ENDOVASCULAR DEVICES AND METHODS FOR EXPLOITING INTRAMURAL SPACE

• US 20100063534A1
• Filed: 11/20/2007
• Published: 03/11/2010
• Est. Priority Date: 11/21/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad John, Olson, Ross Arlen, Atkinson, Robert Emmet, Olson, Matthew Jonathan, Robinson, David B.
• Granted Patent: US 11,109,883 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Devices and methods for exploiting intramural (e.g., subintimal) space of a vascular wall to facilitate the treatment of vascular disease, particularly total occlusions. For example, the devices and methods disclosed herein may be used to visually define the vessel wall boundary, protect the vessel wall boundary from perforation, bypass an occlusion, and/or remove an occlusion.

Claims

1-2. -2. (canceled)

3. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the device terminating at a distal tip configured for controlled deflection;

a first actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the first actuation member;

an orienting element having a first collapsed configuration and a second expanded, substantially planar configuration; and

a second actuation member connected to a portion of the planar orienting element and extending to a proximal end of the shaft for causing expansion of the orienting element upon actuation of the second actuation member.

4. The system of claim 3, wherein the orienting element is biased toward the collapsed configuration.

5. The system of claim 3, wherein the elongate shaft includes an inner layer and an outer layer.

6. The system of claim 3, wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

7. The system of claim 6, wherein a distal end of the second actuation member is connected to either the proximal collar or the distal collar.

8. The system of claim 6, wherein the orienting element exhibits the second expanded configuration upon moving the distal collar and the proximal collar closer together.

9. The system of claim 6, wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

10. The system of claim 6, wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

11. The system of claim 3, wherein the orienting element includes a pair of wings that extend along opposing sides of the device, each wing having a distal end and a proximal end.

12. The system of claim 11, wherein the wings exhibit the second expanded configuration upon moving the distal wing ends and the proximal wing ends closer together.

13. The system of claim 11, further comprising radiopaque markers designating the distal and proximal wing ends.

14. The system of claim 13, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

15. The system of claim 11, further comprising radiopaque markers designating an intermediate location along each wing.

16. The system of claim 15, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

17. The system of claim 3, wherein the substantially planar configuration is slightly curved to conform to the shape of a vascular lumen.

18. The system of claim 3, wherein the distal tip is configured to deflect only in a plane substantially perpendicular to the plane of the expanded orienting element.

19. The system of claim 3, wherein the first actuation member comprises a tension member.

20. The system of claim 3, wherein the first actuation member comprises a push member.

21. The system of claim 3, wherein the first actuation member includes two actuation members formed along opposing surfaces of the distal tip for causing deflection of the distal tip in two substantially orthogonal directions each substantially perpendicular to the plane of the expanded orienting element.

22. The system of claim 3, wherein the distal tip includes a pattern of rings formed with opposing longitudinal spines formed in the inner layer of the elongate shaft arranged to allow deflection only in a plane substantially perpendicular to the plane of the expanded orienting element.

23. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the shaft including an inner layer and an outer layer;

an orienting element at a distal end of the device including a pair of wings that extend along opposing sides of the device, the wings having a first collapsed configuration and a second expanded, substantially planar configuration; and

each wing having a distal end and a proximal end, and wherein the wings exhibit the second expanded configuration upon moving the distal wing ends and the proximal wing ends closer together.

24. The system of claim 23, further comprising radiopaque markers designating the distal and proximal wing ends.

25. The system of claim 24, wherein:

the radiopaque markers are separated by a first distance when the wings are assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the wings are assuming the second expanded, substantially planar configuration; and

the second distance is smaller than the first distance.

26. The system of claim 23, further comprising radiopaque markers designating an intermediate location along each wing.

27. The system of claim 26, wherein:

the radiopaque markers are separated by a first distance when the wings are assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the wings are assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

28. The system of claim 23. wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

29. The system of claim 28. wherein a distal end of an actuation member is connected to either the proximal collar or the distal collar.

30. The system of claim 28, wherein the orienting element exhibits the second expanded configuration upon moving the distal collar and the proximal collar closer together.

31. The system of claim 30, wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

32. The system of claim 30, wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

33. The system of claim 23, wherein the device terminates at a distal tip configured for controlled deflection.

34. The system of claim 33, wherein the distal tip is configured to deflect only in a plane substantially perpendicular to the plane of the expanded orienting element.

