Obesity treatment tools and methods

• US 20020183768A1
• Filed: 05/30/2001
• Published: 12/05/2002
• Est. Priority Date: 05/30/2001
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Satiety, Inc.
• Inventors: French, Ronald G., Sutton, Douglas S., Andreas, Bernard H., Deem, Mark E., Gifford, Hanson S.
• Granted Patent: US 6,558,400 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like

Abstract

Various obesity treatment tools and methods are described herein, as well as treatments for other gastric-related diseases, e.g., GERD. Treatment includes reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be done by creating a smaller gastric pouch within the stomach directly from the interior of the stomach itself. The smaller pouches may be made through the use of individual anchoring devices, rotating probes, or volume reduction devices. A pyloroplasty procedure may also be performed to render the pyloric sphincter incompetent. A gastric bypass procedure may additionally be performed using atraumatic magnetic anastomoses devices so that sugars and fats are passed directly to the bowel while bypassing the stomach. Many of these procedures may be done in a variety of combinations. Treatment may create enforced behavioral modifications by discouraging the ingestion of high-caloric foods.

Claims

1. A method for forming a lumen from an interior of an organ comprising:

placing at least a first anchor on a first area of the interior;

placing at least a second anchor on a second area of the interior; and

drawing at least the first anchor and at least the second anchor in proximity to each other such that the lumen is formed.

2. The method of claim 1 wherein the organ comprises a stomach.

3. The method of claim 1 wherein the first anchor comprises a fastener selected from the group consisting of staples, ratcheted wires, zip ties, clips, tags, eyelets, crimps, and screws.

4. The method of claim 1 wherein the second anchor comprises a fastener selected from the group consisting of staples, ratcheted wires, zip ties, clips, tags, eyelets, crimps, and screws.

5. The method of claim 1 wherein placing at least the second anchor on the second area of the interior comprises placing the second anchor in apposition to the first anchor within the organ.

6. The method of claim 1 wherein drawing at least the first anchor and at least the second anchor in proximity comprises passing a suture through each of the anchors and pulling the suture such that the first area and the second area of the interior are drawn together.

7. The method of claim 6 wherein the suture is passed through each of the anchors in a zig-zag manner.

8. The method of claim 1 wherein the first anchor and the second anchor each comprise a crimping member.

9. The method of claim 8 wherein each of the crimping members are configured to interlock together.

10. The method of claim 1 further comprising interlocking the first anchor to the second anchor such that the first area and the second area of interior surface are in apposition.

11. A fastening device for securing tissue in an organ interior comprising:

a helical member having a distal end and a proximal end with a coiled length therebetween,

wherein at least two coils at the distal end of the helical member each comprise a diameter which is equal,

the helical member being configured for delivery through a lumen defined through a length of an elongate member having a proximal end and a distal end.

12. The fastening device of claim 11 wherein the diameter of the two coils is larger than a diameter of a proximal coil.

13. The fastening device of claim 11 wherein the coiled length is tapered.

14. The fastening device of claim 11 wherein the diameter of the two coils is equal to a diameter of the lumen of the elongate member.

15. The fastening device of claim 11 wherein the distal end of the helical member is configured to pierce tissue.

16. The fastening device of claim 11 wherein the helical member is configured to maintain an orientation parallel to a longitudinal axis of the elongate member during delivery.

17. The fastening device of claim 11 wherein the coiled length is at least partially covered with securing members.

18. The fastening device of claim 17 wherein the securing members are selected from the group consisting of barbs and whisker-like filaments.

19. The fastening device of claim 11 wherein the helical member comprises a bioabsorbable or biocompatible material.

20. The fastening device of claim 19 wherein the bioabsorbable or biocompatible material is selected from the group consisting of polymers and superelastic alloys.

21. A marking device for marking a location on an interior surface within an organ comprising:

an elongate member having a proximal end and a distal end with a length therebetween,

the length defining a shape which approximates a lumen to be formed from the interior surface,

the length further defining at least one dye port, the dye port being configured to contact an area of the interior surface and deliver dye.

22. The marking device of claim 21 further comprising an inflatable balloon at the distal end of the elongate member.

23. The marking device of claim 21 wherein the length further defines at least one vacuum port in communication with the distal end of the elongate member.

