the alternative prosthesis - final report internship sri lanka 2002 - w.d.van dorsser and b.m.wisse

The Alternative Prosthesis Final report internship Sri Lanka 2002

September 2002 – Colombo - Sri Lanka,February 2003 Delft – the Netherlands

Authors: Boudewijn Wisse - IO9964426Wouter van Dorsser - IO9195386

Mentors: Johan MolenbroekHenk Kooijstra

Jan Witte

Counterpart: Consortium of Humanitarian Agencies, Malathi Thalgodapitiya

The Alternative Prosthesis TU-Delft 2002-2003 Wisse & v Dorsser

Page 1 version date: 18-10-2004

1. Preface Amputees, prostheses, Sri Lanka, the great experiences and people we met. For already a full year they are daily on our (Wouter and Boudewijn) minds. It’s not finished. It never will be, I guess, not as long there’s war and poverty. But this project feels unfinished in particular, because it’s potency. The problem is defined, a solution at hand, but implementation is still difficult. With this report we hope to encourage and to inspire the reader to find ways to improve. To improve prostheses, to improve the world, to improve your and our experiences and to inspire all the fantastic people we met. People who inspired us in the first place.

Support in the Netherlands First of all we have to thank Dr. Henk Kooistra who initiated the project and later supported us in Sri Lanka. Johan Molenbroek, teacher of the subject "Design for All", and Inne ten Have who inspired us during the analysis, just as Jan van den Berg from the Dijkzigt Hospital who helped us understanding the medical aspects of designing a prosthesis.

Financial support The Fleur Groenendijk foundation made everything possible financially. We also like to thank Karin Paasen and the “Fonds Internationale Stages” (TU Delft).

Team Happily, Farshad Soleymani and Michelle Kriesels (designers as well) teamed up with us in Sri Lanka. Together we were able to produce these results. Barbara de Nooijer, who lived with us in Sri Lanka, supported us with ideas as well in other ways.

Support in Sri Lanka In the fist place we have to thank the Colombo Friends in Need Society, especially the Colombo headquarters. Within the CFINS-C we have to thank Ms. Kalyani Ranasigne (president), Ms. Rupa Jayasekera (administrative secretary), Mr. Francis (chief foot and polypropylene department) Mr. Nepala (chief aluminium department), the employees (the "boys" at the workshop, who were extremely friendly to us) and of course we also like to thank all the amputees who were willing to help us and gave us feedback on our ideas. Besides these people we like to thank Ron McGaw, a prosthetist from the United Kingdom, who was always willing to assist us with his knowledge and evaluate our ideas. Outside the FINS we like to thank our neighbours who cared for us like parents. Also we like to thank Prof. Dr. Anton Jayasuriya, who offered us the great opportunity to speak on the world congress of "Medicina Alternativa". For our support in Sri Lanka we like to thank Malathi Thalgodapitiya, our counterpart working at the Consortium of Humanitarian Agencies. Last but not least we have to thank our parents for their never failing support in every situation.



2. Contents 1. Preface........................................................1 1. Preface........................................................1 2. Contents .....................................................2 3. Summary ....................................................3 4. Introduction................................................4 5. Project history............................................5

5.1. Start & Initiation 5 5.2. Analysis (NL) 6 5.3. Research and Development (SL) 8 5.4. Finalization (NL) 9

6. Developing alternatives for developing countries...................................................10 6.1. Process 10 6.2. Collecting Information 11 6.3. Sharing information 12

7. Developing Prostheses in Sri Lanka .....13 7.1. Current designs 13 7.2. Current production situation 13

8. Recommendations ..................................14 8.1. Final product proposal 14 8.2. Optimisation 15 8.3. Project continuation 15 8.4. New projects 15

9. Conclusion ...............................................16 10. Evaluation.................................................16

Appendix A. Problem definitions ......................................1

A.1. Summary start ................................1 A.2. Analysis (NL) ..................................2 A.3. Research and Development (SL) ...2

B. Figures ...........................................................3 B.1. Sri Lanka: .......................................3 B.2. Properties of Amputees..................5 B.3. Worldwide.......................................8

C. List of references..........................................9 C.1. UN...................................................9 C.2. Consortium of Humanitarian

Agencies.........................................9 C.3. CFINS - Colombo ...........................9 C.4. CFINS - Kandy Branch.................10 C.5. Army .............................................10 C.6. CT, the Cambodia Trust ...............10 C.7. ICRC.............................................11 C.8. WHO.............................................11 C.9. Medics ..........................................11 C.10. Team Design for All ......................11 C.11. Experts in NL ................................11

D. Current designs ..........................................12 E. The Friends in Need Society......................13

E.1. Departments .................................13 E.2. Internal research...........................15

F. Contacts and Residences ..........................16 G. Price estimation ..........................................17 H. Flowchart – socket designs.......................17 I. Flowchart – foot design .............................17



3. Summary These are the results of a project in which a new concept for prostheses for the trans-tibial (below-knee) amputees of Sri Lanka was developed. Although civilian landmine victims are a minor cause, Sri Lanka copes with a shortage of care for amputees. The lack of prosthetists is the bottleneck, resulting in a low production capacity of prostheses and little aftercare. Other problems include: Price, locating amputees, difficulties distributing prostheses and the long time needed to fit, produce and adjust prostheses. Research trails and prototypes strongly suggest that the situation could be improved with an alternative for trans-tibial prostheses, in this report presented as the “DFU” (Designed For You).. Though the design philosophy is very strong, the actual design is not optimised and could still be altered. Therefore this project needs to be continued, so the design will be implemented and much more trans-tibial amputees can be helped. Not only trans-tibial amputees will benefit fin such a way. The freed production capacity can then be used to produce above knee prostheses or otheses.



4. Introduction This report contains the results of the “The Alternative Prosthesis” project done from March 2002 till March 2003. Although this is the “final” report, continuation of the project is still sought. The project focused on the design of a new concept for below-knee prostheses. The project team consists of students of the Delft University of Technology (the Netherlands. Doctor Henk Kooistra initiated the project in the context of the subject “Design for All”. He assisted us in Sri-Lanka as well, where the main part of the project took place.

How to read this report The purpose of this report is to inform everybody who is interested in designing (below-knee) prostheses, which can be produced and used in developing countries, especially in Sri Lanka. In chapter 5 the history of this project can be found. A summary of the results of the first part of the project, the analysis done and concepts created in the Netherlands, can be found in the chapter 5.1. The second part of the project (see chapter 5.2) was the research and development done in Sri-Lanka (August 2002-December 2002). The end result of this part was a totally new design concept for a below-knee prosthesis and a presentation held in the world 40th congress of Medicina Alternativa, Colombo, November 2002. The last part of the project is the finalization in the Netherlands and can be found in chapter 5.3. Chapter 6 consists of several recommendations on the development of alternatives (in developing countries). Chapter 7 consists of recommendations for the development of prostheses in Sri Lanka specifically. Chapter 8 contains the final product proposal and project recommendations.



5. Project history A quick history will explain the choices made. It will also give you an idea about the subject and the process followed. Ever description of a phase of the project will be split in two main parts: first the “problem definition and design philosophy” and secondly the “designs and results.”).

Problem definition and design philosophy To create a good design, you need to know the problem well. Therefore designers often start with a description of the problem, the problem definition. The design philosophy contains the most basic requirements and values needed to tackle the problem (according to the designers). The problem definition and design philosophy are directly related to each other. At the moment the problem definition changes, the design philosophy changes as well. It is important to do the right thing before doing things right. Here the right thing is to make sure what the real and main problem is and redefine the design philosophy before developing a good prosthesis for the wrong situation.

Designs and Results In this section the design concepts will be shortly discussed, As well as “side products” such as presentations and reports. An overview of all the design concepts can be found in Appendixes H: “Flowchart – socket designs” & I “Flowchart – foot design”.

5.1. Start & Initiation In March 2002 this project was started as part of the subject “Design for All” at the Delft University of Technology. Dr. Henk Kooistra spotted the problem that in Sri Lanka amputees are still not treated well enough. Understanding that Industrial Design Engineers could address this problem, he discussed this problem with dr. ir. Johan Molenbroek. Johan in his turn introduced the project to the students.

Problem definition and design philosophy Henk Kooistra made a project description1 using the information from the landmine report Malathi

1 See appendix A.1 for a summary

Thalgodapitiya gave him in Sri Lanka and his contact with other experts. The focus was on children and a different approach to the production and design of prostheses. Prostheses are being designed for over 150 years, but mainly by medical professionals. Instead of a medical basis for the design, Industrial Design Engineers base their designs on user interaction and production possibilities. Different projects were started addressing the landmine awareness problem as well.

Designs and Results Maybe it is appropriate to introduce Inne ten Have’s design here, because it was a major source of inspiration (just as Inne himself). Inne, a designer from Eindhoven, designed a prosthesis for Cambodia as final subject ten years ago. At that time, the amount of limbless in Cambodia was enormous. Very little prosthetists and resources were available. Inne designed a prosthesis, which could easily be adjusted and produced by the amputee himself. Unfortunately, he had no opportunity to test the design and could not find a party interested enough to get his design produced or otherwise implemented. More about his project can be found on his website2.

Figure “Inne”: Here the design of Inne is shown. It is easy to see the low-cost material usage and ease of production.

