Flexible reduced pressure treatment appliance

• US 8,795,243 B2
• Filed: 03/08/2010
• Issued: 08/05/2014
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Bluesky Medical Group Inc. (Smith & Nephew PLC)
• Inventors: Weston, Richard Scott
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): TREYGER, ILYA Y
• Application Number:
  US12/719,767
• Publication Number:
  US 20100160880A1
• Time in Patent Office: 1,611 Days
• Field of Search: 604/313, 604/314, 604/316, 604/305, 604540-544
• US Class Current: 604/313
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61M 1/60 Containers for suction drainage, adapted to be used with an external suction source containers not adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 1/682 bulb-type, e.g. nasal mucus aspirators
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/98 Containers specifically adapted for negative pressure wound therapy
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24

Abstract

A wound treatment appliance is provided for treating all or a portion of a wound. In some embodiments, the appliance comprises an impermeable flexible overlay that covers all or a portion of the wound for purposes of applying a reduced pressure to the covered portion of the wound. In other embodiments, the wound treatment appliance also includes a vacuum system to supply reduced pressure to the wound in the area under the flexible overlay. In yet other embodiments, the wound treatment appliance also includes wound packing means to prevent overgrowth of the wound or to encourage growth of the wound tissue into an absorbable matrix comprising the wound packing means. In still other embodiments, the appliance may include a suction drain. In other embodiments, the appliance may include a collection chamber to collect and store exudate from the wound. In yet other embodiments, a suction bulb may be used to provide a source of reduced pressure to an impermeable overlay that covers all or a portion of the wound. Finally, methods are provided for using various embodiments of the wound treatment appliance.

Claims

1. An apparatus for administering reduced pressure treatment to a wound on a body, comprising:

a flexible overlay positionable over the wound and adapted to maintain reduced pressure under the flexible overlay, the flexible overlay configured to form a seal surrounding the wound and having at least one opening therein;

a vacuum source configured to provide reduced pressure through the opening to a space under the overlay;

a conduit for connecting the overlay to the vacuum source;

a hydrophobic filter positioned at the opening, wherein the hydrophobic filter is configured to retain wound exudate in the space under the overlay;

wherein the flexible overlay defines at least in part a collection chamber configured such that exudate from the wound can flow into the collection chamber and is retained therein, but the wound exudate within the collection chamber is prevented from flowing past the hydrophobic filter;

and further comprising a membrane that acts as a barrier separating the collection chamber and the flexible overlay, so that the membrane acts as a portion of the surface of the collection chamber and a portion of the surface of the flexible overlay.

4. The apparatus of claim 1, further comprising a tissue protection member beneath the overlay.

5. The apparatus of claim 4, wherein adhesive is applied to the tissue protection member.

6. The apparatus of claim 1, further comprising a wound packing member beneath the overlay.

7. The apparatus of claim 6, wherein the wound packing member is an absorbable matrix.

8. The apparatus of claim 1, wherein the chamber is integrally formed with the overlay.

9. The apparatus of claim 1, further comprising a port supported by the overlay adapted to connect to the vacuum source.

10. The apparatus of claim 1, further comprising an adhesive applied to the flexible overlay.

11. The apparatus of claim 1, wherein the flexible overlay comprises a semi-rigid material configured to maintain its shape in the absence of vacuum.

12. The apparatus of claim 11, wherein the opening in the flexible overlay is provided at an apex of the flexible overlay and the flexible overlay comprises a base opening sized to substantially encompass the wound.

13. The apparatus of claim 12, wherein the flexible overlay has a shape selected from the group consisting of bell-shaped, conical-shaped, and cup-shaped.

14. The apparatus of claim 12, wherein the collection chamber is positioned below the apex of the flexible overlay and above the base opening.

35. The apparatus of claim 1, wherein the membrane is configured to prevent wound exudate within the collection chamber from flowing back into the wound.

36. The apparatus of claim 1, wherein the membrane has at least one port therein so that the volume within the collection chamber is in fluid communication with the volume under the flexible overlay in the area of the wound.

2. An apparatus for administering reduced pressure treatment to a wound on a body, comprising:

a flexible overlay positionable over the wound and adapted to maintain reduced pressure under the flexible overlay, the flexible overlay configured to form a seal surrounding the wound and having at least one opening therein;

a vacuum source configured to provide reduced pressure through the opening to a space under the overlay;

a conduit for connecting the overlay to the vacuum source;

a hydrophobic filter positioned at the opening, wherein the hydrophobic filter is configured to retain wound exudate in the space under the overlay;

wherein the flexible overlay defines at least in part a collection chamber configured such that exudate from the wound can flow into the collection chamber and is retained therein, but the wound exudate within the collection chamber is prevented from flowing past the hydrophobic filter; and

further comprising a membrane configured to prevent wound exudate within the collection chamber from flowing back into the wound.

3. The apparatus of claim 2, wherein the membrane comprises at least one one-way valve.

15. A method of treating a wound, comprising:

positioning a flexible overlay over the wound, the flexible overlay forming a seal surrounding the wound, wherein the flexible overlay comprises a membrane that prevents wound exudate within the chamber from flowing back to the wound;

supplying a source of reduced pressure to the overlay through an opening in the overlay, wherein a hydrophobic filter is positioned at the opening;

drawing wound exudate from the wound into a collection chamber defined at least in part by the flexible overlay; and

preventing wound exudate within the chamber from flowing past the hydrophobic filter.

16. The method of claim 15, wherein supplying a source of reduced pressure to the overlay comprises providing a conduit coupled to a port on the flexible overlay.

