STENTS HAVING BIOABSORBABLE LAYERS

• US 20090292351A1
• Filed: 04/17/2009
• Published: 11/26/2009
• Est. Priority Date: 04/17/2008
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B., Taylor, Douglas
• Granted Patent: US 9,789,233 B2
• Time in Patent Office: Days
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/604 Biodegradation
• 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 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; 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 device comprising

a. a stent;

and

b. a plurality of layers that form a laminate coating on said 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 a portion of the active agent is in crystalline form.

2. A device comprising

a. a stent;

b. a plurality of layers that form a laminate coating on said stent;

wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises a pharmaceutical agent selected from rapamycin, a prodrug, a derivative, an analog, a hydrate, an ester, and a salt thereof, wherein at least a portion of the pharmaceutical agent is in crystalline form.

3. The device of claim 2, wherein said device has at least one pharmaceutical agent layer defined by a three-dimensional physical space occupied by crystal particles of said pharmaceutical agent and said three dimensional physical space is free of polymer.

4. The device of claim 3, wherein at least some of the crystal particles in said three dimensional physical space defining said at least one pharmaceutical agent layer are in contact with polymer particles present in a polymer layer adjacent to said at least one pharmaceutical agent layer defined by said three-dimensional space free of polymer.

5. The device of claim 2, wherein said plurality of layers comprises a first polymer layer comprising a first bioabsorbable polymer and a second polymer layer comprising a second bioabsorbable polymer, wherein said at least one layer comprising said pharmaceutical agent is between said first polymer layer and said second polymer layer.

6. The device of claim 5, wherein said first and second bioabsorbable polymers are the same polymer.

7. The device of claim 5, wherein said first and second bioabsorbable polymers are different.

8. The device of claim 5, wherein said second polymer layer has at least one contact point with at least one particle of said pharmaceutical agent in said pharmaceutical agent layer and said second polymer layer has at least one contact point with said first polymer layer.

9. The device of claim 8 wherein said stent has a stent longitudinal axis;

and said second polymer layer has a second polymer layer portion along said stent longitudinal wherein said second layer portion is free of contact with particles of said pharmaceutical agent.

10. The device of claim 9, wherein said device has at least one pharmaceutical agent layer defined by a three-dimensional physical space occupied by crystal particles of said pharmaceutical agent and said three dimensional physical space is free of polymer.

11. The device of claim 9, wherein said stent comprises at least one strut having a strut length along said stent longitudinal axis, wherein said second layer portion extends substantially along said strut length.

12. The device of claim 9, wherein said stent has a stent length along said stent longitudinal axis and said second layer portion extends substantially along said stent length.

13. The device of claim 9, wherein said stent comprises at least five struts, each strut having a strut length along said stent longitudinal axis, wherein said second layer portion extends substantially along substantially the strut length of at least two struts.

14. The device of claim 9, wherein said stent comprises at least five struts, each strut having a strut length along said stent longitudinal axis, wherein said second layer portion extends substantially along substantially the strut length of at least three struts.

15. The device of claim 9, wherein said stent comprises at least five struts, each strut having a strut length along said stent longitudinal axis, wherein said second layer portion extends substantially along substantially the strut length of least four struts.

16. The device of claim 9, wherein said stent comprises at least five struts, each strut having a strut length along said stent longitudinal axis, wherein said second layer portion extends substantially along substantially the strut length of all said at least five struts.

17. The device of claim 9, wherein said stent has a stent length along said stent longitudinal axis and said second layer portion extends substantially along said stent length.

18. The device of claim 9, wherein said stent has a stent length along said stent longitudinal axis and said second layer portion extends along at least 50% of said stent length.

19. The device of claim 9, wherein said stent has a stent length along said stent longitudinal axis and said second layer portion extends along at least 75% of said stent length.

20. A device comprising:

a. a stent;

b. a plurality of layers that form a laminate coating on said stent, wherein a first layer comprises a first bioabsorbable polymer, a second layer comprises a pharmaceutical agent, a third layer comprises a second bioabsorbable polymer, a fourth layer comprises the pharmaceutical agent, and a fifth layer comprises a third bioabsorbable polymer,

wherein the pharmaceutical agent is selected from rapamycin, a prodrug, a derivative, an analog, a hydrate, an ester, and a salt thereof, and

wherein at least a portion of the pharmaceutical agent is in crystalline form.