Optimization, Biocompatibility and Safety Assessment of Tongue Implants

舌植入物的优化、生物相容性和安全性评估

• 批准号: 8584092
• 负责人: Maysam Ghovanloo
• 金额: $ 24.12万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8584092
• 关键词: Acute; Adhesions; Anatomy; Animal Model; Animals; Anterior; Area; Behavior; Behavioral; Biological Assay; Biology; Caring; Complex; Computer Interface; Dental; Device Designs; Devices; Dorsal; Effectiveness; Environment; Epithelium; Goals; Grant; Human; Implant; Individual; Inflammatory; Injury; Intervention; Intramuscular; Investigation; Life; Location; Magnetism; Maintenance; Measures; Miniature Swine; Minor; Modeling; Molecular; Motion; Motor; Movement; Muscle; Neuraxis; Oryctolagus cuniculus; Pathology; Patients; Pattern; Performance; Persons; Physiological; Pilot Projects; Procedures; Quadriplegia; Reaction; Resistance; Respiratory Muscles; Risk; Safety; Self-Help Devices; Shapes; Signal Transduction; Solutions; Spinal cord injury; Stress; Surface; System; Testing; Time; Tissues; Titania; Titanium; Tongue; Tooth structure; Tracer; Translations; Wireless Technology; biomaterial compatibility; clinical application; design; expectation; implantation; migration; muscular system; older patient; public health relevance; respiratory; response; technological innovation

DESCRIPTION (provided by applicant): Individuals with high level spinal cord injury (SCI) have limited options for assistive control of their environments due in part to limited signal diversity for computer interface of patients' volitional motor systems. The tongue, a motor system capable of executing diverse movements under voluntary control, is spared in patients with high SCI and is thus a natural substrate for computer interfacing in quadriplegics. We have developed the tongue drive system (TDS) to allow unencumbered translation of tongue movements in real time for computer interfacing via a titanium-encased magnet (Ti-Mag) affixed to the tongue. Despite our technological innovation, TDS application in humans is precluded by a lack of information on Ti-Mag implant bio-compatibility and safety. In Specific Aim 1, we test the effect of implant design (size, shape, surfacing) and location on implant migration and tissue reaction in a rabbit model with a scaled implant to more closely reflect implant/tongue ratio in humans. In Specific Aim 2, using optimal parameters defined in Specific Aim 1, we quantitatively assess the anatomical and molecular responses to Ti-Mag implantation and explantation. We additionally test for possible deficit of tongue function due to implantation and explantation by quantitatively assessing changes in tongue lick performance. In Specific Aim 3 we test anatomical, molecular and physiological responses to Ti-Mag implantation and explantation in the mini-pig using a device designed for human application. We hypothesize that implantation and explantation under optimized parameters will produce only minor and local tissue reaction (e.g., device encapsulation) and will not impair measureable tongue function. Demonstration of device biocompatibility and safety is requisite to direct testing in humans with quadriplegia.

描述（由申请人提供）：患有严重脊髓损伤（SCI）的个体对其环境的辅助控制的选择有限，部分原因是患者意志运动系统的计算机接口的信号多样性有限。舌头是一种能够在自愿控制下执行各种运动的运动系统，在严重脊髓损伤的患者中不会受到影响，因此是四肢瘫痪患者计算机接口的天然基础。我们开发了舌头驱动系统 (TDS)，允许实时无阻碍地翻译舌头运动，以便通过固定在舌头上的钛封装磁铁 (Ti-Mag) 与计算机连接。尽管我们进行了技术创新，但由于缺乏有关 Ti-Mag 植入物生物相容性和安全性的信息，TDS 在人体中的应用仍然受到阻碍。在具体目标 1 中，我们在兔子模型中测试了种植体设计（尺寸、形状、表面）和位置对种植体迁移和组织反应的影响，该模型具有缩放种植体，以更准确地反映人类种植体/舌头的比例。在特定目标 2 中，使用特定目标 1 中定义的最佳参数，我们定量评估对 Ti-Mag 植入和移出的解剖学和分子反应。我们还通过定量评估舌头舔性能的变化来测试由于植入和取出而可能出现的舌头功能缺陷。在特定目标 3 中，我们使用专为人类应用设计的设备测试小型猪对 Ti-Mag 植入和移出的解剖学、分子和生理学反应。我们假设在优化参数下的植入和移出只会产生轻微的局部组织反应（例如装置封装），并且不会损害可测量的舌头功能。必须证明设备的生物相容性和安全性才能在四肢瘫痪的人类身上进行直接测试。