Methods, devices, and systems for obesity treatment

• US 9,808,367 B2
• Filed: 06/13/2017
• Issued: 11/07/2017
• Est. Priority Date: 11/19/2004
• Status: Active Grant

• Current Assignee: Fulfillium, Inc.
• Original Assignee: Fulfillium, Inc.
• Inventors: Dauskardt, Reinhold H., Jones, Christopher S., Johanson, Craig A., Chen, Richard D. Y., Taub, Mark B.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/621,795
• Publication Number:
  US 20170273813A1
• Time in Patent Office: 147 Days
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• 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 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 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0046 with wireless means
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: G08B 21/18 Status alarms G08B21/02 takes precedence

Abstract

In one aspect, a gastric balloon structure includes multiple isolated non-concentric inflatable chambers and a valve system for introducing fluid into each chamber, where the structure assumes, upon inflating, a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity.

Claims

1. A free floating, untethered gastric balloon structure for deploying in a gastric cavity of a patient, comprising:

at least two isolated non-concentric inflatable chambers, wherein each chamber of the at least two isolated non-concentric inflatable chambers has a respective inflated state volume such that deflation of any single chamber of the at least two isolated non-concentric inflatable chambers leaves the inflated state volume of the remaining chambers of the at least two isolated non-concentric inflatable chambers unaffected;

a valve system for introducing a fluid into the at least two isolated non-concentric inflatable chambers and for retaining, upon inflation, the fluid in the at least two isolated non-concentric inflatable chambers; and

a flexible member spanning a gap between and fixedly attached to both a first chamber of the at least two isolated non-concentric inflatable chambers and a second chamber of the at least two isolated non-concentric inflatable chambers, said flexible member carrying inflation tubes that are in fluid communication with the at least two isolated non-concentric inflatable chambers;

wherein the gastric balloon structure is configured to float freely in the patient'"'"'s gastric cavity and is not connected to any catheter, lumen or tether after deployment in the patient'"'"'s gastric cavity;

wherein the gastric balloon structure, in its inflated state, assumes a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity, such that the flexible member flexibly conforms, upon at least partially filling the at least two isolated non-concentric inflatable chambers, the gastric balloon structure to the natural three-dimensional kidney shape of the gastric cavity.

2. The gastric balloon structure of claim 1, wherein the gastric balloon structure is configured to provide for modulated passage of food through the gastric cavity upon inflation.

3. The gastric balloon structure of claim 2, wherein the inflated state volumes of the at least two isolated non-concentric inflatable chambers are configured to leave in the gastric cavity a residual volume proximal to the gastric balloon structure unoccupied by the gastric balloon structure during a resting state of the gastric cavity, and wherein said residual volume is 10 ml to 100 ml.

4. The gastric balloon structure of claim 1, wherein the flexible member is in fluid communication with the valve system.

5. The gastric balloon structure of claim 4, wherein the flexible member encloses an inflation lumen for introducing the fluid into the at least two isolated non-concentric inflatable chambers.

6. The gastric balloon structure of claim 1, wherein the gastric balloon structure is configured to maintain the inflated state volume of each of the at least two isolated non-concentric inflatable chambers while deployed in the gastric cavity of the patient without controlled adjustment.

7. The gastric balloon structure of claim 1, wherein each chamber of the at least two isolated non-concentric inflatable chambers is filled with a same fluid.

8. The gastric balloon structure of claim 1, wherein the walls of the at least two isolated non-concentric inflatable chambers are comprised of two layers of silicone bonded to one another.

9. The gastric balloon structure of claim 8, wherein the two layers of silicone include an inner layer and outer layer, wherein the inner layer has a greater strength than the outer layer and the outer layer has a greater acid resistance than the inner layer.

10. The gastric balloon structure of claim 1, further comprising a protective sheath which surrounds at least a portion of the gastric balloon structure.

11. The gastric balloon structure of claim 1, wherein, upon inflation, the gastric balloon structure is configured to rest within the gastric cavity without exerting pressure at any point in the gastric cavity sufficient to cause abrasion, pressure induced lesions, or other trauma.

12. The gastric balloon structure of claim 11, wherein an outer surface of each of the isolated non-concentric inflatable chambers is configured to align against greater and lesser curvatures of the gastric cavity.

13. The gastric balloon structure of claim 1, wherein said inflation tubes include a first inflation tube and a second inflation tube, the first inflation tube being connected by a first orifice to the first chamber of the at least two isolated non-concentric inflatable chambers, the second inflation tube being connected by a second orifice to the second chamber of the at least two isolated non-concentric inflatable chambers.

14. The gastric balloon structure of claim 13, wherein the two said orifices extend through the side wall of the flexible member to the at least two isolated non-concentric inflatable chambers.

15. The gastric balloon structure of claim 14, wherein the first orifice is oriented in a first radial direction perpendicular to a longitudinal axis of the structure and the second orifice is oriented in a second radial direction which is offset from the first radial direction.

16. An obesity treatment system for deployment in a stomach of a patient such that the system is free-floating and untethered after deployment, comprising:

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

at least two valves to introduce at least one fluid into each of the plurality of inflatable space-filling compartments and to retain, after inflation, fluid in the plurality of inflatable space-filling compartments, wherein each valve is a one-way valve and wherein at least one of the at least two valves has a proximal end configured to removably attach to an inflation tube;

wherein the plurality of inflatable space-filling compartments form, upon at least partially filling the plurality of inflatable space-filling compartments, a dual balloon system that is configured to float within the stomach;

wherein the dual-balloon system is configured to float freely in the patient'"'"'s stomach and is not connected to any catheter, lumen or tether after deployment in the patient'"'"'s stomach;

wherein, upon inflation, the dual balloon system is configured to float within the stomach without exerting pressure at any point in the stomach sufficient to cause abrasion, pressure induced lesions, or other trauma.

17. The obesity treatment system of claim 16, wherein an outer surface of each of the inflatable space-filling compartments abuts a greater or lesser curvature of the stomach.

18. The obesity treatment system of claim 16, wherein the plurality of inflatable space-filling compartments are untethered in the stomach after inflation.

19. The obesity treatment system of claim 16, further comprising a flexible central spine structure spanning a gap between and connecting the plurality of adjacent, spaced apart inflatable space-filling compartments.

20. The obesity treatment system of claim 19, wherein the flexible central spine structure is in fluid communication with the valve system.

21. The obesity treatment system of claim 20, wherein the flexible central spine structure encloses an inflation lumen for introducing the fluid into the plurality of inflatable space-filling compartments.

22. The obesity treatment system of claim 16, wherein fluid in each of the plurality of inflatable space-filling compartments is a same type of gas.

23. The obesity treatment system of claim 16, further comprising chemicals adapted to be reacted to produce a gas that inflates at least one of the plurality of adjacent, spaced apart inflatable space-filling compartments.