Stent with therapeutically active dosage of rapamycin coated thereon

• US 6,585,764 B2
• Filed: 06/04/2001
• Issued: 07/01/2003
• Est. Priority Date: 04/18/1997
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Rakos, Ronald, King, Kristen, Wright, Carol, Llanos, Gerard H.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/874,117
• Publication Number:
  US 20010027340A1
• Time in Patent Office: 757 Days
• Field of Search: 623/1.15, 623/1.39, 623/1.42, 623/1.4, 427/2--
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/606 Coatings
• 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
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Delivery of rapamycin locally, particularly from intravascular stent, directly from micropores in the stent body or mixed or bound to a polymer coating applied on stent, to inhibit neointimal tissue proliferation and thereby prevent restenosis. This invention also facilitates the performance of the stent in inhibiting restenosis.

Claims

1. A stent having a coating containing rapamycin, said coating formed from a polymer mixed carrier containing the rapamycin;

and said coating applied to said stent.

2. The stent of claim 1 wherein the stent is dip-coated.

3. The stent of claim 1 wherein the stent is sprayed with said coating.

4. A stent having a coating containing rapamycin or its analogs, wherein said rapamycin or said analogs are contained in the coating at a weight percentage of 0.0001% to 30%.

5. The stent of claim 4 wherein a polymer is mixed to the rapamycin or its analogs.

6. The stent of claim 4 wherein a polymer is bound to the rapamycin or its analogs.

7. The stent of claim 4 wherein the rapamycin or its analogs is entrapped on the surface of the stent by a polymer.

15. The stent of claim 4 wherein said polymer is bound to the rapamycin or its analogs.

8. A stent having a coating containing rapamycin, said coating formed from a polymer mixed carrier containing the rapamycin or its analogs;

and said coating applied to said stent;

wherein the polymer is biocompatible and degradable; and

wherein the polymer is chosen from;

lactone-based polyesters, lactone-based copolyesters;

polyanhydrides;

polyaminoacids;

polysaccharides;

polyphosphazenes;

poly(ether-ester) copolymers, and blends of such polymers.

9. A stent having a coating containing rapamycin, said coating formed from a polymer mixed carrier containing the rapamycin or its analogs;

and said coating applied to said stent; and

wherein the polymer is chosen from;

lactone-based polyesters, lactone-based copolyesters;

polyanhydrides;

polyaminoacids;

polysaccharides;

polyphosphazenes;

poly(ether-ester) copolymers, and blends of such polymers.

10. A stent having a coating containing rapamycin, said coating formed from a polymer mixed carrier containing the rapamycin or its analogs;

and said coating applied to said stent;

wherein the polymer is nonabsorbable; and

wherein the polymer is chosen from;

polydimethylsiolxane;

poly(ethylene)vinylacetate;

poly(hydroxy)ethylmethylmethacrylate, polyvinyl pyrrolidone;

polytetrafluoroethylene; and

cellulose esters.

11. A stent having a coating containing rapamycin or its analogs, said coating formed from a polymer mixed carrier containing the rapamycin or its analogs;

and said coating applied to said stent; and

wherein the polymer is chosen from;

polydimethylsiolxane;

poly(ethylene)vinylacetate;

poly(hydroxy)ethylmethylmethacrylate, polyvinyl pyrrolidone;

polytetrafluoroethylene; and

cellulose esters.

12. A stent having a coating containing rapamycin or its analogs, said coating formed from a polymer mixed carrier containing the rapamycin or its analogs;

and said coating applied to said stent; and

further comprising;

a generally thin walled cylinder, said cylinder containing a plurality of generally solid struts, said applied to said strut, and a channel formed in at least one of said struts, said channel having a closed perimeter on all sides and an open top, and said channel smaller in all dimensions than said strut, said channel containing a reservoir of said rapamycin coating applied therein.

13. A stent having a coating containing rapamycin or its analogs, wherein said rapamycin or said analogs are contained in the coating at a weight percentage of 0.0001% to 30%, wherein the coating is a polymer.

14. The stent of claim 13 wherein said polymer is mixed to the rapamycin or its analogs.

16. The stent of claim 13 wherein the rapamycin or its analogs is entrapped on the surface of the stent by said polymer.

17. A stent containing a polymer and rapamycin or its analogs wherein said rapamycin or its analogs are contained in a therapeutically beneficial amount to combat restenosis.

18. The stent of claim 17 wherein said polymer is mixed to the rapamycin or its analogs.

19. The stent of claim 17 wherein said polymer is bound to the rapamycin or its analogs.

20. The stent of claim 17 wherein the rapamycin or its analogs is entrapped on the surface of the stent by said polymer.