COATINGS FOR IMPLANTABLE MEDICAL DEVICES

Abstract

An implantable medical device comprising an expandable balloon having an outer surface, a polymer coated on at least a portion of the outer surface of the balloon, and a pharmaceutically active agent dispersed within the polymer.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the invention will be understood from the following description, the appended claims and the accompanying drawings, in which:

FIG. 1 is a visual schematic of an embodiment of a biological mechanism by which heparin acts;

FIG. 2 is a schematic of the action of sirolimus on cell division; and

FIG. 3 is an experimental set-up for a heparinization process for poly(l-lactide).

Claims

1. An implantable medical device, comprising: an expandable balloon having an outer surface,a polymer coated on at least a portion of the outer surface of the balloon,a pharmaceutically active agent dispersed within the polymer.

2. The device of claim 1, wherein the polymer is biodegradable.

3. The device of claim 1, wherein the polymer is chosen from poly(l-lactide), racemic polylactide, poly(l-lactide-co-glycolide), racemic poly(l-lactide-co-glycolide), poly(l-lactide-co-caprolactone poly(d,l-lactide-co-caprolactone), poly(l-lactide-co-trimethylene carbonate) and poly(d,l-lactide-co-trimethylene carbonate).

4. The device of claim 1, wherein the at least one polymer is chosen from polylactides.

5. The device of claim 2, wherein the pharmaceutically active agent is chosen from heparin, flavonoids, paclitaxel and its analogs, rapamycin and its analogs and benzopyran-4-one compounds.

6. The device of claim 1, wherein the device is selected from catheters and intraluminal devices.

7. The device of claim 5, wherein the concentration of the pharmaceutically active agent based on the surface area of the stent ranges from 0.1 to about 5 μg/mm2.

8. The device of claim 5, wherein the pharmaceutically active agent is a flavonoid selected from narigenin, naringin, eriodictyol, hesperetin, hesperidin (esperidine), kampferol, quercetin, rutin, cyanidol, meciadonol, catechin, epi-gallocatechin-gallate, taxifolin (dihydroquercetin), genistein, genistin, daidzein, biochanin, glycitein, chrysin, diosmin, luetolin, apigenin, tangeritin and nobiletin.

9. The device of claim 8 wherein the pharmaceutically active agent is genistein.

10. The device of claim 5 wherein the polymer is chosen from poly(l-lactide), racemic polylactide, poly(l-lactide-co-glycolide), racemic poly(l-lactide-co-glycolide), poly(l-lactide-co-caprolactone poly(d,l-lactide-co-caprolactone), poly(l-lactide-co-trimethylene carbonate) and poly(d,l-lactide-co-trimethylene carbonate).

11. The device of claim 10 wherein the polymer is a polylactide.

12. The device of claim 1 wherein the polymer contains an electrophilic group and the pharmaceutically active agent contains a nucleophilic group reactive with the electrophilic group to covalently bond the pharmaceutically active agent to the polymer.

13. Method of revascularizing a luminal passage in a subject comprising: selecting a catheter having an expandable balloon,coating the balloon with a selected polymer in which a selected pharmaceutically active agent is dispersed,routing the catheter through a predetermined length of the luminal passage,expanding the balloon at one or more selected positions along the predetermined length.

14. The method of claim 13 wherein the polymer is selected from poly(l-lactide), racemic polylactide, poly(l-lactide-co-glycolide), racemic poly(l-lactide-co-glycolide), poly(l-lactide-co-caprolactone poly(d,l-lactide-co-caprolactone), poly(l-lactide-co-trimethylene carbonate) and poly(d,l-lactide-co-trimethylene carbonate).

15. The method of claim 13 wherein the pharmaceutically active agent is selected from heparin, flavonoids, paclitaxel and its analogs, rapamycin and its analogs and benzopyran-4-one compounds.

16. The method of claim 15 wherein the pharmaceutically active agent is selected from heparin and genistein.

17. The method of claim 13 wherein the pharmaceutically active agent is covalently bonded to the polymer.