Temperature monitoring and control for negative pressure wound therapy systems

Abstract

Negative pressure therapy can include a negative pressure source configured to provide negative pressure to a patient's wound covered by a wound dressing, first and second sensors configured to measure the temperature of the negative pressure system, an electronic control circuit configured to control operation of the negative pressure source in response to the temperature measured by the first sensor, and a programmable controller configured to control operation of the negative pressure source in response to the temperature measured by the second sensor, wherein the controller is configured to control operation of the negative pressure source independently of the electronic control circuit.

Description

[Technical Field]

[0001] SUMMARY OF THE INVENTION The embodiments described herein relate to devices, systems, and methods for treating wounds, for example, using dressings in combination with negative pressure wound therapy.

[0002] 2. Description of Related Art Treatment of open or chronic wounds that are too large to close naturally or that otherwise do not heal through the application of negative pressure to the wound site is well known in the art. Negative pressure wound therapy ("NPWT") systems currently known in the art involve placing a fluid-impermeable or semi-permeable cover over the wound, using various means to seal the cover against the patient's tissue surrounding the wound, and connecting a source of negative pressure (such as a vacuum pump) to the cover in such a way that negative pressure is created and maintained directly beneath the cover. Such negative pressure is believed to promote wound healing by promoting the formation of granulation tissue at the wound site and supporting the body's normal inflammatory process, while simultaneously removing excess fluid that may contain harmful cytokines and / or bacteria. However, further improvements in NPWT are needed to fully realize the therapeutic benefits. Summary of the Invention

[0003] The negative pressure wound therapy system can include a negative pressure source configured to provide negative pressure to a patient's wound covered by a wound dressing. The negative pressure system can include a first sensor configured to measure a temperature of at least a first portion of the negative pressure system. The negative pressure system can include a second sensor configured to measure a temperature of at least one of the patient or at least a second portion of the negative pressure system. The negative pressure system can include an electronic control circuit configured to control operation of the negative pressure source in response to a temperature measured by the first sensor. The negative pressure system can include a controller configured to control operation of the negative pressure source in response to a temperature measured by the second sensor. The controller can be programmable. The controller can be configured to control operation of the negative pressure source independently of the electronic control circuit.

[0004] The negative pressure wound therapy system of the preceding paragraph and / or any of the negative pressure wound therapy systems, apparatuses, or devices disclosed herein may include one or more of the following features. The controller may be configured to reduce activity of the negative pressure source in response to a temperature measured by the second sensor meeting a second temperature threshold lower than the first temperature threshold and not meeting the first temperature threshold. Reducing activity of the negative pressure source may include reducing the duty cycle of the negative pressure source. The negative pressure wound therapy system may include a wound dressing. At least one of the negative pressure source, the first sensor, the second sensor, the electronic control circuitry, or the controller may be at least partially supported by the wound dressing. The temperature measured by the first sensor may indicate the temperature of the negative pressure source. The electronic control circuitry may be configured to shut down the negative pressure source in response to a determination that the temperature measured by the first sensor meets a temperature threshold indicative of unsafe operation. The electronic control circuitry may include a comparator configured to output a determination that the temperature measured by the first sensor meets a temperature threshold indicative of unsafe operation. The comparator can accept the temperature measured by the first sensor as a first input. The comparator can accept a temperature threshold as a second input. The comparator can be configured to operate in the presence of noise as a result of at least one of filtering one or more inputs of the comparator or providing feedback between the first or second input of the comparator and an output of the comparator. The first and second inputs of the comparator can be low-pass filtered. The feedback can include a resistor positioned between the non-inverting input of the comparator and the output of the comparator. The negative pressure wound therapy system can include at least a power supply that can be configured to provide power to the negative pressure source. The negative pressure wound therapy system can include a boost converter configured to increase the power provided by the power supply and provide the increased power to the negative pressure source. The first sensor can be configured to measure the temperature of the boost converter. The first sensor can be positioned proximate to the boost converter.

[0005] The negative pressure wound therapy system of any of the preceding paragraphs and / or any of the negative pressure wound therapy systems, apparatus, or devices disclosed herein may include one or more of the following features: The second sensor may include a pair of sensors. The controller may be configured to determine a temperature of at least one of the negative pressure source or another component of the negative pressure system based on a difference between a measurement value of a first sensor and a measurement value of a second sensor of the pair of sensors. The first sensor and the second sensor of the pair of sensors may be configured to measure pressure and temperature. The first sensor of the pair of sensors may be positioned at an inlet of the negative pressure source, and the second sensor of the pair of sensors may be positioned at an outlet of the negative pressure source. The controller can be configured to control operation of the negative pressure source in response to the temperature measured by the second sensor by at least one of: shutting down the negative pressure source in response to the temperature measured by the second sensor meeting a first temperature threshold indicative of unsafe operation; reducing activity of the negative pressure source in response to the temperature measured by the second sensor meeting a second temperature threshold less than the first temperature threshold but not meeting the first temperature threshold; or taking no action in response to the temperature measured by the second sensor not meeting the second temperature threshold. Reducing activity of the negative pressure source can include reducing a duty cycle of the negative pressure source. The controller can be configured to store in memory a first indication that at least one of the first temperature threshold or the second temperature threshold has been met and a second indication that the temperature measured by the first sensor meets the temperature threshold indicative of unsafe operation.

[0006] The negative pressure wound therapy system of any of the preceding paragraphs and / or any of the negative pressure wound therapy systems, apparatus, or devices disclosed herein may include one or more of the following features: The controller may be configured to disable activation of the negative pressure source in response to determining that a temperature measured by at least one of the first sensor or the second sensor meets a temperature threshold indicative of unsafe operation. The first and second portions of the negative pressure system may be the same. The negative pressure wound therapy system may include a switch configured to enable activation of the negative pressure source. The switch may be configured to deactivate in response to determining that a temperature measured by at least one of the first sensor or the second sensor meets a temperature threshold indicative of unsafe operation. The second sensor may be configured to measure a patient temperature. The controller may be configured to deactivate the negative pressure source in response to determining that a temperature measured by the second sensor meets a temperature threshold indicative of a high patient temperature. The controller may be configured to execute instructions to control operation of the negative pressure source in response to a temperature measured by the second sensor.

[0007] Disclosed is a negative pressure wound therapy system of any of the preceding paragraphs and / or a method of operating any of the negative pressure wound therapy systems, apparatus, or devices disclosed herein. [Brief explanation of the drawings]

[0008] [Figure 1A] 1 illustrates a wound dressing incorporating a negative pressure source and / or other electronic components within the wound dressing. [Figure 1B] 1 illustrates a wound dressing incorporating a negative pressure source and / or other electronic components within the wound dressing. [Figure 1C] 1 illustrates a wound dressing incorporating a negative pressure source and / or other electronic components within the wound dressing. [Figure 2A] 1 illustrates an electronic unit that may be incorporated into a wound dressing. [Figure 2B]1 illustrates an electronic unit that may be incorporated into a wound dressing. [Figure 3] FIG. 1 is an exploded perspective view of one embodiment of an electronic assembly enclosing an electronic unit within a housing. [Figure 4A] 4 illustrates a bottom perspective view of the electronic assembly of FIG. 3. [Figure 4B] 4 illustrates a top perspective view of the electronic assembly of FIG. 3. [Figure 5A] FIG. 1 is an exploded view of a wound dressing incorporating an electronic assembly within the wound dressing layer. [Figure 5B] 1 illustrates a cross-sectional layout of material layers of a wound dressing incorporating an electronic assembly within the dressing. [Figure 6A] 1 shows components of an electronic assembly. [Figure 6B] 1 shows components of an electronic assembly. [Figure 7A] 1 shows components of an electronic assembly. [Figure 7B] 1 shows components of an electronic assembly. [Figure 8] 1 shows the pump outlet mechanism. [Figure 9] A block diagram of the TNP system electronics is shown. [Figure 10A] 1 shows the electronics and other components of the TNP system. [Figure 10B] 1 shows the electronics and other components of the TNP system. [Figure 11] 1 shows a circuit diagram of a portion of a TNP system. DETAILED DESCRIPTION OF THE INVENTION

[0009] Embodiments disclosed herein relate to devices and methods for treating wounds with reduced pressure, including negative pressure sources and wound dressing components and devices, including, but not limited to, wound overlays, backing layers, cover layers, drapes, sealing layers, spacer layers, absorbent layers, transmission layers, wound contact layers, packaging materials, fillers, and / or fluid connectors, which devices and components may be collectively referred to herein as dressings.

[0010] It will be understood that throughout this specification, references will be made to wounds. The term wound should be interpreted broadly to encompass open and closed wounds where the skin is torn, incised, or perforated, or where trauma causes contusion, or any other surface or other condition or defect in a patient's skin, or anything else that would benefit from reduced pressure treatment. A wound is therefore broadly defined as any damaged area of ​​tissue, which may or may not produce fluid. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incisional wounds resulting from surgery, trauma, sternotomy, fasciotomy, or other conditions, dehiscence wounds, acute wounds, chronic wounds, subacute and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers, and venous ulcers.

