past 18 years. I see myself as a healthy young man with the
possibility to put the skills I have learned during my Industrial Design study to good use
right now and hopefully this summer, designing prostheses for disabled people in Sri
Lanka.

In July and August of the year 2000 I and a student colleague of mine went to the west
coast of Mexico to work in a wheelchair workshop which was situated in a small village
called Ajoya. The village, a cluster of run-down houses slowly baking in the hot Mexican
sun, is buried deep in the Sierra Madre Mountains, where peasants are dirt poor and
local drug-lords murder each other for control of the region's marijuana crop.
And we knew we were heading to the wild Wild West before hand, but the work was too
important to turn down. In Mexico, parents who can't afford to buy wheelchairs must
carry or drag their disabled children around or some even leave their children always at
home.
Projimo, a community-based rehabilitation project run by and for disabled people, aims
to empower local people by providing training and self-help medical manuals. With their
meager funds unable to meet the overwhelming demand for their services, Projimo was
delighted to welcome us two TU students.
Our destination was Projimo’s 'Children's Wheelchair Project', where Gabriel, a
paraplegic, runs the workshop. Using wood, metal, bicycle tires and basic designs, they
build six wheelchairs a month. The wheelchairs are built from scratch, right down to
putting the spokes on the wheels. The wheelchairs are then transported down the
mountain to Mazatlan, where they're distributed to children for free.
Having endured a 24-hour bus ride from Mexico City to Ajoya and been rudely welcomed
in our new home by a tarantula, we set to work completing a project begun by Mauritz
Zijp, a TU student who had worked in Ajoya a year prior to us.
We redesigned and completed an 'evaluation measurement wheelchair', to be used
during consultations. Before, children were measured with a tape measure, which is not
precise enough. All of our evaluation chair's parts were adjustable and we painted it with
bright colors to make it fun for kids.

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We then made a standardized form to be filled in during consultations. Previously,


measurements were scribbled on scraps of paper, often illegibly. Consequently,
mistakes were made during construction and children were hugely disappointed when
their new wheelchairs didn't fit them properly.
We also wrote a wheelchair design manual, detailing the TU's Method of Industrial
Design. Our guidelines can be used in Ajoya and also in other poor countries where
people want to start a wheelchair workshop.
Ajoya proved to be a productive place to work. With no television or Internet, the only
distraction was the occasional sound of government helicopters flying off to drop
pesticide bombs on marijuana fields. Of course, drug-lords pay off the pilots to make
sure they don't drop the pesticides on their marijuana crop.

One night it was very hot, 35º C. The heat and a chorus of madly barking village dogs
made sleep impossible. At 2 a.m., a masked gunman entered our home, pointed a pistol
at us and demanded "Dinero!"
Although the gunman wore a mask, I recognized his eyes. It was a young guy from the
village. We knew that if we gringos reported the crime, local thugs might retaliate and
we'd lose more than just some money. Everyone in Ajoya has been scarred by violence,
it comes with the territory and you accept it.
A few pesos poorer, we pressed on with our final project, designing and building a
special seating wheelchair for children afflicted with Cerebral Palsy (CP). Chairs for CP
victims must have adjustable seat angles and because CP children have great strength
and can crack metal frames, we decided to use wood.
Wood offered several advantages. It's supple, bending without snapping under pressure,
unlike metal. And in poor regions, wood is usually available and inexpensive. Moreover,
wooden wheelchairs can be built and repaired using hand-tools. We completed our
prototype wheelchair, but some fine-tuning work remained.
Despite the extra pressures of working in Ajoya, we both were glad we accepted the
challenge and helped the needy. It was a life-changing experience, professionally,
culturally and spiritually. It also made us value the law, order and quality of medical care
we enjoy in The Netherlands.
Because we had to adapt our ideas to the available materials and tools, we learned to
be creative and the practical trial and error method we used taught us a lot of manual
skills.
Learning to speak Spanish turned out to be the foundation for a good working
environment for us. We could learn the right manners of conduct and were able to have
a nice chit-chat with the village people.
The Mexican kitchen was very different from the Dutch one, which caused both our
stomachs to irrupt. I was sick for one day with diarrhea and my colleague for almost a
week. Adapting, acclimatizing and accepting were meaningful behaviours we learned to
make our own. We saw how different the way of life is. We in The Netherlands seem to
be in a hurry all the time and forget to find time to reflect.

