Stent delivery system

• US 5,669,880 A
• Filed: 06/16/1995
• Issued: 09/23/1997
• Est. Priority Date: 08/24/1993
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Solar, Ronald J.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/491,136
• Time in Patent Office: 830 Days
• Field of Search: 604/96, 604/95, 604/101, 604/102, 604/52, 604/53, 604/27, 604/28, 606/108, 606/192-194, 606/198
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

This invention relates to a balloon dilatation catheter and its use in delivering a balloon expandable stent. More particularly, the catheter comprises a first, inflation lumen extending therethrough and having distal and proximal ends, the distal end of the first lumen opening into and being in fluid communication with the interior of an inflatable dilatation balloon having distal and proximal ends, and a second lumen extending coextensively with and exterior to the dilatation balloon.

Claims

1. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a catheter shaft defining a first, inflation lumen and a second lumen, each of said first and second lumens having proximal and distal ends, and

an inflatable dilatation balloon having proximal and distal ends,

wherein the distal end of said first lumen opens into and is in fluid communication with the interior of the dilatation balloon and the second lumen extends longitudinally with the first lumen, the proximal end of the second lumen being adjacent to the proximal end of the first lumen, the distal end of the second lumen being open and distal to the distal end of the first lumen, the section of the second lumen distal to the proximal end of the dilatation balloon being exterior to the dilatation balloon, the distal end of the second lumen being open and distal to the distal end of the dilatation balloon, and the second lumen being sufficiently linear to allow the catheter to be slidingly advanced over a guidewire.

3. The method of claim 1 or 2, wherein the first inflation lumen of the catheter is a metal hypotube.

4. The method of claim 1 or 2, wherein a radiopaque marker is located within the second lumen of the catheter at a point between the proximal and distal ends of the balloon.

5. The method of claim 4, wherein the radiopaque marker of the catheter has a triangular shape.

6. The method of claim 4, wherein the radiopaque marker of the catheter has an outwardly extending sharp edge opposite the balloon.

7. The method of claim 1 or 2, wherein the catheter comprises one or more additional lumens.

8. The method of claim 1 or 2, wherein the dilatation balloon of the catheter is bonded axially along its entire length to the second lumen.

9. The method of claim 1 or 2, wherein the balloon and the second lumen are made from one piece.

2. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a catheter shaft defining a first, inflation lumen and a second lumen, each of said first and second lumens having proximal and distal ends, and

an inflatable dilatation balloon having proximal and distal ends,

wherein the distal end of the first lumen opens into and is in fluid communication with the interior of the dilatation balloon, the proximal end of the second lumen being open and being located substantially distal to the proximal end of the first lumen, the section of the second lumen distal to the proximal end of the dilatation balloon being exterior to the dilatation balloon, the distal end of the second lumen being open and distal to the distal end of the dilatation balloon, and the second lumen being sufficiently linear to allow the catheter to be slidingly advanced over a guidewire.

10. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a first inflation lumen extending therethrough and having distal and proximal ends, the distal end of the said first lumen opening into and being in fluid communication with the interior of an inflatable dilatation balloon having distal and proximal ends, and

a second lumen extending coextensively with the first lumen, having proximal and distal ends, wherein the proximal end of the second lumen is adjacent to the proximal end of the first lumen, the distal end of the second lumen is open and distal to the distal end of the balloon, and wherein the distal section of the second lumen is exterior to the balloon an has an opening proximal, adjacent, or distal to the proximal end of the dilatation balloon, and the section of the second lumen distal to the opening is enlarged as compared to the proximal section of the second lumen.

11. The method of claim 10, wherein the proximal, unenlarged section of the second lumen of the catheter contains a pushing wire.

12. The method of claim 10, wherein the pushing wire has proximal and distal ends and said distal end is positioned at or near the opening of the second lumen.

