Medical device coating process
View Patent ↗Methods for coating medical devices for implantation within a body vessel are provided comprising providing a cylindrical container, placing a medical device inside the cylindrical container, and applying a polymer in liquid form inside the container.
1. A method of forming a coating on an abluminal surface of an implantable medical device, comprising the steps of:
providing a cylindrical container having a longitudinal axis and an inner surface;
placing the medical device comprising a lumen inside and co-axially aligned with the cylindrical container;
rotating the cylindrical container about the longitudinal axis, the cylindrical container positioned such that the longitudinal axis is horizontal;
applying a first polymer in liquid form inside the cylindrical container;
at least partially solidifying the first polymer while rotating: and
expanding the medical device such that the abluminal surface of the medical device contacts the inner surface of the cylindrical container.
2. The method of claim 1 , further comprising applying the first polymer in liquid form to the lumen of the medical device to thereby form a coating on the lumen.
3. The method of claim 2 , further comprising:
applying a second polymer in liquid form on the luminal surface of the cylindrical container;
at least partially solidifying the second polymer while rotating to form an abluminal coating layer; and
inserting the medical device inside the cylindrical container, wherein an abluminal surface of the medical device is in contact with the abluminal coating layer.
4. The method of claim 1 , further comprising
applying the first polymer in liquid form on the luminal surface of the cylindrical container, wherein partially solidifying the first polymer while rotating forms an abluminal coating layer; and
inserting the medical device inside the cylindrical container, wherein an abluminal surface of the medical device is in contact with the abluminal coating layer.
5. The method of claim 2 , wherein the first polymer comprises a polyurethane urea.
6. The method of claim 2 , wherein the first polymer comprises a polyetherurethane urea blended with a siloxane containing surface modifying additive.
7. The method of claim 2 , wherein the first polymer comprises a base polymer and about 0.5% to about 5% by weight of a surface modifying additive based on the weight of the base polymer;
where the surface modifying additive comprises polydimethylsiloxane and the reaction product of diphenylmethane diisocyanate and 1,4-butanediol; and
where the base polymer is a polyetherurethane urea comprising polytetramethylene oxide and the reaction product of 4,4′-diphenylmethane diisocyanate and ethylene diamine.
8. The method of claim 3 , wherein the second polymer comprises a polyurethane urea.
9. The method of claim 3 , wherein the second polymer comprises a polyetherurethane urea blended with a siloxane containing surface modifying additive.
10. The method of claim 3 , wherein the second polymer comprises a base polymer and about 0.5% to about 5% by weight of a surface modifying additive based on the weight of the base polymer;
where the surface modifying additive comprises polydimethylsiloxane and the reaction product of diphenylmethane diisocyanate and 1,4-butanediol; and
where the base polymer is a polyetherurethane urea comprising polytetramethylene oxide and the reaction product of 4,4′-diphenylmethane diisocyanate and ethylene diamine.
11. The method of claim 1 , wherein the medical device comprises a graft, stent, or ring.
12. The method of claim 1 , further comprising applying a first bioactive agent to the medical device.
13. The method of claim 12 , wherein the first bioactive agent is an antithrombogenic agent, antiplatelet agent, immunosuppressant agent, antiproliferative agent, fibrolytic agent, or antibacterial.
14. The method of claim 12 , further comprising admixing the first bioactive agent with the first polymer in liquid form.
15. The method of claim 12 , further comprising applying a first bioactive agent in contact with the polymer.
16. The method of claim 3 , further comprising applying a second bioactive agent in contact with the second polymer.
17. The method of claim 4 , further comprising applying a second bioactive agent in contact with the first polymer.
18. The method of claim 17 , wherein the second bioactive agent is an antithrombogenic agent, antiplatelet agent, immunosuppressant agent, antiproliferative agent, fibrolytic agent, or antibacterial.
19. The method of claim 1 , further comprising the steps
placing the cylindrical container on a bed of rollers; and
rotating the bed of rollers.
20. The method of claim 4 , further comprising the separating the medical device comprising the abluminal coating layer from the cylindrical container.