Drug-eluting stent and delivery system with tapered stent in shoulder region

• US 7,156,869 B1
• Filed: 01/27/2003
• Issued: 01/02/2007
• Est. Priority Date: 01/27/2003
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Pacetti, Stephen Dirk
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/353,219
• Time in Patent Office: 1,436 Days
• Field of Search: 623/1.11, 623/1.15, 623/1.16, 623/1.17, 606/108, 606/192, 606/194, 606/195, 606/96.01, 606/104, 606/264
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A drug-eluting stent delivery system for the treatment of edge restenosis in a blood vessel. The drug-eluting stent delivery system has a balloon disposed about at least a portion of a catheter, the balloon having a first end and a second end and a working length therebetween, the first end and the second end each including a tapered portion, each tapered portion being attached to the catheter, the balloon being inflatable from a collapsed configuration to an inflated configuration. A drug-eluting stent contacts a wall of the blood vessel to maintain the patency of the vessel. The drug-eluting stent has a first end and a second end, the first end and the second end each including a tapered portion, wherein the drug-eluting stent is disposed over the balloon such that at least a portion of the first end and the second end of the balloon are covered by the tapered drug-eluting stent. A method for making the same is also disclosed herein.

Claims

1. A drug-eluting stent delivery system for the treatment of edge restenosis in a blood vessel, comprising:

a tubular catheter;

a balloon disposed about at least a portion of the catheter, the balloon having a first end and a second end and a working length therebetween, the first end and the second end each including a tapered portion, each tapered portion being attached to the catheter, the balloon being inflatable from a collapsed configuration, wherein the working length and at least a portion of each tapered portion are substantially flattened, to an inflated configuration; and

a drug-eluting stent configured to contact a wall of a blood vessel so as to maintain the patency of the vessel, the drug-eluting stent having a first end and a second end, the first end and the second end each including a tapered portion, wherein the drug-eluting stent is disposed over the balloon such that at least a portion of the first end and the second end of the balloon are each covered by the drug-eluting stent, and wherein the drug-eluting stent is loaded with a therapeutic drug.

2. The drug-eluting stent delivery system of claim 1, wherein the drug-eluting stent further comprises a pattern of struts having a plurality of flexible cylindrical rings being expandable in a radial direction, each of the rings having a first delivery diameter and a second implanted diameter.

3. The drug-eluting stent delivery system of claim 2, wherein at least onelink of the drug-eluting stent is attached between adjacent rings to form the drug-eluting stent.

4. The drug-eluting stent delivery system of claim 2, wherein the patternof struts is configured such that the number of cylindrical rings in the tapered portions of the first end and second end of the drug-eluting stent are less than that in the remainder of the drug-eluting stent.

5. The drug-eluting stent delivery system of claim 2, wherein the pattern of struts is configured such that the density of cylindrical rings in the tapered portions of the first end and second end of the drug-eluting stent is lower than that in the remainder of the drug-eluting stent.

6. The drug-eluting stent delivery system of claim 2, wherein at least one of the struts has a cross-section different than the other struts.

7. The drug-eluting stent delivery system of claim 2, wherein the cylindrical rings are configured to provide flexibility to the stent.

8. The drug-eluting stent delivery system of claim 2, wherein the pattern of struts is configured such that at least one of the struts has a smaller thickness in the tapered portion of the drug-eluting stent than in a non-tapered portion of the drug-eluting stent.

9. The drug-eluting stent delivery system of claim 1, wherein the drug-eluting stent has a central portion.

10. The drug-eluting stent delivery system of claim 9, wherein the central portion of the drug-eluting stent is expanded to a size that is greater than that of the vessel and the tapered portions of the balloon.

11. The drug-eluting stent delivery system of claim 1, wherein the drug-eluting stent is formed at least in part of a metallic material.

12. The drug-eluting stent delivery system of claim 11, wherein the metallic material forming the drug-eluting stent is from the group consisting of stainless steel, platinum, titanium, tantalum, nickel-titanium, cobalt-chromium, and alloys thereof.

13. The drug-eluting stent delivery system of claim 1, wherein the therapeutic drug is selected from the group consisting of antiplatelets, anticoagulants, antifibrins, antiinflammatories, antithrombins, and antiproliferatives.

14. The drug-eluting stent delivery system of claim 1, wherein the tapered portions of the balloon each have a length in a range of from about 1 up to about 7 mm.

15. A drug-eluting stent delivery system for the treatment of edge restenosis in a blood vessel, comprising:

a tubular catheter;

a balloon disposed about at least a portion of the catheter, the balloon having a first end and a second end and a working length therebetween, the first end and the second end each including a tapered portion, each tapered portion being attached to the catheter, the balloon being inflatable from a collapsed configuration, wherein the working length and at least a portion of each tapered portion are substantially flattened, to an inflated configuration; and

means for interconnecting a pattern of struts to form a stent structure having a drug-eluting component disposed thereon configured to contact a wall of a blood vessel so as to maintain the patency of the vessel, the stent structure and drug-eluting component having a first end and a second end, the first end and the second end each including a tapered portion, wherein the stent structure and drug-eluting component are disposed over the balloon such that the first end and the second end of the balloon are at least partially covered by the stent structure and the drug-eluting component, and wherein the drug-eluting component is loaded with a therapeutic drug.