Intragastric space fillers and method of in vitro testing

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.

1 . A process for manufacturing an intragastric device, comprising, in combination:
 providing a balloon having a body, a cuff extending from the body, and a collar at an end of the cuff;   providing a shaft through the cuff and the collar of the balloon;   folding the cuff on itself within the body of the balloon, whereby the cuff is brought to the body of the balloon and whereby the cuff forms overlapping surfaces and a folded inner surface;   adhering the overlapping surfaces of the cuff to each other at a balloon-to-balloon interface; and   adhering the folded inner surface to the shaft at a balloon-to-shaft interface.   
     
     
         2 . The process of  claim 1 , wherein the overlapping surfaces of the cuff are adhered to each other with a silicone-based adhesive. 
     
     
         3 . The process of  claim 2 , wherein the adhesive has a hardness about the same as the hardness of the balloon. 
     
     
         4 . The process of  claim 1 , wherein the folded inner surface is adhered to the shaft with a silicone-based adhesive. 
     
     
         5 . The process of  claim 4 , wherein the adhesive has a hardness less than the hardness of the shaft. 
     
     
         6 . A product by the process of  claim 1 . 
     
     
         7 - 15 . (canceled) 
     
     
         16 . A kit, comprising, in combination:
 a shaft;   a balloon having a body and two cuffs, each with a collar at an end thereof, the cuffs configured to receive the shaft through the two cuffs and the body of the balloon while in an assembled state, wherein the shaft and balloon form at least one balloon-to-shaft transition where an exposed surface portion of the balloon meets with an exposed surface portion of the shaft while in the assembled state; and   a surface fillet configured to be placed across the balloon-to-shaft transition while in the assembled state, wherein the surface fillet reduces stress concentrations near the balloon-to-shaft transition to facilitate a smoother transition from balloon to shaft.   
     
     
         17 . The kit of  claim 16 , wherein the balloon, the shaft, and the surface fillet are in the assembled state. 
     
     
         18 . An intragastric device, comprising, in combination:
 a shaft having shore durometer hardness of at most about 55 A;   a balloon having shore durometer hardness of at least about 20 A and comprising a body, a cuff extending from the body, and a collar at an end of the cuff; and   a surface fillet across the exposed surface portion of the balloon and the exposed surface portion of the shaft at a balloon-to-shaft transition, the surface fillet having a hardness between the hardness of the shaft and the hardness of the balloon.   
     
     
         19 . The intragastric device of  claim 18 , wherein the surface fillet is a sheet bonded by an adhesive. 
     
     
         20 . The intragastric device of  claim 18 , wherein the sheet forms a washer concentric with the shaft. 
     
     
         21 . The intragastric device of  claim 18 , wherein the surface fillet is an adhesive. 
     
     
         22 . An intragastric device, comprising, in combination:
 a shaft; and   a balloon comprising a body, a cuff extending from the body, and a collar at an end of the cuff;   wherein an interior portion of the body has an inner fillet having a thickness greater than a thickness of an equator of the balloon and configured to transition an interior wall of the balloon to at least one of the shaft and the cuff when folded within the body of the balloon.