Stent delivery system having a fixed guidewire

• US 6,936,065 B2
• Filed: 05/30/2002
• Issued: 08/30/2005
• Est. Priority Date: 11/22/1999
• Status: Expired due to Term

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Fischell, David R., Burgermeister, Robert, Fischell, Robert E., Khan, I. John
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US10/158,714
• Publication Number:
  US 20020147491A1
• Time in Patent Office: 1,188 Days
• Field of Search: 623/1.11, 623/1.24, 606/108, 606/194, 606/191, 606/192, 606/193, 606/195, 606/198, 606/113, 604/103.04, 604/103.05, 604/103.08
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing 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 short section of guidewire fixedly attached to the distal section of a balloon angioplasty catheter onto which a stent is co-axially mounted. By not having a guidewire that slides through the balloon of the balloon angioplasty catheter, the deflated balloon on which the stent is mounted can have a reduced diameter. Therefore, the outer diameter of the pre-deployed stent mounted onto that balloon is also minimized. This provides a smaller profile, i.e., a smaller outer diameter, for the stent. The time to perform a stent delivery procedure is reduced; a separate guidewire does not have to be placed prior to using the stent delivery system to place the stent at the site of a stenosis. Another embodiment of the present invention has a core wire that extends for nearly the entire length of the stent delivery system, the guidewire having different levels of stiffness for different portions of the core wire'"'"'s length.

Claims

1. A stent delivery system comprising:

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

a stent co-axially mounted on the inflatable balloon; and

a flexible guidewire attached to and extending distally from the distal section of the balloon catheter, the guidewire having a central core wire therethrough that extends from the guidewire in a proximal direction through the stent delivery system, the central core wire being formed from a shape memory alloy and having a distal portion that has a transition temperature higher than body temperature.

2. The stent delivery system of claim 1 wherein the core wire has a proximal portion proximal to the distal position, and the core wire proximal to the position having a transition temperature below body temperature.

3. The stent delivery system of claim 1 wherein the guidewire is substantially straight over its entire length.

4. The stent delivery system of claim 1 wherein the guidewire has a distal section that is substantially curved.

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

6. The stent delivery system of claim 1 wherein the length of the guidewire extending beyond the distal section of the balloon catheter is less than 5 cm.

7. 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.

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

9. 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 catheter includes a distal elastic band that is placed around the distal section of the balloon prior to balloon inflation.

10. The stent delivery system of claim 1 wherein the balloon has a proximal end fixedly attached to a central tube having a central lumen with fluid communication to the environment.

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

12. 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.

13. The stent delivery system of claim 1 wherein the core wire has a first and smaller cross sectional area where it passes through the fixed guidewire and the balloon, and the core wire has a second and larger cross-sectional area for most of the remainder of its where it passes through a proximal tube that extends for most of the length of the stent delivery system.

14. The stern delivery system of claim 1 wherein the core wire has a first and smallest cross-sectional area where it passes through the fixed guidewire and the balloon;

a second and largest cross-sectional area for most of the remainder of its length, and has a third cross-sectional area between the first and second cross-sectional areas.

15. The stent delivery system of claim 1 wherein the stent is coated with a medication useful to reduce restenosis.

16. The stent delivery system of claim 1 further including a heater into which the guidewire portion of the stent delivery system can be placed, the heater being capable of raising the temperature of the guidewire to a temperature above the transition temperature for the core wire.

17. The stent delivery system of claim 1 wherein the helical coil surrounding the core wire of the fixed guidewire of the stern delivery system is formed from a high-density metal.

18. A stent delivery system comprising:

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

a balloon expandable stent co-axially mounted on the inflatable balloon; and

a flexible guidewire attached to and extending distally from the distal section of the balloon catheter, the guidewire having a central core wire therethrough that extends through the guidewire and extends from the guidewire in a proximal direction through the stent delivery system, the central core wire being formed with at least three different cross sectional areas, and the central core wire being formed from a shape memory alloy and having a distal portion that has a transition temperature higher than body temperture.