MICA: Integrated interfacial sensors for assessments of lower limb prosthetics

提出的研究旨在解决下肢假肢中存在的技术缺陷，即残肢-插座负载测量，这也是该领域最重要的未满足需求。如果没有一个解决方案，提供了一个实用的手段，动态负载测量的残肢-接受腔界面，确定接受腔配合，单一的最大因素决定假肢的结果将仍然是不量化的和有问题的。该解决方案的影响不能被夸大，因为它可能会产生一个范式转变，在假肢护理和导致新的知识和了解的动态残肢插座接口loading.The目的拟议的研究是生产一个验证的“智能班轮”原型，提供结合机械压力和剪切载荷测量在这个重要的加载接口。智能内衬将围绕标准假体内衬解决方案构建，因此其形式对于正常的日常假体使用是实用的，克服了现有仅压力测量解决方案的实用性缺陷。重要的是，与所提出的解决方案相比，现有的测量系统以对于日常正常使用不实用并且仅适合于短持续时间的实验室测量的形式存在。此外，没有现有的商业化系统具有压力和剪切测量的组合能力。剪切载荷是关节窝界面处载荷的基本和潜在损伤成分，可显著导致组织损伤。迄今为止，这虽然被广泛认为是一个重要的问题，但由于缺乏合适的传感技术，在很大程度上仍然没有量化。为了得到这个原型，第一个目标是开发一个实验室为基础的树桩插座接口模拟器和系统的“控制”测试，可用于班轮设计优化。将通过步态分析测量验证模拟载荷测试，以确保模拟器提供生物力学有效的载荷，并具有高度的可重复性和可靠性。下一个阶段是将智能衬板设计优化为实用的形式，并且可以在短期到中期内可靠地用于负载测量。最终目的是进一步验证原型和组合测量系统，同时考虑可能决定测量可重复性的临床因素，例如穿/脱传感器定位变化。最终的结果是一个原型班轮设计与组合仪表和数据可视化，这是准备商业化。该项目的总体成果将证明该解决方案在商业规模生产上的技术可行性。此外，智能内衬设计将通过初步临床测试验证其可行性，以实现商业临床产品应用。

The research proposed aims to address a technology shortfall that exists in lower limb prosthetics, that is stump-socket loading measurement which is also the single most important unmet need in the field. Without a solution which offers a practical means of dynamic load measurement of the stump-socket interface, determination of socket fit, the single biggest factor determining prosthetic outcomes will remain un-quantified and problematic. The impact of the solution cannot be overstated, as it is likely to yield a paradigm shift in prosthetics care and lead to new knowledge and understanding of the dynamics of stump-socket interface loading.The aim of the proposed research is to produce a validated "intelligent liner" prototype which provides combined mechanical pressure and shear load measurements at this important loading interface. The intelligent liner will be built around a standard prosthetic liner solution and thus be in a form practical for normal everyday prosthetic use overcoming the practicality deficit of existing pressure only measurement solution. It is important to state in comparison with the proposed solution, existing measurement system exist in a form which are not practical for everyday normal use and are only suitable for short duration laboratory measurement. Furthermore no existing commercialised system has the combined capability of pressure and shear measurement. Shear loading is a fundamental and potentially damaging component of loading at the socket interface which can contribute significantly to tissue damage. This to date while widely known as a significant issue has remained largely un-quantified to the lack of suitable sensing technologies. To get to this prototype, the first objective is to develop a laboratory based stump-socket interface simulator and a system of "control" tests which can be used for liner design optimization. The simulated load tests will be validated from gait analysis measurement to ensure the simulator provides loading which is valid biomechanically and which have a high degree of repeatability and reliability. The next stage is to optimize the intelligent liner design into a form that is practical and can be reliably used in the short to-medium term for loading measurement. The final aims are is to further validate the prototype and combined measurement system taking into account clinical factors that may determine the repeatability of measurements for example such as don/doffing sensor positioning variations. The final outcome is a prototype liner design with combined instrumentation and data visualization which is ready for commercialization. The overall outcome of the project will have demonstrated the technical feasibility of the solution for production on a commercial scale Moreover the intelligent liner design will have been validated for viability through preliminary clinical testing towards commercial clinical product applications.