Pyloric valve corking device

• US 20070135831A1
• Filed: 11/20/2006
• Published: 06/14/2007
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Burnett, Daniel
• Granted Patent: US 9,642,735 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• 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 adapted to expand from a first configuration to a larger second configuration; and

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 is further adapted to permit the occluding member to intermittently move relative to the gastric opening.

2. The device of claim 1, wherein the occluding member is adapted to expand from the first configuration during delivery to the second configuration during placement within the gastric opening.

3. The device of claim 1, wherein the occluding member comprises an inflatable member adapted to expand from the first configuration to the second configuration.

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

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

6. The device of claim 3, further comprising a visible dye or marker within the inflatable member.

7. The device of claim 3, wherein the inflatable member is comprised of a distensible material.

8. The device of claim 3, wherein the inflatable member is comprised of a material visually distinct from bodily tissue.

9. 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.

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

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

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

13. The device of claim 12, wherein the scaffolding is comprised of a shape memory alloy adapted to self-expand.

14. The device of claim 13, wherein the shape memory alloy comprises Nitinol.

15. The device of claim 12, wherein the scaffolding is comprised of a super-elastic alloy.

16. The device of claim 1, wherein the occluding member is further adapted to collapse from the second configuration to the first configuration.

17. 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.

18. The device of claim 1, further comprising a second occluding member connected to a distal end of the bridging member, wherein the second occluding member is adapted to expand from a first configuration to a larger second configuration.

19. The device of claim 18, wherein the second occluding member and the occluding member are in fluid communication through the bridging member.

20. The device of claim 18, wherein the second configuration of the second occluding member is smaller relative to the second configuration of the occluding member.

21. The device of claim 18, wherein the second configuration of the second occluding member is larger relative to the second configuration of the occluding member.

22. The device of claim 18, wherein the second configuration of the second occluding member is equivalent in size to the second configuration of the occluding member.

23. The device of claim 18, wherein the second occluding member comprises an inflatable member adapted to expand from the first configuration to the second configuration.

24. The device of claim 23, further comprising a visible dye or marker within the inflatable member.

25. The device of claim 23, wherein the inflatable member is comprised of a distensible material.

26. The device of claim 23, wherein the inflatable member is comprised of a material visually distinct from bodily tissue.

27. The device of claim 23 further comprising a biodegradable covering over the second occluding member, the covering being adapted to degrade upon insertion within a gastric lumen.

28. The device of claim 27, wherein the occluding member also comprises a biodegradable covering thereon, the covering over the second occluding member being adapted to degrade at a rate different from a degradation rate of the covering over the occluding member.

29. The device of claim 27, wherein the occluding member also comprises a biodegradable covering thereon, the covering over the second occluding member being adapted to degrade at a rate similar to a degradation rate of the covering over the occluding member.

30. The device of claim 18, wherein the second occluding member comprises an expandable foam.

31. The device of claim 18, wherein the second occluding member comprises an expandable hydrogel.

32. The device of claim 18, wherein the second occluding member comprises an expandable scaffolding.

33. The device of claim 32, wherein the scaffolding is comprised of a shape memory alloy adapted to self-expand.

34. The device of claim 33, wherein the shape memory alloy comprises Nitinol.

35. The device of claim 32, wherein the scaffolding is comprised of a super-elastic alloy.

36. The device of claim 18, wherein the second occluding member is further adapted to collapse from the second configuration to the first configuration.

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

38. The device of claim 1, wherein the bridging member has a diameter which is less than a diameter of the second configuration.

39. The device of claim 1, wherein the bridging member is adapted to expand from a first diameter to a larger second diameter.

40. The device of claim 1, wherein the bridging member is flexible.

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

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

43. The device of claim 1, wherein a distal end of the bridging member is weighted.

44. The device of claim 1, wherein a distal end of the bridging member comprises at least one retaining member.

45. The device of claim 44 wherein the retaining member comprises hooks or barbs.

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

47. The device of claim 46, further comprising a valve positioned within the lumen.

48. The device of claim 47, wherein the valve comprises a unidirectional valve.

49. The device of claim 47, wherein the valve comprises a passively-controlled valve.

50. The device of claim 47, wherein the valve comprises an actively-controlled valve.

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

52. The device of claim 51, wherein the inflation port is self-sealing.

53. The device of claim 51, wherein the inflation port is comprised of a metallic material.

54. The device of claim 53, wherein the metallic material is magnetic.

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

a first occluding member and a second occluding member each adapted to expand from a first configuration to a larger second configuration; and

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

wherein the bridging member has a 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 occluding member, and wherein the bridging member is further adapted to permit the first occluding member to intermittently move relative to the gastric opening.