35. The system of claim 33, further comprising at least one actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the actuation member.

36. The system of claim 33, further comprising two actuation members formed along opposing surfaces of the distal tip for causing deflection of the distal tip in two substantially orthogonal directions each substantially perpendicular to the plane of the expanded orienting element.

37. The system of 33, wherein the distal tip includes a pattern of rings formed with opposing longitudinal spines formed in the inner layer of the elongate shaft arranged to allow deflection only in a plane substantially perpendicular to the plane of the expanded orienting element.

38. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening,

an orienting element provided along the shaft and having a first collapsed configuration and a second expanded, substantially planar configuration;

a bearing surface mounted to a portion of the elongate shaft along the orienting element;

a first actuation member connected to the orienting element, extending distally around the bearing surface, and then proximally to a proximal end of the device; and

a second actuation member connected to the orienting element and extending proximally to the proximal end of the device;

wherein actuating the first actuation member causes controlled expansion of the orienting element, and actuating the second actuation member causes controlled collapse of the orienting element.

39. The system of claim 38, wherein the first and second actuation members are connected so as to form an integral member.

40. The system of claim 38, wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

41. The system of claim 40, wherein both the first and second actuation members are connected to the proximal collar.

42. The system of claim 40, wherein the bearing surface is located distally of the proximal collar.

43. The system of claim 40, wherein the orienting element comprises a first radiopaque marker and a second radiopaque marker.

44. The system of claim 43, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is smaller than the first distance.

45. The system of claim 43, wherein:

the radiopaque markers are separated by a first distance when the orienting element is assuming the first collapsed configuration;

the radiopaque markers are separated by a second distance when the orienting element is assuming the second expanded, substantially planar configuration; and

the second distance is greater than the first distance.

46. The system of claim 40, wherein the orienting element exhibits the second expanded configuration upon moving the distal collar and the proximal collar closer together.

47. The system of claim 46. wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

48. The system of claim 46. wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

49. The system of claim 38, wherein the device terminates at a distal tip configured for controlled deflection.

50. The system of claim 49, wherein the distal tip is configured to allow deflect only in a plane substantially perpendicular to the plane of the expanded orienting element.

51. The system of claim 49, further comprising a third actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the third actuation member.

52. The system of claim 49, further comprising two actuation members formed along opposing surfaces of the distal tip for causing deflection of the distal tip in two substantially orthogonal directions substantially perpendicular to the plane of the expanded orienting element.

53. The system of claim 49, wherein the distal tip includes a pattern of rings formed with opposing longitudinal spines formed in the inner layer of the elongate shaft arranged to allow deflection only in a plane substantially perpendicular to the plane of the expanded orienting element.

54-63. -63. (canceled)

64. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a lumen extending therethrough to a side port, the device terminating at a distal tip configured for controlled deflection;

an orienting element having a first collapsed configuration and a second expanded, substantially planar configuration in a first plane;

wherein the side port is located along the shaft proximal of the orienting element and facing a direction substantially perpendicular to the first plane; and

wherein the distal tip is configured to allow deflection only in a second plane substantially perpendicular to the first plane such that upon deflection the tip is deflected either toward the side port or away from the side port.

65. The system of claim 64, further comprising an actuator at a proximal end of the device, wherein actuating the actuator in a first direction causes deflection of the tip toward the side port and actuating the actuator in a second direction causes deflection of the tip away from the side port.

66. The system of claim 65, wherein the first actuation direction is substantially 180 opposite to the second actuation direction.

67. The system of claim 64, wherein the lumen extends proximally leading to an access port at the proximal end of the device, the access port being oriented along the device to extend in substantially the same angular orientation as the side port.

68. The system of claim 67, further comprising an actuator at a proximal end of the device, wherein actuating the actuator in a first direction towards the access port causes deflection of the tip toward the side port and actuating the actuator in a second direction away from the access port causes deflection of the tip away from the side port.

69. The system of claim 64, wherein the orienting element is biased toward the collapsed configuration.

70. The system of claim 64, wherein the elongate shaft includes an inner layer and an outer layer.

71. The system of claim 64, wherein the orienting element is mounted along the elongate shaft by a proximal collar and a distal collar.

72. The system of claim 71, further comprising at least one actuation member connected o either the proximal collar or the distal collar.

73. The system of claim 72, wherein the orienting element exhibits the second configuration upon moving the distal collar and the proximal collar closer together.

