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

双粘性网片固定系统：创建用于疝气治疗和预防的网片固定系统

• 批准号: 9621898
• 负责人: John Patrick Fischer
• 金额: $ 22.49万
• 依托单位: PARADIGM SURGICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2019-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9621898
• 关键词: Abdomen; Address; Adopted; Adoption; Anterior; Biomechanics; Cadaver; Computer software; Custom; Data; Dental Inlays; Device Designs; Devices; Effectiveness; Ensure; Epidemic; Failure; Family suidae; Fascia; Fire - disasters; Gold; Grant; Hand; Hernia; Human; Incidence; Industry Collaboration; Interruption; Legal patent; Letters; Mediating; Methods; Modality; Modeling; Morbidity - disease rate; Movement; Operative Surgical Procedures; Outcome; Patients; Phase; Play; Prevention; Procedures; Process; Public Health; Recurrence; Research; Risk; Role; Secure; Side; Speed; Surgeon; Surgical incisions; Surgical sutures; System; Techniques; Technology; Tensile Strength; Testing; Time; United States; Width; abdominal wall; arm; combat; comparative efficacy; cost; design; experience; experimental study; high risk; improved; in vivo; innovation; interest; iterative design; novel; novel strategies; optimal treatments; prevent; prototype; repaired; sample fixation; success; usability

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.

联系PD/PI：Fischer，John Dual Tack补片固定系统-创建用于疝治疗和预防的补片固定系统 切口疝（IH）是美国（US）的一个重大公共卫生问题，估计有153，000例 每年有超过70亿美元用于疝气治疗。手术修补IH的复发率为12 - 54%，并且那些经历复发的人容易受到发病率恶性循环的影响，因为每个随后的 修复带来了更大的技术挑战、成本和增加的复发风险。为了解决这个问题， 随着流行病的日益严重，建立疝的最佳治疗方式至关重要， 预防的机会。已证明补片贴附手术可有效地做到这两点，因为它减少了 疝治疗的复发，并防止高风险开放筋膜闭合时发生疝， 存在疝气。综合效果是复发性疝和切口疝更少。 尽管有这些既定的好处和可接受的风险，但尚未广泛采用 补片贴附手术。外科医生级别的障碍是采用的一个关键障碍，因为网格增加了时间 高嵌体及其技术复杂性。尽管已经开发了各种技术来尝试 减少了手术时间和手术的技术难度，这些技术中的许多技术 设计用于腹腔镜手术，因此在开放手术中使用时具有固有的设计局限性。张开 手术仍然在很大程度上被认为是疝治疗的“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。 Dual Tacker SystemTM为现有钉合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，用于疝的治疗和预防。Dual Tacker是 第一个装置允许同时张紧和固定网。它也是第一个利用 双击发机制，通过1次扣动扳机击发2个钉穿过补片和筋膜。此外， 较大的定制设计的大头钉相对于当前使用的大头钉提高了多功能性和可靠性， 较大倒钩的固定力更高。这些创新，沿着改变臂间距离的能力 并允许在多个点和以各种网孔尺寸固定，允许使用者快速、均匀地 有效地拉紧和固定补片，以加强腹前筋膜，所有操作均通过一个手持式系统完成。 我们提出了一种系统性的方法来改进和验证双钉系统的概念。成功 第一阶段的建议将通过创建一个系统原型来定义，该原型可以包含我们的专有技术， 钉，能够快速双侧补片固定和预张紧，并能够快速臂间宽度 操作以适应各种网格尺寸。原型评估阶段的成功将是 通过相对于其他固定方法减少的时间和手部运动次数来定义， 改善修复的生物力学强度。建议的研究目标将促进更广泛的 使用补片覆盖手术，从而有助于中断疝的恶性循环。