Coatings for medical devices
A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which includes an amphiphilic polymer or copolymer, in embodiments polyethylene glycol, having a substantially water-insoluble therapeutic agent dispersed therein. In some embodiments, the coating may also include iodine. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.
1. A catheter assembly for insertion into the vasculature comprising:
a balloon having an outer surface; and
a coating disposed on the outer surface of the balloon, wherein the coating comprises;
an amphiphilic polymer matrix;
a therapeutic agent dispersed throughout the polymer matrix; and
iodine,
wherein a ratio of the amphiphilic polymer matrix to the therapeutic agent to the iodine is about 50:45:5 to about 70:25:5,
wherein the coating has a thickness from about 0.01 μm to about 10 μm and a therapeutic agent density of from about 0.1 μg/mm 2 to about 1.5 μg/mm 2 .
2. The catheter assembly of claim 1 , wherein the polymer matrix comprises a polymer selected from the group consisting of polyethylene glycol, polyvinyl pyrrolidone and hydroxypropyl cellulose.
3. The catheter assembly of claim 1 , wherein the therapeutic agent is paclitaxel.
4. The catheter assembly of claim 1 , wherein the polymer matrix comprises polyethylene glycol.
5. The catheter assembly of claim 4 , wherein the polyethylene glycol has a molecular weight of 1.5 KD to 50 KD.
6. The catheter assembly of claim 1 , wherein the coating has a therapeutic agent density of from about 0.25 μg/mm 2 to about 0.8 μg/mm 2 .
7. A catheter assembly for insertion into the vasculature comprising:
a balloon having an outer surface;
an amphiphilic coating comprising:
a polymer matrix complexed with iodine disposed on the outer surface of the balloon; and
a therapeutic agent dispersed in the matrix complexed with the iodine,
wherein a ratio of the polymer matrix to the therapeutic agent to the iodine is about 50:45:5 to about 70:25:5,
wherein the amphiphilic coating has a thickness from about 0.01 μm to about 10 μm and a therapeutic agent density of from about 0.1 μg/mm 2 to about 1.5 μg/mm 2 .
8. The catheter assembly of claim 7 , wherein the iodine is complexed with polyethylene glycol, polyvinyl pyrrolidone, or hydroxypropyl cellulose.
9. The catheter assembly of claim 7 , wherein the therapeutic agent is paclitaxel.
10. The catheter assembly of claim 7 , wherein the polymer matrix comprises polyethylene glycol.
11. The catheter assembly of claim 10 , wherein the polyethylene glycol has a molecular weight of 1.5 KD to 50 KD.
12. The catheter assembly of claim 7 , wherein the coating has a therapeutic agent density of from about 0.25 μg/mm 2 to about 0.8 μg/mm 2 .
13. A catheter assembly for insertion into the vasculature comprising:
a balloon having an outer surface;
an amphiphilic coating disposed on the outer surface of the balloon, the amphiphilic coating comprising:
polyethylene glycol
a therapeutic agent comprising paclitaxel dispersed throughout the polyethylene glycol; and
iodine,
wherein a ratio of the polymer matrix to the therapeutic to the iodine is about 50:45:5 to about 70:25:5,
wherein the amphiphilic coating has a therapeutic agent density of from about 0.1 μg/mm 2 to about 1.5 μg/mm 2 , and
wherein the amphiphilic coating has a thickness from about 0.01 μm to about 10 μm.
14. The catheter assembly of claim 1 , wherein the polymer matrix comprises at least one amphiphilic polymer.
15. The catheter assembly of claim 1 , wherein the polymer matrix comprises at least one amphiphilic copolymer.
16. The catheter assembly of claim 7 , wherein the polymer matrix comprises at least one amphiphilic polymer.
17. The catheter assembly of claim 7 , wherein the polymer matrix comprises at least one amphiphilic copolymer.