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. 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 method of manufacturing a hemostatic device comprising:
providing a hemostatic clay material;
providing a substrate; providing a high-G alginate salt;
applying the high-G alginate salt and hemostatic clay material to the substrate; crosslinking the high-G alginate salt using a crosslinking agent to provide a crosslinked binder;
wherein the hemostatic 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; and
wherein the crosslinked binder has an effect of immobilizing the hemostatic clay material on the substrate when exposed to blood.
2. The method of claim 1 , wherein the crosslinking agent is calcium chloride.
3. The method of claim 1 , further comprising rinsing the substrate to remove unbound components at a time after the high-G alginate salt and hemostatic clay material have been applied to the substrate.
4. The method of claim 1 , further comprising subjecting the substrate to a drying process at a time after the hemostatic clay material has been applied to the substrate to provide the hemostatic device.
5. The method of claim 1 , further comprising sterilizing the hemostatic device.
6. The method of claim 1 , wherein the high-G alginate salt is selected from the group consisting of high-G sodium alginate, high-G potassium alginate, and high-G ammonium alginate.
7. The method of claim 1 , wherein the high-G alginate salt comprises high-G sodium alginate.
8. The method of claim 7 , further comprising allowing a soluble portion of the high-G sodium alginate to remain on the substrate.
9. The method of claim 1 , wherein the substrate comprises at least one of the following: a gauze material, a woven material, a sponge, a sponge matrix, strands, fibers, or a foamed polymer.
10. The method of claim 1 , wherein the substrate is non-woven.
11. The method of claim 1 , wherein the substrate is woven.
12. The method of claim 1 , wherein the substrate comprises a woven fabric.
13. The method 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.
14. The method of claim 1 , wherein at least one of the high-G alginate salt and hemostatic clay material is applied to the substrate by a spraying process.
15. The method of claim 1 , wherein at least one of the high-G alginate salt and hemostatic clay material is applied to the substrate using a slot die.
16. The method of claim 1 , wherein at least one of the high-G alginate salt and hemostatic clay material is applied to the substrate using a roller.
17. The method of claim 1 , wherein at least one of the high-G alginate salt and hemostatic clay material is applied by immersing the substrate in a liquid comprising at least one of the high-G alginate salt and the hemostatic clay material.
18. The method of claim 1 , wherein the high-G alginate salt and the hemostatic clay material are mixed together in aqueous medium and are applied to the substrate together.
19. A method of making a hemostatic device comprising:
providing a high-G alginate salt solution comprising a high-G alginate salt;
providing a hemostatic clay material solution comprising a hemostatic clay material;
applying the high-G alginate salt and the hemostatic clay material to a substrate crosslinking the high-G alginate salt using a crosslinking agent to provide a crosslinked binder;
subjecting the substrate to a drying process;
wherein the crosslinked binder has an effect of substantially retaining the hemostatic clay material on the substrate when immersed in fluids including saline and water; and
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 contact with blood to assist in accelerating clotting.
20. The method of claim 19 , further comprising providing 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.
21. The method of claim 19 , 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.
22. The method of claim 19 , 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.
23. The method of claim 19 , further comprising disposing a release agent on the hemostatic device.