Zwitterionic-coated surgical mesh to minimize intra-abdominal adhesions

Unmet Need

Four million abdominal surgeries are performed annually in the United States. Abdominal adhesions, or fibrous bands that bind tissue together, represent a significant postoperative complication occurring in >50% of patients undergoing abdominal surgery. In a subset of cases (~5% or 200,000 patients), adhesions can lead to a range of serious health issues, including small bowel obstruction, infections, chronic pain, and inflammation, some of which require additional surgery. Moreover, the financial burden associated with managing and treating these complications is substantial, with estimates suggesting hospital and surgeon expenditures exceeds $1 billion annually in the United States. The current standard of care utilizes meshes coated with a hydrophilic biodegradable film designed to support damaged tissue, with the coating acting to inhibit protein binding and thus reduce tissue adhesions. However, these meshes often fall short in durability leading to micro-fractures and delamination, and they degrade rapidly. There is a need for improved meshes with robust mechanical properties coated in enhanced materials to prevent or reduce the formation of adhesions.

Technology

Duke inventors have developed an improved biodegradable mesh for use in abdominal surgeries known to cause adhesions. This invention features an elastomer mesh base offering superior durability, with a functionalized coating shown to reduce adhesion formation. This is intended for surgeons to implant in patients undergoing abdominal surgery. Specifically, the inventors developed a novel propargyl derivatized thiol-yne elastomer and functionalized it with zwitterions to suppress protein adsorption and therefore adhesion formation. This has been demonstrated in both murine and rabbit models. In rabbit hernia models, implantation demonstrated a reduction in both extent and severity of adhesions by 94% and 90%, respectively.

Other Applications

This technology could be used in other surgical indications requiring mesh, such as pelvic organ prolapse repair, reconstructive surgery, and wound management. Additionally, this technology could be used for implantable bioelectronic devices. This has been demonstrated in a craniotomy model in rats.

Advantages

• Zwitterion coated mesh reduced the extent and severity of adhesions by 94% and 90% in rabbit hernia models, respectively
• Protein adsorption is substantially reduced (73% reduction in binding fibrinogen)
• Mechanical tests demonstrate the coating remains intact, outperforming existing coated meshes that fracture.