# US 8,771,258 B2 · Hemostatic sponge

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- Number: US 8,771,258 B2
- Document ID: US8771258B2
- Status: Granted
- Kind: B2
- Application number: 12/970,203
- Filed: 2010-12-16
- Published: 2011-08-18
- Granted: 2014-07-08
- Earliest claimed: 2009-12-16
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Hans Christian Hedrich; Joris Hoefinghoff; Woonza M. Rhee; Atsushi Edward Osawa
- Inventors: Hans Christian Hedrich; Joris Hoefinghoff; Woonza M. Rhee; Atsushi Edward Osawa
- Web page: https://patentgrep.com/patent/US8771258B2

## CPC

- A61L 15/425: {Porous materials, e.g. foams or sponges}
- A61F 13/0213: {the fluid retention member being a layer of hydrocolloid, gel forming material}
- A61F 13/025: {having a special distribution arrangement of the adhesive}
- A61F 13/0253: {characterized by the adhesive material}
- A61F 13/0289: {manufacturing of adhesive dressings}
- A61F 13/15577: {Apparatus or processes for manufacturing}
- A61L 15/225: {Mixtures of macromolecular compounds}
- A61L 15/58: Adhesives
- C08G 65/334: containing sulfur
- C08L 71/02: Polyalkylene oxides
- C09J 171/02: Polyalkylene oxides
- A61F 13/01012: {being made of natural material, e.g. cellulose-, protein-, collagen-based}
- A61F 2013/00463: {haemostatic}
- A61F 2013/00468: {applying local pressure}
- A61F 2013/00472: {with chemical means}
- A61L 2400/04: Materials for stopping bleeding
- C08L 2205/05: containing polymer components which can react with one another
- 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)
- C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)
- C09J: ADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES (preparation of glue or gelatine C09H)

## Abstract

The present invention provides a hemostatic composite sponge comprising a porous matrix of a biomaterial and a material enhancing the adherence of said sponge to the applied tissue stably associated with at least one surface of said sponge, a method of producing these sponges and their use in hemostasis.

## Claims

### Claim 1

A hemostatic composite sponge comprising a porous sponge of a matrix of a biomaterial and a material enhancing the adherence of said porous sponge to an applied tissue stably associated with at least one surface of said porous sponge, wherein said adherence-enhancing material is essentially free of a hydrogel forming component, wherein the adherence-enhancing material comprises a first cross-linkable component and a second cross-linkable component, wherein the first cross-linkable component includes multiple nucleophilic groups and the second cross-linkable component includes multiple electrophilic groups, and wherein the first cross-linkable component and the second cross-linkable component are polymerized to form a polymer.

### Claim 2 (depends on 1)

The sponge according to claim 1, wherein said biomaterial is selected from the group consisting of collagen, gelatin, fibrin, a polysaccharide, and a derivative thereof.

### Claim 3 (depends on 2)

The sponge according to claim 2, wherein the polysaccharide comprises chitosan.

### Claim 4 (depends on 2)

The sponge according to claim 2, wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

### Claim 5 (depends on 1)

The sponge according to claim 1, wherein the first cross-linkable component cross-links with the second cross-linkable under reaction enabling conditions.

### Claim 6 (depends on 5)

The sponge according to claim 5, wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

### Claim 7 (depends on 1)

The sponge according to claim 1, wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

### Claim 8 (depends on 1)

The sponge according to claim 1, wherein said material enhancing the adherence of said porous sponge to the applied tissue forms a continuous or discontinuous layer on at least one surface of said porous sponge.

### Claim 9 (depends on 1)

The sponge according to claim 1 having an overall thickness of about 1 mm to about 2.5 mm.

### Claim 10 (depends on 1)

The sponge according to claim 1 for use in minimal invasive surgery.

### Claim 11 (depends on 10)

The sponge according to claim 10, wherein the minimal invasive surgery comprises a laparoscopic application.

### Claim 12 (depends on 1)

The sponge according to claim 1 wherein the material enhancing the adherence of said porous sponge to the applied tissue is present in a concentration of 5 to 500 mg per cm2 of biomaterial.

### Claim 13 (depends on 12)

The sponge according to claim 12, wherein the material enhancing the adherence of said porous sponge to the applied tissue is present in a concentration of between 5 to 100 mg per cm2.

### Claim 14 (depends on 1)

A method of treating a wound, a hemorrhage, damaged tissue and/or bleeding tissue comprising administering a hemostatic composite sponge of claim 1.

### Claim 15 (depends on 14)

The method of claim 14, further comprising sterilizing the composite sponge.

### Claim 16 (depends on 1)

The hemostatic composite sponge according to claim 1, wherein the material is present in a grid pattern on the porous sponge.

### Claim 17 (depends on 1)

The hemostatic composite sponge according to claim 1, wherein the material coats at least one surface of the porous sponge.

### Claim 18

A method of manufacturing a hemostatic composite sponge comprising:
providing a porous sponge of a matrix of a biomaterial;
providing a material enhancing the adherence of said porous sponge to an applied tissue in the form of a suspension, a solution or powder, wherein said material is essentially free of a hydrogel forming component, and wherein the material comprises a first cross-linkable component and a second cross-linkable component that are polymerized to form a polymer; and
contacting the porous sponge and the material so that the material is stably associated with at least one surface of said porous sponge so that the hemostatic composite sponge is obtained.

### Claim 19 (depends on 18)

The method according to claim 18, wherein the first cross-linkable component cross-links with the second cross-linkable component under reaction enabling conditions.

### Claim 20 (depends on 18)

The method according to claim 18, wherein said first and/or second cross-linkable component comprise a derivative of polyethylene glycol.

### Claim 21 (depends on 18)

The method of claim 18, further comprising drying the composite sponge.

### Claim 22 (depends on 18)

The method of claim 18, further comprising sterilizing the composite sponge.

### Claim 23

A hemostatic composite sponge comprising:
a porous sponge of a matrix of a biomaterial; and
a material enhancing the adherence of the porous sponge to an applied tissue stably associated with at least one surface of the porous sponge,
wherein the material is essentially free of a hydrogel forming component, wherein the material comprises a first cross-linkable component and a second cross-linkable component, and wherein there is cross-linking between the two cross-linkable components and the porous sponge.

### Claim 24 (depends on 23)

The hemostatic composite sponge according to claim 23, wherein the material is distributed throughout the porous sponge.

### Claim 25

A method of manufacturing a hemostatic composite sponge, the method comprising:
providing a porous sponge of a matrix of a biomaterial;
providing a material enhancing the adherence of the porous sponge to an applied tissue in the form of a suspension, a solution, or powder, wherein the material is essentially free of a hydrogel forming component, and wherein the material comprises a first cross-linkable component and a second cross-linkable component; and
contacting the porous sponge and the material so that the material is stably associated with at least one surface of the porous sponge, and there is cross-linking between the two cross-linkable components and the porous sponge, so that the hemostatic composite sponge is obtained.

### Claim 26

A method of using a hemostatic composite sponge to treat a patient, the method comprising:
administering the hemostatic composite sponge to a treatment site of the patient,
wherein the hemostatic composite sponge comprises a porous sponge of a matrix of a biomaterial, and a material enhancing the adherence of the porous sponge to an applied tissue stably associated with at least one surface of the porous sponge, wherein the material is essentially free of a hydrogel forming component, wherein the material comprises a first cross-linkable component and a second cross-linkable component, and wherein there is cross-linking between the two cross-linkable components and the porous sponge.
