Reduced pressure therapy apparatuses and methods of using same

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 through the pump, and 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. The one-way flow valve can be configured to substantially prevent a flow of gas through the one-way flow valve in a direction of flow away from the pump. The pump assembly can have a controller supported within or by the housing, the controller being configured to control an operation of the pump. The pump has been 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.

1 - 88 . (canceled) 
     
     
         89 . A sterile negative pressure wound therapy device comprising:
 a housing;   a negative pressure source supported by the housing and configured to be connected via a fluid flow path to a wound dressing that covers a wound, the negative pressure source configured to provide negative pressure to the wound via the fluid flow path;   an inlet and an outlet supported by the housing, the inlet and outlet being in fluid communication with the negative pressure source;   a first valve supported by the housing and configured to control a flow of a fluid through the inlet; and   a second valve supported by the housing and configured to control a flow of a fluid through the outlet,   wherein each of the first and second valves is configured to permit a flow of fluid at a flow rate between 0.1 mL/min and 10 mL/min when closed to allow a sterilization gas to penetrate into the housing.   
     
     
         90 . The device of  claim 89 , further comprising a one-way flow valve supported by the housing and being in fluid communication with the inlet and the negative pressure source, the one-way flow valve being configured to prevent the flow of fluid toward the inlet. 
     
     
         91 . The device of  claim 89 , further comprising a pressure sensor configured to monitor pressure in the fluid flow path and a manifold supported by the housing, the manifold comprising a first port in fluid communication with a pressure sensor, a second port in fluid communication with the negative pressure source, and a third port in fluid communication with the inlet. 
     
     
         92 . The device of  claim 89 , wherein each of the first and second valves is configured to permit the flow of gas at a flow rate between 5 mL/min and 10 mL/min when closed. 
     
     
         93 . The device of  claim 89 , further comprising a plurality of indicators positioned at least partially on an exterior surface of the housing, the plurality of indicators comprising:
 a first indicator configured to indicate a leak condition in the fluid flow path; and   a second indicator configured to indicate a remaining capacity of a power source.   
     
     
         94 . The device of  claim 93 , wherein the plurality of indicators comprises a third indicator configured to indicate that the negative pressure source has been activated. 
     
     
         95 . The device of  claim 89 , further comprising a switch positioned at least partially on an exterior surface of the housing, wherein the switch is a sole switch configured to manipulated by a user to activate and deactivate the negative pressure source. 
     
     
         96 . The device of  claim 95 , further comprising a controller supported by the housing and programmed to:
 monitor a duration of time following an initial activation of the device;   in response to manipulation of the switch by the user, activate the negative pressure source to cause provision of negative pressure by the negative pressure source; and   in response to a determination that the duration of time has reached a lifetime threshold, disable provision of negative pressure by the negative pressure source.   
     
     
         97 . The device of  claim 96 , wherein the initial activation comprises connection of a power source. 
     
     
         98 . The device of  claim 96 , further comprising a plurality of indicators positioned at least partially on the exterior surface of the housing, wherein the controller is further programmed to indicate with the plurality of indicators that the duration of time has reached the lifetime threshold. days. 
     
     
         99 . The device of  claim 96 , wherein the lifetime threshold comprises at least ten 
     
     
         100 . A sterile negative pressure wound therapy kit comprising the device of  claim 89  enclosed in a sterile packaging. 
     
     
         101 . The kit of  claim 100 , wherein the sterile packaging comprises a first packaging container and a second packaging container configured to be removably coupled with the first packaging container, at least one of the first or second packaging containers including one or more recesses sized to receive the device. 
     
     
         102 . The kit of  claim 101 , wherein at least one of the first and second packaging containers includes one or more recesses sized to receive one or more batteries configured to be inserted into the housing. 
     
     
         103 . The kit of  claim 102 , wherein the device has been sterilized after being positioned in the sterile packaging. 
     
     
         104 . A method of sterilizing the device of  claim 89  comprising exposing the device to the sterilization gas, wherein the sterilization gas comprises ethylene oxide. 
     
     
         105 . The method of  claim 104 , further comprising placing the device in a chamber and reducing pressure in the chamber relative to atmospheric pressure. 
     
     
         106 . The method of  claim 105 , further comprising, subsequent to reducing pressure in the chamber, introducing the sterilization gas into the chamber and exposing the device to the sterilization gas for a duration of time. 
     
     
         107 . The method of  claim 105 , wherein the sterilization gas is introduced into the chamber at a reduced pressure relative to atmospheric pressure. 
     
     
         108 . The method of  claim 106 , further comprising, subsequent to expiration of the duration of time, flushing the chamber with nitrogen or air.