2 http://www.xs4all.nl/~inne/ ; See Appendix H.2



5.2. Analysis (NL) The first part of the project started with Dr. Henk Kooistra’s problem definition. Loads of questions needed to be answered and our knowledge about prosthetics needed to be increased. After the analysis we made a new problem definition3 together with some design and implementation concepts. The results of the first part of the project can be found in the first report4 written in the Netherlands. It mainly consists of an analysis and some concepts for a solution.

Problem definition and design philosophy Instead of focussing on children, It’s only fair to first reduce the amount of victims on the waiting list. Therefore a proper design for adults is first priority. At this moment most designs are custom-made. The socket fits only one amputee. Other parts are modular. But some research shows that a highly adjustable design could also provide enough comfort for the amputee. All parts of the prosthesis are then standardized, so one design fits all (full standardization of the design of shank and feet and a modular system for the socket). Local (see textbox) carpenters, or other small village workshops, should be able to produce, repair or replace the prosthesis. The prosthesis must have a ‘Western look’ and the owner of the prosthesis learns to reproduce all the parts, so he can use this design principle for the rest of his life. Basic prostheses are provided the first time, but the amputee can improve the aesthetics himself.

3 Appendix A.2 4 “Prostheses for Tibial Amputees focused on the 3rd World; Introduction Report “Design for All” “ – April 2002 – Dorsser, Wisse and Soleymani. A Summary can be found at www.kladder.nl

Designs and Results Eventually we came up with our first concepts: 1. Inne+ The design as made by Inne ten Have is theoretically right, but was never taken into production. Therefore we decided to modify the design, mainly by adding some parts.

When an extra rubber piece is added 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, also increases comfortable use. A western look can be obtained by adding a nice aesthetic cover from foam or polypropylene. The appearance is lifelike, but a local carpenter can still make the underlying skeleton. By having different sized inserts ("klickable" solutions) customized prostheses can be presented. The measuring time can be reduced to minutes instead of days.

Figure “Inne+”: The total Inne+ can be seen on the left. The arrows indicate the places where the forces (pressure) will be high. Therefore at those places extra padding is added. On the right is an impression of the socket.

Local: Many use the term “local” to describedifferent situations. In this report we use thefollowing definition hierarchy:

• International • National • Regional • Local



2. The textile & Leather Socket The leather design is on the outside made from the materials leather and denim. On the inside special padding can be found at the places on the limb where two wooden sticks will suspend the limb. The padding is meant to give the prosthesis more comfort and also to create a larger contact surface. The great advantage of the leather socket is that it can be adjusted easily to a persons stump.

Figure “Leather socket” The inside and the application of the leather prosthesis are shown here. The leather socket is easy to produce and adjusts itself to the form of the stump.

3. Implementation plan Implementation could be as follows: Start the (development and) production of a mechanically and medical correct, but very basic design, which is focussed on productivity and comfort. Later implement an aesthetic design: The ideas can be found in the report5; the final design should be made in Sri-Lanka. Eventually produce luxurious versions: In the future, if the trials are successful, a new and improved, more expensive design could be made. This design could be sold to third parties, such as the army or the world market, thus making the whole project self-sufficient.

5 Prostheses for Tibial Amputees focused on the 3rd World; Introduction Report “Design for All” “ – April 2002 – Dorsser, Wisse and Soleymani



5.3. Research and Development (SL) Convincing the project initiators with our ideas and the underlying research, and winning their harts with our enthusiasm, we were selected to travel to Sri Lanka to continue our project.

Problem definition and design philosophy During the stay in Sri Lanka the problem definition and therefore also the design philosophy needed to be adjusted several times. While optimising the concepts created in the Netherlands (we wanted to implement them) new information was collected all the time. Eventually we understood that the focus of the project was completely wrong. Instead of focussing on price or production capacity, the real problem was the total amount of prosthetists (experts) available. At the end we came up with our final problem definition6 and design philosophy. This design philosophy helped us to design a totally new concept for below-knee prostheses: “There is a market-niche for a new type of prosthesis. This prosthesis can be produced in developing countries, but has market potential all over the world. Mass production is necessary and should ideally be sponsored by local (read: Sri Lankan) chemical industries. To enable mass-production, while reducing the price, the prosthesis needs an adjustable socket principle. The amputee must be able to adjust the prosthesis himself through time. This way the design is suitable for children as well. The prostheses can be fitted everywhere, thus reducing the need for amputee to travel. The current workshops are still needed to produce unconventional lower limbs, upper-limbs and ortheses. The design should require less attention from prosthetists. This can be achieved by the use of use-cues (clues integrated with the product how to use it). And last but not least, the design needs to be highly comfortable. Only if these requirements combine into one product the market-niche is reached and the amount of limbless can be decreased. “

6 Appendix A.3

Designs and Results Sockets As might be noticed, the design philosophy has its emphasis on the socket. This is because the socket is very crucial and the major innovation is this part. The Inne+ and the Jaipur+ were redesigned many times during the process. In the flowchart the most important innovations can be found. More details about the development of these designs can be obtained by contacting the writers or Michelle Kriesels7.

Feet Some development was also conducted on the feet of the prosthesis. Current “Western” designs cannot be used globally. Other materials are required, the foot should be lifelike and usable without shoes, on unpaved roads, etc. Eventually we settled for a design based on a design made 150 years ago. This design was replaced for a simple reason: price. We believe nowadays a simple, cost-efficient variation is possible. Eventually we came up with our (total) final design proposal, which is described in the chapter 8.

7 See Appendix C.10



Presentation At the 40th World Congress of Medicina Alternativa, this project was presented. The emphasis was on the development of alternatives. Therefore the “Beat Tradition” presentation8 was divided in two parts: “Alternatives: “Can we beat tradition?” (How to develop alternatives) and “The Alternative Prosthesis” (case description).

Figure “The flyer”: This flyer was distributed at the world congress. It promoted our lecture about the development of alternatives. We wanted to improve our network of acquaintances.

8 See Chapter 6.1 & 8.1 for a summary and www.kladder.nl for the complete download.

5.4. Finalization (NL) In the Netherlands the project was finalized. Well, finalized, continuation would still be preferred9. For continuation by others new students or a company interested in the results need to be found and informed. Therefore this report is written in a way that most vital information is present.

Problem definition and design philosophy The final problem definition should be broader than for Sri Lanka only. No solution is anticipated to encourage different project groups to think about the same problem:

“Worldwide there are about 15 million amputees. With 39 percent of them living in the Asia’s, this area deserves special attention. In some countries landmines are a problem, though most common causes are accidents, diabetics, cancer, infections and congenital deformities. Heath care for the amputees is in many cases insufficient. The production capacity is low and there is a lack of experts (prosthetist) to fit the prostheses. Current designs are expensive, outdated or unsuitable for different environments (social and geographical) worldwide. Aftercare is often forgotten. Although different groups are thinking about (and working on) this problem and developing alternatives, no alternatives are implemented yet.

The design philosophy is concentrating around the development of a new concept for prostheses:

“A new (design) concept for prostheses could improve the situation of amputees. Evidence shows possibilities for an adjustable but comfortable socket. This enables mass production. Distribution will speed up, among others because the need to travel to distribution points is cancelled. Costs will reduce. Children amputees can use the prostheses longer. The prostheses should be easy to fit and adjust, thus reducing the lack of prosthetists. Ideally, the end users are capable of adjusting the prostheses themselves.

9 In the first place we can think of continuation by ourselves. Probably one of us will graduate on this project.



The new design adds to the produced amount of prostheses. Current production should not be replaced, because it is needed for extraordinary prostheses and ortheses. The design should be accepted worldwide, though the function and price may be a little different“

Apart from this the speed up the development of prostheses could be improved. Research groups should team up, while leaving room for different viewpoints, thus improving the service for the amputees.”

Designs and Results After November 2002 (end stay in Sri Lanka) no improvements were made to the final design proposal, although many improvements are possible (see chapter; “recommendations”). New contacts were acquired. While giving a lecture (“Ergonomics 2: Designing for specific target groups”) we met Bram Joosen10. Bram has designed a artificial knee joint in Tanzania, while doing his internship for the Haagse Hogeschool. Because his project came to a dead end (as well), we discussed the possibilities for a platform, which will aid in the passing on of (development) projects11. Our final result is this report itself.

10 Bram Joosen, alumni Technology of Human Kinetics, Haagse Hogeschool. His report: “Plastic Atrificial Leg”, Tanzania, Dar es Salaam, November - March 2002. 11 More details can be found on the website www.kladder.nl at “Platform Zinvolle Stage”,

6. Developing alternatives for developing countries Developing alternatives is not easy. Some of our findings on how to do it the best way can be found in the following paragraphs.

6.1. Process Most of this text was published on a flyer12 we spread at the World Congress and after:

Analysis Start with a good analysis. Just doing something seldom leads to a satisfactory result. Get acquainted with the subject: What is opinion and what is inherently true? Making a list with the primary functions or the basic requirements helps you to look further than the current solutions.

Think different Dare to think different. Dare to imagine and dream. Great inventions were dreamed about and many now conventional thoughts were condemned in the time of their conception. Think of “unconventional” ideas such as the sun as the centre of the solar system. Generate many ideas (quantity = quality). Eventually you’ll be able to find great possibilities.

Find the range of possibilities of the alternative Now you’ve come up with an alternative, make a list of all the strengths and weaknesses you can image around your innovation. What are the possible applications of the alternative? And which applications have a “conventional” solution? It is also important not to forget yourself. What are your possibilities? Do you have spare time or financial assets? Maybe you’ll have a vast network of acquaintances that might be willing to help you. In brief, find the “strengths” and “weaknesses” of yourself.

