Intelligent Prosthetic Socket with Variable Volume and Elevated Vacuum Systems

具有可变容量和高真空系统的智能假肢接受腔

• 批准号: 8058471
• 负责人: GEORGE PAPAIOANNOU
• 金额: $ 38.96万
• 依托单位: SMART SURFACE DESIGNS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-05 至 2012-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8058471
• 关键词: Academia; Air Sacs; Amendment; American; Amputees; Anthropometry; Benchmarking; Bladder; Cells; Clinical; Clinical Trials; Code; Collaborations; Data Collection; Devices; Elements; Expert Systems; Feasibility Studies; Feedback; Gait; Grant; Health Benefit; Hospitals; Hour; Intervention; Ions; Kinetics; Knowledge; Laboratories; Legal patent; Life; Limb Prosthesis; Lower Extremity; Marketing; Medical; Metabolic; Methodology; Methods; Miniaturization; Moderate Exercise; Monitor; ORALIT; Outcome Measure; Pain-Free; Patient Care; Patients; Performance; Phase; Physical activity; Physiological; Production; Property; Prosthesis; Protocols documentation; Publications; Questionnaires; Rehabilitation therapy; Research Personnel; Research Support; Running; Safety; Sales; Skin; Source; Speed; Strenuous Exercise; Stress; Suction; Suspension substance; Suspensions; System; Techniques; Technology; Testing; Time; Tissues; Vacuum; Validation; Walking; Weight; Wireless Technology; Work; base; bone; clinical practice; cohort; cost; design; functional outcomes; improved; indexing; innovation; kinematics; meetings; novel; patient population; pressure; prototype; respiratory; safety study; sensor; shear stress; socioeconomics; stem; symposium; tool; virtual; voltage

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.

描述（由申请人提供）：患者的关节窝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。眼窝功能差是一个非常不典型的多因素问题，导致皮肤变性和患者不适（约占所有患者的75%）。这个建议有两个范围：(a)结合两种新颖的插座技术（提升真空ev和可变体积VV系统），以便首次实现插座提升真空和插座内部体积的实时可控性；(b)通过引入通用插座性能指数（SPI）参数（实验验证），在许多实验室内外的临床试验中评估其创新的插座原型，以进行可靠的，非患者特定的插座设备评估。对于非常剧烈的活动，插座原型系统的彻底验证，稳健的可行性研究将扩展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，并将通过实验室内外的临床试验功能测试来完成。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，这些方法源于公司和学术界多年的合作。iSOCKET将增强患者的自主性（改善持续无痛插槽使用的时间，与竞争产品相比提高SPI），并将解决期待已久的与非常剧烈的活动相关的插槽性能挑战。iSOCKET设备将发展成为一种经济实用的插座，具有实时压力/剪切/应力释放功能。iSOCKET希望证明预防性干预的新选择，而拟议的工作也将提供新的临床工具来支持下肢假体使用者的日常安装、康复和监测。该提案取决于由公司、医院、用户群体、临床医生和学术中心组成的非常多样化的联盟的协同作用。SSDL将利用拟议技术的技术成熟度和成本/效率比来克服科学知识和临床实践中的关键障碍。