Intragastric space fillers and methods of manufacturing including in vitro testing
View Patent ↗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 a balloon of an intragastric device, the process comprising:
subjecting materials for the balloon to a heated environment, wherein a fraction of a target property for the balloon is achieved by partial cross-linking due to the heated environment, and wherein the materials for the balloon are elastomeric materials;
removing the balloon from the heated environment, wherein additional cross-linking is achieved and driven by residual heat retained from the heated environment; and
subjecting the balloon to radiation-based sterilization, wherein about 100% of the target property is achieved.
2. The process of claim 1 , wherein the target property is resistance to failure when subjected to a chemical stress.
3. The process of claim 1 , wherein the target property is resistance to failure when subjected to a mechanical stress.
4. The process of claim 3 , wherein the mechanical stress is torque.
5. The process of claim 3 , wherein the mechanical stress is elongation.
6. The process of claim 1 , wherein the target property is tensile strength.
7. The process of claim 1 , wherein the target property is resistance to ingress and egress across walls of the balloon.
8. The process of claim 1 , wherein the materials for the balloon are silicone-based.
9. The process of claim 1 , wherein the radiation-based sterilization is gamma sterilization.
10. The process of claim 1 wherein the fraction is between about 85% and about 95% of the target property.