Catheter assembly

• US 20070088323A1
• Filed: 08/07/2006
• Published: 04/19/2007
• Est. Priority Date: 01/17/2003
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Eskaros, Sherif, Vonesh, Michael, Campbell, Carey, Foutrakis, George, Cully, Edward, Mann, James, Roeber, Peter, Trapp, Benjamin
• Granted Patent: US 7,625,337 B2
• Time in Patent Office: Days
• US Class Current: 604/523
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Novel catheter constructions comprising thin covering or wrapping materials such as polymer films. A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. Moreover, polymer film can be used in combination with one or more elements to produce novel catheter constructions.

Claims

1. A wire catheter sized to be advanced into a patient'"'"'s vasculature comprising:

a longitudinally extending wire having a length and at least an outer surface with at least one cut therein, a proximal end, and a distal end;

polymer film covering at least a portion of the outer surface of the wire; and

a device at the wire distal end.

2. The wire catheter of claim 1, wherein the polymer film is a film wrap.

3. The wire catheter of claim 2, wherein the polymer film wrap comprises ePTFE.

4. The wire catheter of claim 1, wherein the polymer film is a tubular shrink wrap.

5. The wire catheter of claim 3, wherein the film wrap is provided as a helical wrap.

6. The wire catheter of claim 1, wherein the device is selected from the group consisting of therapeutic devices and diagnostic devices.

7. The wire catheter of claim 6, wherein the therapeutic device is selected from the group consisting of expandable balloons, stents, energy emitting devices, and fiber optic device.

8. The wire catheter of claim 7, wherein the stent is self-expanding.

9. The wire catheter of claim 7, wherein the stent is mounted over an expandable balloon.

10. The wire catheter of claim 1, wherein the wire further includes an inner surface defining at least one lumen extending for at least a portion of the wire length.

11. The wire catheter of claim 10, wherein the at least one lumen extends from the proximal end to a point proximal to the distal end.

12. The wire catheter of claim 10, wherein the lumen extends from the proximal end to the distal end.

13. The wire catheter of claim 11, wherein an expandable balloon having an interior is located at the distal end of the wire.

14. The wire catheter of claim 13, wherein the lumen extends from the proximal end to near the distal end and is in fluid communication with the interior of the expandable balloon.

15. The wire catheter of claim 11, wherein at least a portion of the inner surface of the wire is provided with a polymer film covering.

16. The wire catheter of claim 10, wherein the at least one cut extends from the outer surface to the inner surface.

17. The wire catheter of claim 16, wherein the at least one cut is a spirally extending cut extending for at least a portion of the length of the wire.

18. The wire catheter of claim 17, wherein the spirally extending cut extends from the proximal end to the distal end.

19. The wire catheter of claim 1, wherein at least one radiopaque material is provided to the device.

20. The wire catheter of claim 11, wherein the device is a self-expanding stent, the stent being held in a compressed state by a sheath located over the stent, and further comprising deployment line extending from the proximal end, through the lumen, exiting the lumen at a point proximal to the sheath through a port formed through the wire, the deployment line being connected to the sheath.

21. The wire catheter of claim 20, further comprising an expandable balloon having an interior, the interior being in fluid communication with the lumen.

22. The wire catheter of claim 11, further comprising providing a stiffening device to the at least one lumen.

23. The wire catheter of claim 22, wherein the stiffening device is capable of being moved proximally and distally in the at least one lumen.

24. The wire catheter of claim 22, wherein the stiffening device is selected from the group consisting of stylets, wires, tubes, braids, and combinations thereof.

25. The wire catheter of claim 24, wherein the stiffening device is solid.

26. The wire catheter of claim 24, wherein the stiffening device is hollow.

27. The wire catheter of claim 22, wherein the stiffening device has a variable stiffness along at least a portion of its length.

28. The wire catheter of claim 22, wherein the stiffening device comprises a material selected from the group consisting of metals, metalloids, and polymers.

29. The wire catheter of claim 26, wherein the stiffening device includes a lumen extending for the length of the device.

30. The wire catheter of claim 4, wherein the tubular shrink wrap is pretreated prior providing the tubular shrink wrap to the wire outer surface.

31. The wire catheter of claim 1, wherein the wire outer surface is pretreated prior to providing the polymer covering.

32. The wire catheter of claim 15, wherein the inner surface polymer covering is a lower friction material as compared to the wire inner surface.