I don’t know what I’ll be doing in the future, but doing this project for Sri Lanka is at this
moment very important to me.

I will stay in Sri Lanka for approximately one month.

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Wouter

In the motivation given below, I will describe why I am following this optional module and
specifically why I choose for this design project.

After I finished my secondary school (firstly HAVO, later VWO) I wanted to study
medicine. The number of students who signed up for this course was far too much in
comparison with the available number of places. After drawing lots I heard that I was not
going to be studying medicine. Industrial Design and Development was an intuitive
second choice.

Nevertheless my interest for medicine is still increasing. I am specialising myself through


means of optional modules, with subjects such as designing and developing products
which have much ground in common with the medical discipline. During the first part of
my study I followed two ergonomic modules. This year I followed several optional
modules. An example is Bone Mechanics and Implants, which discussed the history of
bones, the way in which a bone is build, several implants and their failure scenario’s.
Another part of this module was a design project of a fall simulator to simulate in which
way a femur will break. Biomechanics was about the appearing muscle activity in several
parts of the human body during static and dynamic loads. Design for All continues this
list of optional modules which also has much ground in common with the medical
discipline. Comparable to Bone Mechanics and Implants, a part of the Design for All
course is also a design project; the design of a prosthesis for people in Sri Lanka. It was
especially this project that attracted me to follow this module. Why…..?

Industrial Design and Development is creating products for people. But for me it is much
more; Industrial Design and Development is creating useful products for people. What I
mean with the word ‘useful’ is quite difficult to explain, it is a feeling I have that has very
much in common with ‘doing the right thing, before doing things right’. This is the first
design project that according to me can really contribute to people’s health.

Besides the fact that this project contains the design of a medical product, I like the idea
to design a product which is directly used by its consumer (patient), instead of designing
a product for a (large) company of which the only purpose is to make a good profit.

I believe it is clear enough that, therefore, I would like to give my internship (6 weeks) a
medical aspect. If it is possible to combine my internship with this Design for All project I
would like to do everything that is possible to design a good product for the amputees in
Sri Lanka who really need a prosthesis.

During the first six years of my life I lived in Saudi Arabia. In spite the fact that I was very
young, I can remember very much about this period. Living in a country which has a
complete different culture compared to the Netherlands will sometimes let you think
completely different about certain things. What is really important in my life? Should I
always think through a European window?

A more practical reason to me to go to Sri Lanka is the fact that my girlfriend is going to
Sweden for about half a year (August to January). It would be most convenient if I could
go to Sri Lanka for my internship in that same time period (three months there).

Yours Sincerely, Wouter

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Appendix II: Exercises

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Appendix III: Manual – Producing prostheses

WARNING: THIS MANUAL IS TEMPORARILY AND HAS TO BE FINISHED

This page is the title page for a compact checklist manual for the prostheses builders
who are involved in making a prosthesis for people of all ages.

The next chapters are included:


• Introduction
• Consultation
• Measuring
• Evaluation

These chapters are omitted, because we still have to improve the final design:

• Producing the prosthesis


• Running the workshop

INTRODUCTION

This manual will be a guideline throughout the design process of Prosthesis. People all
over the world are in title of having a careless childhood and enough means to have a
socially integrated life. People who can not walk will be soon living in isolation. Of course
the family or caretakers will be around sometimes, but you can’t expect the caretakers
being around all day.
The problem of this situation can partly be solved. What if the person can improve his
mobility with special aids like a prosthesis or even a wheelchair!
With some basic tools, materials, a handyman and this manual it must be possible with
some positive energy to build prostheses for everybody.

If there is a will there is a way!

Of course it is easily said than done. But at this moment somewhere else on Sri Lanka,
people are making prostheses using these methods.
The improved mobility of the amputees gives them the opportunity to live their life as a
worthy human being.
This manual includes some questionnaires that can be handy to consult the amputees
needs. Always try to keep the amputee as the central subject. After all the information is
gathered, it is wise to make a summary to get a clear picture of the wants and needs.
We will call this a set of demands to fulfil. This set can be extended with wishes.
The next step is taking the measurements of the limb. This can be done by the
technician, physiotherapist and a physician if available, but with some patients, you will
do fine too.
Most measurements can be found with normal measurement tools. For a perfect fit,
probably several tries for the shape of the socket are needed. (Also see Appendix VII).

