Hemostatic devices and methods of making same

• US 20040265371A1
• Filed: 06/25/2003
• Published: 12/30/2004
• Est. Priority Date: 06/25/2003
• Status: Abandoned Application

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Looney, Dwayne Lee, Lamb, Bruce, Walthall, Benjamin, Troger, Kenneth
• Application Number:
  US10/603,320
• Publication Number:
  US 20040265371A1
• Time in Patent Office: Days
• US Class Current: 424/464
• CPC Class Codes: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 15/425 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 26/0023 Polysaccharides
• CPC Class Codes: A61L 26/0085 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 26/0095 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: C08L 1/26 Cellulose ethers

Abstract

The present invention includes compositions suitable for use in a hemostatic device and hemostatic devices utilizing such compositions, as well as methods of making the compositions and the medical devices utilizing such compositions, where the compositions contain biocompatible, oxidized cellulose particles having an average designated nominal particle size of about 0.035-4.35 mm and a biocompatible, water-soluble or water-swellable polysaccharide porous binder component.

Claims

1. A composition, comprising:

biocompatible, oxidized cellulose particles having an average designated nominal particle size of from about 0.035 to about 4.35 mm; and

a biocompatible, porous water-soluble or water-swellable polysaccharide binder component;

wherein said composition is suitable for use in a hemostatic device.

2. The composition of claim 1 wherein the oxidized cellulose is selected from the group consisting of carboxylic-oxidized cellulose or aldehyde-oxidized cellulose.

3. The composition of claim 2 wherein said water-soluble or water-swellable polysaccharide is selected from the group consisting of methylcellulose, hydroxyalkyl cellulose, salts of carboxymethyl cellulose, carboxymethyl cellulose and carboxyethyl cellulose.

4. The composition of claim 2 wherein said water-soluble or water-swellable polysaccharide is sodium carboxymethyl cellulose.

5. The composition of claim 1 wherein the weight ratio of said water-soluble or water-swellable polysaccharide to said oxidized cellulose particles is from about 1:

99 to about 20;

80.

6. The composition of claim 4 wherein the weight ratio of said sodium carboxymethyl cellulose to said oxidized cellulose particles is from about 3:

97 to about 10;

90.

7. The composition of claim 6 wherein said particles comprise fibers.

8. The composition of claim 7 wherein said fibers have an average designated nominal particle size of from about 0.68 to about 4.35 mm.

9. The composition of claim 1 comprising a sponge having said oxidized cellulose particles dispersed through said binder component.

10. The composition of claim 1 comprising an agglomerate of said oxidized cellulose particles and said binder component.

16. The hemostatic device of claim 4 wherein the weight ratio of said sodium carboxymethyl cellulose to said oxidized cellulose is from about 3:

97 to about 10;

90.

17. The hemostatic device of claim 16 wherein said particles comprise fibers.

18. The hemostatic device of claim 17 wherein said fibers have an average designated nominal particle size of from about 0.68 to about 4.35 mm.

11. A hemostatic device comprising a composition suitable for use therein, said composition comprising:

biocompatible, oxidized cellulose particles having an average designated nominal particle size of from about 0.035 to about 4.35 mm; and

a biocompatible, porous water-soluble or water-swellable polysaccharide binder component.

12. The hemostatic device of claim 11 wherein the oxidized cellulose is selected from the group consisting of carboxylic-oxidized regenerated cellulose or aldehyde-oxidized cellulose.

13. The hemostatic device of claim 12 wherein said water-soluble or water-swellable polysaccharide is selected from the group consisting of methylcellulose, hydroxyalkyl cellulose, salts of carboxymethyl cellulose, carboxymethyl cellulose and carboxyethyl cellulose.

14. The hemostatic device of claim 12 wherein said water-soluble or water-swellable polysaccharide is sodium carboxymethyl cellulose.

15. The hemostatic device of claim 11 wherein the weight ratio of said water-soluble or water-swellable polysaccharide to said oxidized cellulose is from about 1:

99 to about 20;

80.

19. The hemostatic device of claim 11 comprising a sponge having said oxidized cellulose particles dispersed through said binder component.

20. The hemostatic device of claim 11 comprising an agglomerate of said oxidized cellulose particles and said binder component.

21. The hemostatic device of claim 11 comprising said composition in the form of a powder, a patch, a plug, a slurry and a paste.

22. A composition suitable for use in a hemostatic device, said composition produced according to the steps of:

providing a polymer solution having a water-soluble or water-swellable polysaccharide polymer dissolved in a suitable solvent therefore,

providing biocompatible, oxidized cellulose particles having an average designated nominal size from about of 0.035 to about 4.35 mm,

contacting said polymer solution with said oxidized cellulose particles under conditions effective to disperse said oxidized cellulose particles substantially homogenously throughout said polymer solution to form a substantially homogenous dispersion,

subjecting said polymer solution having said particles dispersed throughout to conditions effective to solidify said substantially homogenous dispersion; and

removing said solvent from the solidified dispersion, thereby forming said composition comprising said particles and a porous, water-soluble or water-swellable polysaccharide polymer binder component.

23. A process for making a composition useful in a hemostatic device, comprising:

providing a polymer solution having a water-soluble or water-swellable polysaccharide polymer dissolved in a suitable solvent therefore,

providing biocompatible, oxidized cellulose particles having an average designated nominal size from about of 0.035 to about 4.35 mm,

contacting said polymer solution with said oxidized cellulose particles under conditions effective to disperse said oxidized cellulose particles substantially homogenously throughout said polymer solution to form a substantially homogenous dispersion,

subjecting said polymer solution having said particles dispersed throughout to conditions effective to solidify said substantially homogenous dispersion; and

removing said solvent from the solidified dispersion, thereby forming said composition comprising said particles and a porous, water-soluble or water-swellable polysaccharide polymer binder component.

24. The process of claim 23 wherein said oxidized cellulose comprise carboxylic-oxidized regenerated cellulose.

25. The process of claim 23 wherein said water-soluble or water-swellable polysaccharide polymer is selected from the group consisting of methylcellulose, hydroxyalkyl cellulose, salts of carboxymethyl cellulose, carboxymethyl cellulose and carboxyethyl cellulose.

26. The process of claim 25 wherein said polymer is sodium carboxymethyl cellulose.

27. The process of claim 26 wherein the weight ratio of said sodium carboxymethyl cellulose to said fibers or beads is from about 1:

99 to about 20;

80.

28. The process of claim 26 wherein the weight ratio of said sodium carboxymethyl cellulose to said fibers or beads is from about 3:

97 to about 10;

90.