33. The wire catheter of claim 15, wherein the inner surface is pretreated prior to providing the polymer covering.

34. The wire catheter of claim 17, wherein the wire comprises hypotube.

35. The wire catheter of claim 34, wherein the polymer film comprises helically wrapped ePTFE.

36. A system for providing treatment to a bifurcation comprising:

a first balloon on a wire device comprising a first elongated wire having a length, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, a proximal end and a distal end, and a first expandable balloon at the wire distal end;

a second balloon on a wire device comprising a second elongated wire having a length, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, a proximal end and a distal end, and a second expandable balloon at the wire distal end;

an elongated tube having a length, an outer surface, an inner surface defining a lumen, a proximal end, and a distal end, the lumen extending from the proximal end to the distal end; and

wherein the first balloon on a wire device and the second balloon on a wire device are in a sliding relationship within the lumen of the elongated tube.

37. The system of claim 36, wherein the elongated tube has an inner diameter of about 1 mm or less.

38. The system of claim 37, further comprising a catheter having a length, a proximal end, a distal end, and a lumen extending for at least a portion of the length of the catheter;

and

the elongated tube being located within the catheter lumen and in sliding relationship with the catheter.

39. The system of claim 36, wherein at least one of the elongated tube outer surface and tube inner surface is provided with an at least partial coating of a lubricious material.

40. The system of claim 36, wherein the elongated tube comprises a material selected from the group consisting of metals and plastics.

41. The system of claim 40, wherein the plastics are extruded plastics.

42. The system of claim 36, wherein the length of the elongated tube is less than the length of at least one of the first balloon on a wire device and the second balloon on a wire device.

43. The system of claim 42, wherein the length of the elongated tube is less than the length of the first balloon on a wire device and the second balloon on a wire device.

44. The system of claim 36, wherein the length of the elongated tube is adjustable.

45. The system of claim 44, wherein at least a portion of the elongated tube is scrunchable.

46. The system of claim 36, wherein the first expandable balloon and the second expandable balloon are selected from the group consisting of occlusion balloons and dilatation balloons.

47. The system of claim 36, wherein a stent is mounted over at least one of the first expandable balloon and the second expandable balloon.

48. The system of claim 36, wherein the elongated tube is provided with a polymer covering along at least a portion of the length thereof.

49. The system of claim 36, wherein the polymer covering is a film wrap.

50. The system of claim 49, wherein the film wrap comprises ePTFE.

51. The system of claim 50, wherein the film wrap is a helical wrap.

52. The system of claim 51, wherein at least one of the first wire and the second wire comprise hypotube and the at least one cut is spirally extending.

53. The system of claim 36, wherein the polymer covering is a polymer shrink tube.

54. The system of claim 36, wherein the outer surface of the elongated tube is provided with at least one port located between the proximal end and the distal end.

55. The system of claim 36, wherein at least one of the first balloon on a wire device, the second balloon on a wire device, and the elongated tube further comprise at least one radiopaque material.

56. A stent delivery system comprising:

a balloon on a wire device comprising an elongated wire having a length, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, an inner surface defining a lumen, a distal end, and a proximal end;

an expandable balloon having an interior space at the distal end;

a self expanding stent at the distal end;

a stent containment member located over the self expanding stent, holding the stent in a compressed state; and

a deployment mechanism coupled to the stent containment member, the deployment mechanism extending proximally from the containment member.

57. The stent delivery system of claim 56, wherein the expandable balloon is located proximal to the self expanding stent.

58. The stent delivery system of claim 56, wherein the expandable balloon is located distal to the self expanding stent.

59. The stent delivery system of claim 56, wherein the expandable balloon is selected from the group consisting of occlusion balloons and dilatation balloons.

60. The stent delivery system of claim 56, wherein a stent is loaded over the expandable balloon.

61. The stent delivery system of claim 56, wherein the stent containment member is a longitudinally extending sheath.

62. The stent delivery system of claim 61, wherein the sheath is a longitudinally extending sheath.

63. The stent delivery system of claim 62, wherein the sheath completely covers the self expanding stent.

64. The stent delivery system of claim 57, wherein the lumen extends from the proximal end to a point distal to the stent containment member and further comprises a port being in communication with the lumen and located proximal to the stent containment member.

65. The stent delivery system of claim 64, wherein at least a portion of the deployment mechanism is located within the lumen.

66. The stent delivery system of claim 57, further comprising a second lumen, the second lumen being in fluid communication with the interior space of the expandable balloon.

67. The stent delivery system of claim 57, wherein the deployment mechanism extends proximally from the stent containment member to the proximal end of the balloon on a wire device.

