Peripheral Stents Having Layers

• US 20100241220A1
• Filed: 03/22/2010
• Published: 09/23/2010
• Est. Priority Date: 03/23/2009
• Status: Abandoned Application

• Current Assignee: Micell Technologies Inc.
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B., Taylor, Douglas
• Application Number:
  US12/729,156
• Publication Number:
  US 20100241220A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• 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 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/63 Crystals
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• 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

Provided herein is a coated coronary stent, comprising: a. stent; b. a plurality of layers deposited on said stent to form said coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Claims

1. A coated stent having a plurality of stent struts for delivery to a peripheral body lumen comprising:

a stent;

a coating comprising a pharmaceutical agent and a polymer wherein at least part of the pharmaceutical agent is in crystalline form and wherein the coating is substantially resistant to stent strut breakage.

2. The coated stent of claim 1, wherein the polymer comprises at least one of a durable polymer and a bioabsorbable polymer.

3. The coated stent of claim 1, wherein the coating comprises a plurality of layers deposited on said stent to form said coated stent.

4. The coated stent of claim 1, wherein the polymer provides radial strength for the coated stent.

5. The coated stent of claim 1, wherein the polymer provides durability for the coated stent.

6. The coated stent of claim 1, wherein the polymer is impenetrable by a broken strut of the stent.

7. The coated stent of claim 1, wherein the coating comprises a fiber reinforcement.

17. The coated stent of claim 1, wherein heparin is attached to the stent by reaction with an aminated silane.

18. The coated stent of claims 17, wherein an onset of heparin anti-coagulant activity is obtained at week 3 or later, and wherein heparin anti-coagulant activity remains at an effective level for at least one of:

at least 90 days after onset of heparin activity, at least 120 days after onset of heparin activity, and at least 200 days after onset of heparin activity.

8. A coated stent having a plurality of stent struts for delivery to a peripheral body lumen comprising:

a stent;

a coating comprising a pharmaceutical agent and a polymer wherein at least part of the pharmaceutical agent is in crystalline form and wherein the coating provides a release profile whereby the pharmaceutical agent is released over a period longer than two weeks.

9. The coated stent of claim 8, wherein said coating provides a release profile whereby the pharmaceutical agent is released over a period longer than at least one of 1 month, 2 months, 3 months, 4 months, 6 months, and 12 months.

10. The coated stent of claim 8, wherein at least one of:

over 1% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 2% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 5% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 10% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 25% of said pharmaceutical agent coated on said stent is delivered to the vessel, and over 50% of said pharmaceutical agent coated on said stent is delivered to the vessel.

11. The coated stent of claim 8, wherein said stent provides an elution profile wherein about 10% to about 50% of pharmaceutical agent is eluted at week 20 after the stent is implanted in a subject under physiological conditions, about 25% to about 75% of pharmaceutical agent is eluted at week 30 and about 50% to about 100% of pharmaceutical agent is eluted at week 50.

12. The coated stent of claim 8, wherein the pharmaceutical agent is detected in vivo after two weeks by blood concentration testing.

13. The coated stent of claim 8, wherein the pharmaceutical agent is detected in-vitro after a two weeks time period or a correlatable time period thereof by elution testing in 37 degree buffered saline at infinite sink conditions.

14. A coated stent having a plurality of stent struts for delivery to a peripheral body lumen comprising:

a stent;

a coating comprising a pharmaceutical agent and a polymer wherein at least part of the pharmaeutical agent is in crystalline form and wherein said coating is substantially conformal to the stent struts when the coated stent is in an expanded state.

15. The coated stent of claim 14, wherein the coating is applied when the stent is in a collapsed state.

16. The coated stent of claim 14, wherein said coated stent has a radial expansion ratio of about 1 in a collapsed state and at least one of:

up to about 3.0 in the expanded state, up to about 3.0 in the expanded state, up to about 4.0 in the expanded state, up to about 5.0 in the expanded state, up to about 6.0 in the expanded state, over about 3.0 in the expanded state, and over about 4.0 in the expanded state.

19. A method for preparing a coated stent comprising the following steps:

providing a stent;

forming a coating comprising a pharmaceutical agent and a polymer on the stent wherein at least part of the pharmaceutical agent is in crystalline form, and wherein the coating is substantially resistant to stent strut breakage.

22. The method of claim 19, wherein forming the coating comprises depositing at least one of the pharmaceutical agent and the polymer in dry powder form.

23. The method of claim 19, wherein the forming the coating comprises depositing a plurality of layers on said stent to form said coated stent.

24. The method of claim 19, wherein forming the coating comprises depositing alternate pharmaceutical agent and polymer layers.

25. The method of claim 19, wherein forming the coating comprises depositing a fiber reinforcement on the stent.

26. The method of claim 19, comprising forming a silane layer on the stent, and covalently attaching heparin to the silane layer.

27. The method of claim 26, wherein onset of heparin anti-coagulant activity is obtained at week 3 or later, and wherein heparin anti-coagulant activity remains at an effective level for at least one of:

90 days after onset of heparin activity, at least 120 days after onset of heparin activity, at least 200 days after onset of heparin activity.

28. The method of claim 22, wherein the forming coating is done when the stent is in a collapsed state.

29. The method of claim 22, wherein said coated stent has a radial expansion ratio of about 1 in a collapsed state and at least one of:

up to about 3.0 in the expanded state, up to about 3.0 in the expanded state, up to about 4.0 in the expanded state, up to about 5.0 in the expanded state, up to about 6.0 in the expanded state, over about 3.0 in the expanded state, and over about 4.0 in the expanded state.

30. The method of claim 19, wherein the polymer provides radial strength for the coated stent.

31. The method of claim 19, wherein the polymer provides durability for the coated stent.

32. The method of claim 19, wherein the polymer is impenetrable by a broken strut of the stent.

20. A method for preparing a coated stent comprising the following steps:

providing a stent;

forming a coating comprising a pharmaceutical agent and a polymer on the stent wherein at least part of the pharmaceutical agent is in crystalline form, and wherein the coating provides a release profile whereby the pharmaceutical agent is released over a period longer than 2 weeks.

33. The method of claim 20, wherein said coating provides a release profile whereby the pharmaceutical agent is released over a period longer than at least one of 1 month, 2 months, 3 months, 4 months, 6 months, and 12 months.

34. The method of claim 20, wherein at least one of:

over 1% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 2% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 5% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 10% of said pharmaceutical agent coated on said stent is delivered to the vessel, over 25% of said pharmaceutical agent coated on said stent is delivered to the vessel, and over 50% of said pharmaceutical agent coated on said stent is delivered to the vessel.

35. The method of claim 20, wherein said stent provides an elution profile wherein about 10% to about 50% of pharmaceutical agent is eluted at week 20 after the stent is implanted in a subject under physiological conditions, about 25% to about 75% of pharmaceutical agent is eluted at week 30 and about 50% to about 100% of pharmaceutical agent is eluted at week 50.

36. The method of claim 20, wherein the pharmaceutical agent is detected in vivo after two weeks by blood concentration testing.

37. The method of claim 20, wherein the pharmaceutical agent is detected in-vitro after a two weeks time period or a correlatable time period thereof by elution testing in 37 degree buffered saline at infinite sink conditions.

21. A method for preparing a coated stent comprising the following steps:

providing a stent;

forming a coating comprising a pharmaceutical agent and a polymer on the stent wherein at least part of the pharmaceutical agent is in crystalline form, and wherein said coating is substantially conformal to the stent struts when the coated stent is in an expanded state.