Opioid-Sparing Non-Surgical, Bioresorbable Nerve Stimulator for Pain Relief

节省阿片类药物的非手术生物可吸收神经刺激器,用于缓解疼痛

基本信息

  • 批准号:
    10759642
  • 负责人:
  • 金额:
    $ 34.7万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2023
  • 资助国家:
    美国
  • 起止时间:
    2023-09-20 至 2025-08-31
  • 项目状态:
    未结题

项目摘要

Project Summary The lack of effective pain treatments has catalyzed the opioid epidemic in America, causing an estimated 93,000 deaths in 2020, calling for more effective and non-opioid based management. One alternative pain treatment is via nerve stimulators, which are devices placed near a peripheral nerve or on the spinal cord and use electrical signals to modulate the perception of pain. Most nerve stimulators are surgically implanted and made of permanent metal wires. A pulse generator and battery pack are also surgically implanted under the skin. These devices can provide effective pain relief to patients, but have excessively high complication rates of 30-40%, resulting from the wire moving, breaking, not working, or the implantable battery pack or permanent wire causing new sites of pain. These complications require yet another surgery to correct the problem, increasing costs for the patient and the healthcare system. Temporary nerve stimulators can mitigate some of the complications, but these are made of permanent materials and must be removed after 60 days, while the removal causes 10- 15% lead fracture leaving the lead permanently in the body. Vanish Therapeutics proposes a bioresorbable, non- surgical peripheral nerve stimulator to treat chronic pain. Once inserted, the device will provide electrical stimulation for up to 60 days, after which it will be safely degraded by applying an anodic electrical stimulus resulting in resorption by the body, eliminating the need for any revision surgeries. This Phase I project will establish feasibility and produce safety/efficacy data for a Phase II application. Towards this goal, we will 1) Develop the minimally invasive stimulation lead composed of entirely bioresorbable components. The electrochemical properties and degradation profile will be characterized and optimized to meet the application needs. Stimulation will be tested in physiological saline solution, and the electrode must be capable of delivering at least 550,000,000 stimulation pulses, equivalent to 60 days of full-time clinical stimulation. The degradation of the device will then be accelerated with an anodic electrical stimulus. The toxicity of the material/device and degradation products will be evaluated following ISO standards. 2) Design the wearable external pulse generator with programmable stimulation current profiles and an active impedance measurement circuit. The device will deliver the electrical stimulations for pain relief and drive the degradation of the wire after the end of stimulation. 3)Validate the stimulation efficacy and degradation safety of the integrated stimulator in a rat neuropathic pain model. Using the previously developed pulse generator and injectable electrode, animals will be stimulated for 60 days, with weekly electrochemical and electrophysiological measurements to monitor the electrode function. After stimulation, the electrode will be subjected to electrically driven degradation, resulting in rapid bioresorption of the device. Histology up to 180 days post-implant will be performed to evaluate the long term safety and degradation profile.
项目摘要 缺乏有效的疼痛治疗已经催化了阿片类药物在美国的流行,估计造成93,000人死亡。 2020年的死亡人数,呼吁更有效和非阿片类药物的管理。一种替代疼痛治疗方法是 通过神经刺激器,神经刺激器是放置在周围神经附近或脊髓上的装置, 调节疼痛感知的信号。大多数神经刺激器都是通过手术植入的, 永久金属线脉冲发生器和电池组也通过手术植入皮肤下。这些 装置可以为患者提供有效的疼痛缓解,但是具有30- 40%的过高的并发症发生率, 由于导线移动、断裂、不工作或植入式电池组或永久性导线导致 新的疼痛部位。这些并发症需要另一次手术来纠正问题,增加了治疗费用。 患者和医疗系统。临时神经刺激器可以减轻一些并发症, 但这些都是由永久性材料制成的,必须在60天后拆除,而拆除会导致10- 15%电极导线断裂,电极导线永久留在体内。Vanish Therapeutics提出了一种生物可吸收,非 外科外周神经刺激器治疗慢性疼痛。一旦插入,该装置将提供电力 刺激长达60天,之后将通过施加阳极电刺激安全降解 导致被身体再吸收,从而消除了任何修正手术的需要。第一期工程将 确定可行性并为II期应用提供安全性/有效性数据。为了实现这一目标,我们将 1)开发由完全生物可吸收组件组成的微创刺激电极导线。的 电化学性能和降解曲线将被表征和优化,以满足应用 需求将在生理盐水溶液中测试刺激,电极必须能够输送 至少550,000,000个刺激脉冲,相当于60天的全时临床刺激。的降解 然后用阳极电刺激加速该装置。材料/器械的毒性和 将按照ISO标准评价降解产物。 2)设计具有可编程刺激电流分布和有源的可穿戴外部脉冲发生器 阻抗测量电路该装置将提供电刺激以缓解疼痛,并驱动 刺激结束后导丝降解。 3)验证集成刺激器对大鼠神经病理性疼痛的刺激效果和降解安全性 模型使用先前开发的脉冲发生器和可注射电极,动物将被刺激, 60天,每周进行电化学和电生理学测量以监测电极功能。 刺激后,电极将受到电驱动降解,导致快速生物吸收 设备的。将在植入后180天内进行组织学检查,以评价长期安全性和 降解曲线

项目成果

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会议论文数量(0)
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XINYAN Tracy CUI其他文献

XINYAN Tracy CUI的其他文献

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{{ truncateString('XINYAN Tracy CUI', 18)}}的其他基金

Efficiency and Safety of Microstimulation Via Different Electrode Materials
通过不同电极材料进行微刺激的效率和安全性
  • 批准号:
    10622204
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Efficiency and Safety of Microstimulation Via Different Electrode Materials
通过不同电极材料进行微刺激的效率和安全性
  • 批准号:
    10421288
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Ultra sensitive and flexible MEAs for chronic dopamine detection at both tonic and phasic levels
超灵敏且灵活的 MEA,用于强直和阶段性水平的慢性多巴胺检测
  • 批准号:
    9814422
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Optimization and Delivery of Bioactive Coating for High Yield and Stable Neural Recording
用于高产量和稳定神经记录的生物活性涂层的优化和交付
  • 批准号:
    10264798
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Efficiency and Safety of Microstimulation Via Different Electrode Materials
通过不同电极材料进行微刺激的效率和安全性
  • 批准号:
    10653699
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Efficiency and Safety of Microstimulation Via Different Electrode Materials
通过不同电极材料进行微刺激的效率和安全性
  • 批准号:
    10183351
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Efficiency and Safety of Microstimulation Via Different Electrode Materials
通过不同电极材料进行微刺激的效率和安全性
  • 批准号:
    9979986
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Efficiency and Safety of Microstimulation Via Different Electrode Materials
通过不同电极材料进行微刺激的效率和安全性
  • 批准号:
    10842106
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Optimization and Delivery of Bioactive Coating for High Yield and Stable Neural Recording
用于高产量和稳定神经记录的生物活性涂层的优化和交付
  • 批准号:
    10470899
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:
Optimization and Delivery of Bioactive Coating for High Yield and Stable Neural Recording
用于高产量和稳定神经记录的生物活性涂层的优化和交付
  • 批准号:
    10022175
  • 财政年份:
    2019
  • 资助金额:
    $ 34.7万
  • 项目类别:

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