68. The stent delivery system of claim 57, wherein the polymer film is a polymer shrink tube.

69. The stent delivery system of claim 57, wherein the polymer film is a polymer film wrap.

70. The stent delivery system of claim 69, wherein the polymer film wrap comprises ePTFE.

71. The stent delivery system of claim 70, wherein the polymer film wrap is a helical wrap.

72. The stent delivery system of claim 70, wherein the at least one cut is a spirally extending cut.

73. The stent delivery system of claim 72, wherein the wire is hypotube.

74. A balloon on a wire device comprising an elongated wire having a length, an outer surface having a least one cut therein, polymer film covering at least a portion of the outer surface, an inner surface defining a first longitudinally extending lumen, a proximal end and a distal end;

a first expandable balloon having an interior space and a second expandable balloon having an interior space;

the first expandable balloon and the second expandable balloon being in spaced apart relation at the distal end of the wire; and

the first longitudinally extending lumen extending distally from a port at the proximal end of the wire and being in fluid communication with the interior space of at least one of the first expandable balloon and the second expandable balloon.

75. The balloon on a wire device of claim 74, wherein the first longitudinally extending lumen is in fluid communication with the interior of the first expandable balloon and the interior of the second expandable balloon.

76. The balloon on a wire device of claim 74, the elongated wire further comprising a second longitudinally extending lumen.

77. The balloon on a wire device of claim 76, wherein the first longitudinally extending lumen is in fluid communication with the interior of the first expandable balloon and the second longitudinally extending lumen is in fluid communication with the interior of the second expandable balloon.

78. The balloon on a wire device of claim 74, wherein the polymer film is a film wrap.

79. The balloon on a wire device of claim 78, wherein the polymer film comprises ePTFE.

80. The balloon on a wire device of claim 79, wherein the film wrap is provided as a helical wrap.

81. The balloon on a wire device of claim 74, wherein the polymer film is polymer shrink tube.

82. The balloon on a wire device of claim 80, wherein the at least one cut is spirally extending.

83. The balloon on a wire device of claim 82, wherein the elongated wire is hypotube.

84. The balloon on a wire device of claim 74, wherein the cuts extend from the outer surface to the inner surface.

85. The balloon on a wire device of claim 74, wherein at least a portion of the inner surface is provided with polymer covering.

86. The balloon on a wire device of claim 74, wherein at least one radiopaque material is provided to the device.

87. Method for removing thrombus from a patient'"'"'s vasculature comprising the steps of:

introducing into a patient'"'"'s vasculature a balloon on a wire device comprising an elongated wire having a length, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, an inner surface defining a first longitudinally extending lumen, a proximal end, and a distal end;

at least a first expandable balloon having an interior space and a second expandable balloon having an interior space;

the first expandable balloon and the second expandable balloon being in spaced apart relation at the distal end; and

the first longitudinally extending lumen extending distally from a port at the proximal end and being in fluid communication with the interior space of at least one of the first expandable balloon and the second expandable balloon;

advancing the distal end of the balloon on a wire device past a thrombus located in the patient'"'"'s vasculature such that the thrombus is located between the first expandable balloon and the second expandable balloon;

expanding the first expandable balloon and the second expandable balloon; and

removing the balloon on a wire device from the patient'"'"'s vasculature.

88. Microcatheter comprising:

a microcatheter shaft having a length, an outer surface, a proximal end, a distal end, and a first longitudinally extending catheter lumen and a second longitudinally extending catheter lumen;

the first longitudinally extending catheter lumen extending from the proximal end to near the distal end;

the second longitudinally extending catheter lumen extending from a first port at the distal end to a second port located proximal to the distal end; and

a balloon on a wire device at least partially located in the second longitudinally extending catheter lumen, the balloon on a wire device having a length, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, a distal end and a proximal end, an inner surface defining a longitudinally extending wire lumen extending from the proximal end to a point distal thereto, and an expandable balloon with an interior space at the wire distal end.

89. The microcatheter of claim 88, wherein the second port is relatively closer to the distal end and relatively further from the proximal end of the microcatheter shaft.

90. The microcatheter of claim 88, wherein the longitudinally extending wire lumen is in fluid contact with the interior space of the expandable balloon.

91. The microcatheter of claim 88, wherein the at least one cut is a spirally extending cut.

92. The microcatheter of claim 88, wherein the polymer film is a film wrap.

93. The microcatheter of claim 92, wherein the polymer film comprises ePTFE.

94. The microcatheter of claim 93, wherein the film wrap is a helical wrap.

95. The microcatheter of claim 88, wherein the polymer film is polymer shrink tube.

96. The microcatheter of claim 94, wherein the at least one cut is a spirally extending cut.

97. The microcatheter of claim 96, wherein the longitudinally extending wire is hypotube.

98. The microcatheter of claim 88, wherein the expandable balloon is selected from the group consisting of dilatation balloons and occlusion balloons.

