Paradigm Surgical LLC — Department of Health and Human Services STTR Phase I: 300

Description

Incisional hernia IH can be prevented using prophylactic mesh placement PMP which involved placement of mesh to reinforce an abdominal fascia closure before herniation occurs at the index of surgery PMP reduced the absolute risk of IH with an acceptable complication profile Open abdominal surgery techniques remain commonplace and contribute to the estimated cases of IH performed in the United States US and the associated $ billion spent on hernia treatment To reduce these hernias more widespread adoption of PMP is needed yet barriers exist to adopting PMP in practice Surgeon level barriers are a key impediment due to the added time for PMP minutes A rapid mesh application system can reduce this time and increase utilization of PMP Further the reliability and technical challenges inherent to PMP pose significant challenges These barriers highlight an unmet clinical need for an effective well engineered intra operative technology to decrease the time and circumvent the technical challenges of applying mesh to the abdominal wall fascia for hernia prevention The SafeClose Mesh Augmentation System is a medical grade hand held mesh affixing system The system increases the speed of mesh affixation and circumvents technical intra operative challenges by integrating several key steps of the PMP process including positioning tensioning and affixation into one system The system includes sterilized mesh with pre integrated fastener anchors along with a customized applicator that houses the mesh fastener system inside By pulling the applicator along the length of the incision the mesh rolls out of the applicator and is simultaneously affixed by the fasteners In one continuous motion the entire incision can be reinforced When the surgeon reaches the bottom of the incision he she can cut the mesh off using the built in cutting mechanism This newly updated design satisfies important end user needs by providing an ergonomic yet robust application mechanism while at the same time allowing the device to accommodate for different incision lengths and sizes giving the user full ability to control the length of mesh that is used We propose a feasible systematic and step wise approach to refinement and proof of concept for the SafeClose System Success of this Phase I proposal will be defined by creation of a refined applicator whose core functionality includes a built in cutting mechanism to reliably and safely cut the mesh after the surgeon has completed the procedure AND demonstration that the SafeClose significantly reduces the time relative to a hand sewn technique Aim Experiment while achieving equivalent or improved biomechanical strength of the repair Aim Experiment The proposed research objectives will advance hernia care and begin a shift towards more preventative risk reductive interventions in abdominal surgery Development and Validation of the SafeClose Mesh Augmentation System for Prevention of Incisional Hernia Incisional hernia IH can be prevented using prophylactic mesh placement PMP however barriers to adoption of PMP in practice exist The SafeClose Mesh Augmentation system solves the technical challenges and added time associated with PMP by integrating several key steps of the PMP process including positioning tensioning and affixation into one system