17. The method of claim 16, wherein supplying a source of reduced pressure comprises connecting a vacuum source to the conduit.

18. The method of claim 15, further comprising positioning a tissue protection member adjacent the wound.

19. The method of claim 15, further comprising positioning a wound packing member between the chamber and the wound.

20. The method of claim 15, wherein a portable vacuum pump supplies reduced pressure to the overlay.

21. The method of claim 15, wherein the membrane comprises a valve.

22. The method of claim 15, further comprising preventing wound exudate within the chamber from flowing back into the wound.

23. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

an impermeable flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the impermeable flexible overlay in the area of the wound;

a collection chamber to receive and hold fluid aspirated from the wound;

collection chamber attachment means to operably attach the collection chamber to the impermeable flexible overlay, wherein reduced pressure and the fluid are permitted to flow between the collection chamber and the impermeable flexible overlay; and

reduced pressure supply means to operably connect the collection chamber to a reduced pressure supply source that provides a supply of reduced pressure to the collection chamber, so that the volume within the collection chamber and under the impermeable overlay in the area of the wound to be treated are supplied with reduced pressure by the reduced pressure supply source;

wherein;

the impermeable flexible overlay collapses in the approximate direction of the area of the wound to be treated when reduced pressure is supplied to the volume under the impermeable flexible overlay in the area of the wound, such collapse causing the formation of an approximately hermetic seal between the impermeable flexible overlay and the body in the area of the wound;

the collection chamber is positioned approximately adjacent to the impermeable flexible overlay on the side of the impermeable flexible overlay opposite the wound;

the collection chamber attachment means comprises a membrane;

the membrane acts as a barrier separating the collection chamber and the impermeable flexible overlay, so that the membrane acts as a portion of the surface of the collection chamber and a portion of the surface of the impermeable flexible overlay;

the membrane has at least one port therein so that the volume within the collection chamber is in fluid communication with the volume under the impermeable flexible overlay in the area of the wound.

24. The appliance of claim 23, wherein:

the impermeable flexible overlay has an approximately conical shape or approximately elongated conical shape and comprises;

a base end opening having an either approximately circular shape or approximately elliptical shape, wherein the approximately circularly shaped or approximately elliptically-shaped base end opening is sized to be placed over and enclose the area of the wound to be treated; and

a top end opening opposite the base end opening, wherein the top end opening has either an approximately circular shape or approximately elliptical shape; and

the membrane is sized to be of the same shape and size as the top end opening and the membrane is positioned so that it is attached to the entire perimeter of the top end opening and covers the entire top end opening.

25. The appliance of claim 24, wherein the collection chamber has an approximately conical shape or approximately elongated conical shape and further comprises:

a chamber bottom end opening having an either approximately circular shape or approximately elliptical shape, wherein the approximately circularly shaped or approximately elliptically-shaped chamber bottom end opening is adapted to be of approximately the same size and shape as the top end opening of the impermeable flexible overlay; and

a reduced pressure supply port positioned at the apex of the collection chamber opposite the chamber bottom end opening;

wherein the reduced pressure supply port operably connects the reduced pressure supply means to the collection chamber.

26. The appliance of claim 25, further comprising a micropore filter, a hydrophobic filter, or both, operably connected to the reduced pressure supply port.

27. The appliance of claim 23, wherein the collection chamber attachment means further comprises flow control means operably connected with the at least one port, wherein the flow control means permits the fluid to flow from the volume under the impermeable flexible overlay in the area of the wound through the at least one port to the collection chamber, but not in the opposite direction.

28. The appliance of claim 27, wherein the flow control means comprises a flapper-type valve.

29. An appliance for administering reduced pressure treatment to a wound on a body, the appliance comprising:

a flexible overlay sized to be placed over and enclose the area of the wound to be treated and adapted to maintain reduced pressure in the volume under the flexible overlay in the area of the wound;

a collection chamber to receive and hold fluid aspirated from the wound, the collection chamber being attached to the flexible overlay such that reduced pressure and the fluid are permitted to flow through the collection chamber and the flexible overlay;

a membrane between the overlay and the collection chamber, the membrane forming a bottom surface of the collection chamber;

a port at the top of the collection chamber;

one or more conduits that, in operation, couple the port at the top of the collection chamber with a reduced pressure supply source and provide a supply of reduced pressure to the collection chamber so that the volume within the collection chamber and under the overlay in the area of the wound to be treated are supplied with reduced pressure; and

a hydrophobic filter positioned at the port to retain exudate from the wound within the collection chamber;

wherein;

the collection chamber is positioned approximately adjacent to the flexible overlay on the side of the flexible overlay opposite the wound;

the membrane acts as a barrier separating the collection chamber and the flexible overlay, so that the membrane acts as a portion of the surface of the collection chamber and a portion of the surface of the flexible overlay;

the membrane has at least one port therein so that the volume within the collection chamber is in fluid communication with the volume under the flexible overlay in the area of the wound.

30. The appliance of claim 29, wherein the membrane is approximately elliptically shaped.

31. The appliance of claim 29, wherein the appliance has an approximately elliptical shaped opening surrounding the wound.

32. The appliance of claim 29, wherein a portion of the collection chamber closest to the wound is approximately elliptically shaped.

33. The appliance of claim 29, wherein the appliance is configured to permit a fluid to flow from the volume under the flexible overlay in the area of the wound through the at least one port to the collection chamber, but not in the opposite direction.

34. The appliance of claim 33, wherein the membrane comprises a flapper-type valve.