Stent with albumin coating for enhanced thromboresistance

• US 9,474,834 B2
• Filed: 04/11/2014
• Issued: 10/25/2016
• Est. Priority Date: 04/11/2014
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Pacetti, Stephen D., Trollsas, O. Mikael, Sheehy, Alexander J.
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US14/251,536
• Publication Number:
  US 20150290363A1
• Time in Patent Office: 928 Days
• Field of Search: 427/2.24, 427/2.25, 427/2.3, 427/2.28, 623/1.48
• US Class Current: 1/1
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 31/08 Materials for 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: A61L 33/128 Other specific proteins or polypeptides not covered by A61L33/122 - A61L33/126
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

Coatings for medical devices, the coatings including albumin, the methods of forming the coatings, and the coated medical devices are disclosed. In preferred embodiments the medical device is a bioabsorbable stent. The albumin coating layer improves the thromboresistance of the device.

Claims

1. A method comprising:

disposing over a surface of a medical device a coating solution comprising a polymer, a drug, microparticulate albumin, and an organic solvent; and

removing the solvent to form a coating comprising albumin.

2. The method of claim 1, wherein the polymer of the coating solution comprises at least one member of the group consisting of poly(L-lactide), poly(D-lactide), poly(D,L-lactide), poly(L-lactide-co-glycolide), poly(D-lactide-co-glycolide), poly(caprolactone-co-L-lactide), poly(caprolactone-co-D,L-lactide), and poly(D,L-lactide-co-glycolide).

3. The method of claim 1, wherein the drug of the coating solution comprises at least one member of the group consisting of sirolimus, Biolimus, ridaforolimus, tacrolimus, temsirolimus, pimecrolimus, novolimus, myolimus, zotarolimus, everolimus, umirolimus, merilimus, 40-O-(3-hydroxypropyl)rapamycin, 40-O-[2-(2-hydroxy)ethoxy]-ethyl-rapamycin, 40-O-tetrazolylrapamycin, and 40-epi-(N1-tetrazolyl)-rapamycin.

4. The method of claim 1, wherein the albumin comprises human serum albumin, recombinant human serum albumin, sub-domains of human serum albumin cleaved from the other sub-domains, the recombinant equivalent to sub-domains of human serum albumin cleaved from the other sub-domains, or any combination thereof.

5. The method of claim 1, wherein the microparticulate albumin comprises particles consisting essentially of albumin.

6. The method of claim 1, wherein the microparticulate albumin comprises particles comprising albumin grafted onto a polymer.

7. The method of claim 6, wherein the polymer of the micro-particulate albumin comprises at least one member of the group consisting of poly(D,L-lactide), block copolymers of poly(D,L lactide) and polyethylene glycol, poly(D,L-lactide-co-glycolide), block copolymers of poly(glycolide) and polyethylene glycol, poly(L-lactide), block copolymers of poly(L-lactide) and polyethylene glycol, poly(caprolactone-co-L-lactide), poly(caprolactone-co-D,L-lactide), poly(caprolactone-co-glycolide), poly(caprolactone-block-L-lactide), poly(caprolactone-block-D,L-lactide), poly(caprolactone-block-glycolide), poly(ethylene-co-vinyl alcohol), polycysteine, polypropylene sulfide, polylysine, polyallylamine, polysaccharides, polyacrylates with pendant vinyl groups, poly(meth)acrylates with pendant vinyl groups, and poly-alpha-hydroxyesters.

8. The method of claim 1, wherein the solvent of the coating solution comprises acetone.

9. The method of claim 1, further comprising at least one additional processing operation.

10. The method of claim 1, wherein the medical device is a stent.

11. The method of claim 1, wherein the medical device is a bioabsorbable stent.

12. A method comprising:

disposing over a surface of a medical device a coating solution comprising microparticulate albumin, and an organic solvent; and

removing the solvent to form a coating comprising albumin;

wherein the microparticulate albumin comprises particles comprising albumin grafted onto a polymer.

13. The method of claim 12, wherein the polymer of the microparticulate albumin comprises at least one member of the group consisting of poly(D,L-lactide), block copolymers of poly(D,L lactide) and polyethylene glycol, poly(D,L-lactide-co-glycolide), block copolymers of poly(glycolide) and polyethylene glycol, poly(L-lactide), block copolymers of poly(L-lactide) and polyethylene glycol, poly(caprolactone-co-L-lactide), poly(caprolactone-co-D,L-lactide), poly(caprolactone-co-glycolide), poly(caprolactone-block-L-lactide), poly(caprolactone-block-D,L-lactide), poly(caprolactone-block-glycolide), poly(ethylene-co-vinyl alcohol), polycysteine, polypropylene sulfide, polylysine, polyallylamine, polysaccharides, polyacrylates with pendant vinyl groups, poly(meth)acrylates with pendant vinyl groups, and poly-alpha-hydroxyesters.

14. The method of claim 12, wherein the medical device is a stent.

15. The method of claim 14, wherein the medical device is a bioabsorbable stent.

16. The method of claim 12, further comprising at least one additional processing operation.

17. A method comprising:

disposing over a surface of a medical device a coating solution comprising microparticulate albumin, and acetone; and

removing the acetone to form a coating comprising albumin.

18. The method of claim 17, wherein the medical device is a stent.

19. The method of claim 18, wherein the medical device is a bioabsorbable stent.

20. The method of claim 17, further comprising at least one additional processing operation.