LCP Nerve Cuff with Telemetry for Prosthetic Sensation

带遥测功能的 LCP 神经袖带用于假肢感觉

• 批准号: 7492641
• 负责人: RONALD Raymond RISO
• 金额: $ 92.91万
• 依托单位: INNERSEA TECHNOLOGY, INC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7492641
• 关键词: Amputees; Animal Model; Animal Testing; Area; Biocompatible; Biocompatible Materials; Bladder; Body Image; Chronic; Code; Computer software; Cutaneous; Data; Detection; Development; Devices; Electrodes; Electronics; Esthesia; Evaluation; Fascicle; Feedback; Fostering; Hand; Human; Implant; Incidence; Individual; Intestines; Joints; Limb structure; Marketing; Methods; Modality; Nerve; Neural Pathways; Occupational Therapist; Paralysed; Patients; Perception; Performance; Peripheral Nerve Stimulation; Phantom Limb Pain; Phase; Physiology; Polymers; Printing; Process; Prosthesis; Quality of life; Residual state; Sales; Sensory; Spinal cord injury; Stroke; System; Techniques; Technology; Telemetry; Testing; United States Food and Drug Administration; Upper Extremity; Upper arm; Work; advanced system; animation; base; electric impedance; grasp; implantable device; improved; instrument; liquid crystal polymer; median nerve; neurophysiology; new technology; novel; prototype; research clinical testing; sensor; sensory feedback; volunteer

DESCRIPTION (provided by applicant): Three companies have partnered to develop advanced systems for upper extremity prosthetics control. The combined expertise includes chronic nerve interface technology, bioresistant/biocompatible materials, polymer substrate electronics assembly and packaging, low impedance electrodes, sensory neurophysiology, coding techniques for prosthetic sensation, and advanced control, powered upper extremity prostheses. The specific aim is to improve upper extremity amputee prosthetic dexterity by providing important sensory feedback information beginning with grasp force, and slip detection but ultimately extending to joint angle and other sensory modalities. To accomplish this specific aim, implantable multi-channel peripheral nerve stimulation cuffs to provide prosthetic sensation to amputees will be further developed and marketed. Multi-channel nerve stimulation cuffs allow the input of sensory information with graded activity levels within individual fascicles of the residual median nerve for example. Since individual fascicles of cutaneous afferents are primarily associated with particular areas of the hand, and represented proportional to the importance of the function, the proposed selective stimulation system will provide anatomically appropriate loci of cutaneous perceptions. These implantable devices will have monolithic Liquid Crystal Polymer (LCP) substrates with integral interconnects and electronics with telemetry of power and data. LCP substrates are a novel, dimensionally stable, biocompatible and bioresistant material. This material can be processed in similar fashion to printed circuit boards and integrated circuits using photolithographic and micromachining methods. Prototype devices that are based on the successful Phase I developmental work will be fabricated thoroughly tested and then evaluated in an animal model. Following successful animal testing, 3 devices will be implanted in volunteer amputee subjects for providing sensory feedback from their instrumented powered arms. Appropriate sensors and feedback control software will be developed and fitted to each prosthesis. Where possible quantitative testing and analyses are planned finishing with independent performance evaluations by an independent occupational therapist. Early marketing to physiology groups will help further develop the technology. Based on results of the preliminary human testing, FDA approval will be obtained, limited sales will begin, and a full clinical test will be planned to further refine, evaluate and deploy the technology. LCP Nerve Cuff Project Narrative This new technology for providing sensory information from a prosthetic limb to the correlate neural pathways will substantially improve the quality of life of amputees by dramatically improving the utility of the prosthesis, improving the "body image" of the prosthesis, and may reduce the incidence of phantom pain since the neural pathways will be more normally active. This same technology will find application in re-animation of paralyzed limbs of the spinal cord injured and stroke patients, and restore bladder and bowel function as examples.

描述（由申请人提供）：三家公司合作开发上肢假肢控制的先进系统。结合的专业知识包括慢性神经接口技术，生物抗性/生物相容性材料，聚合物基板电子组装和包装，低阻抗电极，感觉神经生理学，假肢感觉编码技术，以及先进的控制，动力上肢假肢。其具体目标是通过提供重要的感觉反馈信息来提高上肢截肢者的假肢灵活性，所述感觉反馈信息从抓握力和滑动检测开始，但最终延伸到关节角度和其他感觉方式。为了实现这一特定目标，将进一步开发和销售植入式多通道外周神经刺激袖带，以向截肢者提供假体感觉。例如，多通道神经刺激袖带允许在残余正中神经的各个神经束内输入具有分级活动水平的感觉信息。由于皮肤传入神经的各个神经束主要与手的特定区域相关，并且与功能的重要性成比例地表示，因此所提出的选择性刺激系统将提供解剖学上适当的皮肤感知位点。这些植入式设备将具有单片液晶聚合物（LCP）基板，其具有集成互连和具有电力和数据遥测的电子器件。LCP基材是一种新型的、尺寸稳定的、生物相容性和生物耐受性材料。这种材料可以以类似的方式处理印刷电路板和集成电路，使用光刻和微机械加工方法。基于成功的I期开发工作的原型器械将进行彻底测试，然后在动物模型中进行评价。动物试验成功后，将在志愿截肢受试者体内植入3件器械，以从其装有器械的动力臂提供感觉反馈。将开发适当的传感器和反馈控制软件，并安装到每个假肢上。在可能的情况下，计划进行定量测试和分析，最后由独立的职业治疗师进行独立的绩效评估。早期向生理学团体营销将有助于进一步发展这项技术。根据初步人体测试的结果，将获得FDA的批准，有限的销售将开始，并计划进行全面的临床测试，以进一步完善，评估和部署该技术。LCP神经袖带项目叙述这种新技术用于从假肢向相关神经通路提供感觉信息，通过显著提高假肢的实用性，改善假肢的“身体形象”，将大大提高截肢者的生活质量，并可能减少幻痛的发生率，因为神经通路将更正常地活跃。同样的技术将应用于脊髓损伤和中风患者的瘫痪肢体的重新动画，并恢复膀胱和肠道功能。