Intragastric space fillers and methods of manufacturing including in vitro testing

摘要

An in vitro testing process for simulating conditions of a stomach, comprising, in combination: providing an intragastric device to an acetone bath; inducing swelling of the intragastric device; exacerbating weak spots in the intragastric device; observing the results; and estimating the results of an in vivo study. Improvements to an intragastric space filler to reduce failure at a balloon to shaft area including an adhesive fillet, washers, a balloon cuff and collar, a molded in balloon fillet, and a one-piece molded balloon assembly.

主权项

1. A process for manufacturing intragastric space fillers, the process comprising:
providing an intragastric device having a balloon and a shaft extending through at least one wall of the balloon, wherein the shaft is affixed to the balloon, and wherein the balloon and the shaft form a balloon-to-shaft transition where an exposed surface portion of the balloon meets with an exposed surface portion of the shaft; and providing a surface fillet at or adjacent to the balloon-to-shaft transition, wherein the surface fillet is configured to reduce stress concentrations near the balloon-to-shaft transition to increase failure resistance proximate to the balloon-to-shaft transition.