A minimally invasive, single incision, rechargeable spinal cord Stimulation system for chronic pain

用于治疗慢性疼痛的微创、单切口、可充电脊髓刺激系统

• 批准号: 10255353
• 负责人: Dane William Grasse
• 金额: $ 25.6万
• 依托单位: TELIATRY, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10255353
• 关键词: Architecture; Area; Bluetooth; Characteristics; Charge; Collaborations; Communication; Coupling; Data; Dependence; Development; Electrodes; Electronics; Elements; Encapsulated; Family suidae; Feasibility Studies; Fractals; Fracture; Glass; Implant; Industry; Laminectomy; Lead; Level of Evidence; Life Style; Low Back Pain; Magnetic Resonance Imaging; Mainstreaming; Memory; Modeling; Muscle; Neurostimulation procedures of spinal cord tissue; Neurosurgeon; Operative Surgical Procedures; Opioid; Pain; Pain management; Patients; Phase; Physiologic pulse; Polychlorinated Biphenyls; Polymers; Post-Traumatic Stress Disorders; Process; Production; Public Health; Research; Resort; Safety; Shapes; Signal Transduction; Site; Spinal Cord; Spinal cord injury; Stimulus; Stroke; Surface; Surgical incisions; System; Techniques; Technology; Temperature; Thinness; Time; Titanium; Vagus nerve structure; Wait Time; Work; Wound Infection; base; chronic back pain; chronic pain; chronic pain management; cost; cost effective; cost effectiveness; data modeling; design; disability; effective therapy; electric impedance; epidural space; experience; implantation; improved; migration; minimally invasive; neuroregulation; novel; pain reduction; prototype; relating to nervous system; sensor; solid state; system architecture

Project Summary Teliatry proposes to build world’s smallest (0.75cc), most cost-effective, minimally invasive single incision surgery, 16-channel, rechargeable, Spinal Cord Stimulator (SCS) system to bring proven SCS therapy to mainstream chronic pain management. It eliminates the need for creating an IPG pocket, eliminates tunneling, exploits a novel shape memory polymer (SMP)lead that can be inserted percutaneously without altering current surgical technique but “unrolls” into a paddle in epidural space. It also softens to conform to the epidural space mitigating issues with lead migration and lead breakage. The electrodes on the paddle are high surface area, low polarization, fractal topology Titanium Nitride (TiN) that further reduce the energy required by up to 70% of percutaneous cylindrical electrodes. This in turn reduces the battery capacity requirement and allows us to exploit a miniature, multi-stack solid state battery (SSB) architecture that is manufactured at wafer level on a glass substrate. It is intrinsically safe, MRI compatible and has extremely high charge & discharge rate (20C) and high recharge cycle (2000+) equating to 10+ years lifetime. This further eliminates the need for repeat battery replacement surgery every few years. In recent times, miniature, battery less SCS systems have entered the market but they limit patients comfort and lifestyle by forcing external power & communications module(PCM) to be worn at all times and also have issues with alignment of the PCM with the implant for proper power coupling. Our proposed system is even smaller than these batteries less system and with an average recharge time of <10 minute/day in the worst case, it eliminates the external wearable PCM and long recharge cycles wait time that hinder patient’s lifestyle. In addition, our systems low production costs due to parallel fabrication of multiple implants on one glass wafer will improve the short-term cost effectiveness (currently @ 40%) to its long term cost effectiveness (80%) making this a mainstream electroceutical for pain management and in turn reducing dependence on Opioids for chronic pain sufferers. We will perform feasibility study on all critical components and aspects of the system architecture in Phase 1 allowing us to build a successful prototype during Phase 2. We propose a system design including IPG architecture, battery and lead design that are all based on our proven technology and will enable us to realize a novel SCS system by synergistically combining advantages and on-going advancements of these core technologies 1) glass IPG, 2) glass SSB, 3)new softening and unrolling leads. SCS therapy for chronic back pain is our prime target specially because there is high level of evidence for safety, efficacy, and long-term cost-effectiveness of SCS with more than half of all patients experiencing sustained and significant levels of pain reduction following SCS treatment. We believe we will not only bring SCS to mainstream pain management, but our modular technology platform will impact the entire neuromodulation industry.

项目概要 Teliatry 提议打造世界上最小（0.75cc）、最具成本效益的微创单 切口手术、16 通道、可充电、脊髓刺激器 (SCS) 系统带来经过验证的 SCS 疗法成为慢性疼痛管理的主流。它消除了创建 IPG 的需要 口袋，消除隧道效应，采用可插入的新型形状记忆聚合物 (SMP) 引线 经皮手术无需改变当前的手术技术，而是在硬膜外腔中“展开”成桨状。它 还可以软化以适应硬膜外腔，从而减轻导线迁移和导线断裂的问题。这 桨上的电极是高表面积、低极化、分形拓扑的氮化钛 (TiN)， 进一步减少高达70%经皮圆柱形电极所需的能量。这反过来又减少了 电池容量要求，使我们能够开发微型多堆栈固态电池 (SSB) 在玻璃基板上以晶圆级制造的架构。它本质安全，兼容 MRI 并具有极高的充放电倍率（20C）和高充电循环（2000+）相当于10+ 年寿命。这进一步消除了每隔几年重复进行电池更换手术的需要。在 最近，微型、无电池 SCS 系统已进入市场，但它们限制了患者的舒适度 通过强制始终佩戴外部电源和通信模块（PCM）来改变生活方式 PCM 与植入体对齐以实现正确的功率耦合存在问题。我们建议的系统是 甚至比这些电池更小，更少的系统，平均充电时间<10分钟/天 在最坏的情况下，它消除了阻碍患者的外部可穿戴 PCM 和较长的充电周期等待时间 生活方式。此外，由于在一个系统上并行制造多个植入物，我们的系统生产成本较低 玻璃晶圆将提高其长期成本的短期成本效益（目前为 40%） 有效性 (80%) 使其成为疼痛管理的主流电子疗法，从而减少疼痛 慢性疼痛患者对阿片类药物的依赖。我们将对所有关键的项目进行可行性研究 第一阶段系统架构的组件和方面使我们能够构建成功的原型 在第 2 阶段。我们提出了一个系统设计，包括 IPG 架构、电池和引线设计， 所有这些都基于我们经过验证的技术，将使我们能够通过协同作用实现新颖的 SCS 系统 结合了这些核心技术的优势和持续进步：1) 玻璃 IPG，2) 玻璃 SSB， 3）新的软化和展开引线。 SCS 治疗慢性背痛是我们的首要目标 因为有大量证据表明 SCS 的安全性、有效性和长期成本效益 超过一半的患者在 SCS 后经历持续且显着的疼痛减轻 治疗。我们相信，我们不仅会将 SCS 引入主流疼痛管理，而且我们的模块化 技术平台将影响整个神经调节行业。