Multi-electrode Arrays with Non-hermetic Encapsulation for Neural Prostheses

用于神经假体的非气密封装多电极阵列

• 批准号: 7804292
• 负责人: Stuart F Cogan
• 金额: $ 17.97万
• 依托单位: EIC LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2012-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7804292
• 关键词: Address; Adhesions; Adoption; Animal Testing; Animals; Area; Biomedical Research; Blindness; Boston; Ceramics; Charge; Chicago; Chronic; Clinical; Collaborations; Communication; Contracts; Coupling; Data; Development; Devices; Disease; Electric Stimulation; Electrodes; Electronics; Encapsulated; Epilepsy; Film; Foot-drop; Gases; Housing; Implant; In Vitro; Ions; Laboratories; Lead; Legal patent; Letters; Life; Location; Marketing; Medical Device; Medical Technology; Mental Depression; Metals; Nerve; Operative Surgical Procedures; Patients; Pattern; Peripheral Nerves; Peripheral Nervous System; Phase; Physiologic pulse; Polymers; Property; Prosthesis; Rehabilitation therapy; Relative (related person); Services; Shapes; Silanes; Silicon; Silicones; Site; Spinal cord injury; Stroke; Structure; Surface; Techniques; Technology; Testing; Tissues; Titanium; Tremor; Universities; Vision; Walking; Water; base; clinical application; design; electric impedance; femoral nerve; flexibility; improved; in vitro testing; in vivo; innovation; iridium oxide; motor control; neural prosthesis; neural stimulation; programs; public health relevance; relating to nervous system; retinal stimulation; seal; sensory prosthesis; silane; silicon carbide; vagus nerve stimulation

DESCRIPTION (provided by applicant): Neural prostheses presently in commercial use employ foil and wire electrodes connected to implantable pulse generators (IPGs) housed in hermetically sealed titanium cans. Each electrode is individually connected to the IPG by insulated multistrand wire assembled into a flexible lead. This construction constrains treatment options by limiting the number and size of the electrodes that can be used in a prosthesis. Our objective is the development of polymer-based multielectrode arrays that overcome these limitations. The arrays are polyimide-based with electrode sites suitable for iridium oxide and other low-impedance, high charge capacity coatings. The enabling innovations are 1) the use of a thin-film inorganic dielectric encapsulation and adhesion layer that provides hermetic-like barrier properties and 2) a non-hermetic encapsulation that employs thin films of surface-functionalized dielectrics and silicone-based sealants. The non-hermetic encapsulation will allow placement of application specific integrated circuits (ASICs) directly on the arrays and will replace the traditional titanium or ceramic case used to house batteries, pulse generators, and communications circuitry. The combination of silicone encapsulants covalently bonded to thin-film inorganic dielectrics is expected to protect active circuitry and electrical interconnects on the arrays for the life of the patient. The advantages of the proposed technology, relative to previous thin-film approaches and existing clinical multielectrode leads and IPGs include: 1) a non-hermetic encapsulation that provides chronic protection of metallization, ASICs, and interconnects on the arrays; and 2) an implanted electronic package that is small and flexible allowing placement of the device in locations that would be surgical difficult and poorly tolerant of rigid IPGs. The Phase I objective is to demonstrate the fabrication and functioning of non-hermetically encapsulated multielectrode arrays employing a 16-channel ASIC stimulator. These arrays and ASICs would be subjected to accelerated in vitro testing to establish the durability of the devices and to provide confidence in the long-term stability of the arrays for chronic animal testing in Phase II. The Phase I Aims are as follows: Aim 1. To develop and test non-hermetic encapsulation based on surface functionalized inorganic coatings and silicone encapsulants; Aim 2. To demonstrate the encapsulation of a 16-channel stimulation ASIC on a polyimide array and to conduct stimulation pulse testing and accelerated in vitro testing of the assembly. The program is a collaboration between EIC Laboratories (Norwood, MA) and Sigenics Inc. (Chicago, Ill). In Phase I, EIC will conduct the array fabrication and testing while Sigenics Inc. will provide ASICs, wire bonding, and expertise in testing polymer-based encapsulation. PUBLIC HEALTH RELEVANCE: The development of flexible polymer encapsulated multielectrode arrays and implanted electronics will allow the development of neural prostheses with a significantly greater number of electrodes than is possible with present technology. The small size of the electronic package resulting from replacement of titanium cans with polymer encapsulation will allow surgical placement of devices at sites in the body that would not be otherwise possible with conventional devices. These arrays will benefit patients with spinal cord injury, stroke, blindness and other diseases or disorders requiring electrical stimulation for treatment.

描述（由申请人提供）：目前商业用途的神经假体使用箔和导线电极连接到密封钛罐中的可植入脉冲发生器（ipg）。每个电极单独连接到IPG通过绝缘多股线组装成一个灵活的引线。这种结构通过限制可用于假体的电极的数量和大小来限制治疗选择。我们的目标是开发基于聚合物的多电极阵列，以克服这些限制。该阵列以聚酰亚胺为基础，电极位置适用于氧化铱和其他低阻抗、高电荷容量涂层。这些创新包括：1)使用薄膜无机介电封装和粘附层，提供类似密封的屏障性能；2)使用表面功能化介电薄膜和硅基密封剂的非密封封装。非密封封装将允许将特定应用集成电路（asic）直接放置在阵列上，并将取代用于容纳电池，脉冲发生器和通信电路的传统钛或陶瓷外壳。有机硅封装剂与薄膜无机电介质共价结合的组合有望为患者的生命保护阵列上的有源电路和电气互连。与之前的薄膜方法和现有的临床多电极引线和ipg相比，所提出的技术的优势包括：1)非密封封装，可为阵列上的金属化、asic和互连提供长期保护；2)一种小而灵活的植入电子封装，允许将设备放置在手术困难且刚性ipg耐受性差的位置。第一阶段的目标是展示采用16通道ASIC刺激器的非密封封装多电极阵列的制造和功能。这些阵列和asic将进行加速体外测试，以建立设备的耐久性，并为II期慢性动物试验提供阵列的长期稳定性的信心。第一阶段的目标如下：目标1。开发和测试基于表面功能化无机涂层和有机硅封装剂的非密封封装；目标2。演示在聚酰亚胺阵列上封装16通道刺激ASIC，并对该组件进行刺激脉冲测试和体外加速测试。该项目是EIC实验室（马萨诸塞州诺伍德）和Sigenics公司（伊利诺伊州芝加哥）的合作项目。在第一阶段，EIC将进行阵列制造和测试，而Sigenics公司将提供asic、电线键合和测试聚合物封装的专业知识。