Deep Brain Stimulation Probe Insertion System Utilizing Ultrasonic Vibration for Less Invasive Implantation with Improved Targeting Accuracy for Addiction Therapy

深部脑刺激探针插入系统利用超声波振动进行侵入性较小的植入，并提高成瘾治疗的靶向精度

• 批准号: 10013712
• 负责人: Ryan S Clement
• 金额: $ 33.31万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10013712
• 关键词: Achievement; Addictive Behavior; Address; Air; Americas; Animals; Award; Blood specimen; Brain; Businesses; Cerebrospinal Fluid; Clinic; Collaborations; Coupling; Craniotomy; Custom; Deep Brain Stimulation; Development; Devices; Disease; Drug Addiction; Dura Mater; Electrodes; Electrophysiology (science); Engineering; Enteral Feeding; Excision; Goals; Illicit Drugs; Implant; Investigation; Legal patent; Location; Magnetic Resonance Imaging; Mechanics; Medical; Medical Research; Metals; Microelectrodes; Modeling; Motion; Needles; Neurons; North Carolina; Nucleus Accumbens; Operative Surgical Procedures; Opioid; Parkinson Disease; Pathway interactions; Patient-Focused Outcomes; Performance; Phase; Polymers; Postoperative Period; Procedures; Process; Public Health; Rattus; Research; Research Personnel; Rewards; Rodent; Sales; Site; Slide; Small Business Innovation Research Grant; Standardization; Structure; Surface; Surgical Equipment; System; Technology; Testing; Thinness; Tissues; Transducers; Tube; Ultrasonics; United States; United States National Institutes of Health; Universities; addiction; base; brain tissue; clinical application; commercialization; cranium; craving; equipment acquisition; experience; flexibility; human subject; implantable device; implantation; improved; in vivo; innovation; neural implant; neuropsychiatric disorder; novel therapeutic intervention; novel therapeutics; opioid epidemic; pre-clinical; pre-clinical research; preclinical study; relating to nervous system; response; success; verification and validation; vibration

This Phase I SBIR develops and tests a Deep Brain Stimulation Probe Insertion System Utilizing Ultrasonic Vibration for Less Invasive Implantation with Improved Targeting Accuracy for Addiction Therapy. This submission is in response to: RFA –19-019 HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis. Problem to be solved: Currently, drug addiction is a major public health concern. In the U.S., more than 7 million people suffer from some type of illicit drug disorder. Due to success treating Parkinson’s and neuropsychiatric disorders with Deep Brain Stimulation (DBS), it is being investigated as a potential drug addiction treatment. The rationale behind addiction stimulation therapy involves reestablishing normal brain function in target regions in an effort to dampen addictive behaviors. Targeting the Nucleus Accumbens (NA), a key structure in the mesolimbic reward pathway, has demonstrated success preclinically as well as with human subjects (outside the U.S.). DBS probe placement requires metal guide tube placement to mechanically support and maintain trajectory during insertion. Placement also requires dura resection (durotomy), which can cause brain shifts relative to the skull resulting from cerebrospinal fluid (CSF) loss and/or subdural air invasion, decreasing accuracy of pre-surgical mapping. This project develops the Accurate DBS Placement (ADP) system to oscillate DBS probes during insertion, allowing thinner/more flexible probes to be placed precisely into deep neural structures, with smaller, more shallowly inserted guide tubes, or without requiring them at all. Controlled insertion through the dura will be evaluated, which would minimize brain shifting. Product and Long-Term Goal. The ultimate goal is to standardize/simplify the DBS procedure, making it a more successful and attractive addiction treatment, enabling use in a wider range of surgical centers. The product for sale – the ADP system - would be an insertion system that clinics purchase to deliver the therapy. Additional markets exist for placing DBS electrodes for Parkinson’s disease. Initial sales will be to preclinical researchers. Phase I Hypothesis and Aims. Hypothesis: The ADP System can enable improved DBS probe placement accuracy with reduced overall surgical invasiveness. Aim 1: Develop and test the ADP system for placement of multiple DBS probe styles: investigate dura and guide tube placement options. Acceptance Criteria. >70% reduction in insertion force compared to non-vibrated insertion in models and/or ex vivo tissue; at up 10 cm insertion depth, demonstrate <1 mm deviation from target path with 50% reduction in implantation footprint. Aim 2: Demonstrate ADP system improves insertion reliability and accuracy of polymer-based MR- compatible and flexible DBS probes into the Nucleus Accumbens (NA) in preclinical study. Acceptance Criteria: Improved insertion success and accuracy demonstrated with the placement of ‘UNC probes’ (research partner) into NA, verified by Magnetic Resonance Imaging (MRI) and electrophysiology recording.

第一阶段SBIR开发并测试了利用超声波的脑深部刺激探头插入系统 振动用于微创植入，提高成瘾治疗的靶向准确性。这 RFA-19 - 019 HEAL倡议：美国的初创公司和小企业建立 技术阻止阿片类药物危机 有待解决的问题：目前，吸毒成瘾是一个主要的公共卫生问题。在美国，超过7 100万人患有某种非法药物紊乱症。由于成功治疗帕金森氏症， 脑深部电刺激（DBS）治疗神经精神疾病，它正在作为一种潜在的药物进行研究 戒毒治疗成瘾刺激疗法背后的基本原理包括重建正常的大脑 在目标区域发挥作用，以抑制成瘾行为。靶向伏隔核（NA），a 中脑边缘奖赏通路中的关键结构，已经在临床前以及人类中证明了成功 受试者（美国境外）。DBS探头放置需要放置金属导管， 在插入过程中支撑并保持轨迹。放置还需要硬脑膜切除术（硬脑膜切开术）， 可导致脑移位相对于颅骨造成脑脊液（CSF）损失和/或硬膜下空气 侵袭，降低术前标测的准确性。该项目开发了准确的DBS放置 (ADP)在插入过程中振荡DBS探头的系统，允许放置更薄/更灵活的探头 精确地进入深层神经结构，用更小，更浅插入的导管，或者不需要 他们在所有。将评价通过硬脑膜的受控插入，这将最大限度地减少大脑移位。 产品和长期目标。最终目标是标准化/简化DBS程序，使其成为 更成功、更有吸引力的成瘾治疗，能够在更广泛的外科中心使用。的 销售的产品-ADP系统-将是诊所购买以提供治疗的插入系统。 存在用于放置DBS电极以治疗帕金森病的其他市场。最初的销售将是临床前 研究人员第一阶段的假设和目标。假设：ADP系统可以实现改进的DBS探头 定位准确性，降低整体手术侵入性。目标1：开发和测试ADP系统， 多种DBS探头类型的放置：研究硬脑膜和导管放置选项。验收 的搜索.与模型和/或离体组织中的非振动插入相比，插入力降低>70%; 在插入深度达10 cm时，证实与靶路径的偏差<1 mm，植入减少50% 脚印目的2：证明ADP系统提高了聚合物基MR的插入可靠性和准确性- 在临床前研究中，将兼容且灵活的DBS探针插入伏隔核（NA）。验收 标准：通过放置“双探头”证明插入成功率和准确性提高（研究 通过磁共振成像（MRI）和电生理记录验证。