Coated stents

• US 9,981,072 B2
• Filed: 03/31/2010
• Issued: 05/29/2018
• Est. Priority Date: 04/01/2009
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: Taylor, Douglas, McClain, James B.
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/751,902
• Publication Number:
  US 20100256748A1
• Time in Patent Office: 2,981 Days
• Field of Search: 623 146
• 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 comprising a plurality of stent struts;

b. a coating comprising an active agent and a bioabsorbable polymer, wherein the active agent is a macrolide immunosuppressive drug in crystalline form, the coating formed under conditions that do not substantially modify the morphology of the drug, and 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 stent struts;

wherein a ratio of an abluminal coating thickness to a luminal coating thickness is at most 90;

10,

wherein a coated stent strut thickness measured from the abluminal surface of the coated stent strut to the luminal surface of the coated stent strut is at most 75 microns.

2. 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.

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

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 with the coating without shielding the luminal surfaces.

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 with the coating wherein the stent is in at least one of:

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

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

at most 65 microns, and at most 63 microns.

7. The coated stent of claim 1, wherein the coating contacts at least one of:

at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 99% of the abluminal, luminal, and sidewall surfaces of the struts of the stent.

8. The coated stent of claim 7, wherein contact of the coating to the stent surfaces is measured by scanning electron microscopy of at least one cross section of a strut of the stent.

9. The coated stent of claim 7, wherein contact of the coating is measured when the stent is at least one of:

in a collapsed condition, and in an expanded condition.

10. The coated stent of claim 1, wherein the macrolide immunosuppressive (limus) drug comprises rapamycin.

11. The coated stent of claim 1, wherein at least 50%, 60%, 70%, 80%, 90%, or 100% of the macrolide immunosuppressive (limus) drug is in crystalline or semi-crystalline form.

12. The coated stent of claim 1, wherein the coating adds at most 17 microns thickness to the coated stent.

13. The coated stent of claim 1, wherein the abluminal coating thickness is an average of a plurality of measurements along the abluminal surface, and wherein the luminal coating thickness is an average of a plurality of measurements along the luminal surface.

14. The coated stent of claim 1, wherein the abluminal coating thickness is a single measurement near the center of the abluminal surface, and wherein the luminal coating thickness is a single measurement near the center of the luminal surface.

15. The coated stent of claim 1, wherein the bioabsorbable polymer comprises 50:

50 poly(d,l-lactide-co-glycolide).