Balloon catheter with distal guide wire lumen

• US 5,395,334 A
• Filed: 03/22/1993
• Issued: 03/07/1995
• Est. Priority Date: 08/28/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Keith, Peter T., Euteneuer, Charles L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Cermak, Adam J.
• Application Number:
  US08/035,254
• Time in Patent Office: 715 Days
• Field of Search: 604/96-103, 604/282, 606/192-196, 600/18
• US Class Current: 604/103.09
• 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 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• 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 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An over-the-wire balloon dilatation catheter has a stainless steel hypotube catheter shaft, an intermediate sleeve section bonded to the shaft and a distal balloon section connected to the sleeve section. The sleeve section is formed from relatively flexible polymer materials and includes an inner core tube which defines a guide wire lumen extending only through a distal portion of the catheter (including its sleeve and balloon sections) to facilitate fast balloon catheter exchanges. A distal end of the hypotube shaft is crimped laterally and the core tube is nested and bonded within the crimp to provide a proximal outlet for the guide wire lumen. The hypotube shaft provides an inflation lumen for the balloon, with the inflation lumen being continued as an annular inflation lumen through the sleeve section where an outer sleeve is bonded about the core tube and extends from the distal end of the hypotube shaft to the balloon section. A kink-resistant coil structure extends distally from the distal end of the hypotube shaft to provide a gradual change in stiffness along the length of the catheter from the relatively stiff hypotube shaft to the relatively flexible distal portion of the catheter.

Claims

1. In an elongate dilatation catheter of the type that can be slidably moved along a guide wire that can extend past a distal end of the catheter, wherein the guide wire is received in a guide wire lumen of the catheter, the guide wire extending from a distal guide wire lumen opening to a proximal guide wire lumen opening disposed in a portion of the catheter that is spaced distally from a proximal end of the catheter, the dilatation catheter including an inflatable balloon and an inflation lumen extending through the catheter separate from the guide wire lumen, an improvement comprising:

a tube formed from a relatively stiff material composition, the tube defining a first shaft section having a proximal end and a distal end;

a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section and having the guide wire lumen extending through a portion thereof; and

a transition section generally disposed between the first shaft section and the second shaft section, the transition section including a portion which is of diminished dimension relative to the tube such that at least the portion of the transition section is more flexible than the first shaft section, less flexible than the second shaft section, and extends at least in part across the proximal guide wire lumen opening.

2. The improved catheter of claim 1 wherein the tube is formed from a metallic material.

3. The improved catheter of claim 1 wherein the proximal guide wire lumen opening is disposed adjacent the proximal end of the second shaft section.

4. The improved catheter of claim 1 wherein the proximal guide wire lumen opening is disposed adjacent the distal end of the first shaft section.

5. In an elongate dilatation catheter which has an inflatable balloon and an inflation lumen extending through the catheter, wherein the catheter is of the type that can be slidably moved along a guide wire which can extend past a distal end of the catheter through a guide wire lumen of the catheter, wherein the guide wire lumen is separate from the inflation lumen and extends from a distal guide wire lumen opening to a proximal guide wire lumen opening disposed in a portion of the catheter that is spaced distally from a proximal end of the catheter so that the guide wire lumen is shorter than the inflation lumen, an improvement comprising:

a first proximal shaft section of the catheter defined by a tubing of relatively rigid material;

a second shaft section disposed distally of the first shaft section, the second shaft section being relatively more flexible than the first shaft section; and

a transition section generally disposed between the first shaft section and the second shaft section and extending adjacent to the proximal guide wire lumen opening, the transition section having decreased rigidity intermediate the first and second shaft sections, to provide a stepped transition in flexibility between the first shaft section and the second shaft section, the transition section having a distal terminal end spaced proximally from the balloon.

6. The improved catheter of claim 5 in which the tubing is formed from a metallic material.

7. The improved catheter of claim 5 in which the transition section extends at least in part around the inflation lumen.

8. The improved catheter of claim 5 in which the proximal guide wire lumen opening is disposed adjacent the proximal end of the second shaft section.

9. The improved catheter of claim 5 in which the proximal guide wire lumen opening is disposed adjacent the distal end of the first shaft section.

10. In an elongate dilatation catheter of the type that has a relatively long proximal shaft section, a second shorter distal shaft section disposed distally of the first shaft section, an inflatable balloon attached to the distal end of the second shaft section wherein the first and second shaft sections have an inflation lumen defined therethrough so that the balloon is in fluid communication with the inflation lumen, and wherein the catheter is of the type that can be slidably moved along a guide wire which can extend through a guide wire lumen of the catheter, the guide wire lumen being separate from the inflation lumen and extending from a distal guide wire lumen opening at the distal end of the catheter to a proximal guide wire lumen opening adjacent the proximal end of the second shaft section so that the guide wire lumen is shorter than the inflation lumen, an improvement comprising:

the first proximal shaft section of the catheter defined by a tubing of relatively rigid material;

the second shaft section of the catheter being relatively more flexible than the first shaft section and having a relatively short reinforced proximal portion and a relatively long nonreinforced distal portion; and

the reinforced proximal portion including a transition member disposed adjacent to the proximal guide wire lumen opening and extending distally along the second shaft section to provide a reinforcement therefor, the transition member including a metallic element having a uniform reduced dimension relative to the tubing as it extends distally along the catheter to provide a stepped transition in rigidity in the distal direction, the transition member having a distal terminal end spaced from the balloon by the length of the nonreinforced distal portion of the second shaft section.

11. The improved catheter of claim 10 in which the tubing is formed from a metallic member.

12. The improved catheter of claim 10 in which the transition member extends at least in part distally of the proximal guide wire lumen opening.

13. The improved catheter of claim 10 in which the transition member extends at least in part around the inflation lumen.

14. The improved catheter of claim 10 in which the transition member comprises a coil.

15. The improved catheter of claim 10 in which the proximal guide wire lumen opening is disposed adjacent the distal end of the first shaft section.