Rapid exchange stent delivery balloon catheter

• US 5,814,061 A
• Filed: 06/16/1997
• Issued: 09/29/1998
• Est. Priority Date: 01/18/1996
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Osborne, Thomas A., Eells, Scott E.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): YU, JUSTINE ROMANG
• Application Number:
  US08/876,838
• Time in Patent Office: 470 Days
• Field of Search: 606/194, 606/195, 606/108, 606/198, 604/96
• US Class Current: 606/194
• 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 method of making a rapid exchange stent delivery balloon catheter, comprising the steps of:

a) providing a first length of first tubing having a first lumen, a proximal end and a distal end;

b) closing the first tubing distal end;

c) providing a first mold having interior dimensions substantially equal to desired balloon dimensions;

d) placing a portion of the first tubing into the first mold;

e) heating the portion of the first tubing in the first mold;

f) pressurizing the first lumen such that the portion of the first tubing in the first mold expands to the interior dimensions of the first mold, thereby forming a balloon;

g) cooling the portion of the first tubing in the first mold such that the portion of the first tubing in the first mold retains a shape of the interior of the first mold;

h) removing the first tubing from the first mold;

i) cutting the first tubing distal end at a point distal to a distal end of the balloon;

j) providing a second length of second tubing having a second lumen, a proximal end and a distal end;

k) inserting a mandrel into the second lumen at least adjacent the second tubing distal end;

l) placing the first tubing distal end and the second tubing distal end adjacent one another in a second mold; and

m) heating the first and second tubing distal ends until they bond together to form a catheter tip, thereby bonding the second tubing to the first tubing only at the first tubing distal end completely distal of the distal end of the balloon.

2. The method of claim 1, further comprising the steps of:

n) providing a stiffening wire having a proximal end and a distal end; and

o) inserting the stiffening wire through the first lumen and through an interior of the balloon until the stiffening wire distal end extends into the catheter tip.

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

p) cooling the catheter tip until the catheter tip solidifies; and

q) removing the mandrel from the second lumen.

4. The method of claim 2, wherein step (n) further comprises providing a stainless steel stiffening wire having at least one radiopaque marker band thereon.

5. The method of claim 4, wherein step (o) further comprises inserting the stiffening wire until one of the at least one radiopaque marker bands is substantially aligned with the distal end of the balloon.

6. The method of claim 1, wherein step (a) further comprises providing a first length of tubing formed from cross-linked polyethylene.

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

a) providing a first length of first tubing having a first lumen, a proximal end and a distal end;

b) forming a balloon having proximal and distal ends in the first tubing adjacent the first tubing distal end;

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

d) connecting and bonding the second tubing to the first tubing only at the first tubing distal end completely distal of the distal end of the balloon.

8. The method of claim 7, wherein step (b) further comprises the steps of:

b.1) closing the first tubing distal end;

b.2) providing a first mold having interior dimensions substantially equal to desired balloon dimensions;

b.3) placing a portion of the first tubing into the first mold;

b.4) heating the portion of the first tubing in the first mold;

b.5) pressurizing the first lumen such that the portion of the first tubing in the first mold expands to the interior dimensions of the first mold, thereby forming a balloon; and

b.6) cooling the portion of the first tubing in the first mold such that the portion of the first tubing in the first mold retains a shape of the interior of the first mold.

9. The method of claim 7, further comprising the step of:

e) inserting a mandrel into the second lumen at least adjacent the second tubing distal end prior to performing step (d).

10. The method of claim 7, wherein step (d) further comprises the steps of:

d.1) inserting a mandrel into the second lumen at least adjacent the second tubing distal end;

d.2) placing the first tubing distal end and the second tubing distal end adjacent one another in a second mold; and

d.3) heating the first and second tubing distal ends until they bond together to form a catheter tip.

11. The method of claim 10, further comprising the steps of:

e) providing a stiffening wire having a proximal end and a distal end; and

f) inserting the stiffening wire through the first lumen and through an interior of the balloon until the stiffening wire distal end extends into the catheter tip.

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

g) cooling the catheter tip until the catheter tip solidifies; and

h) removing the mandrel from the second lumen.

13. The method of claim 11, wherein step (e) further comprises providing a stainless steel stiffening wire having at least one radiopaque marker band thereon.

14. The method of claim 13, wherein step (f) further comprises inserting the stiffening wire until one of the at least one radiopaque marker bands is substantially aligned with the distal end of the balloon.

15. The method of claim 7, wherein step (a) further comprises providing a first length of tubing formed from cross-linked polyethylene.