Shunt apparatus for treating obesity by extracting food

• US 20080091146A1
• Filed: 07/03/2007
• Published: 04/17/2008
• Est. Priority Date: 07/05/2006
• Status: Abandoned Application

• Current Assignee: Aspire Bariatrics, LLC
• Original Assignee: Aspiration Medical Technologies LLC
• Inventors: Solovay, Kenneth, Klein, Samuel, Shike, Moshe, Solomon, Stephen
• Application Number:
  US11/824,953
• Publication Number:
  US 20080091146A1
• Time in Patent Office: Days
• US Class Current: 604/174
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

To treat obesity, a tube is positioned so that it passes through a patient'"'"'s abdominal wall into the upper digestive system of the patient. The patient is allowed to carry out his/her everyday affairs including ingesting food. After ingestion, food is extracted by pumping it out of the upper digestive system through the tube. The embodiments described herein take advantage of some properties of ePTFE to provide a number of significant advantages.

Claims

1. An apparatus comprising:

a. a tube comprising

i. a distal segment having a sidewall with a plurality of holes located therein, wherein said distal segment is adapted to be disposed in an upper digestive system of a patient; and

ii. a proximal segment that is configured to pass through the patient'"'"'s abdominal wall when the distal segment is disposed in the upper digestive system of the patient; and

b. a helical support disposed on an outside surface of at least a portion of the tube.

2. The apparatus of claim 1, wherein the helical support is disposed on the proximal segment of the tube.

3. The apparatus of claim 1, wherein the proximal segment inner diameter measures from about 5 mm to about 10 mm.

4. The apparatus of claim 1, wherein the proximal segment inner diameter measures about 7 mm.

5. The apparatus of claim 1, wherein the proximal segment inner diameter measures 1 mm smaller than its outer diameter.

6. The apparatus of claim 1, wherein the helical support is selected to provide a desired radial strength to the portion of the tube.

7. The apparatus of claim 1, wherein the helical support is selected to provide at least one of a desired radial strength, flexibility, and kink-resistance.

8. The apparatus of claim 1, wherein the helical support comprises one or more of:

PTFE, Kevlar, and metal.

9. The apparatus of claim 1, wherein the diameter of the helical support ranges from about 0.25 mm to about 1 mm.

10. The apparatus of claim 9, wherein the helical support has a helical pitch measuring from about 2 mm to about 3 mm.

11. The apparatus of claim 1, wherein at least a portion of the tube comprises ePTFE.

12. The apparatus of claim 11, wherein at least a portion of the tube has a water entry pressure measuring at least 4 psi.

13. The apparatus of claim 1, wherein the proximal segment comprises ePTFE.

14. The apparatus of claim 1, wherein at least a portion of the proximal segment comprises ePTFE.

15. The apparatus of claim 14, wherein the ePTFE has an internodal distance of from about 5 μ

m to about 120 μ

m.

16. The apparatus of claim 15 wherein the internodal distance is selected to achieve a desired biological incorporation of the tube.

17. The apparatus of claim 1, wherein at least a portion of the tube comprises a microporous material.

18. The apparatus of claim 1, wherein a bumper is disposed between the distal segment and the proximal segment.

19. The apparatus of claim 1, further comprising a first retention member attached to the tube to prevent dislodgement of the tube.

20. The apparatus of claim 1, further comprising a flange configured with respect to the proximal segment, an inside surface of the flange is adapted to mate with a portion of the proximal segment such that a portion of the flange will lie substantially flush with the patient'"'"'s abdominal surface when the distal segment of the tube is disposed in the upper digestive system of the patient.

21. The apparatus of claim 20, wherein a portion of the proximal segment exterior to the flange is removed.

22. The apparatus of claim 20, wherein the inside surface of the flange comprises a thread that complements the helical support.

23. The apparatus of claim 20, wherein the inside surface of the flange comprises at least one indentation that complements at least one detent disposed on the outside surface of the proximal segment.

