Intragastric device with expandable portions

• US 10,537,453 B2
• Filed: 10/26/2016
• Issued: 01/21/2020
• Est. Priority Date: 12/16/2015
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Brister, Mark C., Wong, Betty, Drake, Neil R., Nelson, Sheldon, Proctor, Daniel J., Sapp, Kate, McCarthy, Eleanor
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US15/335,256
• Publication Number:
  US 20170172778A1
• Time in Patent Office: 1,182 Days
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/10185 Valves

Abstract

Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.

Claims

1. An intragastric balloon configured to reside in an in vivo gastric environment for at least 30 days, comprising:

a polymeric wall configured to have, under conditions of an in vivo gastric environment, a permeability to CO₂ of more than 10 cc/m²/day, such that a rate and an amount of diffusion of CO₂ from the in vivo gastric environment into a lumen of the intragastric balloon through the polymeric wall is controlled, at least in part, by a concentration of an inert gas in an initial fill gas, wherein the polymeric wall is formed of a flexible material, wherein the flexible material includes one or more non-expandable sections and one or more expandable sections, wherein the expandable sections are configured to stretch from 10% to 400% in response to an increased volume of a fluid inside the lumen of the intragastric balloon; and

a valve system configured for introducing the initial fill gas into the lumen of the intragastric balloon in the in vivo gastric environment.

2. The intragastric balloon of claim 1, wherein the polymeric wall comprises a three layer CO₂ barrier material consisting of nylon/polyvinylidene chloride/polyethylene.

3. The intragastric balloon of claim 1, wherein the polymeric wall comprises a two layer CO₂ barrier material consisting of nylon/polyethylene material and no additional CO₂ barrier material.

4. The intragastric balloon of claim 1, wherein the initial fill gas consists essentially of SF₆ and N₂.

5. The intragastric balloon of claim 1, wherein the initial fill gas consists essentially of SF₆.

6. The intragastric balloon of claim 1, wherein each of the one or more expandable sections is a band wrapped around a circumference of the intragastric balloon.

7. The intragastric balloon of claim 6, wherein the band has one or more curved or angled sections.

8. The intragastric balloon of claim 1, wherein the one or more expandable sections comprises multiple bands of expandable material.

9. The intragastric balloon of claim 1, wherein each of the one or more nonexpandable sections comprises a non-expandable band that wraps around a circumference of the intragastric balloon.

10. The intragastric balloon of claim 1, comprising a plurality of expandable panels.

11. The intragastric balloon of claim 10, wherein the expandable panels are each the same size.

12. The intragastric balloon of claim 10, comprising a plurality of nonexpandable panels.

13. The intragastric balloon of claim 12, wherein the nonexpandable panels comprise a mesh.

14. The intragastric balloon of claim 12, wherein there are an equal number of expandable panels and nonexpandable panels.

15. The intragastric balloon of claim 1, comprising one or more expandable protrusions configured to protrude from a surface of the intragastric balloon.

16. The intragastric balloon of claim 1, wherein the polymeric wall comprises a plurality of layers, wherein one or more sections of the layers are expandable.

17. The intragastric balloon of claim 1, wherein the polymeric wall comprises 10% or less expandable material.

18. The intragastric balloon of claim 1, in a compacted state and inside of a swallowable-sized container adapted to transcend an esophagus which has a diameter of approximately 2.5 cm.

19. The intragastric balloon of claim 1, wherein the one or more non-expandable sections are patch segments.

20. A method for inflating an intragastric balloon, comprising:

introducing, in an in vivo intragastric environment, an initial fill gas comprising an inert gas into a lumen of an intragastric balloon according to claim 1; and

exposing the balloon to the in vivo intragastric environment for at least 30 days, wherein a rate and an amount of diffusion of CO₂ from the in vivo gastric environment into the lumen of the balloon through the polymeric wall is controlled, at least in part, by a concentration of an inert gas in the initial fill gas.