Granted Patent B2

US 12,440,358 · App. 18/484,290 · Granted Oct 14, 2025

Inventors: Mark C. Brister (San Diego, CA); Neil R. Drake (Carlsbad, CA); Daniel J. Proctor (Carlsbad, CA); Madeline Campbell (Poway, CA)

Assignee: RESHAPE LIFESCIENCES INC.

A61F5/0036A61F5/003A61F5/004A61F5/0043A61F5/0089A61M25/10181A61F5/0076A61M25/10185A61M25/10187

Abstract

Claims (28)

1. A device for detecting placement of an inflatable intragastric balloon within an anatomical constrained space, the device comprising:

a pressure sensor for detecting a balloon pressure within the inflatable intragastric balloon in vivo; and

a computing device configured to:

a) control delivery of an inflation fluid into the inflatable intragastric balloon;

b) receive a balloon pressure value from the pressure sensor during a balloon administration procedure; and

c) compare the received balloon pressure value to a predetermined pressure range during the balloon administration procedure, wherein a received balloon pressure between 17.2 kPa and 60 kPa and a rate of pressure decrease less than 0.2 kPa/s is indicative of placement of the inflatable intragastric balloon in the anatomical constrained space, and wherein a received balloon pressure less than 17.2 kPa in an absence of a rate of change of less than 0.2 kPa/s in 3 seconds is indicative of placement of the inflatable intragastric balloon in an anatomical unconstrained space.

2. The device of claim 1 , wherein the anatomical constrained space is a hiatal hernia.

3. The device of claim 1 , wherein the anatomical constrained space is within an esophagus.

4. The device of claim 1 , wherein the anatomical constrained space has a volume of less than or equal to 180 cm 3 .

5. The device of claim 1 , wherein a target pressure is between 9.5 kPa and 13 kPa.

6. The device of claim 1 , wherein a target pressure is between 8.3 kPa and 17.2 kPa.

7. The device of claim 1 , wherein the inflation fluid comprises SF 6 and nitrogen.

8. The device of claim 1 , wherein the pressure sensor is positioned between the inflatable intragastric balloon and a plurality of valves.

9. The device of claim 8 , wherein the plurality of valves is configured to control the flow of the inflation fluid between the pressure sensor and the inflatable intragastric balloon.

10. The device of claim 8 , wherein when the plurality of valves is closed, a reading of the pressure sensor is indicative of the pressure inside the inflatable intragastric balloon.

11. The device of claim 8 , wherein the plurality of valves is configured to open or close in response to instructions received from the computing device.

12. A method of detecting placement of an inflatable intragastric balloon within an anatomical constrained space, comprising:

a) iteratively delivering an inflation fluid into the inflatable intragastric balloon in vivo, so as to partially inflate the inflatable intragastric balloon;

b) measuring a balloon pressure of the inflatable intragastric balloon while iteratively delivering the inflation fluid into the inflatable intragastric balloon; and

c) comparing the balloon pressure to a predetermined pressure, wherein a balloon pressure between 17.2 kPa and 60 kPa and a rate of pressure decrease less than 0.2 kPa/s is indicative of placement of the inflatable intragastric balloon in the anatomical constrained space, and wherein a balloon pressure less than 17.2 kPa in an absence of a rate of change of less than 0.2 kPa/s in 3 seconds is indicative of placement of the inflatable intragastric balloon in an anatomical unconstrained space.

13. The method of claim 12 , wherein the anatomical constrained space is a hiatal hernia.

14. The method of claim 12 , wherein the anatomical constrained space is within an esophagus.

15. The method of claim 12 , wherein the inflation fluid comprises SF 6 and nitrogen.

16. The method of claim 12 , wherein a target pressure is between about 9.5 kPa to about 13 kPa.

17. The method of claim 12 , wherein a target pressure is between about 8.3 kPa to about 17.2 kPa.

18. The method of claim 12 , wherein a pressure sensor is positioned between the inflatable intragastric balloon and a plurality of valves.

19. The method of claim 18 , wherein the plurality of valves is configured to control the flow of the inflation fluid between the pressure sensor and the inflatable intragastric balloon.

20. The method of claim 18 , wherein when the plurality of valves is closed, a reading of the pressure sensor is indicative of the pressure inside the inflatable intragastric balloon.

Assignments (4)

Continuity (5)

References Cited (263)