Method and apparatus for modifying the exit orifice of a satiation pouch

• US 20040158331A1
• Filed: 03/12/2003
• Published: 08/12/2004
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Synecor LLC
• Inventors: Williams, Michael S., Glenn, Richard A., Stack, Richard S., Balbierz, Dan, Lunsford, John, Athas, William L., Silverstein, Fred E., Every, Nathan
• Granted Patent: US 7,146,984 B2
• Time in Patent Office: Days
• 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 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

A prosthetic device is described that is positionable within the gastro-esophageal junction region of a patient. The prosthetic device includes a proximal opening and a distal orifice that is adjustable in size prior to and/or following implantation. During use, the prosthetic device is attached to tissue of the gastro-esophageal junction region of the patient, with the device positioned such that food ingested by the patient passes from the esophagus through the proximal opening into the interior of the prosthetic device, and eventually exits the prosthetic device via the distal opening.

Claims

1. A method of positioning a prosthetic device within a patient having an esophagus, a stomach, and a gastro-esophageal junction region, the method comprising the steps of:

providing a prosthetic device having a proximal opening and a central passage;

securing the prosthetic device at the gastro-esophageal junction region of the patient, with the prosthetic device oriented such that food ingested by the patient passes from the esophagus into the proximal opening and through the central passage, and exits the prosthetic device through an exit orifice into the interior of the stomach; and

modifying the size of the exit orifice.

2. The method of claim 1 wherein the modifying step is performed after the securing step.

3. The method of claim 1 wherein the modifying step is performed prior to the securing step.

4. The method of claim 1 wherein:

the prosthetic device includes a pouch having a distal opening, and the method further provides a first component attachable to the pouch, the first component including a distal orifice having a size different than a size of the distal opening;

the modifying step includes attaching the component to the pouch such that ingested food exiting the central passage flows through the distal orifice and into the stomach.

5. The method of claim 4, further including the step of replacing the first component with a second component, the second component having an second distal orifice having a size different from the size of the first distal orifice.

6. The method of claim 4, further including the step of removing the component from the pouch to further modify the size of the exit orifice.

7. The method of claim 4 wherein the first component includes a flow restrictive insert positionable within the central passage of the pouch.

8. The method of claim 4 wherein the first component includes a flow restrictive device attachable to an exterior portion of the pouch.

9. The method of claim 1, wherein the prosthetic device includes a deformable member coupled to the prosthetic device, and wherein modifying step includes deforming the deformable member to modify the size of the exit orifice.

10. The method of claim 9 wherein the deformable member is formed of malleable material.

11. The method of claim 9 wherein the deformable member is formed of ductile material.

12. The method of claim 9 wherein the deformable member is formed of an inflatable chamber and the modifying step includes modifying the volume of inflation fluid within the inflatable chamber.

13. The method of claim 9 wherein the modifying step includes the step of extending a dilator through the central passage and expanding the dilator to expand the deformable member.

14. The method of claim 9 wherein the modifying step includes applying compressive forces against the exterior of the prosthetic device to compact the deformable member.

15. The method of claim 1 wherein the prosthetic device includes a longitudinal slit extending from the distal opening along a wall of the prosthetic device, and a zipper carriage engaged with wall sections adjacent the longitudinal slit and moveable in a proximal direction to increase the effective length of the slit and in a distal direction to decrease the effective length of the slit, the modifying step including the step of moving the zipper carriage.

16. The method of claim 1 wherein the prosthetic device includes a diaphragm extending at least partially across the central passage, the diaphragm including a shutter defining the distal opening and being rotatable between expanded and contracted positions to increase and decrease the effective diameter of the distal opening, wherein the modifying step includes rotating the shutter.

17. The method of claim 1 wherein the providing step provides a cord forming a loop around at least a portion of the prosthetic device, and wherein the modifying step includes adjusting the effective diameter of the loop.

18. The method of claim 1 wherein the modifying step includes removing a portion of the prosthetic device adjacent to the distal opening.

19. The method of claim 18 wherein the removing step includes cutting the prosthetic device using an energized electrode.

20. The method of claim 18 wherein the removing step includes cutting the prosthetic device using a sharpened tool.

21. The method of claim 18 wherein the removing step includes cutting the prosthetic device using a laser.

22. The method of claim 18 wherein the removing step includes cutting the prosthetic device using a chemical stream.

23. A medical device positionable within a gastro-esophageal junction region of a patient having an esophagus and a stomach, the medical device comprising:

a prosthetic device having a proximal opening, an exit orifice, and an central passage between the proximal opening and exit orifice, a proximal portion of the prosthetic device positionable within the gastro-esophageal junction region such that the proximal opening is in substantial alignment with the esophagus; and

a flow restrictive component on a distal portion of the prosthetic device, the flow restrictive component moveable between a first position in which the exit orifice has a first size and a second position in which the exit orifice has a second size that is smaller than the first size.

24. The medical device of claim 23 wherein in the first position the flow restrictive component is detached from to the prosthetic device and wherein in the second position the flow restrictive component is attached to the prosthetic device.

25. The medical device of claim 24 wherein the flow restrictive component is attachable to a distal portion of the prosthetic device.

26. The medical device of claim 24 wherein the flow restrictive component is an insert positionable within the central passage.

27. The medical device of claim 23 wherein the flow restrictive component is a deformable member, wherein the first position is a compressed position and the second position is an expanded position.

