Reinforced absorbable multilayered hemostatis wound dressing

• US 9,439,997 B2
• Filed: 04/10/2006
• Issued: 09/13/2016
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Omrix Biopharmaceuticals Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson), Omrix Biopharmaceutical, Inc.
• Inventors: Gorman, Anne Jessica, Pendharkar, Sanyog Manohar, Zhang, Guanghui, Bar, Liliana, Nur, Israel, Meidler, Roberto
• Primary Examiner(s): Barham, Bethany
• Assistant Examiner(s): Cao, Ping
• Application Number:
  US11/400,849
• Publication Number:
  US 20060257458A1
• Time in Patent Office: 3,809 Days
• Field of Search: None
• US Class Current: 1/1
• 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 hemostatic multilayered wound dressing comprising a first carrier layer with thrombin and fibrinogen, each is in the form as a dispersed powder, wherein the first carrier layer is an absorbable nonwoven fabric having a basis weight of about 0.01 to 0.2 g/in² that comprises glycolide/lactide copolymer and a staple fiber having a length from about 1.0 to 1.3 inches that is derived from fiber of about 1 to 4 denier per filament, and one or more second absorbable woven or knitted fabric having a basis weight of about 0.001 to 0.2 g/in² that comprises oxidized regenerated cellulose that reinforces the first carrier layer and is separate from the dispersed powders, wherein the multilayered dressing has a basis weight of about 0.1 to 1.0 g/in², wherein the first absorbable nonwoven fabric comprises from about 70 to 95% by molar basis of polyglycolide and the remainder polylactide.

2. The multilayered dressing of claim 1, where the staple fiber is crimped.

3. The multilayered dressing of claim 1, wherein the thrombin activity on the multilayered dressing ranges from about 20 to 500 IU/cm², and the fibrinogen amount on the multilayered dressing ranges from about 2 to 15 mg/cm².

5. The multilayered wound dressing according to claim 3, wherein the dressing is sterilized.

8. A hemostatic multilayered wound dressing as set forth in claim 1 or 4 wherein the fibrinogen amount is between 5-10 mg/cm².

9. A hemostatic multilayered wound dressing as set forth in claim 1 or 4 wherein the weight ratio of the fibrinogen to the carrier and reinforcing layers is in the range of 0.26:

1 to 0.52;

1.

4. A hemostatic multilayered dressing comprising a first carrier layer with thrombin and fibrinogen, each is in the form as a dispersed powder, wherein the first carrier layer is an absorbable nonwoven fabric comprising glycolide/lactide copolymer and a staple fiber having a length from about 0.75 to 1.5 inch, a second absorbable woven or knitted fabric that is a reinforcing layer attached to the first carrier layer and is separate from the dispersed powders comprising oxidized regenerated cellulose, wherein the glycolide/lactide copolymer comprises from about 70 to 95% by molar basis of polyglycolide and the reminder polylactide, the thrombin activity on the multilayered dressing ranges from about 20 to 500 IU/cm², the fibrinogen amount on the multilayered dressing ranges from about 2 to 15 mg/cm².

6. The multilayered wound dressing according to claim 4, wherein the dressing is sterilized.

7. A hemostatic multilayered wound dressing comprising a first absorbable nonwoven fabric and thrombin and fibrinogen as dispersed powders;

one or more second absorbable woven or knitted fabric that comprises oxidized regenerated cellulose.