Intragastric space fillers and methods of manufacturing including in vitro testing
First Claim
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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.
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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.
155 Citations
16 Claims
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1. A process for manufacturing intragastric space fillers, the process comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of manufacturing an intragastric space filler, the method comprising:
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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. - View Dependent Claims (12, 13, 14, 15, 16)
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Specification