Reduced pressure therapy apparatuses and methods of using same

• US 9,084,845 B2
• Filed: 11/02/2011
• Issued: 07/21/2015
• Est. Priority Date: 11/02/2011
• Status: Active Grant

• Current Assignee: Smith & Nephew PLC
• Original Assignee: Smith & Nephew PLC
• Inventors: Adie, Gordon Campbell, Allen, Julie, Beadle, Victoria, Collinson, Sarah Jenny, Fryer, Christopher John, Hartwell, Edward Yerbury, Jennings, Elizabeth Anne Fyfe, Nicolini, Derek, Peron, Yannick Louis
• Primary Examiner(s): Hand, Melanie
• Application Number:
  US13/287,897
• Publication Number:
  US 20130110058A1
• Time in Patent Office: 1,357 Days
• Field of Search: 604/313, 604/317, 604/319, 417/1, 417/14, 417/15, 417/18, 417/25, 417/31, 417/38, 417/43, 417/44, 417/2, 417/3, 417/234, 417/235, 417/321, 417/323
• US Class Current: 1/1
• CPC Class Codes: A61M 1/732 Visual indicating means for vacuum pressure
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• 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 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/90 Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
• CPC Class Codes: A61M 1/912 Connectors between dressing and drainage tube
• CPC Class Codes: A61M 1/962 having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
• CPC Class Codes: A61M 1/966 having a pressure sensor on or near the dressing
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/42 Reducing noise
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment

Abstract

Some embodiments comprise a pump assembly for reduced pressure wound therapy, comprising a housing, a flow pathway through the pump, one or more valves in communication with the flow pathway, a pump supported within or by the housing, and a one-way flow valve in fluid communication with the pump. The pump assembly can have a pressure sensor in communication with the flow pathway, and at least one switch or button supported by the housing in communication with a pump controller. The one-way flow valve can substantially prevent a flow of gas therethrough in a direction of flow away from the pump. The pump can be sterilized following the assembly of the pump such that an inside and an outside of the housing, the flow pathway, the one or more valves, the pump, the controller, the battery compartment, and the at least one switch or button have been sterilized.

Claims

1. A pump assembly for reduced pressure wound therapy, comprising:

a housing;

a pump supported within or by the housing, the pump comprising;

a motor;

an inlet and an outlet;

a first valve configured to control a flow of a fluid through the inlet; and

a second valve configured to control a flow of a fluid through the outlet;

a flow pathway through the pump assembly; and

a one-way flow valve in fluid communication with the pump and supported within a manifold that is disposed in the housing and coupled to the inlet of the pump, the one-way flow valve being configured to substantially prevent a flow of gas through the flow pathway in a direction of flow away from the pump.

2. The pump assembly of claim 1, wherein the pump assembly is canisterless.

3. The pump assembly of claim 1, further comprising a controller supported within or by the housing, the controller being configured to control an operation of the pump.

4. The pump assembly of claim 1, further comprising a pressure sensor in communication with the flow pathway.

5. The pump assembly of claim 1, further comprising only one switch or button supported by the housing, the at least one switch or button being accessible to a user and being in communication with the controller.

6. The pump assembly of claim 1, wherein the first valve and the second valve leak at a rate of approximately 0.1 mL/min and 10 mL/min at nominal working pressures.

7. The pump assembly of claim 1, wherein the pump assembly has been sterilized such that at least an inside and an outside of the housing, the flow pathway, the first and second valves, and the pump have been sterilized.

8. The pump assembly of claim 1, further comprising one or more LED lights supported by the housing.

9. The pump assembly of claim 1, wherein the pump assembly comprises one or more batteries and weighs between 80 and 90 grams, including the weight of the one or more batteries.

10. The pump assembly of claim 1, wherein an outside surface of the pump assembly defines a volume of between 60 and 80 cubic centimeters.

11. A negative pressure therapy kit, comprising:

the pump assembly of claim 1;

a dressing;

a conduit coupleable with the dressing and the pump assembly and configured to provide a fluid pathway of reduced pressure to the dressing;

one or more batteries; and

a first packaging element and a second packaging element configured to be removably coupled with the first packaging element, at least one of the first and second packaging elements having recesses for receiving the pump assembly, the dressing, the conduit, and the one or more batteries.

12. The negative pressure therapy kit of claim 11, wherein the negative pressure kit is sterile, having been sterilized after the pump assembly, the dressing, the conduit, and the one or more batteries have been supported inside at least one of the first packaging element and the second packaging element.

13. The negative pressure therapy kit of claim 11, further comprising one or more adhesive sealing strips.

14. The negative pressure therapy kit of claim 11, wherein the one or more batteries are supported outside the housing.

15. The negative pressure therapy kit of claim 11, wherein the negative pressure therapy kit is sterilized with ethylene oxide.