Find a non-invasive niche With all the information found in step three, you’ll be able to find an evasive market niche. Beginning the development of the alternative is easier when others don’t think of you as a threat. Often found niches consist of small or specific groups, which are often neglected by big companies. It’s also 12 This flyer/folder can be downloaded at www.kladder.nl



rewarding to think about groups without access to money or other requirements (like time or transport). If you find an application where there are none yet, than that’s your way to realize you ideas, because you’ll be the alternative to nothing!

Produce enough confidence How will you convince your surrounding to accept your idea and to help you? Most important is to start with yourself. If you think of (easy) ways to validate some advantages of your idea, validate them! Don’t try to convince every sceptic, especially when (they think) money or jobs are on stake. Better find a few, reliable contacts. Also, don’t get lost in searching for or producing statistical data and figures. These are always difficult, because there is always room for objections. Instead, rely on the smile of the customer.

Act different While fine-tuning your alternative, it’s time to start thinking about the implementation. Be generous with your knowledge (were possible), you’ll earn trust. When the situation allows it, grow gradually. This enables development while deploying your alternative and is less risky. Speaking of risk, expect to rise and fall. Few developments where a first time success! You will encounter new problems and will have to adjust. Last of all, don’t focus on money. Where the focus is on money, little room is left for innovation or development.

6.2. Collecting Information Information is of fundamental importance when you are doing a research and development project. In developing countries specific difficulties while collecting information can be anticipated.

The need for information Every decision is based on information. The more recent and accurate the information is, the better the decision will be. Without (the right) information you will spend lots of energy (time and money) without any results.

Information types During the project different information will be needed at different moments. The first information you need is the information related to the problem definition. In this project the

problem definition changed several time because new (other) information was collected. Secondly in the conceptualisation specific information needs to be collected. Another type of information needed, especially in developing countries, is daily information, Problem definition. The first information needed is related to the problem definition. Important questions to be answered are: What are the (main) problems? For who do we need a solution? Do we really need a product to solve the problem? Why is the problem not solved yet? What will happen if the problem will not be solved or what will happen if the problem will be solved, does this imply new problems? The subject. Before starting drawing and systematically thinking about solutions a proper knowledge of the subject is required. The main part of this type of information related to this project can be found in the first report13. In developing countries it’s important to collect information about social aspects specifically. While developing alternatives information on new developments and existing products is very important as well. Specific Information. This information is needed in a later stage of the project. In this case we can think of information about stump measurements, specific material data or specific production methods. Daily information. Another type of information is daily information. While doing a project abroad daily information can be very important for the progress of the project. For example, what is the political situation? Are there any health care issues, disturbance, roadblocks or strikes which disable you to travel? What is the weather forecast (think about the rain seasons)? When are the holidays (shop close)? The knowledge of all kinds of these information will be very helpful for the progress and planning of the project. Buy a travel guide.

13 “Prostheses for Tibial Amputees focused on the 3rd World; Introduction Report “Design for All” “ – April 2002 – Dorsser, Wisse and Soleymani. A Summary can be found at www.kladder.nl



Information sources When a project is done abroad conventional sources, like books, companies and other connections can be unavailable. Nowadays the internet closes this gap. In our project a lot of crucial information was collected by internet. While doing a project in another country a backup team in your home country can be very helpful. Search people who know about the subject and are willing to spend some time. Especially when you operate in developing countries networking is very important. Often you will start without any connections in the foreign country. But be aware of the reliability of the information you get. What is your source’s second agenda?

Reliability Three important issues determine how reliable your information is. Match your specific target group. Not all the information you can find on your topic is applicable on your target group. For example, ergonomic measurements (ergonometrics) differ from country to country. Information ages. A lot of information is out of date. Of course, some information can be used for a longer period but be sure the information still applies. Sources. Governments, companies, NGO’s, army’s or newspapers, they will often offer you false information. Sometimes because they do not know better, but as often in purpose. Everybody has second agenda’s (which is not always negative). Try to make a list of all sources and their second agenda. Combine their information and draw your own conclusions.

Adapt information It will often happen that the information you seek is not available. The most difficult information to collect is statistical data. First of all ask around if someone can help you. If not, you can conduct your own research. But be aware, this will take a lot of energy. Make sure you really need the (specific) information. Don’t focus too much on the data. Use available data, adjust it and apply a safety margin. For

example, if the ergonometrics of a group is known (for example DINES) and we know our population (target group) is 20% less tall we could use that factor on all properties. Increasing the error margin will increase the reliability of the estimations.

6.3. Sharing information It’s possible that you want to spread your collected information and other findings to help others or just to tell your opinion (the truth?) about something.

Be careful It is important to be careful with your knowledge. Especially when you are developing alternatives people are not always happy with your information. They can be afraid of you(r ideas), although you think they are helpful. On the other hand, some will try to get all your information, just to copy and make money out of it. Your ideas will loose market value and the following production and distribution will be uncontrollable. In this case it can be good ideas to think about patents before sharing your knowledge.

Be generous If your are sure you want to share your knowledge you can think about media like the Internet, television, newspapers, forums, reports and congresses. Especially the last one can be very helpful when you have developed something totally new because on congresses you can find a lot of people especially interested in your topic.



7. Developing Prostheses in Sri Lanka

7.1. Current designs At the moment there are several designs available in Sri-Lanka. (Here follows a summary. For a complete overview, see appendix D: “ Current designs”). The main technology used is the Jaipur limb, which is easy to produce and low cost. It is produced by local production methods. Recently there is also an adjusted version using Poly Propylene sockets. The foot is extremely suitable for tropical climates and uses an esthetical design. The similar Mukti system uses a biocompatible material (High Density Poly Ethylene) for the socket. Also the ICRC is comparable. It was designed to be made of recycled Polypropylene by local mass production. But unfortunately recycled Poly Propylene does not have the recommended stiffness and strength. So now non-recycled Poly Propylene is used. This is why some believe the ICRC failed. Western prostheses simple are the state of the art. But the best in Europe or America is not always the best in the Asia’s. A recently new technology introduced in Sri Lanka by the Kandy branch of the FINS is the Mobility Kit from India. Important to notice is that the all use a non-adjustable, custom-made principle for the socket.

7.2. Current production situation Providers of prosthetic services The main provider of prosthetic services in Sri Lanka is the Colombo Friends in Need Society (CFINS), a non-governmental organization, based in Colombo (headquarters), Kandy, Jaffna and Galle. Others providers of prosthetic services are the Army Rehabilitation Centre of the Sri Lanka Army in Ragama and White Pigeon which operates in the Vanni. (See appendix E: “The Friends in Need Society” and appendix C: “List of references” for more information). Together they produce around 230 prostheses a month (= 2700 a year). From the start of

production (1984) a total of at most 20.000 prostheses were distributed.

Amount of limbless We believe there are at least 23.000 civilian, trans-tibial (below knee) amputees in Sri Lanka of which at least 13.000 are still limbless (without any prosthesis) (2002). But it is probable this number is much higher, up to 44.000 civilian, trans-tibial amputees of which 35.000 are still limbless. (For more figures see appendix B: “Figures”).



8. Recommendations In this chapter the final product proposal (design concept) and project recommendations can be found.

8.1. Final product proposal After a year of development we came to belief it is possible to design prostheses according to an unconventional philosophy, which consists of the thoughts found in Chapter 5. This philosophy combined with a lot of research let to a new trans-tibial design, the “DFU” (Design(ed) For You). Some of the advantages follow.

Figure “Total Kit”: The total DFU could be distributed as a kit. Also see Appendix I

One design fits all One of the advantages of an adjustable socket is that there are fewer prostheses needed through time. Normally a patient needs at least a new socket every two years due to the deformation of the stump. Another advantage is the possibility to use it direct (within the first month) after the amputation. Especially for the West this advantage is very interesting. But the main advantage is that a one-design-fits-all principle enables mass production, which in turn has a positive effect on the costs and the production capacity.

Alignment If we combine these advantages with the advantages of a prosthesis alignable by the end user instead of the prosthetist, prosthetists can focus on extraordinary cases, thus improving overall care. We implemented use-cues to make this possible. Use-cues are indications how to handle (in this case how to align) a product.

Specifications

The DFU has an adjustable socket, suitable for trans-tibial amputees with stump lengths between 10 to 23 cm long, measured from the patellar tendon (p.t.). The prosthesis fits stumps with a circumference (at the p.t.) of 25 to 35 cm. Knee extension of 5 degrees and flexion up to 15° can be compensated, abduction and adduction both up to 10°. The price is estimated at € 6614 apiece based on 20.000 pieces in 2 years. The total prosthesis (including foot and cosmetic cover) will be available as a kit.

Market possibilities In figure “Niche”, the market possibilities are shown of popular prostheses in respect to the DFU. Though the DFU is less comfortable as the Western designs and approximately as comfortable as the Mukti limb, the adjustability makes the DFU a winner. The DFU is suitable for the use in the Asia’s as well as in the West.

Figure “Niche”: in this figure on the Y-axis the most adjustable sockets can be found. On the X-axis the most comfortable sockets can be found. The combination of the two shows the strength of de DFU.

