Satiation devices and methods

• US 20040172142A1
• Filed: 03/04/2004
• Published: 09/02/2004
• Est. Priority Date: 08/27/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Fred E. Silverstein, Nathan Every, Richard A. Glenn, Richard S. Stack, Trevor J. Moody, William S. Eubanks Jr
• Inventors: Glenn, Richard A., Stack, Richard S., Moody, Trevor J., Eubanks, William S. Jr., Silverstein, Fred E., Every, Nathan
• Granted Patent: US 7,121,283 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 2/07 Stent-grafts
• 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 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 5/0069 in the wall of the stomach
• 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

Abstract

A device for inducing weight loss in a patient includes a tubular prosthesis self-expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter. In a method for inducing weight loss, the prosthesis is placed in the collapsed position and inserted into a stomach of a patient. The prosthesis is allowed to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach, where it induces feelings of satiety and/or inhibits modulation of satiety-controlling factors such as Ghrelin.

Claims

19. A method of effecting weight loss in a patient, comprising the steps of:

providing a prosthesis including an antral tube expandable from a collapsed position in which the antral tube has a first diameter to an expanded position in which the antral tube has a second, larger, diameter;

further providing a bowel tube attachable to a distal portion of the antral tube, the bowel tube having a diameter smaller than the second diameter of the antral tube;

with the antral tube in the collapsed position, inserting the antral tube into an antrum of a patient;

allowing the antral tube to self-expand from the collapsed position to the expanded position and into contact with the walls of the atrum;

attaching the bowel tube to the antral tube; and

positioning the bowel tube within the intestine of the patient.

20. The method of claim 19 wherein the attaching step is performed prior to the inserting step.

21. The method of claim 19 wherein the attaching step is performed after the inserting step.

22. The method of claim 19, including the step of causing food ingested by the patient to pass through the antral tube and the bowel tube.

24. The method of claim 19 wherein the antral tube includes a waist section, and wherein the method includes causing the waist section to seat at the pyloric sphincter of the stomach.

25. The method of claim 19 wherein the contact between the antral tube and the walls of the stomach secures the antral tube in place in the stomach.

26. The method of claim 19 wherein the contact between the antral tube and the walls of the stomach causes feelings of satiation in the patient.

27. The method of claim 26 wherein the contact between the prosthesis and the walls of the stomach suppresses production in the patient of a chemical mediator of the sensation of hunger.

28. The method of claim 27 wherein the chemical mediator includes Ghrelin.

32. The method of claim 19 wherein the antral tube is formed of a mesh.

33. The method of claim 24 wherein the antral tube includes a valve at the waist section and wherein the method includes preventing reflux of bile from the duodenum into the antrum using the valve.

34. The method of claim 19 wherein the antral tube includes a proximal end and wherein the method includes the step of inserting a snare into the stomach, placing the snare around the proximal end, and withdrawing the snare to collapse the antral tube.

35. The method of claim 34 further including the step of further withdrawing the snare to remove the collapsed antral tube from the stomach.

36. The method of claim 19 wherein the inserting step includes the steps of placing the antral tube in an elongate sheath and inserting the elongate sheath into the stomach, and wherein the allowing step includes withdrawing the elongate sheath from the antral tube, causing the antral tube to spring to the expanded position.

23. The method of claim 23 wherein the step of causing food to pass through the bowel tube includes preventing contact between the food and the portion of the intestine surrounding the bowel tube.

37. A method of effecting weight loss in a patient, comprising the steps of:

providing a prosthesis including an antral tube expandable from a collapsed position in which the antral tube has a first diameter to an expanded position in which the antral tube has a second, larger, diameter;

further providing a fundal basket attachable to a proximal portion of the antral tube;

with the antral tube in the collapsed position, inserting the antral tube into an antrum of a patient;

allowing the antral tube to self-expand from the collapsed position to the expanded position and into contact with the walls of the atrum;

attaching the fundal basket to the antral tube; and

positioning the fundal basket within the fundus of the stomach.

38. The method of claim 37 wherein the attaching step is performed prior to the inserting step, wherein the fundal basket includes a collapsed position and an expanded condition, and wherein the step of positioning the fundal basket in the fundus includes introducing the fundal basket and antral tube into the stomach in their collapsed positions, and allowing the fundal basket and antral tube to self expand into their expanded positions.

