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植入中获益。该项目的目标是加快翻译 硅基、多位点、穿透微电极阵列到耳蜗核听觉假体。我们最近在猫模型中的设备上取得了重大技术进步，与高计数电缆和馈电线一起，将为开发适合临床使用的多位点微电极阵列提供独特的机会。这 该项目将证明将多个微刺激位点的多位点微电极阵列与植入式脉冲发生器（IPG）连接的可行性，为后续的临床试验做准备。耳蜗核植入物的临床应用验证也将推进其他配置的硅基板多位点微电极阵列的临床应用。这些包括听觉神经和听觉中脑（下丘），甚至可能是初级听觉皮层。我们建议根据两个ISO（国际标准化组织）指南进行适当的测试：（1）目标1中的ISO 10933，以确认电极阵列和相关电缆的生物相容性，以及（2）目标2中的ISO 14708，用于将阵列和电缆连接到神经刺激器。在目标2中，我们将开发IPG的接口，并根据ISO 14708（规定了神经刺激器可靠接口的要求）确定系统的体外合规性。这些测试是优化我们的器械以获得FDA未来研究器械豁免的关键一步。该项目的成功成果将是新一代多位点穿透硅微电极阵列的翻译，该阵列将植入人类耳蜗核，从而前所未有地进入核的音调组织。最后，这些多部位硅设备可以修改为其他神经系统疾病，包括脊髓和深部脑刺激。