At this moment our goal is to make a standard design which will be fitted on the patient,
with the idea that the patient won’t ever have to come back for a second one, because
he/she or his/her surroundings can repair and adjust it themselves.

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CONSULTATION

The fitting process


When a patient is getting a prosthesis fitted at the prosthesis builder’s workshop, it is
recommended to develop a trusting relationship between the patient (his family) and the
team of prostheses builders.
In the beginning also the patient’s measurements are taken to have a good check for
when the prosthesis is being fitted. The measurements can possibly be documented in a
standard fill in form.
Close interaction and experimentation at that time with the prosthesis is needed to make
a good fit for the patient.
A very important part of the fitting process is to evaluate how the patient uses the
prosthesis, which has been made for him, and if it fits correctly.

Consultation
If in the future different designs are made of the prosthesis, which provide solutions for
different needs, then a deeper consultation of the patient with information about the
patient and his daily life patterns can become important.

We have made an exemplary checklist of things which can be looked at, when a patient
is being consulted. Shown on the next page.

Checklist Consultation
The information obtained by the questions in the checklist must be looked at carefully
and used during the design and the production of the prosthesis. It is wise to make a
summary to get a clear picture of the wants and needs of the patient.
This is a set of demands to fulfil. This set can be extended with wishes.

We think the general needs are:


1. Safety
2. Near family and friends
3. Movement
4. Discovering
5. Participation
6. Comfort
7: Self-respect

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Checklist Consultation – Personal particulars


Male / female _________________________ Name _____________
Last name _________________________ Street _____________
Town/village _________________________ Day of birth ________
Name parents/caretakers name brothers/sisters __________________

Kind of impairment?
Abilities and disabilities (because of impairment) __________________

Condition of the lower extremities –


Power of disabled leg __________________
Power of normal leg __________________

What abilities does the patient still have?


• What about the strength and possibilities of the non-effected limbs?
• Is there a possibility to improve the affected body parts by (for example) training?
• What about the mental situation of the patient, is the patient likely to learn and cooperate?
• Can the patient stand up without using an artificial leg?

What are the daily activities of the patient?


Getting up in the morning _________ Breakfast _______________
Between breakfast and lunch _________ Lunch _______________
Between lunch and diner after diner _________ Bedtime _______________

Does he go to school? __________________________


Have some kind of work? __________________________
Does the patient have to be transported for that? __________________________
On what kind of terrain is the patient transported? ________________ Distance __
Can he fully join the school/ work program? __________________________
Does the patient have special plans for the nearby future? __________________________
Are there special wishes of the patient? __________________________
What are the patient’s hobbies? __________________________
What is the main purpose of using the prosthesis? __________________________
What locations does he go to? __________________________
What are the general activities at home? cooking/cleaning/gardening/repair
Is the patient active or passive? __________________________
Which extra features does the prosthesis need? __________________________
About the family:
How poor or rich are they? __________________________
• Can they support the costs of the prosthesis themselves or do they need the aid of funds?
• What about special cultural habits in the patient’s environment?
• What about the family’s and community’s acceptance of the patient’s impairment?

Checklist “Consultation”: This checklist can be used for gathering important


information about the disabled.

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MEASURING
When the designer is making a prosthesis, he could use a chart of average human
measures. The average prosthesis can’t meet with every person’s measurements. Of
course, when you are making a prosthesis for a specific patient, you should take the
measures of that patient.
Measuring is a very important and delicate part of prosthesis making. For example
children have very different proportions in comparison to adults.

When the prosthesis has adjustable parts, the designer should call the patient’s attention
to the adjustability of the prosthesis, because sometimes the patient’s are not aware of
the possible adjustability’s of their prosthesis.

Considerable help in determining the quality of the made prosthesis would be to develop
a test procedure for prostheses. With the help of these tests, you could evaluate the
prosthesis and if necessary add adaptations or change specific parts. Also possible is
the use of a measuring prosthesis (see Appendix VII).

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EVALUATION
If possible, you should try to make a periodical evaluation. Of course, you can not expect
people to travel a lot for this evaluation. But maybe there are users of the prosthesis in
the neighbourhood. Asking them sometimes about their experience with the prosthesis
can be rewarding. Either it tells you about the amputee’s feelings about the prosthesis or
it can show you important improvements or adjustments to the design. Hereafter a short
“checklist for aftercare and evaluation” is given, in order to obtain a good view on the
problems that have occurred during use of the prosthesis.

