STENT GRAFT DELIVERY SYSTEM

• US 20100036360A1
• Filed: 04/24/2009
• Published: 02/11/2010
• Est. Priority Date: 04/25/2008
• Status: Abandoned Application

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: Kumar, Anant, Hellewell, Matthew R., Laroya, Gil, Evans, Michael A., Rao, K.T. Venkateswara, Herbowy, Steven L.
• Application Number:
  US12/429,474
• Publication Number:
  US 20100036360A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/10188 : Inflation or deflation data displays

Abstract

A system for treating an aneurysm comprises an elongate flexible shaft and an expandable member. An expandable scaffold is disposed over the expandable member and may be expanded from a collapsed configuration to an expanded configuration. A double-walled filling structure is disposed over the scaffold and has an outer wall and an inner wall. The filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a substantially tubular lumen to provide a path for blood flow. In the expanded configuration the scaffold engages the inner wall of the filling structure. A tether is releasably coupled with the filling structure and the flexible shaft thereby constraining axial movement of the structures relative to each other.

Claims

1. A system for treating an aneurysm in a blood vessel, the system comprising:

an elongate flexible shaft having a proximal region and a distal region;

a first double-walled filling structure disposed over the distal region of the shaft, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a first substantially tubular lumen to provide a path for blood flow; and

at least a first expandable scaffold disposed adjacent the filling structure, the first scaffold radially expandable within at least a portion of the tubular lumen of the filling structure,

wherein the filling structure is separate from the first scaffold and axially separated therefrom.

2. The system according to claim 1, wherein the first scaffold is proximal to the filling structure.

3. The system according to claim 1, wherein the first scaffold is distal to the filling structure.

4. The system according to claim 1, wherein a spacing exists between one end of the first scaffold and one end of the filling structure.

5. The system according to claim 1, wherein the first scaffold is slidably received by the filling structure such that the first scaffold and the filling structure are concentric with one another.

6. The system according to claim 1, further comprising a sheath disposed at least partially over the filling structure.

7. The system according to claim 1, further comprising a sheath disposed at least partially over the scaffold.

8. The system according to claim 1, further comprising a tapered sheath disposed at least partially over the flexible shaft.

9. The system according to claim 8, wherein the tapered sheath comprises axially oriented slits near a distal end thereof.

10. The system according to claim 1, further comprising a pusher tube disposed at least partially over the flexible shaft and slidably engageable with the first double-walled filling structure.

11. The system according to claim 1, further comprising a first tether coupled with the filling structure, the tether adapted to guide movement of the first double-walled filling structure relative to the first scaffold axially along the shaft.

12. The system according to claim 11, wherein the first tether extends between the proximal and distal regions of the flexible shaft.

13. The system according to claim 11, wherein the filling structure is slidably engaged with the first tether.

14. The system according to claim 11, further comprising a second tether coupled with the filling structure.

15. The system according to claim 14, wherein the second tether extends between the proximal and distal regions of the flexible shaft.

16. The system according to claim 11, wherein the filling structure comprises one or more eyelets.

17. The system according to claim 11, further comprising a nosecone coupled with the distal region of the flexible shaft, wherein the tether is coupled with the nosecone.

18. The system according to claim 11, wherein a portion of the tether extends outside of a patient'"'"'s body.

19. The system according to claim 11, wherein the tether is releasably coupled with the filling structure.

20. The system according to claim 1, wherein the filling structure comprises a receptacle coupled with a wall of the filling structure, the receptacle adapted to slidably receive a tube.

21. The system according to claim 1, further comprising a pressure monitor, the pressure monitor coupled with the filling structure so as to permit pressure monitoring of the filling structure as the filling structure is filled with the hardenable fluid filling medium.

22. The system according to claim 21, wherein the pressure monitor is fluidly coupled with the filling structure.

23. The system according to claim 21, wherein the pressure monitor comprises a pressure gage.

24. The system according to claim 21, wherein the pressure monitor comprises a digital display or waveform monitor.

25. The system according to claim 1, further comprising an inflation device fluidly coupled with the filling structure.

26. The system according to claim 25, wherein the inflation device comprises a syringe.

27. The system according to claim 1, wherein the filling structure comprises a relief valve.

28. The system according to claim 27, wherein the filling structure comprises a reservoir fluidly coupled with the relief valve

29. The system according to claim 28, wherein the reservoir is adapted to receive the hardenable fluid filling medium from the relief valve at a predetermined pressure.

