Coated stents

• US 10,653,820 B2
• Filed: 04/24/2018
• Issued: 05/19/2020
• Est. Priority Date: 04/01/2009
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: Taylor, Charles Douglas, McClain, James B.
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/960,836
• Publication Number:
  US 20180272043A1
• Time in Patent Office: 756 Days
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 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 comprising

a. a stent having a plurality of struts;

b. a coating having an active agent and a bioabsorbable polymer, wherein the active agent is a macrolide immunosuppressive drug in crystalline form, wherein the active agent remains in crystalline form after being included in the coating;

wherein said coating is substantially conformal to abluminal, luminal, and sidewall surfaces of the struts of the stent to form a plurality of coated struts and a ratio of an abluminal coating thickness to a luminal coating thickness is at most 90;

10.

2. The coated stent of claim 1, wherein a coated strut thickness measured from the abluminal surface of the coated strut to the luminal surface of the coated strut is at most 65-85 microns.

3. The coated stent of claim 1, wherein the ratio of abluminal coating thickness to luminal coating thickness is at least one of:

at most 50;

50, at most 65;

35, at most 70;

30, and at most 80;

20.

4. The coated stent of claim 1, wherein the ratio of abluminal coating thickness to luminal coating thickness is achieved during coating of the stent without a masking element.

5. The coated stent of claim 1, wherein the ratio of abluminal coating thickness to luminal coating thickness is achieved during coating of the stent without shielding the luminal surfaces.

6. The coated stent of claim 1, wherein the ratio of abluminal coating thickness to luminal coating thickness is achieved during coating of the stent, wherein the stent is in at least one of:

a collapsed condition, an expanded condition, and an intermediate condition.

7. The coated stent of claim 1, wherein an average coated strut thickness when measured from the abluminal surface of the coated strut to the luminal surface of the coated strut is at least one of:

at most 85 microns and at most 75 microns.

8. A coated medical device comprising

a. a medical device having first, second, third and fourth surfaces;

b. a coating having an active agent and a bioabsorbable polymer, wherein the active agent is a macrolide immunosuppressive drug in crystalline form, wherein the active agent remains in crystalline form after being included in the coating;

wherein said coating is substantially conformal to the first, second, third and fourth surfaces and a ratio of a first surface coating thickness to a second surface coating thickness is at most 90;

10.

9. The coated medical device of claim 8, wherein a thickness measured from the coated first surface to the coated second surface is at most 65-85 microns.

10. The coated medical device of claim 8, wherein the ratio of first surface coating thickness to the second surface coating thickness is at least one of:

at most 50;

50, at most 65;

35, at most 70;

30, and at most 80;

20.

11. The coated medical device of claim 8, wherein the ratio of the first surface coating thickness to the second surface coating thickness is achieved during coating of the medical device without a masking element.

12. The coated medical device of claim 8, wherein the ratio of the first surface coating thickness to the second surface coating thickness is achieved during coating of the medical device without shielding the second surface.

13. The coated medical device of claim 8, wherein the ratio of the first surface coating thickness to the second surface coating thickness is achieved during coating of the medical device, wherein the medical device is in at least one of:

a first condition, a second condition and a third condition.

14. The coated medical device of claim 8, wherein an average coated thickness when measured from the first surface to the second surface is at least one of:

at most 85 microns and at most 75 microns.

15. A method of coating a stent comprising

a. depositing at least one bioabsorbable polymer layer on a plurality of struts of the stent;

b. depositing at least one a macrolide immunosuppressive drug layer on the plurality of struts of the stent, the drug being in crystalline form and remaining in crystalline form after being included in the coating; and

c. repeating at least one of steps (a) and (b),

wherein said coating is substantially conformal to abluminal, luminal, and sidewall surfaces of the struts of the stent to form a plurality of coated struts and a ratio of an abluminal coating thickness to a luminal coating thickness is at most 80;

20.

16. The method of claim 15, wherein a resultant coated strut thickness measured from the abluminal surface of the coated strut to the luminal surface of the coated strut is at most 65-85 microns.

17. The method of claim 15, wherein the ratio of abluminal coating thickness to luminal coating thickness is at least one of:

at most 50;

50, at most 65;

35, and at most 70;

30.

18. The method of claim 15, wherein the ratio of abluminal coating thickness to luminal coating thickness is achieved during coating of the stent without a masking element and without shielding the luminal surfaces.

19. The method of claim 15, wherein the depositing steps are performed when the stent is in at least one of:

a collapsed condition, an expanded condition, and an intermediate condition.

20. The method of claim 15, wherein an average coated strut thickness when measured from the abluminal surface of the coated strut to the luminal surface of the coated strut is at least one of:

at most 85 microns and at most 75 microns.