MESOCELLULAR OXIDE FOAMS AS HEMOSTATIC COMPOSITIONS AND METHODS OF USE

• US 20090047329A1
• Filed: 08/13/2008
• Published: 02/19/2009
• Est. Priority Date: 08/14/2007
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Baker, Sarah, Stucky, Galen, Sawvel, April
• Granted Patent: US 8,202,549 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61L 15/425 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Abstract

The present invention relates to hemostatic compositions comprising a mesocellular oxide foam and, optionally, a biologically active agent such as a procoagulant, as well as devices and methods of use to promote blood clotting.

Claims

1. A hemostatic composition comprising a hemostatically effective amount of a sterile, mesocellular oxide foam, wherein the mesocellular foam is characterized by an average pore size of from about 10 nm to 100 nm, and wherein the mesocellular foam has an average pore window size of at least 11 nm.

2. The hemostatic composition of claim 1, wherein the mesocellular foam has an average pore window size of at least 20 nm.

3. The hemostatic composition of claim 1, wherein the mesocellular foam has an average pore window size ranging from about 11 nm to about 35 nm.

4. The hemostatic composition of claim 1, wherein the mesocellular foam has an average pore volume of at least 1 cm³/g.

5. The hemostatic composition of claim 1, wherein the mesocellular foam has an average pore volume of at least 1.4 cm³/g.

6. The hemostatic composition of claim 1, wherein the mesocellular foam has an average pore volume ranging from about 1 cm³/g to about 2.5 cm³/g.

7. The hemostatic composition of claim 1, wherein the mesocellular foam comprises a bound biologically active agent.

8. The hemostatic composition of claim 7, wherein the biologically active agent is covalently bound in or on the mesocellular foam.

9. The hemostatic composition of claim 7, wherein the biologically active agent is non-covalently bound in or on the mesocellular foam.

10. The hemostatic composition of claim 7, wherein the biologically active agent is a clot promoting agent.

11. The hemostatic composition of claim 10, wherein the clot promoting agent is thrombin.

14. A medical device comprising:

the hemostatic composition of claim 1 or 12; and

a sterile substrate on which the hemostatic composition is disposed.

15. The device of claim 14, wherein the substrate is adapted for delivery of the hemostatic composition to a bleeding wound.

16. The device of claim 15, wherein the substrate is a bandage, gauze, or sponge.

17. A method of clotting blood flowing from a wound, comprising:

applying to a wound in a subject the hemostatic composition of claims 1 or 12 to a bleeding wound of the subject; and

maintaining the hemostatic composition in contact with the wound for a period of time sufficient to at least initiate blood clotting.

12. A thrombin-loaded mesocellular oxide foam comprising at least 5% by weight thrombin, wherein the mesocellular foam is characterized by an average pore size of from about 10 nm to 100 nm, and wherein the mesocellular foam has an average pore window size of at least 11 nm.

13. The thrombin-loaded mesocellular foam of claim 12, wherein the mesocellular foam comprises at least 10% to 25% by weight thrombin.

18. A method of making a hemostatic composition, the method comprising:

contacting a mesocellular oxide foam characterized by an average pore size of from about 10 nm to 100 nm and an average pore window size of at least 11 nm with a solution containing a biologically active agent, said contacting being for a time sufficient to provide for adsorption or absorption of the biologically active agent to the mesocellular foam;

wherein a hemostatic composition comprising the mesocellular oxide foam and bound biologically active agent is produced.

19. The method of claim 18, wherein the hemostatic composition comprising the mesocellular foam and a bound biologically active agent is washed with a buffer to remove un-bound biologically active agents.

20. The method of claim 18, wherein the method further comprises:

packaging the hemostatic composition in a container adapted to retain sufficient moisture to facilitate maintenance of activity of the biologically active agent.