Integrated sensor enabled wound monitoring and/or therapy dressings and systems

Abstract

A wound monitoring and/or therapy system can include a substantially stretchable substrate supporting a plurality of electronic components, including sensors, and a plurality of electronic connections that connect at least some of the electronic components. The electronic components can also include a circuit board supporting at least one controller configured to control at least some of the sensors, the circuit board configured to operate without failure when the substrate is flexed as a result of strain. A calibration track can be positioned on the substrate and connected to a monitoring circuit configured to measure a change in resistance of the calibration track indicative of resistance change of at least some of the plurality of electronic connections. The system can include a controller with a circuit board supporting a plurality of electrical components and an antenna configured to communicate with the substrate, the antenna at least partially enclosing the circuit board.

1 . A wound monitoring and/or therapy system comprising:
 a wound dressing configured to be positioned over a wound, the wound dressing comprising a substantially stretchable substrate supporting a plurality of electronic components and a plurality of electronic connections that connect at least some of the plurality of electronic components,   the plurality of electronic components comprising a plurality of sensors configured to obtain measurement data of at least one of the wound or periwound, and   the plurality of electronic components comprising at least one controller positioned on a circuit board, the at least one controller configured to control at least some of the plurality of sensors, the circuit board formed from a reinforced material and configured to operate without failure when the circuit board is flexed as a result of strain on the wound dressing.   
     
     
         2 . The system of  claim 1 , wherein the reinforced material of the circuit board has been reinforced by being subjected to compression in order to increase resiliency of the reinforced material of the circuit board to flexing. 
     
     
         3 . The system of  claim 1 , wherein the reinforced material of the circuit board has been reinforced by being pre-strained. 
     
     
         4 . The system of  claim 1 , wherein the wound dressing comprises a coating covering at least some of the plurality of electronic components and at least some of the plurality of electronic connections, and wherein the reinforced material of the circuit board has been reinforced by the coating compressing the reinforced material of the circuit board when being applied to the wound dressing. 
     
     
         5 . The system of  claim 4 , wherein the coating is hydrophobic and/or biocompatible. 
     
     
         6 . The system of  claim 1 , wherein the wound dressing further includes an antenna configured to communicate measurement data to a remote computing device. 
     
     
         7 . The system of  claim 1 , further comprising a power source positioned on the substrate, the power source configured to power the plurality of electronic components. 
     
     
         8 . The system of  claim 7 , wherein the power source is not enclosed in a separate casing or enclosure. 
     
     
         9 . The system of  claim 7 , wherein the substrate comprises first and second portions, wherein the power source comprises an anode supported by the first portion of the substrate and a cathode supported by the second portion of the substrate, and wherein the power source further comprises an electrolyte layer positioned between the anode and cathode. 
     
     
         10 . The system of  claim 9 , wherein the anode is positioned on a first electronic connection of the plurality of electronic connections and the cathode is positioned on a second electronic connection of the plurality of electronic connections. 
     
     
         11 . The system of  claim 1 , wherein the at least one controller is configured to be activated by one or more of: flexing the wound dressing, activating an activation switch, bursting a bubble of conductive material, charging a transistor, initiating a magnetic trigger, or triggering a piezoelectric element. 
     
     
         12 . The system of  claim 1 , wherein the system is not configured to be physically connected to an external controller that controls any of the plurality of sensors or receives any of the measurement data. 
     
     
         13 . The system of  claim 1 , wherein the substrate comprises a plurality of perforations configured to allow fluid to pass through the substrate. 
     
     
         14 . The system of  claim 1  further comprising a negative pressure source configured to be fluidically connected to the wound dressing, the negative pressure source configured to supply negative pressure to the wound. 
     
     
         15 . The system of  claim 1  further comprising:
 a control device including at least one controller configured to obtain the measurement data from the plurality of sensors and a power source configured to provide power to the at least one controller and the plurality of sensors, the at least one controller and power source enclosed in an enclosure. 
 
     
     
         16 . The system of  claim 15 , wherein the enclosure comprises a first portion supporting the at least one controller and the power source and a second portion configured to be attached to at least one pin positioned on the first portion. 
     
     
         17 . The system of  claim 15 , wherein the enclosure is configured to substantially shield the at least one controller from at least one of electromagnetic interference (EMI) or electrostatic discharge (ESD). 
     
     
         18 . A method of manufacturing a wound dressing configured to be positioned over a wound and be used in a wound monitoring and/or therapy system, the method comprising:
 pre-straining a circuit board comprising a controller by at least one of:
 stretching at least a portion of a substantially flexible substrate of the wound dressing, positioning the circuit board on at least the portion of the substrate, and subsequently relaxing at least the portion of the substrate; or 
 compressing the circuit board and subsequently positioning the circuit board on the substrate, 
   wherein the substrate supports a plurality of sensors configured to obtain measurement data of at least one of the wound or periwound and a plurality of electronic connections that connect at least some of the plurality of sensors and the controller, and wherein the controller is configured to control at least some of the plurality of sensors, and   wherein pre-straining the circuit board increases resiliency of the circuit board to flexing and causes the circuit board to operate without failure when the circuit board is flexed as a result of strain being applied to the substrate.   
     
     
         19 . The method of  claim 18 , wherein pre-straining the circuit board further comprises positioning the circuit board on the substrate, covering at least a portion of the substrate including the circuit board with coating, and causing the coating to shrink by curing the coating, thereby applying compression to at least the portion of the substrate including the circuit board. 
     
     
         20 . The method of  claim 19 , wherein the coating is at least one of biocompatible or hydrophobic. 
     
     
         21 - 44 . (canceled)