Stent delivery system with a fixed guide wire

• US 6,375,660 B1
• Filed: 11/22/1999
• Issued: 04/23/2002
• Est. Priority Date: 11/22/1999
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/444,104
• Time in Patent Office: 883 Days
• Field of Search: 606/108, 606/191, 606/192, 606/193, 606/194, 606/195, 606/198, 606/113, 604/103.04, 604/103.05, 604/103.08, 604/265, 623/1.11, 623/1.24
• US Class Current: 606/108
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 2025/0186 Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded

Abstract

The present invention is a stent delivery system that uses a short section of a guide wire that is fixedly attached to a distal section of a balloon angioplasty catheter. By not having a guide wire that slides through the balloon of the balloon angioplasty catheter, the balloon on which the stent is mounted can have a reduced diameter. Therefore, the outside diameter of the undeployed stent mounted onto that balloon is also minimized. This provides a minimum profile, i.e., a minimum outside diameter, for the stent. A minimum profile at the distal section of the stent delivery system is highly advantageous for improving the percentage of cases that can be treated by direct stenting; i.e., without requiring pre-dilation of a stenosis.

Claims

1. A stent delivery system for placing a stent in a vessel of the human body, the stent delivery system comprising:

a balloon angioplasty catheter having a distal section with a single inflatable balloon located at the distal section;

a balloon expandable stent co-axially mounted onto the inflatable balloon, the stent being adapted for permanent implantation into the vessel of the human body; and

a flexible guide wire fixedly attached to and extending distally in a bare manner from the distal section of the balloon angioplasty catheter.

2. The stent delivery system of claim 1 wherein the guide wire is substantially straight over its entire length.

3. The stent delivery system of claim 1 wherein the guide wire has a distal section that is substantially curved.

4. The stent delivery system of claim 1 wherein the guide wire has an outside diameter that is less than 0.035 inches.

5. The stent delivery system of claim 4 wherein the guide wire has an outside diameter of 0.014 inches.

6. The stent delivery system of claim 1 wherein the length of the guide wire extending in a bare manner beyond the distal section of the balloon catheter is less than 5 cm.

7. The stent delivery system of claim 1 wherein the stent is mechanically crimped onto the balloon.

8. The stent delivery system of claim 1 wherein the stent is nested onto the balloon.

9. The stent delivery system of claim 1 wherein the balloon has a longitudinal axis and the balloon is wrapped in a spiral around the balloon'"'"'s longitudinal axis prior to placement of the stent onto the balloon.

10. The stent delivery system of claim 1 wherein the balloon is folded with a multiplicity of wings as is conventional for a balloon of a balloon angioplasty catheter.

11. The stent delivery system of claim 1 wherein the balloon has a proximal section that has the shape of a frustum of a cone when the balloon is fully inflated and the balloon angioplasty catheter includes a proximal elastic band that is wrapped around the proximal section of the balloon prior to balloon inflation.

12. The stent delivery system of claim 1 wherein the balloon has a distal section that has the shape of a frustum of a cone when the balloon is fully inflated and the balloon angioplasty catheter includes a distal elastic band that is wrapped around the distal section of the balloon prior to balloon inflation.

13. The stent delivery system of claim 1 wherein the balloon has a proximal end that is fixedly attached to a central tube having a central lumen through which balloon inflation fluid can be injected or removed to respectively inflate or deflate the balloon.

14. The stent delivery system of claim 13 wherein the central tube is attached to a proximal tube that has a proximal end and a distal end, the proximal tube extending for most of the length of the stent delivery system, the proximal tube having a Luer fitting at its proximal end, the Luer fitting being adapted for connection to a source of balloon inflation fluid.

15. The stent delivery system of claim 14 wherein the flexible guide wire has a central core wire, the length of the core wire being substantially equal to the length of the guide wire.

16. The stent delivery system of claim 14 wherein the flexible guide wire has a central core wire that extends longitudinally throughout the entire length of the balloon.

17. The stent delivery system of claim 16 wherein the proximal end of the core wire is fixedly attached near the distal end of the proximal tube.

18. The stent delivery system of claim 16 wherein the proximal end of the core wire is attached near the proximal end of the proximal tube.

19. The stent delivery system of claim 1 wherein the balloon overhang length beyond each edge of the stent is less than 1.0 mm.

20. The stent delivery system of claim 1 wherein the balloon overhang length beyond each edge of the stent is less than 0.5 mm.

21. The stent delivery system of claim 1 wherein the longitudinal length of the stent when deployed is approximately equal to the length of the cylindrical section of the inflated balloon thereby resulting in an approximately zero length of balloon overhang beyond the edges of the stent.