Implantable medical device coatings with biodegradable elastomer and releasable taxane agent
View Patent ↗A coated medical device, such as a stent, that elutes a taxane agent in a controlled manner is provided. In one embodiment, the taxane agent is paclitaxel and at least a portion of the paclitaxel is present in a dihydrate solid form. The medical device may be coated with a layer including a taxane agent and a layer of bioabsorbable elastomer over the layer including the taxane agent. Methods of manufacturing and using the coated medical device are also provided.
1. A coated implantable medical device comprising a coating configured to release a taxane agent adhered to a surface of the medical device, the coating comprising:
a first layer comprising a taxane agent, wherein the taxane agent is paclitaxel comprising at least one of amorphous paclitaxel and anhydrous paclitaxel and at least 40% dihydrate paclitaxel; and
a second layer positioned over the first layer and comprising biodegradable elastomer, the biodegradable elastomer having a molecular weight of 50-500 kDa, and being present in an amount between 1 and 20 times the weight of the therapeutic agent in the first layer.
2. The coated implantable medical device of claim 1 , wherein the biodegradable elastomer is poly(lactic acid).
3. The coated implantable medical device of claim 1 , wherein the taxane agent comprises at least 60% dihydrate paclitaxel.
4. The coated implantable medical device of claim 1 comprising a radially-expandable vascular stent.
5. A coated implantable medical device comprising a coating configured to release a taxane agent adhered to a surface of the medical device, the coating comprising:
a first layer comprising a taxane agent, wherein the taxane agent is paclitaxel comprising at least one of amorphous paclitaxel and anhydrous paclitaxel and at least 20% dihydrate paclitaxel; and
a second layer positioned over the first layer and comprising a biodegradable elastomer, the biodegradable elastomer being present in an amount between 1 and 20 times the weight of the taxane agent in the first layer.
6. The coated implantable medical device of claim 5 , wherein the dihydrate paclitaxel comprises at least 40% of the taxane agent.
7. The coated implantable medical device of claim 6 , wherein the dihydrate paclitaxel comprises at least 60% of the taxane agent.
8. The coated implantable medical device of claim 5 , wherein the biodegradable elastomer is poly(lactic acid).
9. A coated implantable medical device comprising a coating configured to release a taxane agent adhered to a surface of the medical device, the coating comprising:
a first layer comprising paclitaxel in a first solid form and a second solid form, wherein the first solid form is dihydrate paclitaxel, wherein the second taxane solid form is selected from the group consisting of amorphous paclitaxel and anhydrous paclitaxel, and wherein at least 10% of the paclitaxel is in the first solid form; and
a second layer positioned over the first layer and comprising a biodegradable elastomer, the biodegradable elastomer having a molecular weight of 50-500 kDa, and being present in an amount between 1 and 20 times the weight of the therapeutic agent in the first layer.
10. The coated implantable medical device of claim 9 , wherein the biodegradable elastomer is poly(lactic acid).
11. The coated implantable medical device of claim 9 , wherein the coated implantable medical device is a balloon.
12. The coated implantable medical device of claim 9 , wherein the paclitaxel comprises at least 20% dihydrate paclitaxel.
13. The coated implantable medical device of claim 12 , wherein the paclitaxel comprises at least 40% dihydrate paclitaxel.
14. The coated implantable medical device of claim 13 , wherein the paclitaxel comprises at least 60% dihydrate paclitaxel.
15. The coated implantable medical device of claim 14 , wherein the paclitacel comprises at least 80% dihydrate paclitaxel.
16. The coated implantable medical device of claim 1 , wherein the coated implantable medical device is a balloon.
17. The coated implantable medical device of claim 16 , wherein the balloon is for use in the peripheral arteries.
18. The coated implantable medical device of claim 17 , wherein the balloon is for use in the superficial femoral artery.
19. The coated implantable medical device of claim 1 , wherein the coated implantable medical device is a radially-expandable vascular stent for use in the peripheral arteries.
20. The coated implantable medical device of claim 19 , wherein the radially-expandable vascular stent is for use in the superficial femoral artery.