SBIR Phase II: Novel Surgical Closure Device for Minimally Invasive Procedures

这个小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是一个更广泛计划的一部分，该计划旨在开发、验证和营销这种新的外科设备，覆盖涉及内切口的各种手术(仅在美国每年就有1000万例手术)。这项技术在快速增长的微创手术市场上具有特别的价值，在这个市场上，由于表面切口较小，内部闭合变得困难。这些市场代表着美国每年600多万例手术，为正在开发的封堵设备平台创造了超过25亿美元的国内市场潜力。最初，该系统直接满足了一个尚未得到满足的特定临床需求：减少了微创子宫切除术中内闭合的技术要求，以及在这一过程中使用缝合线的重大并发症。2013年，美国大约进行了42万例这样的手术，占美国子宫切除术总数的三分之二以上。以这种方式进行的子宫切除术的这一部分仍在继续增长，并将代表着每年可实现的国内市场总规模，最高销售额为2亿美元(全球为6亿美元)。拟议的项目开发了一种用于在内窥镜检查中关闭内切口的新型外科闭合系统。我们最初的应用是在腹腔镜(微创)子宫切除术中。在腹腔镜手术中，缝合线通常用于闭合内口。抛环和打结是腹腔镜手术中最困难的部分；这些困难减缓了腹腔镜子宫切除术的采用。在第二阶段，技术目标是(1)改进闭合系统以满足最小可行产品的要求；(2)在大型动物模型中证明该系统的安全性和有效性；以及(3)在身体模型中证明该系统在腹腔镜子宫切除术中的有效性。这些目标旨在根据外科团体确定的产品要求完成对这种新型闭合系统的性能评估，并在设计过程中使用。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is as part of a broader plan to develop, validate, and market this new surgical device across a broad spectrum of surgeries involving internal incisions (a total of 10 million procedures annually in the U.S. alone). This technology 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 platform of closure devices under development. Initially, the system directly addresses a specific unmet clinical need: reducing both the technical demands of internal closure during minimally-invasive hysterectomy and the significant complications associated with the use of sutures in this procedure. There were approximately 420,000 of these surgeries performed in the U.S. in 2013, representing more two-thirds of all U.S. hysterectomies. This fraction of hysterectomies performed in this manner is continuing to grow, and will represent a total annual addressable domestic market size at peak sales of $200 MM ($600 MM globally).The proposed project develops a novel surgical closure system for closing internal incisions in endoscopy. Our initial application is in laparoscopic (minimally-invasive) 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 laparoscopic hysterectomy. In Phase II, the Technical Objectives are (1) to refine the closure system to meet the requirements of a minimum viable product; (2) to demonstrate safety and efficacy of the system in a large animal model of laparoscopic hysterectomy; and (3) to demonstrate efficacy of the system in laparoscopic hysterectomy in a cadaveric model. These objectives are designed to complete the evaluation of the performance of this novel closure system against product requirements identified by the surgical community and utilized in the design process.