24. The marking device of claim 21 wherein the length further defines a plurality of additional dye ports.

25. The marking device of claim 21 wherein the organ comprises a stomach.

26. The marking device of claim 21 wherein the elongate member is curved.

27. The marking device of claim 26 wherein the curved elongate member is configured to follow a lesser curvature of a stomach.

28. The marking device of claim 26 wherein the dye port is defined along an outer radius of curvature of the curved elongate member.

29. The marking device of claim 21 wherein the elongate member is configured to be delivered to the interior surface trans-esophageally.

30. A method of marking a location on an interior surface within an organ comprising:

inserting a marking device into the organ, the marking device comprising an elongate member having a proximal end and a distal end with a length therebetween, the length defining a shape which approximates a lumen to be formed from the interior, the length further defining at least one dye port, the dye port being configured to contact an area of the interior surface and deliver dye;

reducing a volume of the organ such that the interior surface contacts the elongate member;

passing a dye through the dye port; and

increasing the volume of the organ.

31. The method of claim 30 wherein reducing a volume of the organ such that the interior surface contacts the elongate member comprises removing contents of the organ via a vacuum.

32. The method of claim 31 wherein the vacuum is created in a vacuum port defined along the length of the elongate member.

33. The method of claim 30 wherein passing a dye through the dye port further comprises marking the area of the interior surface in contact with the dye.

34. The method of claim 30 wherein the dye comprises a biocompatible dye selected from the group consisting of methylene blue, thionine, acridine orange, acridine yellow, acriflavine, quinacrine and its derivatives, brilliant green, gentian violet, crystal violet, triphenyl methane, bis naphthalene, trypan blue, and trypan red.

35. A method for forming a lumen from an interior of an organ comprising:

delineating a first boundary of the lumen on a first area and a second boundary of the lumen on a second area of the membrane using the method as described in claim 30;

removing the marking device from the organ;

placing at least a first anchor along the first boundary;

placing at least a second anchor along the second boundary; and

drawing at least the first anchor and at least the second anchor in proximity to each other such that the lumen is formed.

36. The method of claim 35 wherein the first anchor comprises a fastener selected from the group consisting of staples, ratcheted wires, zip ties, clips, tags, eyelets, crimps, and screws.

37. The method of claim 35 wherein the second anchor comprises a fastener selected from the group consisting of staples, ratcheted wires, zip ties, clips, tags, eyelets, crimps, and screws.

38. The method of claim 35 wherein drawing at least the first anchor and at least the second anchor in proximity comprises passing a suture through each of the anchors and pulling the suture such that the first area and the second area of the interior surface are drawn together.

39. The method of claim 38 wherein the suture is passed through each of the anchors in a zig-zag manner.

40. The method of claim 35 wherein the first anchor and the second anchor each comprise a crimping member.

41. The method of claim 40 wherein each of the crimping members are configured to interlock together.

42. A device for forming a lumen from an interior of an organ comprising:

a tissue adhering member having a proximal end and a distal end with a length therebetween, the member having at least two releasably adherable regions for releasably positioning a first area of the interior near a second area of the interior,

whereby the lumen is formed upon fastening the first area to the second area.

43. The device of claim 42 further comprising at least one fastener disposable within the tissue adhering member for fastening the first area to the second area.

44. The device of claim 42 wherein the first area is positioned adjacent to the second area.

45. The device of claim 42 wherein the first area is in apposition to the second area.

46. The device of claim 42 wherein the tissue adhering member defines a slot along the length, the slot being adapted to receive a retractable septum.

47. The device of claim 46 wherein the retractable septum defines at least one surface adapted to abrade an adjacent portion of the interior.

48. The device of claim 47 wherein the adjacent portion of the interior surface is abraded by the retractable septum using a method selected from the group consisting of cutting, scoring, heating, freezing, and chemical ablation.

49. The device of claim 42 wherein each of the two releasably adherable regions are separated by an angle between about 20°

to 180°

about a longitudinal axis defined by the length.

50. The device of claim 49 wherein the two releasably adherable regions are separated by an angle between about 90°

to 180°

.

51. The device of claim 42 wherein the first area and the second area are adhered to the tissue adhering member via a vacuum created in each of the two releasably adherable regions.

