Composition for sealing and healing wounds

• US 4,453,939 A
• Filed: 02/11/1982
• Issued: 06/12/1984
• Est. Priority Date: 02/16/1981
• Status: Expired due to Term

• Current Assignee: Nycomed Arzneimittel GmbH
• Original Assignee: Hormon-Chemie Munchen GmbH
• Inventors: Schiele, Ulrich, Zimmerman, Eberhard
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Vinyard, Sherri E.
• Application Number:
  US06/347,817
• Time in Patent Office: 852 Days
• Field of Search: 424/177, 128/155-156, 604/891, 604/896-897, 604/47, 604/285, 604/286, 604/288, 604/304-306, 604/356, 604/358, 604/364, 604/368
• US Class Current: 604/368
• CPC Class Codes: A61L 15/325 Collagen
• CPC Class Codes: A61L 24/102 Collagen
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: Y10S 602/90 Method of making bandage structure

Abstract

A composition and its use for sealing and healing of wounds, comprising a collagen carrier which is coated on one face or all faces with a mixture of (1) a fibrinogen component which contains fibrinogen, factor XIII-containing fibrinogen or a mixture thereof, and (2) a thrombin component which contains thrombin, a substance which liberates thrombin in the presence of body fluid or a mixture of such substances. The mixture of (1) and (2) optionally may additionally contain conventional additives, such as calcium ions, protease inhibitors, heparin antagonists, substances which promote the infiltration and growth of fibroblasts, such as fibronectin, as well as antibiotics and/or bactericides.

Claims

1. A process for the preparation of a composition for sealing and healing wounds which comprises adding a mixture of (1) a fibrinogen component containing fibrinogen, factor XIII-containing fibrinogen or a mixture thereof, and (2) a thrombin component containing thrombin, a substance which liberates thrombin in the presence of body fluid, or a mixture of such substances, to an organic solvent, in the absence of water, homogenizing the resulting slurry to form a homogeneous suspension of the mixture in the solvent, applying the said suspenion to one or more surfaces of a collagen carrier and evaporating the organic solvent, whereby particles of the said mixture remain adhering to the surface or surfaces of the collagen.

2. A process according to claim 1, in which the mixture of (1) and (2) also includes one or more conventional additives selected from the group consisting of calcium ions, protease inhibitors, heparin antagonists, substances which promote the infiltration and growth of fibroblasts and anti-infection medicaments.

3. A process according to claim 1, in which the organic solvent is a straight-chain or branched C₁ -C₅ alkanol, an aliphatic halogenated hydrocarbon, an ester, a nitrile, a ketone or an aliphatic or cycloaliphatic ether.

4. A composition for sealing and healing wounds prepared by the process according to claim 1 and comprising a collagen carrier which is coated on one face or all faces with a mixture of (1) a fibrinogen component containing fibrinogen, factor XIII-containing fibrinogen or a mixture thereof, and (2) a thrombin component, containing thrombin, a substance which liberates thrombin in the presence of body fluid, or a mixture of such substances.

5. A composition according to claim 4, in which the mixture of (1) and (2) also includes one or more conventional additives selected from the group consisting of calcium ions, protease inhibitors, heparin antagonists, substances which promote the infiltration and growth of fibroblasts and anti-infection medicaments.

6. A composition according to claim 4 or 5, wherein the collagen carrier is a collagen foam.

7. A composition according to claim 4 or 5, wherein the amount of the fibrinogen component is 0.05 to 20 mg/cm².

8. A composition according to claim 7, wherein the amount of the fibrinogen component is 0.5 to 5 mg/cm².

9. A composition according to claim 4 or 5, wherein the amount of the thrombin component is 1 μ

g to 5 mg/cm².

10. A composition according to claim 9, wherein the amount of the thrombin component is 50 μ

g to 1 mg/cm².

11. A composition according to claim 5, wherein the conventional additive which promotes the infiltration and growth of fibroblasts is fibronectin.

12. A method for the treatment of wounds, which comprises administering to the wound a composition prepared by the process according to claim 10 and comprising a collagen carrier which is coated on one face or all faces with a mixture of (1) a fibrinogen component containing fibrinogen, factor XIII-containing fibrinogen or a mixture thereof, and (2) a thrombin component, containing thrombin, a substance which liberates thrombin in the presence of body fluid, or a mixture of such substances.