[0011] It will be appreciated that embodiments of the present disclosure are generally applicable for use in NPWT or topical negative pressure ("TNP") therapy systems. Briefly, negative pressure wound therapy can assist in the closure and healing of many forms of "difficult-to-heal" wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, and removing excessive exudate, reducing bacterial load (and therefore infection risk). In addition, therapy can reduce wound unrest, leading to faster healing. TNP therapy systems can also assist in the healing of surgically closed wounds by removing fluid and helping to stabilize tissue in an apposed position for closure. Further beneficial uses of TNP therapy can be found in grafts and flaps, where removal of excess fluid is important and graft proximity to tissue is required to ensure tissue viability.

[0012] As used herein, a reduced pressure or negative pressure level, such as -X mmHg, represents a pressure level relative to normal ambient air pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, 1013.25 mbar, etc.). Thus, a negative pressure value of -X mmHg reflects an absolute pressure that is X mmHg less than 760 mmHg, or in other words, an absolute pressure of (760-X) mmHg. Additionally, a negative pressure that is "lower" or "less" than X mmHg corresponds to a pressure that is closer to atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). A negative pressure that is "higher" or "greater" than -X mmHg corresponds to a pressure that is further from atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg). In some cases, the local ambient air pressure is used as a reference point, and such local air pressure may not necessarily be, for example, 760 mmHg.

[0013] The negative pressure range can be approximately -80 mmHg, or between about -20 mmHg and -200 mmHg. Note that these pressures are relative to normal ambient air pressure, which can be 760 mmHg. Thus, -200 mmHg would effectively be about 560 mmHg. In some cases, the pressure range can be between about -40 mmHg and -150 mmHg. Alternatively, pressure ranges of -75 mmHg or less, -80 mmHg or less, or greater than -80 mmHg can be used. Also, in some cases, pressure ranges below -75 mmHg can be used. Alternatively, pressure ranges of approximately -100 mmHg or even above -150 mmHg can be provided by the negative pressure device.

[0014] wound dressing The negative pressure source (e.g., pump) and some or all other components of the TNP system, such as power sources, sensors, connectors, user interface components (e.g., buttons, switches, speakers, screens), etc., can be integrated into the wound dressing. The material layers can include a wound contact layer, one or more absorbent layers, one or more spacer or permeable layers, and a backing or cover layer covering the one or more absorbent and spacer or permeable layers. The wound dressing can be placed over the wound and sealed to the wound with the pump and / or other electronic components contained within the wound dressing under the cover layer. The dressing can be provided as a single item with all wound dressing elements (including the pump) pre-attached and integrated into a single unit. The periphery of the wound contact layer can be attached to the periphery of the cover layer, which encloses all of the wound dressing elements, as shown in Figures 1A-1C.

[0015] The pump and / or other electronic components can be configured to be positioned adjacent to or next to the absorbent and / or permeable layers so that the pump and / or other electronic components remain a single item applied to the patient. The pump and / or other electronics can be positioned away from the wound site. While certain features disclosed herein may be described as relating to systems and methods for controlling the operation of a negative pressure wound therapy system in which the pump and / or other electronic components are located within or on the wound dressing, the systems and methods disclosed herein are applicable to any negative pressure wound therapy system or any medical device. FIGS. 1A-1C illustrate a wound dressing incorporating a negative pressure source and / or other electronic components within the wound dressing. FIGS. 1A-1C illustrate a wound dressing 100 in which the pump and / or other electronics are positioned away from the wound site. The wound dressing can include an electronics area 161 and an absorbent area 160. The dressing may comprise a wound contact layer 110 (not shown in FIGS. 1A-1B) and a moisture vapor permeable film, cover layer, or backing layer 113 positioned over the contact layer and other layers of the dressing. The wound dressing layer and components of the electronics area and absorbent area may be covered by one continuous cover layer 113, as shown in FIGS. 1A-1C.

[0016] A layer of porous material 111 can be positioned above the wound contact layer 110. As used herein, the terms porous, spacer, and / or permeable layer can be used interchangeably to refer to a layer of material within the dressing configured to distribute negative pressure across the wound area. This porous or permeable layer 111 allows fluids, including liquids and gases, to permeate away from the wound site into the upper layers of the wound dressing. In particular, the permeable layer 111 preferably ensures that the absorbent layer can maintain open air channels to transmit negative pressure over the wound area even when it absorbs a significant amount of exudate. As described above, the layer 111 should preferably remain open under the normal pressures that would be applied during negative pressure wound therapy, thereby ensuring that the entire wound site experiences equal negative pressure. The layer 111 can be formed from a material having a three-dimensional structure. For example, a knitted or woven spacer fabric (e.g., Baltex 7970 weft knit polyester) or a nonwoven fabric can be used.

[0017] Additionally, one or more absorbent layers (such as layers 122, 151) can be utilized to absorb and retain exudate aspirated from the wound. Superabsorbent materials can be used in the absorbent layers 122, 151. One or more layers 122, 151 of absorbent material can be provided above the transmission layer 111. During use, each of the absorbent layers experiences negative pressure, and the absorbent layer material can be selected to absorb liquid under these conditions. The absorbent layers 122, 151 can include a composite including superabsorbent powder, a fibrous material such as cellulose, and a binder fiber. The composite can be a wind-based, thermally bonded composite.

[0018] The electronics area 161 can include a negative pressure source (e.g., a pump) and some or all other components of the TNP system that may be integrated with the wound dressing, such as a power source, sensors, connectors, user interface components (buttons, switches, speakers, screens, etc.), etc. For example, the electronics area 161 can include a button or switch (shown in FIGS. 1A-1B as covered by a pull tab). The dressing can include a wound contact layer 110 (not shown in FIGS. 1A-1B) and a moisture vapor permeable film, cover layer, or backing layer 113 positioned over the contact layer and other layers of the dressing.

[0019] The electronics area 161 of the covering can comprise one or more layers of transparent or spacer material and / or absorber material, and the electronic components can be embedded within the one or more layers of transparent or spacer material and / or absorber material. The layers of transparent or absorber material can have recesses or cutouts for embedding the electronic components therein while providing structure to prevent collapse. As shown in FIG. 1C , recesses 128 and 129 can be provided in absorber layers 151 and 122, respectively.

[0020] As used herein, the terms "top layer," "uppermost layer," or "upper layer" refer to the layer that is furthest from the skin or wound surface while the dressing is in use and positioned over the wound. Accordingly, the terms "lower surface," "lower layer," "bottom layer," or "lower layer" refer to the layer that is closest to the skin or wound surface while the dressing is in use and positioned over the wound. Furthermore, a layer can have a proximal, wound-facing surface, referred to as the side or surface of the layer closest to the skin or wound, and a distal surface, referred to as the side or surface of the layer that is furthest from the skin or wound.

[0021] The cover layer may include a cutout 172 positioned over at least a portion of the aperture 128 in the absorbent layer 122 to allow access to and fluid communication with at least a portion of the underlying absorbent layers 122 and 151, transmission layer 111, and wound contact layer 110. An electronic assembly, as described below, may be positioned within the apertures 128, 129, and 172 of the first and second absorbents 151 and 122 and cover layer 113. The electronic assembly may include a pump, a power supply, and a printed circuit board, as described with reference to Figures 3 and 4A and 4B.

[0022] Prior to use, the dressing may include one or more delivery layers 146 adhered to the bottom surface of the wound contact layer. The delivery layer 146 may cover the adhesive or apertures on the bottom surface of the wound contact layer 110. The delivery layer 146 may provide support to the dressing and may aid in sterilization and proper placement of the dressing on the patient's wound and skin. The delivery layer 146 may include a handle that a user can use to separate the delivery layer 146 from the wound contact layer 110 before applying the dressing to the patient's wound and skin.

[0023] Electronic assemblies incorporated within wound dressings Figures 2A and 2B illustrate an electronic unit 267 that can be incorporated into a wound dressing. Figure 2A illustrates a top view of the electronic unit. Figure 2B illustrates the bottom or wound-facing side of the electronic unit. The electronic unit 267 can include a pump 272 and one or more power sources 268, such as a battery. The electronic unit 267 can include a circuit board 276 configured to electrically communicate with the pump 272 and / or the power source 268. The circuit board 276 can be flexible or substantially flexible.

[0024] 2A, the electronics unit 267 may include a single button or switch 265 on the top surface of the unit. The single button or switch 265 may be used as an on / off button or switch to stop and start operation of the pump and / or electronic components. The electronics unit 267 may also include one or more vents or exhaust apertures 264 on the circuit board 276 for venting air exhausted from the pump. As shown in FIG. 2B, a pump outlet exhaust mechanism 274 (sometimes referred to as a pump exhaust mechanism or pump outlet mechanism) may be attached to the outlet of the pump 272.

