Methods, devices, and systems for obesity treatment

• US 9,445,930 B2
• Filed: 12/16/2015
• Issued: 09/20/2016
• Est. Priority Date: 11/19/2004
• Status: Active Grant

• Current Assignee: Fulfillium, Inc.
• Original Assignee: Fulfillium, Inc.
• Inventors: Taub, Marc B., Dauskardt, Reinhold H., Jones, Christopher S., Johanson, Craig A., Chen, Richard D. Y.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/971,795
• Publication Number:
  US 20160100800A1
• Time in Patent Office: 279 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/008 Alarm means
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0046 with wireless means
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: G08B 21/18 Status alarms G08B21/02 takes precedence

Abstract

Upon filling multiple inflatable chambers of a gastric balloon structure in a patient'"'"'s stomach, the gastric balloon structure assumes a natural three-dimensional kidney shape of the gastric cavity. A flexible central spine may span a gap between two inflatable chambers and may include lumens for inflation of one or both chambers. The plurality of compartments, when in an inflated state, may form a cavity therebetween through which food may pass and may leave in a stomach a residual volume of 10 ml to 100 ml.

Claims

1. An obesity treatment device for deploying in a stomach of a patient, comprising:

a plurality of adjacent, spaced apart inflatable space-filling compartments, wherein each compartment of the plurality of inflatable space-filling compartments has a respective inflated state volume that is maintained during treatment of the patient; and

a valve system for introducing a fluid into each compartment of the plurality of inflatable space-filling compartments and for retaining, upon inflation, fluid in the plurality of inflatable space-filling compartments, wherein

the valve system comprises a respective valve structure for introducing fluid into each inflatable space-filling compartment of the plurality of inflatable space-filling compartments, wherein each respective valve structure includes at least a first valve in series with a second valve;

wherein the obesity treatment device is to form, upon at least partially filling the plurality of inflatable space-filling compartments, to a curved shape conforming to a natural three-dimensional kidney shape of the stomach such that an outer surface of the obesity treatment device aligns against greater and lesser curvatures of the stomach.

2. The obesity treatment device of claim 1, wherein the plurality of inflatable space-filling compartments form, when in an inflated state, a cavity therebetween through which food may pass.

3. The obesity treatment device of claim 1, wherein a respective fluid volume for filling each compartment of the plurality of inflatable space-filling compartments leaves in the stomach a residual volume proximal to the obesity treatment device unoccupied by the obesity treatment device during a resting state of the stomach, and wherein said residual volume is 10 ml to 100 ml.

4. The obesity treatment device of claim 1, wherein, upon inflation, the obesity treatment device rests within the stomach without exerting pressure at any point in the stomach sufficient to cause ulceration.

5. The obesity treatment device of claim 1, wherein an outer surface of each of the inflatable space-filling compartments aligns against greater and lesser curvatures of the stomach.

6. The obesity treatment device of claim 5, wherein the obesity treatment device is untethered in the stomach after inflation.

7. The obesity treatment device of claim 1, wherein the first valve structure includes a one-way valve.

8. The obesity treatment device of claim 1, further comprising a flexible central spine structure spanning a gap between and connecting at least a first compartment of the plurality of inflatable space-filling compartments and a second compartment of the plurality of inflatable space-filling compartments, wherein aligning the outer surface of the obesity treatment device against the greater and lesser curvatures of the stomach comprises flexibly conforming the obesity treatment device to the natural three dimensional kidney shape of the stomach through flexing the flexible central spine structure.

9. The obesity treatment device of claim 8, wherein the flexible central spine structure is in fluid communication with the valve system.

10. The obesity treatment device of claim 9, wherein the flexible central spine structure encloses an inflation lumen for introducing the fluid into the plurality of inflatable space-filling compartments.

11. The obesity treatment device of claim 1, wherein fluid in each of the plurality of inflatable space-filling compartments is a same type of fluid.

