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）：三个公司合作开发用于上肢假肢控制的先进系统。综合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封装、低阻抗电极、感觉神经生理学、假肢感觉编码技术以及先进控制、动力上肢假肢。具体目标是通过提供重要的感觉反馈信息（从抓握力和滑动检测开始，最终延伸到关节角度和其他感觉方式）来提高上肢截肢者假肢的灵活性。为了实现这一特定目标，将进一步开发和销售为截肢者提供假肢感觉的植入式多通道周围神经刺激袖带。例如，多通道神经刺激袖带允许输入带有残余正中神经各个束内分级活动水平的感觉信息。由于皮肤传入的各个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。这些植入式设备将采用单片液晶聚合物 (LCP) 基板，带有集成互连件和具有电力和数据遥测功能的电子设备。 LCP 基材是一种新型、尺寸稳定、生物相容性和生物抗性材料。这种材料可以使用光刻和微机械加工方法以与印刷电路板和集成电路类似的方式进行加工。基于第一阶段成功开发工作的原型设备将经过彻底测试，然后在动物模型中进行评估。在成功进行动物测试后，3 个设备将被植入志愿者截肢受试者体内，以从他们的仪器动力手臂提供感官反馈。将开发适当的传感器和反馈控制软件并将其安装到每个假肢上。在可能的情况下，计划进行定量测试和分析，并由独立职业治疗师进行独立绩效评估。早期向生理学团体进行营销将有助于进一步开发该技术。根据初步人体测试的结果，将获得 FDA 批准，开始限量销售，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 这项新技术向相关神经通路提供从假肢的感觉信息，将通过显着提高假肢的实用性、改善假肢的“身体形象”和可能会减少幻痛的发生率，因为神经通路会更加活跃。同样的技术还将应用于脊髓损伤和中风患者瘫痪肢体的恢复，以及恢复膀胱和肠道功能等。