13. The method of claim 10, wherein the enlarged portion of the second lumen comprises lubricious material.

14. The method of claim 13, wherein the lubricious material is in the form of tubing within the enlarged section.

15. The method of claim 14, wherein the distal end of the pushing wire is held in position by the lubricious tubing and the second lumen wall.

16. The method of claim 10, wherein the portion of the second lumen proximal to the opening has been heat shrunk around the pushing wire.

17. The method of claim 10, which comprises at least one additional coextensive lumen having open proximal and distal ends.

18. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a catheter shaft defining a first, inflation lumen and a second lumen, each of said first and second lumens having proximal and distal ends, and

an inflatable dilatation balloon having proximal and distal ends,

wherein the distal end of said first lumen opens into and is in fluid communication with the interior of the dilatation balloon and the second lumen extends longitudinally with the first lumen, the proximal end of the second lumen being adjacent to the proximal end of the first lumen, the distal end of the second lumen being open and distal to the distal end of the first lumen, the section of the second lumen distal to the proximal end of the dilatation balloon being exterior to the dilatation balloon and containing a rigid or substantially rigid triangularly-shaped lubricious liner, the distal end of the second lumen being open and distal to the distal end of the dilatation balloon, and the second lumen being sufficiently linear to allow the catheter to be slidingly advanced over a guidewire.

19. The method of claim 18, wherein the first inflation lumen is a metal hypotube.

20. The method of claim 18, wherein a radiopaque marker is located within the second lumen at a point between the proximal and distal ends of the balloon.

21. The method of claim 20, wherein the radiopaque marker has a triangular shape.

22. The method of claim 18, wherein a portion of the distal section of the second lumen has an opening located between the proximal and distal ends of the balloon.

23. The method of claim 18, wherein the diameter of the second lumen is smaller than the diameter of the inflated dilatation balloon.

24. The method of claim 18, wherein the balloon is bonded axially along its entire length to the second lumen.

25. The method of claim 18, wherein the balloon and the second lumen are made from one piece.

26. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a catheter shaft defining a first, inflation lumen and a second lumen, each of said first and second lumens having proximal and distal ends, and

an inflatable dilatation balloon having proximal and distal ends,

wherein the distal end of the first lumen opens into and is in fluid communication with the interior of the dilatation balloon, the proximal end of the second lumen being open and being located substantially distal to the proximal end of the first lumen, the section of the second lumen distal to the proximal end of the dilatation balloon being exterior to the dilatation balloon and containing a rigid or substantially rigid triangularly shaped lubricious liner, the distal end of the second lumen being open and distal to the distal end of the dilatation balloon, and the second lumen being sufficiently linear to allow the catheter to be slidingly advanced over a guidewire.

27. The method of claim 26, wherein the diameter of the second lumen is smaller than the diameter of the inflated dilatation balloon.

28. The method of claim 26, wherein the balloon is bonded axially along its entire length to the second lumen.

29. The method of claim 26, wherein the balloon and the second lumen are made from one piece.

30. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a first, inflation lumen extending therethrough and having distal and proximal ends, the distal end of said first lumen opening into and being in fluid communication with the interior of an inflatable dilatation balloon having distal and proximal ends, and

a second lumen extending coextensively with the first lumen, having proximal and distal ends, wherein the proximal end of the second lumen is adjacent to the proximal end of the first lumen, the distal end of the second lumen is open and distal to the distal end of the balloon, and wherein the distal section of the second lumen is exterior to the balloon and has an opening proximal, adjacent, or distal to the proximal end of the dilatation balloon, and the section of the second lumen distal to the opening is enlarged as compared to the proximal section of the second lumen and contains a rigid or substantially rigid triangularly shaped lubricious liner.

31. The method of claim 30, wherein the proximal, unenlarged section of the second lumen contains a pushing wire.

32. The method of claim 31, wherein the pushing wire has proximal and distal ends and said distal end is positioned at or near the opening of the second lumen.

33. The method of claim 31, wherein the distal end of the pushing wire is held in position by the lubricious liner and the second lumen wall.