74. The system of claim 72, wherein the proximal collar is fixed along the elongate shaft and the distal collar is slidable relative to the elongate shaft.

75. The system of claim 72, wherein the distal collar is fixed along the elongate shaft and the proximal collar is slidable relative to the elongate shaft.

76. The system of claim 64, wherein the orienting element includes a pair of wings that extend along opposing sides of the device, each wing having a distal end and a proximal end.

77. The system of claim 76, wherein the wings exhibit the second configuration upon moving the distal wing ends and the proximal wing ends closer together.

78. The system of claim 76, further comprising radiopaque markers designating the distal and proximal wing ends.

79. The system of claim 76, further comprising radiopaque markers designating an intermediate location along each wing.

80. The system of claim 64, wherein the substantially planar configuration is slightly curved to conform to the shape of a vascular lumen.

81. The system of claim 64, wherein the shaft includes a central lumen extending therethrough to a distal opening.

82. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the device terminating at a distal tip configured for controlled deflection;

at least one actuation member connected to the distal tip and extending to a proximal end of the shaft for causing deflection of the distal tip upon movement of the actuation member; and

an inflatable orienting member having a first collapsed configuration and a second expanded, substantially planar configuration in a first plane; and

wherein the distal tip is configured to allow deflection only in a second plane substantially perpendicular to the first plane.

83. The system of claim 82, wherein the orienting device defines separate lumens extending parallel to each other and in a planetary fashion around the central lumen.

84. The system of claim 83, wherein the separate lumens include at least one actuation men for housing the at least one actuation member and an inflation lumen for supplying an inflation fluid to actuate the inflatable member.

85. The system of claim 83, wherein the separate lumens comprise two actuation lumens for housing actuation members and two inflation lumens for supplying an inflation fluid to inflate the inflatable member.

86. The system of claim 85, wherein the actuation lumens are spaced approximately 180 degrees apart, and the inflation lumens are spaced approximately 180 degrees apart.

87. The system of claim 85, wherein the two inflation lumens lie approximately 90 degrees from the first plane.

88-106. -106. (canceled)

107. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the device terminating at a distal tip configured for controlled deflection,

at least one tension member connected to the distal tip at a first end and a point along the shaft at a second end;

at least one inflation member; and

wherein the at least one tension member is aligned with the inflation member such that deflection of the tip occurs upon inflation of the at least one inflation member.

108. The system of claim 107, wherein the at least one tension member includes two tension members spaced approximately 180 degrees apart along the elongate shaft.

109. The system of claim 108, wherein the at least one inflation member includes two inflation members, each inflation member located to expand along the path of a tension member.

110. The system of claim 107, wherein the orienting device includes a substantially planar inflatable member.

111. The system of claim 107, wherein the orienting device includes an inflatable member having an central axis offset from a central axis of the elongate shaft.

112. The system of claim 107, wherein the at least one tension member only extends be between the distal tip and a point just proximal of the inflation member.

113. The system of claim 110, wherein the orienting device includes an inflatable member having a width and a height, and wherein the width is substantially greater than the height when the inflatable member is in an expanded configuration.

114. The system of claim 113, wherein the at least one tension member extends along the table member following a path substantially following a midpoint along the width of the inflatable member.

115. The system of claim 114, wherein the at least one tension member includes two tension members spaced approximately 180 degrees apart, with one tension member extending along an upper surface of the orienting and another tension member extending along a lower surface opposite the upper surface.

116. The system of claim 115, wherein each tension member only extends between the tip and a point just proximal of the corresponding inflation member.

117. The system of claim 107, wherein the orienting device defines separate lumens ending parallel to each other and in a planetary fashion around a circumference of the central lumen.

118. The system of claim 117, wherein the orienting device includes a substantially planar inflatable member, and wherein the separate lumens include at least one inflation lumen for actuating the inflation member and another inflation lumen for actuating the inflatable member.

119. The system of claim 117, wherein the separate lumens comprise two inflation lumens for actuating the inflation member and two inflation lumens for actuating the inflatable member.

120. The system of claim 119, wherein the lumens for actuating the inflation member are iced approximately 180 degrees apart, and the lumens for actuating the inflatable member are spaced approximately 180 degrees apart.

121. The system of claim 117, wherein the lumens for actuating the inflation member comprise two inflation lumens, each spaced approximately 90 degrees from a plane defined by the inflatable member in an expanded position.

