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）：三家公司已经合作开发上肢假肢控制的高级系统。组合的专业知识包括慢性神经界面技术，生物抗性/生物相容性材料，聚合物底物电子组装和包装，低阻抗电极，感觉神经生理学，假体感觉的编码技术，用于假体感觉和高级控制，高级控制，上肢较高的肢体专业。具体的目的是通过提供重要的感觉反馈信息，从抓紧力开始，并最终扩展到关节角度和其他感觉方式，从而改善上肢截肢的敏捷性。为了实现这一特定目标，将进一步开发和销售可植入的多通道周围神经刺激袖口，以向截肢者提供假肢。例如，多通道神经刺激袖口允许在残留中位神经的单个束中的分级活动水平的感觉信息输入。由于皮肤传入的各个束主要与手的特定区域有关，并且与功能的重要性成正比，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基因座。这些可植入的设备将具有具有整体互连和电子和数据遥控器的整体液晶聚合物（LCP）底物。 LCP底物是一种新颖的，尺寸稳定的，生物相容性的和生物抗性的材料。可以使用光刻和微加工方法以类似于印刷电路板和集成电路的方式处理该材料。基于成功的I期发展工作的原型设备将进行彻底测试，然后在动物模型中进行评估。成功进行动物测试后，将植入3台设备，以提供仪表式动力臂的感觉反馈。适当的传感器和反馈控制软件将被开发并安装到每个假体中。在可能的定量测试和分析的情况下，由独立职业治疗师进行独立的绩效评估计划。生理学小组的早期营销将有助于进一步发展该技术。根据初步人类测试的结果，将获得FDA批准，将开始有限的销售，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神经袖口项目叙事这种新技术，用于提供从假肢到相关神经途径的感官信息，可以通过显着改善假体的实用性，改善假体的“身体形象”，从而实质上改善截肢者的生活质量，并可以减轻幻影疼痛的发生率，因为神经疼痛的发生率会更高。相同的技术将发现在重新动画脊髓受伤和中风患者的瘫痪的肢体中，并恢复膀胱和肠的功能作为例子。