34. The method of claim 30, wherein the portion of the second lumen proximal to the opening has been heat shrunk around the pushing wire.

35. The method of claim 30, wherein the second lumen is capable of receiving a guidewire in a sliding fit.

36. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises

a catheter shaft defining a first, inflation lumen and a second lumen, each of said first and second lumens having proximal and distal open ends,

an inflatable dilatation balloon having proximal and distal ends,

wherein the distal end of the first lumen opens into and is in fluid communication with the interior of the dilatation balloon, the distal end of the second lumen being distal to the distal end of the first lumen and the second lumen being exterior to the dilatation balloon, the proximal and distal ends of the second lumen being relatively disposed perfusion openings, and the second lumen permitting blood flow past the dilatation balloon while the balloon is forcefully inflated with pressurized fluid.

37. The method of claim 36, wherein the second lumen comprises a triangularly-shaped liner.

38. The method of claim 36, wherein the second lumen comprises a coiled support member.

39. The method of claim 36, wherein the catheter comprises a catheter shaft, an expansible balloon section carried at a distal end portion of the catheter shaft, and a perfusion conduit exterior to the balloon section and defining proximal and distal perfusion openings respectively disposed relative to said balloon section and communicating with one another via a passage of said perfusion conduit, said perfusion conduit maintaining said conduit passage open to permit perfusion blood flow past said balloon while the latter is forcefully inflated with pressurized fluid.

40. The method of claim 39 further including an inflation lumen communicating pressurized inflation fluid to said expansible balloon section.

41. The method of claim 39 further including a guidewire assembly movably disposed in said perfusion conduit.

42. In a method for delivering a balloon-expandable stent wherein the stent in non-expanded form is firmly positioned around the balloon on the distal portion of a balloon dilatation catheter, the distal portion of said catheter is inserted percutaneously into a patient'"'"'s body to a desired site, the balloon is inflated to cause the stent to expand, the balloon is deflated, and the catheter is removed proximally from the patient'"'"'s body, the improvement wherein the balloon dilatation catheter comprises:

a catheter shaft defining a first inflation lumen and a second lumen, each of said first and second lumens having proximal and distal ends, and

an inflatable dilatation balloon having proximal and distal ends,

wherein the distal end of said first lumen opens into and is in fluid communication with the interior of the dilatation balloon, and a portion of the second lumen extends longitudinally with a portion of the first lumen, the distal end of the second lumen being open and distal to the distal end of the first lumen, the section of the second lumen distal to the proximal end of the dilatation balloon being exterior to the dilatation balloon, the distal end of the second lumen being open and distal to the distal end of the dilatation balloon, and the second lumen being sufficiently linear to allow the catheter to be slidingly advanced over a guidewire.

43. A balloon-expandable stent system for delivering a stent percutaneously to a desired site in a patent'"'"'s body and deploying such a stent by expanding it to hold open a body lumen, comprising:

a catheter shaft defining an inflation lumen and guidewire lumen, said shaft and each lumen having proximal and distal ends;

an inflatable dilatation balloon having and distal ends, said balloon being affixed to said catheter shaft near the distal end of the shaft;

wherein the distal end of said inflation lumen opens into and is in fluid communication with the interior of the dilatation balloon, said guidewire lumen defining a proximal guidewire port disposed between said proximal end of the balloon and the proximal and of the inflation lumen, said guidewire lumen communicating between said proximal guidewire port and said guidewire distal end, whereby said guidewire lumen is adapted to slidingly accept a guidewire, the distal end of the guidewire lumen being open and distal to the inflation lumen distal end and the balloon distal end, the portion of the guidewire lumen distal to the proximal end of the balloon being exterior to the balloon, the second lumen being sufficiently linear to allow the catheter to be slidingly advanced over a guidewire; and

a flexible stent crimped around said balloon in a deflated condition, such that said stent will expand when said balloon is inflated.