30. The system according to claim 29, wherein the reservoir is radiopaque when the reservoir is at least partially filled with the hardenable fluid filling medium.

31. The system according to claim 27, wherein the relief valve is fluidly isolated from the first filling structure.

32. The system according to claim 1, wherein the filling structure comprises a visual indicator fluidly coupled therewith and having first and second positions, wherein the indicator moves from the first position to the second position when a predetermined pressure is applied to the visual indicator.

33. The system according to claim 32, wherein the indicator is visible under fluoroscopy.

34. The system according to claim 1, further comprising a collapsible member fluidly coupled with a pressure gage, the expandable member positioned between the outer wall of the filling structure and the inside surface of the aneurysm, the pressure gage adapted to indicate pressure of the filling structure as it is filled.

35. The system according to claim 34, wherein the collapsible member comprises a balloon.

36. The system according to claim 1, further comprising a collapsible member positioned between the outer wall of the filling structure and the inside wall of the aneurysm, the collapsible member fluidly coupled with a compression mechanism having a first position and a second position, the compression mechanism adapted to provide a predetermined force opposing the force exerted by the collapsible member as the filling structure is filled, the compression mechanism moving from the first position to the second position when the force exerted by the collapsible member exceeds the predetermined force.

37. The system according to claim 36, wherein the compression mechanism comprises a spring.

38. The system according to claim 36, wherein the collapsible member comprises a balloon.

39. The system according to claim 1, further comprising a locking mechanism, wherein the locking mechanism prevents fluid from filling the filling structure when the filling structure is filled to a predetermined pressure.

40. The system according to claim 1, wherein the filling structure comprises a compliant compartment adapted to deform as the outer wall of the filling structure conforms to the inside surface of the aneurysm.

41. The system according to claim 40, wherein the compartment is fluidly coupled with a pressure indicator.

42. The system according to claim 35, wherein the balloon comprises a substantially flat section.

43. The system according to claim 1, wherein the first scaffold comprises crushable regions and remainder regions, the crushable regions adapted to collapse when the filling structure is pressurized to a predetermined value while the remainder regions remain fully expanded.

44. The system according to claim 1, further comprising an expandable member expandable from a contracted configuration to an expanded configuration and coupled with the shaft near the distal region.

45. The system according to claim 44, wherein the expandable member comprises a balloon.

46. The system according to claim 45, wherein the balloon comprises a pre-shaped, curved or tapered region.

47. The system according to claim 44, wherein the expandable member is coupled to a pressure monitoring device.

48. The system according to claim 1, wherein the scaffold is balloon expandable.

49. The system according to claim 1, wherein the scaffold comprises a metal.

50. The system according to claim 1, wherein the scaffold or the filling structure carries a therapeutic agent adapted to being released therefrom in a controlled manner.

51. The system according to claim 1, wherein the filling structure comprises a polymer.

52. The system according to claim 1, further comprising a releasable coupling mechanism coupled with the first filling structure and the shaft, wherein the coupling mechanism is adapted to reduce relative axial movement along the shaft of the first filling structure relative to the first scaffold.

53. The system according to claim 52, wherein the releasable coupling mechanism comprises a tether releasably coupled with the shaft and the first filling structure.

54. The system according to claim 1, wherein the first filling structure comprises a filling tube fluidly coupled therewith and adapted to fill the filling structure with the filling medium.

55. The system according to claim 54, wherein the filling tube comprises an inner tube slidably disposed in the filling tube, both the inner tube and the filling tube fluidly coupled with the filling structure.

56. The system according to claim 1, further comprising:

a second double-walled filling structure having an outer wall and an inner wall, wherein said second double-walled filling structure is adapted to be placed adjacent the first filling structure in the aneurysm and to be filled with a hardenable fluid filling medium so that the outer wall conforms to the inside surface of the aneurysm and to the first filling structure and forms a second generally tubular lumen to provide a path for blood flow; and

at least a second scaffold separate from the first scaffold and the filling structures which can be expanded within at least a portion of the second tubular lumen of the second filling structure,

wherein the second scaffold is axially separated from the second filling structure.