14 Details can be found in Appendix G: “prices”

Most adjustable

Most comfortable

Jaipur

Alignment in time possibleNo alignment through time

DFU

Mukti

ICRC Western The Asia's

The West



8.2. Optimisation At the moment the design is ready to be optimised and implemented. Strength and strain analyses and long-term / cyclic tests have to be performed. We are working on improving the aesthetics of the design.

8.3. Project continuation This project is worthless if it is not continued. Too often this type of projects end up where they started because no implementation was done. With difficulties collected information and knowledge will get lost. New projects will be started by other people while other projects are still unfinished. The cause of this is often the lack of persistence of the initiators. It would be better (more efficient) if already existing projects would be finished firstly before new, similar, projects would be started. For this project in particular we can find different ways of continuation. As mentioned before the final product proposal is not finished yet. It is possible that one (or both) of us will continue this project and graduate on it. Otherwise we will inform and motivate a group of new students who can finish this project. Another solution is to involve a company interested in the results. The choice for this commercial solution is defendable if the situation of the amputees increases significantly. If the project has commercial value, patents on the design(s) must be bought. Also, an independent company could sponsor the project (e.g. a plastic manufacturer). This way, a third party would still control the project while funds would be available. But which way eventually will be chosen: The project must go on.

8.4. New projects We think, to continue this and other projects, there is a need for a platform, an organisation where people doing development projects all around the world can share their knowledge (and projects) and are able to meet and help each other. The Internet is perfect for this.15 An internship-system for prosthetists in education could increase the amount of working prosthetists in Sri Lanka. Also the knowledge about the need and possibilities for prostheses in developing countries will improve. This could result in more appropriate solutions.

15 More about this on the website www.kladder.nl at “zinvolle stage”.



9. Conclusion After a full year of research and development we came up with a good design philosophy. As mentioned before in the preface, the amputee problem is not solved and it never will be, we guess, not as long there’s war and poverty. But this project feels unfinished in particular, because it’s potency. The problem is defined, a solution at hand, but implementation is still difficult. Especially we are confident about our final design philosophy. It offers a total new approach opening new possibilities. The DFU is just one possible solution. Using the design philosophy, other good solutions could be found. In this report a lot of figures can be found. It was very hard and it took us a long time to collect and rightly interpret all these figures. The figures about the amount and properties of amputees are extremely useful to understand the scale of the problem and not to be misled by people or (non governmental) organisations with second agenda’s. Besides these figures, the figures about stump measurements can be very useful to design (adjustable) prostheses. In this report also an idea how to develop alternatives (in developing countries) is given. Thinking about the process can be very helpful to develop and implement alternatives. Also the words said about collecting and sharing information can be helpful while designing alternatives, especially in foreign counties. As said before, with this report we hope to encourage the reader to find ways to improve. To improve prostheses, to improve the world, to improve your and our experiences. Most of all we want to inspire all the fantastic people we met. People who inspired us in the first place.

10. Evaluation At the Friends in Need Society we have seen that the production of a prosthesis is a difficult process. Different aspects have to be taken in account. One of the most important issues is that the prosthesis has to be comfortable and well aligned. People have to walk on it, every day! You can’t put pressure on every part of the stump. Besides this it has to be light, but also stiff and strong enough. Not to forget the social aspects. Nowadays most of the prostheses in developing countries like Sri Lanka are custom made. If we want to produce them in mass production, it will be even more difficult; besides a comfortable prosthesis we now also need an adjustable and re-alignable one. If you know there is a great difference in stump measurements and contractures you can imagine it’s a difficult job to design a prosthesis suitable for mass production. It took us a long time to understand all the problems and to come up with a good design philosophy. We also made a product proposal but unfortunately we did not have time enough to implement our ideas. There is need for people who can combine medical knowledge with technical (especially industrial designing and developing) knowledge. With this combination good solutions can be found to help al lot of different patients (not only amputees). We think the technical university of Delft has to take a leading role in this. Sri Lanka inspired us to look to the medical world at a different approach. We met people who made us think in a different way, who inspired us. You can’t, and do not have to, think in high-tech materials only to help people. Not only patients who can effort this need to be helped. There is a need to think in global solutions.

Appendix Appendix ..............................................................0 A. Problem definitions ......................................1

A.1. Summary start ................................1 A.2. Analysis (NL) ..................................2 A.3. Research and Development (SL) ...2

B. Figures ...........................................................3 B.1. Sri Lanka:........................................3 B.2. Properties of Amputees ..................5 B.3. Worldwide .......................................8

C. List of references ..........................................9 C.1. UN...................................................9 C.2. Consortium of Humanitarian

Agencies .........................................9 C.3. CFINS - Colombo ...........................9 C.4. CFINS - Kandy Branch .................10 C.5. Army .............................................10 C.6. CT, the Cambodia Trust ...............10 C.7. ICRC .............................................11 C.8. WHO.............................................11 C.9. Medics ..........................................11 C.10. Team Design for All ......................11 C.11. Experts in NL ................................11

D. Current designs ..........................................12 E. The Friends in Need Society......................13

E.1. Departments .................................13 E.2. Internal research...........................15

F. Contacts and Residences ..........................16 G. Price estimation ..........................................17 H. Flowchart – socket designs.......................17 I. Flowchart – foot design..............................17



Problem definitions Different problem definitions were used during the project. Here they are presented:

A.1. Summary start This is a summary of the short report of Dr. Kooistra’s visits to Sri Lanka16. Dr. Kooistra had conversations with many experts, organisations and victims.

Prospectus POF The prospectus from the Pakistan Ordnance Factories: “The mine has been designed with a view to disable personnel. Operating research has shown that it is better to disable 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.” In Sri Lanka there rages (raged) a war for over 18 years. Landmines are used, the Mine Ban Treaty is not signed.

Amount of Amputees: Reliable figures are difficult to get, but the amount lies between ten and twenty thousand amputees. 80% is male, 60 percent is between 11 and 13 years old. 78% is below-knee amputee.17.

Facilities (services) There are three main services producing prostheses. The Army rehab centre, the Colombo Friend in need Society and White Pigeon. These are all dependent on external funds (redaction: US-Aid is most important). Only army receives governmental funds (for two prostheses per amputee), but their production capacity is lacking. Total maximum amount of prostheses produced per year is 2500 pieces. Average is about 1800. But 5000 pieces per year are needed for replacement only18. This results in waiting times

16 Redaction: In 2001/2002 17 Redaction: read the figures section in the appendix about the reliability of these figures 18 Redaction: Excluding reparation

of up to 15 years. Even without increasing the amount of amputees helped, an enormous increase in production is needed. Because of the return of refugees to their home-area and the spread of landmines in these area’s, the amount of amputees is expected to rise drastically. US-Aid puts around 75 USD19 at disposal for every produced prosthesis. This does not meet the expenses. Children are being neglected, resulting in contractures in their knees. At this moment the Jaipur limb is used. Now, to increase the imago, the polypropylene technique is used as well. This technique is high-tech but expense and it takes years to learn.

Conclusion Possibilities for cheaply produced prostheses have to be researched. Wear-resistant materials need to be used. Ergonomic research could lead to a good gait without the use of an ankle joint. The local (in Sri Lanka) production needs to be analysed, so training time can be reduced. A bicycle repairer should be able to produce the prosthesis. A socket should be developed specially for growing children, reducing the replacement rate. The prosthesis needs to be basic, but if possible have a Western High-tech atmosphere as well. Mine Awareness should be increased. Maybe by creating a game. The following parties are interested in the results and will provide (some) support: o Army rehab o CFINS o Anti Landmine Advocacy o Presidential Secretary Human Intervention

Unit The consortium of Humanitarian Agencies will act as counterpart.

19 Redaction: Actually 100 USD



A.2. Analysis (NL) 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. Sri Lanka is one of the countries where landmines are still used resulting in many landmine victims, which usually loose a lower limb (78%). At this moment the production capacity in Sri-Lanka is too small to provide everyone with prostheses. To increase the production capacity in the currently available workshops the technicians needs a training of at least two years. Although there are some workplaces in Sri-Lanka that provide prostheses for free most people can’t afford one. Even if they have enough money they can’t leave their family for a long time to fit a prosthesis and rehabilitate (learn to use it). For children the situation is even worse. Because they are growing they will need replacements (too) often. At this moment most children have to wait until they are full-grown. But if they do not use their muscles several years heavy contractures in their knees will appear and they will never be able to walk on a prosthesis. The waiting lists need to be reduced, so the children can be helped at last. Some of the current prostheses provided in Sri-Lanka are recycled prostheses from Europe and America. Apart from the price, the problem with these prostheses is that the materials used are not suitable for the (sub)tropical climates. Besides, they are difficult to repair and not suitable for typical local work. Especially working in the paddy fields and fishing are major sources of income in developing countries. It is necessarily to come up with a new, simple solution to provide all limbless with a suitable prosthesis.

