# US 8,784,876 B2 · Clay-based hemostatic agents and devices for the delivery thereof

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- Number: US 8,784,876 B2
- Document ID: US8784876B2
- Status: Granted
- Kind: B2
- Application number: 13/911,616
- Filed: 2013-06-06
- Published: 2013-10-10
- Granted: 2014-07-22
- Earliest claimed: 2006-05-26
- Assignees: Z-Medica, LLC
- Applicants: Z-Medica, LLC
- Inventors: Raymond J. Huey; Denny Lo; Daniel J. Burns; Giacomo Basadonna; Francis X. Hursey
- Web page: https://patentgrep.com/patent/US8784876B2

## CPC

- A61F 13/534: having an inhomogeneous composition through the thickness of the pad (A61F13/538, A61F13/539 take precedence)
- A61L 15/18: containing inorganic materials
- A61L 15/44: Medicaments
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/402: Anaestetics, analgesics, e.g. lidocaine
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2400/04: Materials for stopping bleeding
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.

## Claims

### Claim 1

A device incorporating a hemostatic feature, the device comprising:
a substrate material;
a clay material disposed on the substrate material;
a calcium alginate binder, comprising a material distinct from the substrate material and the clay material that adheres at least a portion of the clay material to a surface of the substrate material so that the device is substantially free of loose clay material;
wherein the device is substantially dry; and
wherein the device is configured such that when blood contacts the surface of the device, at least a portion of the blood is brought into contact with at least a portion of the clay material to accelerate the clotting of the blood.

### Claim 2 (depends on 1)

The device of claim 1, wherein the clay comprises kaolin.

### Claim 3 (depends on 1)

The device of claim 1, wherein the binder further comprises chitosan, polyvinyl alcohol, guar gum, gelatinized starches, polysaccharides, cellulose, or carboxymethylcellulose.

### Claim 4 (depends on 1)

The device of claim 1, wherein the substrate material comprises at least one of a nonwoven or a woven material.

### Claim 5 (depends on 1)

The device of claim 1, wherein the substrate material comprises at least one of cotton, silk, wool, plastic, cellulose, rayon, or polyester.

### Claim 6 (depends on 1)

The device of claim 1, wherein the substrate material comprises at least one of cloth, felt, paper, cotton balls, or cotton swabs.

### Claim 7 (depends on 1)

The device of claim 1, wherein the substrate material comprises a film.

### Claim 8 (depends on 1)

The device of claim 1, wherein the substrate material comprises a plastic material.

### Claim 9 (depends on 1)

The device of claim 1, wherein the substrate material comprises fibrous strands.

### Claim 10 (depends on 1)

The device of claim 1, wherein at least some of the clay material is impregnated into the substrate material.

### Claim 11 (depends on 2)

The device of claim 2, wherein at least one of an antibiotic, an antifungal agent, an anti-microbial agent, silver ions, or copper ions is mixed with, associated with, or incorporated into the kaolin.

### Claim 12 (depends on 2)

The device of claim 2, wherein at least one of an analgesic or an anti-inflammatory agent is mixed with, associated with, or incorporated into the kaolin.

### Claim 13 (depends on 11)

The device of claim 11, wherein an analgesic is mixed with, associated with, or incorporated into the kaolin.

### Claim 14

A hemostatic device for promoting the clotting of blood, the device comprising:
a substrate material having at least one surface;
a clay material disposed on the surface of the substrate material;
a calcium alginate binder that is distinct from the substrate material and the clay, that adheres at least a portion of the clay material to the surface of the substrate material so that the surface is substantially free of loose clay;
wherein the clay material is positioned on the surface of the device in a region configured to contact blood from a bleeding wound, thereby promoting clotting.

### Claim 15 (depends on 14)

The device of claim 14, wherein the clay comprises kaolin.

### Claim 16 (depends on 14)

The device of claim 14, wherein the binder further comprises chitosan, polyvinyl alcohol, guar gum, gelatinized starches, polysaccharides, cellulose, or carboxymethylcellulose.

### Claim 17 (depends on 14)

The device of claim 14, wherein the substrate material comprises at least one of a cotton material, a silk material, a wool material, a polymer material, or a cellulose material.

### Claim 18 (depends on 14)

The device of claim 14, further comprising fibrous strands of which the substrate material comprises at least one of the components of the fibrous strands.

### Claim 19 (depends on 17)

The device of claim 17, wherein the cotton material comprises at least one of cloth, cotton balls, or cotton swabs.

### Claim 20 (depends on 17)

The device of claim 17, wherein the polymer material comprises at least one of plastic, rayon, or polyester.

### Claim 21 (depends on 20)

The device of claim 20, wherein the plastic polymer material is a plastic.

### Claim 22

A hemostatic device for promoting the clotting of blood, the device comprising:
a substrate;
a clay material comprising kaolin disposed on the substrate; and
a binder that adheres at least a portion of the clay material to the substrate, the substrate being distinct from the clay material and the binder;
wherein the device is subjected to a drying process, the device substantially suppressed clay dust, and the device is configured such that when blood contacts the substrate, it interacts with at least some of the clay material on the substrate, which assists in accelerating clotting.

### Claim 23 (depends on 22)

The device of claim 22, wherein the binder comprises calcium alginate, chitosan, polyvinyl alcohol, guar gum, gelatinized starches, polysaccharides, cellulose, carboxymethylcellulose, or combinations thereof.

### Claim 24 (depends on 22)

The device of claim 22, wherein the substrate comprises at least one of a nonwoven or a woven material.

### Claim 25 (depends on 22)

The device of claim 22, wherein the substrate comprises at least one of cotton, silk, wool, plastic, cellulose, rayon, or polyester.

### Claim 26 (depends on 22)

The device of claim 22, wherein the substrate comprises at least one of cloth, felt, non-breathable plastic material, paper, cotton balls, cotton swabs, or fibrous strands.

### Claim 27 (depends on 22)

The device of claim 22, wherein at least one of an antibiotic, an antifungal agent, an anti-microbial agent, a silver ions, or copper ions is mixed with, associated with, or incorporated into the kaolin.

### Claim 28 (depends on 22)

The device of claim 22, wherein at least some of the clay material is impregnated into the substrate.

### Claim 29 (depends on 22)

The device of claim 22, wherein at least one of an analgesic or an anti-inflammatory agent is mixed with, associated with, or incorporated into the kaolin.

### Claim 30 (depends on 29)

The device of claim 29, wherein an analgesic is mixed with, associated with, or incorporated into the kaolin.