39. The method of claim 37 wherein the attaching step is performed after the inserting step.

40. The method of claim 37, including the step of causing food ingested by the patient to pass through the fundal basket and the antral tube.

41. The method of claim 37 wherein the contact between the prosthesis and the walls of the stomach secures the prosthesis in place in the stomach.

42. The method of claim 37 wherein contact between the antral tube and the walls of the stomach causes feelings of satiation in the patient.

43. The method of claim 42 wherein the contact between the prosthesis and the walls of the stomach suppresses production in the patient of a chemical mediator of the sensation of hunger.

44. The method of claim 43 wherein the chemical mediator includes Ghrelin.

45. The method of claim 37 wherein the antral tube is formed of a shape memory material.

46. The method of claim 45 wherein the shape memory material is nitinol.

47. The method of claim 45 wherein the shape memory material is a shape memory polymer.

48. The method of claim 37 wherein the antral tube is formed of a mesh.

49. The method of claim 37 wherein the fundal basket includes a proximal end and wherein the method includes the step of inserting a snare into the stomach, placing the snare around the proximal end, and withdrawing the snare to collapse the fundal basket and antral tube.

50. The method of claim 49 further including the step of further withdrawing the snare to remove the collapsed fundal basket and antral tube from the stomach.

51. The method of claim 37 wherein the inserting step includes the steps of placing the fundal basket in an elongate sheath and inserting the elongate sheath into the stomach, and wherein the allowing step includes withdrawing the elongate sheath from the fundal tube.

52. The method of claim 38 wherein the inserting step includes the steps of placing the fundal basket and antral tube in an elongate sheath and inserting the elongate sheath into the stomach, and wherein the allowing step includes withdrawing the elongate sheath from the fundal basket and antral tube.

53. The method of claim 37 further including the steps of:

attaching a bowel tube to a distal portion of the antral tube; and

positioning the bowel tube within the intestine of the patient.

54. The method of claim 53 wherein step of attaching the bowel tube is performed prior to the step of inserting the antral tube into the antrum of a patient.

55. The method of claim 53 wherein step of attaching the bowel tube is performed after the step of inserting the antral tube into the antrum of a patient.

56. The method of claim 53, further including the step of causing food ingested by the patient to pass through the fundal basket, antral tube, and bowel tube.

57. An apparatus for inducing weight loss in a patient, comprising:

a prosthesis proportioned for placement in the stomach, the prosthesis defining a lumen for passage of food therethrough, the prosthesis self-expandable from a collapsed position to an expanded position, the prosthesis further including

an antral portion sized for positioning within an antrum of a stomach such that exterior walls of the antral portion contact adjacent walls of the stomach,

an intestinal portion sized for positioning within the duodenum such that exterior walls of the intestinal portion contact adjacent walls of the duodenum, and

an intermediate portion extending between the antral portion and the intestinal portion for placement within the pyloric sphincter of the stomach.

1. A method of inducing weight loss in a patient, comprising the steps of:

providing a tubular prosthesis expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter;

with the prosthesis in the collapsed position, inserting the prosthesis into a stomach of a patient; and

allowing the prosthesis to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach.

2. The method of claim 1 wherein the inserting step includes inserting the prosthesis into the antrum of a stomach and wherein the allowing step causes the prosthesis to self-expand into contact with the walls of the antrum.

3. The method of claim 2 wherein the prosthesis includes a waist section, and wherein the method includes causing the waist section to seat at the pyloric sphincter of the stomach.

4. The method of claim 1 wherein the contact between the prosthesis and the walls of the stomach secures the prosthesis in place in the stomach.

5. The method of claim 1 wherein the contact between the prosthesis and the walls of the stomach causes feelings of satiation in the patient.

6. The method of claim 5 wherein the contact between the prosthesis and the walls of the stomach suppresses production in the patient of a chemical mediator of the sensation of hunger.

7. The method of claim 6 wherein the chemical mediator includes Ghrelin.

8. The method of claim 1 wherein the prosthesis includes a self-expanding framework in combination with a fluid impermeable barrier, the fluid impermeable barrier preventing movement of food material through the walls of the prosthesis and into the stomach.

9. The method of claim 1 wherein the prosthesis includes a fluid-permeable reservoir containing a satiety-controlling substance, and wherein the method includes allowing the satiety-controlling substance to pass from the fluid-permeable reservoir into the stomach.

