Sprayable Hydrogel for Instant Sealing of Vascular Anastomosis. Issue 43 (3rd October 2022)

• Record Type: Journal Article
• Authors: Muñoz Taboada, Gonzalo; Dosta, Pere; Edelman, Elazer R.; Artzi, Natalie
• Is Part Of: Advanced materials. Volume 34:Issue 43(2022)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2022-10-03
• Subjects: adhesive hydrogels -- surgical sealants -- translational research; Materials -- Periodicals; Chemical vapor deposition -- Periodicals; 620.11
• DOI: 10.1002/adma.202203087
• Languages: English
• ISSNs: 0935-9648

Abstract

Abstract: Bleeding‐related complications following vascular surgeries occur in up to half of the patients—500 000 cases annually in the United States alone. This results in additional procedures, increased mortality rate, and prolonged hospitalization, posing a burden on the healthcare system. Commercially available materials rely, in large, on forming covalent bonds between the tissue and the biomaterial to achieve adhesion. Here, it is shown that a biomaterial based on oxidized alginate and oxidized dextran together with polyamidoamine (PAMAM) dendrimer amine provides simultaneous electrostatic and covalent interactions between the biomaterial and the tissue, maximizing adhesion. This study finds that the material withstands supraphysiological pressures (≈300 mmHg) and prevents bleeding in a rabbit aortic puncture model and in a pig carotid bilateral poly(tetrafluoroethylene) graft model—achieving superior performance to commercially available materials such as Tisseel and BioGlue. Material biocompatibility is validated in comprehensive in vitro and in vivo studies in accordance with the US Food and Drug Administration (FDA) guidelines, including in vitro neutral red uptake test, subcutaneous implantation in rabbits, ames genotoxicity, and guinea pig maximization test. This material has the potential to provide with adequate seal and reduced complications following complex vascular surgeries, including hard‐to‐seal tissue–graft interfaces. Abstract : Bleeding related complications following vascular surgery represent a real challenge for patients and their clinicians. Commercially available materials force clinicians to choose between adequate performance or adequate biocompatibility. An adhesive hydrogel approach, combining oxidized dextran, oxidized alginate, and polyamidoamine (PAMAM) allows sealing at the tissue:graft interface while maintaining biocompatibility. The biocompatibility and functionality of this family of materials is been tested in small and large animal models.