[0025] The electronics unit 267 may include a pump inlet protection mechanism 280 positioned on a portion of the electronics unit closest to the absorbent area and aligned with the inlet of the pump 272, as shown in FIG. 2B. The pump inlet protection mechanism 280 is positioned between the pump inlet and the absorbent area or layer of the dressing. The pump inlet protection mechanism 280 may include a hydrophobic material to prevent fluid from entering the pump 272. The pump inlet protection mechanism 280 (or any of the inlet protection mechanisms disclosed herein) may include a filter.

[0026] The top surface of the electronics unit 267 can include one or more indicators 266 to indicate the status of the pump and / or the pressure level within the dressing. The indicators can be small LED lights or other light sources visible through a dressing component on the indicator or through a through-hole in the dressing component. The indicators can be green, yellow, red, amber, or any other color. For example, there can be two lights: one green and one amber. A green light can indicate that the device is working properly, while an amber light can indicate that there is a problem with the pump (e.g., a leak, a saturated level in the dressing, a blockage downstream of the pump, a blockage in the exhaust, a low battery, etc.).

[0027] The power supply 268 can be in electrical communication with the circuit board 276. One or more power connections are connected to the surface of the circuit board 276. The circuit board 276 can have other electronics integrated therein. For example, the circuit board 276 can support various sensors, including, but not limited to, one or more pressure sensors, temperature sensors, optical sensors and / or cameras, and / or saturation indicators.

[0028] Figure 3 illustrates an electronic assembly 300 that encloses an electronic unit within a housing. As illustrated in Figure 3, the housing of the electronic assembly 300 can include a plate 301 and a flexible film 302 that enclose an electronic unit 303 therein. The electronic unit 303 can include a pump 305, an inlet protector 310, a pump exhaust mechanism 306, a power supply 307, and a circuit board 309. The circuit board 309 can be flexible or substantially flexible.

[0029] As shown, the pump exhaust mechanism 306 can be an enclosure such as a chamber. The electronics unit 303 and pump 305 can be used without the inlet protection mechanism 310. However, the pump exhaust mechanism 306 and pump 305 can be seated within an extended casing 316.

[0030] A flexible film 302 can be attached to the plate 301 to form a fluid-tight seal and enclosure around the electronic components. The flexible film 302 can be attached to the plate at its periphery by heat welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique.

[0031] The flexible film 302 may include an aperture 311. The aperture 311 may allow the inlet protection feature 310 to be in fluid communication with the absorbent and / or permeable layers of the wound dressing. The periphery of the aperture 311 in the flexible film 303 may be sealed or attached to the inlet protection feature 310 by forming a fluid-tight seal and enclosure around the inlet protection feature 310, thereby keeping the electronic component 303 protected from fluids within the dressing. The flexible film 302 may be attached to the inlet protection feature 310 at its periphery by heat welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique. The inlet protection feature 310 may prevent wound exudate or liquid from the wound and collected within the absorbent area 160 of the wound dressing from entering the pump and / or electronic components of the electronic assembly 300.

[0032] The electronic assembly 300 shown in FIG. 3 can be incorporated into a wound dressing, as described herein, in communication with apertures in the casing 316 and circuit board 309 such that when the dressing is applied to a patient's body, air from within the dressing can be pumped through the inlet protection mechanism 310 and towards the pump exhaust mechanism 306.

[0033] 4A and B illustrate an electronic assembly 400 that includes a pump inlet protection mechanism 410 sealed to the exterior of a flexible film 402, similar to the description with reference to FIG. 3. Also shown is an exhaust mechanism 406, which may be similar to exhaust mechanism 306.

[0034] FIG. 4A shows the wound-facing underside of electronic assembly 400. FIG. 4B shows the top side of plate 401 (which may face the patient or user) of electronic assembly 400. The top side of plate 401 may include an on / off switch or button cover 443 (shown as a pull tab), an indicator 444, and / or one or more vent holes 442. Removal of pull tab 443 may trigger activation of electronic assembly 400, such as providing power from a power source to the electronic assembly. Further details of the operation of pull tab 443 are described in PCT International Application No. PCT / EP2018 / 079745, filed October 30, 2018, entitled "SAFE OPERATION OF INTEGRATED NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES," which is incorporated herein by reference in its entirety.

[0035] An electronic assembly 400 having a pump inlet protection feature 410 extending from and sealed to the film 402 can be positioned within the aperture 172 of the cover layer 113 and absorbent layer (122, 151), as shown in FIG. 1C. The periphery of the electronic assembly 400 can be sealed to the upper surface of the outer periphery of the aperture 172 of the cover layer 113, as shown in FIG. 1C and described in more detail herein with reference to FIGS. 5A and 5B. The electronic assembly 400 can be sealed to the cover layer 113 using a sealant gasket, adhesive, heat welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique. The electronic assembly 400 can be permanently sealed to the cover layer 113 and cannot be removed from the cover layer without destroying the covering material.

[0036] In some embodiments, the electronic assembly 400 is available with a single enclosure and can be disposed of along with the enclosure. In some cases, the electronic assembly 400 can be available with a series of enclosures.

[0037] FIG. 5A shows a wound dressing, such as the one of FIG. 1C, incorporating an electronic assembly 500 within a wound dressing layer 590. FIG. 5B illustrates a cross section of a wound dressing incorporating the electronic assembly of FIG. 5A. The electronic assembly 500 can be provided within an aperture 172 in the cover layer and apertures 129 and 128 in the first and second absorbent layers 122, 151. The electronic assembly 500 can be sealed to the periphery of the aperture 172 in the cover layer. The dressing can include a wound contact layer 110, a moisture vapor permeable film, a cover layer or backing layer 113 positioned over the contact layer 110 and other layers of the dressing. A layer 111 of porous material can be positioned above the wound contact layer 110. As used herein, the terms porous material, spacer, and / or transmission layer can be used interchangeably to refer to layers of material within the dressing configured to distribute negative pressure across the wound area. This porous or permeable layer 111 allows fluids, including liquids and gases, to permeate away from the wound site and into the upper layers of the wound dressing. Additionally, one or more absorbent layers (such as layers 122, 151) can be utilized to absorb and retain exudate drawn from the wound. One or more layers 122, 151 of absorbent material can be provided above the permeable layer 111. There can be a small aperture absorbent layer 151 and a large aperture absorbent layer 122. The small aperture absorbent layer 151 can be positioned above the large aperture absorbent layer 122. In some cases, the small aperture absorbent layer 151 can be positioned below the large aperture absorbent layer 122. Prior to use, the dressing can include one or more delivery layers 146 adhered to the bottom surface of the wound contact layer. The delivery layer 146 can cover the adhesive or apertures on the bottom surface of the wound contact layer 110.

[0038] 6A and 6B and 7A and 7B illustrate an electronic assembly 1500 having a pump inlet protection feature 1710 and a pump exhaust feature 1074 on a pump 1072. The assembly 1500 can include cavities 1082 and 1083 (shown in FIGS. 7A and 7B) on the pump inlet protection feature 1710 and the pump exhaust feature 1074, respectively. The inlet protection and pump exhaust feature can be glued to the inlet and outlet of a pump described herein. The assembly 1500 can be assembled using an adhesive and allowed to cure before being incorporated into an electronic assembly.

[0039] The pump inlet can be covered by or fitted with a pump inlet protection mechanism 1710. The pump inlet protection mechanism 1710 can be pressed onto the pump inlet, as illustrated by the arrow in FIG. 7A . This can be a friction fit. The port in the pump inlet protection mechanism 1710 that receives a portion of the pump inlet can be sized and shaped to fit complementarily around the pump inlet. The pump inlet protection mechanism 1710 can be bonded to the pump inlet using a silicone sealant or any other sealant or sealing technique. FIG. 7B illustrates the pump inlet protection mechanism 1710 covering the pump inlet and a pump exhaust mechanism 1074 covering the pump outlet. The pump exhaust mechanism 1074 can include one or more apertures or vents 1084 to allow gas drawn by the pump to be exhausted from the pump exhaust mechanism 1074. In some cases, the check valve and / or filter membrane of the pump exhaust mechanism can be included within the pump exhaust mechanism 1074.

[0040] 7A and 7B illustrate a pump inlet protection mechanism 1710 and a pump exhaust mechanism 1074 having cavities 1082 and 1083. A pump assembly including the pump inlet protection mechanism 1710 and the pump exhaust mechanism 1074 can be disposed on a surface of a circuit board 1081. When the pump assembly is in contact with the surface of the circuit board 1081, the cavities 1082 and 1083 can at least partially enclose sensors on the circuit board 1081, such as pressure sensors 1091 and 1092 on the circuit board 1081, as shown in FIG.