10. The method of claim 1 wherein the prosthesis includes a membrane impregnated with a satiety-controlling substance, and wherein the method includes allowing the satiety-controlling substance to pass from the membrane into the stomach.

11. The method of claim 1 wherein the prosthesis is formed of a shape memory material.

12. The method of claim 11 wherein the shape memory material is nitinol.

13. The method of claim 12 wherein the shape memory material is a shape memory polymer.

14. The method of claim 1 wherein the prosthesis is formed of a mesh.

15. The method of claim 2 wherein the prosthesis includes a valve at the waist section and wherein the method includes preventing reflux of bile from the duodenum into the antrum using the valve.

16. The method of claim 1 wherein the prosthesis includes a proximal end and wherein the method includes the step of inserting a snare into the stomach, placing the snare around the proximal end, and withdrawing the snare to collapse the prosthesis.

17. The method of claim 16 further including the step of further withdrawing the snare to remove the prosthesis from the stomach.

18. The method of claim 1 wherein the inserting step includes the steps of placing the prosthesis in an elongate sheath and inserting the elongate sheath into the stomach, and wherein the allowing step includes withdrawing the elongate sheath from the prosthesis.

29. The method of claim 1 wherein the antral tube is formed of a shape memory material.

30. The method of claim 29 wherein the shape memory material is nitinol.

31. The method of claim 29 wherein the shape memory material is a shape memory polymer.

58. The apparatus of claim 57 wherein the prosthesis is formed of a self-expandable mesh.

59. The apparatus of claim 58 wherein the mesh is formed of stainless steel.

60. The apparatus of claim 58 wherein the mesh is formed of shape memory material.

61. The apparatus of claim 60 wherein the mesh is formed of nitinol.

62. The apparatus of claim 57 wherein the prosthesis is formed of shape memory polymer.

63. The apparatus of claim 58 wherein the prothesis includes a fluid impermeable barrier on the antral portion.

64. The apparatus of claim 63 wherein the elongate element is a wire.

65. The apparatus of claim 63 wherein the elongate element is a ribbon.

66. The apparatus of claim 63 wherein the elongate element is a suture.

63-1. The apparatus of claim 57 wherein the antral portion and the intestinal portions are formed of wire coil, and wherein the intermediate portion includes an elongate element extending between the antral portion and the intestinal portions.

67. A method for inducing weight loss in a patient, comprising the steps of:

providing a pouch having a proximal opening and a distal opening;

positioning the pouch within the stomach of a patient;

placing the proximal opening of the pouch at the distal end of the esophagus and approximately aligning said proximal opening with said distal end, securing the pouch within the stomach; and

causing food ingested by the patient to flow from the esophagus into the pouch.

68. The method of claim 67 wherein the proximal opening has a diameter that is larger than the diameter of the distal opening.

69. The method of claim 68 wherein the pouch has an approximate funnel shape.

70. The method of claim 67 further including the steps of:

attaching the pouch to a cage; and

positioning the cage within the stomach.

71. The method of claim 70 wherein the step of attaching the pouch to the cage is performed after to the step of positioning the cage within the stomach.

72. The method of claim 70 wherein the step of attaching the pouch to the cage is performed prior to the step of positioning the cage within the stomach.

73. The method of claim 70 wherein the step of positioning the cage within the stomach includes placing a portion of the cage at the fundus of the stomach.

74. The method of claim 67 including the step of positioning an alignment tube in the distal portion of the patient'"'"'s esophagus, the alignment tube directing food from the esophagus into the proximal opening of the pouch.

75. An apparatus for inducing weight loss in a patient, the apparatus comprising:

a tubular pouch having a proximal opening and a distal opening, the pouch proportioned such that when the proximal opening is positioned at the distal end of a patient'"'"'s esophagus, the distal opening opens into the proximal region of the stomach such that food from the esophagus passes directly into the proximal opening, passes through the pouch and then into the proximal region of the stomach.

76. The apparatus of claim 75 wherein the proximal opening has a diameter that is larger than the diameter of the distal opening.

