Closed wound drainage system

• US 7,520,872 B2
• Filed: 07/30/2004
• Issued: 04/21/2009
• Est. Priority Date: 09/13/2002
• Status: Active Grant

• Current Assignee: Convatec Limited (ConvaTec Group Plc)
• Original Assignee: Neogen Technologies, Inc.
• Inventors: Biggie, Lydia B., Biggie, John J., Dawson, John A.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Bogart; Michael G
• Application Number:
  US10/909,222
• Publication Number:
  US 20050137539A1
• Time in Patent Office: 1,726 Days
• Field of Search: 604/289, 604/290, 604/304, 604/305, 604/313, 604/315, 604/316, 604/540, 604/543, 604/317, 604/319, 604/322, 604/327, 604/332, 604/334, 604/336, 604/356, 601 6- 14
• US Class Current: 604/319
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/78 Means for preventing overflow or contamination of the pumping systems combined with drainage containers A61M1/60
• CPC Class Codes: A61M 1/784 by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/882 Draining devices provided with means for releasing antimicrobial or gelation agents in the drained fluid
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 1/94 with gas supply means
• CPC Class Codes: A61M 1/98 Containers specifically adapted for negative pressure wound therapy
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

A portable closed wound drainage system that uses a pouch shaped dressing which is inserted into a wound. At least a portion of the outer surface of the pouch 1 is porous to allow exudates to enter. Exudates are removed from the pouch by flexible tubing which is secured inside the pouch at one end, and secured at the other end to a portable drain/suction unit. The pouch contains porous material, and may optionally contain beads and fillers which are antibacterial in nature. The tubing can have a single or multi-lumen structure with perforations in the side walls of the end of the tube that is inserted in the pouch to allow body fluids to enter laterally. The portable drain/suction unit is preferably a portable battery powered device. The pouch and the tube are sealed by a flexible sealing material which is applied to the outer surface of the skin around the periphery of the pouch and the tubing as it exits the pouch. This sealing material is preferably a hydro-colloid, a silicone, or a lyogel, such as a hydrogel, which are easily deformable. A cosmetic cover sheet is attached to the patient'"'"'s skin over the closed wound drainage system.

Claims

1. A closed wound dressing system comprising:

a layer of moisture permeable gel for application to an upper surface of a wound area and forming a cavity in the gel layer that is open to a wound adjacent to the lower surface of the gel layer, the gel layer being sized to extend beyond the upper surface of the wound area to cover and extend over the wound area without extending into the wound area for attachment to healthy skin outside the wound area, the lower surface of the gel layer adhering to the healthy skin around the wound area without the use of adhesives, the gel layer is permeable to moisture,

tubing having an inner conduit, a distal end and a proximal end, a distal end portion of the tubing extending into the cavity, the tubing being attached to a gel sealant and extending into the cavity formed in the gel layer,

a vacuum pump attached to the proximal end of the tubing to apply a negative pressure to the inner conduit,

a porous material attached to the lower surface of the gel layer extending across an opening to the cavity below the distal end of the tubing without extending into the wound area so that material drawn from a wound into the tubing passes through the porous material,

a porous packing packed in the cavity in the gel layer without extending into the wound area; and

a container connected to a proximal end portion of the tubing to accept material drawn into the tubing from a wound.

2. The closed wound dressing system of claim 1 wherein the gel layer is at least one material selected from hydro-colloids, lyogels, hydrogels and self-sustaining, non-flowable, pliable gels having a water soluble humectant entrapped within a polymeric matrix having therein acrylic acid or acrylamide monomer moieties.

3. The closed wound dressing system of claim 1 wherein the gel layer is a self-sustaining pliable gel comprising from about 10 to 25% by weight synthetic polymeric matrix, from about 10 to 50% by weight water, and a substantial quantity of water soluble humectant entrapped within the matrix, the gel layer being characterized by the property of absorbing and desorbing moisture.

4. The closed wound dressing system of claim 1 wherein the gel layer stabilizes temperature in the wound area.

5. The closed wound dressing system of claim 1 wherein the gel layer maintains moisture levels in the wound area and in the healthy skin outside the wound area.

6. The closed wound dressing system of claim 1 wherein the gel layer is impermeable to gas.

7. The closed wound dressing system of claim 1 wherein the gel layer is flexible.

8. The closed wound dressing system of claim 1 wherein the gel layer is capable of forming an airtight seal with the healthy skin outside the wound area.

9. The closed wound dressing system of claim 1 wherein the gel layer is a polymer matrix having a high glycerine content and bacteriostatic and fungistatic properties.

10. The closed wound dressing system of claim 1 wherein the tubing further comprises at least a first lumen and a second lumen, wherein the first lumen applies vacuum pressure to the wound area.

