Drug eluting medical implant

• US 8,888,840 B2
• Filed: 04/16/2013
• Issued: 11/18/2014
• Est. Priority Date: 05/20/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Palasis, Maria, You, Changcheng, Concagh, Daniel, Core, Lee, Sharma, Upma, Zugates, Gregory T., Ho, Kirchel
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/863,632
• Publication Number:
  US 20130317600A1
• Time in Patent Office: 581 Days
• Field of Search: 623 111- 123, 623 138- 154, 606191-195
• US Class Current: 623/1.38
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• 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 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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
• CPC Class Codes: C08L 75/04 Polyurethanes

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.

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 2, 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. 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.

10. The medical implant of claim 9, wherein said second conformal coating comprises between 5 micrograms and 13 micrograms of paclitaxel per 10 millimeters of length of the tubular structure.

11. The medical implant of claim 9, wherein said poly(lactic acid-co-caprolactone) comprises about 50 weight percent of lactic acid and about 50 weight percent of caprolactone.

12. The medical implant of claim 9, 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.

13. The medical implant of claim 12, wherein said diisocyanate is hexamethylene diisocyanate.

14. The medical implant of claim 9 wherein said first polymeric material comprises poly(lactic acid co-glycolic acid).

15. The medical implant of claim 9, wherein said second conformal coating has a thickness up to 8 microns.

16. The medical implant of claim 9, wherein the second conformal coating comprises between 0.3 weight percent and 5 weight percent of paclitaxel.