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 method of coating a catheter balloon comprising:
coating a catheter balloon with a coating solution comprising poly(HEMA), iodine, an organic solvent, and a substantially water-insoluble therapeutic agent; and
drying the catheter balloon to form a water soluble coating on the catheter balloon, wherein the poly(HEMA) is complexed with the iodine in the water soluble coating.
2. The method of claim 1 , wherein coating the catheter balloon with a coating solution comprises dip coating the catheter balloon in the coating solution.
3. The method of claim 1 , wherein the substantially water-insoluble therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.
4. The method of claim 3 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
5. The method of claim 1 , wherein the poly(HEMA) is prepared by atom transfer radical polymerization (ATRP) using a morpholine based initiator (ME-Br).
6. The method of claim 1 , wherein the poly(HEMA) has a Mn below 8 KD.
7. The method of claim 6 , wherein the poly(HEMA) has a Mn of approximately 7 KD.
8. The method of claim 1 , wherein the organic solvent is 2-propanol.
9. The method of claim 1 , wherein the coating solution comprises acetone.
10. The method of claim 1 , wherein the coating solution comprises propylene glycol.
11. A method of coating a catheter balloon comprising:
coating a catheter balloon with a coating solution comprising poly(HEMA), iodine, an organic solvent, and a substantially water-insoluble therapeutic agent; and
drying the catheter balloon to form a water soluble coating on the catheter balloon, wherein the iodine is non-covalently bound in the water soluble coating.
12. The method of claim 11 , wherein coating the catheter balloon with a coating solution comprises dip coating the catheter balloon in the coating solution.
13. The method of claim 11 , wherein the substantially water-insoluble therapeutic agent is selected from the group consisting of an anti-proliferative agent, anti-platelet agent, anti-inflammatory agent, anti-thrombotic agent, and thrombolytic agent.
14. The method of claim 11 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
15. The method of claim 11 , wherein the poly(HEMA) is prepared by atom transfer radical polymerization (ATRP) using a morpholine based initiator (ME-Br).
16. The method of claim 11 , wherein the poly(HEMA) has a Mn below 8 KD.
17. The method of claim 16 , wherein the poly(HEMA) has a Mn of approximately 7 KD.
18. The method of claim 11 , wherein the organic solvent is 2-propanol.
19. The method of claim 11 , wherein the coating solution comprises acetone.
20. The method of claim 11 , wherein the coating solution comprises propylene glycol.