Zip-stitch for Laparoscopic Hysterectomy - Clinical Validation

项目摘要 这个直接到第二阶段的小企业创新研究项目将进一步发展， Zip-stitch，一种专利的外科伤口闭合系统，用于内部手术切口。Zip-stitch系统 专门针对腹腔镜子宫切除术开发，以解决阴道子宫切除术中的两个关键问题。 断端闭合：（1）腹腔镜手术的技术难度和（2）阴道断端裂开或伤口 分居Zip-stitch系统由一系列生物可吸收夹组成， 将施用工具施加到阴道断端伤口的相对边缘上。以足够的压力应用结扎夹 以在不刺穿组织的情况下实现止血并导致伤口愈合。 本建议的临床验证和开发的拉链缝合系统是响应之一， NICHD妇科健康与疾病分支（GHDB）的既定研究目标：“器械 和/或旨在解决妇科手术中的手术挑战的技术，包括 子宫切除术”为此，Zip-stitch改进了微创手术中最具挑战性的步骤， 子宫切除术，使袖口关闭更容易和更快，愈合更好。第二阶段研究计划 建立在实验室、动物研究和初步临床研究评价的成功结果基础上。的 本提案的目的是评价Zip缝合在临床环境中的安全性和有效性， 为商业化准备施用器。这将通过59名患者的临床试验来实现。 研究和工程设计改进，包括原型和台架测试。 第二阶段的技术目标是： 1.评价Zip-stich在临床环境中的安全性和有效性; 2.确定拉链式施源器改进的优先级;以及 3.重新设计Zip-stitch可重复使用施源器用户界面。 该项目是一个更广泛的计划的一部分，以开发，验证和市场的拉链缝合系统在一个 涉及内部切口的各种微创手术。这些市场代表着 美国每年有超过六百万例手术，国内市场潜力超过 25亿美元用于闭合装置的Zip-stitch平台。最初，拉链缝合系统直接 解决了腹腔镜子宫切除术中未满足的特定临床需求。大约有 每年在美国进行50万例微创直肠切除术， 国内拉链缝市场规模可达3亿美元。

Project Abstract This Direct to Phase II Small Business Innovation Research project will further the development of Zip-stitch, a patented surgical wound closure system for internal surgical incisions. The Zip-stitch system has been developed specifically for laparoscopic hysterectomy to address two key problems in vaginal cuff closure: (1) the technical difficulty of laparoscopic suturing and (2) vaginal cuff dehiscence or wound separation. The Zip-stitch system is comprised of a series of bioabsorbable clips deployed by an applicator tool onto opposing edges of the vaginal cuff wound. Clips are applied with sufficient pressure to achieve hemostasis without piercing tissue and lead to wound healing. This proposal for the clinical validation and development of the Zip-stitch system is responsive to one of the stated research goals of the Gynecologic Health and Disease Branch (GHDB) of NICHD: “Devices and/or technologies designed to address surgical challenges in gynecologic surgeries, including hysterectomy.” To this end, Zip-stitch improves the most challenging step in minimally invasive hysterectomy, making cuff closure easier and faster, and healing better. This Phase II research proposal builds on successful results from benchtop, animal study and pilot clinical study evaluations. The objectives of this proposal are to evaluate the safety and efficacy of Zip-stitch in a clinical setting and to prepare the applicator for commercialization. This will be accomplished by means of a 59-patient clinical study and engineering design refinement, including prototyping and benchtop testing. The Phase II Technical Objectives are: 1. Evaluate the safety and effectiveness of Zip-stich in a clinical setting; 2. Determine priorities for Zip-stitch Applicator improvements; and 3. Re-design the Zip-stitch Reusable Applicator user interface. This project is part of a broader plan to develop, validate, and market the Zip-stitch System across a broad spectrum of minimally-invasive surgeries involving internal 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 Zip-stitch platform of closure devices. Initially, the Zip-stitch system directly addresses a specific unmet clinical need in laparoscopic hysterectomy. There are approximately 500,000 minimally-invasive hysterectomies performed in the U.S. each year, representing an annual addressable domestic market size for Zip-stitch of $300 MM.