Methods of coating an implantable device having depots formed in a surface thereof

• US 6,506,437 B1
• Filed: 10/17/2000
• Issued: 01/14/2003
• Est. Priority Date: 10/17/2000
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Scheinpflug, Kurt W., Yoe, Brandon, Wu, Steven Z., Harish, Sameer
• Primary Examiner(s): Prebilic, Paul B.
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US09/690,907
• Time in Patent Office: 819 Days
• Field of Search: 623/1.15, 623/1.34, 623/1.39, 623/1.42, 623/1.43, 623/1.45, 623/1.46, 427/2.14, 427/2.24, 427/2.25, 427/2.28, 427/2.1
• US Class Current: 427/2.25
• 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

Abstract

The present invention provides methods of coating an implantable device, such as a stent or a graft, having a plurality of depots formed in a surface thereof. An exemplary method includes applying a composition including a polymer and a solvent to the implantable device proximate to the depots. Such application of the composition is performed at a first gas pressure. The method also includes applying a second gas pressure, which is greater than the first gas pressure, to the composition-coated device so that air pockets in the depots are eliminated, or at least reduced in size. The method also includes the act of removing the solvent from the composition to form a coating. An implantable device coated in accordance with the method is also provided.

The compositions employed in the methods may include one or more therapeutic substances such as antineoplastics, antimitotics, antiinflammatories, antiplatelets, anticoagulants, antifibrins, antithrombins, antiproliferatives, antibiotics, antioxidants, antiallergics, radioisotopes, and combinations thereof.

Claims

1. A method of depositing a polymer into a plurality of depots formed in an outer surface of a stent comprising:

applying a composition comprising a polymer and a solvent to said plurality of depots, wherein said act of applying said composition is performed at a first gas pressure;

applying a second gas pressure to said composition in said depots, wherein said second gas pressure is greater than said first gas pressure and less than the pressure which causes phase separation or precipitation of said polymer in said composition, and wherein said second gas pressure is sufficient to remove air pockets from said composition in said depots; and

removing said solvent from said composition, wherein a polymeric deposit is formed substantially free from air pockets in said depots of said stent.

2. The method of claim 1, wherein said composition comprises a therapeutic substance.

3. The method of claim 2, wherein said therapeutic substance is selected from a group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antiproliferative, antibiotic, antioxidant, and antiallergic substances and combinations thereof.

4. The method of claim 2, wherein said therapeutic substance is selected from a group consisting of radioisotopes and radiopaque substances.

5. The method of claim 1, wherein said second gas pressure is a gauge pressure of about 29.4 PSI to about 58.8 PSI.

6. The method of claim 1, wherein said second gas pressure is greater than atmospheric pressure.

7. The method of claim 1, wherein the act of applying said composition to said depots comprises applying said composition to said stent and allowing said composition to penetrate into said depots.

8. The method of claim 7, further comprising removing said composition from portions of said outer surface of said stent outside of said depots.

9. The method of claim 1, further comprising applying a polymeric topcoat at least over said depots.

10. The method of claim 1, wherein said second pressure is applied for a duration of about 0.5 minutes to about 20 minutes.

11. The method of claim 1, wherein said first pressure is at least atmospheric pressure.

12. A method of loading a substance into a plurality of depots of a stent comprising:

applying a composition including a polymer and a solvent to said depots, said composition having a polymer content between about 0.5% and 20% by weight, and wherein said act of applying said composition is performed at a first gas pressure of at least atmospheric pressure;

placing the stent in a sealable pressure chamber; and

applying a second gas pressure to said composition, said second gas pressure being a gauge pressure of about 29.4 PSI to about 58.8 PSI, wherein said second gas pressure is greater than said first gas pressure and less than the pressure which causes phase separation or precipitation of said polymer in said composition and is sufficient to remove air pockets from said composition in said depots.

13. The method of claim 12, wherein said polymer is selected from a group consisting of bioabsorbable polymers, biomolecules, and biostable polymers.

14. The method of claim 13, wherein said composition further comprises a therapeutic substance.

15. The method of claim 14, wherein said therapeutic substance is selected from a group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antiproliferative, antibiotic, antioxidant, and antiallergic substances and combinations thereof.

16. The method of claim 14, wherein said therapeutic substance is selected from a group consisting of radioisotopes.

17. The method of claim 14, further comprising applying a polymeric topcoat over said depots.

18. The method of claim 12, further comprising removing said solvent from said composition.

19. The method of claim 12, wherein said second pressure is applied for a duration of about 0.5 minutes to about 20 minutes.

20. A method of depositing a substance in depots of an implantable device, comprising:

applying said substance in a liquid carrier to said device wherein said substance and said liquid carrier are allowed to penetrate into said depots;

placing said device in a sealable pressure chamber;

applying a first pressure greater than atmospheric pressure to said device so as to significantly reduce the size of the air pockets in said depots;

removing said liquid carrier from said device while applying a second pressure greater than atmospheric pressure to maintain the reduced size of the air pockets; and

applying a third pressure to said device subsequent to said removal of said liquid carrier wherein said third pressure is less than said first and second pressures.

21. The method of claim 20, wherein said substance is a polymer.

22. The method of claim 20, wherein said substance is a drug.

23. The method of claim 20, wherein said substance is a mixture of a polymer and a drug.

24. The method of claim 20, wherein said first pressure does not cause phase separation or precipitation of said substance in said liquid carrier.

25. The method of claim 20, wherein said first pressure is equal to said second pressure.

26. The method of claim 20, wherein said application of said substance is performed while said device is in said pressure chamber.

27. A method of depositing a substance in depots of a stent, comprising:

applying a composition including a substance to said stent wherein said composition penetrates into said depots of said stent; and

applying a pressure to said composition to essentially remove air pockets or reduce the size of air pockets from said composition in said depots, wherein said pressure does not cause phase separation or precipitation of said substance in said composition in said depots of said stent.

28. The method of claim 27, wherein said substance includes a drug.

29. The method of claim 27, wherein said substance includes a polymer.

30. The method of claim 27, wherein said substance is a mixture of a polymer and a drug.

31. The method of claim 27, wherein said composition includes a solvent and wherein said method additionally comprises allowing said solvent to evaporate.

32. A method of depositing a substance in depots of an implantable device, comprising:

applying said substance in a liquid carrier to said device wherein said substance and said liquid carrier are allowed to penetrate into said depots;

placing said device in a sealable pressure chamber;

applying a first pressure to said device so as to significantly eliminate or reduce the size of the air pockets in said depots;

removing said liquid carrier from said device; and

applying a second pressure to said device subsequent to said removal of said liquid carrier wherein said second pressure is less than said first pressure.