Method of making a reinforced absorbable multilayered hemostatic wound dressing

• US 9,358,318 B2
• Filed: 03/09/2009
• Issued: 06/07/2016
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson), Omrix Biopharmaceutical, Inc.
• Original Assignee: Ethicon Incorporated (Johnson & Johnson), Omrix Biopharmaceutical, Inc.
• Inventors: Gorman, Anne Jessica, Pendharkar, Sanyog Manohar
• Primary Examiner(s): Orwig, Kevin S
• Application Number:
  US12/400,522
• Publication Number:
  US 20090246238A1
• Time in Patent Office: 2,647 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• 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: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

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 method for making a multilayered wound dressing having a first absorbable nonwoven fabric that comprises fibers comprised of aliphatic polyester polymers or copolymers of one or more monomers selected from the group consisting of lactic acid, lactide, glycolic acid, glycolide, ε

-caprolactone, p-dioxanone, and trimethylene carbonate;

one or more second absorbable woven or knitted fabric that comprises oxidized polysaccharides;

thrombin and 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;

(d) attaching the first absorbable nonwoven fabric to the second absorbable woven or knitted fabric to form a multilayered wound dressing;

(e) applying thrombin and fibrinogen as a suspension in a liquid carrier onto the first absorbable nonwoven fabric, wherein said liquid carrier is a perfluorinated hydrocarbon in which thrombin and fibrinogen are not soluble, and;

(f) drying said multilayered wound dressing.

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 glycolide/lactide copolymer.

4. The method of claim 1, where the second absorbable woven or knitted fabric comprises oxidized cellulose.

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

6. The method of claim 4, where the second absorbable woven or knitted fabric is an absorbable knitted fabric comprising oxidized regenerated cellulose.

7. 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.

8. The method of claim 7, where the first absorbable nonwoven fabric comprises staple having a length from about 0.75 to 1.5 inches.

9. The method of claim 7, where the first absorbable nonwoven fabric comprises staple having a length from about 1.0 to 1.3 inches.

10. The method of claim 7, 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.

11. The method of claim 9, where the staple is derived from fiber of about 1 to 4 denier per filament.

12. The method of claim 7, 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.

13. The method of claim 7, wherein the thrombin activity on the multilayered dressing ranges from about 20 to 500 IU/cm², and the concentration of fibrinogen on the multilayered dressing ranges from about 2 to 15 mg/cm².

14. The method according to claim 1, further comprising the step of sterilizing the multilayered wound dressing.

15. The method according to claim 14, wherein the multilayered wound dressing is sterilized by radiation.

16. The method according to claim 14, wherein the multilayered wound dressing is sterilized by electron beam radiation.

17. The method of claim 1, wherein the step (e) is performed while maintaining a room temperature of about 60 to 75 degrees F.

18. The method of claim 17, wherein the step (e) is performed while maintaining a relative humidity of about 10 to 45%.

19. The method of claim 1, wherein step (f) is performed at ambient room temperature following step (e).

20. The method of claim 13 wherein the fibrinogen concentration on the resulting wound dressing after drying in step (f) is between about 4.9 and 12.5 mg/cm².