99. The microcatheter of claim 88, wherein a stent is mounted over the expandable balloon.

100. The microcatheter of claim 88, wherein at least a portion of the inner surface of the wire is provided with polymer covering.

101. The microcatheter of claim 88, wherein at least one radiopaque material is provided to at least one of the microcatheter shaft and the balloon on a wire device.

102. The microcatheter of claim 88, wherein the first longitudinally extending catheter lumen is reinforced with a material selected from the group consisting of braids and tubes.

103. The microcatheter of claim 88, wherein the first longitudinally extending catheter lumen is defined by an inner surface of a polymer tubular extrusion.

104. The microcatheter of claim 88, wherein the second longitudinally extending catheter lumen is defined by an inner surface of a polymer tubular extrusion.

105. The microcatheter of claim 88, wherein the second longitudinally extending catheter lumen is defined by an inner surface of a polymer film wrap.

106. Method for advancing a catheter to a treatment site in a patient'"'"'s vasculature comprising:

providing a balloon catheter device having a length, a proximal end, a distal end, an outer surface, a first longitudinally extending catheter lumen, the first longitudinally extending catheter lumen extending from the proximal end to near the distal end, and a second longitudinally extending catheter lumen, the second longitudinally extending catheter lumen extending proximally from a distal port at the distal end of the balloon catheter device; and

a first expandable balloon having an interior space at the catheter distal end, the balloon interior space being in fluid communication with the first longitudinally extending catheter lumen;

providing a balloon on a wire device comprising an elongated wire having a length, a proximal end, a distal end, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, and an inner surface, the inner surface defining a longitudinally extending wire lumen; and

a second expandable balloon having an interior space at the wire distal end, the balloon interior space being in fluid communication with the longitudinally extending wire lumen wherein at least a portion of the balloon on a wire device is slidably located within the second longitudinally extending catheter lumen;

advancing the balloon catheter device and the balloon on a wire device into a patient'"'"'s vasculature, toward a treatment site; and

advancing the second expandable balloon to a point distal to the catheter distal port and expanding the second expandable balloon;

and while the second expandable balloon is expanded, distally advancing the balloon catheter device.

107. The method of claim 106, further comprising the steps of:

expanding the first expandable balloon;

contracting the second expandable balloon; and

while the first expandable balloon is expanded, distally advancing the balloon on a wire device.

108. The method of claim 106, wherein the second longitudinally extending catheter lumen extends proximally from the distal port to a proximal port located proximal to the first expandable balloon.

109. The method of claim 108, wherein the proximal port is located at the balloon catheter proximal end.

110. The method of claim 108, wherein the proximal port is located distal to the balloon catheter proximal end.

111. The method of claim 110, wherein the proximal port is located relatively close to the distal port and relatively further from the balloon catheter proximal end.

112. A balloon on a wire device comprising:

an elongated wire having a length, an inner surface defining a longitudinally extending lumen, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, a proximal end, a distal end, a proximal section having a first outer diameter, and a distal section having a second outer diameter that is less than the first outer diameter;

an expandable balloon having an interior, a compressed state, an expanded state, a proximal end, and a distal end, the distal end of the expandable balloon being sealed to the wire distal section having a second outer diameter; and

the expandable balloon interior being in fluid communication with the longitudinally extending lumen.

113. The balloon on a wire device of claim 112, wherein the proximal end of the expandable balloon is sealed to the wire proximal section.

114. The balloon on a wire device of claim 112, wherein the proximal end of the expandable balloon is sealed to the wire distal section.

115. The balloon on a wire device of claim 112, wherein the balloon in the compressed state has an outer diameter substantially equal to or less than the first outer diameter of the wire.

116. The balloon on a wire device of claim 112, wherein a stent is loaded over the expandable balloon.

117. The balloon on a wire device of claim 112, wherein the longitudinally extending lumen extends from the wire proximal end to the expandable balloon interior.

