LCP Nerve Cuff with Telemetry for Prosthetic Sensation

描述（由申请人提供）：三家公司合作开发先进的上肢假肢控制系统。联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，聚合物衬底电子组装和封装，低阻抗电极，感觉神经生理学，假肢感觉编码技术，以及先进的控制，动力上肢假肢。具体目标是通过提供重要的感官反馈信息，从抓握力开始，到滑移检测，最终扩展到关节角度和其他感官形态，提高上肢截肢者假肢的灵活性。为了实现这一特定目标，植入式多通道外周神经刺激袖带将进一步开发和销售，为截肢者提供假肢感觉。例如，多通道神经刺激袖带允许在残余正中神经的单个束内输入具有分级活动水平的感觉信息。由于单个皮肤传入神经束主要与手部的特定区域相关，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合适的皮肤感知位点。这些植入式设备将采用单片液晶聚合物（LCP）衬底，具有集成互连和具有电力和数据遥测的电子设备。LCP基板是一种新型的、尺寸稳定的、具有生物相容性和生物抗性的材料。这种材料可以用类似于印刷电路板和集成电路的方式使用光刻和微加工方法进行加工。基于成功的第一阶段开发工作的原型设备将被制造彻底测试，然后在动物模型中进行评估。在成功的动物实验之后，3个设备将被植入志愿者截肢者体内，通过他们的仪器供电手臂提供感官反馈。适当的传感器和反馈控制软件将被开发并安装到每个假肢上。在可能的情况下，计划定量测试和分析，并由独立的职业治疗师进行独立的绩效评估。早期对生理学小组的营销将有助于进一步发展这项技术。根据初步人体试验的结果，将获得FDA的批准，开始有限的销售，并计划进行全面的临床试验，以进一步完善、评估和部署这项技术。LCP神经袖项目叙述：这种将假肢的感觉信息提供给相关神经通路的新技术，将显著提高假肢的实用性，改善假肢的“身体形象”，从而大大提高截肢者的生活质量，并可能减少幻肢痛的发生率，因为神经通路将更加正常地活跃。同样的技术将应用于脊髓损伤的瘫痪肢体和中风患者的再激活，以及恢复膀胱和肠道功能的例子。

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.