Towards Clinical Translation of Penetrating Multisite Device for Cochlear Nucleus

耳蜗核穿透性多部位装置的临床转化

• 批准号: 9486908
• 负责人: Martin Han
• 金额: $ 39.21万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-19 至 2020-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9486908
• 关键词: 3-Dimensional; Acoustic Nerve; Animals; Auditory; Auditory area; Brain; Cell Nucleus; Clinical; Clinical Trials; Cochlear Implants; Cochlear nucleus; Communication; Consensus; Consultations; Deep Brain Stimulation; Devices; Dimensions; Electrodes; Family Felidae; Felis catus; Future; Generations; Goals; Human; Implant; In Vitro; Industry; Inferior Colliculus; International; Investigation; Length; Medical Device; Microelectrodes; Midbrain structure; Modeling; Neurologic; Outcome; Patients; Penetration; Physiologic pulse; Preparation; Sampling; Silicon; Site; Social Impacts; Specific qualifier value; Spinal Cord; Spinal cord injury; Standardization; Structure; Surface; System; Testing; Translating; Translations; United States Food and Drug Administration; Validation; Weight; Work; auditory pathway; base; biomaterial compatibility; clinical application; clinical translation; density; economic impact; implantation; in vitro testing; in vivo; prototype; public health relevance; research clinical testing; sound; standardize guidelines

 DESCRIPTION (provided by applicant): Patients with severely damaged auditory nerves cannot benefit from cochlear implants. The goal of this project is to accelerate the translation of silicon-based, multisite, penetrating microelectrode arrays to a cochlear nucleus auditory prosthesis. We have recently made significant technological advances with our devices in the cat model, which together with high-count cables and feedthroughs will provide a unique opportunity to develop arrays of multisite microelectrodes that are suitable for clinical use. This project will demonstrate the feasibility of interfacing a multisite microelectrode array with a lare number of microstimualting sites to an implantable pulse generator (IPG), in preparation for a subsequent clinical trial. Validation of the cochlear nucleus implant for clinical use will also advance other configurations of silicon- substrate multisite microelectrode arrays toward clinical use. These include the auditory nerve and the auditory midbrain (inferior colliculus), and perhaps even the primary auditory cortex. We are proposing to conduct appropriate tests under two ISO (International Organization for Standardization) guidelines: (1) ISO 10933 in Aim 1 to validate the biocompatibility of the electrode array and associated cables, and (2) ISO 14708 in Aim 2 for interfacing the array and cable to a neurostimulator. In Aim 2, we will develop the interface to an IPG, and determine the compliance of the system in-vitro per ISO 14708 which specifies requirements for reliable interfaces to neurostimulators. These tests are a critical majo step to optimizing our devices for a future investigational device exemption by the FDA. The successful outcome of the project will be the translation of a new generation of multisite, penetrating silicon microelectrode arrays that will be implanted in a human cochlear nucleus, allowing for unprecedented access to the tonotopic organization of the nucleus. Finally, these multisite silicon devices can be modified for other neurological conditions including spinal cord and deep brain stimulation.

 描述（由申请人提供）：听觉神经严重受损的患者无法从人工耳蜗中受益该项目的目标是加速人工耳蜗的转化。 我们最近在猫模型中使用我们的设备取得了重大技术进步，它与高计数电缆和馈通一起将为开发多站点阵列提供独特的机会。适合临床使用的微电极。 该项目将展示将具有大量微刺激位点的多位点微电极阵列连接到可植入脉冲发生器（IPG）的可行性，为随后的临床试验验证耳蜗核植入物的临床使用也将推进其他配置。我们建议将硅基多点微电极阵列用于临床，其中包括听觉神经和听觉中脑（下丘），甚至可能是初级听觉皮层。根据两个 ISO（国际标准化组织）准则进行适当的测试：(1) 目标 1 中的 ISO 10933，用于验证电极阵列和相关电缆的生物相容性；(2) 目标 2 中的 ISO 14708，用于连接阵列和电缆在目标 2 中，我们将开发与 IPG 的接口，并根据 ISO 14708 确定系统的体外合规性，该标准规定了可靠接口的要求。这些测试是优化我们的设备以获得 FDA 未来研究设备豁免的关键一步。该项目的成功成果将是新一代多位点穿透性硅微电极阵列的转化，并将其植入到神经刺激器中。人类耳蜗核，允许前所未有地进入核的音位组织最后，这些多部位硅装置可以针对其他神经系统疾病进行修改，包括脊髓和深部脑刺激。