Call for Interdisciplinary Projects – Sevres 2015 A: General Information Project title: Dynamic Open-source Leg Prosthetics Helping Individual Needs Acronym: DOLPHIN Keywords (5): bioengineering, personalized medicine, performance enhancement, functional aesthetics, ethics Team members Names Hamizah Cognart Vincent Foulonneau Fahed Faraz Mian Anna Sawicka Guillaume Villain Alexandra Zak Fields of interest Personalised medicine/biomedical science Physics/Algorithmic/Biology/Sports Pharmaceutical and biological sciences Molecular biology/clinical trials/ethics Synthetic Biology/ Proteins Evolution/Programming Arts/immunology/philosophy Abstract The famous case of Oscar Pistorius shows the abilities of currently available artificial legs. However, the standard prosthesis is expensive and not adapted to the individual needs of a given patient. The goal of the project is to develop an open-source, low-cost robotized prosthesis. We want to emphasize the design of it, as the appearance of the artificial leg influences the social interactions of a patient and their process of recovery. The prototype will be tested to establish the muscle response to it. In the next step the prosthesis can be adapted to the individual needs of a patient, i.e. the administration of specific drugs or the connection to the nerves. The project will be conducted in cooperation with clinicians. In connection to the experimental part the ethical questions will be resolved. The use of modern prosthesis changes the situation of disabled people in an unprecedented way. We want to discuss if they should be still considered disabled, either in terms of their relations with the society, or in their own personal view of themselves. B: Description of the project B-1 General Introduction The major causes of leg amputation are: peripheral arterial disease, injuries due to accident or burning, cancerous tumour and malignant infections. After the surgery wounds are healed, the patients are usually advised to buy a prosthesis. Beyond the pain to lose a part of itself, the patient want a prosthesis which is the closest to the lost part and it has to be the most functional as possible. To let the patient believe there was no amputation, modern prosthesis has very advance design but not always functional. On the other side, the prosthesis may be very efficient, as we can see with the south Africa athlete Pistorius, but in this case, the technology is far from human leg, as design and anatomic stride are concerned. The DOLPHIN project give a solution on both side in addition to give a neuronal connection to the prosthesis through a new bio-technological device which will be presented further. B-2 Objectives and specific aims Objectives: 1. Treating people with lower limb disability. 2. Creating affordable aesthetic prostheses to avoid social inequality. 3. Overcoming stereotypes of disability and prosthetics in the society. Aims: 1. To build an open-source prosthetic leg. 2. To design an artificial leg that caters to each individual’s needs. 3. To facilitate drug administration on an optional basis based on personalized medicine. C: Detailed description of the project An ideal prosthesis should be controlled very accurately, and should be a part of the body. It is important to achieve that harmony between the body and the machine. We should find a better connection between the two objects, with an electronic connection with the nerves. That relation between the object and the body can be basis of multiple modification of human capacity, either to restore abilities for a handicapped person or to increase the performance of humans for competition purposes. 1. How could it be possible to establish a connection between the nerves and an electronic component? We need an interface with the brain, which can give us the ability to control an articulated device. 2. What is the basis of the neurotransmission that leads to the movement of the muscle? We would like to understand how such command could be converted and delivered to control a robotized prosthesis. We will develop the prosthetics using only open source hardware and software to allow us a rapid prototyping and get faster feedback from the community. With this approached we will be able to design a product that will have a more affordable price. Companies that decide to manufacture the end products won't have to pay the research and development fees. The designs will be open and freely available online. We will create an online platform to share the design being transparent about our need and aiming to bring together designer, hacker and maker communities with Amputees. Investigating the interaction between the muscles and the prosthetics In order to check the physiological effects of the prosthetics on the human part of the leg, the follow’s biological tests has to be performed. Biopsy: In order to control the mean amount of stem and muscle cells and also the mean size of muscle’s cells, a biopsy has to be done once time per month. It will allow us to quantify the earnings due to the greater motility offered by the prosthetics to the users. This test will also check for prospective necrosis of the tissues near the biotechnology interface. Iso-Kinetic test: This test allows quantifying the eccentric strength of both quadriceps and hamstrings for the two legs. The strength & conditional protocol for the training of the patient will be adapted to equilibrate as much as possible the power developed by the two legs and also optimize the power ratio between quadriceps and hamstrings (that should theoretically converge to one.). This test has to be done every two weeks the first year. Blood pressure: This measure is important to know if the blood near the biological interface with the prosthetics do not vary and do not make mechanical constraints on blood vessels that could lead to muscles tissues asphyxia. This test has to be done every two weeks. Overcoming secondary complications due to prosthetic reconstruction Allografts and transplantation increases both local and systemic levels of inflammation and is associated with increased rate of malignancies, although the association may be confounded by immunosuppressive therapy. For example: Joint prostheses have overall survival rates of 75% over 10 years, and 52% over 20 years. Allografts infectious complications occur within the first few years. Current prosthetic replacements are mostly due to mechanical causes. Possible solutions or mitigations: Monitoring the level of inflammatory markers regularly over 2-5 years. Administer drugs to treat specific infections and to slow down muscle atrophy after prosthetic reconstruction. Psychological effects and ethical issues surrounding the use of prostheses and prosthetic reconstruction When your leg has been amputated, you pass between different stages to accept this. Usually you pass through five stages, which are: denial, anger, bargaining, depression and finally acceptance and hope (1,2). Thanks to the fact that the envisioned prosthesis is aesthetically and functionally more similar to a biological one, can we reduce the time or the level of depression to accept faster this new leg? The question can be answered by a psychological study comparing two groups of patients. The first group would wear our prosthesis and the second one the standard ones. To measure the rate of anxiety and depression, we will use the HADS questionnaire (Hospital Anxiety and Depression Scale) (3). The final aim of the therapy is to accept the new leg as a part of the organism and then to deal with it to go back to life. This leads us to the question: what is disability? Should people with prosthesis be still considered "disabled"? Or maybe they are "cured"? The question will be explored along two main lines of interest: A) In every-day life disabled people meet with all sorts of difficulties and therefore they are entitled to social help (e.g. social fund, priorities in shops and offices). Will the "perfect prosthesis" change it? Should people with prosthesis still benefit from such help? B) The prosthesis change the way the person looks at themselves. While wearing the prosthesis, should they recognise themselves as being disabled? (e.g. protect themselves, take greater care of their health) Or, maybe, they should forget it, and lead a "normal" life? (1) Frank RG et al, Br J Psychiatry, 1984. (2) Saul Morris' PhD, The psychological aspects of amputation, 2003. (3) K Srivastava et al, MJAFI, 2010. D: Scientific Interest in the project of all the participants and beyond We would like to very much improve the quality of life for the people with disability of the lower limbs. We are motivated to investigate the interaction between the muscles and the prosthetics. Our curiosity in biomimetism drives us to develop this biomimetic device. We would like to challenge and surpass the actual and current human capacity. We would also like to explore the ethical issues pertaining prosthetics particularly by looking at the society’s reactions towards prosthetics and their uses. Finally, we would like to explore the psychological effects of prosthetics on their users. This project will interest other scientists because we are trying to achieve a medical progress by setting-up multidisciplinary care pathways between pediatric surgeons and surgeons treating adult patients. Furthermore, this project will change the society’s view on prosthetics and their uses as we aim to enhance its aesthetics and reduce its costs. E: BUDGET (1 million euro max for 3 years including salaries, equipment, consumables, etc.)