57. The system according to claim 56, wherein the second scaffold is balloon expandable.

58. The system according to claim 56, wherein the second scaffold comprises a metal.

59. The system according to claim 56, wherein the second filling structure comprises a polymer.

60. The system according to claim 1, further comprising a flowable polymer filling material curable in situ.

61. A method for treating an aneurysm, said method comprising:

providing an elongate flexible shaft having a proximal end and a distal end, the flexible shaft carrying a first double-walled filling structure and a first scaffold adjacent the distal end;

advancing the elongate shaft in a patient'"'"'s vasculature such that the first double-walled filling structure traverses the aneurysm;

axially moving the first scaffold relative to the first filling structure such that at least a portion of the first scaffold is disposed within the first double-walled filling structure;

radially expanding the first scaffold from a contracted configuration to an expanded configuration; and

filling the first filling structure with a fluid filling medium so that an outer wall of the first filling structure conforms to an inside surface of the aneurysm and an inner wall of the first filling structure forms a first substantially tubular lumen to provide a first blood flow path across the aneurysm, and wherein the at least a portion of the first double-walled filling structure is disposed in the first substantially tubular lumen.

62. The method of claim 61, wherein axially moving the first scaffold comprises moving the first scaffold distally into the first lumen.

63. The method of claim 61, wherein axially moving the first scaffold comprises proximally retracting the first filling structure over the first scaffold.

64. The method of claim 61, wherein axially moving the first scaffold comprises proximally retracting the first scaffold into the first lumen.

65. The method of claim 61, wherein axially moving the first scaffold comprises moving the first filling structure distally over the first scaffold.

66. The method of claim 61, wherein axially moving the first scaffold comprises guiding the first filling structure over a tether line.

67. The method of claim 61, wherein axially moving the first scaffold comprises pulling the first filling structure with a tether line.

68. The method of claim 61, further comprising retracting a sheath from the first filling structure so that the first filling structure is unconstrained from expansion.

69. The method of claim 68, wherein retracting the sheath comprises splitting the sheath.

70. The method of claim 61, further comprising retracting a sheath from the first scaffolding so that the first scaffolding is unconstrained from expansion.

71. The method of claim 61, further comprising hardening the fluid filling medium in the first filling structure.

72. The method of claim 61, further comprising engaging a pusher tube with the first filling structure thereby preventing movement thereof.

73. The method of claim 61, further comprising monitoring a pressure.

74. The method of claim 73, wherein the pressure is exerted by the filling medium within the first filling structure.

75. The method of claim 61, wherein the step of filling the filling structure comprises controlling pressure or volume of the fluid filling medium.

76. The method of claim 73, wherein the monitored pressure is within a space between an external wall of the first filling structure and a wall of the aneurysm.

77. The method of claim 76, wherein monitoring the pressure comprises placing a catheter in the space.

78. The method of claim 77, wherein the catheter comprises a fluid filled balloon.

79. The method of claim 76, wherein monitoring the pressure comprises placing a pressure transducer in the space.

80. The method of claim 73, wherein filling the filling structure comprises actuating an injection device and wherein the pressure is monitored at a position adjacent the injection device.

81. The method of claim 73, further comprising relieving pressure in the filling structure with a relief valve when the pressure exceeds a predetermined value.

82. The method of claim 81, further comprising filling a reservoir fluidly coupled with the relief valve.

83. The method of claim 82, further comprising observing the reservoir.

84. The method of claim 81, further comprising isolating the relief valve from the first filling structure so that the relief valve is fluidly isolated therefrom.

85. The method of claim 73, further comprising observing a visual indicator coupled with the first filling structure, the indicator having first and second positions, wherein the indicator moves from the first position to the second position when a predetermined pressure is applied to the visual indicator.

