Medical device

• US 8,118,791 B2
• Filed: 10/31/2007
• Issued: 02/21/2012
• Est. Priority Date: 09/05/1995
• Status: Expired due to Term

• Current Assignee: Argentum Medical LLC
• Original Assignee: Argentum Medical LLC
• Inventors: Flick, A. Bartholomew, Silver, Gregg, Miller, Thomas
• Primary Examiner(s): Anderson, Lynne
• Application Number:
  US11/930,541
• Publication Number:
  US 20080125687A1
• Time in Patent Office: 1,574 Days
• Field of Search: 604/304, 604/307, 604/308
• US Class Current: 604/304
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 13/022 having more than one layer with different fluid retention characteristics
• CPC Class Codes: A61F 13/36 Surgical swabs, e.g. for absorbency or packing body cavities during surgery A61F13/38 takes precedence
• CPC Class Codes: A61F 2013/00119 elastic
• CPC Class Codes: A61F 2013/00251 with macroscopic openings
• CPC Class Codes: A61F 2013/00327 to create projections or depressions in surface
• CPC Class Codes: A61F 2013/00553 with detachable parts
• CPC Class Codes: A61F 2013/00578 conformable; soft or flexible, e.g. elastomeric
• CPC Class Codes: A61F 2013/00604 Multilayer
• CPC Class Codes: A61F 2013/0074 containing foams
• CPC Class Codes: A61F 2013/00859 with macroscopic openings
• CPC Class Codes: A61F 2013/0091 with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61F 2013/00936 metal wound bandages with a metallic layer A61F2013/00234

Abstract

A medical device for example a wound dressing having antibacterial and optionally, antifungal properties, are provided together with methods for making the device. An exemplary dressing includes a layer of silver-containing fabric, (optionally) a layer of absorbent material, and (optionally) a layer of flexible air-permeable and/or water-impermeable material. The dressing can be used for prophylactic and therapeutic care and treatment of skin infections and surface wounds (including surgical incisions), as a packing material, and as a swab for surface cleaning.

Claims

1. A device comprising:

a conductive fabric comprising

a) fibers uniformly coated with metallic silver, wherein the fibers comprise multiple filaments uniformly coated with metallic silver;

b) non-coated elastomer fibers;

c) a surface resistance of 0.001 to 10 ohms/cm²; and

d) a plurality of apertures effective to allow liquids and gases to pass through the device,

wherein the conductive fabric passively releases an effective amount of ionic silver into a wound to reduce or maintain the microorganism population of the wound to less than 10⁵CFU/ml.

2. The device of claim 1, wherein the device has a liquid wicking value of 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or more.

3. The device of claim 1, wherein the apertures have an average diameter of less than about 0.2 microns.

4. The device of claim 1, wherein the device comprises approximately 5 to about 40 wt. % silver.

5. The device of claim 1, wherein the surface resistance is no greater than approximately 5 ohms/cm².

6. The device of claim 1, wherein the surface resistance is no greater than approximately 1 ohm/cm².

7. The device of claim 1, wherein the fabric comprises one or more polymers, yarns, foams, or combinations thereof

8. The device of claim 7, wherein the one or more yarns comprises a synthetic polymer fiber and an elastic component.

9. The device of claim 8, wherein the elastic component comprises a long-chain synthetic polymer comprising at least 85% of a segmented polyurethane.

10. The device of claim 9, wherein the elastic component is not coated with the anti-microbial metal.

11. The device of claim 9, wherein the elastic component is wrapped around the synthetic polymer fiber.

12. The device of claim 11, wherein the synthetic polymer fiber comprises nylon.

13. The device of claim 1, further comprising a second layer.

14. The device of claim 13, wherein the second layer comprises a second layer of conformable, conductive fabric.

15. The device of claim 14, wherein the second layer of conformable conductive fabric is separated from the first conformable, conductive fabric by a plurality of supports.

16. The device of claim 15, wherein the supports comprise nylon.

17. The device of claim 15, wherein the supports are not coated with an anti-microbial metal.

18. The device of claim 16, wherein the nylon supports are uniformly coated with silver.

19. The device of claim 7, wherein the substrate comprises woven or knitted fibers or yarns.

20. The device of claim 7, wherein the substrate comprises non-woven fibers or yarns.

21. The device of claim 14, further comprising a third layer adjacent to said second layer, said third layer made of an air-permeable material.

22. The device of claim 14, further comprising a third layer adjacent to said second layer, said third layer made of a water-permeable material.

23. The device of claim 1, wherein the device maintains a transepithelial electrical potential of a wound at about −

10 mvolts to about −

70 mvolts.

24. The device of claim 1, wherein the device is configured to reduce a wound potential by about 0.1 mV to about 20 mV.

25. The wound dressing of claim 1, wherein ionic silver released into the pathology reduces and maintains the microorganism population of the pathology by at least two log units over a period of 24 hours to accelerate or enhance wound healing of the pathology.

26. The wound dressing of claim 1 wherein the microorganism population comprises bacteria.

27. The wound dressing of claim 1, wherein the microorganism population comprises fungi.

28. The wound dressing of claim 1, wherein the effective amount of ionic silver is released into the pathology for at least three days.

29. The wound dressing of claim 1 wherein the elastomer comprises a polyurethane-polyurea copolymer.

30. The wound dressing of claim 1 wherein the fabric is a knit fabric, woven fabric, twisted and knotted fabric, non-woven fabric, or compound/complex fabric.

31. A medical device comprising:

a conductive fabric comprising

a) fibers uniformly coated with metallic silver, wherein the fibers comprise multiple filaments uniformly coated with metallic silver;

b) non-coated elastomer fibers;

c) a surface resistance of 0.001 to 10 ohms/cm²; and

d) a plurality of apertures effective to allow liquids and gases to pass through the device,

wherein the conductive fabric passively releases more than 3 μ

g/ml of ionic silver in about 1 hour when in contact with fluid exudate.