Gastrointestinal sleeve device and methods for treatment of morbid obesity

• US 7,220,284 B2
• Filed: 06/29/2005
• Issued: 05/22/2007
• Est. Priority Date: 11/01/2002
• Status: Expired due to Fees

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Dann, Mitchell, Guterman, Lee, Kagan, Jonathan, Balliro, James
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/169,341
• Publication Number:
  US 20050240279A1
• Time in Patent Office: 692 Days
• Field of Search: 623 2365- 2368, 606/139, 606/153
• US Class Current: 623/23.65
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00

Abstract

Apparatus and methods are described for treatment of morbid obesity using minimally invasive techniques. The apparatus includes a system of components that may be used separately or in combination for effectively reducing stomach volume, bypassing a portion of the stomach and/or small intestines, reducing nutrient absorption in the stomach and/or small intestines and/or depositing minimally or undigested food farther than normal into the intestines, thereby stimulating intestinal responses. The components described include an artificial stoma device, a gastric sleeve device, an intestinal sleeve device and a combined gastrointestinal sleeve device.

Claims

1. A method of treating a patient, comprising the steps of:

providing an artificial stoma device;

transesophageally advancing the device to an attachment site in the vicinity of the gastroesophageal junction; and

attaching the device at the attachment site;

wherein the attaching step comprises advancing at least one anchor through a delivery cannula and through the wall of the stomach, the wall having a mucosal surface and a serosal surface, and positioning the anchor against the serosal surface; and

wherein the anchor is enlargeable from a first configuration for passing through the cannula, to a second configuration for functioning as an anchor.

2. A method of treating a patient as in claim 1, further comprising the step of attaching a proximal end of an elongate flexible tube to the stoma device, and positioning a distal end of the elongate tube in the intestine.

3. A method of treating a patient as in claim 1, wherein the stoma device provides a stoma having an inside diameter approximately equal to the diameter of the gastroesophageal junction.

4. A method of treating a patient as in claim 1, wherein the anchor is biased toward the second configuration.

5. A method of treating a patient as in claim 4, wherein the second configuration comprises a button shape.

6. A method of treating a patient, comprising the steps of:

providing an elongate tubular sleeve having a proximal end and a distal end;

transesophageally advancing the sleeve to an attachment site in the vicinity of the gastroesophageal junction;

positioning the distal end of the sleeve in the intestine; and

attaching the proximal end of the sleeve at the attachment site;

wherein the attaching step comprises advancing at least one anchor through the wall of the stomach, the wall having a mucosal surface and a serosal surface, and positioning the anchor against the serosal surface.

7. A method of treating a patient as in claim 6, wherein the advancing step comprises advancing the anchor through a delivery cannula.

8. A method of treating a patient as in claim 7, wherein the anchor is enlargeable from a first configuration for passing through the cannula, to a second configuration for functioning as an anchor.

9. A method of treating a patient as in claim 8, wherein the anchor is biased toward the second configuration.

10. A method of treating a patient as in claim 9, wherein the second configuration comprises a button shape.

11. A method of treating a patient as in claim 6, wherein at least a portion of the sleeve has a diameter of 20 to 30 mm.

12. A method of treating a patient as in claim 6, wherein at least a portion of the sleeve has a diameter on the order of 10 to 20 mm.

13. A method of treating a patient as in claim 6, wherein the wall of the sleeve is sufficiently flexible to allow peristaltic motion of the stomach to move food through the sleeve.

14. A method of treating a patient as in claim 6, wherein the providing step comprises providing an elongate tubular sleeve having reinforcement rings.

15. A method of treating a patient as in claim 6, wherein the providing step comprises providing an elongate tubular sleeve having a low friction coating.

16. A method of treating a patient as in claim 6, additionally comprising the step of reducing the volume of the stomach.

17. A method of treating a patient as in claim 6, wherein the providing step comprises providing an elongate tubular sleeve having one or more radiopaque marker.

18. A method of treating a patient as in claim 6, wherein at least a portion of the sleeve is semi-permeable.

19. A method of treating a patient as in claim 6, wherein at least a portion of the sleeve is impermeable.

20. A method of treating a patient as in claim 6, wherein the positioning the distal end of the sleeve step comprising positioning the distal end of the sleeve such that partially digested or undigested nutrients exit from the sleeve into the jejunum.

21. A method of treating a patient as in claim 6, wherein the providing step comprises providing an elongate tubular sleeve having a length of approximately 60 to 180 cm.

22. A method of treating a patient, comprising the steps of:

providing an elongate tubular sleeve having a proximal end and a distal end, wherein at least a portion of the sleeve is semi-permeable;

transesophageally advancing the sleeve to an attachment site in the vicinity of the gastroesophageal junction; and

attaching the proximal end of the sleeve at the attachment site;

wherein the attaching step comprises advancing at least one anchor through the wall of the stomach, the wall having a mucosal surface and a serosal surface, and positioning the anchor against the serosal surface.

23. A method of treating a patient as in claim 22, further comprising the step of positioning the distal end of the sleeve in the intestine.

24. A method of treating a patient as in claim 23, wherein the positioning the distal end of the sleeve step comprising positioning the distal end of the sleeve such that partially digested or undigested nutrients exit from the sleeve into the jejunum.

25. A method of treating a patient as in claim 22, wherein the advancing step comprises advancing the anchor through a delivery cannula.

26. A method of treating a patient as in claim 25, wherein the anchor is enlargeable from a first configuration for passing through the cannula, to a second configuration for functioning as an anchor.

27. A method of treating a patient as in claim 26, wherein the anchor is biased toward the second configuration.

28. A method of treating a patient as in claim 27, wherein the second configuration comprises a button shape.

29. A method of treating a patient as in claim 22, wherein at least a portion of the sleeve has a diameter of 20 to 30 mm.