Checklist for aftercare and evaluation


Male / female _________________________ Name _____________
Last name _________________________ Street _____________
Town/village _________________________ Day of birth ________
Name parents/caretakers name brothers/sisters __________________

Situation
• For how long have you been using the prosthesis? _______ years
• Did you use the prosthesis like suggested during consultation?

Repairs
• Did the prosthesis have to be repaired by others?
• Which parts of the prosthesis has been defect? (Note down in detail: when cause and
frequency)
• By whom was it done? self - family/friends - local workshop
• How long did you have to do without the prosthesis?
• What kind of defects have you got at this moment?

Intensity of use
• Frequency per week hours per day wearing / walking? Do others use the prosthesis?
• After how long do you need a rest?
• What kind of problems have you got with the prosthesis?

Problems with dimenions


Fit of the socket good - too tight - too loose
Gait good – acceptable – looking funny – unpleasant - pain
Length of the shank too long – good – too short
Cushions comfortable – useless – too much friction - sliding
Comfort and safety
Do you have problems or pain, caused by wearing the prosthesis? no - yes
If yes, where? __________________________________________
Do you have problems or pain, caused by walking with the prosthesis? no - yes
If yes, where? __________________________________________

When do you need help from others? going uphill – sit / stand – dress /undress - other

Have there been accidents during use of the prosthesis?


Do you walk on a road with busy traffic?
yes - no
If not, why not? unsafe - too far away - not necessary

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Appendix IV: Manual - How to design prostheses

WARNING: THIS MANUAL IS TEMPORARILY AND HAS TO BE FINISHED

Introduction
This is a manual which describes a method for designing prostheses. It shows a method
for designing all kinds of things as in taught in the Netherlands. Of course, designing is
an activity which can be done in many ways. If you have your own way and if the results
are good, just go on with doing what you are doing. But if you are stuck, you can try
some tips described here and see if it helps.

Designing in a group
There are several design methods that can be used for designing a new prosthesis.
For example there is a method used by small businesses. This method is characterized
by the early production of a prototype. The design is refined through repeated prototype/
Evaluation/ Prototype cycles. The designer learns about the problem through the
generation and evaluation of sequential prototypes.
During this process the prosthesis builder, who is the designer, should analyze all the
information that he has obtained from the patient. During this he could look for functional
and optional solutions for all the particular needs of the prosthesis and the patient. This
is a very useful method

We industrial design and development students have learned, at the Technical


University of Delft in the Netherlands, to use the following design process while
designing.
The design process exists of different phases described in the next schematic overview.

ANALYSIS --------Evaluate-------
PROBLEM DEFINITION --------Evaluate -------
IDEA --------Evaluate--------
CONCEPT (s) --------Evaluate--------
ASSIGN MATERIAL/ OPTIMIZE --------Evaluate--------
FINAL DESIGN --------Evaluate--------
ASSEMBLY PLANNING --------Evaluate--------
ASSEMBLY --------Evaluate---------
TESTING --------Evaluate---------

After each step you can evaluate the quality of the content.
When you are not satisfied you can take a step back. Sometimes you can even take
more steps back in the process. Design is an iterative process.

ANALYSIS
This is the process of looking for information about the topic/product of the design
process, to understand the problem at hand.

Case
An important analysis is the analysis of use. Try imagining all kinds of different
situations the prosthesis and the patient could be in. For example, you should
consider in your design how the patient stands up from his/her sitting posture.

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PROBLEM DEFINITION
A problem definition is a short summary of the problems that must be solved in order to
obtain a satisfied product. It is recommended writing it down for example like a few
questions.

Case
Our problem definition:
After writing the problem definition you will need to obtain a list of demands.
When you design a product think before you start of the most important demands
that your design needs to fulfil. The demands can be determined by
• The future user (think of consulting the patient)
• Product analysis
The obtained demands will be your reflection guide during the design process.
When one of the demands is not fulfilled, take a step back into the design
process and try to also fit this demand into your design.

Case: In our case we used product analysis, literature study and talking with
experts in this field.

LIST OF REQUIREMENTS
In this list you can collect all the requirements and a list of wishes for your prosthesis

IDEA
The IDEA phase is drawing or writing as much as possible ideas and solutions according
to the problem definition. By generating a lot of different ideas, the chance of a good
design is more likely. Alternatives for specific elements of the design enable you to
combine these elements into a total quality design.