52. The device of claim 51 wherein each of the two releasably adherable regions are in fluid communication with a common channel defined within the tissue adhering member.

53. The device of claim 42 further comprising a delivery member having a proximal end and a distal end with a length therebetween, the tissue adhering member being attached to the distal end of the delivery member.

54. The device of claim 53 wherein the tissue adhering member is in fluid communication with the proximal end of the delivery member.

55. The device of claim 43 further comprising a wedge slidingly disposed within an interior channel defined by the tissue adhering member, the wedge being adapted to urge the fastener from an open first configuration to a closed second configuration.

56. The device of claim 55 wherein the fastener comprises a mechanical fastener selected from the group consisting of C staples, U staples, clips, and tags.

57. The device of claim 55 further comprising a wire attached to the wedge.

58. The device of claim 42 wherein the length of the tissue adhering member is straight.

59. The device of claim 42 wherein the length of the tissue adhering member defines an arc approximating a curvature of the organ.

60. The device of claim 42 wherein a geometry of the tissue adhering member is adjustable.

61. The device of claim 42 wherein the distal end of the tissue adhering member flares away from a curvature of the organ.

62. The device of claim 42 wherein the organ comprises a stomach.

63. The device of claim 62 wherein the tissue adhering member is adapted to be inserted into the stomach endoscopically via an esophageal passageway.

64. The device of claim 43 wherein the fastener comprises a screw having a helical shape.

65. The device of claim 64 wherein a diameter of a distal end of the screw is larger than a diameter of a proximal end of the screw.

66. The device of claim 65 wherein a length between the distal end of the screw and the proximal end of the screw is tapered.

67. The device of claim 64 wherein at least two coils at a distal end of the screw each comprise a diameter which is equal.

68. The device of claim 64 wherein a distal end of the screw is configured to pierce tissue.

69. The device of claim 64 wherein the screw is at least partially covered with securing members.

70. The device of claim 69 wherein the securing members are selected from the group consisting of barbs and whisker-like filaments.

71. The device of claim 64 wherein the screw comprises a bioabsorbable or biocompatible material.

72. The device of claim 71 wherein the bioabsorbable or biocompatible material is selected from the group consisting of polymers and superelastic alloys.

73. The device of claim 66 wherein the screw is configured to alternatingly pierce a first area of tissue and a second area of tissue while approximating the first area of tissue and the second area of tissue together.

74. The device of claim 43 further comprising a plurality of additional fasteners, each of the fasteners being configured to fasten the first area to the second area while juxtaposed linearly to form a continuous fixation line.

75. A method for creating a lumen from an interior of an organ comprising:

releasably adhering a first area of the interior to a tissue adhering member;

displacing the first area of the interior via the tissue adhering member;

releasably adhering a second area of the interior to the tissue adhering member such that the first area is positioned near the second area; and

,

fastening the first area to the second area to form the lumen.

76. The method of claim 75 wherein the first area and the second area are releasably adhered to the tissue adhering member via a vacuum created in at least two releasably adherable regions defined in the tissue adhering member.

77. The method of claim 75 wherein the first area is positioned adjacent to the second area.

78. The method of claim 75 wherein the first area is in apposition to the second area.

79. The method of claim 75 wherein releasably adhering a second area of the interior surface to the tissue adhering member such that the first area is positioned near the second area further comprises removing a septum disposed in the tissue adhering member such that the first area contacts the second area.

80. The method of claim 79 further comprising inducing a healing response in the first area or the second area while removing the septum.

81. The method of claim 79 further comprising abrading the first area or the second area while removing the septum.

82. The method of claim 81 wherein abrading the first area or the second area comprises a method selected from the group consisting of cutting, scoring, heating, freezing, and chemical ablation.

83. The method of claim 75 wherein fastening the first area to the second area further comprises sliding a wedge disposed within an interior channel defined by the tissue adhering member such that the wedge urges a mechanical fastener to cinch the first area to the second area.

84. The method of claim 83 wherein the mechanical fastener is selected from the group consisting of C staples, U staples, clips, and tags.

85. The method of claim 75 further comprising disengaging the first area and the second area from the tissue adhering member.

