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 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 is 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 delivering a substantially water-insoluble therapeutic agent to a vascular lumen comprising: providing a catheter assembly having a non-durable coating disposed on an outer surface of an expandable structure of the catheter assembly, wherein the non-durable polymer coating is complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein; introducing the catheter assembly into a vascular lumen; expanding the expandable structure of the catheter assembly to contact the non-durable coating against the vascular lumen; and contracting the expandable structure.
2. 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.
3. The method of claim 2 , wherein at least 50% of the non-durable coating is dissolved within 180 seconds of the expanding.
4. The method of claim 3 , wherein at least 90% of the non-durable coating is dissolved within 300 seconds of the expanding.
5. The method of claim 2 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
6. The method of claim 5 , wherein at least 5% of the therapeutic agent contained in the non-durable coating is imparted into tissue of the vascular lumen within one hour of contracting the expandable structure.
7. The method of claim 6 , wherein at least 25% of the therapeutic agent contained in the non-durable coating is imparted into tissue of the vascular lumen within one hour of contracting the expandable structure.
8. The method of claim 1 , wherein the iodine is complexed with a polymer selected from the group consisting of polyethylene glycol (PEG), polyvinyl pyrrolidone (PVP) and hydroxypropyl cellulose (HPC) in the non-durable coating.
9. The method of claim 1 , wherein the iodine is complexed with a polymer selected from the group consisting of methyl cellulose and hydroxypropyl methylcellulose, or a co-polymer of N-vinylpyrrolidone with a reactive double bond containing monomer.
10. A method of delivering a substantially water-insoluble therapeutic agent to a vascular lumen comprising:
providing a catheter assembly having a non-durable coating disposed on an outer surface of an expandable structure of the catheter assembly, wherein the non-durable coating comprises a substantially water-insoluble therapeutic agent dispersed amongst non-covalently bound iodine within a polymer matrix;
introducing the catheter assembly into a vascular lumen;
expanding the expandable structure of the catheter assembly to contact the non-durable coating against the vascular lumen; and
contracting the expandable structure.
11. The method of claim 10 , 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.
12. The method of claim 11 , wherein at least 50% of the non-durable coating is dissolved within 180 seconds of the expanding.
13. The method of claim 12 , wherein at least 90% of the non-durable coating is dissolved within 300 seconds of the expanding.
14. The method of claim 11 , wherein the substantially water-insoluble therapeutic agent is paclitaxel.
15. The method of claim 14 , wherein at least 5% of the therapeutic agent contained in the non-durable coating is imparted into tissue of the vascular lumen within one hour of contracting the expandable structure.
16. The method of claim 15 , wherein at least 25% of the therapeutic agent contained in the non-durable coating is imparted into tissue of the vascular lumen within one hour of contracting the expandable structure.
17. The method of claim 10 , wherein the polymer matrix comprises a polymer selected from the group consisting of polyethylene glycol (PEG), polyvinyl pyrrolidone (PVP) hydroxypropyl cellulose (HPC), methyl cellulose and hydroxypropyl methylcellulose, or a co-polymer of N-vinylpyrrolidone with a reactive double bond containing monomer.
18. The method of claim 10 , wherein paclitaxel is dispersed amongst non-covalently bound iodine within a polymer matrix comprising polyethylene glycol (PEG).
19. The method of claim 10 , further comprising withdrawing a protective sheath from over the expandable structure prior to expanding the expandable structure.
20. The method of claim 10 , further comprising contacting the non-durable coating against an atheroscolerotic or restenotic lesion.