Intragastric space fillers and methods of manufacturing including in vitro testing
AssigneeReShape Medical, Inc.
InventorsMark Ashby, Outhit Bouasaysy
Life of this patent
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Abstract
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.
Claims16
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.
A method of manufacturing an intragastric space filler, the method comprising:
- connecting a shaft to a balloon, wherein the balloon and the shaft meet at a balloon-to-shaft transition, and wherein the shaft extends through at least a portion of the balloon;
- and
- forming a surface fillet proximate the balloon-to-shaft transition, wherein the surface fillet is configured to reduce stress concentrations proximate to the balloon-to-shaft transition.
Dependencies are inferred from the claim text.