LCP Nerve Cuff with Telemetry for Prosthetic Sensation

描述（由申请人提供）：该项目旨在开发一种多通道神经袖带，带有板载无线控制，用于刺激主干神经内的特定纤维束。临床应用包括：1）刺激截肢者残肢中的感觉神经，以提供来自其假肢的触觉。通过激活正中神经的特定成分，将有可能诱导截肢者似乎从手指和手的特定区域发出的感觉。通过同时提供来自每个接触手指的输入，假体使用者将能够知道哪些手指与抓握物体接触以及力如何分布。此外，电激活截肢的感觉神经已被证明允许截肢者认为他们的假肢是他们身体的一部分，并且这种电刺激已被证明可用于预防或管理幻肢疼痛。2)肌肉 在脊髓损伤和中风的情况下恢复手部功能或站立和行走的刺激系统。使用不需要连接导线的多通道袖带可以减少植入刺激硬件所需的手术，并消除将单独电极植入这些系统中的每块肌肉的需要，并且它将提供改善的肌肉可控性。3)多通道袖带也可用于人工视觉的视神经刺激。将开发的袖带采用自盘绕设计，由薄硅胶片层压在包含电极触点和互连迹线的单独网格结构周围制成。晶格由液晶聚合物片材（LCP）制成，具有植入电子设备的理想特性：包括低组织反应性;高抗拉伸，撕裂和重复弯曲断裂;以及微加工形成任意图案的能力。 电子元件和互连很容易安装在LCP上，并且可以通过将LCP“帽”焊接到衬底来形成气密封装。使用LCP的这种包装优势使刺激和无线控制电路能够直接位于袖带上。第1阶段项目包括袖带的初始台架试验以及整体电子器件和包装方法。第二阶段的工作将包括在动物模型中进行体内测试，然后在截肢志愿者和脊髓损伤和中风患者的临床试验中进行评估。

DESCRIPTION (provided by applicant): This project seeks to develop a multi-channel nerve cuff with on board wireless control for stimulating specific bundles of fibers within trunk nerves. Clinical applications include: 1) Stimulating the sensory nerves in the residual limbs of amputees to provide touch sensations from their prosthetic arms. By activating specific components of the median nerve, it will be possible to induce sensations that appear to the amputee to emanate from specific regions of the fingers and hand. By providing input from each of the contacting fingers at the same time, a prosthesis user will be able to know which fingers are in contact with a grasp object and how the forces are distributed. Additionally, electrical activation of amputated sensory nerves has been demonstrated to allow amputees to consider their prosthesis to be more a part of their body, and such electrical stimulation has been shown to be useful for preventing or managing phantom limb pain. 2) Muscle stimulation systems that restore hand function or standing and walking in cases of spinal cord injury and stroke. The use of multi-channel cuffs that don't require attached lead wires can reduce the surgery needed to implant stimulation hardware and eliminate the need to implant separate electrodes into each muscle in these systems, and it will offer improved muscle controllability. 3) The multi-channel cuff would also be useful for optic nerve stimulation for artificial vision. The cuff that will be developed uses a self-coiling design made from thin silicone sheeting laminated around a separate lattice structure containing the electrode contacts and interconnect traces. The lattice is made from Liquid Crystal Polymer sheeting (LCP) which has ideal properties for implanted electronic devices: including low tissue reactivity; high resistance to stretching, tearing and breakage from repeated bending; and the ability to be micro-machined to form arbitrary patterns. Electronic components and interconnects are easily mounted on LCP, and a vapor tight package can be formed by welding an LCP 'cap' to the substrate. This packaging advantage of using LCP enables the stimulation and wire-less control circuitry to be located directly on the cuff. The PHASE 1 project includes initial bench testing of the cuffs and the integral electronics and packaging methods. PHASE II work will involve in-vivo tests in animal models followed by evaluation in clinical trials with amputee volunteers and with spinal cord injury and stroke patients.