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

Paradigm Surgical, Llc, Philadelphia PA

Investigators

Abstract

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.