86. The method of claim 75 wherein the organ comprises a stomach.

87. The method of claim 86 wherein the tissue adhering member is endoscopically inserted into the stomach via an esophageal passageway prior to releasably adhering a first area of the interior to a tissue adhering member.

88. The method of claim 75 wherein fastening the first area to the second area defines a boundary between the lumen and a remaining portion of the organ.

89. The method of claim 88 wherein the boundary is straight.

90. The method of claim 88 wherein the boundary approximates a curvature of the organ.

91. The method of claim 88 wherein the boundary is adjustable.

92. The method of claim 88 wherein the boundary flares towards the remaining portion of the organ.

93. The method of claim 75 wherein fastening the first area to the second area to form the lumen further comprises urging a fastener through an interior channel defined in the tissue adhering member to fasten the first area and the second area together.

94. The method of claim 93 wherein the fastener has a tapering helical shape with a piercing end.

95. The method of claim 93 wherein urging the fastener through the interior channel comprises rotating the fastener about a longitudinal axis defined by the fastener such that the first area and the second area cinches together.

96. A system for forming a lumen from an interior of an organ and for dilating an opening defined by the organ comprising:

a tissue adhering member having a proximal end and a distal end with a length therebetween, the member having at least two releasably adherable regions for releasably positioning a first area of the interior near a second area of the interior, whereby the lumen is formed upon fastening the first area to the second area; and

,

an elongate device having a proximal end and a distal end with a length therebetween, the elongate device having a modifying region for contacting tissue in or around the opening and for delivering a stimulus to the tissue to dilate the opening.

97. The system of claim 96 further comprising at least one fastener disposable within the tissue adhering member for fastening the first area to the second area.

98. The system of claim 96 wherein the tissue adhering member defines a slot along the length.

99. The system of claim 98 wherein the slot is adapted to receive a retractable septum.

100. The system of claim 98 wherein the retractable septum defines at least one surface adapted to abrade an adjacent portion of the interior.

101. The system of claim 100 wherein the adjacent portion of the interior is abraded by the retractable septum using a method selected from the group consisting of cutting, scoring, heating, freezing, and chemical ablation.

102. The system of claim 96 wherein the first area and the second area are adhered to the tissue adhering member via a vacuum created in each of the two releasably adherable regions.

103. The system of claim 102 wherein each of the two releasably adherable regions are in fluid communication with a common channel defined within the tissue adhering member.

104. The system of claim 96 wherein the opening defined by the organ comprises a pylorus located at a distal end of the organ.

105. The system of claim 96 wherein the modifying region comprises a cutting member adapted to cut the tissue in or around the opening.

106. The system of claim 96 wherein the stimulus comprises a form of energy selected from the group consisting of heat energy, electrical energy, chemical energy, RF energy, and pressure.

107. The system of claim 96 wherein the elongate device comprises a dilatation device disposed near the distal end.

108. The system of claim 107 wherein the dilatation device comprises an angioplasty balloon.

109. The system of claim 96 wherein the elongate device comprises an angioplasty balloon disposed near the distal end, the balloon having the modifying region disposed on an exterior surface of the balloon.

110. The system of claim 109 wherein the modifying region comprises at least one cutting member disposed on the exterior surface.

111. The system of claim 110 wherein the cutting member is selected from the group consisting of blades and wires.

112. The system of claim 96 wherein the elongate device comprises a dilation wire basket disposed near the distal end, the dilation wire basket being adapted to deliver the stimulus to the tissue.

113. The system of claim 112 wherein the stimulus comprises a change in temperature.

114. The system of claim 96 wherein the modifying region comprises at least one probe extending from the distal end of the elongate device, the probe having a distal end adapted for piercing the tissue in or around the opening.

115. The system of claim 114 wherein the probe distal end is adapted to deliver a stimulus selected from the group consisting of heat energy, electrical energy, chemical energy, and RF energy.

116. The system of claim 96 wherein the stimulus comprises a chemical delivered through an opening defined in the modifying region.

117. The system of claim 116 wherein the chemical is ablative to the tissue in or around the opening.

118. The system of claim 117 wherein the chemical is selected from the group consisting of alcohol, sotrodecol, and Botox virus.

119. The system of claim 96 wherein the modifying region comprises a cutting wire extending between the elongate device distal end and a region proximal of the elongate device distal end.

