Reinforced absorbable multilayered hemostatis wound dressing

• US 20060257458A1
• Filed: 04/10/2006
• Published: 11/16/2006
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Omrix Biopharmaceuticals Incorporated (Johnson & Johnson)
• Original Assignee: Omrix Biopharmaceuticals Incorporated (Johnson & Johnson)
• Inventors: Meidler, Roberto, Nur, Israel, Bar, Liliana, Zhang, Guanghui, Gorman, Anne Jessica, Pendharkar, Sanyog Manohar
• Granted Patent: US 9,439,997 B2
• Time in Patent Office: Days
• US Class Current: 424/445
• CPC Class Codes: A61F 13/01029 made of multiple layers
• 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 15/28 Polysaccharides or their derivatives 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: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/64 specially adapted to be resorbable inside the body
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: B32B 2250/20 All layers being fibrous or filamentary
• CPC Class Codes: B32B 2262/0276 Polyester fibres
• CPC Class Codes: B32B 2262/04 Cellulosic plastic fibres, e.g. rayon
• 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 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 multilayered wound dressing comprising a first absorbable nonwoven fabric, one or more second absorbable woven or knitted fabric, thrombin and/or fibrinogen.

2. The multilayered dressing 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.

3. The multilayered dressing of claim 2, where the first absorbable nonwoven fabric comprises glycolideaactide copolymer.

4. The multilayered dressing of claim 2, where the second absorbable woven or knitted fabric comprises oxidized polysaccharides.

5. The multilayered dressing of claim 4, where the second absorbable woven or knitted fabric comprises oxidized cellulose.

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

7. The multilayered dressing of claim 5, where the second absorbable woven or knitted fabric is an absorbable knitted fabric comprising oxidized regenerated cellulose.

8. The multilayered dressing 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.

9. The multilayered dressing of claim 8, where the first absorbable nonwoven fabric comprises staple having a length from about 0.75 to 1.5 inches.

10. The multilayered dressing of claim 9, where the staple is crimped.

11. The multilayered dressing of claim 8, where the first absorbable nonwoven fabric comprises staple having a length from about 1.0 to 1.3 inches.

12. The multilayered dressing of claim 11, where the staple is crimped.

13. The multilayered dressing of claim 8, where the first absorbable nonwoven fabric comprises from about 70 to 95% by molar basis polyglycolide and the remainder polylactide, and the second absorbable woven or knitted fabric comprises oxidized regenerated cellulose.

14. The multilayered dressing of claim 11, where the staple is derived from fiber of about 0.001 to 4 denier per filament.

15. The multilayered dressing of claim 14, 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/in².

16. The multilayered dressing of claim 8, wherein the thrombin activity on the multilayered dressing ranges from about 20 to 500 U/cm² , and the fibrinogen activity on the multilayered dressing ranges from about 2 to 15 mg/cm².

17. The multilayered dressing comprising a first absorbable nonwoven fabric comprising glycolide/lactide copolymer staple having a length from about 0.75 to 1.5 inch, a second absorbable woven or knitted fabric comprising oxidized regenerated cellulose, thrombin and/or fibrinogen;

wherein the glycolide/lactide copolymer comprises from about 70 to 95% by molar basis polyglycolide and the remainder polylactide, the thrombin activity on the multilayered dressing ranges from about 20 to 500 IU/cm², the fibrinogen activity on the multilayered dressing ranges from about 2 to 15 mg/cm², and about 50 to 75 mass percent of the dressing is capable of being absorbed after about 14 days.

18. A method for treating a wound comprising the step of applying the multilayered dressing of claim 17 to achieve hemostasis and /or seal fluid leaks.