Method and apparatus for creating intrauterine adhesions

• US 20050171569A1
• Filed: 10/29/2004
• Published: 08/04/2005
• Est. Priority Date: 04/25/2000
• Status: Abandoned Application

• Current Assignee: AUB Holdings LLC (Johnson & Johnson)
• Original Assignee: Impres Medical, Inc. (Johnson & Johnson)
• Inventors: Coad, James Elliott, Peterson, Karen Elizabeth, Duchon, Douglas J., Girard, Michael J., Danielson, Paul, Presthus, James
• Application Number:
  US10/978,176
• Publication Number:
  US 20050171569A1
• Time in Patent Office: Days
• US Class Current: 606/193
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 6/14 : intra-uterine type
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

In general, the present invention contemplates an implantable device for treating excessive bleeding in a body cavity. The device comprises a biocompatible material, for example polyethylene teraphathalate (PET), which is deliverable into the body cavity. The biocompatible material contains an attribute(s) that promotes tissue reaction or growth that results in a tissue response and/or adhesion formation within the body cavity to reduce or stop the excessive bleeding.

Claims

1. An intrauterine implant comprising:

a body member having an elongated body and at least two arm members fixed near an end of said body member; and

a scaffold material disposed on said body member, said scaffold material formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

2. An intrauterine implant according to claim 1, wherein said scaffold material is PET.

3. An intrauterine implant according to claim 1, wherein said scaffold material has a triangular shape as disposed on said body member.

4. An intrauterine implant according to claim 1, wherein said scaffold material encapsulates said body member.

5. An intrauterine implant according to claim 1, wherein said scaffold material includes adhesion bridging apertures interspersed along a surface of said material.

6. An intrauterine implant according to claim 5, wherein said adhesion bridging apertures are approximately 1/16 inch in diameter.

7. An intrauterine implant according to claim 1, further comprising a fallopian tube extension structure extending from each of said at least two arms;

said fallopian tube extension structure being sized to extend from each of said at least two arms towards an opening of fallopian tubes of a uterus.

8. An intrauterine implant according to claim 1, further comprising a cervical extension structure from said elongated body;

said cervical extension structure being sized to extend from said elongated body into a cervix.

9. An intrauterine implant according to claim 1, wherein said scaffold material is a fabric material.

10. An intrauterine implant according to claim 9, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

11. An intrauterine implant according to claim 1, wherein said body member is comprised of a polymer.

12. An intrauterine implant according to claim 1, wherein said body member is comprised of a metal.

13. An intrauterine implant according to claim 7, wherein a scaffold material is disposed on said fallopian tube extension structure.

14. An intrauterine implant according to claim 8, wherein a scaffold material is disposed on said cervical extension structure.

15. An intrauterine implant according to claim 1, wherein said scaffold material is formulated to cause the formation of adhesions.

16. An intrauterine implant according to claim 1, wherein said scaffold material is formulated to cause the formation of fibrosis.

17. An intrauterine implant according to claim 1, wherein said scaffold material has a pore size between fibers of approximately 50 to 250 micrometers.

18. An intrauterine implant according to claim 17, wherein said scaffold material has a pore size of approximately 100-200 micrometers.

19. An intrauterine implant comprising:

a body member having two arm members connected to form an overall V-shape;

a scaffold material spanning a space between said two arm members;

said scaffold material formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

20. An intrauterine implant according to claim 19, wherein said scaffold material is comprised of randomly oriented yarn fibers.

21. An intrauterine implant according to claim 19, wherein said scaffold material is comprised of a layer of open mesh structure.

22. An intrauterine implant according to claim 19, wherein said scaffold material is comprised of PET.

23. An intrauterine implant according to claim 21, wherein said scaffold material is comprised of two layers.

24. An intrauterine implant according to claim 20, wherein said scaffold material has a pore size between yarn fibers of approximately 50 to 250 micrometers.

25. An intrauterine implant according to claim 19, wherein said arm members are configured to be resiliently compressible between a compressed delivery state to an expanded deployed state, said expanded deployed state being of sufficient size so as to match said implant with the intrauterine cavity shape.

26. An intrauterine implant according to claim 19, wherein said scaffold material is a fabric material.

27. An intrauterine implant according to claim 26, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

28. An intrauterine implant according to claim 19, wherein said body member is comprised of a polymer.

29. An intrauterine implant according to claim 19, wherein said body member is comprised of a metal.

30. An intrauterine implant according to claim 19, wherein said scaffold material is formulated to cause the formation of adhesions.

