Intragastric space filler

• US 9,962,276 B2
• Filed: 04/08/2013
• Issued: 05/08/2018
• Est. Priority Date: 10/31/2005
• Status: Expired due to Fees

• Current Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Quijano, Rodolfo C., Tu, Hosheng, Cragg, Andrew H., Purkait, Bobby
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US13/858,767
• Publication Number:
  US 20130296914A1
• Time in Patent Office: 1,856 Days
• Field of Search: 606192
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

A gastric space filler device for treating obesity in a patient by reducing the stomach volume comprising an inflatable space filler and a safety element secured to the space filler, wherein the safety element yields a noticeable signal for causing removal of the space filler.

Claims

1. A gastric space filler device for treating obesity in a patient by reducing the patient'"'"'s stomach volume, the gastric space filler device comprising:

a plurality of inflatable gastric space fillers including at least a first inflatable gastric space filler and a second inflatable gastric space filler;

a plurality of connecting members extending between and connected to the first and second inflatable gastric space fillers such that the first and second inflatable space fillers are arranged in tandem when in the patient'"'"'s stomach, wherein opposing ends of the first and second inflatable gastric space fillers are spaced apart from each other by the connecting members; and

a safety element configured to yield a noticeable signal for causing a removal of the gastric space filler device from the patient;

wherein the gastric space filler device approximates a natural J-shape of a stomach of the patient and is sized to occupy at least 90% of the patient'"'"'s stomach volume to reduce stomach volume for weight loss.

2. The gastric space filler device of claim 1, wherein the safety element is a pressure sensor element configured to sensing an internal pressure of at least one of the first inflatable gastric space filler and the second inflatable gastric space filler.

3. The gastric space filler device of claim 2, wherein the pressure sensor element includes a transmitter configured to wirelessly transmitting the sensed internal pressure to a receiver outside a body of the patient.

4. The gastric space filler device of claim 1, wherein the safety element includes a pH sensor element for sensing a pH of a stomach of the patient.

5. The gastric space filler device of claim 4, wherein the pH sensor element includes a transmitter for wirelessly transmitting the sensed pH to a receiver outside a body of the patient.

6. The gastric space filler device of claim 1, wherein the safety element is anchored to an inner wall of a stomach of the patient.

7. The gastric space filler device of claim 1, wherein the safety element and/or at least one of the first and/or second inflatable gastric space fillers are ultrasonically visible.

8. The gastric space filler device of claim 1, further comprising an ultrasonic transducer configured to emit an ultrasonic signal.

9. The gastric space filler device of claim 1, wherein the gastric space filler device is configured to be deliverable through an esophagus of the patient.

10. The gastric space filler device of claim 1, wherein at least a portion of an external surface of the gastric space filler device is treated with an anti-acid substance.

11. The gastric space filler device of claim 1, wherein at least a portion of an external surface of the gastric space filler device is treated with a corrosion-resistant substance.

12. The gastric space filler device of claim 1, wherein at least a portion of an external surface of the gastric space filler device is treated with an anti-adhesion substance.

13. The gastric space filler device of claim 1, wherein at least a portion of an external surface of the gastric space filler device is treated with albumin or melatonin.

14. The gastric space filler device of claim 1, wherein at least a portion of an external surface of the gastric space filler device is treated with phosphorylcholine.

15. The gastric space filler device of claim 1, wherein the inflatable space filler includes a central opening extending therethrough.

16. The gastric space filler device of claim 1, wherein at least one of the first and/or second inflatable gastric space fillers has an adjustable volume.

17. The gastric space filler device of claim 1, wherein the first and second inflatable gastric space fillers include a volume-adjusting mechanism for adjusting a volume of the inflatable space filler over time, wherein the volume-adjusting mechanism adjusts the volume to a first volume configured to allow initial acceptance by a stomach of the patient, and wherein the volume-adjusting mechanism increases the volume to a second volume configured to induce weight loss and minimize nausea and vomiting.

18. The gastric space filler device of claim 1, wherein the safety element is an inflatable balloon made of a biodegradable material.

19. The gastric space filler device of claim 1, wherein the safety element is secured to the first and/or second inflatable gastric space fillers.

20. The gastric space filler device of claim 1, wherein the safety element is one of the first and/or second inflatable gastric space fillers.

21. The gastric space filler device of claim 1, wherein the first inflatable gastric space filler is configured to be inflated to a first volume in a stomach of the patient and the second inflatable gastric space filler is configured to be inflated to a second volume inside the stomach of the patient, and wherein the first volume and the second volume are configured to occupy at least 90% of the stomach volume.