56. The system of claim 55, wherein each of the first and the second occluding members is adapted to expand from the first configuration during delivery to the second configuration during placement within the gastric opening.

57. The system of claim 55, wherein each of the first and the second occluding members comprises an inflatable member adapted to expand from the first configuration to the second configuration.

58. The system of claim 55, further comprising a fluid for inflating at least one of the occluding members.

59. The system of claim 55, further comprising a visible dye or marker in at least one of the occluding members.

60. The system of claim 55, wherein at least one of the occluding members is comprised of a distensible material.

61. The system of claim 55, wherein at least one of the occluding members is comprised of a material visually distinct from bodily tissue.

62. The system of claim 55, further comprising a biodegradable covering over each of the occluding members, each covering being adapted to degrade upon insertion within a gastric lumen.

63. The system of claim 55, wherein at least one of the occluding members is comprised of an expandable foam.

64. The system of claim 55, wherein at least one of the occluding members is comprised of an expandable hydrogel.

65. The system of claim 55, wherein at least one of the occluding members is comprised of an expandable scaffolding.

66. The system of claim 55, wherein at least one of the occluding members is comprised of a shape memory alloy adapted to self-expand.

67. The system of claim 66, wherein the shape memory alloy is comprised of a super-elastic alloy.

68. The system of claim 66, wherein the shape memory alloy is comprised of Nitinol.

69. The system of claim 55, wherein at least one of the occluding members is further adapted to collapse from the second configuration to the first configuration.

70. The system of claim 55, wherein the first and the second occluding members are in fluid communication through the bridging member.

71. The system of claim 55, wherein the second configuration of the second occluding member is smaller relative to the second configuration of the first occluding member.

72. The system of claim 55, wherein the second configuration of the second occluding member is larger relative to the second configuration of the first occluding member.

73. The system of claim 55, wherein the second configuration of the second occluding member is equivalent in size to the second configuration of the first occluding member.

74. The system of claim 55, wherein the bridging member has a diameter which is less than a diameter of the second configuration.

75. The system of claim 55, wherein the bridging member is adapted to expand from a first diameter to a larger second diameter.

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

77. The system of claim 55, wherein the bridging member defines a lumen therethrough.

78. The system of claim 77, further comprising a valve positioned within the lumen.

79. The system of claim 78, wherein the valve comprises a unidirectional valve.

80. The system of claim 78, wherein the valve comprises a passively-controlled valve.

81. The system of claim 78, wherein the valve comprises an actively-controlled valve.

82. The system of claim 55, further comprising at least one inflation port defined upon at least one of the occluding members.

83. The system of claim 82, wherein the inflation port is self-sealing.

84. The system of claim 82, wherein the inflation port is comprised of a metallic material.

85. The system of claim 84, wherein the metallic material is magnetic.

86. The system of claim 55, 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.

87. The system of claim 55, further comprising a first flexible tubing adapted to deliver the first and a second occluding members to the gastric opening.

88. The system of claim 87, wherein the flexible tubing defines a lumen therethrough in fluid communication with at least one of the first and second occluding members.

89. The system of claim 87, wherein the flexible tubing further comprises a metallic attachment at a distal end of the tubing.

90. The system of claim 89, wherein the metallic attachment is magnetic.

91. The system of claim 87, further comprising a second flexible tubing adjacent to the first flexible tubing, the second tubing defining a lumen for delivery of fluids therethrough.

92. The system of claim 87, further comprising a third flexible tubing adjacent to the first flexible tubing, the third tubing defining a lumen for aspiration of fluids therethrough.

93. The system of claim 55, further comprising at least one filler defining an occupying volume for occupying a space within a gastric lumen occluded by the first occluding member.

94. The system of claim 93, further comprising a plurality of additional fillers.