Local delivery of water-soluble or water-insoluble therapeutic agents to the surface of body lumens
View Patent ↗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 comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. 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 medical device coating comprising:
poly(hydroxyethyl methacrylic) acid complexed with iodine; and
a substantially water-insoluble therapeutic agent dispersed in the poly(hydroxyethyl methacrylic) acid complexed with the iodine.
2. The medical device coating of claim 1 , wherein the medical device coating is uniformly dissolvable in an aqueous solvent.
3. The medical device coating of claim 1 , wherein the poly(hydroxyethyl methacrylic) acid has a Mn molecular weight below 8 KD.
4. The medical device coating of claim 1 , wherein the poly(hydroxyethyl methacrylic) acid is co-polymerized with a monomer.
5. The medical device coating of claim 4 , wherein the monomer is glycidyl methacrylate.
6. The medical device coating of claim 4 , wherein the monomer is acrylic acid.
7. The medical device coating of claim 4 , wherein the co-polymer is a block co-polymer.
8. The medical device coating of claim 4 , wherein the co-polymer is a random co-polymer.
9. The medical device coating of claim 1 , wherein the iodine is present in the medical device coating at a weight ratio from 1 to 30% of the medical device coating dry weight.
10. The medical device coating of claim 1 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
11. The medical device coating of claim 1 , wherein the iodine and the substantially water-insoluble therapeutic agent are dispersed throughout the medical device coating.
12. The medical device coating of claim 1 , wherein the therapeutic agent is present at a density from about 0.1 to 10 μg/mm 2 .
13. A medical device coating comprising:
poly(hydroxyethyl methacrylic) acid; and
a substantially water-insoluble therapeutic agent and non-covalently bound iodine dispersed throughout the poly(hydroxyethyl methacrylic) acid.
14. The medical device coating of claim 13 , wherein the medical device coating is uniformly dissolvable in an aqueous solvent.
15. The medical device coating of claim 13 , wherein the poly(hydroxyethyl methacrylic) acid has a Mn molecular weight below 8 KD.
16. The medical device coating of claim 13 , wherein the poly(hydroxyethyl methacrylic) acid is co-polymerized with a monomer.
17. The medical device coating of claim 16 , wherein the monomer is selected from the group consisting of glycidyl methacrylate and acrylic acid.
18. The medical device coating of claim 13 , wherein the iodine is present in the medical device coating at a weight ratio from 1 to 30% of the medical device coating dry weight.
19. The medical device coating of claim 13 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
20. The medical device coating of claim 13 , wherein the therapeutic agent is present at a density from about 0.1 to 10 μg/mm 2 .