Pyloric valve corking device

• US 9,642,735 B2
• Filed: 11/20/2006
• Issued: 05/09/2017
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Burnett, Daniel R.
• Primary Examiner(s): David, Shaun L.
• Application Number:
  US11/602,620
• Publication Number:
  US 20070135831A1
• Time in Patent Office: 3,823 Days
• Field of Search: 623 2364, 623 2365, 623 2371, 606151, 606157, 600 37
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12086 magnetically detachable
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

Pyloric valve corking devices are disclosed herein that generally include an occluding member, expanding from a first configuration to a larger second configuration, and a bridging member extending from the occluding member. The bridging member has a length that is adapted to pass at least partially through the gastric opening, so to enable the occluding member to obstruct the gastric opening, and that is also adapted to permit the occluding member to intermittently move relative to the gastric opening. A second occluding member may be attached to the distal end of the bridging member. The reduction in flow of gastric contents into the duodenum can be actively regulated using a pump or valve, or can be passively regulated with movements of the occluding device.

Claims

1. A device for obstructing a gastric opening, comprising:

an occluding member having an inflated state and an uninflated state, wherein an outer diameter of the occluding member is configured to expand when fluid enters the occluding member and the occluding member is inflated from the uninflated state to the inflated state after deployment, wherein the occluding member is further adapted to collapse from the inflated state back to the uninflated state for removal and wherein the inflated state of the occluding member is a radially expanded shape which inhibits permanent obstruction of the gastric opening;

a bridging member extending from the occluding member, wherein the bridging member has a length adapted to pass at least partially through the gastric opening and to enable the occluding member to obstruct the gastric opening, and wherein the length further maintains a diameter which is sufficient to permit the occluding member and the bridging member to intermittently move relative to the gastric opening without obstructing the gastric opening, wherein the bridging member maintains its shape prior to and after deployment through the gastric opening; and

a second member connected to a distal end of the bridging member, where the second member has a diameter which is relatively larger than the bridging member and smaller than the outer diameter of the occluding member when the occluding member is in the inflated state.

2. The device of claim 1, wherein the occluding member is adapted to expand from the uninflated state during delivery to the inflated state during placement within the gastric opening.

3. The device of claim 1, further comprising a fluid for inflating the occluding member.

4. The device of claim 3, wherein the fluid comprises a liquid or gas.

5. The device of claim 1, further comprising a visible dye or marker infused within the occluding member.

6. The device of claim 1, wherein the occluding member is comprised of a distensible material.

7. The device of claim 1, wherein the occluding member is comprised of a material visually distinct from bodily tissue.

8. The device of claim 1, further comprising a biodegradable covering over the occluding member, the covering being adapted to degrade upon insertion within a gastric lumen.

9. The device of claim 1, wherein the occluding member comprises an expandable foam.

10. The device of claim 1, wherein the occluding member comprises an expandable hydrogel.

11. The device of claim 1, wherein the occluding member comprises an expandable scaffolding.

12. The device of claim 1, wherein the occluding member defines a cross-sectional shape along a longitudinal axis, the shape being selected from the group consisting of circles, ellipses, triangles, diamonds, rectangles, squares, and combinations thereof.

13. The device of claim 1, wherein the second member comprises a weighted member.

14. The device of claim 13, wherein the second occluding member comprises an expandable foam.

15. The device of claim 13, wherein the second occluding member comprises an expandable hydrogel.

16. The device of claim 13, wherein the second member comprises an expandable scaffolding.

17. The device of claim 1, wherein the second member and the occluding member are in fluid communication through the bridging member.

18. The device of claim 1, wherein the second member is inflatable.

19. The device of claim 18, further comprising a visible dye or marker within the second member.

20. The device of claim 18, wherein the second member is comprised of a distensible material.

21. The device of claim 18, wherein the second member is comprised of a material visually distinct from bodily tissue.

22. The device of claim 18 further comprising a biodegradable covering over the second member, the covering being adapted to degrade upon insertion within a gastric lumen.

23. The device of claim 22, wherein the occluding member also comprises a biodegradable covering thereon, the covering over the second member being adapted to degrade at a rate different from a degradation rate of the covering over the occluding member.

24. The device of claim 22, wherein the occluding member also comprises a biodegradable covering thereon, the covering over the second member being adapted to degrade at a rate similar to a degradation rate of the covering over the occluding member.

25. The device of claim 1, wherein the second member is further adapted to collapse.

26. The device of claim 1, wherein the bridging member has a length of at least 2 cm.

27. The device of claim 1, wherein the bridging member has a diameter which is less than a diameter of the occluding member in the inflated state.

28. The device of claim 1, wherein the bridging member defines a lumen therethrough with a seal adapted to close the lumen.

29. The device of claim 1, wherein the bridging member comprises a weight.

30. The device of claim 1, wherein the bridging member is adapted to be positioned through the gastric opening and remain within a gastric lumen.