31. An intrauterine implant according to claim 19, wherein said scaffold material is formulated to cause the formation of fibrosis.

32. An intrauterine implant according to claim 19, further comprising at least one pressure member disposed on at least one of said arm members and extending away therefrom, said at least one pressure member being sized and shaped to create a pressure point on a uterine wall following implantation of said body in a uterus.

33. An intrauterine implant according to claim 32, wherein said at least one pressure member includes a plurality of pressure members being disposed on each of said two arm members.

34. An intrauterine implant according to claim 32, wherein at least one pressure member is a cutting member with sufficient sharpness for said cutting member to cut into at least the endometrium aspect of the myometrium of said uterus.

35. An implant for reducing intrauterine bleeding comprising:

at least one cylindrically shaped roll of fabric material;

said at least one cylindrically shaped roll of scaffold material sized and shaped for positioning in a uterus;

said scaffold material being formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

36. An implant according to claim 35, wherein said scaffold material is PET.

37. An implant according to claim 35, wherein said implant includes a plurality of cylindrically shaped rolls of scaffold material.

38. An implant according to claim 35, wherein each of said at least one cylindrically shaped roll of scaffold material is about 2-4.5 mm in diameter and about 1.75 cm in length.

39. An implant according to claim 35, wherein said at least one cylindrically shaped roll of scaffold material has approximately four layers of scaffold material.

40. An implant according to claim 35, wherein said scaffold material includes a plurality of apertures for promoting bridging adhesions.

41. An implant according to claim 35, wherein said scaffold material is a fabric material.

42. An implant according to claim 41, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

43. An implant according to claim 35, wherein said scaffold material is formulated to cause the formation of adhesions).

44. An implant according to claim 35, wherein said scaffold material is formulated to cause the formation of fibrosis.

45. An implant according to claim 35, wherein said scaffold material has a pore size of approximately 50 to 250 micrometers.

46. An intrauterine implant comprising:

a body member having an elongated body and at least two arm members extending substantially laterally from one end of said elongated body;

said elongated body comprising a scaffold material; and

, said scaffold material being formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

47. An intrauterine implant according to claim 46, wherein said elongated body is a cylindrical roll of said scaffold material.

48. An intrauterine implant according to claim 47, wherein said cylindrical roll of scaffold material includes approximately four layers of scaffold material.

49. An intrauterine implant according to claim 46, wherein said elongated body further includes a structural member extending within said scaffold material.

50. An intrauterine implant according to claim 49, wherein said structural member is a semi rigid member.

51. An intrauterine implant according to claim 46, wherein said scaffold material includes a plurality of apertures for promoting bridge adhesions.

52. An intrauterine implant according to claim 46, wherein said scaffold material is a fabric material.

53. An intrauterine implant according to claim 52, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

54. An intrauterine implant according to claim 46, wherein said body member is comprised of a polymer.

55. An intrauterine implant according to claim 46, wherein said body member is comprised of a metal.

56. An intrauterine implant according to claim 46, wherein said scaffold material is formulated to cause the formation of adhesions.

57. An intrauterine implant according to claim 46, wherein said scaffold material is formulated to cause the formation of fibrosis.

58. An intrauterine implant according to claim 46, wherein said scaffold material has a pore size of approximately 50 to 250 micrometers.

59. An implant to reduce uterine bleeding comprising:

a cone shaped plug member;

said plug member being comprised of a resiliently deformable material;

said plug member having a maximum diameter such that said plug member frictionally engages an internal endocervical os of a patient when released from a deformed state and thereby retains said plug member in position in said internal endocervical os.

60. An implant according to claim 59, wherein said resiliently deformable material is silicone.

61. An implant according to claim 59, wherein said resiliently deformable material is a material that is formulated to react with uterine tissue.

62. An implant according to claim 61, wherein said resiliently deformable material is PET.

63. An intrauterine implant comprising:

a scaffold material sized and shaped to fit within a uterus of a patient;

a plurality of depressions disposed on one face of said scaffold material;

said scaffold material being formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

64. An intrauterine implant according to claim 63, wherein said plurality of depressions includes a plurality of parallel spacers.

65. An intrauterine implant according to claim 63, wherein said scaffold material is PET.

66. An intrauterine implant according to claim 63, wherein said depressions include a plurality of rectangularly shaped depressions.

