Method of coating a folded medical device
A non-polymeric or biological coating applied to a radially expandable interventional medical device in a collapsed, wrapped, or folded configuration. Properties of the coating material applied to the medical device are adjusted or varied to result in a desired combination of coverage of the surface of the medical device, drug loading, and coating thickness. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device.
1. A radially expandable medical device with a coating formed thereon, comprising:
a body having an interior and an exterior surface; and
a coating material applied to at least a portion of the exterior surface of the body when in a collapsed configuration with at least one fold to form a therapeutic coating;
wherein the coating is compositioned to transfer and adhere to a targeted tissue location; and
wherein the coating material comprises a non-polymeric bio-absorbable cross-linked gel component.
2. The device of claim 1 , wherein the medical device comprises a balloon.
3. The device of claim 1 , wherein the medical device comprises a balloon catheter or an angioplasty balloon.
4. The device of claim 1 , wherein the coating material is a viscous coating material which substantially covers the surface of the medical device.
5. The device of claim 1 , wherein the coating material is a viscous coating material which covers only a portion of the surface of the medical device.
6. The device of claim 1 , wherein the coating material has a viscosity between about 1 cPs and about 1,500 cPs.
7. The device of claim 1 , wherein the coating material has a viscosity between about 10,000 cPs and about 100,000 cPs.
8. The device of claim 1 , wherein the coating material has a viscosity of between about 1 cPs and about 100,000 cPs.
9. The device of claim 1 , wherein the coating material further comprises at least one therapeutic agent.
10. The device of claim 1 , wherein the coating material further comprises at least one therapeutic agent mixed with a solvent.
11. The device of claim 1 , wherein the coating is applied to the medical device subsequent to removal of solvent from the coating material.
12. The device of claim 1 , wherein the coating material further comprises a solvent subsequent to application to the medical device, wherein the solvent is removed prior to clinical use.
13. The device of claim 1 , wherein the non-polymeric bio-absorbable component is derived from an oil composition.
14. The device of claim 13 , wherein the oil composition comprises a fatty acid molecule or a glyceride.