28. The medical device of claim 27 wherein the deformable member is formed of malleable material.

29. The medical device of claim 27 wherein the deformable member is formed of ductile material.

30. The medical device of claim 27 wherein the deformable member is formed of an inflatable chamber.

31. The medical device of claim 23 wherein the flow restrictive component includes a diaphragm extending at least partially across the central passage, the diaphragm including a shutter defining the distal opening and being rotatable between expanded and contracted positions to increase and decrease the effective diameter of the distal opening.

32. The medical device of claim 23 wherein the flow restrictive component includes a cord forming a loop around at least a portion of the prosthetic device, the loop adjustable to a tightened position to compress the prosthetic device.

33. A method of treating obesity, comprising the steps of:

providing a prosthetic device having a proximal opening and a central passage;

securing the prosthetic device at the gastro-esophageal junction region of the patient, with the prosthetic device oriented such that food ingested by the patient passes from the esophagus into the proximal opening;

causing food ingested by the patient to pass from the esophagus into the proximal opening and through the central passage, and to exit the prosthetic device through an exit orifice into the interior of the stomach; and

modifying the size of the exit orifice.

34. The method of claim 33 wherein the modifying step is performed after the securing step.

35. The method of claim 34 wherein:

prior to the modifying step food ingested by the patient flows through the exit orifice at a first rate; and

following the modifying step food ingested by the patient flows through the exit orifice at a second rate different than the first rate.

36. The method of claim 35 wherein the first rate is faster than the second rate.

37. The method of claim 35 wherein the first rate is slower than the second rate.

38. The method of claim 33 wherein the modifying step is performed prior to the securing step.

39. The method of claim 33 wherein:

the prosthetic device includes a pouch having a distal opening, and the method further provides a first component attachable to the pouch, the first component including a distal orifice having a size different than a size of the distal opening;

the modifying step includes attaching the component to the pouch such that ingested food exiting the central passage flows through the distal orifice and into the stomach.

40. The method of claim 39, further including the step of replacing the first component with a second component, the second component having an second distal orifice having a size different from the size of the first distal orifice.

41. The method of claim 39, further including the step of removing the component from the pouch to further modify the size of the exit orifice.

42. The method of claim 39 wherein the first component includes a flow restrictive insert positionable within the central passage of the pouch.

43. The method of claim 39 wherein the first component includes a flow restrictive device attachable to an exterior portion of the pouch.

44. The method of claim 33, wherein the prosthetic device includes a deformable member coupled to the prosthetic device, and wherein modifying step includes deforming the deformable member to modify the size of the exit orifice.

45. The method of claim 44 wherein the deformable member is formed of malleable material.

46. The method of claim 44 wherein the deformable member is formed of ductile material.

47. The method of claim 44 wherein the deformable member is formed of an inflatable chamber and the modifying step includes modifying the volume of inflation fluid within the inflatable chamber.

48. The method of claim 44 wherein the modifying step includes the step of extending a dilator through the central passage and expanding the dilator to expand the deformable member.

49. The method of claim 44 wherein the modifying step includes applying compressive forces against the exterior of the prosthetic device to compact the deformable member.

50. The method of claim 33 wherein the prosthetic device includes a longitudinal slit extending from the distal opening along a wall of the prosthetic device, and a zipper carriage engaged with wall sections adjacent the longitudinal slit and moveable in a proximal direction to increase the effective length of the slit and in a distal direction to decrease the effective length of the slit, the modifying step including the step of moving the zipper carriage.

51. The method of claim 33 wherein the prosthetic device includes a diaphragm extending at least partially across the central passage, the diaphragm including a shutter defining the distal opening and being rotatable between expanded and contracted positions to increase and decrease the effective diameter of the distal opening, wherein the modifying step includes rotating the shutter.

52. The method of claim 33 wherein the providing step provides a cord forming a loop around at least a portion of the prosthetic device, and wherein the modifying step includes adjusting the effective diameter of the loop.

53. The method of claim 33 wherein the modifying step includes removing a portion of the prosthetic device adjacent to the distal opening.

54. The method of claim 53 wherein the removing step includes cutting the prosthetic device using an energized electrode.

55. The method of claim 53 wherein the removing step includes cutting the prosthetic device using a sharpened tool.

56. The method of claim 53 wherein the removing step includes cutting the prosthetic device using a laser.

57. The method of claim 53 wherein the removing step includes cutting the prosthetic device using a chemical stream.

58. A method of treating obesity, comprising the steps of:

providing a base device and a prosthetic device having a proximal opening and a central passage;

securing the base device at the gastro-esophageal junction region of the patient;

allowing tissue of the gastro-esophageal junction region to at least partially heal for a period of time following the securing step;

after the allowing step, attaching the prosthetic device to the base device, with the prosthetic device oriented such that food ingested by the patient passes into the proximal opening;

causing food ingested by the patient to pass into the proximal opening and through the central passage, and to exit the prosthetic device through an exit orifice into the interior of the stomach.

59. The method of claim 58 wherein the period of time is at least one day.

60. The method of claim 58 wherein the period of time is more than one week.

61. The method of claim 58, wherein the proximal opening is larger than the exit orifice.

62. The method of claim 58 further including the step of modifying the size of the exit orifice.

63. The method of claim 62 wherein the modifying step is performed after the step of attaching the prosthetic device to the base device.

64. The method of claim 62 wherein:

prior to the modifying step food ingested by the patient flows through the exit orifice at a first rate; and

following the modifying step food ingested by the patient flows through the exit orifice at a second rate different than the first rate.

65. The method of claim 64 wherein the first rate is faster than the second rate.

66. The method of claim 64 wherein the first rate is slower than the second rate.