30. A method of treating a patient as in claim 22, wherein at least a portion of the sleeve has a diameter on the order of 10 to 20 mm.

31. A method of treating a patient as in claim 22, wherein the wall of the sleeve is sufficiently flexible to allow peristaltic motion of the stomach to move food through the sleeve.

32. A method of treating a patient as in claim 22, wherein the providing step comprises providing an elongate tubular sleeve having reinforcement rings.

33. A method of treating a patient as in claim 22, wherein the providing step comprises providing an elongate tubular sleeve having a low friction coating.

34. A method of treating a patient as in claim 22, additionally comprising the step of reducing the volume of the stomach.

35. A method of treating a patient as in claim 22, wherein the providing step comprises providing an elongate tubular sleeve having one or more radiopaque marker.

36. A method of treating a patient as in claim 22, wherein at least a portion of the sleeve is impermeable.

37. A method of treating a patient as in claim 22, wherein the providing step comprises providing an elongate tubular sleeve having a length of approximately 60 to 180 cm.

38. A method of treating a patient, comprising the steps of:

providing an elongate tubular sleeve having a proximal end and a distal end, wherein at least a portion of the sleeve is semi-permeable;

transesophageally advancing the sleeve to an attachment site in the vicinity of the gastroesophageal junction;

attaching the proximal end of the sleeve at the attachment site; and

positioning the distal end of the sleeve in the intestine, wherein the positioning the distal end of the sleeve step comprising positioning the distal end of the sleeve such that partially digested or undigested nutrients exit from the sleeve into the jejunum;

wherein the attaching step comprises advancing at least one anchor through the wall of the stomach, the wall having a mucosal surface and a serosal surface, and positioning the anchor against the serosal surface.

39. A method of treating a patient as in claim 38, wherein the advancing step comprises advancing the anchor through a delivery cannula.

40. A method of treating a patient as in claim 39, wherein the anchor is enlargeable from a first configuration for passing through the cannula, to a second configuration for functioning as an anchor.

41. A method of treating a patient as in claim 40, wherein the anchor is biased toward the second configuration.

42. A method of treating a patient as in claim 41, wherein the second configuration comprises a button shape.

43. A method of treating a patient as in claim 38, wherein at least a portion of the sleeve has a diameter of 20 to 30 mm.

44. A method of treating a patient as in claim 38, wherein at least a portion of the sleeve has a diameter on the order of 10 to 20 mm.

45. A method of treating a patient as in claim 38, wherein the wall of the sleeve is sufficiently flexible to allow peristaltic motion of the stomach to move food through the sleeve.

46. A method of treating a patient as in claim 38, wherein the providing step comprises providing an elongate tubular sleeve having reinforcement rings.

47. A method of treating a patient as in claim 38, wherein the providing step comprises providing an elongate tubular sleeve having a low friction coating.

48. A method of treating a patient as in claim 38, additionally comprising the step of reducing the volume of the stomach.

49. A method of treating a patient as in claim 38, wherein the providing step comprises providing an elongate tubular sleeve having one or more radiopaque marker.

50. A method of treating a patient as in claim 38, wherein at least a portion of the sleeve is semi-permeable.

51. A method of treating a patient as in claim 38, wherein at least a portion of the sleeve is impermeable.

52. A method of treating a patient as in claim 38, wherein the providing step comprises providing an elongate tubular sleeve having a length of approximately 60 to 180 cm.

53. A method of treating a patient, comprising the steps of:

providing an elongate tubular sleeve having a proximal end and a distal end;

transesophageally advancing the sleeve to an attachment site in the vicinity of the gastroesophageal junction; and

attaching the proximal end of the sleeve at the attachment site;

wherein the attaching step comprises advancing at least one anchor through a delivery cannula, and through the wall of the stomach, the wall having a mucosal surface and a serosal surface, and positioning the anchor against the serosal surface;

wherein the anchor is enlargeable from a first configuration for passing through the cannula, to a second configuration for functioning as an anchor.

54. A method of treating a patient as in claim 53, further comprising the step of positioning the distal end of the sleeve in the intestine.

55. A method of treating a patient as in claim 54, wherein the positioning the distal end of the sleeve step comprising positioning the distal end of the sleeve such that partially digested or undigested nutrients exit from the sleeve into the jejunum.

56. A method of treating a patient as in claim 53, wherein the anchor is biased toward the second configuration.

57. A method of treating a patient as in claim 56, wherein the second configuration comprises a button shape.

58. A method of treating a patient as in claim 53, wherein at least a portion of the sleeve has a diameter of 20 to 30 mm.

59. A method of treating a patient as in claim 53, wherein at least a portion of the sleeve has a diameter on the order of 10 to 20 mm.

60. A method of treating a patient as in claim 53, wherein the wall of the sleeve is sufficiently flexible to allow peristaltic motion of the stomach to move food through the sleeve.

61. A method of treating a patient as in claim 53, wherein the providing step comprises providing an elongate tubular sleeve having reinforcement rings.

62. A method of treating a patient as in claim 53, wherein the providing step comprises providing an elongate tubular sleeve having a low friction coating.

63. A method of treating a patient as in claim 53, additionally comprising the step of reducing the volume of the stomach.

64. A method of treating a patient as in claim 53, wherein the providing step comprises providing an elongate tubular sleeve having one or more radiopaque marker.

65. A method of treating a patient as in claim 53, wherein at least a portion of the sleeve is semi-permeable.

66. A method of treating a patient as in claim 53, wherein at least a portion of the sleeve is impermeable.

67. A method of treating a patient as in claim 53, wherein the providing step comprises providing an elongate tubular sleeve having a length of approximately 60 to 180 cm.