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 water-soluble or water-insoluble therapeutic agents to the surface 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 an amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer. The medical disposable device is inserted into a body lumen, and expanded to contact the amphiphilic polymer coating against the body lumen. The total solubility of the polymer or co-polymer in vivo prevents any embolic hazard associated with the amphiphilic polymer coating.
1. A method of coating a medical disposable device comprising:
preparing a first solution comprising a water-insoluble drug, a first lower alcohol, and acetone;
preparing a second solution comprising a second lower alcohol, non-covalently bound iodine, and an amphiphilic polymer;
mixing the first and second solutions to form a coating solution; and
dip coating an expandable structure of a medical disposable device in the coating solution to form a non-durable coating on the expandable structure,
wherein the non-covalently bound iodine is complexed with the amphiphilic polymer and the water-insoluble drug is dispersed throughout the non-durable coating.
2. The method of claim 1 , wherein preparing the second solution comprises dissolving the non-covalently bound iodine in the second lower alcohol, and then adding the amphiphilic polymer.
3. The method of claim 2 , further comprising agitating and heating the second solution until the amphiphilic polymer dissolves.
4. The method of claim 1 , wherein the first lower alcohol comprises ethanol.
5. The method of claim 1 , wherein the second lower alcohol comprises 2-propanol.
6. The method of claim 1 , wherein the water-insoluble drug to amphiphilic polymer weight ratio is 25 to 100%.
7. The method of claim 1 , wherein the water-insoluble drug is paclitaxel.
8. The method of claim 1 , further comprising treating the expandable structure of the medical disposable device in an argon plasma prior to dip coating.
9. The method of claim 1 , wherein the amphiphilic polymer is polyvinylpyrrolidone.
10. The method of claim 1 , wherein the amphiphilic polymer is hydroxypropyl cellulose.
11. The method of claim 1 , wherein dip coating comprises extracting the expandable structure of the medical disposable device from the coating solution at a rate of 0.05 to 0.4 in/min.
12. A method of coating a medical disposable device comprising:
preparing a coating solution comprising a water-insoluble drug, non-covalently bound iodine, an amphiphilic polymer or co-polymer, and a solvent including acetone; and
applying the coating solution to an expandable structure of a medical disposable device to form a non-durable coating on the expandable structure;
wherein the non-covalently bound iodine is complexed with the amphiphilic polymer and the water-insoluble drug is dispersed throughout the amphiphilic polymer or co-polymer in the non-durable coating.
13. The method of claim 12 , wherein the solvent comprises an alcohol.
14. The method of claim 13 , wherein the alcohol is ethanol.
15. The method of claim 12 , further comprising expanding the expandable structure prior to applying the coating solution.
16. The method of claim 12 , wherein the drug is paclitaxel.
17. The method of claim 12 , further comprising treating the expandable structure of the medical disposable device in an argon plasma prior to applying the coating solution.
18. The method of claim 12 , wherein the amphiphilic polymer is selected from the group consisting of polyvinylpyrrolidone and hydroxypropyl cellulose.
19. The method of claim 12 , wherein applying the coating solution comprises dip coating.
20. The method of claim 19 , wherein dip coating comprises extracting the expandable structure of the medical disposable device from the coating solution at a rate of 0.05to 0.4 in/min.
21. A method of coating a medical disposable device comprising:
preparing a first solution comprising a water-insoluble drug, a first lower alcohol, and acetone;
preparing a second solution comprising a second lower alcohol different from the first lower alcohol, non-covalently bound iodine, and an amphiphilic polymer;
mixing the first and second solutions to form a coating solution; and
dip coating an expandable structure of a medical disposable device in the coating solution to form a non-durable coating on the expandable structure.