Drug-eluting stent and methods of making the same

• US 7,144,422 B1
• Filed: 11/13/2002
• Issued: 12/05/2006
• Est. Priority Date: 11/13/2002
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Rao, K. T. Venkateswara
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/293,108
• Time in Patent Office: 1,483 Days
• Field of Search: 623/1.15, 623/1.13, 623/1.12, 623/1.23, 623/1.39, 623/1.42, 623/1.44
• US Class Current: 623/1.42
• 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 2002/91508 the meander having a difference in amplitude 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An intravascular stent having a prefabricated, patterned polymeric sleeve for controlled release of therapeutic drugs and for delivery of the therapeutic drugs in localized drug therapy in a blood vessel is disclosed. The polymeric sleeve is attached to at least a portion of an outside surface area of the stent structure. Alternatively, a plurality of individual microfilament strands are longitudinally attached to an outer surface of a stent structure in a spaced apart orientation and loaded with at least one therapeutic drug for the release thereof at a treatment site. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen. Methods for making the same are also disclosed.

Claims

1. A drug-eluting stent delivery system for controlled release of therapeutic drugs and for delivery of the therapeutic drugs in localized drug therapy in a blood vessel, comprising:

a pattern of struts interconnected to form a structure capable of contacting the walls of a body lumen to maintain the patency of the vessel,

wherein a polymeric sleeve, fabricated as a prepatterned tube comprising polymer elements, is loaded with at least one therapeutic drug for the release thereof at a treatment site, the polymeric sleeve being attached to at least a portion of an outside surface area of the stent structure and

wherein the prepatterning enables the detachment of the polymer elements upon stent expansion,

wherein the polymeric sleeve includes a plurality of four-sided, filament strands attached to the surface of the stent, and

wherein a barrier coating layer is disposed on three sides of the plurality of four-sided filament strands to enable drug elution along the fourth side.

2. The drug-eluting stent delivery system of claim 1, wherein the pattern of struts comprises 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 and being aligned on a common longitudinal axis.

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

4. The drug-eluting stent delivery system of claim 3, wherein the metallic material forming the stent is from the group consisting of stainless steel, platinum, titanium, tantalum, nickel-titanium, cobalt-chromium, and alloys thereof.

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

6. The drug-eluting stent delivery system of claim 1, wherein the polymeric sleeve comprises a material selected from the group consisting of PMMA, EVAL, PBMA, PGA, and PLLA, and copolymers and blends thereof.

7. The drug-eluting stent delivery system of claim 1, wherein the polymeric sleeve is fabricated from a predesigned pattern having individual drug-loaded elements to form a desired local drug-elution profile.

8. The drug-eluting stent delivery system of claim 7, wherein upon expansion of the stent structure, the drug-loaded polymeric sleeve breaks away in the predesigned pattern and individual drug-loaded filament strands are held against the vessel wall by the stent structure.

9. The drug-eluting stent delivery system of claim 7, wherein the predesigned pattern is fabricated to expand along a length of the stent to overcome strain.

10. The drug-eluting stent delivery system of claim 1, wherein the drug-loaded polymeric sleeve is prefabricated in a desired dimension using at least one of the polymer processing techniques comprising extrusion, injection molding, laser cutting, slip casting, and plasma polymerization.

11. The drug-eluting stent delivery system of claim 1, wherein the polymeric sleeve includes at least one additional layer of polymer material as a barrier layer to further control elution of the therapeutic drug at the treatment site.

12. The drug-eluting stent delivery system of claim 1, wherein the drug-loaded polymeric sleeve has a thickness in the range of about 0.001 to about 100 microns.

13. A method of making a drug-eluting stent delivery system for controlled release of therapeutic drug(s) and for delivery of the therapeutic drug(s) in localized drug therapy in a blood vessel, comprising:

forming a pattern of struts that form a stent capable of contacting the walls of a body lumen to maintain the patency of the vessel,

wherein at least a portion of the outside surface of the stent surface attaches to a polymeric sleeve that

is fabricated as a prepatterned tube comprising a plurality of four-sided, filament strands attached to the surface of the stent, and

is loaded with at least one therapeutic drug for the release thereof at a treatment site,

wherein the prepatterning enables the detachment of the filament strands upon stent expansion, and

wherein a barrier coating layer is disposed on three sides of the plurality of four-sided filament strands to enable drug elution along the fourth side.

14. The method of claim 13 wherein the therapeutic drug is selected from the group consisting of antiplatelets, anticoagulants, antifibrins, antithrombins, and antiproliferatives.

15. The method of claim 13 wherein the polymeric sleeve comprises a material selected from PMMA, EVAL, PBMA, PGA, PLLA, copolymers thereof or blends thereof.

16. The method of claim 13 wherein the polymeric sleeve includes at least one additional layer of polymer material as a barrier layer to further control elution of the therapeutic drug at the treatment site.