24. The apparatus of claim 20, further comprising a cap that removably mates with the flange.

25. The apparatus of claim 24, wherein the cap removably mates with the flange by one or more of complementary threads, tension fit with an exterior of a portion of the flange, tension fit with an interior of a portion of the flange, and magnetic attachment.

26. The apparatus of claim 20, further comprising a cap having internal threads disposed on an inside surface, wherein the internal threads are dimensioned to mate with external threads disposed on an outside surface of the flange.

27. The apparatus of claim 20, further comprising a valve that mates with the flange, the valve prevents and allows fluid flow into and out of the tube.

28. The apparatus of claim 1, further comprising a proximal leader attached to a proximal end of the proximal segment, wherein a pull wire attached to a tapered dilater is disposed on a proximal end of the proximal leader.

29. The apparatus of claim 28, wherein the proximal leader is detached from the proximal segment by cutting.

30. An apparatus comprising:

a. a tube comprising

i. a distal segment having a sidewall with a plurality of holes located therein, wherein said distal segment is adapted to be disposed in an upper digestive system of a patient; and

ii. a proximal segment comprising ePTFE, wherein the proximal segment is configured to pass through the patient'"'"'s abdominal wall when the distal segment is disposed in the upper digestive system of the patient.

31. The apparatus of claim 30, further comprising a helical support disposed on an outside surface of at least a portion of the tube.

32. The apparatus of claim 30, wherein a bumper is disposed between the distal segment and the proximal segment.

33. The apparatus of claim 30, further comprising a flange configured with respect to the proximal segment, an inside surface of the flange is adapted to mate with a portion of the proximal segment such that the flange will lie substantially flush with the patient'"'"'s abdominal surface when the distal segment of the tube is disposed in the upper digestive system of the patient.

34. The apparatus of claim 33, wherein the inside surface of the flange comprises a thread that complements a helical support disposed on the outside surface of at least a portion of the tube.

35. The apparatus of claim 33, wherein a portion of the proximal segment exterior to the flange is removed.

36. The apparatus of claim 35, wherein a portion of the proximal segment exterior to the flange is plastically deformable and is expanded by exposure to intraluminal radial force.

37. The apparatus of claim 36, wherein a cap comprising a cap tube couples to the flange such that the cap tube enters a lumen in the proximal segment.

38. The apparatus of claim 33, wherein the inside surface of the flange comprises at least one indentation that complements at least one detent disposed on the outside surface of the proximal segment.

39. The apparatus of claim 33, further comprising a cap that removably mates with the flange.

40. The apparatus of claim 33, further comprising a valve that mates with the flange, the valve prevents and allows fluid flow into and out of the tube.

41. The apparatus of claim 30, wherein the ePTFE has an internodal distance of from about 5 μ

m to about 120 μ

m.

42. The apparatus of claim 41 wherein the internodal distance is selected to achieve a desired biological incorporation of the tube.

43. The apparatus of claim 30, wherein the proximal segment inner diameter measures from about 5 mm to about 10 mm.

44. The apparatus of claim 30, wherein the proximal segment inner diameter measures about 7 mm.

45. The apparatus of claim 30, wherein the proximal segment inner diameter measures 1 mm smaller than its outer diameter.

46. The apparatus of claim 30, wherein at least a portion of the tube has a water entry pressure measuring at least 4 psi.

47. The apparatus of claim 30, further comprising a proximal leader attached to a proximal end of the proximal segment, wherein a pull wire attached to a tapered dilater is disposed on a proximal end of the proximal leader.

48. The apparatus of claim 47, wherein the proximal leader is detached from the proximal segment by cutting.

49. An apparatus comprising:

a. a tube comprising

i. a distal segment having a sidewall with a plurality of holes located therein, wherein said distal segment is adapted to be disposed in an upper digestive system of a patient;

ii. a proximal segment that is configured to pass through the patient'"'"'s abdominal wall when the distal segment of the tube is disposed in the upper digestive system of the patient; and

b. a tubular sleeve comprising ePTFE configured to surround the outer diameter of at least a portion of the proximal segment of the tube.