67. An intrauterine implant according to claim 64, wherein said parallel spacers are comprised of a material harder than said scaffold material so as to provide localized contact surfaces against uterine tissue.

68. An intrauterine implant according to claim 63, further comprising a second layer of scaffold material for overlay onto said scaffold material and to thereby enclose said depressions.

69. An intrauterine implant according to claim 63, wherein said scaffold material has a pore size of approximately 50 to 250 micrometers.

70. An implant for reducing intrauterine bleeding comprising:

a plurality of generally spherical members;

said generally spherical implants sized and shaped for placement within a uterus of a patient;

said generally spherical implants being formulated from a material that reacts with uterine tissue so as to substantially inhibit uterine bleeding.

71. An implant according to claim 70, wherein said spherical members are comprised of a scaffold material.

72. An implant according to claim 71, wherein said scaffold material is PET.

73. An implant according to claim 70, wherein said scaffold material is a fabric material.

74. An implant according to claim 73, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

75. An implant according to claim 70, wherein said scaffold material is formulated to cause the formation of adhesions.

76. An implant according to claim 70, wherein said scaffold material is formulated to cause the formation of fibrosis.

77. An implant for reducing intrauterine bleeding comprising:

a resiliently deformable ring member having a substantially circular relaxed state and a substantially linear stressed state;

at least one end of said deformable ring member having a sharp point for penetration into a myometrium of a uterus of a patient;

a scaffold material disposed on said ring;

said scaffold material being formulated for reacting with uterine tissue so as to substantially inhibit uterine bleeding.

78. An implant according to claim 77, wherein said ring member is comprised of Nitinol.

79. An implant according to claim 77, wherein said scaffold material is PET.

80. An implant according to claim 77, wherein said scaffold material is disposed internal to said ring.

81. An implant according to claim 80, wherein said ring includes a plurality of apertures disposed on said ring thereby exposing said scaffold material to tissue ingrowth in said uterus.

82. An implant according to claim 77, wherein said scaffold material is disposed on an external surface of said ring.

83. An implant according to claim 77, wherein said scaffold material has a pore size of approximately 50 to 250 micrometers.

84. An intrauterine implant comprising:

an implant body;

a scaffold material disposed on said implant body, said scaffold material being formulated to react with uterine tissue and thereby inhibit uterine bleeding;

a plurality of struts extending away from said implant body a sufficient amount so as to cause injury to uterine tissue when said implant body is positioned in a uterus.

85. An intrauterine implant according to claim 84, wherein said implant is at least partially bioresorbable.

86. An intrauterine implant according to claim 84, wherein said struts are bioresorbable.

87. An intrauterine implant according to claim 86, wherein said struts are comprised of a bioresorbable material sufficiently strong to penetrate into at least an endometrium of said uterus.

88. An intrauterine implant according to claim 87, wherein said bioresorbable material is PGA.

89. An intrauterine implant according to claim 84, wherein said struts contain said scaffold material.

90. An intrauterine implant according to claim 89, wherein said scaffold material on said struts is PET.

91. An intrauterine implant according to claim 84, wherein said scaffold material is a fabric material.

92. An intrauterine implant according to claim 91, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

93. An implant according to claim 84, wherein said scaffold material is formulated to cause the formation of adhesions.

94. An implant according to claim 84, wherein said scaffold material is formulated to cause the formation of fibrosis.

95. An implant according to claim 84, wherein said plurality of struts extend a sufficient amount so as to contact myometrial tissue.

96. An implant according to claim 84, wherein said scaffold material has a pore size of approximately 50 to 250 micrometers.

97. A uterine device for inhibiting bleeding in a uterus comprising:

a tie member extendable between opposing walls of said uterus; and

a fastening mechanism disposed on said tie member such that said tie member may be constrained so as to bring said opposing walls of said uterus into close proximity to each other.

98. A uterine device according to claim 97, wherein said tie member is rigid.

99. A uterine device according to claim 97, wherein said tie member is semi-rigid.

100. A uterine device according to claim 97, wherein said opposite ends of said tie member are sufficiently sharp so as to puncture uterine tissue of said opposing walls of said uterus.

101. A uterine device according to claim 97, wherein said fastener is sized to distribute load caused by said tie member causing contact of said opposing inner walls of said uterus.

