Intragastric device

• US 8,647,358 B2
• Filed: 01/21/2011
• Issued: 02/11/2014
• 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): Jackson, Gary
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US13/011,842
• Publication Number:
  US 20120191123A1
• Time in Patent Office: 1,117 Days
• Field of Search: 606191-197, 604 9601- 9904, 604/164.1, 604/907, 600/37, 137/223, 137/231, 137/234.5, 137/246, 137/246.11, 137/251.1, 251/364, 403 34- 37
• US Class Current: 606/191
• CPC Class Codes: A61F 2005/0016 comprising measuring means
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0043 using injection ports
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/10186 One-way valves
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

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. A system for inflating an intragastric balloon, the system comprising:

an inflation catheter, wherein the inflation catheter comprises a needle assembly comprising a hollow needle and a bell-shaped needle sleeve;

an intragastric balloon comprising a polymeric wall, wherein the polymeric wall comprises one or more layers, and a balloon valve system comprising a self-sealing septum in a retaining structure, wherein the septum is configured for piercing by the needle, wherein the retaining structure comprises a concentric valve system with a smaller inner cylinder housing the septum and a larger outer cylinder housing a material providing compressive forces against the bell-shaped needle sleeve of the inflation catheter for inflation and detachment, wherein the material providing compressive forces is a harder durometer material than the septum, and wherein the smaller inner cylinder comprises a lip configured for an interference fit with the bell-shaped needle sleeve to provide sealing of the valve to the inflation catheter sufficient to maintain the seal during inflation of the balloon while permitting detachment of the inflation catheter from the valve after inflation of the balloon in vivo is complete;

a balloon outer container; and

an inflation source container, wherein the inflation source container is configured to connect to the inflation catheter;

wherein the inflation catheter connected to the intragastric balloon prior to inflation is of a size and shape configured for swallowing by a patient in need thereof.

2. The system of claim 1, wherein the one or more layers include a polyethylene layer and a nylon layer.

3. The system of claim 1, wherein the one or more layers include a linear low density polyethylene layer adhesively bonded to a Nylon 12 film.

4. The system of claim 1, wherein the one or more layers include a nylon layer, an ethylene vinyl alcohol and low density polyethylene layer.

5. The system of claim 1, wherein the one or more layers include a high density polyethylene layer and an ethylene vinyl alcohol layer.

6. The system of claim 1, wherein the one or more layers include a polypropylene layer laminated to an ethylene vinyl alcohol layer.

7. The system of claim 1, wherein the one or more layers include a nylon layer laminated to a polypropylene layer.

8. The system of claim 1, wherein the one or more layers include a nylon layer and a high density polyethylene layer.

9. The system of claim 1, wherein the one or more layers include a Nylon 6 layer, an ethyl vinyl alcohol layer, and a linear low density polyethylene layer.

10. The system of claim 1, wherein the one or more layers include an ethyl vinyl alcohol layer and a nylon layer.

11. The system of claim 1, wherein the one or more layers include a first polyethylene layer, an ethyl vinyl alcohol layer, and a second polyethylene layer.

12. The system of claim 1, wherein the outer container is selected from the group consisting of a push-fit capsule, a wrap, and a band, and wherein the outer container comprises a material selected from the group consisting of gelatin, cellulose, and collagen.

13. The system of claim 1, wherein the septum is cone-shaped.

14. The system of claim 1, wherein the inflation source container is configured to connect to the inflation catheter via a connector or an inflation valve.

15. The system of claim 1, wherein the inflation catheter is from 1 French to 6 French in diameter, and is from about 50 cm to about 60 cm in length.

16. The system of claim 1, wherein the inflation catheter is a dual lumen catheter comprising an inflation lumen and a detachment lumen, wherein the inflation lumen is in fluid connection to the inflation source container, and wherein the detachment lumen is configured for connection to a detachment liquid source container, wherein the detachment liquid comprises a physiological compatible liquid, and wherein the interference fit is insufficient to maintain a seal upon application of a hydraulic pressure by the detachment liquid, such that upon application of the hydraulic pressure to the needle assembly it is ejected from the balloon valve.

17. The system of claim 1, wherein the inflation catheter comprises a single lumen and a structural member providing increased tensile strength, and an inflation valve configured for connecting the single lumen to the inflation source container and a detachment liquid source container, wherein the detachment liquid comprises a physiological compatible liquid, and wherein the interference fit is insufficient to maintain a seal upon application of a hydraulic pressure by the detachment liquid, such that upon application of the hydraulic pressure to the needle assembly it is ejected from the balloon valve.

18. The system of claim 1, wherein the inner cylinder is configured to control alignment of the needle assembly with the septum, provide a barrier to the needle piercing the polymeric wall, and provide compression such that the septum reseals after inflation and needle withdrawal.

19. The system of claim 1, wherein a plurality of intragastric balloons is connected to a single inflation catheter.

20. The system of claim 1, wherein the inflation catheter is of a variable stiffness.

21. The system of claim 1, wherein the inflation source comprises a syringe.

22. The system of claim 1, wherein the inflation source is configured to utilize information regarding inflation pressure as a function of time to provide feedback to a user, wherein the feedback indicates a condition selected from the group consisting of failure by mechanical blockage, failure by esophagus constraint, failure by inflation catheter leak or detachment, and successful balloon inflation.

23. A method for inflating an intragastric balloon, the method comprising:

providing the system of claim 1;

piercing the septum by the needle of an inflation catheter, whereby an interference fit is created between the bell-shaped needle sleeve and the lip of the smaller inner cylinder;

causing the intragastric balloon in an outer container attached by the interference fit to the inflation catheter to be swallowed by a patient in need thereof;

degrading the outer container so as to permit inflation of the intragastric balloon;

inflating the intragastric balloon in the patient'"'"'s stomach via the inflation catheter, wherein the inflation catheter is connected to an inflation fluid source container; and

detaching the intragastric balloon from the inflation catheter, wherein a detachment liquid comprising a physiological compatible liquid is forced through the inflation catheter to apply hydraulic pressure to the needle assembly such that the interference fit between the lip and the bell-shaped needle sleeve is broken, the needle assembly is ejected from the balloon valve and the self-sealing septum reseals.

24. The method of claim 23, wherein the inflation catheter is a dual lumen catheter comprising an inflation lumen and a detachment lumen, wherein the inflation lumen is configured for fluid connection to the inflation source container, and wherein the detachment lumen is configured for connection to a detachment liquid source container for detachment of the balloon.

25. The method of claim 23, wherein the inflation catheter is a single lumen catheter comprising a structural member providing increased tensile strength and an inflation valve configured for first connecting the single lumen catheter to the inflation source container and then to a detachment liquid source container for detachment of the balloon.

26. The method of claim 23, further comprising monitoring inflation pressure as a function of time and detaching when a predetermined ending pressure is obtained, wherein successful balloon inflation is indicated by achievement of the preselected ending pressure, which is based on a starting pressure in the inflation source and an inflation volume of the balloon.