A.3. Research and Development (SL) As described in our previous problem definition landmines indeed strike thousands of innocent victims every year, shattering lives and destroying futures. Sri-Lanka is one of the countries where landmines are used, but the amount of landmine victims is only a few percentage (The data shows 6%, we believe a maximum of 8%, because the services in the North (where the most landmines can be found) are very minimal.) of which about 75% end up with a trans-tibial amputation.) of the total amount of civilian amputees. Most civilian amputees are traffic victims (29%), diabetic patients (21%) or had an amputation after an infection (15%). This does not take away that it is indeed true that at this moment the production capacity in Sri-Lanka is too low to provide everyone with a prosthesis. About 2800 prostheses are made every year (2002), but the amount of prostheses still functioning (still being used) is insufficient for the current amount of (civilian) amputees. To increase the production capacity in the workshops the technicians need a training of at least two years. With the current designs, increasing the production takes time, but it is possible. But technicians are not prosthetists. All the current prostheses (using an unadjustable socket principle) are made by the technicians. Every patient gets his own custom-made prosthesis. After that an available and well-educated prosthetist has to align it for a decent gait. We believe there are about a maximum of 10 prosthetists in Sri Lanka at this moment (2002). In three years (2005) there will be probably about 15-20 prosthetists in Sri Lanka. In the current situation Sri Lanka needs at least about 12520 prosthetists for proper healthcare. Education of a prosthetist will take about 4 to 5 years and is expensive. Education usually takes place in India or Cambodia. After they finished their studies, many prosthetists start their practice in Europe or America, thus decreasing the amount of prosthetists further. Apart from the amount of prosthetists, the costs of prostheses are still high. Limbless can’t leave their family for a long time to measure a prosthesis and rehabilitate.

20 See appendix “figures”



For children the situation is even worse. They grow and need replacements often, because current prostheses are difficult to adjust. At this moment most children have to wait until they are full-grown, resulting in contractures. There is need for a design, which is easily adjusted, thus reducing the time needed by the prosthetists to improve the gait. The (sub)tropic climate and society should be taken in account; the prostheses need to be produced and used in developing countries. The production should require fewer technicians and be low-cost. The goal is a system, which will provide everybody with a suitable prosthesis. Still difficult is the aftercare for amputees. Now, amputees are barely checked, prostheses are barely adjusted. “If you provide one prosthesis, you’ll have to be able to provide the amputee their entire live”.

B. Figures B.1. Sri Lanka:

Amount of limbless We believe there are at least 23.000 civilian, trans-tibial (below knee) amputees in Sri Lanka of which at least 13.000 are still limbless (without any prosthesis) (2002). 21 It is probable there are 44.000 civilian, trans-tibial amputees in Sri Lanka of which 35.000 are still limbless.22 From the figures of the WHO we can estimate that Sri Lanka has proximally 70.000 civilian foot or leg amputees. (also see appendix B.3: “Figures – Worldwide”) • The population of Sri Lanka is about

20.000.000 (2002). If we multiply this amount with its area factor (0,370 %) we find 74.000 foot or leg amputees. [If we multiply this amount with the European factor (0,162) for an estimation of the minimum of foot or leg amputees we find 32.000 amputees.]

• According to the Sri Lanka Army (see appendix C.5: “List of references – Army”) the Army has about 4.000 (5%) foot and leg amputees. So we believe there are a proximally (74.000 - 4000 =) 70.000 (95%) civilian foot and leg amputees in Sri Lanka. [The total (civilian and military) amount of foot and leg amputees is 32.000 (89%) + 4000 (11%) = 36.000 amputees].

From the data collected from the CFINS we can estimate that about 44.000 (63% of 70000) civilians are below knee (trans-tibial) amputees. (see appendix B.2. Figures – Properties of amputees) • From the data we can expect that about

23.000 (33% of 70000) of these civilian amputees are above knee amputees (trans-femoral). [Trans femoral civilian = 33% of 36.000 ≈ 12000]

21 In blue this minimal calculation is given. 22 This estimation is given in a normal font colour.



• About 44.000 (63% of 70.000) are below knee (trans-tibial) amputees. [Trans tibial civilian = 63% of 36.000 ≈ 23000]

• From the data collected from the CFINS we can also see that almost all the Army victims are below knee amputees (92%). The cause of this is the high amount of landmine victims in the Army. So we can estimate that the total amount of below knee amputees in Sri Lanka will be proximally 48.000 (44.000 + 4.000) [23000 + 4000 = 27000].

There are still 57.000 [21.000] limbless (without any prosthesis) in Sri Lanka of which 35.000 [13.000] are below knee amputees. • The CFINS has about 13.000 patients in its

archives (18.000 prostheses and ortheses produced). Together with the other providers of prosthetic services we believe there are at most 20.000 patients already once helped in Sri Lanka. This includes arm prostheses and ortheses.

• The amount of arm amputees is 22.000 (0,11% of the population) [14000 if we take the European factor of 0,07%] (see appendix B.3: “Figures – Worldwide”)

• The total amount of amputees (foot, leg and arm amputees) in Sri Lanka will be proximally 96.000 of which about 74.000 (77%) foot and leg amputees and about 22.000 (23%) arm amputees. [Total = 36.000 (72%) + 14.000 (28%) = 50.000].

• So if we presuppose that the CFINS and the other providers of prosthetic services have the same type of amputees helped in the same percentages there will be a proximally 15000 (77% of 20.000) foot and leg amputees already helped once.

• This means there are still 59.000 (74.000 – 15.000) foot and leg limbless (without any prosthesis) in Sri Lanka of which 37.000 (63% of 59.000) are below knee amputees and 20.000 (33%) are above knee amputees. [foot and leg limbless: 36.000 – 15.000 = 21.000 of which 63% trans tibial ≈ 13.000 and 33% trans femoral ≈ 7.000].

Estimated production Current The current production rate of ortheses and prostheses (trans tibial, trans femoral and arm prostheses) is about 2.800 a year (2002) • In the table “services” we find 230 prostheses

and ortheses a month are produced. 230*12 = 2.760 ≈ 2.800.

Service Amount Source Reliability Army: 50-80 C.5 Reliable FINS-C: 80 C.3 Reliable FINS-J: 20 C.3,7 Probably FINS-K: 90 C.4 Too high, not true 30 C.7 Probably 10 C.3 At least true.

Although some suspect even less

FINS-G 5-10 C.7 Reliable White P 15 C.7 Varies strongly. It

dependents on the amount of materials received. Capacity with enough materials max: 40-50 (10)

Totaal: 180-280 230 a month is a good estimation

Table “Services”: The amount of prostheses produced per month and as well the total production capacity. In the first column the service-centre. The Source-column refers to Appendix C. The reliability is about our impression of the trustworthiness of the figures.



Needed With a replacement rate of three years (according to Dr. Gratzl (C.7) a prosthesis has an average life expectancy of 3 years or less depending on the income generation of the amputee) at least 7000 a year need to be produced for the currently registered amputees • 20.000 patients known get 1 prosthesis (*1)

per 3 years (/ 3) ≈ 7000 a year. For all the estimated amputees a production of at least 17.000 prostheses a year is needed. It is probable 32.000 prostheses are needed. • 96.000 patients estimated get 1 prosthesis

(*1) per 3 years (/ 3) ≈ 32.000 a year. [At least 50.000/3 ≈ 17.000 a year are needed]

• Of which trans tibial civilian amputees are: 48.000/3 ≈ 16.000 [At least 23.000/3 ≈ 8.000]

• And trans femoral civilian amputees are: 23.000/3≈ 8.000 [At least 12.000/3 ≈ 4.000]

Amount of prosthetists (needed) We believe there are about 10 prosthetists in Sri Lanka (2002). In three years (2005) there will be about 15-20 prosthetists in Sri Lanka. For a proper care Sri Lanka needs at least 125 prosthetists. • For proper care one prosthetist is needed for

400 patients. • 20.000 / 400 = 50 prosthetist needed for the

current situation. • For the minimal estimated amputees a total

of 50.000 / 400 = 125 prosthetists. • For the estimated amount of amputees a

total of 96.000 / 400 = 240 prosthetists. • Prosthetists needed for patients with

ortheses are not even taken in account in this figures.

B.2. Properties of Amputees

Measurements of below knee amputees Important data, derived from 139 patient cards: Column1 stump lengths

Mean 166 mm

Standard Error 4,4 mm

Median 160 mm

Mode 140 mm

Standard Deviation 52 mm

Minimum 0 mm

Maximum 381 mm

Sum 2312,145

Population (n) 139

Graph “stump lengths”: In this figure the spread of the stump lengths is found to be nearly a standard deviation.

0

20

40

0 20 400

0,1

0,2

0,3

0,4

0,5

0,6

0,7

0,8

0,9

1

actualcounts

expectedspread



Below knee and Above Knee This data is from the FINS’s databases January 1993 to December 1997 (total of samples (n) = 2214):

Civilian Army Amount % Amount %Above knee 391 33,3 78 7,5Below knee 744 63,4 955 91,7Both legs 30 2,6 8 0,8On knee 8 0,7 0 0Total 1173 100 1041 100

Cause of amputation This data is from the FINS’s databases 1993 to 1997: Category Amount %Total civilians (n)23 1105 100 Subtotal diseases 449 41 Cancer 101 9 Diabetic 233 21 Congenital24 27 2 Other Diseases25 88 8 Subtotal trauma 506 46 Accidents26 320 29 Infection27 163 15 Trapguns 23 2 Subtotal max-war 150 14 Blasts28 89 8 Landmines29 61 6 Total military30 1020 100Subtotal diseases 1 0Subtotal trauma 29 3Subtotal max-war 990 97 Landmines 916 90

23 From the 2228 (including the second prosthesis of bilaterals 2246) entries only 1105 civilians and 1020 military are taken into account. 24 Also wounds 25 Diseases of the blood or of the bone. 26 These Accidents are mainly traffic, train and accidents which occurred during work 27 Gangrenous but also snakebites, etc. Also "wounds", which could belong to another section as well. 28 Bomb blasts, shell blast, but also gun shots (of which the minimal of 23 trap guns are excluded and transferred to subtotal trauma) 29 Pressure mines or landmines and UXO’s. 30 Military= Army + Air force + Navy + Police



Age spread On this page the amount of amputees (helped at the FINS Headquarters 1993-1997) per age can be found. Red is military (subtotal = 1029), blue is civilian (subtotal = 1172) adding up to 2200 patients of which the age was recorded. Age-group Civilian Military 0-15 56 3 16-30 256 961 31-45 302 62 46-60 372 2 61-75 168 0 76+ 18 1 Totals (n=): 1172 1029

Graph “Age Spread”: This graph stacks the amount of the Military and Civilians by age. For example 20 civilians were helped at the age of 22 and about 150 military adding up to 170 twenty-two-year-old amputees (given a prosthesis by the FINS between 1993 and 1997).

