# US 9,750,843 B2 · Haemostatic material

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- Number: US 9,750,843 B2
- Document ID: US9750843B2
- Status: Granted
- Kind: B2
- Application number: 12/988,332
- Filed: 2009-04-27
- Published: 2011-03-03
- Granted: 2017-09-05
- Earliest claimed: 2008-04-25
- Assignees: Medtrade Products Limited
- Applicants: Craig Hardy; Andrew Darby; Guy Eason
- Inventors: Craig Hardy; Andrew Darby; Guy Eason
- Web page: https://patentgrep.com/patent/US9750843B2

## CPC

- A61L 26/0023: {Polysaccharides}
- A61F 13/0243: {characterised by the properties of the skin contacting layer, e.g. air-vapor permeability}
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 31/722: Chitin, chitosan
- A61L 15/28: Polysaccharides or their derivatives {(A61L15/225 takes precedence)}
- A61L 15/42: Use of materials characterised by their function or physical properties (liquid bandages A61L26/00)
- A61L 15/44: Medicaments
- A61L 15/48: Surfactants
- A61L 15/58: Adhesives
- A61L 15/62: {Compostable,} hydrosoluble or hydrodegradable materials
- A61L 26/0061: {Use of materials characterised by their function or physical properties}
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61F 2013/00463: {haemostatic}
- A61F 2013/00604: {Multilayer}
- A61F 2013/00655: {adhesive}
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2300/608: having two or more layers
- A61L 2400/04: Materials for stopping bleeding
- Y10T 156/10: Methods of surface bonding and/or assembly therefor
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

A haemostatic material according to claim 1 wherein both surfaces of the carrier layer are at least partially coated with haemostat.

### Claim 3 (depends on 1)

A haemostatic material according to claim 1 further comprising a material which is degradable in the body.

### Claim 4 (depends on 1)

A haemostatic material according to claim 1 wherein the haemostat comprises two or more haemostats.

### Claim 5 (depends on 1)

A haemostatic material according to claim 1, comprising wound contact layer on an upper and lower surface of the carrier layer.

### Claim 6 (depends on 1)

A haemostatic material according to claim 1, further comprising a soluble, dispersible or removable retaining layer on top of the wound contact layer.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 8)

A haemostatic material according to claim 8, wherein the chitosan salt comprises chitosan succinate.

### Claim 10

A haemostatic material according 1 wherein the chitosan salt constitutes at least about 5% by weight of the haemostat.

### Claim 11 (depends on 1)

A haemostatic material according to claim 1, wherein the haemostat is granular.

### Claim 12 (depends on 1)

A haemostatic material according to claim 1 further comprising a medical surfactant.

### Claim 13 (depends on 12)

A haemostatic material according to claim 12, wherein the medical surfactant constitutes from about 0.001 to about 10% by weight of the haemostat.

### Claim 14 (depends on 12)

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.

### Claim 15 (depends on 14)

A haemostatic material according to claim 14, wherein the medical surfactant is a fatty acid selected from lauric acid and oleic acid.

### Claim 16 (depends on 1)

A haemostatic material according to claim 1 further comprising at least one inert material.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 16)

A haemostatic material according to claim 16 wherein the inert material constitutes up to about 95% by weight of the haemostat.

### Claim 19 (depends on 1)

A haemostatic material according to claim 1 wherein the haemostat comprises particles which cannot pass through a 200 mesh sieve.

### Claim 20 (depends on 1)

A haemostatic material according to claim 1 wherein the adhesive layer comprises a bonding agent wherein the bonding agent is a meltable material.

### Claim 21 (depends on 1)

A haemostatic material according to claim 1 wherein the carrier layer is degradable in a human or animal body.

### Claim 22 (depends on 1)

A haemostatic material according to claim 1 wherein the carrier layer comprises a viscose non-woven material.

### Claim 23 (depends on 1)

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.

### Claim 24 (depends on 12)

A haemostatic material according to claim 12 wherein the particle size of the haemostat and the particle size of the medical surfactant are equivalent.

### Claim 25 (depends on 1)

A haemostatic material according to claim 1 wherein the haemostat has a pH of from about 3.5 to about 8.0.

### Claim 26 (depends on 1)

A haemostatic material according to claim 1 further comprising an absorbent layer.

### Claim 27 (depends on 1)

A haemostatic material according to claim 1 wherein the material comprises part of a first aid plaster.

### Claim 28 (depends on 1)

A haemostatic material according to claim 1 wherein the material further comprises a quantity of a substance which is opaque to X-rays.

### Claim 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.

### Claim 30 (depends on 1)

A haemostatic material according to claim 1, wherein the chitosan salt is of an organic acid.

### Claim 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.
