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 medical disposable device comprising:
an expandable structure having an outer surface; and
an amphiphilic polymer coating disposed on the outer surface of the expandable structure, said amphiphilic polymer coating comprising an amphiphilic polymer or co-polymer complexed with iodine and a hydrophobic therapeutic agent interdispersed in said amphiphilic polymer or co-polymer complexed with iodine;
wherein at least 90% of said amphiphilic polymer coating is dissolved within 300 seconds of expanding said expandable structure in vivo.
2. The medical disposable device of claim 1 , wherein said amphiphilic polymer or co-polymer is a non-ionizable thermoplastic.
3. The medical disposable device of claim 2 , wherein said amphiphilic polymer or co-polymer is selected from the group consisting of hydroxypropyl cellulose (HPC) and polyvinyl pyrrolidone (PVP).
4. The medical disposable device of claim 2 , wherein said amphiphilic polymer coating further comprises a plasticizer selected from the group consisting of polyethylene glycol with a molecular weight below 10 K Daltons, propylene glycol, triethyl citrate, glycerol, and dibutyl sebacate.
5. The medical disposable device of claim 2 , wherein said amphiphilic polymer coating further comprises a wax selected from the group consisting of bees wax, carnauba wax, polypropylene glycol, polydimethyl siloxane (PDMS), and PDMS derivatives.
6. The medical disposable device of claim 2 , wherein said hydrophobic 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.
7. The medical disposable device of claim 2 , wherein said hydrophobic therapeutic agent is selected from the group consisting of paclitaxel and dexamethasone acetate.
8. The medical disposable device of claim 2 , further comprising a sheath which is extendable over and retractable from said expandable structure.
9. The medical disposable device of claim 2 , wherein said expandable structure is a balloon of a balloon catheter.
10. A medical disposable device comprising:
an expandable structure having an outer surface; and
a coating disposed on the outer surface of the expandable structure, said coating consisting essentially of at least one amphiphilic polymer or co-polymer complexed with iodine and at least one hydrophobic therapeutic agent interdispersed in said at least one amphiphilic polymer or co-polymer complexed with iodine;
wherein at least 90% of said coating is dissolved within 300 seconds of expanding said expandable structure in vivo.
11. The medical disposable device of claim 10 , wherein said hydrophobic 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 medical disposable device of claim 10 , wherein said coating further comprises a plasticizer at a concentration of less than 20% wt of said at least one amphiphilic polymer or co-polymer complexed with iodine.
13. The medical disposable device of claim 10 , wherein said coating further comprises a wax at a concentration of less than 1% wt of said at least one amphiphilic polymer or co-polymer complexed with iodine.
14. The medical disposable device of claim 10 , wherein said expandable structure is a balloon of a balloon catheter.
15. A medical disposable device comprising:
an expandable structure having an outer surface; and
a coating layer disposed on the outer surface of the expandable structure, the coating layer comprising non-covalently bound iodine and a hydrophobic therapeutic agent interdispersed throughout an aggregate polymer matrix of the coating layer;
wherein the aggregate polymer matrix is dissolvable in both aqueous and non-aqueous solvents.
16. The medical disposable device of claim 15 , wherein the hydrophobic 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.
17. The medical disposable device of claim 15 , wherein the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel and dexamethasone acetate.
18. The medical disposable device of claim 15 , further comprising a sheath which is extendable over and retractable from the expandable structure.
19. The medical disposable device of claim 15 , wherein the expandable structure is a balloon of a balloon catheter.
20. The medical disposable device of claim 15 , wherein the coating layer further comprises a plasticizer.
21. The medical disposable device of claim 15 , wherein the coating layer further comprises a wax.