122. The system of claim 110, wherein the distal tip is configured such that deflection of distal tip only occurs in a plane substantially orthogonal to a plane defined by the inflatable member in an expanded position.

123. The system of claim 117, wherein the separate lumens are spaced approximately 90 degrees apart around a circumference of the central lumen.

124. The system of claim 117, wherein the lumens located around the central lumen each contain a metallic element therein.

125. The system of claim 123, wherein the lumens located around the central lumen each contain a metallic element therein.

126. The system of claim 117, wherein the metallic elements terminate at different positions along the orienting device.

127. The system of claim 111, wherein the distal tip and at least one tension member is figured such that deflection of the distal tip only occurs in a direction from the central axis of the elongate shaft toward the central axis of the inflatable member.

128. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a central lumen extending therethrough to a distal opening, the device terminating at a distal tip configured for controlled deflection;

an inflatable member positioned proximal from the distal tip;

at least one tension member connected to the distal tip at a first end such that displacement of the tension member causes deflection of the tip;

separate lumens extending parallel to each other and in a planetary fashion around a circumference of the central lumen; and

wherein the lumens located around the central lumen each contain a metallic element therein.

129. The system of claim 128, wherein the inflatable member has a width and a height, wherein the width is substantially greater than the height when the inflatable member is in an expanded configuration.

130. The system of claim 128, further comprising, the at least one tension member connecting to a point along the shaft at a second end;

at least one inflation member; and

wherein the at least one tension member is aligned with the inflation member such that deflection of the tip occurs upon inflation of the at least one inflation member.

131. The system of claim 128, wherein the distal tip is configured such that deflection of distal tip only occurs in a plane substantially orthogonal to a plane defined by the inflatable member in an expanded configuration.

132. The system of claim 128, wherein the metallic elements terminate at different positions along the orienting device.

133. The system of claim 128, wherein the at least one tension member includes two tension members spaced approximately 180 degrees apart along the elongate shaft.

134. The system of claim 133, wherein the at least one inflation member includes two inflation members, each inflation member located to expand along the path of a tension member.

135-138. -138. (canceled)

139. A device comprising:

an elongate shaft defining a first planetary lumen; and

a first balloon defining an interior in fluid communication with the first planetary lumen.

140. The device of claim 139, wherein the first balloon and the elongate shaft are monolithic.

141. The device of claim 139, wherein the first balloon and the elongate shaft are seamlessly formed from a single piece of material.

142. The device of claim 139, wherein the first balloon comprises an extruded portion of an outer wall of the elongate shaft.

143. The device of claim 139, wherein the elongate shaft defines a second planetary lumen.

144. The device of claim 143, further including a second balloon defining an interior in fluid communication with the second planetary lumen.

145. The device of claim 144, wherein the first balloon has a first length and the second balloon has a second length that is greater than the first length.

146. The device of claim 144, wherein the second balloon and the elongate shaft are monolithic.

147. The device of claim 144, wherein the first balloon, the second balloon and the elongate shaft are seamlessly formed from a single piece of material.

148. The device of claim 144, wherein the first balloon and the second balloon each comprise an extruded portion of an outer wall of the elongate shaft.

149. The device of claim 144, wherein the outer wall of the elongate shaft partially defines the first planetary lumen and the second planetary lumen.

150. The device of claim 139, wherein the elongate shaft defines a third planetary lumen.

151. The device of claim 150, further including a first reinforcement strip disposed in the third planetary lumen.

152. The device of claim 151, wherein the reinforcement strip comprises a metallic material.

153. The device of claim 151, wherein the elongate shaft defines a fourth planetary lumen.

154. The device of claim 153, further including a second reinforcement strip disposed in the fourth planetary lumen.

155. The device of claim 154, wherein the second reinforcement strip comprises a metallic material.

156. The device of claim 139, wherein the elongate shaft comprises a thermoplastic material.

157. A catheter comprising:

an elongate shaft defining a first planetary lumen; and

a first wire disposed in the first planetary lumen.

158. The catheter of claim 157, wherein the elongate shaft defines a second planetary men.

159. The catheter of claim 158, further including a second wire disposed in the second planetary lumen.

160. The catheter of claim 157, wherein a torsional rigidity of the catheter increases when a proximal end of the elongate shaft is rotated relative to a distal end of the elongate shaft.