118. The balloon on a wire device of claim 112, wherein the at least one cut is spirally extending.

119. The balloon on a wire device of claim 112, wherein the elongated wire is metal.

120. The balloon on a wire device of claim 119, wherein the metal is hypotube.

121. The balloon on a wire device of claim 120, wherein the at least one cut is spirally extending.

122. The balloon on a wire device of claim 112, wherein the polymer film is a film wrap.

123. The balloon on a wire device of claim 122, wherein the polymer film comprises ePTFE.

124. The balloon on a wire device of claim 123, wherein the film wrap is provided as a helical wrap.

125. The balloon on a wire device of claim 112, wherein the polymer film is polymer shrink tubing.

126. The balloon on a wire device of claim 112, wherein at least a portion of the inner surface is provided with polymer covering.

127. The balloon on a wire device of claim 124, wherein the at least one cut is spirally extending.

128. The balloon on a wire device of claim 112, wherein the device further comprises at least one radiopaque material.

129. Catheter comprising:

an elongated catheter body having a length, a proximal end, and a distal end;

at least a first lumen and a second lumen extending distally from the proximal end;

an expandable balloon having an interior space at the distal end of the catheter body, the interior space being in fluid communication with the first lumen; and

the second lumen terminating at a port located proximal of the expandable balloon.

130. The catheter of claim 129, further comprising a balloon on a wire device slidably located within the second lumen.

131. The catheter of claim 129, wherein the catheter further comprises at least one radiopaque material.

132. The catheter of claim 130, wherein the balloon on a wire device further comprises at least one radiopaque material.

133. The catheter of claim 129, wherein the first lumen is provided with a first component having a change in stiffness from a first point to a second point.

134. The catheter of claim 133, wherein the first component is selected from the group consisting of hollow tube, wire, and braiding.

135. The catheter of claim 134, wherein the hollow tube comprises metal.

136. The catheter of claim 135, wherein the metal is hypotube.

137. The catheter of claim 133, wherein the first component extends to a point distal to the port.

138. The catheter of claim 129, wherein the second lumen is provided with a second component having a change in stiffness from a first point to a second point.

139. The catheter of claim 138, wherein the second component extends essentially from the proximal end to the port.

140. The catheter of claim 138, wherein the second component is selected from the group consisting of hollow tube, wire, and braiding.

141. The catheter of claim 140, wherein the hollow tube comprises metal.

142. The catheter of claim 141, wherein the metal is hypotube.

143. The catheter of claim 129, wherein the balloon is a dilatation balloon.

144. The catheter of claim 129, wherein a stent is loaded onto the balloon.

145. The catheter of claim 129, further comprising a third lumen extending proximally from a port at the distal end.

146. The catheter of claim 145, wherein the third lumen extends from the distal port to a port at the proximal end.

147. The catheter of claim 145, wherein the third lumen extends from the distal port to a port located proximal to the expandable balloon and distal to the proximal end.

148. A balloon on a wire device comprising:

a proximal elongated wire having a length, an inner surface defining a longitudinally extending lumen, an outer surface having at least one cut therein, polymer film covering at least a portion of the outer surface, a proximal end, a distal end, and an outer diameter;

an intermediate elongated wire having a length, an inner surface defining a longitudinally extending lumen, an outer surface, a proximal end attached to the distal end of the proximal elongated wire, a distal end, and an outer diameter that is less than the proximal wire outer diameter;

a distal elongated wire having a length, an inner surface defining a longitudinally extending lumen, an outer surface, a proximal end attached to the distal end of the intermediate wire, a distal end, and an outer diameter that is greater than the intermediate wire outer diameter;

an expandable balloon sealed to the device and having an interior, a compressed state, an expanded state, a proximal end, and a distal end; and

the expandable balloon interior being in fluid communication with at least one of the proximal wire lumen, the intermediate wire lumen, and the distal wire lumen through a port provided in at least one of the proximal, intermediate, and distal wires.

149. The balloon on a wire device of claim 148, wherein at least one of the intermediate and distal elongated wires further comprise at least one cut in the outer surface.

150. The balloon on a wire device of claim 148, wherein at least one of the intermediate and distal elongated wires further comprise polymer film covering at least a portion of the outer surface.

151. The balloon on a wire device of claim 148, wherein the balloon compressed state has an outer diameter substantially equal to or less than the outer diameter of the proximal wire and the distal wire.

152. The balloon on a wire device of claim 151, wherein a stent having a compressed state and an expanded state is mounted over the balloon and the stent compressed state is equal to or less than the proximal and distal ends of the balloon in the balloon'"'"'s compressed state.

153. The balloon on a wire device of claim 148, wherein the distal end of the balloon is sealed to the distal wire and the proximal end of the balloon is sealed to the proximal wire.

154. The balloon on a wire device of claim 148, wherein the distal end and the proximal end of the balloon are sealed to the intermediate wire.