INTRAGASTRIC SPACE FILLERS AND METHODS OF MANUFACTURING INCLUDING IN VITRO TESTING

• US 20100251837A1
• Filed: 04/02/2010
• Published: 10/07/2010
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Bouasaysy, Outhit, Ashby, Mark
• Granted Patent: US 8,683,881 B2
• Time in Patent Office: Days
• US Class Current: 73/865.600
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: B29C 53/36 Bending and joining, e.g. for making hollow articles B29C53/56 takes precedence
• CPC Class Codes: B29D 22/00 Producing hollow articles tubular articles B29D23/00; pneumatic tyres B29D30/00
• CPC Class Codes: B29L 2022/005 having dividing walls, e.g. additional elements placed between object parts
• CPC Class Codes: Y10T 156/1005 by inward collapsing of portion of hollow body
• CPC Class Codes: Y10T 156/1038 Hollow cylinder article

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.

Claims

1. An in vitro testing process for accelerated simulation of conditions in a stomach, in combination:

providing an intragastric device to an acetone bath;

inducing swelling of the intragastric device;

exacerbating weak spots in the intragastric device.

2. The process of claim 1, further comprising:

observing the results.

3. The process of claim 1, further comprising:

estimating the results of an in vivo study.

4. The process of claim 1, wherein the swelling is induced in proportion to the permeability of the intragastric device.

5. The process of claim 1, wherein the acetone bath contains at least about 95% acetone by volume.

6. The process of claim 1, wherein the acetone bath is provided at room temperature.

7. The process of claim 1, wherein the intragastric device and the acetone bath are maintained in a sealed environment.

8. The process of claim 1, wherein a time to failure of the intragastric device in the in vitro testing process is linearly related to a projected time to failure in an in vivo study.

9. An in vitro testing process for accelerated simulation of conditions in a stomach, comprising, in combination:

providing an intragastric device to a hydrochloric bath of pH between about 1.0 and about 1.5, heated to between about 50°

C. and about 60°

C.;

exacerbating weak spots in the intragastric device.

10. The process of claim 9, further comprising:

observing the results;

11. The process of claim 9, further comprising:

estimating the results of an in vivo study.

12. A process for manufacturing a balloon of an intragastric device, comprising, in combination:

subjecting materials for the balloon to a heated environment, whereby between about 85% and about 95% of a target property for the balloon is achieved by partial cross-linking;

removing the balloon from the heated environment, whereby additional cross-linking is achieved and driven by residual heat retained from the heated environment; and

subjecting the balloon to radiation-based sterilization, whereby about 100% of the target property is achieved.

13. The process of claim 12, wherein the target property is resistance to failure when subjected to a mechanical stress.

14. The process of claim 12, wherein the target property is resistance to failure when subjected to a mechanical stress.

15. The process of claim 14, wherein the mechanical stress is torque.

16. The process of claim 14, wherein the mechanical stress is elongation.

17. The process of claim 12, wherein the target property is tensile strength.

18. The process of claim 12, wherein the target property is resistance to ingress and egress across walls of the balloon.

19. The process of claim 12, wherein the materials for the balloon are silicone-based.

20. The process of claim 12, wherein the radiation-based sterilization is gamma sterilization.

21. A product by the process of claim 12.