[0041] Pressure sensors 1091 and 1902 shown in Figure 6B can be used to measure and / or monitor the pressure level at the wound and atmospheric pressure. Pressure sensor 1091 can be used to measure and / or monitor the pressure at the wound (e.g., below a wound dressing), which can be achieved by measuring and / or monitoring the pressure in a fluid flow path connecting the negative pressure source or pump 1072 and the wound. Pressure sensor 1091 can measure and / or monitor the pressure in cavity 1082 of pump inlet protector 1710 shown in Figures 7A and 7B. Power supply 1068 (shown as two batteries in Figure 6A) can provide power to the negative pressure source 1072 and the electronics.

[0042] A pressure sensor 1092 can be used to measure and / or monitor the pressure outside the wound dressing. The pressure sensor 1092 can measure and / or monitor the pressure within the cavity 1083 of the pump exhaust mechanism 1074 shown in Figures 7A and 7B. The pressure sensor 1092 can measure the pressure outside the wound dressing, which can be relative to atmospheric pressure because atmospheric pressure varies depending on, for example, the altitude used or the pressurized environment in which the TNP device may be used. These measurements can be used to establish a desired negative pressure differential (or set point) at the wound relative to the external pressure.

[0043] Circuit board 1081 (including any of the circuit boards described herein) can include at least control circuitry, such as one or more processors or controllers, that can control the delivery of negative pressure by negative pressure source 1072 according to a comparison of the pressure monitored by pressure sensor 1091 and the pressure monitored by pressure sensor 1092. The control circuitry can operate negative pressure source 1072 in a first mode (which can be referred to as an initial pump-down mode) that activates negative pressure source 1072 to establish a negative pressure set point at the wound. The set point can be set to a value in the range of, for example, about −70 mmHg to about −90 mmHg, among others. Once the set point is established, which can be verified based on the difference between the pressure measured by pressure sensor 1091 (or wound pressure) and the pressure measured by pressure sensor 1092 (or external pressure), the control circuitry can stop (or pause) operation of negative pressure source 1072. The control circuit may operate the negative pressure source 1072 in a second mode (which may be referred to as a maintenance pump-down mode) in which the negative pressure source 1072 is periodically activated to re-establish the negative pressure set point when the wound is depressurized as a result of one or more leaks. The control circuit may activate the negative pressure source 1072 in response to the wound pressure (monitored by the pressure sensor 1091) becoming more positive than a negative pressure threshold, which may be set to the same negative pressure as the set point or a lower negative pressure.

[0044] Embodiments of the wound dressings, wound treatment devices, and methods described herein may also be used in combination with, or in addition to, one or more features described in PCT International Application No. PCT / EP2017 / 060464, entitled "NEGATIVE PRESSURE WOUND THERAPY DEVICE ACTIVATION AND CONTROL," filed May 3, 2017; U.S. Patent No. 8,734,425; and U.S. Patent No. 8,905,985, each of which is incorporated herein by reference in its entirety.

[0045] One or more self-adhesive gaskets can be applied to the pump inlet protection feature 1710 and the pump exhaust feature 1074 to seal the pump inlet and pump exhaust cavities 1082 and 1083 around the sensors on the circuit board 1081, as well as around the exhaust feature vents and corresponding vents in the circuit board 1081 (as described herein). Preformed adhesive sheets can be used to form sealing gaskets between the pump inlet and pump exhaust feature cavities 1082 and 1083 and the sensors on the circuit board 1081, as well as between the exhaust feature vents and vents in the circuit board 1081. In some cases, adhesive can be used to seal the pump inlet protection feature 1710 and the pump exhaust feature 1074 cavities 1082 and 1083 around the sensors on the circuit board 1081, as well as around the exhaust feature vents 1084 and corresponding vents in the circuit board (see 1094 in FIG. 10B ). As described herein, the electronic assembly 1500 may be embedded within a layer of coating material, such as within a cutout or recess within which the electronic assembly may be placed.

[0046] The pump inlet protection feature 1710 can provide a large surface area available for the vacuum drawn by the pump inlet. The pump inlet (shown as a rounded protrusion in FIG. 7A ) can fit within a recess in the pump inlet protection feature 1710. The pump inlet can be attached by a friction fit and / or can form a complementary fit with the recess in the pump inlet protection feature.

[0047] The pump inlet protection mechanism 1710 can allow air or gas to pass through but can block liquid from reaching the negative pressure source. The pump inlet protection mechanism 1710 can include a porous material. The pump inlet protection mechanism 1710 can include one or more porous polymeric molded components. The pump inlet protection mechanism 1710 can include a hydrophobic or substantially hydrophobic material. The material included in the pump inlet protection mechanism 1710 can have a pore size ranging from approximately 5 microns to approximately 40 microns. In some cases, the pore size can be approximately 10 microns. The pump inlet protection mechanism 1710 can include a polymer that can be one of hydrophobic polyethylene or hydrophobic polypropylene. In some cases, the pump inlet protection mechanism can include a Porvair Vyon material having a pore size of 10 microns. Any of the pump inlet protection mechanisms described herein can include one or more features of the pump inlet protection mechanism 1710.

[0048] The pump exhaust mechanism 1074 (or any of the pump exhaust or outlet mechanisms described herein) can include a check valve or check valve 1210, as shown in FIG. 8. The check valve 1210 can be any suitable mechanical one-way valve, such as a reed valve, duckbill valve, ball valve, loose-leaf valve, or umbrella valve, among others. The check valve can be similar to any of the check valves described in PCT International Application No. PCT / EP2017 / 055225, filed March 6, 2017, entitled "WOUND TREATMENT APPARATUSES AND METHODS WITH NEGATIVE PRESSURE SOURCE INTEGRATED INTO WOUND DRESSING," which is incorporated herein by reference in its entirety. The pump exhaust mechanism 1074 can be bonded to the pump outlet using a sealant, such as a silicone sealant. The outlet or exhaust of the pump exhaust mechanism 1074 can include an antibacterial film and / or other filter membrane that filters gases that are exhausted outside the NPWT system, such as the atmosphere. As shown, the pump exhaust mechanism 1074 can be a substantially sealed housing or chamber to prevent the ingress of gases or fluids other than through the vent 1084.

[0049] Any of the embodiments described herein may be incorporated by reference in any of the following applications: International Application No. PCT / EP2018 / 074694, filed September 13, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; International Application No. PCT / EP2018 / 074701, filed September 13, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; International Application No. PCT / EP2018 / 079345, filed October 25, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; International Application No. PCT / EP2018 / 079345, filed March 10, 2020, entitled "EXHAUST BLOCKAGE DETECTION FOR NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; The present invention may also or alternatively include one or more features described in International Application No. PCT / EP2020 / 056317, entitled "PRESSURE WOUND TREATMENT APPARATUSES," each of which is incorporated herein by reference in its entirety.

[0050] Temperature Monitoring and Control FIG. 9 shows a block diagram of the electronics 2000 of a TNP system (which may be any of the TNP systems described herein). The electronics (or electronics components) may include a power supply 2010, a latch circuit 2020, a controller 2030 (which may be programmable), a memory 2012, a boost converter (or regulator) 2040 (sometimes referred to as a boost converter circuit or boost regulator circuit), a driver circuit 2050, and a negative pressure source 2060. The negative pressure source 2060 may include a piezoelectric pump (such as a pump operated by a piezoelectric actuator or transducer). In some cases, the driver circuit 2050 may include an H-bridge circuit. The power supply 2010 may include one or more batteries (e.g., two 3V batteries). The power supply 2010 may provide power to the other electronics components.

[0051] Latch circuit 2020 may include one or more active components (e.g., transistors) that activate any one or more other components illustrated in FIG. 9 in response to activation of the TNP device, such as removal of a pull tab. Activation can cause latch circuit 2020 to facilitate the provision of power from power supply 2010 to one or more other components, such as controller 2030. In some cases, latch circuit 2020, responsive to activation, can provide an indicator or signal 2022 to controller 2030. Latch circuit 2020 can transition from an inactive state (which may be a default state) to an active state in response to activation. In response to receiving signal 2022, controller 2030 can operate negative pressure source 2060. For example, the controller can operate boost converter 2040 via signal 2032 (e.g., a reference voltage or current) and driver circuit 2050 via signal 2034 (e.g., a pulse-width modulated signal). Further details of the operation of the latch circuit are described in International Application No. PCT / EP2018 / 079745, filed October 30, 2018, entitled "SAFE OPERATION OF INTEGRATED NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES," which is incorporated herein by reference in its entirety.

[0052] The power supplied by the power supply 2010 (e.g., around 3V, around 4V, around 5V, around 6V, around 7V, around 8V, around 9V, etc.) may need to be increased to power the negative pressure source 2060. The boost converter 2040 can increase the power provided by the power supply 2010 to a power level appropriate for powering the negative pressure source 2060. The boost converter 2040 can include electronic circuitry configured to generate a higher level of power (e.g., a higher voltage of DC power) from a lower input power (e.g., battery power). In some cases, the boost converter 2040 can be a switched-mode power supply. The boost converter 2040 can be a DC-DC converter having an output voltage greater than the input or source voltage. The boost converter 2040 can increase or step up the power level of the power supply 2010 to a power level for operating the negative pressure source 2060. For example, the power supply 2010 may provide 6V DC power (or less or more), and the negative pressure source 2060 may require between 30V (or less or more) and 22V (or less or more) DC power.

