INTRAGASTRIC BALLOON SYSTEM AND THERAPEUTIC PROCESSES AND PRODUCTS

• US 20080243071A1
• Filed: 03/30/2007
• Published: 10/02/2008
• Est. Priority Date: 03/30/2007
• Status: Active Grant

• Current Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Cragg, Andrew H., Wallace, George, Tu, Hosheng, Quijano, Rodolfo C., Sosnowski, Stephen A.
• Granted Patent: US 8,226,602 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0046 with wireless means
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A gastric space filler device for treating obesity in a patient by reducing the stomach volume features at least one inflatable space filler with drag delivery and stimulation features and includes therapeutic devices and anchoring apparatus enabling tracking, visualization and optimized management of inter-balloon connecting sections, drug reservoirs and pumping systems along with related improvements.

Claims

1. A system for controlled drug delivery on-demand to a gastrointestinal system of a patient, comprising, in combination;

a gastric space filler;

a drug reservoir secured to the gastric space filler device;

a pump secured to the reservoir for dispensing the drug from the drug reservoir; and

,

a sensor able to receive at least one signaling parameter from the interior of the stomach, the sensor being functionally connected to the pump and being configured for triggering delivery of the drug when the at least one parameter reaches a threshold of a pre-set value.

2. The system of claim 1, wherein the gastric space filler comprises at least two balloons and an inter-balloon section connecting said two balloons, wherein the pump is located at the inter-balloon section.

3. The system of claim 2, wherein the inter-balloon section consists essentially of at lease one material selected from a group consisting of polyethylene, polystyrene, polyurethane, silicone, fluoro-polymer, polyether-ether-ketone (PEEK), co-polymers thereof, and inert ceramics comprising pyrolytic carbon material.

4. The system of claim 2, wherein at least a substantial portion of one of the at least two balloons is the drug reservoir.

5. The system of claim 1, wherein the drug is selected from a group consisting of an anti-emetic drug, anti-nausea agent, and hormones known to produce feeling of satiety.

6. The system of claim 1, wherein the sensor is selected from a group consisting of a pressure sensor, a pH sensor, a flow sensor, a temperature sensor, and an electrolyte sensor.

7. The system of claim 1, further comprising a power source connected to the pump or to the sensor, wherein the power source is a battery.

8. The system of claim 1, further comprising;

a power source with an antenna, wherein the power source is connected to the pump or to the sensor, wherein the power source receives energy telemetrically via the antenna using electromagnetic or induction coupling.

9. The system of claim 1, wherein an operating mode of the pump is selected from a group consisting of centrifugal axial, pulsatile, rotary, and combinations thereof.

10. The system of claim 1, wherein the drug is dispensed into the stomach-adjacent portion of an intestine of the gastrointestinal system.

11. The system of claim 10, wherein the drug is dispensed into the distal portion of the intestine.

12. A system for sustained drug delivery to a gastrointestinal system of a patient, comprising, in combination:

a gastric space filler, wherein drug is coated onto at least a portion of an exterior surface of the filler, wherein the drug coating consists of a drug carrier loaded with a drug.

13. The system of claim 12, wherein the drug coating is in a form of at least one of layer, a line and or a cluster.

14. The system of claim 12, wherein the drug carrier is made of silicone or polyurethane.

15. The system of claim 12, wherein the drug carrier is biodegradable.

16. The system of claim 15, wherein the drug carrier is selected from a group of compounds consisting of lactide, glycolide, caprolactone, polydioxanone, trimethylene carbonate, polyorthoesters, and polyethylene oxide.

17. The system of claim 15, wherein the drug carrier is selected from a group consisting of collagen, chitosan, elastin, gelatin, and combinations thereof.

18. The system of claim 12, wherein the gastric filler has at least one groove on the exterior surface of the balloon and a substantial portion of at least one groove is filled with the drug formulation.

19. A system for electrical stimulating a muscle layer of a stomach wall or associated nerves of the stomach, comprising a gastric space filler, at least one electrode mounted at a circumference of the filled space filler and in contact with said muscle layer or nerves when the space filler is replete, a power source connected to the electrode, and an externally transmitted telemetric signal to activate the power source for stimulation.

20. The system of claim 19, wherein the externally transmitted signal is an RF (radiofrequency) signal.

21. The system of claim 19, wherein the power source receives telemetric energy via an antenna connected to the power source using electromagnetic coupling.

22. The system of claim 19, wherein the electrode is made of a conductive silicone.

23. A system for providing therapy to a gastrointestinal system of a patient, comprising:

a gastric space filler, at least one therapeutic device and an anchoring apparatus for anchoring the at least one therapeutic device to the space filler.

24. The system of claim 23, wherein the therapeutic device is a drug reservoir loaded with a drug for drug release to the stomach or the intestine of the gastrointestinal system.

25. The system of claim 23, wherein the therapeutic device is an electric stimulation assembly for providing electric stimulation to the stomach or the intestine of the gastrointestinal system.

26. The system of claim 23, wherein the therapeutic device is a mechanical motion assembly for providing mechanical massage to at least one of the stomach and the intestine of the gastrointestinal system.

27. The system of claim 23, wherein the therapeutic device is an absorption inhibition product for inhibiting food absorption to at lease one of the stomach and the intestine of the gastrointestinal system.

28. The system of claim 23, wherein the therapeutic device is at least one of a sensor and a diagnostic instrument for sensing a signal or diagnosing a symptom in the stomach or the intestine of the gastrointestinal system.

29. The system of claim 23, wherein the therapeutic device is a nutrition delivery setup loaded with a nutrition, for nutrition release to the stomach or the intestine of the gastrointestinal system.

30. The system of claim 23, wherein the therapy is a small bowel therapy.