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

优化

• 批准号: 10600081
• 负责人: Janet L Gbur
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10600081
• 关键词: Acceleration; 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; Experimental Designs; Exposure to; FPS-FES Oncogene; Family Felidae; Functional disorder; Funding; Future; Generations; Goals; Health; Hip region structure; Histologic; Implant; In Vitro; Intervention; 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; Postoperative Period; Preclinical Testing; Process; Prosthesis; Publishing; Qualifying; 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; biomaterial compatibility; co-clinical trial; combat; density; design; devices for disabled persons; electric impedance; experimental study; fabrication; functional electrical stimulation; functional independence; gait rehabilitation; implantable device; implantation; improved; in vitro testing; interoperability; limb amputation; military veteran; miniaturize; nanoscale; neural; neural prosthesis; neurological rehabilitation; neuroprosthesis; next generation; post stroke; process optimization; programs; recruit; seal; sensory feedback; sensory system; silicon carbide

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， 下一代微型、高密度多通道的必要临床前测试 适合于长期植入患者体内的连接器。这些“HD连接器”将 例如，用于治疗周围神经系统疾病的系统的一部分。 可以用这种方法治疗的疾病是行走问题，比如中风后， 在截肢后恢复幻肢的自然感觉，以及其他例子。 在这项研究中，我们将使用定制的微加工，固体填充连接器机构， 促进持久的神经接口内部和之间的互连。自定义 微型连接器的封装和组装方法， 资金将得到优化。根据这一建议，我们将制造新的高清连接器的变体 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 这些连接器的生物相容性和生物稳定性， 动物手术试验收集的数据将有助于我们向FDA申请 采用该HD连接器技术的医疗器械的后续临床研究。 拟议工作与VA的患者护理使命之间的关系是 这些改进预计将提高组件的可重复性， 用于康复的具有高通道数的可植入神经刺激系统。这将 提高正在开发的新器械的安全性和互操作性，如植入式 助行器和恢复截肢者自然感觉的装置。