Reinforced Absorbable Multi-Layered Fabric for Hemostatic Applications

• US 20110282364A1
• Filed: 05/17/2010
• Published: 11/17/2011
• Est. Priority Date: 05/17/2010
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Zhong, Degang, Moloye-Olabisi, Olajompo, Van Holten, Robert W., Shetty, Dhanuraj S.
• Granted Patent: US 8,329,211 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 15/44 Medicaments
• CPC Class Codes: A61L 15/62 Compostable, hydrosoluble or hydrodegradable materials
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: B32B 2262/0276 Polyester fibres
• CPC Class Codes: B32B 2305/18 Fabrics, textiles
• CPC Class Codes: B32B 2307/72 Density
• CPC Class Codes: B32B 2307/732 Dimensional properties
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 5/022 Non-woven fabric
• CPC Class Codes: B32B 5/06 characterised by a fibrous or filamentary layer mechanically connected, e.g. by needling to another layer, e.g. of fibres, of paper
• 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: D04H 1/435 Polyesters
• CPC Class Codes: D04H 1/4374 using different kinds of webs, e.g. by layering webs
• CPC Class Codes: D04H 1/46 : by needling or like operations to cause entanglement of fibres D04H1/45 takes precedence; needling machines D04H18/00
• CPC Class Codes: Y10T 428/24967 : Absolute thicknesses specified
• CPC Class Codes: Y10T 428/24992 : Density or compression of components

Abstract

The present invention is directed to a synthetic fabric comprising a multi-layered nonwoven fabric made from staples of a polyglycolide/polylactide copolymer, each layer having a different density. The multi-layer fabric can be used as a reinforced absorbable hemostat medical device.

Claims

1. A synthetic fabric comprising a non-woven matrix having at least two layers of a first absorbable staple of a polyglycolide/polylactide copolymer and a second absorbable staple of a polyglycolide/polylactide copolymer, where the first absorbable fabric is compacted to a density of about 60 mg/cc and the second absorbable fabric is compacted to a density of about 120 mg/cc.

2. The synthetic fabric of claim 1, where the first and the second absorbable fabrics consist of a copolymer of glycolide/lactide at a 90/10 mol/mol composition.

3. The synthetic fabric of claim 1, where the first and the second absorbable fabrics comprise of staples having a length from about 0.75 to 2.5 inches.

4. The synthetic fabric of claim 3, where the staples are crimped.

5. The synthetic fabric of claim 4, where the first absorbable fabric is compacted to a thickness of about 0.5 mm to about 1.5 mm, more preferably about 1 mm.

6. The synthetic fabric of claim 5, where the second absorbable fabric is compacted to a thickness of about 0.75 mm to 3 mm, more preferably about 1 mm.

7. The synthetic fabric of claim 5, where one sheet of the first absorbable fabric and one sheet of the second absorbable sheet are needle-punched into each other.

8. The synthetic fabric of claim 7 wherein the fabric further comprises at least one hemostatic agent.

9. The synthetic fabric according to claim 8 wherein the fabric further comprises fibrinogen and thrombin as the hemostatic agent.

10. The synthetic fabric according to claim 9 wherein the fibrinogen and thrombin are provided on the fabric as lyophilized powders.

11. The synthetic fabric according to claim 10 wherein the lyophilized powders are dispersed unevenly as measured from the outer surface of the first layer to the outer surface of the second layer.

12. A method for using the synthetic fabric of claim 11 as a medical device.

13. The method according to claim 12 wherein the device provides and maintains effective hemostasis when applied to a wound requiring hemostasis.

14. The method according to claim 12 wherein the device controls and abates mild to moderate bleeding within an effective time of from about 1 to about 10 minutes.

15. The synthetic fabric according to claim 1 wherein strips of from about ⅜

inch wide to about 2 inches long have measured tensile strengths (Newton/cm) as measured in an Instron Tensile Analyzer of;

a. about 120 in dry condition;

b. about 115 in wet condition for 90 minutes;

c. about 90 in wet condition for 4 days;

d. about 52 in wet condition for 7 days;

e. about 29 in wet condition for 11 days;

f. about 16 in wet condition for 14 days.