[0053] The negative pressure source 2060 can be controlled by alternating activation and deactivation periods of the negative pressure source. The duty cycle of the negative pressure source 2060 can reflect the fraction of time during which the negative pressure source is active for a predetermined time interval (1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, etc.). For example, if the negative pressure source 2060 is active for 15 seconds over a 30-second time interval, the duty cycle is 50%. In some cases, an increase in the duty cycle of the negative pressure source 2060 can be an indication or presence of one or more leaks (e.g., in the seal between the dressing and the patient). This can result from the negative pressure source 2060 being active longer to establish or maintain a negative pressure set point in the presence of one or more leaks. Further details of the operation of the boost converter and the operation of the negative pressure source are described in International Application No. PCT / EP2020 / 064601, filed April 26, 2020, entitled "SYSTEMS AND METHODS FOR EXTENDING OPERATIONAL TIME OF NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES," which is incorporated herein by reference in its entirety.

[0054] One or more electronic components of the TNP system may be located on the upper side of the system (see, e.g., FIGS. 5A, 6A, and 10A). As a result, the upper side of the system (facing away from the patient), particularly the portion of the upper side where the one or more electronic components are located, may be the hottest part of the system during operation. One or more of the components illustrated in FIG. 9 may experience an increase in temperature during operation. For example, the temperature of at least one of the boost converter 2040, the driver circuit 2050, or the negative pressure source 2060 may increase during operation. The negative pressure source 2060 (or power supply 2010 or other components) may be designed to operate safely and effectively at temperatures below a maximum temperature threshold (e.g., around 40° C., around 41° C., around 42° C., around 48° C., around 50° C., around 60° C., around 70° C., around 80° C., around 90° C., etc.). Additionally or alternatively, the electronics may be positioned proximate to the patient (e.g., supported by a wound dressing positioned on the patient's body), such that an increase in the temperature of one or more electronics components could cause discomfort or injury (e.g., burns) to the patient. In some cases, an increase in the patient's body temperature may result in an increase in the temperature of one or more electronics components. To address these issues, the electronics 2000 can monitor the temperature of one or more electronics components. The electronics 2000 can take one or more corrective actions in response to detecting that the temperature meets (e.g., meets or exceeds) one or more temperature thresholds. As described herein, the one or more corrective actions can include disabling one or more electronics components, adjusting the operation of one or more electronics components, or the like.

[0055] The electronic device 2000 may include a sensor 2070 and a circuit 2080 that can implement one or more corrective actions in response to measurements by the sensor 2070 (and provided to the circuit 2080 via a signal 2072). The sensor 2070 may be a temperature sensor (e.g., a thermostat). In some cases, the sensor 2070 may be positioned proximate to one or more components that may experience an increase in temperature. For example, the sensor 2070 may be positioned proximate the boost converter 2040, which may be the electronic component whose temperature increases the most during operation. As shown in FIG. 9 , in some cases, the sensor 2070 may be positioned a distance “d” or less from the boost converter 2040. In some instances, the sensor 2070 may be positioned approximately 4 mm away from the boost converter 2040. In certain implementations, the distance between the sensor 2070 and the boost converter 2040 may be less than or equal to approximately 4 mm. A thermal path (such as a conductive trace) may connect the sensor 2070 to the boost converter 2040. One or more of such positioning of the sensor 2070 or the presence of a thermal path may improve the monitoring of temperature by the sensor 2070.

[0056] Circuit 2080 may include a comparator or the like (described further in connection with FIG. 11 ) configured to provide an indicator responsive to the temperature measured by sensor 2070 meeting (e.g., meeting or exceeding) a maximum temperature threshold (e.g., sometimes referred to as over-temperature detection). The indicator may trigger the provision of one or more corrective actions, such as shutting down negative pressure source 2060 (as illustrated in FIG. 9 by signal 2084, which may shut down boost converter 2040). For example, circuit 2080 may include a switch (e.g., a transistor) or the like that is activated (or deactivated) in response to the comparator providing the indicator. Activation (or deactivation) of the switch may cause latch circuit 2020 to stop providing signal 2022 to controller 2030, via signal 2082, as shown in FIG. 9 . For example, the latch circuit may transition from an activated state to a deactivated state in response to activation (or deactivation) of the switch. In response to no longer receiving signal 2022, controller 2030 can cause the shutdown of negative pressure source 2060 (e.g., by providing one or more of signals 2032 or 2034 or modifying either of these signals). In some cases, circuit 2080 does not include a programmable processor or controller.

[0057] In response to meeting a maximum temperature threshold described herein, deactivation of any negative pressure source may additionally or alternatively include activation of a switch (such as switch 265) configured to allow a user to control the delivery of negative pressure wound therapy. Deactivation of such a switch may be performed by controller 2030. In some cases, multiple comparators may be present to facilitate detection of multiple temperature thresholds.

[0058] The controller 2030 can independently (or in some cases, in addition to the circuit 2080) implement one or more corrective actions responsive to temperature. The sensor 2090 can sense or monitor one or more temperatures of one or more electronic components and / or the patient. The sensor 2090 can provide measurements to the controller 2030 via signal 2092. As described herein, the controller can implement one or more corrective actions based on comparing the sensed temperature to one or more temperature thresholds. For example, the controller 2030 can cause the shutdown of the negative pressure source 2060 (by terminating or altering the provision of one or more of signals 2032 or 2034) in response to determining that the sensed temperature meets a maximum temperature threshold. The inclusion of an independent and redundant mechanism for responding to elevated temperature can be advantageous to ensure the safe and effective delivery of negative pressure wound therapy to the patient.

[0059] Sensor 2090 can include multiple sensors, such as pressure sensors 1091 and 1092, that can monitor pressure and temperature. As described herein, and with further reference to FIGS. 10A and 10B, which illustrate the electronics and other components 2100 of the TNP system, pressure sensor 1091 can be positioned to measure the pressure of the inlet fluid aspirated by negative pressure source 2060. For example, pressure sensor 1091 can be positioned within or proximal to the inlet (e.g., shown as 1710 in FIG. 10A) of the negative pressure source (e.g., designated as 1072 in FIGS. 10A and 10B). Pressure sensor 1091 can measure the internal temperature of the TNP system. As described herein, pressure sensor 1092 can be positioned to measure the pressure of the surrounding environment. Pressure sensor 1092 can measure the external temperature. As described herein, and with further reference to Figures 10A and 10B, a pressure sensor 1092 can be positioned within or proximate to the exhaust of the negative pressure source (e.g., shown as 1074 in Figure 10A) and can be in fluid communication with the ambient environment. To facilitate communication with the ambient environment, there can be one or more vents 1084 within the exhaust mechanism 1074, as shown in Figure 10A. Additionally, there can be one or more vents 1094 within the circuit board 1081, as shown in Figure 10B.

[0060] Due to its positioning, pressure sensor 1091 can monitor the patient's temperature (e.g., by monitoring the temperature of the dressing). For example, pressure sensor 1091 can monitor the temperature of fluid being aspirated from the patient's wound (e.g., as the fluid enters the inlet of the negative pressure source), which can indicate the patient's temperature. Additionally or alternatively, pressure sensor 1091 can monitor the temperature of at least some of the electronic components, including at least one of boost converter 2040, driver circuit 2050, or negative pressure source 2060 (whose temperature may increase during operation). Due to its positioning proximate to the negative pressure source (see FIGS. 10A and 10B), pressure sensor 1092 can monitor the temperature of at least some of the electronic components. The temperature monitored by pressure sensor 1092 can reflect a contribution from at least one of boost converter 2040, driver circuit 2050, or negative pressure source 2060. As shown in Figure 10B, with the inlet and exhaust mechanism housing removed, the pressure sensor 1092 is positioned proximal to the boost converter 2040 (which may be located on the circuit board 1081 in the area indicated by reference numeral 2040, under the cover of the negative pressure source 1072). Because the pressure sensor 1092 is positioned within the fluid flow path of the fluid aspirated from the wound, the pressure sensor 1092 can additionally monitor the temperature contribution from the patient.

[0061] The difference between the temperature monitored by pressure sensor 1092 and the temperature monitored by pressure sensor 1091 can reflect the temperature of one or more electronic components, such as at least one of boost converter 2040, driver circuit 2050, or negative pressure source 2060. This can be because pressure sensor 1091 monitors the patient's temperature and pressure sensor 1092 monitors the temperature of one or more electronic components and the patient. Controller 2030 can compare the temperature difference to one or more thresholds and take one or more corrective actions. As described herein, controller 2030 can compare the temperature difference to a maximum temperature threshold and, in response to determining that the temperature difference meets the maximum temperature threshold, cause the negative pressure source 2060 to shut down.

