ANTIMICROBIAL HEMOSTATIC DEVICES AND METHODS OF USE AND MAKING
The disclosure relates to an antimicrobial hemostatic device having a substrate configured to be in contact with a bleed, where the substrate includes a hemostatic agent, a biguanide based antimicrobial agent, or a pharmaceutically acceptable salt thereof, and a binder configured to maintain the hemostatic agent with the substrate. The disclosure further includes methods of making and using such devices.
1 . An antimicrobial hemostatic device, comprising:
a substrate configured to be in contact with a bleed, said substrate comprising:
a hemostatic agent,
a biguanide based antimicrobial agent, or a pharmaceutically acceptable salt thereof, and
a binder configured to maintain the hemostatic agent with the substrate.
2 . The device of claim 1 , wherein the binder is glycerin.
3 . The device of claim 1 , wherein the hemostatic agent is kaolin.
4 . The device of claim 1 , wherein the biguanide based antimicrobial agent is chlorhexidine (preferably chlorhexidine diacetate or chlorhexidine dichloride) or polyhexamethylene biguanide (PHMB).
5 . The device of claim 1 , wherein said substrate further comprises an effective amount of a silver-based antimicrobial.
6 . The device of claim 5 , wherein the silver-based antimicrobial is colloidal silver, silver chloride, silver sulfadiazine, or silver nitrate.
7 . The device of claim 1 , wherein said substrate further comprises an effective amount of an antimicrobial iodine compound.
8 . The device of claim 7 , wherein the antimicrobial iodine compound is povidone-iodine or cadexomer iodine.
9 . The device of claim 1 , wherein a clot time for the device is less than 180 seconds.
10 . The device of claim 9 , wherein the clot time for the device is less than 150 seconds.
11 . The device of claim 9 , wherein a clot time for the device is between 100 and 150 seconds.
12 . The device of claim 1 , wherein a weight ratio of the biguanide based antimicrobial agent to the hemostatic agent is less than 0.04.
13 . The device of claim 12 , wherein the weight ratio is between 0.04 and 0.001.
14 . The device of claim 13 , wherein the weight ratio is between 0.02 and 0.001.
15 . The device of claim 1 , wherein the substrate is a textile.
16 . The device of claim 15 , wherein the textile is a gauze, preferably polyester-rayon.
17 . The device of claim 1 , wherein the biguanide based antimicrobial agent is present in an amount of 1 ug/cm 2 to 300 ug/cm 2 , preferably 1 to 75, and most preferably 1 to 30.
18 . The device of claim 1 , wherein the substrate consists essentially of the hemostatic agent, the biguanide based antimicrobial agent, and the binder.
19 . The device of claim 1 , wherein the substrate consists of the hemostatic agent, the biguanide based antimicrobial agent, and the binder.
20 . The device of claim 1 , wherein the device at least one log reduction in growth compared to the untreated control, preferably greater than 2 log and most preferably greater than 4 log reduction in bacterial growth compared to an untreated (no antimicrobial agent) control.
21 . A method of controlling or lessening the severity of bleeding, comprising contacting the substrate of the medical device of claim 1 with a bleed.
22 . A method of preparing a device of claim 1 , comprising:
combining the hemostatic agent, biguanide based antimicrobial agent, and binder in a liquid carrier to form a composition;
dipping or spraying the substrate in the composition; and
drying the substrate after the dipping or spraying, preferably wherein drying is at a temperature less than 80° C.
23 . The method of claim 22 , further comprising sterilizing the substrate after drying with gamma radiation.