120. The system of claim 96 wherein the modifying region is disposed at the distal end of the elongate device, the region defining a slot for receiving the tissue in or around the opening, and a cutting edge disposed between a plurality of staples slidingly held within the slot.

122. The method of claim 121 wherein the first area of the interior is releasably adhered to the tissue adhering member via a vacuum created in a first opening defined in the tissue adhering member.

123. The method of claim 121 wherein the second area of the interior is releasably adhered to the tissue adhering member via a vacuum created in a second opening defined in the tissue adhering member.

124. The method of claim 121 wherein releasably adhering a second area of the interior to the tissue adhering member such that the first area is positioned near the second area further comprises removing a septum disposed in the tissue adhering member such that the first area contacts the second area.

125. The method of claim 121 wherein the opening comprises a pyloral sphincter.

126. The method of claim 121 wherein dilating the opening comprises applying a stimulus to tissue in or around the opening via an elongated device having a proximal end and a distal end with a length therebetween.

127. The method of claim 126 wherein the stimulus comprises a form of energy selected from the group consisting of heat energy, electrical energy, chemical energy, RF energy, and pressure.

128. The method of claim 126 wherein the elongated device comprises a dilatation device disposed near the distal end.

129. The method of claim 128 wherein the dilatation device comprises an angioplasty balloon.

130. The method of claim 128 wherein the angioplasty balloon comprises an expandable surface having at least one cutting member disposed thereon.

131. The method of claim 121 wherein dilating the opening defined at the distal end of the organ comprises piercing tissue in or around the opening with at least one elongate probe and applying a stimulus via the elongate probe.

132. The method of claim 131 wherein the stimulus comprises a chemical delivered through an opening defined in a distal end of the probe.

133. The system of claim 132 wherein the chemical is ablative to the tissue in or around the opening.

134. The system of claim 133 wherein the chemical is selected from the group consisting of alcohol, sotrodecol, and Botox virus.

135. The method of claim 126 wherein the elongated device comprises a combination cutting edge and stapler disposed near the distal end.

137. The system of claim 136 further comprising a fastening device specially adapted to fasten a rotated portion of the organ to a remaining portion of the organ.

138. The system of claim 136 wherein the device is rotated at least about 180°

.

139. The system of claim 136 wherein the device is rotated at least about 360°

.

140. The system of claim 136 further comprising a side-to-side anastomosis device for coupling adjacent regions of digestive tract, the anastomosis device comprising a distal segment and a proximal segment, the distal and the proximal segments each being adapted to align in apposition with each other while maintaining the regions of digestive tract therebetween.

141. The system of claim 137 wherein the rotated portion is mechanically fastened to the remaining portion by a fastener selected from the group consisting of staples, blind staples, clips, tags, screws, and adhesives.

142. The system of claim 136 wherein the rotatable device for insertion is inserted into the organ endoscopically via an esophageal passageway.

143. The system of claim 140 wherein the anastomosis device is inserted into the digestive tract endoscopically via an esophageal passageway.

144. The system of claim 140 wherein the anastomosis device is inserted into the digestive tract laparoscopically.

145. The system of claim 136 wherein the rotatable device for insertion comprises an outer tube having a proximal end and a distal end with a lumen defined therebetween, the outer tube defining an opening proximal of the distal end.

146. The system of claim 145 wherein the internal surface within the organ is adhered to the device via a vacuum created in the opening.

147. The system of claim 145 wherein the distal end comprises an enclosed, tapered end.

148. The system of claim 145 wherein the rotatable device for insertion further comprises an inner tube having a proximal end and a distal end with a lumen defined therebetween, the inner tube defining an opening proximal of the distal end.

149. The system of claim 148 wherein the opening of the inner tube is configured to align with the opening of the outer tube.

150. The system of claim 149 wherein the inner tube is counter-rotatable about the longitudinal axis with the outer tube.

151. The system of claim 145 wherein the outer tube further comprises a plurality of attachment points disposed adjacent to the opening, the internal surface within the organ adhering to the outer tube via the attachment points.

152. The system of claim 151 wherein the attachment points are selected from the group consisting of tines, barbs, and hooks.