102. A uterine device according to claim 97, wherein said tie member is a plurality of sutures.

103. A uterine device according to claim 102, wherein said fastening mechanism is a knot.

104. A uterine implant assembly comprising:

a sheath having a lumen;

an implant disposed within said lumen of said sheath;

a boring mechanism operably associated with said implant;

a pushing member disposed in said lumen of said sheath behind said implant;

said pushing member actuatable to move said implant out of said sheath and into uterine tissue to a sufficient degree so as to cause injury to said uterine tissue.

105. A uterine implant assembly according to claim 104, wherein said implant is substantially cylindrical in shape.

106. A uterine implant assembly according to claim 104, wherein said implant is comprised of a braided scaffold material.

107. A uterine implant assembly according to claim 106, wherein said braided scaffold material is PET.

108. A uterine implant assembly according to claim 105, wherein said substantially cylindrical implant further includes an open core.

109. A uterine implant assembly according to claim 105, wherein said substantially cylindrical implant further includes a core probe.

110. A uterine implant assembly according to claim 109, wherein said core probe is bioresorbable.

111. A uterine implant assembly according to claim 104, wherein said boring mechanism is a boring needle disposable within said sheath and movable in and out of said sheath.

112. A uterine implant assembly according to claim 104, wherein said boring mechanism comprises a sharp point disposed on one end of said implant.

113. A uterine implant assembly according to claim 104, wherein said pushing member is sized and shaped to move said implant into said uterine tissue to a sufficient degree so as to contact myometrial tissue.

114. A uterine implant for inhibiting uterine bleeding within a uterus comprising:

a member comprised of shape memory material movable between a normal state and a formed state;

said normal state being a substantially coiled shape;

said formed state being a substantially planar elongated shape suitable for placement of said member in a delivery cannula;

said member having sharp edges so as to cause injury to uterine tissue as said member changes from said formed state to said normal state within said uterus.

115. A uterine implant according to claim 114, wherein said member is wrapped in a scaffold material formulated to react with uterine tissue so as to inhibit uterine bleeding.

116. A uterine implant according to claim 115, wherein said material is PET.

117. A uterine implant according to claim 114, wherein said sharp edges are sufficiently sharp so as to penetrate at least the endometrial tissue of said uterus.

118. A uterine implant according to claim 115, wherein said scaffold material is a fabric material.

119. A uterine implant according to claim 118, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

120. A uterine implant according to claim 114, wherein said scaffold material is formulated to cause the formation of adhesions.

121. An implant according to claim 114, wherein said scaffold material is formulated to cause the formation of fibrosis.

122. An intrauterine implant comprising:

a stent having a first end and a second end; and

a plurality of loops disposed on one of said first and second ends of said stent;

said plurality of loops sized and shaped to substantially conform to a shape of said uterus;

said plurality of loops being comprised of a scaffold material to react with uterine tissue so as to substantially inhibit uterine bleeding in said uterus.

123. An intrauterine implant according to claim 122, wherein said scaffold material is PET.

124. An intrauterine implant according to claim 122, wherein said plurality of loops is removably disposed on said stent.

125. An intrauterine implant according to claim 122, wherein said scaffold material is a fabric material.

126. An intrauterine implant according to claim 125, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

127. An intrauterine implant according to claim 122, wherein said scaffold material is formulated to cause the formation of adhesions.

128. An intrauterine implant according to claim 122, wherein said scaffold material is formulated to cause the formation of fibrosis.

129. An intrauterine implant according to claim 122, wherein said scaffold material has a pore size of approximately 50 to 250 micrometers.

130. An intrauterine implant comprising:

an elongated body member; and

a plurality of angled spines disposed on said elongated body member;

said spines being movable between a compressed state when said elongated body member is disposed in a delivery device and an extended state when said elongated body member is located in a uterus;

said spines being sized and shaped to cause tissue injury when said elongated body is located in said uterus.

131. An intrauterine implant according to claim 130, wherein each spine includes a scaffold material formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

132. An intrauterine implant according to claim 131, wherein said scaffold material is disposed in an internal bore of at least one spine.

133. An intrauterine implant according to claim 131, wherein said scaffold material is disposed on an external surface of at least one spine.

134. An intrauterine implant according to claim 130, wherein said intrauterine implant includes multiple elongated body members being interconnected to each other.

135. An intrauterine implant according to claim 134, wherein said intrauterine implant comprises three elongated body members, each of which being connected to each other at proximal end of said elongated body member.