[0062] Additionally or alternatively, the controller 2030 can cause one or more changes in the operation of the negative pressure source 2060 in response to a temperature difference that does not meet the maximum temperature threshold but meets one or more other thresholds. For example, one or more of the operation time or operation intensity (individually or collectively, which may be referred to as activity) of the negative pressure source 2060 can be adjusted. For example, the activity of the negative pressure source 2060 can be reduced in response to the detection of an elevated temperature. In some cases, the maximum temperature threshold can be set at 40°C, 41°C, or 42°C.

[0063] A second temperature threshold, which may indicate a temperature lower than the maximum temperature threshold, may be used to reduce the operation time or intensity of one or more of the negative pressure source 2060 in response to an increase in the detected temperature. For example, the second temperature threshold may be set at (or around) 35°C. The controller 2030 may reduce the duty cycle of the negative pressure source 2060 in response to a temperature difference that meets the second threshold (but does not meet the maximum temperature threshold). Additionally or alternatively, the intensity of operation of the negative pressure source 2060 may be reduced (e.g., the negative pressure level or set point provided by the negative pressure source may be reduced). Additionally or alternatively, the controller 2030 may shut down the negative pressure source 2060 for a period of time. An increase in temperature may be due to the presence of one or more leaks, which may cause the negative pressure source 2060 to operate more frequently and / or at a higher intensity to overcome the loss of negative pressure due to the one or more leaks. Adjustments to the operation of the negative pressure source 2060 may facilitate a decrease in the temperature of one or more electronic components. In some cases, one or more additional temperature thresholds may be utilized to further regulate the operation of the negative pressure source 2060 in response to an increase in temperature. Advantageously, such control of the operation of the negative pressure source 2060 in response to an increase in temperature may, among other things, improve patient comfort, improve safety, and conserve capacity on the power source 2010 (e.g., by not depleting the power source in an attempt to overcome a loss of negative pressure due to one or more leaks).

[0064] Additionally or alternatively, the controller 2030 can implement one or more corrective actions in response to the temperature measured by the pressure sensor 1091. As described herein, the pressure sensor 1091 can monitor the patient's temperature. To promote patient safety and comfort, the controller 2030 can deactivate (e.g., permanently or temporarily) the negative pressure source 2060 in response to the temperature measured by the pressure sensor 1091 so that a first temperature threshold indicative of an elevated patient temperature is met. For example, the first temperature threshold can correspond to a patient temperature of (or thereabouts) 37.5°C. For example, the first temperature threshold can be the same as a maximum temperature threshold (e.g., 41°C). The controller 2030 can implement such one or more corrective actions to prevent an increase in temperature of one or more electronic components during the delivery of negative pressure wound therapy from further increasing the patient's temperature and causing further discomfort or injury to the patient. Additionally or alternatively, the controller 2030 can reduce the operating time or intensity of one or more of the negative pressure sources 2060 in response to a detected increase in the temperature monitored by the pressure sensor 1091. This can be implemented using any of the approaches described above, such as reducing the duty cycle of the negative pressure source 2060 in response to meeting a second temperature threshold. The second temperature threshold can correspond to a temperature lower than the first temperature threshold. For example, the second temperature threshold can be 40°C (or thereabouts). In some cases, the temperature measured by the pressure sensor 1091 may not be the same as the patient temperature because the aspiration fluid flow may be colder than the patient temperature and / or may cool the pressure sensor 1091. Still, the temperature measured by the pressure sensor 1091 can be indicative of the patient temperature, just as an increase in temperature sensed by the pressure sensor 1091 can indicate an increase in the patient's temperature.

[0065] In some cases, hysteresis can be implemented to control the negative pressure source 2060 in response to an elevated temperature. For example, a delay to take one or more corrective actions can be implemented in response to determining that a maximum temperature threshold (or a second temperature threshold or any other temperature threshold) has been met. This can prevent adjustment of the delivery of negative pressure wound therapy in response to one or more erroneous temperature detections or determinations.

[0066] The one or more determinations that the one or more temperature thresholds have been met can be recorded by electronic device 2000 (e.g., stored in memory 2012). Advantageously, this can aid in compliance with the IEC 60601-1 standard for safe and effective operation of medical devices or other applicable standards. For example, controller 2030 can store the one or more determinations in memory 2012. Controller 2030 can separately store in memory 2012 the detection of an excessive temperature by circuit 2080 and the detection of an excessive temperature by controller 2030. Controller 2030 can additionally separately store in memory 2012 the determination that a second temperature threshold (or any of the other temperature thresholds) has been met. Controller 2030 can store in memory the temperature detected by one or more of sensors 2070 or 2080 (e.g., by one or more of sensors 1091 and 1092). This can facilitate debugging of electronic device 2000. For example, if sensor 2070 determines that the maximum temperature threshold has been met but sensor 2080 has not (or vice versa), it may be concluded that one of the sensors (and / or electrical connections) may be damaged.

[0067] Detection of an excessive temperature can cause electronic device 2000 to disable (temporarily or permanently) negative pressure source 2060. In some cases, electronic device 2000 can transition to an unrecoverable error state (or end-of-life state) in which negative pressure source 2060 can be disabled. For example, controller 2030 can transition to an unrecoverable state (or end-of-life state). In an unrecoverable error state (or end-of-life state), operation (e.g., activation) of negative pressure source 2060 can be permanently disabled. Further details of disabling operation of the negative pressure source are described in International Application No. PCT / EP2020 / 064601, which was published as WO2020 / 239781 and is incorporated herein by reference in its entirety.

[0068] In some cases, the power source 2010 may be depleted in response to a transition to an unrecoverable error state (or end-of-life state). The electronic device 2000 may include circuitry (not shown) for depleting the power source 2010. Such circuitry may include one or more resistors connected to ground. In some cases, depleting the power source 2010 may involve monitoring the temperature and controlling the depletion rate so as not to cause discomfort or injury (such as burns) to the patient. Any of the approaches disclosed herein (e.g., using one or more sensors to monitor the temperature of the power source) can be used to monitor the temperature and control the depletion rate of the power source 2010. In some cases, the power source may be considered to be discharged when its capacity meets a capacity threshold. For example, assuming the power source 2010 includes one or more lithium 3V batteries, the power source 2010 may be considered to be discharged when the voltage of one or more batteries falls below 2V. Depleting the power source 2010 may be advantageous for patient safety, safe disposal, etc.

[0069] 9 can be omitted or replaced with alternative components. In some cases, one or more of the corrective actions described herein can be taken in response to a decrease in temperature, such as a temperature that meets (e.g., meets or falls below) a minimum temperature threshold and / or any other threshold described herein.

[0070] FIG. 11 shows a diagram of a circuit 2200 configured to perform over-temperature detection in a TNP system (which may be any of the TNP systems described herein). Circuit 2200 may correspond at least in part to circuit 2080. A temperature sensor 2210 (which may be similar to sensor 2070) may monitor the temperature of one or more components of the TNP system. For example, temperature sensor 2210 may monitor the temperature of a boost converter. Temperature sensor 2210 may be a thermostat. The temperature monitored by temperature sensor 2210 (which may be output as a voltage signal) may be provided to comparator 2220 (e.g., as input 2224). Comparator 2220 may be an operational amplifier. Another input 2222 to comparator 2220 may correspond to a temperature threshold, such as a maximum temperature threshold. An output 2226 of comparator 2220 may indicate whether the temperature monitored by temperature sensor 2210 meets the temperature threshold. Output 2226 can be used to control switch 2240, such as a transistor (in this case, output 2226 can control the gate of the transistor). The output of switch 2240 can be used to override the output of a latch circuit (e.g., latch circuit 2020). When the temperature monitored by temperature sensor 2210 meets a temperature threshold, switch 2240 turns on. This can override the output of the latch circuit and shut down the negative pressure source, as described herein. For example, activation of switch 2240 can drive output 2202 to a low voltage (e.g., ground), which can provide an indication to a controller (e.g., controller 2030) to shut down the negative pressure source. For example, overriding output 2202 can correspond to providing signal 2084, as described in connection with FIG. 9 . In some cases, overriding output 2202 can shut down a boost converter (such as boost converter 2040).

[0071] As described herein, the controller can independently execute one or more corrective actions responsive to temperature. This can be accomplished via signal 2204, which can correspond to an override signal from the controller. Signal 2204 can correspond to one or more of signal 2032 provided to boost converter 2040 or signal 2034 provided to driver circuit 2050, as described in connection with FIG. 9 . In some cases, signal 2204 can be used to control a switch 2250, such as a transistor (in this case, signal 2204 can control the gate of the transistor). The output of switch 2250 can be used to override the output of a latch circuit, as described above in connection with switch 2240.