86. The method of claim 73, further comprising positioning a collapsible member between the outer wall of the filling structure and the inside wall of the aneurysm and further comprising observing a compression mechanism having a first position and a second position, the compression mechanism adapted to provide a predetermined force opposing the force exerted by the collapsible member as the filling structure is filled, the compression mechanism moving from the first position to the second position when the force exerted by the collapsible member exceeds the predetermined force.

87. The method of claim 86, wherein the compression mechanism comprises a spring.

88. The method of claim 86, wherein the collapsible member comprises a balloon.

89. The method of claim 73, further comprising stopping the filling of the filling structure when the monitored pressure reaches a predetermined pressure.

90. The method of claim 89, wherein stopping the filling comprises mechanically locking a filling device so that fluid may not be delivered therefrom.

91. The method of claim 73, wherein monitoring comprises observing the first scaffold, the first scaffold comprising crushable regions and remainder regions, the crushable regions adapted to collapse when the filling structure is pressurized to a predetermined value while the remainder regions remain fully expanded.

92. The method of claim 61, wherein the step of radially expanding the first scaffold comprises inflating a balloon disposed near the distal end of the elongate shaft.

93. The method of claim 92, wherein the balloon comprises a pre-shaped, curved or tapered region.

94. The method of claim 61, further comprising releasing a releasable coupling mechanism that couples the filling structure with the shaft to allow axial movement of the filling structure relative to the first scaffold and to allow release of the filling structure from the shaft.

95. The method of claim 94, wherein releasing the coupling mechanism comprises releasing a knot in a tether joining the filling structure with the shaft.

96. The method of claim 61, wherein a filling tube is fluidly coupled with the filling structure, and the step of filling the filling structure comprises passing the fluid filling medium through the filling tube to the filling structure.

97. The method of claim 96, wherein the filling tube comprises an inner tube slidably disposed therein and in fluid communication with the filling structure, the method further comprising removing the inner tube and passing additional fluid filling medium through the filling tube after the inner tube has been removed.

98. The method of claim 61, further comprising:

providing a second elongate flexible shaft having a proximal and distal end, the second shaft carrying a second double-walled filling structure and a second scaffold adjacent the distal end;

advancing the second elongate shaft in the patient'"'"'s vasculature such that the second double-walled filling structure traverses the aneurysm;

axially moving the second scaffold relative to the second filling structure such that at least a portion of the second scaffold is disposed within the second double-walled filling structure;

filling the second filling structure with a fluid filling medium so that an outer wall of the second filling structure forms a second substantially tubular lumen to provide a second blood flow path across the aneurysm, and wherein at least a portion of the second scaffold is disposed in the second substantially tubular lumen; and

radially expanding the second scaffold from a contracted configuration to an expanded configuration.

99. The method of claim 98, wherein axially moving the second scaffold comprises moving the second scaffold distally into the second lumen.

100. The method of claim 98, wherein axially moving the second scaffold comprises proximally retracting the second filling structure over the second scaffold.

101. The method of claim 98, wherein axially moving the second scaffold comprises proximally retracting the second scaffold into the second lumen.

102. The method of claim 98, wherein axially moving the second scaffold comprises moving the second filling structure distally over the second scaffold.

103. The method of claim 98, further comprising retracting a sheath from the second filling structure so that the second filling structure is unconstrained from expansion.

104. The method of claim 103, wherein retracting the sheath comprises splitting the sheath.

105. The method of claim 98, further comprising retracting a sheath from the second scaffolding so that the second scaffolding is unconstrained from expansion.

106. The method of claim 98, further comprising hardening the fluid filling medium in the second filling structure.

107. The method of claim 98, further comprising monitoring a second pressure, the second pressure being exerted by the filling medium within the second filling structure.

108. The method of claim 98, wherein the step of filling the second filling structure comprises controlling pressure or volume of the fluid filling medium.

109. The method of claim 98, further comprising inflating a balloon on either the first or second elongate shaft so as to compress the first and second filling structures against one another and against the aneurysm wall.

110. The method of claim 109, wherein filling medium is discharged from either the first or second filling structure.

111. The method of claim 98, further comprising filling either the first or the second filling structure until it engages the other filling structure resulting in filling medium being discharged from either the first or second filling structure.

112. The method of claim 98, wherein the step of radially expanding the second scaffold comprises inflating a balloon disposed near the distal end of the second shaft.