11. The closed wound dressing system of claim 10 wherein the second lumen delivers medication to the wound area.

12. The closed wound dressing system of claim 10 wherein the second lumen provides a path for an electrical line to deliver electrical stimulation to the wound area.

13. The closed wound dressing system of claim 1 wherein the porous packing in the cavity is a woven organic, a non-woven organic, or a fiberfill.

14. The closed wound dressing system of claim 1 wherein the closed wound dressing system is a surface dressing system.

15. The closed wound dressing system of claim 1 wherein the upper surface of the gel layer is covered by a protective material.

16. The closed wound dressing system of claim 1 further including tape for aiding in securing the gel layer over the wound area.

17. The closed wound dressing system of claim 1 wherein the negative pressure modulates from about 1 millimeter of mercury to about 275 millimeters of mercury below atmospheric pressure.

18. The closed wound dressing system of claim 1 wherein the lower surface of the gel layer includes a removable release sheet.

19. The closed wound dressing system of claim 1 wherein the gel layer and the tubing contain an air-tight seal therebetween.

20. The closed wound dressing system of claim 1, wherein the gel layer has a tackiness which is adjustable based on the desired level of adhesion of the gel layer to the healthy skin outside the wound area.

21. The closed wound dressing system of claim 1, wherein the vacuum pump applies negative pressure which is modulated within a selected range.

22. The closed wound dressing system of claim 1 wherein the gel layer is at least one material selected from hydro-colloids, lyogels, and hydrogels.

23. A closed wound dressing system comprising:

a layer of moisture permeable gel for application to an upper surface of a wound area and forming a cavity in the gel layer that is open to a wound adjacent to the lower surface of the gel layer, the gel layer being sized to extend beyond the upper surface of the wound area to cover and extend over the wound area without extending into the wound area for attachment to healthy skin outside the wound area, the lower surface of the gel layer adhering to the healthy skin around the wound area without the use of adhesives, the gel layer is permeable to moisture, the gel layer comprising a water soluble humectant entrapped within a polymeric matrix having therein acrylic acid or acrylamide monomer moieties,

tubing having an inner conduit, a distal end and a proximal end, a distal end portion of the tubing extending into the cavity, the tubing being attached to a gel sealant and extending into the cavity formed in the gel layer,

a vacuum pump attached to the proximal end of the tubing to apply a negative pressure to the inner conduit,

a porous material attached to the lower surface of the gel layer extending across an opening to the cavity without extending into the wound area so that material drawn from a wound into the tubing passes through the porous material, the porous material covering and extending over the wound area without extending into the wound area,

a porous packing packed in the cavity in the gel layer without extending into the wound area; and

a container connected to a proximal end portion of the tubing to accept material drawn into the tubing from a wound.

24. The closed wound dressing system of claim 23 wherein the gel layer stabilizes temperature in the wound area.

25. The closed wound dressing system of claim 23 wherein the gel layer maintains moisture levels in the wound area and in the healthy skin outside the wound area.

26. The closed wound dressing system of claim 23 wherein the gel layer is impermeable to gas.

27. The closed wound dressing system of claim 23 wherein the gel layer is flexible.

28. The closed wound dressing system of claim 23 wherein the gel layer is capable of forming an airtight seal with the healthy skin outside the wound area.

29. The closed wound dressing system of claim 23 wherein the tubing further comprises at least a first lumen and a second lumen, wherein the first lumen applies vacuum pressure to the wound area.

30. The closed wound dressing system of claim 29 wherein the second lumen delivers medication to the wound area.

31. The closed wound dressing system of claim 29 wherein the second lumen provides a path for an electrical line to deliver electrical stimulation to the wound area.

32. The closed wound dressing system of claim 23 wherein the porous packing in the cavity is a woven organic, a non-woven organic, or a fiberfill.

33. The closed wound dressing system of claim 23 wherein the closed wound dressing system is a surface dressing system.

34. The closed wound dressing system of claim 23 wherein the upper surface of the gel layer is covered by a protective material.

35. The closed wound dressing system of claim 23 further including tape for aiding in securing the gel layer over the wound area.

36. The closed wound dressing system of claim 23 wherein the negative pressure modulates from about 1 millimeter of mercury to about 275 millimeters of mercury below atmospheric pressure.

37. The closed wound dressing system of claim 23 wherein the lower surface of the gel layer includes a removable release sheet.

38. The closed wound dressing system of claim 23 wherein the gel layer and the tubing contain an air-tight seal therebetween.

39. The closed wound dressing system of claim 23 wherein the gel layer has a tackiness which is adjustable based on the desired level of adhesion of the gel layer to the healthy skin outside the wound area.

40. The closed wound dressing system of claim 23 wherein the vacuum pump applies negative pressure which is modulated within a selected range.

41. The closed wound dressing system of claim 23 wherein the gel layer absorbs moisture.