Sprayable biomaterial designed to prevent bleeding complications after vascular surgeries

Bleeding complications after surgery occur in up to 45 percent of vascular surgeries, greatly compromising a patient’s treatment. While a range of surgical sealants are currently on the market, clinicians lack a material that is highly compatible with human tissues, adhesive and flexible enough to accommodate a range of vascular conditions, and easy to administer. New research by investigators from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, presents a biocompatible material that can be sprayed onto both blood vessels and grafts, reducing the likelihood of bleeding complications even in complex, high-risk scenarios. Their findings are published in Advanced Materials.

“The material we designed leverages multiple adhesion mechanisms to enable adequate adhesion to tissue surfaces and inert grafts, and to prevent leakage from the tissue/graft interface following vascular surgeries,” said corresponding author Natalie Artzi, PhD, of the Brigham’s Department of Medicine. “The chemistry of this material allows it to interact with tissues in a graded manner based on the underlying tissue conditions and chemical characteristics, paving the way to the design of personalized materials — one of the next steps in personalized medicine.”

A better biomaterial has the potential to be used in challenging clinical scenarios, such as when a patient receives a synthetic graft as part of carotid vascular reconstruction. Graft patients typically receive anticoagulant and antiplatelet therapies following surgery, which can put them at higher risk of bleeding complications. A surgical sealant that is flexible and can coat blood vessels — which become constricted when they are cut during a procedure — could help prevent bleeding while supporting vessel expansion and restoration of blood flow.

Artzi and colleagues developed a material to help with applications like these. The material’s adhesive qualities are a result of its ability to latch onto a variety of different “anchors,” or chemical functional groups, that a tissue may present, forming both reversible ionic and covalent bonds, depending on the circumstance. The material’s mechanical properties further its versatility: the material’s low viscosity means it can be sprayed and gel quickly, interlocking with the pores of synthetic grafts. When bound to both a vessel and a synthetic graft, it withstood pressures of 300mmHG that are well beyond a normal blood pressure of 80-120mmHg.

The researchers compared the safety and efficacy of their material to Tisseel (one of the most biocompatible materials) and BioGlue (one of the most adhesive), finding that it performed as well or better than the existing products. They verified the biocompatibility of the material and tested its efficiency as a sealant through an array of different tests in cell cultures, guinea pigs, rabbits and pigs. The new biomaterial outperformed BioGlue and Tisseel in specific outcomes the researchers measured, passed safety tests in an animal model and withstood sterilization using gamma irradiation, lending promise to its prospects of clinical translation. Going forward, the researchers are looking to scale up the manufacturing of their material to pave the way toward clinical trials.

Disclosures: Artzi and Muñoz Taboada are co-founder and CEO, respectively, of BioDevek, which developed the sealant and is currently working on the scale-up, manufacturing and regulatory aspects of the sealant.

Funding: This work was funded by BioDevek. Inc.

Paper cited: Muñoz Taboada, G et al. “Sprayable hydrogel for instant sealing of vascular anastomosis” Advanced Materials DOI: 10.1002/adma.202203087