Case:
Important while making ideas is to do not think at the first idea “This is it!’. It can
be helpful when you collect more ideas so they can be compared.
The drawings are just simple sketches and don’t have to be very accurate.

Next we draw several solutions for the different design parts. We did this at
random. Evaluating our first ideas did not give us a satisfied feeling.

The process of decision making and evaluation of our designs will maybe be too
fast in our case, because of time pressure. We know that when we’ll be making
the prototype we will learn more and meet new problems.

A concept should show that a design has got potential and is ready for the next
phase, which is the phase where your design gets optimized.

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Choosing the best concept:


A very quick and effective method to choose one your best concept is via a
method, which we’ll call the ‘Date Method’. How does it work? The different
concepts (two or more) will be compared with each other. For example there are
three concepts for the prosthesis. Compare criterion 1 of concept 1 with that of
concept 2. Assign to the concepts for de different criteria - ,-/+ , + or ++. Then do
the same with concept 1 and 3 and concept 2 and 3.

After comparing the plus and minus we can see which concept has got the most
potential for a good design.
The method can be more honest by letting other people do it.

OPTIMIZATION
During this phase we’ll take a more careful look at the concept and try to optimize the
design by assigning the material, the construction method and the measurements to our
design.

In this process you can for example find a new, maybe better solution for your design.
And that’s ok. Like it has already been said, it’s allowed to take a step back in the design
process!
Of course it can happen that you just don’t know how a solution of yours will work out.
Well during your evaluation, during production or even during assembly you can find out
if your design will fulfil the set demands or cause problems.
These problems can then be solved in the workshop.

Case:
Design for Standardization
This section shows a structural way that could lead to make a design for a
standardized prosthesis.
The first step is always, to make it clear for whom you want to design. Since it is
not possible to design a prosthesis to meet the needs of all people in the world,
(most of them can walk), you have to select a relatively small group of people
that share the same basic needs. The smaller the group you select, the more
particular their shared needs will be, and by that, the easier it will be to
standardize the prosthesis. On the other hand, if you choose the group too small,
you will need a lot of different designs to cover the needs of ´all people who need
a prosthesis´. Accordingly, the use of many different designs would not improve
your workshops efficiency either. In this context, we can distinguish between
different levels of standardization:

Level 1
Every prosthesis designed for a particular user. Except from the standard buying
parts you use to build these prostheses, there is no standardization at this level.

Level 2
A wide range of particular standard designs. Each design meets the needs of
only a small range of users. Although, at this level, the prostheses can be highly
standardized, the standardization level of your workshop as a whole is not very
high. The wide range of different models will take a lot of time changing the
production, and causes low routine to build the prostheses.

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Level 3
A small range of partly standardized designs. Each design meets the needs of a
wide range of users. Some adaptations might be standardized, while others have
to be designed to user’s particular needs.

Level 4
A small range of completely standardized designs. At this level, even the most
particular adaptation needs are met by standardized options. For this
standardization level, either an extensive machinery park, or a very ingenious
design would be required.

Level 5
One completely standardized design for adaptation to all needs of all people who
need a prosthesis. Such a prosthesis would be unnecessary complex and costly
for most of its purposes. However, this level could only exist in mass production.

It is important to get yourself insight in the possibilities and restrictions of your


own workshop. Which level of standardization would fit your situation best?
Probably, if your workshop is averagely equipped with some basic machinery and
your production rate is not more then a few prostheses every week, somewhere
around level 3 would be a good aim. We say ´somewhere around´, because
there are no clear borders drawn between the levels. For example, you might
have one design closest to level 4, to serve a wide range of particular needs by
highly standardized solutions, and two designs that together cover the remaining
small range of needs (level 2). The standardization level of your workshop as a
whole would then be somewhere in the middle, around the third level.

When you make it clear for yourself, what kind of standardization would work out
well for your workshop, you will be able to divide all prostheses users into smaller
groups in order to decide what combination of designs would be best to cover all
needs for all users. Choose the groups in such a way, that within each group, the
users have similar needs. A survey like this can help you to make a logical
division. You can make this as extensive as you prefer.

FINAL DESIGN
A final design will give you all the information you need to prepare a plan of assembly.
Mostly this is used to discuss the design of the prosthesis with the people of the
workshop or others involved with the assembly. It’s important to put all the design
specifics on paper and not to keep it in your head, because at some time you will have to
discuss your design with another person, for example the person who will make the
design (or a part of it) for you. Don’t be ashamed for your drawings.
Case: In our case we made a prototype of our design although we had a shortage of
time, also because of the more exploring aspect of our process.

