Enhanced formulations for coating medical devices
Provided are formulations and related methods, for coating or impregnating a medical device, as well as a coated or impregnated medical device, for example, a device that is a catheter or cannula, where a different formulation may be used for interior surface of device and for exterior surface of the device.
1. A method of coating a medical device, the method comprising the steps of:
coating an interior of the medical device with a first solution consisting of:
methyl-ethyl-ketone (50-70%); methanol (10-20%); acetone (15-25%);
chlorhexidine diacetate (1%); and chlorhexidine free base (1%); and
coating an exterior of the medical device with a second solution consisting of:
tetrahydrofuran (THF) (70-90% by weight); methanol (5-15%); polyurethane (1-15%); chlorhexidine diacetate (1%); and chlorhexidine free base (1%), wherein the medical device does not comprise triclosan, silver salt, or zinc and the medical device does not further comprise an anti-thrombogenic agent and, wherein in use and with continued residence in a subject for at least one week, thrombogenesis occurs at a reduced rate of thrombus formation, wherein the reduced rate is tested by comparing the rate (X thrombi/week) of thrombus formation associated with said medical device, with the rate (Y thrombi/week) of thrombus formation associated with a corresponding medical device that does is not coated or impregnated with chlorhexidine, wherein X is less than 70% of Y.
2. The method according to claim 1 , wherein X is selected from one of less than 90% of Y, and less than 80% of Y.
3. The method according to claim 1 , wherein the medical device comprises one or more of a catheter, cannula, introducer, dilator, or sheath.
4. The method according to claim 3 , wherein the medical device has a burst pressure that is selected from at least 250, at least 260, at least 270, at least 280, at least 290, and at least 300 pounds per square inch (psi).
5. The method according to claim 3 , wherein the medical device has an internal volume portion having a concentration of chlorohexidine that ranges from at least 5 uM.