153. The system of claim 136 wherein the rotatable device for insertion comprises a split tube having at least two halves, each of the halves being separatable along a partition defined along the tube, the split tube comprising a proximal end and a distal end with a lumen defined therebetween, the split tube further comprising a plurality of attachment points disposed on each half near the distal end.

154. The system of claim 153 wherein the attachment points are selected from the group consisting of tines, barbs, and hooks.

155. The system of claim 136 wherein the rotatable device for insertion comprises at least two adjacent tubes, each of the tubes having a proximal end and a distal end with a lumen defined therebetween, and each of the tubes defining an opening proximal of the distal end.

156. The system of claim 155 wherein each of the two adjacent tubes are adapted to counter-rotate.

157. The system of claim 155 wherein the internal surface within the organ is adhered to the device via a vacuum created in each of the openings.

158. The system of claim 136 wherein the rotatable device for insertion comprises at least one attachment tube and at least two compression members, the attachment tube being specially adapted to adhere to the internal surface within the organ, and the two compression members being adapted to compress a portion of the internal surface within the organ therebetween.

159. The system of claim 158 wherein the attachment tube defines an opening proximal of a distal end.

160. The system of claim 159 wherein the internal surface within the organ is adhered to the attachment tube via a vacuum created in the opening.

161. The system of claim 140 wherein the distal and the proximal segments are magnetically coupled together while maintaining the regions of digestive tract therebetween.

162. The system of claim 161 wherein the distal and the proximal segments are further coupled by mechanical fasteners.

163. The system of claim 162 wherein the mechanical fasteners are selected from the group consisting of grommet-type swages, snap lock fits, staples, screws, clips, and friction-fittings.

164. The system of claim 140 further comprising a deployment device comprising an elongate tubular member having a proximal end and a distal end with a lumen defined therebetween, the distal end being specially adapted to retain the proximal segment for alignment in apposition with the distal segment.

165. The system of claim 164 wherein the deployment device further comprises a coring ring in the distal end, the coring ring being adapted to pass through a center of the distal segment and the proximal segment for removal of the regions of digestive tract therebetween.

166. The system of claim 164 wherein the deployment device distal end is adapted to be manipulatable via the proximal end.

167. The system of claim 140 further comprising a locating device adapted to urge the distal segment into a predetermined location in the digestive tract.

168. The system of claim 167 wherein the locating device comprises a magnetized device selected from the group consisting of magnetic wands and magnetic pickups.

170. The anastomosis device of claim 169 wherein the distal and the proximal segments are magnetically coupled together while maintaining the regions of digestive tract therebetween.

171. The anastomosis device of claim 170 wherein the distal and the proximal segments are further coupled by mechanical fasteners.

172. The anastomosis device of claim 171 wherein the mechanical fasteners are selected from the group consisting of grommet-type swages, snap lock fits, staples, screws, clips, and friction-fittings.

173. The anastomosis device of claim 169 wherein the deployment device further comprises a coring ring in the distal end, the coring ring being adapted to pass through a center of the distal segment and the proximal segment for removal of the regions of digestive tract therebetween.

174. The anastomosis device of claim 169 wherein the deployment device distal end is adapted to be manipulatable via the proximal end.

175. The anastomosis device of claim 169 further comprising a locating device adapted to urge the distal segment into a predetermined location in the digestive tract.

176. The anastomosis device of claim 175 wherein the locating device comprises a magnetized device selected from the group consisting of magnetic wands and magnetic pickups.

178. The system of claim 177 further comprising a side-to-side anastomosis device for coupling adjacent regions of digestive tract, the anastomosis device comprising a distal segment and a proximal segment, the distal and the proximal segments each being adapted to align in apposition with each other while maintaining the regions of digestive tract therebetween.

179. The system of claim 177 wherein the device for insertion is inserted into the organ endoscopically via an esophageal passageway.

180. The system of claim 178 wherein the anastomosis device is inserted into the digestive tract endoscopically via an esophageal passageway.

181. The system of claim 178 wherein the anastomosis device is inserted into the digestive tract laparoscopically.

182. The system of claim 177 wherein the device for insertion comprises a tube having a proximal end and a distal end with a lumen defined therebetween, the lumen defining a passageway for drawing up the portion of the interior of the organ via a vacuum.

