Development of a high-performance, durable, low-cost, modular recycled Carbon fibre composite prosthetic foot system for Low/Middle income countries

背景/需要世界卫生组织估计，到2011年，生活在LMIC的残疾人对假肢的需求将上升到3000万。为了解决康复问题，制定了过多的立法。尽管如此，LMIC提供的服务水平各不相同。在立法中强调了获得康复服务的权利。然而，在国民总收入低的国家，康复服务很少被列为优先事项，因为初级卫生保健是优先事项，这是可以理解的。相反，随着初级卫生保健倡议取得成功，随着更多的残疾人在婴儿期存活下来，对康复服务的需求也会增加。因此，需要进行更多的研究：a)评估当前LMIC的服务提供模式；b)开发高性能和低成本的工程解决方案，以实现充分的假体干预。研究目的本项目的目的是开发基于可回收碳纤维的仿生踝足系统，该系统具有高性能、耐用性、舒适性以及低成本的能量储存和释放，并有可能在LMIC中制造。这将涉及在先进复合材料、顺应性活性结构和部件、全假体系统设计和计算建模、模拟、测试和验证、规模化制造以及可持续社会企业发展、功能成果量化、需求评估和提供低收入中等收入国家假体服务等关键科学领域的协调努力。所有基础研究部分将由最终的临床和社会需求以及以用户为中心的设计驱动，这是由一个临床团队与LMICs的现有合作伙伴合作以前确定、评估和量化的。这些将满足需要康复和援助以保持假肢使用者独立性的核心使用者群体的需要。为了实现这一目标，我们确定了一系列目标：确定假肢系统目标用户群体的具体需求和认知。为要求苛刻的环境所需的特定行为建立工程规范，以满足目标用户群体确定的需求。设计和开发有针对性的功能顺应性材料，以实现高性能假肢的动态能力。根据用户参与和反馈，制定假肢的产品设计规范。设计、制造和测试一组NFC组件。这包括脚和连接脚与其他假体部件的适配器，如用于经股骨假体的膝部和用于膝部以下假体的插座。评估真实世界中的原型脚。方案和方法工作方案由八个相互关联的工作包(P1-P6)组成，自下而上处理从复合研究和计算建模到完成假肢踝足系统原型和临床验证的开发流程。需要对目标用户群体进行评估和认知P2.确定的天然纤维复合材料的机械特性。P3.高性能组件的设计和优化。P4。机械测试P5。田间试验P6.推荐的规模化生产途径。影响：这项工作成果的直接受益者是膝盖以下截肢者。此外，还将建立与先进复合材料和计算模型数据库有关的知识库，使学术界和工业界受益。

BACKGROUND/NEED The WHO estimates that amongst the disabled people living in LMIC's the need for prostheses will have risen to 30 million by 2011. To address rehabilitation issues a plethora of legislation has been produced. Despite this, varied levels of service provision exist in LMIC's. Entitlement of access to rehabilitation services is emphasised in legislation. However, in countries where the gross national income is low; rehabilitation services are rarely prioritised as primary health care understandably takes precedence. Conversely, as primary health care initiatives achieve success, greater demand is created for rehabilitation services as more disabled people survive infancy. Therefore, more research is required to ; a) assess current models of service provision in LMIC's. and b) to develop high performance and low cost engineering solutions that enable adequate prosthetic intervention.RESEARCH OBJECTIVES The aim of the project is to develop recycled carbon fibre based biomimetic prosthetic ankle-foot system which exhibits high-performance, durability, comfort as well as energy storage and release which is low cost and could potentially be fabricated in LMICs. This will involve a concerted effort in the key scientific areas of advanced composites, compliant active structures and components, full prosthetic system design and computational modelling, simulation, testing and validation, manufacturing to scale, as well as sustainable social enterprise development, functional outcome quantification, need assessment and prosthetic service provision in LMICs. All fundamental research components will be driven by the ultimate clinical and social needs and user centred design as identified, evaluated and quantified previously by a clinical team in collaboration with established partners in LMICs. These will address the needs of the core user groups who require rehabilitation and assistance to maintain independence of prosthetic users. To realise a set of objectives are defined: Determine the specific needs and perceptions of the target user groups for prosthetic feet systems. Establish engineering specifications for the specific behaviour required for demanding environments to meet the identified needs of the target user group. Design and develop targeted functional compliant materials to enable dynamic capability of high-performance prosthetic feet. Develop product design specifications for the prosthetic foot, based on user engagement and feedback. Design, fabricate and test a set of NFC components. This includes feet and adapters to connect the feet to the other prosthetic components i.e. the knee for trans femoral prosthesis and socket for below the knee prosthesis. Evaluate prototype feet in the real world. i.e. UK, India, Rwanda and Malawi.PROGRAMME AND METHODOLOGY The work programme consists of eight interlinked work packages (P1-P6) which address, from the bottom up, the developmental pipeline from composite research and computational modelling to complete prototype prosthetic ankle-foot system and clinical validation. P1.Need assessment and perceptions of the target user groups P2.Mechanical characterisation of the identified natural fibre composites. P3. Design and optimisation of the high-performance components. P4. Mechanical testing P5. Field trials P6.Recommended pathways for production at scale. Impact: The direct beneficiaries of this work's outcomes are persons with a below the knee amputation. In addition, a knowledge base in relation to advanced composites and computational modelling data base will be created benefiting, academia and industry.