136. An intrauterine implant according to claim 131, wherein said scaffold material is a fabric material.

137. An intrauterine implant according to claim 136, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

138. An intrauterine implant according to claim 131, wherein said scaffold material is formulated to cause the formation of adhesions.

139. An intrauterine implant according to claim 131, wherein said scaffold material is formulated to cause the formation of fibrosis.

140. An intrauterine implant according to claim 130, wherein said spines are disposed on each of opposite ends of said elongated member.

141. An intrauterine implant according to claim 130, wherein said spines are disposed substantially along the length of said elongated member.

142. An intrauterine implant comprising:

a fiber thread;

said fiber thread being comprised of a scaffold material formulated to react with uterine tissue so as to substantially inhibit uterine bleeding;

said fiber thread having a length allowing substantial coverage of the inside of a uterus.

143. An intrauterine implant according to claim 142, wherein said fiber thread is comprised of a metal thread covered with fabric material.

144. An intrauterine implant according to claim 143, wherein said fabric material is PET.

145. An intrauterine implant according to claim 142, wherein said fiber thread is a metallic.

146. An intrauterine implant according to claim 145, wherein said metallic fiber thread is sufficiently flexible so as to avoid causing patient discomfort and sufficiently stiff so as to ensure proper contact between said fiber thread and said uterine tissue.

147. An intrauterine implant according to claim 142, wherein said scaffold material is a fabric material.

148. An intrauterine implant according to claim 147, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

149. An intrauterine implant according to claim 142, wherein said scaffold material is formulated to cause the formation of adhesions.

150. An intrauterine implant according to claim 142, wherein said scaffold material is formulated to cause the formation of fibrosis.

151. An intrauterine implant according to claim 142, wherein said fiber thread is comprised of a flowable biocompatible polymer that solidifies within the intrauterine cavity so as to obtain substantial coverage of the intrauterine cavity and contact with desired uterine tissues.

152. An intrauterine implant according to claim 151, wherein said flowable biocompatible polymer is PET.

153. An intrauterine implant assembly comprising:

a deployment body member having an elongated body and at least two arm members disposed at one end of said body member;

a scaffold material having a pair of pockets for removably receiving said at least two arm members;

a delivery cannula;

said deployment body member being movable into and out of said cannula;

said scaffold material formulated to react with uterine tissue so as to substantially inhibit uterine bleeding.

154. An intrauterine implant according to claim 153, wherein said scaffold material is PET.

155. An intrauterine implant according to claim 153, wherein said scaffold material has a triangular shape as deployed by said deployment body member.

156. An intrauterine implant according to claim 153, wherein said scaffold material includes adhesion bridging apertures interspersed along a surface of said material.

157. An intrauterine implant according to claim 156, wherein said adhesion bridging apertures are approximately 1/16 inch in diameter.

158. An intrauterine implant according to claim 153, wherein said scaffold material is a fabric material.

159. An intrauterine implant according to claim 158, wherein said scaffold material is one of a knit mesh, a woven mesh, and a non-woven mesh.

160. An intrauterine implant according to claim 153, wherein said deployment body member is comprised of a metal.

161. An intrauterine implant according to claim 153, wherein said scaffold material is formulated to cause the formation of fibrosis.

162. An intrauterine implant according to claim 153, wherein said scaffold material has a pore size between fibers of approximately 50 to 250 micrometers.

163. An intrauterine implant according to claim 162, wherein said scaffold material has a pore size of approximately 100-200 micrometers.

164. An intrauterine implant according to claim 153, further including a removable suture extending from said delivery cannula to said scaffold material.

165. A method of deploying an uterine implant comprising:

providing a deployment stent movably mounted within a delivery cannula;

providing a scaffold material;

removably locating said scaffold material onto said deployment stent;

urging said scaffold material toward a fundic wall of a uterine cavity;

expanding said scaffold material;

removing said deployment stent from said scaffold material;

retracting said deployment stent into said delivery cannula.

166. A method according to claim 165, wherein the urging of said scaffold material toward a fundic wall includes tensioning said scaffold material with a suture extending to said user.

167. A method according to claim 166, the suture is removed from the scaffold material prior to removing said deployment stent.

168. A method according to claim 165, wherein the providing of said scaffold material includes providing a PET material.

169. A method according to claim 165, wherein the providing of said scaffold material includes providing a triangular fabric material.