Haemostatic material
The present invention relates to a haemostatic material comprising a carrier layer and a material for wound contact comprising at least one haemostat in particulate, granular, powder, flake or short fibrous form. Such a haemostatic material is useful, for example, in reducing or stopping bleeding of a physiological target site in a person or animal, and can also be used to stem bleeding during medical procedures.
1. A haemostatic material comprising:
a carrier layer comprising a non-woven material, woven gauze, a film, a foam or a sheet gel, and
a wound contact layer being a single layer comprising a mixture of at least one haemostat and an adhesive, the wound contact layer being bonded directly to the carrier layer,
wherein the at least one haemostat is in a form selected from the group consisting of: particulate, granular, powder, flake, and short fibrous, wherein said haemostat comprises a chitosan salt, and
wherein the haemostat or adhesive is sufficiently water sensitive to weaken the bond between the haemostat and the adhesive upon contact with a fluid, such that when the wound contact layer is wet with blood a portion of the haemostat will remain at the wound site if the carrier layer is removed.
2. A haemostatic material according to claim 1 wherein both surfaces of the carrier layer are at least partially coated with haemostat.
3. A haemostatic material according to claim 1 further comprising a material which is degradable in the body.
4. A haemostatic material according to claim 1 wherein the haemostat comprises two or more haemostats.
5. A haemostatic material according to claim 1 , comprising wound contact layer on an upper and lower surface of the carrier layer.
6. A haemostatic material according to claim 1 , further comprising a soluble, dispersible or removable retaining layer on top of the wound contact layer.
7. A haemostatic material according to claim 6 , wherein the soluble, dispersible or removable retaining layer is formed from a material susceptible to metabolisation within a human or animal body.
8. A haemostatic material according to claim 1 , wherein the chitosan salt comprises one or more salts selected from the group consisting of chitosan acetate, chitosan lactate, chitosan succinate, chitosan malate, and chitosan acrylate.
9. A haemostatic material according to claim 8 , wherein the chitosan salt comprises chitosan succinate.
10. A haemostatic material according 1 wherein the chitosan salt constitutes at least about 5% by weight of the haemostat.
11. A haemostatic material according to claim 1 , wherein the haemostat is granular.
12. A haemostatic material according to claim 1 further comprising a medical surfactant.
13. A haemostatic material according to claim 12 , wherein the medical surfactant constitutes from about 0.001 to about 10% by weight of the haemostat.
14. A haemostatic material according to claim 12 wherein the medical surfactant comprises one or more components selected from the group consisting of block copolymers based on ethylene oxide and propylene oxide, fatty acids, fatty acid salts, silicone based surfactants and emulsifiers.
15. A haemostatic material according to claim 14 , wherein the medical surfactant is a fatty acid selected from lauric acid and oleic acid.
16. A haemostatic material according to claim 1 further comprising at least one inert material.
17. A haemostatic material according to claim 16 , wherein the at least one inert material comprises one or more selected from the group consisting of cellulose, fumed silica, sand, clay, alginate, microcrystalline cellulose, oxidised regenerated cellulose, polyethylglycol, guar gum, xanthan gum, chitosan, chitosan derivatives, chitin, sucrose, lactose, pectin, carboxymethylcellulose, ground corn meal, collagen, gelataine, polyvinylalcohol, acrylic acid, acrylate (co)polymers, crosslinked acrylic acid-based polymers, barium sulphate, clay, lactose, sucrose, starch, and combinations of any two or more thereof.
18. A haemostatic material according to claim 16 wherein the inert material constitutes up to about 95% by weight of the haemostat.
19. A haemostatic material according to claim 1 wherein the haemostat comprises particles which cannot pass through a 200 mesh sieve.
20. A haemostatic material according to claim 1 wherein the adhesive layer comprises a bonding agent wherein the bonding agent is a meltable material.
21. A haemostatic material according to claim 1 wherein the carrier layer is degradable in a human or animal body.
22. A haemostatic material according to claim 1 wherein the carrier layer comprises a viscose non-woven material.
23. A haemostatic material according to claim 1 wherein the carrier layer comprises a material selected from the group consisting of woven gauze, a film, foam, and a sheet gel.
24. A haemostatic material according to claim 12 wherein the particle size of the haemostat and the particle size of the medical surfactant are equivalent.
25. A haemostatic material according to claim 1 wherein the haemostat has a pH of from about 3.5 to about 8.0.
26. A haemostatic material according to claim 1 further comprising an absorbent layer.
27. A haemostatic material according to claim 1 wherein the material comprises part of a first aid plaster.
28. A haemostatic material according to claim 1 wherein the material further comprises a quantity of a substance which is opaque to X-rays.
29. A haemostatic wound dressing comprising:
a dressing and
a haemostatic material comprising
a carrier layer comprising a non-woven material, woven gauze, a film, a foam or a sheet gel, and
a wound contact layer being a single layer comprising a mixture of at least one haemostat and an adhesive, the wound contact layer being bonded directly to the carrier layer,
wherein the at least one haemostat is in a form selected from the group consisting of: particulate, granular, powder, flake, and short fibrous,
wherein said haemostat comprises a chitosan salt, and wherein the haemostat or adhesive is sufficiently water sensitive to weaken the bond between the haemostat and the adhesive upon contact with a fluid, such that when the wound contact layer is wet with blood a portion of the haemostat will remain at the wound site if the carrier layer is removed.
30. A haemostatic material according to claim 1 , wherein the chitosan salt is of an organic acid.
31. A haemostatic material for application to a wound site, comprising:
a carrier layer comprising a non-woven material having an upper surface and a lower surface; and
a haemostatic wound contact layer adhered to the upper surface of said carrier layer,
said haemostatic wound contact layer comprising a mixture of chitosan salt haemostat and a bonding agent, said mixture being applied directly to said upper surface of said carrier layer by heat, said wound contact layer being a single layer,
said chitosan salt haemostat being provided in a physical form selected from the group consisting of powder, particulate, granular, flake and fiber,
said bonding agent being provided in a granular form, said bonding agent being at least partially water soluble,
wherein said haemostat and said bonding agent are mixed together prior to application to said carrier material, scatter coated onto said carrier material, and adhered to said carrier material by heat thus forming a water soluble wound contact layer on said upper surface of said carrier material,
said wound contact layer being sufficiently water sensitive to weaken the adhesive bonds when the wound contact layer is wet thus releasing the haemostat from the wound contact layer for therapeutic effect and whereby at least a portion of the haemostat remains in the wound when the carrier layer is removed.