Intragastric device

• US 10,610,396 B2
• Filed: 02/27/2018
• Issued: 04/07/2020
• 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:
  US15/906,942
• Publication Number:
  US 20180185185A1
• Time in Patent Office: 770 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 balloon system comprising:

a) an intragastric balloon comprising;

i) a polymeric wall with an inner surface defining a balloon lumen;

ii) a self-sealing valve system attached to the polymeric wall'"'"'s inner surface, the valve system comprising;

(1) a tube septum comprising;

(a) an outer cylinder with a first end facing the w polymeric wall'"'"'s inner surface and a second end facing the balloon lumen; and

(b) an inner cylinder concentrically disposed within the outer cylinder and having a third end facing the polymeric wall'"'"'s inner surface, and a fourth end facing the balloon lumen, the third end including an inward radial lip;

(2) a self-sealing septum housed within the inner cylinder and compressed against the inner cylinder'"'"'s inward radial lip; and

(3) a polymeric material disposed concentrically between the inner cylinder and the outer cylinder;

b) an outer container releasably containing the intragastric balloon in a folded and compacted state, the outer container comprising;

i) an outer container wall formed of a material that is erodible in an in vivo gastric environment;

ii) an outer container interior; and

iii) an opening in the outer container wall, the opening in the outer container wall providing fluid communication between the outer container interior and the in vivo gastric environment;

wherein

iv) the outer container is sized and shaped so as to be swallowable by normal peristaltic motion;

c) a swallowable inflation catheter comprising;

i) catheter tubing with an open proximal end and open distal end joined by a catheter lumen;

ii) a needle assembly attached to the catheter tubing distal end and including;

(1) a needle sleeve extending through the opening in the outer container wall and reversibly engaged with the valve system, wherein the valve system'"'"'s polymeric material provides compressive forces against the needle sleeve to provide an interference fit and sealing of the valve system to the inflation catheter sufficient to maintain a seal during inflation of the intragastric balloon while permitting detachment of the swallowable inflation catheter from the valve system after inflation of the intragastric balloon in vivo is complete; and

(2) a hollow needle disposed within the needle sleeve and extending longitudinally through the self-sealing septum of the valve system, whereby the tubing lumen is in fluid communication with the intragastric balloon lumen;

iii) a catheter connector attached to the catheter tubing proximal end; and

iv) a tensile cord extending through the tubing lumen and attached to each of the needle assembly and the catheter connector.

2. The system of claim 1, wherein the polymeric material includes a longitudinally extending portion that does not protrude more than 2 mm past an outer surface of the polymeric wall.

3. The system of claim 1, wherein the polymeric material presses against the reversibly engaged needle sleeve to cooperatively provide sealing of the needle sleeve to the inflation valve.

4. The system of claim 1, wherein the needle sleeve is reversibly engaged between the polymeric material cylindrical surface and the inner cylinder.

5. The system of claim 1, the valve system further comprising a retaining ring providing a compressive force against the polymeric material.

6. The system of claim 1, wherein valve system is configured to provide a compressive force against the needle sleeve for inflation and detachment, such that the interference fit can withstand a pressure of 35 PSI during inflation.

7. The system of claim 6, wherein the seal of the valve system and the needle assembly is configured to be broken during detachment using a hydraulic pressure that is between 40 PSI and 200 PSI to separate the connection coupling.

8. The system of claim 1, wherein the polymeric material includes a cylindrical through-bore with a bore surface spaced from the inner cylinder.

9. 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.

10. The system of claim 1, further comprising:

a) an inflation source container comprising;

i) a volume of an inflation fluid, wherein the inflation fluid comprises at least one inert gas;

ii) an inflation valve in fluid communication with the volume of the inflation fluid;

wherein

(1) the inflation valve is sized and shaped to reversibly connect to the catheter connector; and

wherein

(2) the inflation valve includes opened and closed configurations and an actuation handle; and

iii) a pressure gauge attached to the volume of inflation fluid;

wherein

b) the inflation source container 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.

11. The system of claim 10, wherein the pressure gauge provides a pressure within the volume of inflation fluid.

12. The system of claim 10, wherein the inert gas is selected from the group consisting of N₂, O₂, CO₂, a single gas, and a mixture of gases.

13. The system of claim 1, further comprising:

a) a detachment device for detachment of the inflation catheter after inflation of the intragastric balloon in vivo is complete, the detachment device comprising;

i) a volume of physiological compatible detachment liquid;

ii) a connection end configured for connection to the catheter connector; and

iii) a plunger;

wherein

b) actuation of the plunger expels detachment liquid from the detachment device, thereby generating hydraulic pressure against the balloon valve system; and

wherein

c) the interference fit between the needle assembly and the balloon valve system is insufficient to maintain the seal upon application of the hydraulic pressure by the detachment liquid, such that upon application of the hydraulic pressure to the needle assembly is ejected from the balloon valve system.

14. The system of claim 13, wherein the hydraulic pressure is between 40 PSI and 200 PSI to separate the connection coupling.

15. The system of claim 1, wherein the polymeric wall comprises one or more layers.

16. The system of claim 15, wherein the polymeric wall comprises a barrier material comprising nylon and polyethylene.

17. The system of claim 15, wherein the polymeric wall comprises a barrier material comprising nylon, polyvinylidene chloride and polyethylene.

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

19. The system of claim 1, wherein the inflation catheter tubing is from 1 French to 6 French in diameter.

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

21. The system of claim 1, further comprising:

a) a deflation port attached to the wall inner surface, the deflation port comprising

i) a casing with one or more vent pathways attached to the wall inner surface,

ii) an outer sealing member positioned to block the one or more vent pathways; and

iii) a deflation component situated in the casing and is configured to expand upon exposure to moisture inside the balloon lumen via the one or more vent pathways, wherein

iv) the expanding deflation component pushes the outer sealing member to thereby open the one or more vent pathways so as to provide fluid communication between the in vivo gastric environment and the balloon lumen.

22. The system of claim 21, wherein the deflation port is configured to rapidly deflate the intragastric balloon after 60 or more days in vivo.

23. The system of claim 21, wherein the valve system comprises the deflation port.

24. The system of claim 21, wherein the deflation component comprises a solute material encapsulated in a binder material, wherein the deflation component is further surrounded by moisture limiting material that has a predefined moisture vapor transmission rate.

25. The system of claim 24, wherein the solute material is a polyacrylamide.

26. The system of claim 21, wherein the deflation port comprises a rigid retaining structure, and wherein the rigid retaining structure and the casing have a press fit lock that prevents the rigid retaining structure from being expelled from the casing after maximum displacement by the deflation component.