22. The gastric space filler device of claim 1, further comprising:

an infusing tube releasably attached to the gastric space filler device, wherein the infusing tube is configured to be connected to an external fluid source to inflate the inflatable gastric space fillers when the inflatable gastric space fillers are positioned within a stomach of the patient, and wherein the infusing tube is removed from the patient after inflation.

23. An inflatable gastric device, comprising:

a first inflatable space filler;

a second inflatable space filler arranged in tandem with the first inflatable space filler;

a connecting member extending between and connected to the first and second inflatable space fillers, wherein opposing ends of the first and second inflatable space fillers are spaced apart from each other by the connecting member; and

a safety element configured to yield a noticeable signal of failure of the inflatable gastric device,

wherein the first inflatable space filler, the second inflatable space filler, and the connecting member are sealed from fluid passage through the inflatable gastric device after inflation of the first and second inflatable space fillers, and

wherein, after inflation of the first and second inflatable space fillers, the inflatable gastric device approximates a natural J-shape of a stomach of a human patient and is sized to occupy at least 90% of a stomach volume to reduce stomach volume for weight loss of the human patient.

24. The inflatable gastric device of claim 23, wherein the safety element is a pressure sensor element coupled to at least one of the first inflatable space filler and the second inflatable space filler.

25. The inflatable gastric device of claim 23, wherein the safety element is secured to the first and/or second inflatable space fillers.

26. The inflatable gastric device of claim 23, wherein the safety element is one of the first and/or second inflatable gastric space fillers.

27. The inflatable gastric device of claim 26, wherein the safety element includes a dye.

28. The inflatable gastric device of claim 23, further comprising:

an infusing tube releasably attached to the inflatable gastric device, wherein the infusing tube is configured to extend from a stomach of a patient and through a mouth of the patient to connect with an external fluid source, and wherein the infusing tube is configured to be removed the patient after inflation such that the inflatable gastric device is completely positioned within the stomach of the patient.

29. The inflatable gastric device of claim 23, wherein the safety element is a pressure sensor element configured to sensing an internal pressure of at least one of the first inflatable gastric space filler and the second inflatable gastric space filler, and wherein the pressure sensor element includes a transmitter configured to wirelessly transmitting the sensed internal pressure to a receiver outside a body of the patient.

30. The inflatable gastric device of claim 23, wherein the safety element includes a pH sensor element for sensing a pH of a stomach of the patient, and wherein the pH sensor element includes a transmitter for wirelessly transmitting the sensed pH to a receiver outside a body of the patient.

31. The inflatable gastric device of claim 23, wherein the safety element is anchored to an inner wall of a stomach of the patient.

32. The inflatable gastric device of claim 23, further comprising an ultrasonic transducer configured to emit an ultrasonic signal.

33. The inflatable gastric device of claim 23, wherein the gastric space filler device is configured to be deliverable through an esophagus of the patient.

34. The inflatable gastric device of claim 23, wherein at least a portion of an external surface of the gastric space filler device is treated with at least one of anti-acid substance, a corrosion-resistant substance, an anti-adhesion substance, albumin, melatonin, phosphorylcholine.

35. The inflatable gastric device of claim 23, wherein the first and second inflatable space fillers include a central opening extending therethrough.

36. The inflatable gastric device of claim 23, wherein at least one of the first and/or second inflatable space fillers has an adjustable volume.

37. The inflatable gastric device of claim 23, wherein the first and second inflatable space fillers include a volume-adjusting mechanism for adjusting a volume of the inflatable space filler over time, wherein the volume-adjusting mechanism adjusts the volume to a first volume configured to allow initial acceptance by a stomach of the patient, and wherein the volume-adjusting mechanism increases the volume to a second volume configured to induce weight loss and minimize nausea and vomiting.

38. The inflatable gastric device of claim 23, wherein the safety element is an inflatable balloon made of a biodegradable material.

39. An inflatable gastric device, comprising:

a first inflatable space filler;

a second inflatable space filler arranged in tandem with the first inflatable space filler;

a connecting member extending between and connected to the first and second inflatable space fillers, wherein opposing ends of the first and second inflatable space fillers are spaced apart from each other by the connecting member; and

a safety element configured to yield a noticeable signal of failure of the inflatable gastric device,

wherein the first inflatable space filler, the second inflatable space filler, and the connecting member are sealed from fluid passage through the inflatable gastric device after inflation of the first and second inflatable space fillers, and

wherein, after inflation of the first and second inflatable space fillers, the inflatable gastric device tends to assume a natural curved shape of a stomach of a human patient and is sized to occupy at least 90% of a stomach volume of the human patient.