Development of a Suture-less Hernia Mesh with Enhanced Anchoring Strength
Luke P. Poveromo, BS1, Agustin Cornejo, MD1, Richard R. Glisson, BS1, Mohamed M. Ibrahim, MD1, Brian Davis, MS2, Jon Rust, PhD2, Ken Gall, PhD1, Howard Levinson, MD1.
1Duke University, Durham, NC, USA, 2North Carolina State University, Raleigh, NC, USA.
PURPOSE: Ventral hernias are often repaired with surgical mesh anchored by simple interrupted sutures. Recurrence is caused by suture tearing through the tissue, which occurs when the anchor point tensile stress exceeds tissue strength. We propose a polypropylene hernia mesh with seamlessly knit mesh extensions that are sewn into the abdominal fascia to distribute tensile force over a larger surface area, enhancing fixation strength, and preventing mesh dehiscence.
METHODS: Tensile testing was performed on a standard of care (SOC) mesh and several prototype meshes with modified variables (Fig. 1). All variables were compared to a SOC mesh anchored using simple interrupted 0-Prolene sutures placed at 1-cm intervals. Time to fixation for each group was recorded (Fig. 2).
RESULTS: The maximum intra-abdominal force that can be generated by a human abdomen is 16N/cm. In all testing series, our prototype mesh exceeded the 16N/cm threshold with average UTS of 38.8±2.40N/cm across all testing parameters. The SOC UTS was below the 16N/cm threshold with an average of 12.7±1.82N/cm.
CONCLUSIONS: Our prototype mesh increases anchor point area, decreases tensile stress, and resists failure at physiologic stresses. With anchoring strength greatly above maximum tensile stress, dehiscence is unlikely to occur in vivo. Future studies will include manufacturing a knitted mesh under GMP, benchtop testing of the mesh’s mechanical properties, and implantation in an animal model to achieve FDA approval.
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