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.

项目摘要 Teliatry提出建立世界上最小的（0.75cc），最具成本效益，微创单 切口手术，16通道，可充电，脊髓刺激器（SCS）系统， SCS治疗成为慢性疼痛管理的主流。无需创建IPG 口袋，消除隧道，利用一种新的形状记忆聚合物（SMP）的领导，可以插入 在不改变当前手术技术的情况下，Perilum可以在硬膜外腔中“展开”成桨状。它 还软化以符合硬膜外腔，从而缓解电极导线迁移和电极导线断裂的问题。的 桨上的电极是高表面积、低极化、分形拓扑氮化钛（TiN）， 进一步减少了高达70%的经皮圆柱形电极所需的能量。这又降低 电池容量的要求，并允许我们利用一个微型，多堆栈固态电池（SSB） 在玻璃基板上以晶片级制造的架构。本质安全，MRI兼容 具有极高的充放电倍率（20 C）和高充电周期（2000+），相当于10+ 年的寿命。这进一步消除了每隔几年重复更换电池手术的需要。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）， PCM与植入物的对齐存在问题，无法实现正确的功率耦合。我们建议的系统是 甚至比这些电池更少的系统更小，并且平均充电时间<10分钟/天 在最坏的情况下，它消除了外部可穿戴PCM和长充电周期等待时间，这会阻碍患者 生活方式此外，我们的系统由于在一个设备上并行制造多个植入物而降低了生产成本 玻璃晶圆将提高短期成本效益（目前为40%），以其长期成本 有效性（80%），使其成为疼痛管理的主流电疗法， 慢性疼痛患者对阿片类药物的依赖。我们将对所有关键项目进行可行性研究， 组件和方面的系统架构在第一阶段，使我们能够建立一个成功的原型 在第二阶段。我们提出了一种系统设计，包括IPG架构、电池和电极导线设计， 所有这些都基于我们成熟的技术，并将使我们能够通过协同实现一个新的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主要目标， 因为有高水平的证据证明SCS的安全性、有效性和长期成本效益， 超过一半的患者在SCS后疼痛持续显著减轻 治疗我们相信，我们不仅将SCS纳入主流疼痛管理， 技术平台将影响整个神经调节行业。