0

20

40

60

80

100

120

140

160

180

1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85

MilitaryCivilian



B.3. Worldwide The following data is collected from the World Health Organisation (WHO)31 Columns: 1. Area or criterion 2. Total amount of persons in that area 3. Total amount of amputees in that area 4. Total amount of amputees divided by the

total amount of persons = the percentage of that area which has an amputation

5. Total amount of amputees of the area divided by the total amount of amputees of the world = percentage of world figure of amputees living in that area.

Total

Population Amputated

Foot/leg % of pop.

% of all

Africa 655.477.000 3.235.000 0,4935 22

America’s 837.966.000 1.115.000 0,1331 7

Europe 874.178.000 1.416.000 0,1620 9

SE Asia’s 1.559.810.000 5.769.000 0,3699 39

Western Pacific

1.701.689.000 1.591.000 0,0935 11

Eastern Mediterranean

493.091.000 1.833.000 0,3717 12

Males 3.083.884.000 8.025.000 0,2602 54

Females 3.038.327.000 6.934.000 0,2282 46

TOTAL 6.122.211.000 14.959.000 0,2443 100Table “WHO leg”: Figures about the estimated amount of foot or leg amputees by point prevalence according to the World Health Organisation.

31 See Appendix C: “References”

Total

Population Amputated

Arm% of pop.

% of all

Africa 655.477.000 1.041.000 0,1588 19

America’s 837.966.000 662.000 0,0790 12

Europe 874.178.000 614.000 0,0702 11

SE Asia’s 1.559.810.000 1.692.000 0,1085 30

Western Pacific

1.701.689.000 899 0,0001 16

Eastern Mediterranean

493.091.000 644 0,0001 12

Males 3.083.884.000 3.623.000 0,1175 65

Females 3.038.327.000 1.930.000 0,0635 35

TOTAL 6.122.211.000 5.552.000 0,0907 Table “WHO arm”: Figures about the estimated amount of arm amputees by point prevalence according to the World Health Organisation.



C. List of references C.1. UN

Who: Mr. Matthew Todd: Matthew Todd is a professional, sited in the building of the UN in Sri Lanka. He loves figures and statistics and does his utmost to collect reliable figures. The big question: “Does his focus on figures blind him for the real situation?” Matthew researches the effects of the use of pressure mines and UXO’s (unexploded objects) in Sri Lanka. He is the man with the most accurate statistical data in Sri Lanka. He collects among others data from the Army, White Pigeon, the ICRC and UN’s own research. What: Most accurate statistical data on (civilian) landmine victims. His information is (partly) independent of the FINS information. Contact: United Nations Resident Coordination Office, Colombo, Sri Lanka. Website: http://www.icbl.org/lm/2002/sri_lanka.html (Landmine report Sri Lanka), http://www.peaceinsrilanka.org/insidepages/RRR/UNHCR/UNHCR5.asp (internally displaced persons / refugees), http://www.undp.org/erd/mineaction/countries/sri_lanka.htm

C.2. Consortium of Humanitarian Agencies The Consortium of Humanitarian Agencies is an association of agencies working in, and supporting work in, areas affected by conflict. The Consortium aims to enhance the quality, effectiveness, professionalism and transparency of its members so that they may better realise their objectives.

Who: Mrs. Malathi Thalgodapitiya, Programme Officer While Malathi is connected with Matthew Todd (see 1), she has a totally different view on the subject and totally other figures as well. Its possible she has but a wild estimation of the total amount of amputees in Sri Lanka. As well she knows that pressure mine victims is a “sexy subject” in the NGO-business. People are more willing to donate money for war victims than for amputees due to diabetics.

What: Most helpfully, she gave us the report "Impact of Landmines in Sri Lanka", Report of Symposium Colombo, Sri Lanka, March 2001, Contact: Consortium of Humanitarian Agencies, 10 Kynsey Terrace, Colombo 8, SL. E-mail: [email protected] Website: http://www.humanitarian-srilanka.org

C.3. CFINS - Colombo Headquarters of the Colombo Friends in Need Society. The Colombo Friend-in-Need Society (CFINS) started in 1831 is the oldest Charitable Organisation in Sri Lanka. At present CFINS is the largest provider of prosthetic and orthetic services in Sri Lanka.

Who: Mr. Ron McGaw, Volunteer prosthetic consultant Ron McGaw, nicknamed Ronnie, is a prothetist from the UK. He has a good technical knowledge. Except producing (better: supervising the production of) the more difficult limbs, he is busy developing a new design for developing countries (see appendix “Current Research”) and plans a new centre in the north of Sri Lanka. He also works Pakistan and Italy. Ron, in our opinion, sometimes exaggerates. Does he do that in the figures he uses as well?

Who: Mr. Francis, Workshop manager, closely affiliated to FINS-J Mister Francis was one of the major forces in the creation of the Jaffna branch of the Friends in Need Society. Therefore information about (the history of) the Jaffna branch can be found here as well.

Who: Rupa Jayasekera, Administrative Secretary Rupa has (controls) all the access to the (statistical) data of the FINS. She will obey in and check everything with Kalyani. Computer database is available, though it will take some trouble to obtain access.

Who: Kalyani Ranasigne, Chairperson & President Kalyani has access to all the information of the FINS, and thus the best view of the amputee problem in Sri Lanka.



But, it seems not all the information is presented fairly. Look at the website and search for the amount of army victims helped… yes, these are the “civil commotion victims”. What: Statistical data (though very difficult to obtain some details, see website for common), technical knowledge & Jaipur system improvements (Ron) and loads of amputees! Contact: 171, Sir James Peiris Mawatha, Colombo 2, Sri Lanka Email: [email protected] Web: www.cfins.org

C.4. CFINS - Kandy Branch the Kandy branch tries to become independent from the CFINS.

Who: Vinod (Singanayanam?) Vinod is a prosthetist from India, hired by the president of the Kandy branch (T.R.R. Rajan) of the FINS to improve the production of the prosthesis. First, the Kandy branch used the Jaipur design as well, soon they changed to the Mukti-limb. Now they are started to buy and produce the Mobility system from India. Vinod is a reseller of this company. Therefore, the target of Vinod is not so clear and the figures he uses are very positive about the Mobility design. Anyways, Vinod is intelligent and has a very good knowledge about prostheses.

Who: Mr T.R.R. Rajan Mr. Rajan is the president of the local (but well known) match factory Soorya. He believes in the power of his own people and resources. What: Information about the activities of the Kandy branch. Information about the Mukti- and the Mobility-system. Email: Mr. Rajan: [email protected] Website: www.cfins.org

C.5. Army Who: Lt. Colonel S.W. Sunil Somaweera The Colonel is discrete and reliable. If he doesn’t want to give specific information he will elaborate “around” it. Matthew Todd says that it is possible that the army under-reports, but expects that this will change the information only by a few percent. The colonel is very helpful and gave us the feeling he really cares about the landmine victims.

Who: General Perera Although we had little contact with the general he could be willing to assist. What: Global statistical data on military landmine victims and the way landmines are used by the Army and The LTTE. Contact: Office: Commanding Officer,“Ranaviru Sevana”, Army Rehabilitation Centre, Ragama, Sri Lanka Email: lt.col Sunil: [email protected] General Perera:: [email protected] Website: http://www.army.lk/

C.6. CT, the Cambodia Trust Who: These experts have done research about the necessity and ask for an Prosthetists and Orthetists school in Sri Lanka. Therefore they made an estimation of the amount of amputees as well. What: Estimation of amount of amputees and amount of prosthetists.

Website: www.cambodiatrust.org.uk



C.7. ICRC Who: Dr Pierre Gratzl: Although the contact with the ICRC while this project was done in Sri Lanka was worthless, it seems that Dr Gratzl should know more about the subject. The information used is from the "Impact of Landmines in Sri Lanka" report (see 2) in which he wrote an article. Another author in this paper is Joe Williams of the Canadanian Int. Development Agency. Contact: Seemed to be difficult in Sri Lanka. Though we’ve been to the Kandy office as to the Trincomalee office, both new no figures or whatever about amputees. Website: www.icrc.org

C.8. WHO Who: World Health Organisation What: Worldwide figures. Website: http://www.who.int/en/ Report Point Prevalence (see table 1,3,4 of "Discussion Paper 50"): http://www3.who.int/whosis/burden/estimates/2001/….

C.9. Medics Who: Dr. Wickremasinghe: Email: [email protected]

C.10. Team Design for All Who: Boudewijn Wisse Boudewijn is one of the authors of this report. He participated from March 2002 till April 2003 in this project

Who: Wouter van Dorsser Wouter is one of the authors of this report. He participated from March 2002 till April 2003 in this project.

