Intragastric device

• US 10,463,520 B2
• Filed: 08/29/2017
• Issued: 11/05/2019
• Est. Priority Date: 01/21/2011
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Brister, Mark C., Faucher, Paul D., Drake, Neil R., Rasdal, Andrew P., Lake, Matthew S., Markovic, Dubravka, VandenBerg, Amy D. L., Llevares, Antonio C., Nider, Josefina
• Primary Examiner(s): Dang, Anh T
• Application Number:
  US15/690,095
• Publication Number:
  US 20180008446A1
• Time in Patent Office: 798 Days
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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 volume-occupying device system, comprising:

a) a capsule configured to be swallowable by normal peristalsis and to degrade in a gastric environment;

b) a volume-occupying component compacted and contained within the capsule, the volume-occupying component comprising;

i) a composite wall defining an outer surface and an interior cavity with an inner surface,

ii) a self-sealing valve system including a septum, and

iii) a deflation component including an erodible portion, a moisture absorbing expandable portion and an inlet port in fluid communication with the interior cavity;

c) a catheter coupled to the valve system, the catheter comprising;

i) a lumen in fluid communication with the interior cavity of the volume-occupying component, wherein the lumen is configured for filling the volume-occupying component interior cavity with an inflation fluid.

2. The intragastric volume-occupying device system of claim 1, wherein the moisture absorbing expandable portion is sheathed in a water blocking material or a water degradable material.

3. The intragastric volume-occupying device system of claim 2, wherein the inlet ports of the deflation component are configured to control moisture contact by the moisture absorbing expandable portion, wherein the inlet ports are small holes or a wick material configured to draw moisture in a controlled manner.

4. The intragastric volume-occupying device system of claim 3, wherein the deflation component further comprises a section of the composite wall having the moisture absorbing expandable portion located between the outer surface and the inner surface, wherein the section of the composite wall is configured and arranged to rupture the volume-occupying component after more than 60 days.

5. The intragastric volume-occupying device system of claim 4, wherein the section of the composite wall comprises a plurality of material layers, wherein each of the material layers has a different erosion rate, wherein the layers are selected so as to control the time to rupture of the volume-occupying component.

6. The intragastric volume-occupying device system of claim 3, wherein expansion of the moisture absorbing expandable portion exerts a force on the composite wall, thereby causing the volume-occupying component to rupture after a period of more than 60 days.

7. The intragastric volume-occupying device system of claim 1, wherein the deflation component comprises a housing bonded to the composite wall inner surface, wherein the housing includes

a) a vent in fluid communication with the outer surface of the composite wall;

and

b) the moisture absorbing expandable portion;

wherein

c) expansion of the moisture absorbing expandable portion opens a channel joining the vent and the inlet port, such that the interior cavity of the volume-occupying component is in fluid communication with the outer surface of the composite wall.

8. The intragastric volume-occupying device system of claim 7, wherein the housing further includes a displaceable push out component adapted to be pushed inwardly when the moisture absorbing expandable portion expands.

9. The intragastric volume-occupying device system of claim 7, wherein the housing further includes a displaceable push out component adapted to be pushed outwardly when the moisture absorbing expandable portion expands.

10. The intragastric volume-occupying device system of claim 1, wherein the volume-occupying component further comprises a port comprising the valve system and the deflation component.

11. The intragastric volume-occupying device system of claim 10, wherein the port comprises:

a) a housing bonded to the inner surface of the composite wall, the housing including;

i) a vent in fluid communication with the outer surface of the composite wall,

ii) the inlet port, and

iii) the moisture absorbing expandable portion; and

b) the self-sealing valve system located within the housing and between the moisture absorbing expandable portion and the vent, the self-sealing valve system including;

i) a tube septum disposed within the housing, and

ii) a head disposed within the tube septum and forming a compression seal with an interior surface of the housing, wherein the head is configured and arranged to engage the catheter.

12. The intragastric volume-occupying device system of claim 11, wherein expansion of the moisture absorbing expandable portion pushes the self-sealing valve system linearly outwardly, thereby opening a channel joining the vent and the inlet port, such that the interior cavity of the volume-occupying component is in fluid communication with the outer surface of the composite wall.

13. The intragastric volume-occupying device system of claim 1, further comprising an inflation source container in fluid communication with the catheter lumen so as to fill the interior cavity of the volume-occupying component with the inflation fluid based on a pressure decay system.

14. The intragastric volume-occupying device system of claim 1, wherein the composite wall is a multi-layer film comprising an outer protective layer and barrier layer.

15. The intragastric volume-occupying device system of claim 1, wherein the self-sealing valve system is attached to the inner surface of the composite wall.

16. The intragastric volume-occupying device system of claim 1, further comprising a port comprising the self-sealing valve system and the deflation component.

17. The intragastric volume-occupying device system of claim 1, wherein the capsule is configured to degrade within 5 minutes or less in the gastric environment.

18. The intragastric volume-occupying device system of claim 1, wherein the inflation fluid is a liquid inflation fluid selected from the group consisting of a saline solution and pure water.

19. The intragastric volume-occupying device system of claim 1, wherein the inflation fluid is an inert gas.

20. The intragastric volume-occupying device system of claim 1, wherein a wall of the volume-occupying component comprises a barrier layer comprising polyvinylidene chloride or ethylene vinyl alcohol, the wall of the volume-occupying component further comprising polyurethane structural layers placed as outermost layers proximal to the gastric environment and proximal to the lumen of the catheter.