Hemostatic devices
View Patent ↗Hemostatic devices for promoting blood clotting can include a substrate (e.g., gauze, textile, sponge, sponge matrix, one or more fibers, etc.), a hemostatic material disposed thereon such as kaolin clay, and a binder material such as crosslinked calcium alginate with a high guluronate monomer molar percentage disposed on the substrate to substantially retain the hemostatic material material. When the device is used to treat a bleeding wound, at least a portion of the clay material comes into contact with blood to accelerate clotting. Moreover, when exposed to blood, the binder has low solubility and retains a majority of the clay material on the gauze. A bandage that can be applied to a bleeding wound to promote blood clotting includes a flexible substrate and a gauze substrate mounted thereon.
1. A hemostatic device comprising:
a substrate;
a hemostatic clay material; and
a water-insoluble crosslinked binder configured to immobilize the hemostatic clay material on the substrate such that the hemostatic clay material does not separate from the substrate in the presence of water;
wherein a bindin a ent and the hemostatic cla material are a S. lied to the substrate and the binding agent is thereafter crosslinked on the substrate to provide the water-insoluble crosslinked binder;
wherein the hemostatic device is subjected to a drying process;
wherein the crosslinked binder is not substantially dissolved by blood;
wherein the device is configured such that when treating bleeding, application of the device is capable of causing blood to be absorbed into the substrate and causing at least a portion of the hemostatic clay material to come into direct contact with blood to assist in accelerating clotting.
2. The hemostatic device of claim 1 , wherein the water-insoluble crosslinked binder includes covalent crosslinks.
3. The hemostatic device of claim 1 , wherein the water-insoluble crosslinked binder includes ionic crosslinks.
4. The hemostatic device of claim 1 , wherein the water-insoluble crosslinked binder includes ionic and covalent crosslinks.
5. The hemostatic device of claim 1 , wherein the substrate comprises at least one of the following: a gauze material, a woven material, a sponge, a sponge matrix, woven fabric, non-woven fabric, or a foamed polymer.
6. The hemostatic device of claim 1 , further comprising a pharmaceutically-active composition selected from the group consisting of antibiotics, antifungal agents, antimicrobial agents, anti-inflammatory agents, analgesics, antihistamines, compounds containing silver or copper ions, and combinations of the foregoing compositions.
7. The hemostatic device of claim 1 , wherein the substrate comprises a material selected from the group consisting of cotton, silk, wool, plastic, cellulose, rayon, polyester, polyurethane, polyethylene foam, PHEMA foam, polyacrylic acid foam, low-density polyether, polyvinyl alcohol, polyhydroxybutyrate methyl methacrylate, poly methylmethacrylate, or combinations of the foregoing.
8. The hemostatic device of claim 1 , wherein the substrate is flexible to allow the substrate to form to a shape of the bleeding wound and to retain a shape of the bleeding wound.
9. The hemostatic device of claim 1 , wherein the binding agent is applied to the substrate by a spraying process.
10. The hemostatic device of claim 1 , wherein the binding agent is applied to the substrate by immersing the substrate in a liquid comprising the binding agent.
11. The hemostatic device of claim 1 , wherein the binding agent is applied to the substrate using a roller.
12. A hemostatic device comprising:
a substrate;
a hemostatic clay material disposed on at least one side of the substrate; and
a water-insoluble high-G crosslinked binder configured to entrap the hemostatic clay material on the substrate such that the hemostatic clay material does not separate from the substrate in the presence of water;
wherein the hemostatic device is subjected to a drying process;
wherein the binder has an effect of substantially retaining the hemostatic clay material on the substrate when exposed to blood;
wherein the device is configured such that when treating bleeding, application of the device is capable of causing blood to be absorbed into the substrate and causing at least a portion of the hemostatic clay material to come into direct contact with blood to assist in accelerating clotting.
13. The hemostatic device of claim 12 , wherein the substrate comprises at least one of the following: a gauze material, a woven material, a sponge, a sponge matrix, woven fabric, non-woven fabric, or a foamed polymer.
14. A method of manufacturing a hemostatic device comprising:
providing a high-G alginate;
providing a hemostatic clay material;
providing a fabric substrate distinct from the high-G alginate; and
applying the high-G alginate and hemostatic clay material to the fabric substrate;
wherein the resulting hemostatic device is not stiff such that the hemostatic device can readily conform to, be packed within, and/or wrapped around a wound surface or wound cavity;
wherein the hemostatic device is configured such that, when treating bleeding, application of the device is capable of causing at least a portion of the hemostatic clay material to come into direct contact with blood to assist in accelerating clotting.
15. The method of claim 14 , further comprising crosslinking the high-G alginate onto the fabric substrate using a crosslinking agent to provide a crosslinked binder, wherein the crosslinked binder has an effect of substantially retaining the hemostatic clay material on the fabric substrate when exposed to blood.
16. The method of claim 15 , wherein the crosslinking agent is calcium chloride.
17. The method of claim 14 , further comprising rinsing the fabric substrate to remove unbound components at a time after the high-G alginate and hemostatic clay material have been applied to the fabric substrate.
18. The method of claim 14 , further comprising subjecting the fabric substrate to a drying process at a time after the hemostatic clay material has been applied to the fabric substrate to provide the hemostatic device.
19. The method of claim 14 , further comprising sterilizing the hemostatic device.
20. The method of claim 14 , wherein the high-G alginate is selected from the group consisting of high-G sodium alginate, high-G potassium alginate, and high-G ammonium alginate.
21. The method of claim 14 , wherein the high-G alginate comprises high-G sodium alginate.
22. The method of claim 21 , further comprising allowing a soluble portion of the high-G sodium alginate to remain on the fabric substrate.
23. The method of claim 14 , wherein glycerol is applied to the fabric substrate.