Who: Michelle Kriesels Michelle teamed up with us in August 2002, joining us in Sri Lanka. She was the main drive after the Jaipur+. It was initially her design.

Who: Farshad Soleymani Farshad participated from March 2002 till September 2003. What: All you like! Contact: B.M.Wisse: 0031152190549, Buitenwatersloot 177, 2613 TE Delft, NL Email: [email protected], [email protected], [email protected], [email protected] Website: www.kladder.nl

C.11. Experts in NL Who: Inne ten Have Inne ten Have is the intellectual father of the design we for convenience called the Inne. Right now he is a software engineer, but always interested in developments in prosthetics. Who: Johan Molenbroek Dr. ir. Johan Molenbroek is, among other things, the chairman of the Dutch society for Ergonomics (“Nederlandse Vereniging voor Ergonomie”). He is an important researcher at the Faculty of Industrial Design engineering of the Technical University Delft. Who: Henk Kooistra Dr. Henk Kooistra is the person who innitiated this project. He is a medical doctor and an acupuncturist. Henk’s network in Sri Lanka is very good, because his frequent visits to this country for the past five years. What: Project information and research possibilities. Email: [email protected], [email protected], [email protected] Website: www.tudelft.nl, www.xs4all.nl/~inne/



D. Current designs At this moment there are several designs available in Sri-Lanka. We will describe their properties here briefly:

Jaipur Limb: The Jaipur limb is the main technology, which has been used in Sri Lanka from 1984 till now (2002). It’s easy to produce and low cost. The amputee who has been rehabilitated doesn’t have the best prosthesis in the world, but he has the means to walk and work again, to retain his dignity and get back to a “normal” life. The limb is traditionally made of local materials (wood, rubber, aluminium) and is produced by local production methods. The FINS-technicians also make an adjusted version with Poly Propylene (PP). The foot is extremely suitable for tropical climates and can be used without shoes because of its lifelike appearance.

Mukti limb: The Mukti system is based on the same design philosophy as the Jaipur Foot (Easy to produce, low cost, not the best there is but suitable) This design is made of a biocompatible material (High Density Poly Ethylene [HDPE]) simply bought as drainpipes. The foot is (almost) similar to the Jaipur -foot

ICRC limb: Also the ICRC (International Committee of the Red Cross) has the same principle. (Easy to produce, low cost, not the best there is but suitable) The ICRC is made in local mass production. Unfortunately there are only two (mass-producing) factories at the moment (in Geneva and Ethiopia). It was designed to be made of recycled Poly Propylene. But unfortunately recycled Poly Propylene does not have the recommended stiffness and strength. So now non-recycled Poly Propylene (much more expensive, no environmental gain) is used. This is why some believe the ICRC failed.

Western: “Western” prostheses (Otto Bock, Blatchford, etc) simple are the state of the art. But the best in Europe or America is not always the best in the Asia’s. The ‘problem’ with these prostheses is that the materials used are not always suitable for the climate in the Asia’s. Besides, they often need to be repaired because they are not made for the work people do in the Asia’s. (Heavy work in rice field, bare feet walking, etc). And don’t forget the prices.

Mobility Kit: A recently new technology introduced in Sri Lanka by the Kandy branch of the FINS is the so-called Mobility Kit from India. More information can be obtained by Vinod (C.4). The Mobility kit is produced in Bangalore (as far as the authors know: Mobility India, 515 Base Workshop, Bangalore) It uses a modular system with a custom made socket (above and below knee prostheses are both possible). The kit is delivered with sheets for the socket, the shaft (piston), sheets for the fixating exoskeleton, foot and slippers (to reduce wear). The foot is of lower quality than the Jaipur foot. The use of a piston makes fitting easy for a prosthetist, but the need of a exo-skeleton to support the weight makes later adjustments difficult.



E. The Friends in Need Society The Colombo Friends in Need Society is a non-governmental organization (NGO) in Sri-Lanka. The CFINS provides prosthetic services in Sri Lanka and is based in Colombo (headquarters), Kandy, Jaffna and Galle. The main part of this project in Sri Lanka was done at the Colombo Headquarters. The Kandy branch has been visited. The FINS-Colombo produces about 100 prostheses and ortheses a month. They provide below knee, above knee and arm prostheses. Besides prostheses they provide ortheses. All prostheses and ortheses are custom-made. The FINS-C uses the famous Jaipur Foot Technology. The FINS-K produces the Mukti limb and the Mobility kit. The Jaipur Foot prostheses provided by the FINS-C are funded by US-AID and if needed the civilian survivors receive them free-of-charge.

E.1.

Departments Apart from the administrative and financial department, the production floor is divided in several departments.

The Foot department The Jaipur Foot has wooden and rubber parts inside covered by a several rubber layers. It is extremely resistant and has a lot of flexibility, which is very useful for the unpaved areas in Sri Lanka. It has an aesthetic design, which is preferable for walking bare-feet. It lasts a long time but the problem is that there is no adjustment and alignment possible. It is completely fixed. It has a steel bolt which allows the foot to be connected to the Aluminium shank. The production capacity of the FINS-C is eight feet a day. The chief of the feet department is Mr. Francis. He has been the director of the Jaffna branch for many years. There are five employees. One is making the wooden parts and the others are producing the actual feet. “over”-production is “sold” to the other branches. There is a belt saw, a sander, a drill, a bench-vice and a wood file to shape the wood pieces for the feet. Furthermore there is an oven and there are aluminium moulds to produce the feet. The rubber-glue is made of recycled rubber parts and petroleum.



The aluminium department Most of the prostheses produced at the FINS-C still have a aluminium shank and socket combination. They are all custom-made and their shape depends on the measurements of the stump. The circumferences of the stump are taken every two inch downward started from the patella tendon. These measurements are filled in on a form. After this the measurements are drawn on a heat treated sheet of aluminium, the sheet will be cut, bended, welded together and beaten up until the shape is good enough. At the end a round wood piece (Ø = 7 inch) is put in the lower part of the shank. This allows the shank to be connected to the foot.

Picture “Cutting the sheets”: Here one of the authors can be seen cutting the sheets, which will become sockets. The total production time of the shank is about two hours, which is extremely quick. The chief of the aluminium department is Mr. Nepala. He is a well-educated man and has given prosthetic education in Iraq and Sudan. There are five employees. Three of them are producing the shanks and two are painting the prosthesis and producing the leather belts.

Picture “Painting the Prostheses”: The prostheses are given a life-like colour. There is a belt saw (same as the foot department), a sander, a drill and a wood file to shape the wood pieces for the aluminium shank. Furthermore there is a gas burner, to heat the sheets, a welding apparatus, a bench-vice and there are three work areas with a toolbox (hammer, aluminium file, metal scissors, nippers, etc). To produce the leather belts there is a sewing machine. In the aluminium department is also a storage room. All the parts used to produce prostheses have to be taken out of this store. In this way it’s possible to check the rate of production and the amount of material used.

The polypropylene department As described recently polypropylene is being used. Polypropylene is lighter, more convenient and more comfortable for the stump. The disadvantage of polypropylene is that there are few adjustments possible. Besides polypropylene sockets this department also produce ortheses and scoliosis-corsets. The first part of making a polypropylene socket is taking a cast of the stump with bandage and plaster of Paris. After removing the negative-cast it will be filled with plaster of Paris. When the plaster is hard the mould (negative-cast) will be removed. The positive form is no ready for adjustments (Hollow the weight bearing areas and build up the pressure sensitive areas). After the positive form is adjusted a polypropylene sheet will be heated and vacuum formed (pulled) over the positive form. The negative-polypropylene form will be removed from the positive-plaster form and finished. The produced polypropylene socket will be used in combination with an aluminium shank or in combination with a recycled western prosthesis.



The total production time of a polypropylene socket is about one day. The chief of the polypropylene department is also Mr. Francis. There are five employees. One produces arm prostheses and the others produce the sockets.

E.2. Internal research The FINS-C does not have a research department. Research done at the FINS-C is done by individuals. The main technology, which has been used for more than 15 years, is the Jaipur limb technology. (see appendix D: “Current designs)”. According to de FINS-C this technology suffices, so why look for something new?

State of technology The most recent technology that has been introduced is the use of a polypropylene socket instead of an aluminium socket. Now both technologies are used. The shank is still made of aluminium. During our visit at the FINS-Kandy branch we have seen trials with a new design from India (the "mobility kit", see appendix D: “Current Designs”).

Current developments People at the FINS-C who develop improvements are Mr. Francis and Mr. Ron McGaw. Mr Francis, chief of the foot and polypropylene department is developing a plastic (recycled polyproplene) cast piece to replace the wood-piece inside the rubber foot. But Mr. Ron McGaw does the most research at the FINS. Except producing (better: supervising the production of) the more difficult limbs, he is busy developing a new design for developing countries. It must be said: His design is very useful. Of course, he uses the traditional principles (PP-socket + piston + adapted Jaipur foot), but the improvements are promising. Unfortunately, the presentation of his new product (drawings, etc) is not very high standard. Anyways, we hope his design will be implemented soon, because it will improve the production rate and make adjustments (gait) easier, thus reducing the time the prosthetists need to spend. Ron plans to start up a new centre in the north of Sri-Lanka (near Killinochchi).

