Development of a single-use, ready-to-use, sterile, dual chamber, dual syringe sprayable hydrogel to prevent postsurgical cardiac adhesions.

Karios Technologies, Llc, Charlottesville VA

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT There are over 900,000 cardiac surgeries per year in the US, of which, over 20% are reoperations. While surgeries have become safer, over 70% of these reoperation patients will have severe adhesions present that fuse the heart to other tissues in the chest cavity. Cardiac adhesions impair cardiac function and inhibit surgical access in reoperation procedures, leading to increased mortality, morbidity, surgery complexity, operating times, and hospital costs. While a variety of different materials have been investigated in animals and humans, no materials, to date, have been capable of preventing adhesion formation post-cardiac surgery. The main approaches for attempting to reduce cardiac adhesions include drugs, physical barriers, and polymer solutions. Drugs disrupt beneficial biochemical pathways vital for wound healing and do not achieve adequate drug concentration at the site of action. Barriers have shown limited clinical efficacy due to degradation issues and requiring sutures. Polymer solutions require excessively large volumes, possess high swelling (leading to cardiac tamponade), short lifespans, and/or dislodge from the heart. Considering these limitations, TissueShield was engineered and developed in collaboration with cardiac surgeons. We propose to develop and clinically translate TissueShield, a novel single-use, ready-to-use, sterile, dual chamber, dual syringe sprayable hydrogel to prevent postsurgical cardiac adhesions. TissueShield is composed of a rapidly forming poly(ethylene glycol) (PEG) hydrogel that is cross-linked by oxime bonds and includes a tissue binding moiety to ensure the product remains adhered to the heart. Our approach is a 3-component polymer system that can be easily sprayed directly onto the heart forming a robust anti-adhesion layer within seconds. This system has already been optimized to control the degree of swelling and degradation time to prevent adhesions and to not interfere with cardiac function in rat cardiac adhesions models and an initial small pilot study in a porcine model. No product has been shown to have our features (tissue binder, low swelling, and lifespan). Herein, the objective is to prepare TissueShield for clinical trials by establishing preclinical safety, transitioning to and testing a commercially viable two chamber system, completing product development, and scaling up and transferring manufacturing. TissueShield will be the first commercially available sprayable anti-adhesions product designed specifically for preventing cardiac adhesions.