Drug eluting medical implant

• US 9,155,638 B2
• Filed: 05/10/2013
• Issued: 10/13/2015
• Est. Priority Date: 05/20/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: 480 Biomedical, Inc.
• Inventors: Palasis, Maria, You, Changcheng, Concagh, Danny, Core, Lee, Ho, Kicherl, Sharma, Upma, Zugates, Gregory T.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/891,574
• Publication Number:
  US 20130304177A1
• Time in Patent Office: 886 Days
• Field of Search: 623 111- 123, 623 138- 154, 606191-195
• US Class Current: 1/1
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified 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
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2403/0112 One smooth surface, e.g. laminated or coated
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

Disclosed are self-expanding medical implants for placement within a lumen of a patient. The implants comprise a woven or non-woven structure having a substantially tubular configuration, and are designed to be low-profile such that they are deliverable with a small diameter catheter. The implants have a high recoverability and desired mechanical properties.

Claims

1. A medical implant comprising:

a tubular structure comprising a first polymeric material;

a first conformal coating comprising poly (lactic acid-co-caprolactone), said first conformal coating at least partially coating said tubular structure and increasing the mass of said tubular structure by at least about 20 percent;

a second conformal coating at least partially coating said first conformal coating and comprising a second polymeric material and paclitaxel, said second conformal coating comprising between 0.3 weight percent and 5 weight percent of paclitaxel; and

a third conformal coating at least partially coating said second conformal coating and comprising a third polymeric material.

2. The medical implant of claim 1, wherein said poly (lactic acid-co-caprolactone) comprises about 50 weight percent of lactic acid and about 50 weight percent of caprolactone.

3. The medical implant of claim 1, wherein said poly (lactic acid-co-caprolactone) is prepared by a process that comprises the step of crosslinking said poly (lactic acid-co-caprolactone) with diisocyanate.

4. The medical implant of claim 3, wherein said diisocyanate is hexamethylene diisocyanate.

5. The medical implant of claim 1, wherein said first polymeric material comprises poly(lactic acid co-glycolic acid).

6. The medical implant of claim 1, wherein said second conformal coating has a thickness up to 8 microns.

7. The medical implant of claim 1, wherein the medical implant comprises between 2.5 micrograms and 20 micrograms of paclitaxel per 10 millimeters of length of the tubular structure.

8. The medical implant of claim 7, wherein the medical implant comprises between 5 micrograms and 13 micrograms of paclitaxel per 10 millimeters of length of the tubular structure.

9. The medical implant of claim 1, wherein the third conformal coating is biodegradable.

10. The medical implant of claim 1, wherein at least a portion of said third conformal coating does not include paclitaxel.

11. The medical implant of claim 1, wherein said second and third polymeric materials are the same.

12. The medical implant of claim 1, wherein said second and third polymeric materials are different.

13. A medical implant comprising:

a tubular structure comprising a first polymeric material;

a first conformal coating comprising poly (lactic acid-co-caprolactone), said first conformal coating at least partially coating said tubular structure and increasing the mass of said tubular structure by at least about 20 percent;

a second conformal coating at least partially coating said first conformal coating and comprising a second polymeric material and paclitaxel, said second conformal coating comprising between 2.5 micrograms and 20 micrograms of paclitaxel per 10 millimeters of length of the tubular structure; and

a third conformal coating at least partially coating said second conformal coating and comprising a third polymeric material.

14. The medical implant of claim 13, wherein said second conformal coating comprises between 5 micrograms and 13 micrograms of paclitaxel per 10 millimeters of length of the tubular structure.

15. The medical implant of claim 13, wherein said poly (lactic acid-co-caprolactone) comprises about 50 weight percent of lactic acid and about 50 weight percent of caprolactone.

16. The medical implant of claim 13, wherein said poly (lactic acid-co-caprolactone) is prepared by a process that comprises the step of crosslinking said poly (lactic acid-co-caprolactone) with diisocyanate.

17. The medical implant of claim 16, wherein said diisocyanate is hexamethylene diisocyanate.

18. The medical implant of claim 13, wherein said first polymeric material comprises poly(lactic acid co-glycolic acid).

19. The medical implant of claim 13, wherein said second conformal coating has a thickness up to 8 microns.

20. The medical implant of claim 13, wherein the second conformal coating comprises between 0.3 weight percent and 5 weight percent of paclitaxel.

21. The medical implant of claim 13, wherein the third conformal coating is biodegradable.

22. The medical implant of claim 13, wherein at least a portion of said third conformal coating does not include paclitaxel.

23. The medical implant of claim 13, wherein said second and third polymeric materials are the same.

24. The medical implant of claim 13, wherein said second and third polymeric materials are different.