Integration It was the first time a group of foreign students did a (research) project at the FINS. At first it was difficult getting used to each other. They didn't know what they could aspect from us and we didn't know what we could aspect from them. The employees all have their own tasks. They all had an education of at least two years and know their trade well. Everything done in another way than



common was strange, so we first had to inspire confidence. In the end, contact with the technicians was very good. Contact with the management seemed to be well at first, but later we learned our impression was wrong. Even after three month we had difficulties obtaining data (see appendix B: “Figures”).

F. Contacts and Residences Before we went to Sri-Lanka we arranged a back-up team in the Netherlands. Two students were able and prepared to help us if we needed some (research) work done in the Netherlands. Beside this team we had the support of Johan Molenbroek. Our counterpart in Sri-Lanka was Malathi Thalagodapitiya. She works at the humanitarian agencies and arranged transport from the airport to a hotel very close to the FINS during our first day in Sri-Lanka. Unfortunately this hotel was too expensive for us. So we had to look for a cheaper hotel during the first week. Eventually we found a location (guest house) which was much better. When Henk Kooistra came (about two weeks later) he helped us to find a spacey apartment in Mt. Lavinia. Our neighbours helped us very much during our visit in Sri-Lanka. They often invited us for dinner, had a computer and were always prepared to talk to us. A few times we left this home and went out for some days. The first day Malathi introduced us to the director of the FINS-C, Ms. Kalayani Ranasinghe and the chief of the administration department Ms. Rupa. Ms. Kalayani who only works on wednesdays introduces us to Mr.Ron McGaw. He is an English prosthetist who was very helpful to us. We discussed our ideas and concepts with him. Besides Mr.Ron, Mr. Francis (chief of the foot and polypropylene department) and Mr. Nepala (chief of the aluminium department) were very helpful during our daily activities. And last but not least the employees ("boys") of the workshop, they were great! They always took care of us and in some way the always knew what we needed before we even knew it ourselves. Some of the boys are deaf and can't speak. This resulted in a very primitive, but also easy and friendly way of communication. Thanks to Henk Kooistra we were also able to see other workshops like the workshop in Kandy (FINS-K) and the military workshop. He also introduced us to Prof. Dr. Anton Jayasuriya, an acupuncturist. He was the chief of the 40th congress of Medicina Alternativa. When he heard about our project he invited us to speak. Later he also offered us an acupuncture course.



G. Price estimation

Material costs Material Part(sub-) Quantity Material Purchase Productiontech. Price (E) SOCKET 1 Front p.t.piece 1 pp inject.m. /v.f. 1 klitterband 2 stof purchase - 0,25 padding 2 stof purchase - 0,75 backside 1 cfibre inject.m. /v.f. 4 inferface 2 pp/metaal? inject.molding 4 belts 2 stof purchase - 0,25 tentioner 2 pp purchase - 1 length adjust 2 metaal purchase - 0,25 stumpend cup 1 pp vacuum forming 0,5 padding 1 foam purchase - 0,25 suspention 1 metaal? bending/cold-forming 0,25 bolt and nut 1 metaal purchase - 0,05 LINER 1 liner 1 foam purchase - 0,75 FOOT 1 basis 1 pp inject.m. 1 lid 1 pp inject.m. 0,5 anklerubber 1 rubber casting/inject.m. 1 toes 2 pp inject.nm. 1 interface 1 pp? inject.m. 1 sealing (surface) 1 textiel heat&glue 1 bolt and nut 1 metaal purchase - 0,05 rubbers 3 rubber cut 0,25 Finishing Tube (shank) 1 metaal purchase - 2 Cosmetic cover 1 foam purchase - 1,5 Box 1 papier purchase - 1 Measurement card 1 papier purchase - 0,05 Manual 1 papier purchase - 0,5 upperlegbelt 1 leather purchase - 2 material costs (p.p.) 26,15



** All prices in Euros

Investment & Price p.p. stand. 1 year 2 years 5 years avr.wages total limbs: 0 5000 20000 50000

building (/year) 1 100000 100000 200000 500000 Machines Vacuum former 10000 10000 10000 10000 Bender(stance) 10000 10000 10000 10000 Casts 100000 100000 100000 100000 Inject. molder (2) 50000 50000 50000 50000 Personnel Doctors 0 0 0 0 0 Technician 15 10800 10800 21600 54000 60 Admin/year 10 6000 6000 12000 30000 50 Maintenance/clean 10 4800 4800 9600 24000 40 Gas,light,water 1 3600 3600 7200 18000 Quantity*Material cost. 0 130750 523000 1307500 Totals 295200 425950 943400 2103500 Per piece 85,19 47,17 42,07 Rounded: 300.000 85 47 42

The Alternative Prosthesis

version date: 18-10-2004 Page 19

Aluminum prostheses

Plastic prostheses

H. Flowchart - Socket designs

DFU - socket

D

F

E

H

K

The flowchart shows the mostimportant intermediary results of twodesign lines of the socket (andshank). Some other design lines arenot presented.

A, B, C Although many prototypes weremanufactured, in figures A, B and Cthe design steps of the Inne+” can befound. [A] Features: Triangle shank; gluedpatella tendon knob and gluedpadding. Description: The patellar tendonknob is glued on as in the originalconcept. To keep the amount ofmaterial used low, while keeping astiff shank, three strips are weldedtogether making an triangle.Unfortunately the welding processreduces the material strength so ittears apart on strain. [B] Features: A beaten patellatendon knob; thicker material; anextra bar and no padding anymore. Description: The padding seemedto enhance the comfortinsignificantly. To stop the separationof the lower strips of the socket andthe slipping of the stump an extrastrip is added. It helps, but still notenough. [C] Features: adjustable roundshank (bicycle mechanism) Description: To be able to adjustthe length of the prosthesis and to beable to fit her new socket/shank tothe classic Jaipur foot, the end of thesocket had to be round. Thereforethe “bicycle steer mechanism” wascopied, enabling easy adjustment inheight of the prosthesis and angle ofthe foot.

G, H, K The decision to leave the hand-madeprinciple and to design for mass-production enables the use of syntheticmaterials. “Plastics” are highlyformable. [G] Features: A patellar tendon flap atthe front; ski shoe bindings; calf muscleholes at the back; adjustable shanksystem. Description: Holes in the product aresmall (else skin gets trapped), but largeenough to adjust the socket fordifferent stump sizes. The holes at theside make height adjusting possible,but stepwise. [H] Features: A flexible socket; a(flexible) patellar tendon flap; ski shoebindings (not in picture); an aboveknee belt. Description: Difficulties with this designare adjusting the height, contracturecompensation and pressuredistribution. [K] Features: Bearing area on stumpend. Adjustable in height and size. Description: see the chapter 8

D, E, F On the right the design steps of theJaipur+ can be found. [D] Features: A fixed back part; anadjustable front (patella tendon) andadjustable round shank. Desciption: The socket/shankcombination fits in the same piece asused in design [C]. Increasing theamount of material used (should)increase the contact surface,improving comfort. The front piece isdifficult to produce out of aluminium.[E] Features: A calf muscle flap (atthe distal backside); An L-profile formore strength and stiffness Desciption: To improve thepressure distribution for patients withdifferent stump sizes and forms, thebackside is cut loose. This“improvement” is good in mind, butdidn’t work at all in practise.Attaching the belts on the insidedoes not make the prosthesisuncomfortable, but improves theforce distribution to the patellartendon. [F] Features: Folded out of one strip;no calf flap Desciption: To keep the sameprinciple, while reducing materialusage and to ease the manufacturingthe design was adapted so it’s madefrom one strip (and a front piece).

C

B

G

A

The Alternative Prosthesis

version date: 18-10-2004 Page 20

P

I. Flowchart – Foot design

L M

O

N

DFU - socket

K

The flowchart shows the most importantintermediary results of the design of the foot.

L, M Designs L and M were developed in theNetherlands. [L] Features: Low tech, bicycle parts reusingfoot. Description: This design although not verylifelike, is used in some commercialprostheses. The difference is the use of(cheap) bicycle parts and the ease ofmanufacture. Further development could bepromising [M] Features: wood based, lifelike, usingslippers, rocker foot shaped. Description: The rocker foot is a design, whichuses the shape of the bottom for a good gait.A. The bottom has a straight part for stabilitywhile standing. The top is purely aesthetic. Ametal sheet and a slipper protect the foot fromwear. No moving part increase the lifetime ofthe foot.

N, O [N] Features: rubber based, linear alignment) Description: The foot takes the advantages ofthe Jaipur and increases lateral flexibility with adifferent wood piece. The design of the woodpiece enables linear alignment. [O] Features: plastic based, linear and angularalignment, mass production, different stiffness)Description: The foot used in the DFU ismass-produced. The toes are producedseparately (left and right), thus using the samepart for all prostheses. The stiffness in the heeland between the toes and the middle caneasily be increased or decreased (foramputees with different weight and strength). Making the connection of the toes to the middlewaterproof is still a weak point of this design.

P The final DFU kit: All parts are shown,including an easthetic cover, the two mainparts of the socket, L&R toes, a manual andinterfaces. Caution: The drawing containsparts, which do not resemble the actualsolution.

the alternative prosthesis - final report internship sri lanka 2002 - w.d.van dorsser and b.m.wisse

Documents

colombo sri lanka

sri lankain

cfins colombo

developing prostheses

analysis nl

wisse v dorsser

colombo friends

colombo headquarters