Development of a polymeric biomedical device platform with controlled disassembly and in vivo testing in a swine intestinal model

Abstract

The aim of this study was to create a surgical guide platform that maintains its integrity while the surgeon performs an intestinal anastomosis or another similar procedure, which then breaks apart and is eliminated from the body in a controlled manner. The device contains mixed polymeric structures that give it a controlled rate of disassembly that could meet the requirements of a specific surgical purpose. The intraluminal anastomotic guide was manufactured as a hollow cylinder composed of layers of porous polyurethane/PCL with polyvinylpyrrolidone as the binding agent similar to a “brick–mortar” architecture. This combination of polymeric structures is a promising manufacturing method from which a variety of tunable devices can be fabricated for specific medical procedures and site-specific indications. The guide was designed to rapidly disassemble within the intestinal lumen after use, reliably degrading while maintaining sufficient mechanical rigidity and stability to support manipulation during complex surgical procedures. The nature of the device’s disassembly makes it suitable for use in hollow structures that discharge their contents, resulting in their elimination from the body. A swine model of intestinal anastomosis was utilized to validate the use and function of the device.