Dual Tack Mesh Fixation System: Creation of a Mesh Fixation System for Hernia Treatment and Prevention

联系PD/PI：Fischer，John 双针网片固定系统--一种治疗和预防腹股沟疝气的网片固定系统 在美国，切口疝气(IH)是一个重要的公共卫生问题，估计有153,000人 每年的病例和超过70亿美元的疝气治疗花费。外科IH修补术的复发率为12- 54%，那些经历了复发的人容易患上恶性循环的发病率，因为 修复带来了更大的技术挑战、成本和复发风险。为了打击这一现象 在日益流行的情况下，关键是要建立腹股沟疝气的最佳治疗方式，并确定 预防的机会。网状镶嵌程序已被证明有效地做到了这两点，因为它减少了 高危开放筋膜闭合术后复发及预防腹股沟疝发生 出现了疝气。其综合效果是减少了复发的腹股沟和较少的切口性腹股沟。 尽管有这些既定的好处和可接受的风险，但还没有广泛采用 网状镶嵌程序。外科医生层面的障碍是采用网眼的关键障碍，因为网眼需要更多的时间 Onlay及其技术复杂性。尽管已经开发了各种技术来尝试 减少手术时间和手术的技术难度，其中许多技术是 专为腹腔镜使用而设计，因此在开放手术中使用具有固有的设计限制。在打开时 手术在很大程度上仍然被认为是腹股沟疝气治疗的“黄金标准”，因此迫切需要一种 直接解决这些限制的创新和使能技术。 Double Tacker System TM为现有拦截器设备的局限性提供了直接的解决方案，因为它代表了 一种独特的创新方法，用于治疗和预防腹股沟疝气。双重攻击手是 第一个允许同时拉紧和固结网状物的装置。它也是第一个利用 双发射机构，通过网眼和筋膜发射两个大头针，一次扣动扳机。此外，一个 更大的定制设计大头钉通过提供以下功能提高了相对于当前使用的大头钉的通用性和可靠性 倒钩越大，固定力越大。这些创新，以及改变手臂间距离的能力 并且允许在多个点和各种网目尺寸上固定，允许用户快速、均匀和 通过一个手持系统，有效地拉紧和固定网状物以加强腹前筋膜。 我们提出了一个系统的方法，以求精和概念验证的双重Tacker系统。成功 将通过创建系统原型来定义此第一阶段提案，该原型可以结合我们的专有技术 大头针，能够快速双面网眼固定和预紧，并能够快速臂间宽度 操纵以适应各种网格大小。原型评估阶段的成功将是 定义为相对于其他固定方法减少的手部移动时间和次数，同时实现 提高了修复的生物力学强度。拟议的研究目标将促进更广泛的 使用补片填充术，从而有助于中断这一恶性循环的疝气。

Contact PD/PI: Fischer, John Dual Tack Mesh Fixation System – Creation of a Mesh Fixation System for Hernia Treatment and Prevention Incisional hernia (IH) is a significant public health issue in the United States (US) with an estimated 153,000 cases per year and over $7 billion spent on hernia treatment. Recurrence rates for surgical IH repairs are 12 - 54%, and those who experience recurrence are susceptible to a vicious cycle of morbidity as each subsequent repair presents greater technical challenges, costs, and increased risk for recurrence. In order to combat this growing epidemic, it is critical to establish optimal treatment modalities for hernia AND to also identify opportunities for prevention. The mesh onlay procedure has been shown to effectively do both, as it reduces recurrence for hernia treatment and prevents hernia occurrence for high-risk open fascial closures when no hernia is present. The combined effect is fewer recurrent hernias and fewer incisional hernias. Despite these established benefits and the acceptable risk, there is a lack of widespread adoption of the mesh onlay procedure. Surgeon-level barriers are a key impediment to adoption due to the added time for mesh onlay and its technical complexity. Although various technologies have been developed in the attempt of decreasing the operative time and the technical difficulty of the procedure, many of these technologies are designed for laparoscopic use and, therefore have inherent design limitations for use in open surgery. With open surgery still largely being considered the `gold standard' in hernia treatment, there is a critical need for an innovative and enabling technology that directly addresses these limitations. The Dual Tacker SystemTM offers a direct solution to the limitations of existing tacker devices, as it represents a uniquely innovative approach to mesh onlay for both hernia treatment and prevention. The Dual Tacker is the first device to allow for simultaneous tensioning and tacking of the mesh. It is also the first device to utilize a dual-firing mechanism that fires 2 tacks through the mesh and fascia with 1 pull of the trigger. Additionally, a larger, custom-designed tack improves the versatility and reliability relative to currently used tacks by providing higher fixation force with larger barbs. These innovations, along with the ability to change the inter-arm distance and permit fixation at multiple points and in various mesh sizes, allows the user to rapidly, uniformly, and effectively tension and affix the mesh to reinforce the anterior abdominal fascia, all with one hand-held system. We propose a systematic approach to refinement and proof-of-concept for the Dual Tacker System. Success of this Phase I proposal will be defined by creating a prototype of the system that can incorporate our proprietary tack, is capable of rapid dual-sided mesh fixation and pretension, and is capable of rapid inter-arm width manipulation for adaptation across various mesh sizes. Success of the prototype assessment phase will be defined by reduced time and number of hand movements relative to other fixation methods, while achieving improved biomechanical strength of the repair. The proposed research objectives will promote more widespread use of the mesh onlay procedure and thereby aid in interrupting this vicious cycle of hernia.