Optimization & Pre-clinical Testing of Implantable, In-Line High Density 32-Channel Connector

优化

基本信息

批准号：
10045519
负责人：
Douglas B. Shire
金额：
--
依托单位：
LOUIS STOKES CLEVELAND VA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-01 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10045519
关键词：
Address Affect Amendment Amputation Amputees Animal Model Animals Artificial Implants Chronic Clinical Clinical Research Clinical Trials Custom Data Development Devices Documentation Electrodes Encapsulated Enhancement Technology Equipment Malfunction Esthesia Exposure to FPS-FES Oncogene Family Felidae Functional disorder Funding Future Generations Goals Health Hip region structure Histologic Implant In Vitro Intervention Investigation Knee Laboratories Life Location Mechanics Medical Device Methods Mission Modeling Monitor Motor Muscle Nerve Neurologic Deficit Operative Surgical Procedures Paraplegia Partner in relationship Pathologic Patient Care Patients Peripheral Peripheral Nerves Peripheral Nervous System Diseases Phantom Limb Physical activity Population Postoperative Period Preclinical Testing Process Prosthesis Publishing Rehabilitation therapy Research Research Personnel Running Safety Saline Science Sensory Site Solid Spinal cord injury Sterilization Stroke System Techniques Technology Test Result Testing Tissues Update Upper Extremity Validation Variant Vendor Veterans Walking Work base biomaterial compatibility combat density design devices for disabled persons electric impedance experimental study functional electrical stimulation functional independence gait rehabilitation implantable device implantation improved in vitro testing interoperability limb amputation miniaturize nanoscale neural prosthesis neurological rehabilitation neuroprosthesis next generation post stroke process optimization programs recruit relating to nervous system seal sensory feedback sensory system silicon carbide

项目摘要

The aim of this proposal is to optimize the design and materials and to perform necessary pre-clinical testing of next-generation miniature, high-density multi-channel connectors suitable for chronic implantation in a patient's body. These `HD Connectors' will be part of systems that are used, for example, to treat disorders of the peripheral nervous system. Maladies that could be treated in this way are problems with walking, such as after a stroke, and restoring natural sensations in a phantom limb after amputation, among other examples. In this study, we will use custom-microfabricated, solid-filled connector bodies to facilitate interconnections within and among long-lasting neural interfaces. Custom encapsulation and assembly methods for the miniature connectors, developed with pilot funding, will be optimized. Under this proposal, we will fabricate variants of new HD connectors for mating with existing micro-neurostimulator designs. We will also evaluate the long-term biocompatibility and bio-stability of these connectors through both benchtop experiments and animal surgical trials. The data collected will then facilitate our application to the FDA to do follow-on clinical studies of medical devices incorporating this HD connector technology. The relationship between the proposed effort and the patient care mission of the VA is that these improvements are expected to increase the interchangeability of components of implantable neurostimulation systems for rehabilitation that have high channel counts. This will improve the safety and inter-operability of new devices under development, such as implantable walking aids and devices for restoring natural sensation in amputated limbs.

该提案的目的是优化设计和材料并执行下一代微型、高密度多通道的必要临床前测试适合长期植入患者体内的连接器。这些“高清连接器”将是例如，用于治疗周围神经系统疾病的系统的一部分。可以通过这种方式治疗的疾病包括行走问题，例如中风后，以及除其他例子外，截肢后恢复幻肢的自然感觉。在本研究中，我们将使用定制的微加工、固体填充连接器主体来促进持久神经接口内部和之间的互连。风俗与 Pilot 共同开发的微型连接器的封装和组装方法资金投入将进一步优化。根据该提案，我们将制造新型高清连接器的变体用于与现有的微型神经刺激器设计配合。我们还将评估长期通过台式实验和动物手术试验。收集到的数据将有助于我们向 FDA 申请采用这种高清连接器技术的医疗设备的后续临床研究。拟议的工作与 VA 的患者护理使命之间的关系是这些改进预计将增加组件的互换性具有高通道数的用于康复的植入式神经刺激系统。这将提高正在开发的新设备的安全性和互操作性，例如植入式设备助行器和恢复截肢自然感觉的装置。