Rapid exchange stent delivery balloon catheter

• US 6,371,961 B1
• Filed: 11/11/1997
• Issued: 04/16/2002
• Est. Priority Date: 01/18/1996
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Eells, Scott E., Osborne, Thomas A.
• Primary Examiner(s): YU, JUSTINE ROMANG
• Application Number:
  US08/967,521
• Time in Patent Office: 1,617 Days
• Field of Search: 606/108, 606/194, 606/195, 606/198, 600/466, 604/96
• US Class Current: 606/108
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• 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 25/104 used for angioplasty

Abstract

A rapid exchange stent delivery balloon catheter which allows exchange from a balloon angioplasty catheter to a stent delivery catheter without the need to replace the angioplasty catheter wire guide with an exchange-length wire guide before exchanging the catheters. The stent delivery catheter of the present invention includes a relatively short wire guide shaft which is bonded to the catheter shaft only at a location distal to the inflation lumen.

Claims

1. A rapid exchange stent delivery balloon catheter, comprising:

a catheter shaft defining an inflation lumen, the inflation lumen having a proximal end and a distal end;

an inflatable balloon having a proximal end and a distal end;

a wire guide shaft defining a wire guild lumen, the wire guild shaft having a proximal end and a distal end; and

a catheter tip having a proximal end;

wherein the distal end of the inflation lumen opens into and is in fluid communication with an interior of the inflatable balloon, the distal end of the inflatable balloon is sealed by the proximal end of the catheter tip, and the wire guide shaft is coupled to the catheter tip completely distal of the distal end of the inflatable balloon.

8. The method of claim 1, wherein step (a) further comprises providing a first length of plastic tubing.

2. A method of forming a rapid exchange stent delivery balloon catheter, comprising the steps of:

a) providing a first length of tubing having a first proximal end, a first distal end and a first lumen extending from the first proximal end to the first distal end;

b) closing the first distal end;

c) placing a section of the first length of tubing near the closed distal end into a first mold cavity having first interior dimensions equal to desired exterior balloon dimensions of the catheter;

d) heating the section of the first length of tubing;

e) pressurizing the first lumen such that the section of the first length of tubing within the first mold cavity expands to the first interior dimensions of the first mold cavity;

f) cooling the section of the first length of tubing such that the section retains the dimensions of the first mold cavity, thereby forming a balloon having a balloon proximal end and a balloon distal end;

g) removing the section of the first length of tubing from the first mold cavity;

h) cutting the first distal end distal of the balloon distal end, thereby reopening the first lumen;

i) providing a second length of tubing having a second proximal end, a second distal end and a second lumen extending from the second proximal end to the second distal end;

j) placing the second distal end adjacent to the first distal end;

k) inserting a mandrel having a mandrel distal end into the second lumen such that the mandrel distal end is adjacent the second distal end;

l) placing the first and second distal ends into a second mold cavity having second interior dimensions equal to desired exterior dimension of a catheter tip; and

m) heating the first and second distal ends until they are bonded to one another only in a catheter tip region completely distal of the balloon distal end.

3. The method of claim 2, further comprising the step of:

n) inserting a stiffening wire having a stiffening wire distal end through the first lumen and the balloon until the stiffening wire distal end lies within the catheter tip region.

4. The method of claim 3, further comprising the step of:

o) cooling the catheter tip region such that the catheter tip region retains the dimensions of the second mold cavity.

5. The method of claim 4, further comprising the step of:

p) removing the mandrel from the second lumen, thereby reopening the second lumen.

6. The method of claim 5, further comprising the step of:

q) folding the balloon over the second length of tubing.

7. The method of claim 6, further comprising the steps of:

r) providing a stent; and

s) placing the stent around the folded balloon such that the stent is in a radially contracted configuration.

9. A method of forming a rapid exchange stent delivery balloon catheter, comprising the steps of:

a) providing a first length of tubing having a first proximal end, a first distal end and a first lumen extending from the first proximal end to the first distal end;

b) forming a balloon in the first length of tubing adjacent the first distal end;

c) providing a second length of tubing having a second proximal end, a second distal end and a second lumen extending from the second proximal end to the second distal end; and

d) coupling the first and second distal ends to one another only in a catheter tip region completely distal of the balloon distal end.

10. The method of claim 9, wherein step (b) further comprises the steps of:

b.1) closing the first distal end;

b.2) placing a section of the first length of tubing near the closed distal end into a first mold cavity having first interior dimensions equal to desired exterior balloon dimensions of the catheter;

b.3) heating the section of the first length of tubing;

b.4) pressurizing the first lumen such that the section of the first length of tubing within the first mold cavity expands to the first interior dimensions of the first mold cavity;

b.5) cooling the section of the first length of tubing such that the section retains the dimensions of the first mold cavity, thereby forming a balloon having a balloon proximal end and a balloon distal end;

b.6) removing the section of the first length of tubing from the first mold cavity; and

b.7) cutting the first distal end distal of the balloon distal end, thereby reopening the first lumen.

11. The method of claim 10, wherein step (d) further comprises the steps of:

d.1) placing the second distal end adjacent to the first end;

d.2) inserting a mandrel having a mandrel distal end into the second lumen such that the mandrel distal end is adjacent the second distal end;

d.3) placing the first and second distal ends into a second mold cavity having second interior dimensions equal to desired exterior dimension of a catheter tip; and

d.4) heating the first and second distal ends until they are bonded to one another only in a catheter tip region completely distal of the balloon distal end.

12. The method of claim 11, further comprising the step of:

d.5) inserting a stiffening wire having a stiffening wire distal end through the first lumen and the balloon until the stiffening wire distal end lies within the catheter tip region.

13. The method of claim 12, further comprising the step of:

d.6) cooling the catheter tip region such that the catheter tip region retains the dimensions of the second mold cavity.

14. The method of claim 13, further comprising the step of:

d.7) removing the mandrel from the second lumen, thereby reopening the second lumen.

15. The method of claim 14, further comprising the step of:

d.8) folding the balloon over the second length of tubing.

16. The method of claim 15, further comprising the steps of:

d.9) providing a stent; and

d.10) placing the stent around the folded balloon such that the stent is in a radially contracted configuration.

17. The method of claim 9, wherein step (a) further comprises providing a first length of plastic tubing.