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采用箔和线电极，连接到安装在密封钛罐中的植入式脉冲发生器（IPG）。每个电极通过组装成柔性引线的绝缘多股线单独连接到 IPG。这种结构通过限制假体中可使用的电极的数量和尺寸来限制治疗选择。我们的目标是开发基于聚合物的多电极阵列来克服这些限制。该阵列基于聚酰亚胺，具有适合氧化铱和其他低阻抗、高电荷容量涂层的电极位点。实现的创新包括：1) 使用薄膜无机电介质封装和粘合层，提供类似气密的阻隔性能；2) 采用表面功能化电介质薄膜和硅基密封剂的非气密封装。非气密封装将允许将专用集成电路（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。硅酮密封剂与薄膜无机电介质共价结合的组合有望在患者的一生中保护阵列上的有源电路和电气互连。相对于以前的薄膜方法和现有的临床多电极引线和 IPG，所提出的技术的优点包括：1) 非气密封装，可为阵列上的金属化、ASIC 和互连提供长期保护； 2) 一种小型且灵活的植入式电子封装，允许将设备放置在手术困难且对刚性 IPG 耐受性较差的位置。第一阶段的目标是展示采用 16 通道 ASIC 刺激器的非密封多电极阵列的制造和功能。这些阵列和 ASIC 将接受加速体外测试，以确定设备的耐用性，并为第二阶段慢性动物测试中阵列的长期稳定性提供信心。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气密封装；目标 2. 演示聚酰亚胺阵列上 16 通道刺激 ASIC 的封装，并对组件进行刺激脉冲测试和加速体外测试。该计划是 EIC Laboratories（马萨诸塞州诺伍德）和 Sigenics Inc.（伊利诺伊州芝加哥）之间的合作项目。在第一阶段，EIC 将进行阵列制造和测试，而 Sigenics Inc. 将提供 ASIC、引线键合以及测试聚合物封装方面的专业知识。 公共健康相关性：柔性聚合物封装多电极阵列和植入电子设备的开发将允许开发具有比现有技术更多的电极数量的神经假体。用聚合物封装代替钛罐所产生的电子封装尺寸较小，将允许通过手术将设备放置在传统设备无法实现的身体部位。这些阵列将使患有脊髓损伤、中风、失明和其他需要电刺激治疗的疾病或病症的患者受益。