Intragastric space filler and methods of manufacture

Abstract

A gastric space filler device for treating obesity in a patient by reducing the stomach volume comprising at least one inflatable space filler and a pressure sensor secured to the space filler, wherein the pressure sensor yields a noticeable signal for causing removal of the space filler.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

Additional objects and features of the present invention will become more apparent and the invention itself will be best understood from the following Detailed Description of Exemplary Embodiments, when read with reference to the accompanying drawings.

FIG. 1 shows a gastric space filler system with two space fillers secured to and in parallel to each other.

FIG. 2 shows a first space filler of the two space fillers in FIG. 1 with a central passageway therethrough.

FIG. 3 shows a gastric space filler system with two space fillers secured to and in tandem to each other.

FIG. 4 shows a gastric space filler system having an inflatable space filler with a support mechanism thereto.

FIG. 5 shows a cross-sectional view of the support mechanism of FIG. 4.

FIG. 6 shows a pressure sensor element mounted on a space filler in accordance with the principles of the present invention.

FIG. 7 shows a delivery apparatus for non-surgically implanting a gastric space filler system.

FIG. 8 shows one embodiment of removing a gastric space filler system from the patient.

FIG. 9 shows one embodiment of a gastric space filler system with two connected expandable elements.

FIG. 10 shows an illustration of the gastric space filler system of FIG. 9 in a recipient.

FIG. 11 shows one embodiment of an adjustable space filler system.

FIG. 12 shows an alternate embodiment of an adjustable space filler system.

FIG. 13 shows a space filler device comprising a shape retention mechanism.

FIG. 14 shows a perspective view of the space filler device of FIG. 13.

FIG. 15A shows one embodiment of a multi-balloon space filler device.

FIG. 15B shows an alternate embodiment of a multi-balloon space filler device.

FIG. 16A shows one embodiment of a free-floating space filler device.

FIG. 16B shows a simulated placement of the space filler device of FIG. 16A in a stomach.

FIG. 17A shows one embodiment of a non-floating space filler device.

FIG. 17B shows a vertical view of the non-floating space filler device of FIG. 17A.

FIG. 17C shows a simulated placement of the space filler device of FIG. 17A in a stomach.

FIG. 18 shows one embodiment of a double-balloon space filler of the present invention.

FIG. 19A shows detailed description for subassembly manufacturing of the double-balloon space filler.

FIG. 19B shows a horizontal cross-sectional view, section 1-1, of the space filler of FIG. 19A.

FIG. 19C shows a vertical cross-sectional view, section 2-2, of the space filler of FIG. 19A.

FIG. 19D shows a top cross-sectional view, section 3-3, of the space filler of FIG. 19A.

FIG. 20A shows the fluid infusing subassembly of the double-balloon space filler of FIG. 18.

FIG. 20B shows a vertical cross-sectional view, section 4-4, of the fluid infusing subassembly of FIG. 20A.

Claims

1. A double-balloon intragastric space filler for treating obesity in a patient by reducing the stomach volume, comprising a proximal inflatable balloon secured to a distal inflatable balloon by an elongate fluid infusing member having a first lumen and a second lumen, wherein said first lumen has a first slit for fluid communication with the proximal balloon and said second lumen has a second slit for fluid communication with the distal balloon.

2. The intragastric space filler of claim 1, further comprising at least one radiopaque marking.

3. The intragastric space filler of claim 2, wherein the at least one radiopaque marking is located at a proximal end of the elongate fluid infusing member.

4. The intragastric space filler of claim 3, further comprising a retrieval loop located at about the at least one radiopaque marking configured for coupling to a retrieval catheter.

5. The intragastric space filler of claim 4, wherein the retrieval loop has a diameter of between about 1 and 10 mm.

6. The intragastric space filler of claim 4, wherein the loop is located in a recessed zone but accessible to the retrieval catheter when the proximal balloon is substantially inflated.

7. The intragastric space filler of claim 2, further comprising a radiopaque marking located at a distal end of the elongate fluid infusing member.

8. The intragastric space filler of claim 1, wherein the proximal balloon is substantially larger than the distal balloon.

9. The intragastric space filler of claim 1, wherein an overall axial length of the double-balloon space filler is between about 100 and 300 mm.

10. The intragastric space filler of claim 1, wherein an overall axial length of the double-balloon space filler is between about 150 and 200 mm.

11. The intragastric space filler of claim 1, wherein a balloon wall thickness is between about 0.2 and 1.0 mm.

12. The intragastric space filler of claim 1, wherein a balloon wall thickness is between about 0.3 to 0.5 mm.

13. The intragastric space filler of claim 1, wherein a distance between the two balloons is between about 10 to 40 mm.

14. The intragastric space filler of claim 1, wherein a distance between the two balloons is between about 20 and 30 mm.

15. The intragastric space filler of claim 1, wherein the fluid infusing member has an inner diameter of between about 1 and 6 mm.

16. The intragastric space filler of claim 1, wherein the fluid infusing member has an inner diameter of between about 3 and 5 mm.

17. The intragastric space filler of claim 1, wherein a wall thickness of the fluid infusing member is between about 0.2 and 2 mm.

18. The intragastric space filler of claim 1, wherein a wall thickness of the fluid infusing member is between about 0.5 and 1.5 mm.

19. The intragastric space filler of claim 1, wherein the proximal balloon is expandable to a space volume of between about 100 and 600 cc.

20. The intragastric space filler of claim 1, wherein the proximal balloon is expandable to a space volume of between about 300 and 500 cc.