183. The system of claim 182 wherein the fastening device comprises an elastic band disposed about the distal end of the tube and adapted to slide over and secure the portion of the interior.

184. The system of claim 177 wherein the device for insertion comprises at least two elongate members, each member having a proximal end and a distal end with a length therebetween, the members being rotatably connected at the proximal end and the distal end such that the members are biased towards each other.

185. The system of claim 184 wherein the elongate members define an uneven surface.

186. The system of claim 177 wherein the device for insertion comprises an instrument having manipulatable grasping members at a distal end for grasping the portion of the interior of the organ.

187. The system of claim 186 wherein the fastening device comprises a catheter having a cinching distal end adapted to cinch the portion of the interior of the organ.

188. The system of claim 177 wherein the device for insertion comprises a tube having a proximal end and a distal end with a lumen defined therebetween, the distal end defining at least two slots.

189. The system of claim 188 wherein the slots are defined in apposition to each other.

190. The system of claim 188 wherein the device for insertion further comprises a plug adapted to fit into the distal end.

191. The system of claim 190 wherein the plug is biodegradable.

192. The system of claim 191 wherein the plug comprises a biodegradable polymer selected from the group consisting of polylactide, copolymers of polylactide, polyglycolide, and copolymers of polyglycolide.

193. The system of claim 177 wherein the fastening device comprises a clip adapted to be inserted into the lumen.

194. The system of claim 193 wherein the clip comprises two adjacent members attached at a proximal end, the distal ends of each member being configured to pierce tissue.

195. The system of claim 177 wherein the fastening device comprises a screw configured to be inserted into a channel defined within the device.

196. The system of claim 177 wherein the screw comprises a helical shape.

197. The system of claim 196 wherein a diameter of a distal end of the screw is larger than a diameter of a proximal end of the screw.

198. The system of claim 197 wherein a length between the distal end of the screw and the proximal end of the screw is tapered.

199. The system of claim 198 wherein the screw is configured to alternatingly pierce a first area of tissue and a second area of tissue while approximating the first area of tissue and the second area of tissue together.

200. The system of claim 177 further comprising a plurality of additional fastening devices, each of the fastening devices being configured to fasten the portion of interior while juxtaposed linearly to form a continuous fixation line.

216. A method for gastric reduction, comprising:

creating a first side-to-side anastomosis between a first portion of digestive tract and a gastric pouch using the anastomosis device as described in claim 169;

creating a second side-to-side anastomosis between a second portion of digestive tract and a third portion of digestive tract using the anastomosis device as described in claim 169; and

creating a separate gastric lumen from the gastric pouch using the system as described in claim 136.

217. The method of claim 216 wherein the first portion of digestive tract comprises a predetermined section selected from the group consisting of duodenum and jejunum.

218. The method of claim 216 wherein the second portion of digestive tract comprises a predetermined section of duodenum.

219. The method of claim 216 wherein the third portion of digestive tract comprises a predetermined section of ileum.

220. The method of claim 216 wherein creating a second side-to-side anastomosis further comprises closing off a section of digestive tract disposed intermediate of the first portion and the second portion.

221. The method of claim 220 wherein the section of digestive tract disposed intermediate of the first portion and the second portion comprises duodenum.

222. The method of claim 216 wherein the first anastomosis is located about 20 to 50 cm from a pylorus of the gastric pouch.

223. The method of claim 216 wherein the second anastomosis is located about 15 to 55 cm from the pylorus of the gastric pouch.

224. The method of claim 216 wherein the second anastomosis is located about 150 to 200 cm along the digestive tract from the pylorus of the gastric pouch.

226. The modified gastric pouch of claim 225 further comprising a plurality of fasteners attached to an interface defined by the gastric lumen and the gastric pouch.

227. The modified gastric pouch of claim 226 wherein the fasteners comprise biocompatible mechanical fasteners selected from the group consisting of staples, tags, clips, sutures, screws, and adhesives.

228. The modified gastric pouch of claim 225 wherein the gastric lumen is straight.

229. The modified gastric pouch of claim 225 wherein the gastric lumen is tapered such that the distal end is larger than the proximal end.

230. The modified gastric pouch of claim 225 wherein the gastric lumen is tapered such that the proximal end is larger than the distal end.

