Method for making a reinforced absorbable multilayered hemostatic wound dressing

• US 20060257457A1
• Filed: 04/10/2006
• Published: 11/16/2006
• Est. Priority Date: 10/20/2004
• Status: Abandoned Application

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Gorman, Anne Jessica, Pendharkar, Sanyog Manohar
• Application Number:
  US11/400,848
• Publication Number:
  US 20060257457A1
• Time in Patent Office: Days
• US Class Current: 424/445
• CPC Class Codes: A61L 15/26 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/32 Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin A61L15/225 takes precedence
• CPC Class Codes: B32B 2250/20 All layers being fibrous or filamentary
• CPC Class Codes: B32B 2262/0276 Polyester fibres
• CPC Class Codes: B32B 2262/06 Vegetal fibres
• CPC Class Codes: B32B 2262/062 Cellulose fibres, e.g. cotton
• CPC Class Codes: B32B 23/02 in the form of fibres or filaments not used
• CPC Class Codes: B32B 23/10 next to a fibrous or filamentary layer
• CPC Class Codes: B32B 2307/726 Permeability to liquids, absorption
• CPC Class Codes: B32B 2556/00 Patches, e.g. medical patches, repair patches
• CPC Class Codes: B32B 27/36 comprising polyesters
• CPC Class Codes: B32B 5/022 Non-woven fabric
• CPC Class Codes: B32B 5/024 Woven fabric
• CPC Class Codes: B32B 5/026 Knitted fabric
• CPC Class Codes: B32B 5/26 another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 442/2525 Coating or impregnation functions biologically [e.g., insect repellent, antiseptic, insecticide, bactericide, etc.]

Abstract

The present invention is directed to a method of making a reinforced absorbable multilayered hemostatic wound dressing comprising a first absorbable nonwoven fabric, a second absorbable woven or knitted fabric, thrombin and/or fibrinogen.

Claims

1. A method for making a multilayered wound dressing having a first absorbable nonwoven fabric, one or more second absorbable woven or knitted fabric, thrombin and/or fibrinogen, comprising the steps of:

(a) crimping absorbable polymer fibers or yarns in the range of about 10 to 30 crimps per inch;

(b) cutting the crimped fibers or yarns to a staple length between about 0.1 and 2.5 inch;

(c) carding the staple to form the first absorbable nonwoven fabric while controlling the humidity to about 20 to 60%, at a room temperature of about 15 to 24°

C.;

(d) attaching the first absorbable nonwoven fabric to the second absorbable woven or knitted fabric;

(e) applying thrombin and/or fibrinogen to the first absorbable nonwoven fabric.

2. The method of claim 1, wherein the humidity of the environment for step (c) is from about 40 to 60%, at a room temperature of about 15 to 24°

C.

3. The method of claim 1, where the first absorbable nonwoven fabric comprises fibers comprised of aliphatic polyester polymers or copolymers of one or more monomers selected from the group consisting of lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, glycolide, ε

-caprolactone, p-dioxanone, and trimethylene carbonate.

4. The method of claim 3, where the first absorbable nonwoven fabric comprises glycolide/lactide copolymer.

5. The method of claim 3, where the second absorbable woven or knitted fabric comprises oxidized polysaccharides.

6. The method of claim 5, where the second absorbable woven or knitted fabric comprises oxidized cellulose.

7. The method of claim 6, where the second absorbable woven or knitted fabric comprises oxidized regenerated cellulose.

8. The method of claim 6, where the second absorbable woven or knitted fabric is an absorbable knitted fabric comprising oxidized regenerated cellulose.

9. The method of claim 1, where the first absorbable nonwoven fabric comprises glycolide/lactide copolymer, and the second absorbable woven or knitted fabric comprises oxidized regenerated cellulose.

10. The method of claim 9, where the first absorbable nonwoven fabric comprises staple having a length from about 0.75 to 1.5 inches.

11. The method of claim 9, where the first absorbable nonwoven fabric comprises staple having a length from about 1.0 to 1.3 inches.

12. The method of claim 9, where the first absorbable nonwoven fabric comprises a copolymer of glycolide and lactide, in an amount ranging from about 70 to 95% by molar basis of glycolide and the remainder lactide, and the second absorbable woven or knitted fabric comprises oxidized regenerated cellulose.

13. The method of claim 12, where the staple is derived from fiber of about 0.001 to 4 denier per filament.

14. The method of claim 9, where the first absorbable nonwoven fabric has a basis weight of about 0.01 to 0.2 g/in²;

the second absorbable woven or knitted fabric has a basis weight of about 0.001 to 0.2 g/in²; and

the multilayered dressing having the thrombin and/or fibrinogen thereon has a basis weight of about 0.1 and 1.0 g/in.

15. The method of claim 9, wherein the thrombin activity on the multilayered dressing ranges from about 20 to 500 IU/cm², and the fibrinogen activity on the multilayered dressing ranges from about 2 to 15 mg/cm².