[0072] In some instances, comparator 2220 may operate erroneously due to the presence of noise at one or more of inputs 2222 or 2224. For example, noise in the operation of the negative pressure source can affect the grounding of circuit 2200 (e.g., reverberating through a ground plane), which may adversely affect the operation of comparator 2220. As another example, external noise (e.g., environmental noise due to microwave radiation, helicopter or airplane travel, elevator travel, etc.) may adversely affect the operation of comparator 2220. As a result of the presence of noise, comparator 2220 may not respond correctly to a monitored temperature that meets (or does not meet) a temperature threshold (e.g., generating output 2226 at a temperature above or below the temperature threshold). This may compromise patient comfort, safety, etc.

[0073] To address these issues, circuit 2200 may include one or more filters 2232 and 2234 at the input of comparator 2220. Filters 2232 and 2234 may be low-pass filters configured to filter out high-frequency noise (e.g., transient spikes). As shown in FIG. 11, filters 2232 and 2234 may include a resistor and capacitor connected in parallel (or be RC low-pass filters). Additionally or alternatively, feedback may be created via comparator 2220. As shown in FIG. 11, resistor 2238 may be positioned across non-inverting input 2222 and output 2226 of comparator 2220. Resistor 2238 may be referred to as a feedback resistor. Resistor 2238 may introduce hysteresis into output 2224 of comparator 2220 (or cause output 2226 to maintain its current state despite fluctuations in one or more inputs caused by over-current noise).

[0074] The approaches for monitoring temperature and taking one or more corrective actions described herein can be generally applied to any negative pressure wound therapy device configured to be worn by a patient, facilitating the safe and effective delivery of negative pressure wound therapy. A negative pressure wound therapy device may include electronic components, such as a negative pressure source and control circuitry. As described herein, elevated temperatures in one or more electronic components can result in a risk of causing discomfort or injury (such as a burn) to the patient. It may be advantageous to implement one or more of the described techniques for detecting elevated temperatures and taking one or more corrective actions (e.g., adjusting or halting delivery of negative pressure wound therapy). This is particularly important if the patient is unresponsive or otherwise impaired, as this may result in an inability to halt delivery of negative pressure wound therapy or to remove a negative pressure wound therapy device attached to the patient. Alternatively or additionally, negative pressure wound therapy devices may be used in different environments, such as those with elevated environmental temperatures, and therefore the described techniques for detecting elevated temperatures and taking one or more corrective actions may be advantageous to ensure the safe and effective delivery of negative pressure wound therapy.

[0075] Other variations While certain embodiments described herein relate to integrated negative pressure wound therapy systems in which a negative pressure source is supported by a dressing, the systems and methods described herein are applicable to any negative pressure wound therapy system or medical system, particularly systems positioned on (or worn by) a patient. For example, the systems and methods described herein for controlling operation can be used in fluid-resistant (e.g., waterproof) negative pressure wound therapy systems or medical systems. Such systems can be configured with a negative pressure source and / or electronics external to the wound dressing, such that the negative pressure source and / or electronics are positioned in a fluid-proof housing. Additionally, such systems can be configured for use in ultrasound delivery devices, negative pressure devices powered by an external power source, negative pressure devices with a separate pump, and medical devices in general.

[0076] Any of the embodiments disclosed herein may be incorporated by reference in any of the following applications: U.S. Patent No. 7,779,625, entitled "DEVICE AND METHOD FOR WOUND THERAPY," issued August 24, 2010; U.S. Patent No. 7,964,766, entitled "WOUND CLEANSING APPARATUS IN SITU," issued June 21, 2011; U.S. Patent No. 8,235,955, entitled "WOUND TREATMENT APPARATUS AND METHOD," issued August 7, 2012; U.S. Patent No. 7,753,894, entitled "WOUND CLEANSING APPARATUS WITH STRESS," issued July 13, 2010; and U.S. Patent No. 7,753,894, entitled "WOUND CLEANSING APPARATUS WITH STRESS," issued July 1, 2014, each of which is incorporated by reference in its entirety. U.S. Patent No. 8,764,732, entitled "WOUND DRESSING," issued August 19, 2014; U.S. Patent No. 8,808,274, entitled "WOUND DRESSING," issued June 23, 2015; U.S. Patent No. 9,061,095, entitled "WOUND DRESSING AND METHOD OF USE," issued September 18, 2018; U.S. Patent No. 10,076,449, entitled "WOUND DRESSING AND METHOD OF TREATMENT," filed January 30, 2015, published July 9, 2015 as U.S. Publication No. 2015 / 0190286; U.S. Patent Application No. 14 / 418908, entitled "TISSUE DRESSING," issued March 19, 2019. No. 10,231,878, filed July 12, 2012, entitled "WOUND DRESSING AND METHOD OF TREATMENT," PCT International Application No. PCT / GB2012 / 000587, filed May 22, 2013, entitled "APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY," PCT / IB2013 / 001469, filed July 31, 2013, entitled "WOUND DRESSINGPCT International Application No. PCT / IB2013 / 002102, entitled "WOUND DRESSING AND METHOD OF TREATMENT," filed July 31, 2013; PCT International Application No. PCT / IB2013 / 002060, entitled "WOUND DRESSING AND METHOD OF TREATMENT," filed March 12, 2013; PCT International Application No. PCT / IB2013 / 00084, entitled "REDUCED PRESSURE APPARATUS AND METHODS," filed April 26, 2016; PCT / EP2016 / 059329, entitled "REDUCED PRESSURE APPARATUSES," filed April 26, 2017; PCT International Application No. PCT / EP2017 / 059883, filed March 6, 2017, entitled "WOUND TREATMENT APPARATUSES AND METHODS WITH NEGATIVE PRESSURE SOURCE INTEGRATED INTO WOUND DRESSING", PCT International Application No. PCT / EP2017 / 055225, filed September 13, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS", PCT International Application No. PCT / EP2018 / 074694, filed September 13, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS", PCT International Application No. PCT / EP2018 / 074701, filed October 25, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"The present invention may be used in conjunction with one or more features disclosed in PCT International Application No. PCT / EP2018 / 079345, entitled "SAFE OPERATION OF INTEGRATED NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES," filed on October 30, 2018, and PCT International Application No. PCT / EP2018 / 079745, entitled "SAFE OPERATION OF INTEGRATED NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES," filed on October 30, 2018.

[0077] Although certain embodiments described herein relate to wound dressings, the systems and methods disclosed herein are not limited to wound dressings or medical applications. The systems and methods disclosed herein are generally applicable to electronic devices in general, such as electronic devices that can be worn by or applied to a user.

[0078] Any values, such as thresholds, limits, time periods, etc., provided herein are not intended to be absolute values ​​and may therefore be approximate. Additionally, any thresholds, limits, time periods, etc. provided herein may be fixed or variable, either automatically or by a user. Furthermore, as used herein, terms expressing a relative degree, such as greater than, over, or less than, relative to a reference value, are intended to encompass equality to the reference value. For example, exceeding a positive reference value can encompass being equal to or greater than the reference value. Additionally, as used herein, terms expressing a relative degree, such as greater than, over, or less than, relative to a reference value, are intended to encompass the inverse of the disclosed relationship, such as less than, under, or over, relative to the reference value. Furthermore, while various process blocks may be described in terms of determining whether a value meets or does not meet a particular threshold, the blocks may equally be understood in terms of, for example, whether a value (i) is less than or exceeds a threshold, or (ii) meets or does not meet a threshold.

[0079] It should be understood that a feature, material, characteristic, or group described in connection with a particular aspect, embodiment, or example may be applied to any other aspect, embodiment, or example described herein, unless it is inconsistent with that aspect, embodiment, or example. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), or all steps of any method or process similarly disclosed, may be combined in any combination, except combinations in which at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel, or any novel combination, of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process similarly disclosed.

[0080] While certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the protected subject matter. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Additionally, various omissions, substitutions, and changes may be made in the form of the methods and systems described herein. Those skilled in the art will appreciate that, in some embodiments, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the drawings. In some embodiments, certain of the steps described above may be removed, and others may be added. For example, the actual steps or order of steps performed in the disclosed processes may differ from those shown in the drawings.

[0081] Various components illustrated in the figures or disclosed herein may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, and the like, may include logic circuitry. Software or firmware may include instructions stored in non-transitory computer-readable memory. Instructions may be executed by a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, and the like, may include logic circuitry. Furthermore, the features and characteristics of specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure.

[0082] While the present disclosure includes certain specific embodiments, examples, and applications, those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses, and obvious variations and equivalents thereof, including embodiments that do not provide all of the features and advantages described herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments herein, but may be defined by the claims presented herein or hereafter.

