SBIR Phase I: Surgical Closure Device

该小型企业创新研究（SBIR）第一阶段项目开发了一种新型手术闭合系统，用于闭合内窥镜检查中的内部切口。最初的应用是在腹腔镜子宫切除术中关闭阴道断端。缝线通常用于闭合腹腔镜手术中的内部切口。抛环和打结是腹腔镜手术中最困难的部分;这些困难减缓了微创手术的采用，包括腹腔镜子宫切除术。该系统是一系列手术夹，旨在实现难以进入组织的轻松闭合，提高切口闭合的易用性、速度和质量。钛夹不会刺穿组织，而是持续压迫以闭合切口。施源器工具将组织拉至对合位置以进行夹子应用，同时减少组织处理、坏死、缺血和感染风险。该项目更广泛的影响/商业潜力是在涉及内部切口的广泛手术中开发、确认和销售该器械（仅在美国每年就有1000万例手术）。该设备在快速增长的微创手术市场中具有特别的价值，在微创手术市场中，由于浅表切口的尺寸小，内部闭合变得困难。这些市场代表了美国每年超过600万例手术，为闭合器械的器械平台创造了超过25亿美元的国内市场潜力。闭合装置设计简单且使用直观，这在腹腔镜手术中至关重要。最初，闭合器械直接解决了一个特定的未满足的临床需求：降低了腹腔镜子宫切除术中阴道断端闭合的技术要求，以及在该手术中使用缝线相关的严重并发症。在美国，每年大约有300，000例腹腔镜直肠切除术。这一数字估计以每年20%的速度增长，仅腹腔镜子宫切除术的峰值销售额为2亿美元（全球6亿美元）时，这将代表每年可寻址的国内市场总规模。

This Small Business Innovation Research (SBIR) Phase I project develops a novel surgical closure system for closing internal incisions in endoscopy. The initial application is closing the vaginal cuff in laparoscopic hysterectomy. Sutures are typically used to close internal incisions in laparoscopic surgery. Throwing loops and tying knots are among the most difficult parts of laparoscopic procedures; these difficulties have slowed the adoption of minimally-invasive procedures, including laparoscopic hysterectomy. The system is a series of surgical clips that are designed to enable easy closure for difficult-to-access tissue, improving ease of use, speed, and quality of incision closure. The clips do not pierce tissue, but apply continuous compression to close the incision. The applicator tool pulls tissue into apposition for clip application, while reducing tissue handling, necrosis, ischemia, and the risk of infection. The broader impact/commercial potential of this project is to develop, validate, and market the device across a broad spectrum of surgeries involving internal incisions (a total of 10 million procedures annually in the U.S. alone). This device has particular value in the rapidly-growing minimally-invasive surgery market, in which internal closure is made difficult by the small size of superficial incisions. These markets represent more than 6 million surgeries per year in the U.S., creating a domestic market potential of more than $2.5 billion for the device platform of closure devices. The closure device is designed to be simple and intuitive to use, which is critical in laparoscopic procedures. Initially, the closure device directly addresses a specific unmet clinical need: reducing both the technical demands of vaginal cuff closure during laparoscopic hysterectomy and the significant complications associated with the use of sutures in this procedure. There are approximately 300,000 laparoscopic hysterectomies performed in the U.S. annually. This number is growing at an estimated rate of 20% per year, and will represent a total annual addressable domestic market size at peak sales of $200 MM ($600 MM globally) for laparoscopic hysterectomy alone.