Intelligent Prosthetic Socket with Variable Volume and Elevated Vacuum Systems

描述（由申请人提供）：患者接受腔性能是康复进展的关键障碍，是患者不满的最常见来源，也是日益严重的医疗和社会经济问题的一部分。插座性能差是一个非常不典型的多因素问题，可导致皮肤退化和患者不适（约占所有患者的75%）。这项建议有两个方面：（a）结合联合收割机和（真空-EV和可变体积VV系统）为了首次实现插座真空和插座内部体积的实时可控性，以及（B）通过引入通用插座性能指数（SPI）参数，在大量实验室内外临床试验中评估其创新插座原型（实验验证）用于可靠的、非患者特定的插座设备评估。插座原型系统的彻底验证非常艰苦的活动，强大的可行性研究将扩大沿着其整个结构和功能特性，包括灵敏度，可操作性，安全性和耐用性，并将在实验室内外的临床试验中完成功能测试。这里提出的工作将为市场带来一种新的设备（iSOCKET）和新的方法，这些方法源于一批公司和学术界多年的合作。iSOCKET将增强患者的自主性（与竞争产品相比，改善了连续无痛插座使用的时间，改善了SPI），并将解决人们期待已久的与剧烈活动相关的插座性能挑战。iSOCKET设备将发展成为一种经济实惠的实用插座，具有实时压力/剪切/应力释放功能。iSOCKET希望证明预防干预的新选择，而拟议的工作也将提供新的临床工具，以支持下肢假肢用户的日常装配，康复和监测。该提案取决于公司，医院，用户团体，临床医生和学术中心的各种联盟的协同作用。SSDL将利用拟议技术的技术成熟度和成本/效率比，克服科学知识和临床实践中的关键障碍。 公共卫生相关性：iSOCKET假肢装置结合了两种新型的接受腔技术，以实现接受腔真空度和接受腔内部体积的实时可控性，并设计成具有实时压力/剪切/应力释放能力的经济实用的接受腔。该产品旨在通过提高患者自主性和移动性来支持研究人员和临床医生优化患者护理。支持改善假肢使用者的适配和康复的研究将导致更大的患者流动性，从而带来多种长期健康益处。

DESCRIPTION (provided by applicant): Patient socket performance is a critical barrier to progress in rehabilitation, the most common source of patient dissatisfaction and part of a growing medical and socioeconomic problem. Poor socket performance is a greatly uncharacterized multi-factorial problem that leads to skin degeneration and patient discomfort (~75% of all patients). This proposal has a two-folded scope: (a) to combine two novel socket technologies (elevated vacuum-EV and variable volume VV system) in order to enable for the first time real-time controllability of socket elevated vacuum and socket internal volume, and (b) to evaluate its innovative socket prototype in a number of in- and out-of-lab clinical trials by introducing a universal Socket Performance Index (SPI) parameter (that is experimentally verified) for reliable, non-patient specific socket device assessment. Thorough validation of the socket prototype system for very strenuous activities, robust feasibility studies will expand along its entire structural and functional properties, including sensitivity, operability, safety and durability, and will be completed by functional tests in clinical trials in-and-out of the laboratory. The work proposed here will bring to the market horizon a novel device (iSOCKET) and new methodologies that stem from years of collaboration of a cohort of companies and Academia. iSOCKET will enhance the autonomy of patients (improve on the time of continuous pain-free socket use, improve SPI as compared to competitive products) and will solve the long awaited challenges in socket performance associated with very strenuous activities. The iSOCKET device will evolve into an affordable, practical socket with real-time pressure/shear/stress relief capabilities. iSOCKET hopes to prove the new choice for preventative interventions whereas the proposed work will also deliver new clinical tools to support daily fitting, rehabilitation, and monitoring of lower limb prosthesis users. The proposal depends in the synergy of a very diverse consortium of companies, hospitals, user groups, clinicians and academic Centers. SSDL will take advantage of technological maturity and cost/efficiency ratios in the proposed technology to overcome critical barriers in scientific knowledge and clinical practice. PUBLIC HEALTH RELEVANCE: The iSOCKET prosthetic device combines two novel socket technologies in order to enable real-time controllability of socket elevated vacuum and socket internal volume and is designed to be an affordable, practical socket with real-time pressure/shear/stress relief capabilities. The product is intended to support researchers and clinicians in their optimization of patient care by improving patient autonomy and mobility. Research supporting improved fitting and rehabilitation of prosthesis users will result in greater patient mobility, leading to multiple long-term health benefits.