16. The negative pressure therapy kit of claim 11, wherein the dressing comprises:

a transmission layer;

an absorbent layer for absorbing wound exudate, the absorbent layer overlying the transmission layer; and

a cover layer overlying the absorbent layer and comprising an orifice therethrough.

17. The negative pressure therapy kit of claim 11, wherein the dressing comprises a suction port for applying negative pressure to the dressing for the application of topical negative pressure at a wound site.

18. The negative pressure therapy kit of claim 17, wherein the suction port comprises a connector portion for connecting the suction port to the pump assembly and a sealing surface for sealing the suction port to the cover layer of the dressing.

19. The negative pressure therapy kit of claim 11, wherein the dressing comprises a liquid impermeable gas permeable filter element arranged to prevent a liquid from entering the connector portion.

20. The negative pressure therapy kit of claim 11, wherein the first packaging element comprises PETG.

21. A negative pressure therapy system, comprising:

the pump assembly of claim 1; and

a dressing.

22. The negative pressure therapy kit of claim 21, wherein a wound facing surface of the dressing is at least partially covered by a silicone based adhesive configured to create a low leak rate seal with skin surrounding the wound.

23. A method of treating a wound with negative pressure, comprising:

providing a dressing;

applying the dressing over the wound so as to create a substantially fluid tight seal over the wound; and

delivering negative pressure to the wound through the dressing using the pump assembly of claim 1.

24. The method of treating a wound with negative pressure of claim 23, wherein applying the dressing over the wound so as to create a substantially fluid tight seal over the wound and delivering negative pressure to the wound through the dressing using the pump assembly of claim 1 is performed in an operating room.

32. A method for initiating treatment of a wound in an operating room, comprising:

applying a sterile dressing over a wound so as to create a substantially fluid tight seal over the wound;

coupling a sterile pump assembly according to claim 1 to the dressing via a sterile conduit; and

reducing a level of pressure between the dressing and the wound in an operating room by activating the pump assembly in the operating room.

25. A canisterless pump assembly for reduced pressure wound therapy, comprising:

a housing; and

a pump supported within or by the housing, the pump comprising;

a motor;

an inlet and an outlet;

a first valve configured to control a flow of a fluid through the inlet; and

a second valve configured to control a flow of a fluid through the outlet;

wherein;

the pump assembly is canisterless; and

the first and second valves each has a leakage rate of between approximately 5 mL/min and approximately 10 mL/min at nominal working pressures.

26. The pump assembly of claim 25, wherein the pump assembly comprises a one-way flow valve in fluid communication with the pump, the one-way flow valve being configured to substantially prevent a flow of gas through the flow path in a direction of flow away from the pump.

27. The pump assembly of claim 25, wherein the pump assembly has been sterilized following the assembly of the pump assembly such that at least an inside and an outside of the housing, the flow pathway, the one or more valves, and the pump have been sterilized.

28. The pump assembly of claim 25, wherein the pump assembly comprises one or more batteries and weighs between 80 and 90 grams, including the weight of the one or more batteries.

29. The pump assembly of claim 25, wherein an outside surface of the pump assembly defines a volume of between 60 and 80 cubic centimeters.

30. A sterile pump kit, comprising:

the pump assembly of claim 25;

a dressing;

a conduit coupleable with the dressing and the pump assembly and configured to provide a fluid pathway of reduced pressure to the dressing;

one or more batteries; and

a first packaging element and a second packaging element configured to be removably coupled with the first packaging element, at least one of the first and second packaging elements having recesses for receiving the pump assembly, a dressing, a conduit coupleable with the dressing and the pump assembly and configured to provide a fluid pathway of reduced pressure to the dressing;

wherein the sterile pump kit has been sterilized after the pump assembly, the dressing, the conduit, and the one or more batteries have been supported inside at least one of the first packaging element and the second packaging element.

31. The sterile pump kit of claim 30, wherein the dressing comprises a liquid impermeable gas permeable filter element arranged to prevent a liquid from entering the connector portion.

33. The sterile pump kit of claim 30, further comprising one or more sealing strips, wherein the sterile pump kit is configured such that the dressing must be removed from the first packaging element before the sealing strips can be removed from the first packaging element.

34. The pump assembly of claim 25, further comprising a controller supported within or by the housing, the controller being configured to control an operation of the pump.

35. The pump assembly of claim 25, further comprising a pressure sensor in communication with a flow pathway through the pump assembly.

36. The pump assembly of claim 25, further comprising at least one switch or button supported by the housing, the at least one switch or button being accessible to a user and being in communication with the controller.

37. The pump assembly of claim 34, further comprising a battery compartment supported by or formed within the housing.