Peri‐ and postoperative anastomotic leakage from blood vessel anastomosis is a common and potentially life‐threatening complication. As an adjunctive therapy providing an additional layer of safety, a new biodegradable, polyurethane‐based adhesive was developed. It consists of two components: an isocyanate‐functionalized prepolymer and an amino‐based curing agent. The adhesive was investigated in a porcine animal model to seal sutured blood vessel anastomoses of arteries, veins, aortas and prosthetic aortic graft replacements. The material‐determined properties of the adhesive like viscosity, processing and polymerization time as well as bonding strength were well suited for this application. The adhesive stopped perioperative suture‐line bleedings and stayed on all anastomoses until sacrifice. Hematological and serological inflammation marker assessments were unobtrusive. The histological evaluation showed a mild to moderate local tissue reaction to the adhesive constituting a physiological, non‐adverse tissue‐biomaterial interaction. The adhesive did not interfere with vascular wound healing. The adhesive demonstrated to be suitable to improve the outcome of cardiovascular surgeries by securing the classical sutured anastomoses in a fast, easy and safe manner. However, further studies are required to quantitatively evaluate efficacy in terms of anastomotic leakage prevention as well as long‐term tissue compatibility and degradation.
Tissue adhesives constitute a great possibility to improve conventional wound closure. In contrast to sutures, they enable nearly immediate hemostasis and can prevent fluid or air leaks. In the present study, a poly(ester)urethane-based adhesive was investigated which already proved to be suitable for different indications, such as reinforcing vascular anastomosis and sealing liver tissue. Using in vitro and in vivo setups, the degradation of the adhesives was monitored over a period of up to 2 years, to evaluate long-term biocompatibility and determine degradation kinetics. For the first time, the complete degradation of the adhesive was documented. In subcutaneous locations, tissue residues were found after 12 months and in intramuscular locations, tissue degradation was complete after about 6 months. A detailed histological evaluation of the local tissue reaction revealed good biocompatibility throughout the different degradation stages. After full degradation, complete remodeling to physiological tissue was observed at the implant locations. In addition, this study critically discusses common issues related to the assessment of biomaterial degradation kinetics in the context of medical device certification. This work highlighted the importance and encouraged the implementation of biologically relevant in vitro degradation models to replace animal studies or at least reduce the number of animals in preclinical testing prior to clinical studies. Moreover, the suitability of frequently used implantation studies based on ISO 10993-6 at standard locations was critically discussed, especially in light of the associated lack of reliable predictions for degradation kinetics at the clinically relevant site of implantation.
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