SBIR Phase II: Improving the safety and efficacy of epidural anesthesia

这个小企业创新研究二期项目的重点是将一种专有的医疗设备商业化，以提供安全和准确的硬膜外麻醉。硬膜外麻醉为分娩、大手术和慢性背痛提供了良好的疼痛控制，而不必使患者暴露于全身麻醉的风险。硬膜外麻醉包括：(1)进入硬膜外间隙，硬脑膜附近的微小电位空间，脊髓的薄保护层，然后(2)给予局部麻醉剂以浸泡脊神经根并阻断疼痛感觉。目前，硬膜外麻醉需要在进入硬脑膜之前立即停止，用尖针从背部盲目插入。当前方法的困难带来了麻醉药输送到不正确的解剖位置和损伤附近关键结构的风险。据估计，6-25%的病例会出现并发症。InSite医疗技术公司开发了一种技术，该技术消除了尖锐的针尖，并通过独特的周围组织提供了进入硬膜外空间的高度控制。在二期项目中，InSite将完成产品设计，建立质量制造系统，获得FDA 510(k)批准，并实现该设备的首次人类使用。在美国，硬膜外麻醉市场每年约有980万符合条件的患者，其中只有340万患者实际接受了硬膜外麻醉。硬膜外麻醉的不充分利用是由于几个障碍，包括操作困难和医生对并发症的恐惧。硬膜外麻醉市场分为产科、外科和慢性疼痛应用。美国每年有超过400万新生儿，产科是最大的部分。目前，在分娩期间，240万妇女（60%）接受硬膜外麻醉以控制疼痛。第二大部分是手术麻醉，尽管已知的患者预后益处，但在180万例符合条件的病例中，硬膜外麻醉仅用于50万例。最后，脊柱相关的疼痛综合征越来越多地使用硬膜外类固醇和植入刺激器治疗，每年约有60万例。在美国以外，每年有1900万例硬膜外手术，这是一个巨大的潜在国际市场，包括每年1.3亿新生儿。通过创建一个更安全、更准确的硬膜外麻醉系统，InSite医疗技术公司看到了一个机会，可以生产出一种优质的医疗设备，对患者的硬膜外麻醉体验产生积极的影响。

This Small Business Innovation Research Phase II project is focused on commercializing a proprietary medical device to provide safe and accurate delivery of epidural anesthesia. Epidural anesthesia provides excellent pain control for childbirth, major surgery, and chronic back pain without having to expose patients to the risks of general anesthesia. Epidural anesthesia involves (1) accessing the epidural space, a miniscule potential space adjacent to the dura, the thin protective covering of the spinal cord, then (2) delivering local anesthetic to bathe the spinal nerve roots and block pain sensation. Currently, epidural access requires blind insertion of a sharp-tipped needle through the back that is immediately halted just prior to entering the dura. The difficulty of the current method poses risks of anesthetic delivery to incorrect anatomic locations and injury to nearby critical structures. Complications are estimated to occur in 6-25% of cases. InSite Medical Technologies has developed a technology that eliminates the sharp needle tip and provides highly controlled access to the epidural space by uniquely engaging surrounding tissue. During the Phase II project InSite will finalize product design, establish a quality manufacturing system, attain an FDA 510(k) approval and achieve the first human use of the device. The epidural anesthesia market comprises an estimated 9.8 millions eligible patients each year in the United States of which only 3.4 million patients actually receive epidural anesthesia. The underutilization of epidural anesthesia results from several barriers including procedure difficulty and physician fear of complications. The epidural anesthesia market is segmented into obstetric, surgical, and chronic pain applications. With over 4 million births annually in the United States, obstetrics is the largest segment. Currently, during childbirth, 2.4 million women (60%) receive epidural anesthesia for pain control. The second largest segment is surgical anesthesia where, despite known patient-outcome benefits, epidural anesthesia is used in only 500,000 of 1.8 million eligible cases. Finally, spine-related pain syndromes are treated increasingly with epidural steroids and implanted stimulators, accounting for 600,000 annual cases. Outside the U.S., 19 million epidural access procedures are performed annually with a massive potential international market including 130 million births per year. By creating a safer and more accurate system for delivering epidural anesthesia, InSite Medical Technologies sees an opportunity to produce a premium medical device that positively impacts patients' experience with epidural anesthesia.