STTR Phase I: Development and Validation of the SafeClose Mesh Augmentation System for Hernia Prevention

这个STTR第一阶段项目旨在通过开发一种预防疝气发生的系统来解决疝气在美国已经成为一个巨大的问题。据估计，美国每年进行30万例疝修补术。切口疝（IH）在高危人群中的发生率高达70%。疝的流行是显著的，与生活质量降低和每年32亿美元的疝修补医疗费用有关。使用预防性补片可以预防IH，这涉及在疝形成之前放置张紧的补片以加强腹部筋膜闭合。预防性补片已被证明可将IH的风险从35.9%降至1.5%。然而，尽管预防性补片产生了出色的结果，但它尚未被广泛采用，部分原因是该手术带来的技术挑战和增加的手术时间。该项目旨在创建一个系统，使预防性补片手术更简单，更可靠，更快。该项目通过解决采用预防性补片的关键外科医生级障碍，为疝流行病提供了有效的解决方案，因此将促进该手术的更广泛使用。更广泛地使用疝预防将改善结局、生活质量并降低与IH相关的成本。该项目提出开发一种手持式系统，通过整合多个离散的手术任务（包括定位、张紧和将补片固定到腹部筋膜上），简化并缩短进行预防性补片加固的时间。该系统通过利用腹壁和补片的生物力学原理提供了一种用于预防性补片放置的优化策略，以提供一种快速、标准化和可靠的方法来加强腹部切口，从而最大限度地降低疝形成的风险。该系统由三个主要组件组成：施用器、锚钉和补片本身。锚定器代表了该技术的核心功能，同时服务于两个目的：（1.）通过施加器系统的网的相互作用/接合和随后的张力设定;以及（2.）穿透筋膜并将补片固定到筋膜上。施源器是一种简单的人体工程学工具，与锚钉连接，允许外科医生控制补片的空间位置、张力和放置。本项目主要实现两个目标：（1）。改进装置设计，包括实现施用器和锚定器之间的接合的最佳安全性和可靠性，以及（2.）与当前的护理标准相比，评估拟议技术的生物力学强度和速度。通过反复的设备原型设计、测试和改进，将开发出功能齐全的设备。

This STTR Phase I project looks to create a solution to the vast problem that hernia has become in the United States by developing a system that prevents hernia before it occurs. There are an estimated 300,000 hernia repairs performed each year in the US. Incisional hernia (IH) occurs in up to 70% in high-risk populations. The hernia epidemic is significant and is linked to reduced quality of life and $3.2 billion/year in healthcare expenditures for hernia repair. IH can be prevented using prophylactic mesh, which involves placement of tensioned mesh to reinforce abdominal fascia closures before herniation occurs. Prophylactic mesh has been shown to reduce the risk of IH from 35.9% to 1.5%. However, although prophylactic mesh produces outstanding results, it has not become widely adopted in part due to the technical challenge that the procedure poses and added operative time. This project aims to create a system that makes the prophylactic mesh procedure simpler, more reliable, and faster. This project offers an efficient solution to the hernia epidemic by addressing key surgeon-level barriers to adoption of prophylactic mesh and therefore will foster more widespread use of the procedure. Broader use of hernia prevention will improve outcomes, quality of life, and reduce the costs associated with IH.This project proposes the development of a hand-held system that simplifies and reduces the time to perform prophylactic mesh augmentation by integrating multiple discrete operative tasks including locating, tensioning, and affixing mesh onto the abdominal fascia. The system provides an optimized strategy for prophylactic mesh placement by leveraging biomechanical principles of both the abdominal wall and mesh to provide a quick, standardized, and reliable method to strengthen abdominal incisions and as a result minimize the risk of herniation. The system is comprised of three main components: the applicator, the fastener-anchor, and the mesh itself. The fastener-anchor represents a core functionality of the technology while serving two purposes: (1.) interaction/engagement and subsequent tension-setting of the mesh via the applicator system; and (2.) penetration of the fascia and affixation of the mesh onto the fascia. The applicator is a simple, ergonomic tool that interfaces with the fastener-anchors, allowing the surgeon to control the spatial position, tension, and placement of the mesh. This project aims to accomplish two main goals: (1.) to refine the device design, including achieving optimal security and reliability of engagement between the applicator and the fastener-anchors and (2.) to assess the biomechanical strength and speed of the proposed technology compared to current standards of care. Through iterative device prototyping, testing, and refinement, a fully functional device will be developed.