Assembly (and plan of assembly)


A plan of assembly contains all the steps that must be taken in order to build the design
with the aid of tools. Assembly is the manufacturing of the design following the plan of
assembly.

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Exceptions to the rules


In general the next factors can be the cause of not going through the whole design
process step by step:
Time limits (the delivering date is coming soon....)
Money (there is no money to pay the designer)
Skills of the designer (the skills of the designer are not adequate for the job)
Lack of information (there is a lack of information about the topic)
Explorative design - “learning by doing”
If you are experienced, sometimes some steps can be skipped.

Case:
*brainstorm: brainstorm is a creative stimulating process to obtain new ideas.
You sit around a table or elsewhere comfortable. A good brainstorm needs at
least four members to join in. One of the members will make the notes
(facilitator). Start with formulating a question according to the problem that needs
to be solved. The group can start to put forward ideas. There are some rules for
putting forward ideas. 1. Never disrespect an others idea. 2. It doesn’t have to be
true what you’re saying. 3. Try to associate on the idea of others. 4. Don’t be
afraid to put forward strange ideas. 5. See if the facilitator can keep up with the
group, otherwise slowdown.
After a certain amount of time it is wise to change the brainstorm question into
another. Another question will give a new perspective on the problem.
After several rounds eliminate the useless ideas and analyze the ones with
potential. Combining of ideas is also a strong tool.

Test and evaluation


Testing and evaluation of the prototype.

Conclusions and suggestions


Try to summarize your results and to make some suggestions about future things that
have to be done. For example: Future experiments, adjustments or maybe a suggestion
to make another version of the design for other users.

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Appendix V: The measurement prosthesis


In order to build a prosthesis specially to the needs of a specific patient, it’s very
important to determine all the specific measurements. For this reason, it could be very
useful to have a so called 'measurement-prosthesis'. With such a prosthesis it’s possible
to accurately determine the measurements of a patient. The shank of the ‘measurement
prosthesis’ is easily adjustable and the right measurement can then be read, because
there is a measuring scale on the shank of the prosthesis.
After putting the ‘measurement prosthesis’ around the stump and adjusting it to the
specific stump, the measurements can be read with the help of a few measuring tapes
that are attached to the ‘measurement prosthesis’ and which can be put around the
stump. After that the measurements need to be well documented of course. The socket
of the ‘measurement prosthesis’ also needs to be adjustable in height.

Picture “current way of measuring”: This will be the principle, that can be used to
design a measuring prosthesis. Today many limbs are measured the same way.

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Appendix VI: Tempur


Tempur® material is a breakthrough in sleep technology that will
forever change the way you sleep. The original formula was
developed in the early 1970's at NASA's Ames Research Centre
in an effort to relieve astronauts of the incredible g-forces
experienced during lift-off. Fagerdala World Foams of Sweden,
spent almost a decade and millions of dollars researching and
experimenting with the NASA material before discovering a way
to produce a consistent and durable product.
Tempur material relieves pressure because its cellular structure
is completely different. It's made up of billions of high density, viscoelastic, memory cells.
The cells are spherical with windows, and the key is…they're temperature sensitive. The
high density of Tempur material makes the Tempur-Pedic Swedish Mattress so durable
that it's backed by an incredible 20-year limited warranty. In warm areas, they get softer
and pliable. In cooler areas, they stay firm. The cells will literally shift position and
reorganize to conform to your body contours. The cells shift so we don't have to. Imagine
a mattress that's firm where you need it and soft where you want it. It's like having a
mattress custom designed to fit your body.

Acting like a very thick fluid, Tempur material doesn’t compress in the classic sense, it
displaces to accommodate the load. Tempur, like other fluid or fluid-like materials, is also
reactive to heat and pressure. It becomes significantly softer and flows more readily
when the material is warmed close to body temperature than the material which remains
at ambient temperature. This variable degree of viscoelastic stiffness results in the
material molding to the body. Body weight is so effectively distributed over the body
contact area that gross pressure is markedly reduced to therapeutic levels. Although
there are obviously variances in interface pressure at different parts of the body, the
pressure is distributed so evenly that there are minimal pressure spikes.

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Appendix VII: Patents

Page 72

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