231. The modified gastric pouch of claim 225 wherein the gastric lumen proximal end defines a gastric lumen proximal opening and the gastric lumen proximal end and the gastric lumen proximal opening are coaxially located.

121. A method for forming a lumen from an interior of an organ and for dilating an opening defined by the organ comprising:

releasably adhering a first area of the interior to a tissue adhering member;

displacing the first area of the interior via the tissue adhering member;

releasably adhering a second area of the interior to the tissue adhering member such that the first area is positioned near the second area;

fastening the first area to the second area to form the lumen; and

dilating the opening defined at a distal end of the organ.

136. A system for forming a lumen from an interior of an organ, comprising a rotatable device for insertion into the organ, the device being specially adapted to adhere onto an internal surface while being rotated about a longitudinal axis defined by the device.

169. A side-to-side anastomosis device for coupling adjacent regions of digestive tract, the anastomosis device comprising:

a distal segment and a proximal segment, the distal and the proximal segments each being adapted to align in apposition with each other while maintaining the regions of digestive tract therebetween; and

a deployment device comprising an elongate tubular member having a proximal end and a distal end with a lumen defined therebetween, the distal end being specially adapted to retain the proximal segment for alignment in apposition with the distal segment.

177. A system for organ volume reduction, comprising:

a device for insertion into an organ, the device being specially adapted to draw up a portion of an interior of the organ; and

a fastening device specially adapted to fasten the portion of interior.

201. A method of creating a side-to-side anastomosis in a digestive tract, comprising:

providing an anastomosis device comprising a distal segment and a proximal segment, the segments each being adapted to align in apposition with each other;

placing the distal segment into a section of digestive tract;

placing the proximal segment into a gastric pouch; and

aligning the distal segment with the proximal segment such that the segments are coupled together while maintaining a portion of the digestive tract and a portion of the gastric pouch therebetween.

202. The method of claim 201 wherein the distal segment and the proximal segment are aligned and coupled magnetically.

203. The method of claim 202 wherein the distal segment and the proximal segment are further coupled by mechanical fasteners.

204. The method of claim 203 wherein the mechanical fasteners are selected from the group consisting of grommet-type swages, snap lock fits, staples, screws, clips, and friction-fittings.

205. The method of claim 201 wherein the distal segment is placed into the section of digestive tract endoscopically via an esophageal passageway.

206. The method of claim 205 wherein the distal segment is placed into the section of digestive tract via a magnet located externally of the digestive tract.

207. The method of claim 201 wherein the distal segment is placed into the section of digestive tract laparoscopically.

208. The method of claim 201 wherein the proximal segment is placed into the gastric pouch endoscopically via an esophageal passageway.

209. The method of claim 201 further comprising advancing a coring device through a center of the proximal segment and the distal segment.

210. A method of creating a separate gastric lumen from a gastric pouch having a main lumen, comprising:

adhering a portion of interior of the gastric pouch to a device specially adapted to rotate;

rotating the device about a longitudinal axis defined by the device while maintaining adherence to the portion of interior, the device being rotated until the separate gastric lumen is defined; and

fastening the portion of interior to the gastric pouch such that the gastric lumen is maintained.

211. The method of claim 210 wherein the device comprises a tube having a proximal end and a distal end with a lumen defined therebetween, the tube defining an opening proximal of the distal end.

212. The method of claim 211 wherein the portion of interior is adhered to the device via a vacuum created in the opening.

213. The method of claim 211 wherein the portion of interior is adhered to the device via a plurality of attachment points disposed adjacent to the opening.

214. The method of claim 213 wherein the attachment points are selected from the group consisting of tines, barbs, and hooks.

215. The method of claim 210 wherein the portion of interior is fastened to the gastric pouch by a mechanical fastener selected from the group consisting of staples, blind staples, clips, tags, screws, and adhesives.

225. A modified gastric pouch, comprising:

a gastric pouch having an exterior surface and an interior surface defining a main lumen and a proximal gastric pouch opening proximal of the main lumen; and

a gastric lumen having a proximal end and a distal end and an interior surface between these ends formed from a rotated portion of the interior surface of the gastric pouch such that the gastric lumen defines a volume separate from the main lumen, the gastric lumen remaining in communication with an esophagus.