113. The method of claim 112, wherein the balloon on the second shaft comprises a pre-shaped, curved or tapered region.

114. A system for treating an aneurysm in a blood vessel, said system comprising:

an elongate flexible shaft having a proximal region and a distal region;

an expandable member disposed adjacent the distal region;

a first expandable scaffold disposed over the expandable member, the first scaffold radially expandable from a collapsed configuration to an expanded configuration;

a first double-walled filling structure disposed over the first scaffold, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a first substantially tubular lumen to provide a path for blood flow,

wherein the first scaffold in the expanded configuration engages the inner wall of the filling structure; and

a first releasable coupling mechanism releasably coupling the filling structure with the flexible shaft, wherein the coupling mechanism constrains axial movement of the filling structure relative to the flexible shaft.

115. The system of claim 114, wherein the releasable coupling mechanism comprises a first tether.

116. The system of claim 115, wherein the tether comprises a suture.

117. The system of claim 115, further comprising a lockwire disposed alongside the flexible shaft, wherein a distal end of the lockwire is releasably coupled with the flexible shaft.

118. The system of claim 117, wherein the flexible shaft comprises a tapered nosecone having an aperture therein, the nosecone coupled with the distal region of the flexible shaft, and wherein the distal end of the lockwire is releasably coupled with and slidably received in the nosecone aperture.

119. The system of claim 117, wherein the first tether is releasably coupled to the lockwire.

120. The system of claim 119, wherein the filling structure comprises a first tether loop fixedly attached thereto, and wherein the first tether passes through the tether loop.

121. The system of claim 120, wherein the first tether loop is disposed on a distal end of the filling structure.

122. The system of claim 119, wherein the first tether is releasably coupled to the lockwire with a knot.

123. The system of claim 122, wherein the knot comprises a constrictor knot.

124. The system of claim 115, wherein one end of the first tether is fixedly attached with the flexible shaft.

125. The system of claim 117, further comprising a second releasable coupling mechanism releasably coupled with the filling structure and the flexible shaft, the second coupling mechanism disposed on an opposite end of the filling structure as the first coupling mechanism, and wherein the second coupling mechanism constrains axial movement of the filling structure relative to the flexible shaft.

126. The system of claim 125, wherein the second coupling mechanism comprises a second tether.

127. The system of claim 126, wherein the second tether comprises a suture.

128. The system of claim 126, wherein the second tether is releasably coupled to the lockwire.

129. The system of claim 128, wherein the second tether is looped around the lockwire.

130. The system of claim 126, wherein the filling structure comprises a second tether loop fixedly attached thereto and disposed on an opposite end as the first tether loop, and wherein the second tether passes through the second tether loop.

131. The system of claim 126, wherein the second tether is coupled to the flexible shaft.

132. The system of claim 131, wherein the second tether is releasably coupled to the flexible shaft with a knot.

133. The system of claim 132, wherein the knot comprises a constrictor knot.

134. The system of claim 125, wherein the first filling structure comprises a fill tube fluidly coupled therewith, and wherein the second coupling mechanism is coupled with the fill tube so as to prevent release of the fill tube from the filling structure.

135. The system of claim 114, further comprising a second releasable coupling mechanism releasably coupled with the filling structure and the flexible shaft, wherein the second mechanism is disposed on the same end of the filling structure as the first releasable coupling mechanism, and wherein the second mechanism constrains axial movement of the filling structure relative to the flexible shaft.

136. The system of claim 135, wherein the second mechanism comprises a second tether.

137. The system of claim 136, wherein the second tether comprises a suture.

138. The system of claim 136, further comprising a second lockwire disposed alongside the flexible shaft, wherein a distal end of the second lockwire is releasably coupled with the flexible shaft.

139. The system of claim 138, wherein the flexible shaft comprises a tapered nosecone having a second aperture therein, the nosecone coupled with the distal region of the flexible shaft, and wherein the distal end of the second lockwire is releasably coupled with and slidably received in the second nosecone aperture.

140. The system of claim 138, wherein the second tether is releasably coupled to the lockwire.

141. The system of claim 136, wherein the filling structure comprises a second tether loop fixedly attached thereto, and wherein the second tether passes through the second tether loop.