50. The apparatus of claim 49, wherein the tubular sleeve comprises a washer.

51. The apparatus of claim 49, wherein the tubular sleeve comprises a collar.

52. The apparatus of claim 49, wherein the ePTFE has an internodal distance of from about 5 μ

m to about 120 μ

m.

53. The apparatus of claim 52 wherein the internodal distance is selected to achieve a desired biological incorporation of the tube.

54. The apparatus of claim 49, wherein the proximal segment inner diameter measures from about 5 mm to about 10 mm.

55. The apparatus of claim 49, wherein the proximal segment inner diameter measures about 7 mm.

56. The apparatus of claim 49, wherein the proximal segment inner diameter measures 1 mm smaller than its outer diameter.

57. An apparatus comprising:

a. a tube comprising

i. a distal segment adapted to be disposed in a body of a patient; and

ii. a proximal segment that is configured to pass through the patient'"'"'s skin when the distal segment is disposed in the body of the patient; and

b. a helical support disposed on an outside surface of at least a portion of the tube.

58. The apparatus of claim 57, wherein the proximal segment comprises ePTFE.

59. The apparatus of claim 57, wherein the distal segment has a sidewall with a plurality of holes located therein.

60. The apparatus of claim 57, wherein the helical support is disposed on the proximal segment.

61. A tube having a lumen, at least a portion of the tube is configured to pass through a patient'"'"'s skin, wherein the portion has a microporous structure that does not leak when liquid flows through the lumen at a pressure of less than 4 psi.

62. The tube of claim 61, wherein the microporous structure comprises ePTFE.

63. The tube of claim 61, wherein the microporous structure has an internodal distance of from about 5 μ

m to about 120 μ

m.

64. The tube of claim 61, wherein the internodal distance is selected to achieve a desired biological incorporation.

65. The tube of claim 61, wherein a helical support is disposed on the portion.

66. A tube comprising:

a. a distal segment adapted to be disposed in an upper digestive system of a patient, the distal segment comprises an elastomeric extruded material and has a distal segment wall thickness; and

b. a proximal segment comprising a material different from the distal segment, the proximal segment has a proximal segment wall thickness measuring at least 25% less than the distal segment wall thickness, wherein the proximal segment is configured to pass through the patient'"'"'s abdominal wall when the distal segment is disposed in the patient'"'"'s upper digestive system.

67. A kit for use in the body of a patient, the kit comprising:

a. a gastrostomy tube having a helical support disposed on at least a portion of an outside surface of the gastrostomy tube;

b. a flange, an inside surface of the flange having a thread that complements the helical support such that when the flange is screwed down onto the tube a portion of the flange lies substantially flush with an exterior surface of a patient'"'"'s skin; and

c. a cap that couples to the flange.

68. The kit of claim 67, wherein the cap has an inside surface comprising internal threads dimensioned to mate with external threads disposed on an outside surface of the flange.

69. The kit of claim 67, wherein the cap further comprises a valve that prevents and allows fluid flow into and out of the tube.

70. The kit of claim 67, wherein the flange has a low profile.

71. The kit of claim 67, wherein the tube comprises a plastically deformable material.

72. The kit of claim 67, wherein the thread interacts with the helical structure to adjust the tube length by exposing a portion of the tube exterior to the flange.

73. The kit of claim 72, wherein the portion of the tube exterior to the flange is detached by cutting.

74. The kit of claim 67 wherein the cap detachably couples to the flange.

75. A kit for use with a gastrostomy tube having a helical support disposed on at least a portion of an outside surface of the gastrostomy tube, the kit comprising:

a. a flange, an inside surface of the flange having a thread that complements the helical support such that when the flange is screwed down onto the tube a portion of the flange lies substantially flush with an exterior surface of a patient'"'"'s skin; and

b. a cap that couples to the flange.

76. The kit of claim 75 wherein the cap detachably couples to the flange.