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

STTR 第一阶段：用于预防疝气的 SafeClose 网片增强系统的开发和验证

• 批准号: 1648854
• 负责人: Rex Peters
• 金额: $ 22.5万
• 依托单位: Paradigm Surgical LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-01-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1648854&HistoricalAwards=false
• 关键词: STTR; Phase; Development; Validation; SafeClose

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.

STTR 第一阶段项目旨在通过开发一种在疝气发生前预防的系统来解决疝气在美国已成为的巨大问题。据估计，美国每年进行 300,000 例疝气修复手术。在高危人群中，切口疝 (IH) 的发生率高达 70%。疝气流行率很高，与生活质量下降以及每年 32 亿美元的疝气修复医疗支出有关。可以使用预防性网片来预防 IH，其中涉及放置张紧的网片以在疝发生之前加强腹部筋膜闭合。预防性网片已被证明可以将 IH 的风险从 35.9% 降低到 1.5%。然而，尽管预防性网片产生了出色的效果，但由于手术带来的技术挑战和增加的手术时间，它尚未得到广泛采用。该项目旨在创建一个系统，使预防性网格手术更简单、更可靠、更快速。该项目通过解决外科医生层面采用预防性网片的关键障碍，为疝气流行提供了有效的解决方案，因此将促进该手术的更广泛使用。更广泛地使用疝气预防将改善结果、生活质量，并降低与 IH 相关的成本。该项目建议开发一种手持式系统，通过集成多个离散的操作任务，简化并减少执行预防性补片的时间，包括将网定位、拉紧并将其固定到腹部筋膜上。该系统利用腹壁和补片的生物力学原理，为预防性补片放置提供了优化策略，提供快速、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气风险。该系统由三个主要部件组成：涂抹器、紧固件-锚栓和网格本身。紧固件-锚固件代表了该技术的核心功能，同时具有两个目的：（1.）通过施放器系统进行相互作用/接合以及随后的网格张力设置； (2.) 穿透筋膜并将网固定到筋膜上。施用器是一种简单的、符合人体工程学的工具，与紧固件锚连接，允许外科医生控制网的空间位置、张力和放置。该项目旨在实现两个主要目标：(1.) 完善装置设计，包括实现施用器和紧固件锚定件之间啮合的最佳安全性和可靠性，以及 (2.) 评估拟议装置的生物力学强度和速度技术与当前护理标准相比。通过迭代设备原型设计、测试和改进，将开发出功能齐全的设备。