161. The catheter of claim 157, wherein the first wire is biased to assume a substantially straight shape.

162. The catheter of claim 157, wherein the first wire assumes a generally helical shape when a proximal end of the elongate shaft is rotated relative to a distal end of the elongate shaft.

163. The catheter of claim 157, wherein the elongate shaft is biased to assume a shape in which the first planetary lumen is substantially straight.

164. The catheter of claim 157, wherein the elongate shaft assumes a shape in which the first planetary lumen is substantially helical when a proximal end of the elongate shaft is rotated relative to a distal end of the elongate shaft.

165. The catheter of claim 157, wherein the first wire comprises a metallic material.

166. The catheter of claim 157, wherein the elongate shaft defines a third planetary lumen.

167. The catheter of claim 166, further including a third wire disposed in the third planetary lumen.

168. The catheter of claim 157, wherein the elongate shaft defines a fourth planetary lumen.

169. The catheter of claim 165, further including a fourth wire disposed in the fourth planetary lumen.

170. The catheter of claim 157, wherein a column strength of the catheter decreases when a proximal end of the elongate shaft is rotated relative to a distal end of the elongate shaft.

171. The catheter of claim 157, wherein a distal end of the first wire is not fixed to the elongate shaft.

172. The catheter of claim 157, wherein a distal end of the first wire moves relative to a distal end of the elongate shaft when a proximal end of the elongate shaft is rotated relative to the distal end of the elongate shaft.

173. The catheter of claim 157, wherein:

the elongate shaft has a straight shape and a twisted shape;

the elongate shaft has a first rotational stiffness when the elongate shaft is assuming the straight shape;

the elongate shaft has a second rotational stiffness when the elongate shaft is assuming the twisted shape; and

the second rotational stiffness is greater than the first rotational stiffness.

174. The catheter of claim 157, wherein the distal end of the first wire is atraumatic.

175. The catheter of claim 157, wherein a distal portion of the first wire is tapered.

176. The catheter of claim 157, wherein the first wire includes a rounded distal tip.

177. A catheter, comprising:

an elongate shaft; and

a first inflation member that urges a distal portion of the elongate shaft to assume a deflected shape when the first inflation member is inflated.

178. The catheter of claim 177, wherein the deflected shape is a generally accurate shape.

179. The catheter of claim 177, wherein the deflected shape is a bent shape.

180. The catheter of claim 177, wherein the distal portion of the elongate shaft is biased to assume a generally straight shape.

181. The catheter of claim 177, wherein the distal portion of the elongate shaft assumes a generally straight shape when the first inflation member is in a deflated state.

182. The catheter of claim 177, wherein the first inflation member is in fluid communication with an inflation lumen defined by the elongate shaft.

183. The device of claim 177, wherein the first inflation member comprises an extruded portion of an outer wall of the elongate shaft.

184. The catheter of claim 177, a portion of the elongate shaft proximate the first inflation member becomes elongated when the first inflation member is inflated.

185. The catheter of claim 177, further comprising:

a first tension member having a first end and a second end;

the first end of the first tension member being connected to the distal portion of the elongate shaft; and

the second end of the first tension member being connected to the elongate shaft at a location proximal of the first inflation member.

186. The catheter of claim 177, wherein the first tension member overlays the first inflation member so that the first tension member is placed in tension when the inflation member is inflated.

187. The catheter of claim 177, wherein the distal portion of the elongate shaft assumes a deflected shape when the first tension member is placed in tension.

188. The catheter of claim 177, further comprising:

a second tension member having a first end and a second end;

the first end of the second tension member being connected to the distal portion of the elongate shaft; and

the second end of the second tension member being connected to the elongate shaft at a location proximal of the second inflation member.

189. The catheter of claim 179, wherein the first tension member and the second tension member are disposed on opposite sides of the elongate shaft.

190. The catheter of claim 179, wherein the first tension member and the second tension member are disposed approximately 180 degrees apart.

191. The catheter of claim 179, wherein the second tension member overlays the inflation member so that the second tension member is placed in tension when the second inflation member is inflated.

192. The catheter of claim 182, wherein the distal portion of the elongate shaft assumes a second deflected shape when the second tension member is placed in tension.

193. The catheter of claim 177, wherein the elongate shaft defines a central lumen extending therethrough to a distal opening.

194. The catheter of claim 177, a second inflation member that urges a distal portion of the elongate shaft to assume a second deflected shape when the second inflation member is inflated.