12. A method for deploying a gastric balloon structure in a gastric cavity of a patient, comprising:

determining one or more dimensions of the gastric cavity in a feeding state;

selecting a respective fill volume for each chamber of a plurality of isolated chambers of the gastric balloon structure;

introducing the gastric balloon structure to the gastric cavity; and

after said introducing, at least partially filling each chamber of the plurality of isolated chambers of the gastric balloon structure with the respective volume of fluid via a valve system of the gastric balloon structure, wherein

the plurality of isolated chambers are non-concentric and adjacent,

at least partially filling each chamber of the plurality of isolated chambers comprises introducing fluid into the respective chamber via a respective valve structure of the valve system, and

a collective volume of the plurality of isolated chambers remaining inflated after deflation of any single chamber of the plurality of isolated chambers prevents the gastric balloon structure from passing through the pyloric valve of the gastric cavity;

wherein the gastric balloon structure, in its inflated state, is to form to a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity such that an outer surface of the gastric balloon structure aligns against greater and lesser curvatures of the gastric cavity.

13. The method of claim 12, wherein the gastric balloon structure, upon inflation, rests within the gastric cavity without exerting pressure at any point in the gastric cavity sufficient to cause ulceration.

14. The method of claim 12, wherein an outer surface of each of the space-filling compartments aligns against greater and lesser curvatures of the stomach.

15. The method of claim 12, wherein at least partly filling the plurality of isolated chambers comprises:

releasably attaching an inflation tube to the valve system; and

introducing the fluid into a first isolated chamber of the plurality of isolated chambers through the inflation tube.

16. The method of claim 12, wherein introducing the gastric balloon structure to the gastric cavity comprises introducing the gastric balloon structure through an esophagus of the patient.

17. The method of claim 12, wherein a diameter of the gastric balloon structure is no larger than 2 centimeters prior to inflation.

18. The method of claim 12, wherein fluid in each of the plurality of isolated chambers is a same type of fluid.

19. A system for treating obesity, comprising:

a means for conforming a flexible, space-filling structure to a natural kidney shape of a gastric cavity of a patient;

a means for maintaining at least two isolated inflatable regions of the flexible, space-filling structure such that a collective volume of the at least two isolated inflatable regions remaining inflated after deflation of any single isolated inflatable region of the at least two isolated inflatable regions prevents the flexible, space-filling structure from passing through the pylorus of the patient;

a means for introducing a fluid into each of the at least two isolated inflatable regions after positioning the flexible, space-filling structure within the gastric cavity, wherein the means for introducing is configured to be separated from said means for conforming after introducing the fluid; and

a means for receiving the fluid into each region of the at least two isolated inflatable regions and for retaining the fluid in each region, wherein the fluid is received from the means for introducing the fluid.

20. The system of claim 19, wherein the means for conforming is configured to leave in the gastric cavity a residual volume proximal to the means for conforming and unoccupied by the means for conforming during a resting state of the gastric cavity, and wherein said residual volume is 10 ml to 100 ml.

21. The system of claim 19, wherein the means for conforming provides for modulated passage of food through the gastric cavity.

22. The system of claim 19, wherein the means for conforming is configured such that, upon inflation, the flexible space-filling structure rests within the gastric cavity without exerting pressure at any point in the gastric cavity sufficient to cause ulceration.

23. The system of claim 22, wherein undue pressure against the gastric cavity is avoided in part through at least one of i) a fill weight of collective volumes of the at least two isolated inflatable regions, ii) a distribution of the overall space-filling structure, and iii) a buoyancy of the fluid.

24. The system of claim 19, wherein the means for receiving the fluid comprises a respective valve structure of each region of the at least two isolated inflatable regions, the respective valve structure comprising at least a first valve and a second valve.

25. The system of claim 19, further comprising a means for flexibly connecting at least a first region of the at least two isolated inflatable regions and a second region of the at least two isolated inflatable regions by spanning a gap between the first region and the second region, thereby forming a cavity between the first region and the second region through which food may pass.

26. The system of claim 25, wherein the means for flexibly connecting at least the first isolated inflatable region and the second isolated inflatable region is in fluid communication with the means for receiving the fluid.

27. The system of claim 25, wherein the means for flexibly connecting comprises a flexible central spine.

28. The system of claim 19, wherein, each of the at least two isolated inflatable regions comprises a respective inner layer and a respective outer layer.

29. The system of claim 28, wherein, for each of the at least two isolated inflatable regions, the respective inner layer is attached to the respective outer layer.

30. The system of claim 19, wherein fluid in each of the at least two isolated inflatable regions is a same type of fluid.