Stent delivery system using a steerable guide wire

• US 9,254,211 B2
• Filed: 10/06/2005
• Issued: 02/09/2016
• Est. Priority Date: 10/06/2005
• Status: Active Grant

• 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., Fischell, Scott J. S.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US11/244,777
• Publication Number:
  US 20070083253A1
• Time in Patent Office: 3,778 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/200, 623/1.11, 623/1.23, 623/1.24, 623/1.42, 604/103.03
• US Class Current: 1/1
• 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 2025/1056 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 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A thin-walled guide wire tube is fixedly and sealably attached to both a proximal section and a distal section of a balloon angioplasty catheter. A stent is co-axially mounted onto the inflatable balloon of the balloon angioplasty catheter. Because the guide wire tube forms an inner liner for the balloon angioplasty catheter, the fluid inflation lumen of the catheter is sealed so the inflation liquid that pressurizes the balloon will not leak as it would be if there were no “inner liner” and the balloon angioplasty catheter were attached to the guide wire itself. By not having a traditional inner shaft through which a conventional guide wire slides, the deflated balloon on which the stent is mounted can have a reduced diameter.

Claims

1. A stent delivery system for placing a stent into a vessel of a human subject, the stent delivery system including:

a balloon angioplasty catheter having a distal portion with an inflatable balloon located at that distal portion, and a proximal portion located externally to the human subject;

a balloon expandable stent co-axially mounted onto the inflatable balloon, the stent being designed for opening a stenosed vessel of the human subject and the inflatable balloon having a cylindrical distal section and a cylindrical proximal section;

a steerable guide wire co-axial within and sealably attached to a polymer guide wire tube to prevent longitudinal motion of the steerable guide wire within the polymer guide wire tube, a length of steerable guide wire extending distally beyond the distal portion of the balloon catheter, a distal portion of the steerable guide wire configured to have its shape changed after it is placed in the human subject'"'"'s vascular system by manipulation of a proximal portion of the steerable guide wire located externally to the human subject; and

a distal seal having an inner diameter and an outer diameter and a largest outer diameter, the inner diameter of the distal seal fixedly and sealably attached to the polymer guide wire tube, the outer diameter fixedly and sealably attached to the cylindrical distal section of the inflatable balloon, the largest outer diameter distal to the cylindrical distal section of the balloon, and the largest outside diameter of the distal seal is distal to the cylindrical distal section of the inflatable balloon and approximately equal to or slightly greater than the outer diameter of the pre-deployed stent to enhance the ability of the stent to penetrate a tight stenosis.

2. The stent delivery system of claim 1 including a proximal shaft that extends for most of the length of the stent delivery system, the distal end of the proximal shaft being joined to a distal shaft having a distal end that is fixedly attached to the cylindrical proximal section of the inflatable balloon, the proximal shaft having a larger diameter as compared to the diameter of the distal shaft.

3. The stent delivery system of claim 1 where the steerable guide wire has an outside diameter that is less than 0.038 inches.

4. The stent delivery system of claim 1 where the steerable guide wire has an outside diameter of approximately 0.014 inches.

5. The stent delivery system of claim 1 wherein the length of the steerable guide wire extending beyond the distal portion of the balloon catheter is less than 5 cm.

6. The stent delivery system of claim 1 where the stent is a drug eluting stent.

7. The stent delivery system of claim 6 where the drug that is being eluted is sirolimus.

8. The stent delivery system of claim 6 where the drug that is being eluted is paclitaxel.

9. The stent delivery system of claim 1 where the distal seal has a taper in the distal direction that is less than 30 degrees relative to the longitudinal axis of the steerable guide wire, the taper being designed to improve the ability of the distal seal to penetrate a tight stenosis.

10. The stent delivery system of claim 1 where the distal seal has a taper in the distal direction that is less than 15 degrees relative to the longitudinal axis of the steerable guide wire, the taper being designed to improve the ability of the distal seal to penetrate a tight stenosis.

11. The stent delivery system of claim 1 where the outside diameter of the cylindrical distal section of the inflatable balloon is approximately equal to or slightly greater than the outer diameter of the pre-deployed stent to enhance the ability of the stent to penetrate a tight stenosis.

12. The stent delivery system of claim 1 including a proximal seal that is sealably and fixedly attached to a proximal end of the polymer guide wire tube.

13. The stent delivery system of claim 1 where the stent mounted on the balloon of the stent delivery system is formed from a high-density metal selected from the group consisting of tantalum and L605.

14. The stent delivery system of claim 1, wherein the polymer guide wire tube is heat shrunk onto the steerable guide wire.

15. The stent delivery system of claim 1, wherein the polymer guide wire tube is first solvent swelled prior to it being placed onto the steerable guide wire.

16. The stent delivery system of claim 1, further comprising a Luer fitting that is placed at the proximal portion of the balloon angioplasty catheter, the Luer fitting having a pressure tight seal that is fixedly and sealably attached to the polymer guide wire tube.

17. The stent delivery system of claim 16 further comprising a hemostasis valve that is the pressure tight seal that is used to seal the proximal end of the polymer guide wire tube.