Paradigm Surgical Phase II-Development and Validation of SafeClose Roller Mesh Augmentation System for Hernia Treatment and Prevention

范式外科第二阶段-SafeCloseTM用于预防疝气的滚筒网片增强系统的开发和验证 据估计，美国每年有15.3万例切开疝修补术 超过70亿美元花在疝气治疗上。网格镶嵌，包括将网格固定到闭合的 腹壁加强切口，是一种尝试解决腹股沟和腹股沟的方法 复发(疝气治疗)和作为预防手段(疝气预防)。该程序是一种安全可靠的 高效的技术，将IH的风险降低高达34%。传统上，网格镶嵌是由手工完成的- 在腹壁上缝合网状物，这需要额外的手术时间，技术上也很困难-两者 其中一些是进入市场的关键障碍。目前的网目固定技术效率较低，主要原因是：(1) 不能张紧网眼，(2)需要外切网目；(3)网格不均匀，这 损害了生物力学的强度和有效性。尽管有既定的福利和可接受的 尽管存在风险，但还没有广泛采用贴合程序。外科医生级别的障碍是一个关键障碍 由于增加了网状镶嵌的时间和难度，因此无法采用。这些障碍突显了未得到满足的临床需求 作为一种有效的技术，可以缩短时间并绕过网状镶嵌的技术挑战。 SafeCloseTM Roller系统通过提供快速的网状应用系统来满足这些需求 并在腹前筋膜上均匀地应用张紧的网片，以治疗和治疗疝气。 预防。它由一个手持式涂布器组成，它容纳了一条张紧的网眼，并利用 自行开发的弹簧式大头钉固定机构，用于固定网眼。该设备缓解了 通过避免耗时的手工缝合网眼和通过 标准化经常变化的网状物的张拉和固定。SafeClose是有史以来第一个提供 网目固定机构，其将网目耦合到固定系统，还允许个性化网目 大小。这使得用户可以快速地应用和切割预张紧网以加固筋膜。 在这个第二阶段的提案中，我们提出了一种系统的方法来推进SafeClose的设计 系统达到设计冻结的关键点，随后验证设备的性能 身体猪腹壁，活体猪腹壁，和人身体。建议的目标 对于这个第二阶段项目，将在产生重要的、临床相关的数据方面发挥关键作用，这些数据将有助于推动 该设备将在不久的将来获得FDA的批准并成功商业化。这个项目的成功将是 定义为相对于其他固定方法显著减少了手部移动的时间和数量 人体身体研究，同时也达到相当或提高修复的生物力学强度在两者 身体和活体猪模型与照护标准的比较。这些建议的研究 目标将帮助我们的设备更接近商业化，这最终将有助于推广更多 广泛使用的网片覆盖程序，从而有助于中断恶性循环的疝气。

Paradigm Surgical Phase II–Development and Validation of SafeCloseTM Roller Mesh Augmentation System for Hernia Prevention Each year an estimated 153,000 cases of incisional hernia (IH) repairs are performed in the United States and over $7 billion is spent on hernia treatment. Mesh onlay, which involves fixating mesh onto the closed abdominal wall to reinforce the incision, is a procedure that was developed in the attempt to both address hernia recurrence (hernia treatment) and as a means of prophylaxis (hernia prevention). This procedure is a safe and highly effective technique that reduces the risk of IH by up to 34%. Mesh onlay is traditionally performed by hand- sewing mesh onto the abdominal wall, which requires additional operative time and is technically difficult – both of which are key barriers to market entry. Current mesh fixation technologies are inefficient due to their: (1.) inability to tension mesh, (2.) requiring external cutting of mesh, and (3.) lack of mesh uniformity, which compromises biomechanical strength and effectiveness. Despite the established benefits and the acceptable risk, there is a lack of widespread adoption of the onlay procedure. Surgeon-level barriers are a key impediment to adoption due to the added time and difficulty of mesh onlay. These barriers highlight an unmet clinical need for an effective technology that decreases time and circumvents the technical challenges of mesh onlay. The SafeCloseTM Roller system addresses these needs by providing a mesh application system that rapidly and uniformly applies tensioned mesh onto anterior abdominal fascia for BOTH hernia treatment and hernia prevention. It is comprised of a handheld applicator that houses a strip of tensioned mesh and utilizes a proprietarily developed spring-loaded tack fixation mechanism to fixate the mesh. The device mitigates the technical challenge of traditional mesh onlay by obviating time-consuming hand-sewing of the mesh and by standardizing the often variable mesh tensioning and affixation. The SafeClose is the first-ever device to provide a mesh fixation mechanism that couples the mesh to the affixation system, also allowing for individualized mesh sizing. This allows the user to rapidly apply and cut the pre-tensioned mesh to reinforce the fascia. In this Phase II proposal, we propose a systematic approach to advance the design of the SafeClose system to reach the pivotal point of design freeze and subsequently validate the device’s performance in cadaveric porcine abdominal wall, in-vivo porcine abdominal wall, and in human cadavers. The proposed aims for this Phase II project will play a critical role in producing important, clinically relevant data that will help propel the device to FDA clearance and successful commercialization in the near future. Success of this project will be defined by significantly reduced time and number of hand movements relative to other fixation methods in the human cadaver study, while also achieving equivalent or improved biomechanical strength of the repair in both the cadaveric and in-vivo porcine models as compared to the standard-of-care. These proposed research objectives will help bring our device closer to commercialization, which would ultimately help promote more widespread use of the mesh onlay procedure and thereby aid in interrupting the vicious hernia cycle.