142. The system of claim 141, wherein the second tether loop is disposed on the same end of the filling structure as the first tether loop.

143. The system of claim 138, wherein the second tether is releasably coupled to the lockwire with a knot.

144. The system of claim 143, wherein the knot comprises a constrictor knot.

145. The system of claim 136, wherein one end of the second tether is fixedly attached with the flexible shaft.

146. The system of claim 114, further comprising a filling tube fluidly coupled with the filling structure, the filling tube adapted to deliver the hardenable filling medium to the filling structure.

147. The system of claim 146, wherein the filling tube comprises a plurality of apertures near a distal end thereof, the apertures adapted to allow the hardenable filling medium to flow therethrough into the filling structure.

148. The system of claim 146, wherein the filling tube comprises an inner filling tube and an outer filling tube slidably disposed thereover, both inner and outer tubes fluidly coupled with the filling structure.

149. The system of claim 146, further comprising a stylet disposed in the filling tube.

150. The system of claim 146, further comprising a filling tab fluidly coupled with the filling structure and fluidly coupled with the filling tube.

151. The system of claim 150, wherein the filling tab comprises a scored region adapted to permit separation of the filling tab into two portions, the first portion remaining coupled with the filling structure after filling thereof with the hardenable filling medium and the second portion discrete and independent of the first portion.

152. The system of claim 114, further comprising an outer sheath having a lumen, wherein the filling structure, the scaffold and the expandable member are disposed with the sheath lumen during delivery of the system to a treatment site.

153. The system of claim 114, wherein the expandable member comprises an inflatable balloon.

154. The system of claim 153, wherein the balloon comprises a pre-shaped, curved or tapered region.

155. The system of claim 114, further comprising a pressure monitor, the pressure monitor coupled with the first filling structure so as to permit pressure monitoring of the filling structure as the filling structure is filled with the hardenable fluid filling medium.

156. The system of claim 114, further comprising:

a second elongate flexible shaft having a proximal region and a distal region;

a second expandable member disposed adjacent the distal region;

a second expandable scaffold disposed over the second expandable member, the second scaffold radially expandable from a collapsed configuration to an expanded configuration;

a second double-walled filling structure disposed over the second scaffold, the second filling structure having an outer wall and an inner wall, wherein the second filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and to the first double-walled filling structure, and the inner wall forms a first substantially tubular lumen to provide a path for blood flow,

wherein the second scaffold in the expanded configuration engages the inner wall of the filling structure; and

a tether releasably coupled with the second filling structure and the second flexible shaft, wherein the tether constrains axial movement of the second filling structure relative to the second flexible shaft.

157. A method for treating an aneurysm in a patient, said method comprising:

providing an elongate flexible shaft having a proximal end, a distal end, and an expandable member near the distal end, the flexible shaft carrying a first radially expandable scaffold over the expandable member and a first double walled filling structure disposed over the first scaffold;

advancing the shaft in the vasculature of the patient so that the first filling structure is delivered to the aneurysm;

filling the first filling structure with a first fluid filling medium so that an outer wall of the first filling structure conforms to an inside surface of the aneurysm and an inner wall of the first filling structure forms a first substantially tubular lumen to provide a first blood flow path across the aneurysm;

radially expanding the first scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the first scaffold engages the inner wall of the first filling structure;

hardening the fluid filling medium in the first filling structure;

releasing the first filling structure from the flexible shaft; and

retracting the flexible shaft away from the first filling structure.

158. The method of claim 157, further comprising:

pre-filling the first filling structure with a pre-filling fluid until the outer wall of the first filling structure conforms to the inside surface of the aneurysm, thereby unfurling the first filling structure; and

removing the pre-filling fluid from the first filling structure.

159. The method of claim 158, wherein the pre-filling fluid comprises saline.

160. The method of claim 158, further comprising:

pre-filling the first filling structure with pre-filling fluid until the outer wall of the first filling structure conforms to the inside surface of the aneurysm;

measuring the pressure and volume of the pre-filling fluid used to pre-fill the first filling structure; and

removing the pre-filling fluid from the first filling structure, wherein the step of filling the first filling structure with the first fluid filling medium comprises filling the first filling structure with the first filling medium using substantially the same pressure and volume as measured.

