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 comprising:
coating a medical disposable device having an expandable structure with a polymer coating including a poly(hydroxyethyl methacrylic) acid complexed with iodine and a substantially water-insoluble therapeutic agent;
introducing the medical disposable device into a body lumen;
expanding the expandable structure of the medical disposable device to contact the polymer coating against the body lumen, thereby delivering the substantially water-insoluble therapeutic agent to the body lumen; and
contracting the expandable structure.
2. The method of claim 1 , further comprising withdrawing a protective sheath from over the expandable structure prior to expanding the expandable structure.
3. The method of claim 1 , further comprising contacting the polymer coating against an atherosclerotic lesion or a restenotic lesion.
4. The method of claim 1 , wherein the substantially water-insoluble therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, and thrombolytic agents.
5. The method of claim 1 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
6. The method of claim 1 , wherein at least 50% of the polymer coating is dissolved within 180 seconds of expanding the expandable structure.
7. The method of claim 1 , wherein at least 90% of the polymer coating is dissolved within 300 seconds of expanding the expandable structure.
8. The method of claim 1 , wherein at least 5% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.
9. The method of claim 1 , wherein at least 25% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.
10. A method comprising:
coating a medical disposable device having an expandable structure with a polymer coating including a poly(hydroxyethyl methacrylic) acid, non-covalently bound iodine, and a substantially water-insoluble therapeutic agent;
introducing the medical disposable device into a body lumen;
expanding the expandable structure of the medical disposable device to contact the polymer coating against the body lumen, thereby delivering the substantially water-insoluble therapeutic agent to the body lumen; and
contracting the expandable structure.
11. The method of claim 10 , further comprising withdrawing a protective sheath from over the expandable structure prior to expanding the expandable structure.
12. The method of claim 10 , further comprising contacting the polymer coating against an atherosclerotic lesion or a restenotic lesion.
13. The method of claim 10 , wherein the substantially water-insoluble therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, and thrombolytic agents.
14. The method of claim 10 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
15. The method of claim 10 , wherein at least 50% of the polymer coating is dissolved within 180 seconds of expanding the expandable structure.
16. The method of claim 10 , wherein at least 90% of the polymer coating is dissolved within 300 seconds of expanding the expandable structure.
17. The method of claim 10 , wherein at least 5% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.
18. The method of claim 10 , wherein at least 25% of the substantially water-insoluble therapeutic agent contained in the polymer coating is imparted into tissue of the body lumen within one hour of contracting the expandable structure.