77. The apparatus of claim 75 wherein the pouch has an approximate funnel shape.

78. The apparatus of claim 75 wherein the pouch is self-expandable from a collapsed position to an expanded position.

79. The apparatus of claim 78 wherein the pouch is formed of a shape memory material.

80. The apparatus of claim 79 wherein the shape memory material is nitinol.

81. The apparatus of claim 79 wherein the shape memory material is a shape memory polymer.

82. The apparatus of claim 75 wherein the pouch is formed of a coil.

83. The apparatus of claim 75 wherein the pouch is formed of a mesh.

84. The apparatus of claim 75 wherein the pouch includes a sewing ring at the proximal opening.

85. The apparatus of claim 75 further including a cage positionable within the proximal region of the stomach, the pouch attachable to the proximal portion of the cage such that the distal opening extends into the interior of the cage.

86. The apparatus of claim 75 further including an alignment tube positionable within the distal region of the esophagus, the alignment tube including a distal end attachable to the proximal end of the pouch.

87. The apparatus of claim 86 further including a cage positionable within the proximal region of the stomach, the pouch attachable to the proximal portion of the cage such that the distal opening extends into the interior of the cage.

88. A method of inducing weight loss in a patient, comprising the steps of:

providing an elongate tube;

securing the tube within the intestine of a patient, distally of the ampulla of vader; and

causing food passing into the intestine of the patient to pass through the tube, the tube creating a barrier to absorption of the food by the intestine.

89. The method of claim 88 wherein the tube is formed of a shape memory frame covered with a polymeric barrier.

90. The method of claim 89 wherein the shape memory frame is formed of nitinol.

91. The method of claim 90 wherein the shape memory frame is formed of shape memory polymer.

92. A method of inducing weight loss in a patient, comprising the steps of:

providing a tubular prosthesis having a wall surrounding a lumen, the wall formed of a framework that is self-expandable from a collapsed position in which the prosthesis has a first diameter to an expanded position in which the prosthesis has a second, larger, diameter;

with the prosthesis in the collapsed position, inserting the prosthesis into a stomach of a patient; and

allowing the prosthesis to self-expand from the collapsed position to the expanded position and into contact with the walls of the stomach.

93. The method of claim 92 wherein the inserting step includes inserting the prosthesis into the antrum of a stomach and wherein the allowing step causes the prosthesis to self-expand into contact with the walls of the antrum.

94. The method of claim 93 wherein the prosthesis includes a waist section, and wherein the method includes causing the waist section to seat at the pyloric sphincter of the stomach.

95. The method of claim 92 wherein the contact between the prosthesis and the walls of the stomach secures the prosthesis in place in the stomach.

96. The method of claim 92 wherein the contact between the prosthesis and the walls of the stomach causes feelings of satiation in the patient.

97. The method of claim 96 wherein the contact between the prosthesis and the walls of the stomach suppresses production in the patient of a chemical mediator of the sensation of hunger.

98. The method of claim 97 wherein the chemical mediator includes Ghrelin.

99. The method of claim 93 wherein the wall includes a self-expanding framework in combination with a fluid impermeable barrier, the fluid impermeable barrier preventing movement of food material from the lumen through the wall and into the stomach.

100. The method of claim 92 wherein the prosthesis includes a fluid-permeable reservoir containing a satiety-controlling substance, and wherein the method includes allowing the satiety-controlling substance to pass from the fluid-permeable reservoir into the stomach.

101. The method of claim 92 wherein the prosthesis includes a membrane impregnated with a satiety-controlling substance, and wherein the method includes allowing the satiety-controlling substance to pass from the membrane into the stomach.

102. The method of claim 92 wherein the wall is formed of a shape memory material.

103. The method of claim 102 wherein the shape memory material is nitinol.

104. The method of claim 103 wherein the shape memory material is a shape memory polymer.

105. The method of claim 92 wherein the wall is formed of a mesh.

106. The method of claim 93 wherein the prosthesis includes a valve at the waist section and wherein the method includes preventing reflux of bile from the duodenum into the antrum using the valve.

107. The method of claim 92 wherein the prosthesis includes a proximal end and wherein the method includes the step of inserting a snare into the stomach, placing the snare around the proximal end, and withdrawing the snare to collapse the prosthesis.

108. The method of claim 107 further including the step of further withdrawing the snare to remove the prosthesis from the stomach.

109. The method of claim 92 wherein the inserting step includes the steps of placing the prosthesis in an elongate sheath and inserting the elongate sheath into the stomach, and wherein the allowing step includes withdrawing the elongate sheath from the prosthesis.