Customer discovery for minimally invasive nerve block device to treat severe pain and reduce usage of opiates

客户发现微创神经阻滞装置可治疗严重疼痛并减少阿片类药物的使用

• 批准号: 10086831
• 负责人: STEPHEN L MELONI
• 金额: $ 5.5万
• 依托单位: THERMAQUIL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-29 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10086831
• 关键词: Amphibia; Anesthesiology; Chest; Chest Tubes; Devices; Ecosystem; Generations; Human; Incidence; Innovation Corps; Intervention; Interview; Liquid substance; Modeling; Nerve; Nerve Block; Occupations; Operative Surgical Procedures; Opiate Addiction; Outcome; Pain; Parents; Patient Care Team; Patients; Performance; Peripheral; Pharmaceutical Preparations; Recovery; Regulatory Affairs; Rib Fractures; Risk Factors; Role; Small Business Technology Transfer Research; Specialist; System; Thoracic Surgeon; Thoracotomy; Ventral thoracic nerve structure; Work; design; expectation; high risk; minimally invasive; neuropathology; neurosurgery; novel; opioid use; opioid user; pain signal; prescription opioid; prototype; symposium; transmission process

Abstract: Thoracotomy is one of the most painful surgical procedures and patients are at high risk of developing opioid addiction. Recent studies have shown 1 in 7 patients became new persistent opioid users after physical recovery from the surgery was complete. The largest risk factor for opioid addiction is being prescribed opioids in the first place, and Thermaquil wants to reduce this incidence by developing patient-controlled, drug-free, reversible nerve block devices. Our approach involves gently warming and cooling a short segment of any nerve, and we believe that all mammalian and amphibian nerves are susceptible to thermal nerve blocks. In the parent STTR to this I-Corps proposal, we are specifically blocking intercostal nerves that transmit severe thoracic-region pain. The system includes a minimally invasive thermal tip and an externally worn controller/power unit. The thermal tip will be primarily inserted by thoracic surgeons, regional (peripheral) anesthesiologists and interventional pain specialists – so people in these roles will likely be the initial targets of our I-Corps Customer Discovery work. Thermaquil has a highly engaged team of world renowned thought-leaders in neurosurgery, neuropathology, anesthesiology, pain, computational fluid dynamics and thermal modeling, and regulatory affairs. We have designed and built four generations of thermal device prototypes and validated their thermal performance matches expectations to attain thermal nerve block efficacy. Thermal nerve block is potentially applicable to a wide range of human pain conditions. In this I-Corps project we want to confirm that we are selecting most ideal initial target market and that we are developing the right product to fully meet the critical needs of the market and all key stakeholders in the ecosystem. This proposed Customer Discovery will refine Thermaquil’s go to market strategy including our value proposition while also starting to explore reimbursement and revenue considerations to make sure that our selected market is viable financially. If new market needs are identified, alternate nerve block devices or approaches could be adapted to best meet the better understood need. Specifically we seek to understand current surgical and patient / care team workflows and opportunities/challenges with current approaches. We’d like to clarify what ‘job’ we can help each stakeholder accomplish and the outcomes that they are trying to achieve. This will help us define an ideal product-market-fit to confirm that we are approaching the right foothold market with the right technical solution. We’d also like to identify other constraints and concerns that decision-makers will have when considering new pain block solutions. Thermaquil commits to interview over 100 key stakeholders to clarify these points and plans to attend 1-2 national conferences for pain specialists and thoracic anesthesiologists.

抽象的： 胸腔切开术是最痛苦的手术程序之一，患者有高风险 Oopioid成瘾。最近的研究表明，有7名患者在 手术中的身体恢复已完成。阿片类药物成瘾的最大危险因素是 首先，规定了阿片类药物，Thermaquil希望通过开发来减少这一事件 患者控制，无药物，可逆的神经阻滞装置。我们的方法涉及温暖和 冷却任何神经的一小段，我们认为所有哺乳动物和两栖动物都是 易受热神经障碍物的影响。在此I-Corps提案的父母sttr中，我们具体是 阻止肋间神经传递严重的胸腔疼痛。该系统包括一个最小的 侵入性热尖和外部磨损的控制器/动力单元。热尖是主要的 由胸外科医生，区域（周围）麻醉师和介入疼痛专家插入 - 因此，担任这些角色的人很可能是我们I-Corps客户发现工作的最初目标。 Thermaquil拥有一支高度参与的世界著名思想领袖在神经外科手术中的团队， 神经病理学，麻醉学，疼痛，计算流体动力学和热建模，以及 监管事务。我们设计并建造了四代热设备原型和 验证其热性能与达到热神经阻滞效率的期望相匹配。 热神经阻滞可能适用于广泛的人类疼痛状况。在这个i-corps中 项目我们要确认我们正在选择最理想的初始目标市场，并且我们是 开发正确的产品，以充分满足市场的关键需求以及所有主要利益相关者 生态系统。该建议的客户发现将完善Thermaquil的“进入市场策略”，包括 我们的价值提议，同时还开始探索报销和收入注意事项 确保我们所选的市场在财务上是可行的。如果确定了新的市场需求，请替代神经 可以对块设备或方法进行调整，以最好地满足更好的理解需求。 寻求了解当前的手术和患者 /护理团队的工作流程以及机会 /挑战 采用当前的方法。我们想澄清什么“工作”，我们可以帮助每个利益相关者完成和 他们试图实现的结果。这将有助于我们定义理想的产品市场拟合 确认我们正在使用正确的技术解决方案来接近正确的立足市场。我们也会 想确定决策者在考虑新的情况下会产生的其他限制和问题 止痛解决方案。 Thermaquil承诺采访100多个主要利益相关者，以澄清这些要点 并计划参加疼痛专家和胸腔麻醉学家的1-2个国家会议。