31. The device of claim 1, wherein the length of the bridging member is tapered.

32. The device of claim 1, wherein the bridging member defines a lumen therethrough.

33. The device of claim 32, further comprising a valve positioned within the lumen.

34. The device of claim 33, wherein the valve comprises a unidirectional valve.

35. The device of claim 33, wherein the valve comprises a passively-controlled valve.

36. The device of claim 33, wherein the valve comprises an actively-controlled valve.

37. The device of claim 1, further comprising at least one inflation port defined upon the occluding member.

38. The device of claim 37, wherein the inflation port is self-sealing.

39. The device of claim 37, wherein the inflation port is comprised of a metallic material.

40. The device of claim 39, wherein the metallic material is magnetic.

41. A system for intermittently obstructing a gastric opening, comprising:

a first occluding member and a second member, wherein the first occluding member has an inflated state and an uninflated state, wherein an outer diameter of the first occluding member is configured to expand when fluid enters the occluding member and the occluding member is inflated from the uninflated state to the inflated state after deployment, wherein the first occluding member is further adapted to collapse from the inflated state back to the uninflated state for removal and wherein the inflated state of the first occluding member defines a radially expanded shape which inhibits permanent obstruction of the gastric opening; and

a bridging member extending between the first occluding member and the second member,

wherein the bridging member has a flexible length adapted to pass through the gastric opening and to enable the first occluding member to obstruct the gastric opening and to be retained by the second member, wherein the bridging member maintains its shape prior to and after deployment, and wherein the bridging member further maintains a diameter which is sufficient to permit the first occluding member and the bridging member to intermittently move relative to the gastric opening without obstructing the gastric opening, and

wherein the second member is attached to a distal end of the bridging member and has a diameter which is larger than the diameter of the bridging member and smaller than the outer diameter of the first occluding member when the first occluding member is in the inflated state.

42. The system of claim 41, wherein the first occluding member is adapted to expand from the uninflated state during delivery to the inflated state during placement within the gastric opening.

43. The system of claim 41, further comprising a fluid for inflating at least one of the first occluding member and the second member.

44. The system of claim 41, further comprising a visible dye or marker infused within at least one of the first occluding member and the second member.

45. The system of claim 41, wherein at least one of the first occluding member and the second member is comprised of a distensible material.

46. The system of claim 41, wherein at least one of the first occluding member and the second member is comprised of a material visually distinct from bodily tissue.

47. The system of claim 41, further comprising a biodegradable covering over each of the first occluding member and the second member, each covering being adapted to degrade upon insertion within a gastric lumen.

48. The system of claim 41, wherein at least one of the first occluding member and the second member is comprised of an expandable foam.

49. The system of claim 41, wherein at least one of the first occluding member and the second member is comprised of an expandable hydrogel.

50. The system of claim 41, wherein at least one of the first occluding member and the second member is comprised of an expandable scaffolding.

51. The system of claim 41, wherein the second member is further adapted to collapse.

52. The system of claim 41, wherein the first occluding member and the second member are in fluid communication through the bridging member.

53. The system of claim 41, wherein the bridging member has a diameter which is less than a diameter of the first occluding member in the inflated state.

54. The system of claim 41, wherein the bridging member is adapted to expand from a first diameter to a larger second diameter.

55. The system of claim 41, wherein the length of the bridging member is tapered.

56. The system of claim 41, wherein the bridging member defines a lumen therethrough.

57. The system of claim 56, further comprising a valve positioned within the lumen.

58. The system of claim 57, wherein the valve comprises a unidirectional valve.

59. The system of claim 57, wherein the valve comprises a passively-controlled valve.

60. The system of claim 57, wherein the valve comprises an actively-controlled valve.

61. The system of claim 41, further comprising at least one inflation port defined upon at least one of the first occluding member and the second member.

62. The system of claim 61, wherein the inflation port is self-sealing.

63. The system of claim 61, wherein the inflation port is comprised of a metallic material.

64. The system of claim 63, wherein the metallic material is magnetic.

65. The system of claim 41, wherein at least one of the occluding members defines a cross-sectional shape along a longitudinal axis, the shape being selected from the group consisting of circles, ellipses, triangles, diamonds, rectangles, squares, and combinations thereof.

66. The system of claim 41, further comprising a first flexible tubing adapted to deliver the first occluding member to the gastric opening.

67. The system of claim 66, wherein the flexible tubing defines a lumen therethrough in fluid communication with at least one of the first occluding member and the second member.

68. The system of claim 66, wherein the flexible tubing further comprises a metallic attachment at a distal end of the tubing.

69. The system of claim 68, wherein the metallic attachment is magnetic.

70. The system of claim 66, further comprising a second flexible tubing adjacent to the first flexible tubing, the second tubing defining a lumen for delivery of fluids therethrough.

71. The system of claim 66, further comprising a third flexible tubing adjacent to the first flexible tubing, the third tubing defining a lumen for aspiration of fluids therethrough.

72. The system of claim 41, further comprising at least one filler defining an occupying volume for occupying a space within a gastric lumen occluded by the first occluding member.

73. The system of claim 72, further comprising a plurality of additional fillers.