161. The method of claim 160, wherein the pre-filling fluid comprises saline.

162. The method of claim 160, wherein the pre-filling fluid comprises contrast media.

163. The method of claim 158, wherein the step of filling the first filling structure comprises passing the first fluid medium through a filling tube fluidly coupled with the first filling structure.

164. The method of claim 157, wherein the first filling structure comprises a filling tube fluidly coupled therewith, and the step of filling the first filling structure comprises passing the filling medium through the filling tube.

165. The method of claim 164, wherein the filling tube comprises an inner tube slidably disposed therein and fluidly coupled with the first filling structure, the method further comprising removing the inner tube from the filling tube and supplying additional filling medium to the filling structure by passing the additional filling medium through the filling tube after the inner tube has been removed therefrom.

166. The method of claim 157, wherein the step of radially expanding the scaffold comprises inflating a balloon disposed on the flexible shaft.

167. The method of claim 166, wherein the balloon comprises a pre-shaped, curved or tapered region.

168. The method of claim 157, wherein the step of hardening the first fluid filling medium in the first filling structure comprises polymerizing the first fluid filling medium in situ.

169. The method of claim 168, wherein the first fluid filling medium comprises polyethylene glycol.

170. The method of claim 157, wherein a releasable coupling mechanism couples the first filling structure with the flexible shaft and the step of releasing the first filling structure from the flexible shaft comprises releasing the coupling mechanism from the first filling structure.

171. The method of claim 170, wherein the coupling mechanism comprises a tether and the step of releasing the coupling mechanism comprises detaching the tether from the first filling structure.

172. The method of claim 171, wherein one end of the tether is releasably coupled with a lockwire and the step of de-coupling the tether comprises retracting the lockwire thereby detaching the tether from the lockwire.

173. The method of claim 171, wherein detaching the tether comprises releasing the tether from a tether loop on the first filling structure.

174. The method of claim 171, wherein a second releasable coupling mechanism couples the first filling structure with the flexible shaft and the step of releasing the first filling structure from the flexible shaft comprises de-coupling the second coupling mechanism from the first filling structure.

175. The method of claim 171, wherein the first filling structure comprises a fill tube fluidly coupled therewith, and wherein a second releasable coupling mechanism is coupled with the fill tube such that the step of releasing the first filling structure from the flexible shaft comprises de-coupling the second coupling mechanism from the fill tube to allow separation of the fill tube from the filling structure.

176. The method of claim 157, further comprising the step of retracting a sheath away from the first filling structure and the first scaffold to allow expansion thereof.

177. The method of claim 157, further comprising the step of monitoring a pressure during filling of the first filling structure.

178. The method of claim 177, wherein the pressure comprises a pressure of the filling medium in the first filling structure.

179. The method of claim 177, wherein the pressure comprises a pressure in a space between the outer wall of the first filling structure and a wall of the aneurysm.

180. The method of claim 157, further comprising releasing a filling tube from the first filling structure.

181. The method of claim 180, wherein the step of releasing the filling tube comprises severing a filling tab coupled with the first filling structure.

182. The method of claim 157, further comprising:

providing a second elongate flexible shaft having a proximal end, a distal end, and a second expandable member near the distal end, the second flexible shaft carrying a second radially expandable scaffold over the second expandable member and a second double walled filling structure disposed over the second scaffold;

advancing the second shaft in the vasculature of the patient so that the second filling structure is delivered to the aneurysm;

filling the second filling structure with a second fluid filling medium so that an outer wall of the second filling structure conforms to an inside surface of the aneurysm and to the first double-walled filling structure, and an inner wall of the second filling structure forms a second substantially tubular lumen to provide a second blood flow path across the aneurysm;

radially expanding the second scaffold from a contracted configuration to an expanded configuration, wherein in the expanded configuration the second scaffold engages the inner wall of the second filling structure;

hardening the second fluid filling medium in the second filling structure;

releasing the second filling structure from the second flexible shaft; and

retracting the second shaft away from the second filling structure.