[0083] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context of use, is typically intended to convey that certain embodiments include certain features, elements, or steps, while other embodiments do not. Thus, such conditional language is not generally intended to imply that features, elements, or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instruction, whether those features, elements, or steps are included in or should be performed in any particular embodiment. Terms such as "comprise," "include," and "have" are synonymous and used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in an inclusive sense (as opposed to an exclusive sense), so that, for example, when used connecting a list of elements, the term "or" means one, some, or all of the elements in the list. Further, the term "each," as used herein, in addition to having its ordinary meaning, can also refer to any subset of the list of elements to which the term "each" is applied.

[0084] Conjunctive language such as "at least one of X, Y, and Z," unless specifically stated otherwise, is to be construed separately in conjunction with the context in which it is generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive language is not generally intended to suggest that a certain embodiment requires including at least one of X, at least one of Y, and at least one of Z.

[0085] As used herein, terms expressing degrees, such as "approximately," "about," "generally," and "substantially," as used herein, refer to a value, amount, or characteristic that approximates a given value, amount, or characteristic while still performing a desired function or producing a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a given amount.

[0086] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims set forth in this section or elsewhere herein, or set forth hereafter. The claim language is to be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or during the prosecution of this application, which examples are to be construed as non-exclusive. [Additional note 1] 1. A negative pressure wound therapy system comprising: a negative pressure source configured to provide negative pressure to a wound of a patient covered by the wound dressing; a first sensor configured to measure a temperature of at least a first portion of the negative pressure system; a second sensor configured to measure a temperature of at least one of the patient or at least a second portion of the negative pressure system; an electronic control circuit configured to control operation of the negative pressure source in response to the temperature measured by the first sensor; A negative pressure wound therapy system comprising: a programmable controller configured to control operation of the negative pressure source in response to the temperature measured by the second sensor, the programmable controller configured to control operation of the negative pressure source independently of the electronic control circuit. [Additional note 2] The system described in Appendix 1, wherein the controller is configured to reduce activity of the negative pressure source in response to a temperature measured by the second sensor that meets a second temperature threshold lower than the first temperature threshold but does not meet the first temperature threshold. [Additional note 3] The system of claim 2, wherein reducing the activity of the negative pressure source includes lowering the duty cycle of the negative pressure source. [Additional note 4] The system of any one of the preceding claims, further comprising the wound dressing, wherein at least one of the negative pressure source, the first sensor, the second sensor, the electronic control circuit, or the controller is at least partially supported by the wound dressing. [Additional note 5] A system described in any one of the preceding claims, wherein the temperature measured by the first sensor indicates the temperature of the negative pressure source. [Additional note 6] A system described in any one of the preceding paragraphs, wherein the electronic control circuit is configured to stop the negative pressure source in response to determining that the temperature measured by the first sensor meets a temperature threshold indicating unsafe operation. [Additional note 7] 7. The system of claim 6, wherein the electronic control circuit includes a comparator configured to output a determination that the temperature measured by the first sensor meets the temperature threshold indicative of unsafe operation, the comparator accepting the temperature measured by the first sensor as a first input and the temperature threshold as a second input. [Additional note 8] 8. The system of claim 7, wherein the comparator is configured to operate in the presence of noise as a result of at least one of: one or more inputs of the comparator being filtered; or feedback being provided between the first or second input of the comparator and the output of the comparator. [Additional note 9] 9. The system of claim 8, wherein the first and second inputs of the comparator are low-pass filtered. [Additional Note 10] 10. The system of claim 8 or 9, wherein the feedback comprises a resistor positioned between the non-inverting input of the comparator and the output of the comparator. [Additional Note 11] The system of any one of the preceding paragraphs further comprises a power source configured to provide power to at least the negative pressure source, and a boost converter configured to increase the power provided by the power source and provide the increased power to the negative pressure source, wherein the first sensor is configured to measure the temperature of the boost converter. [Additional Note 12] 12. The system of claim 11, wherein the first sensor is positioned proximal to the boost converter. [Additional Note 13] The system of any one of the preceding paragraphs, wherein the second sensor comprises a pair of sensors, and the controller is configured to determine the temperature of at least one of the negative pressure source or another component of the negative pressure system based on the difference between the measurement value of a first sensor and the measurement value of a second sensor of the pair of sensors. [Additional Note 14] 14. The system of claim 13, wherein the first and second sensors of the pair of sensors are configured to measure pressure and temperature. [Additional Note 15] A system as described in appendix 13 or 14, wherein the first sensor of the pair of sensors is positioned at the inlet of the negative pressure source and the second sensor of the pair of sensors is positioned at the exhaust outlet of the negative pressure source. [Additional Note 16] the controller responding to the temperature measured by the second sensor: shutting down the negative pressure source in response to the temperature measured by the second sensor meeting a first temperature threshold indicative of unsafe operation; reducing activity of the negative pressure source in response to the temperature measured by the second sensor satisfying a second temperature threshold that is less than the first temperature threshold and not satisfying the first temperature threshold; or The system described in any one of the preceding paragraphs is configured to control the operation of the negative pressure source by at least one of: taking no action in response to the temperature measured by the second sensor not satisfying the second temperature threshold. [Additional Note 17] 17. The system of claim 16, wherein reducing the activity of the negative pressure source includes reducing the duty cycle of the negative pressure source. [Additional Note 18] The controller stores in a memory: a first indication that at least one of the first temperature threshold or the second temperature threshold has been met; and a second indication that the temperature measured by the first sensor meets a temperature threshold indicative of unsafe operation. [Additional Note 19] The system of any one of the preceding claims, wherein the controller is further configured to disable activation of the negative pressure source in response to determining that the temperature measured by at least one of the first sensor or the second sensor meets a temperature threshold indicating unsafe operation. [Additional Note 20] A system described in any one of the preceding claims, wherein the first and second parts of the negative pressure system are the same. [Additional Note 21] The system of any one of the preceding claims, further comprising a switch configured to enable activation of the negative pressure source, the switch configured to be deactivated in response to a determination that the temperature measured by at least one of the first sensor or the second sensor meets a temperature threshold indicative of unsafe operation. [Additional Note 22] The system of any one of the preceding paragraphs, wherein the second sensor is configured to measure the patient's temperature, and the controller is configured to stop the negative pressure source in response to determining that the temperature measured by the second sensor meets a temperature threshold indicating a high patient temperature. [Additional Note 23] A system described in any one of the preceding claims, wherein the controller is configured to execute instructions to control operation of the negative pressure source in response to the temperature measured by the second sensor. [Additional note 24] A method of operating a negative pressure wound therapy system according to any one of the preceding claims.

Claims

1. 1. A negative pressure wound therapy system comprising: a negative pressure source configured to provide negative pressure to a wound of a patient covered by the wound dressing; a first sensor configured to measure a temperature of the negative pressure source; a second sensor configured to measure a temperature of the patient; and an electronic control circuit configured to control operation of the negative pressure source in response to the temperature measured by the first sensor; a programmable controller configured to control operation of the negative pressure source in response to the temperature measured by the second sensor, the programmable controller configured to control operation of the negative pressure source independently of the electronic control circuitry.

2. 2. The negative pressure wound therapy system of claim 1, wherein the controller is configured to reduce activity of the negative pressure source in response to a temperature measured by the second sensor that meets a second temperature threshold that is lower than the first temperature threshold and does not meet the first temperature threshold.

3. The negative pressure wound therapy system of claim 2 , wherein reducing the activity of the negative pressure source comprises lowering the duty cycle of the negative pressure source.

4. A negative pressure wound therapy system as described in any one of claims 1 to 3, wherein at least one of the negative pressure source, the first sensor, the second sensor, the electronic control circuit, or the controller is at least partially supported by the wound dressing.

5. A negative pressure wound therapy system as described in claim 4, wherein the negative pressure source, the first sensor, the second sensor, the electronic control circuit and the controller are supported by the wound dressing.

6. A negative pressure wound therapy system according to any one of claims 1 to 5, wherein the electronic control circuit is configured to stop the negative pressure source in response to determining that the temperature of the negative pressure source measured by the first sensor meets a temperature threshold indicative of unsafe operation.

7. 7. The negative pressure wound therapy system of claim 6, wherein the electronic control circuit comprises a comparator configured to output a determination that the temperature of the negative pressure source measured by the first sensor meets the temperature threshold indicative of unsafe operation, the comparator accepting the temperature of the negative pressure source measured by the first sensor as a first input and the temperature threshold as a second input.

8. the comparator is configured to operate in the presence of noise as a result of at least one of one or more inputs of the comparator being filtered or feedback being provided between the first or second input of the comparator and an output of the comparator; 8. The negative pressure wound therapy system of claim 7, wherein the feedback comprises a resistor positioned between a non-inverting input of the comparator and the output of the comparator.

9. a power source configured to provide power to at least the negative pressure source; and a boost converter configured to increase the power provided by the power source and provide the increased power to the negative pressure source, wherein the first sensor is configured to measure a temperature of the boost converter; 9. The negative pressure wound therapy system of claim 1, wherein the first sensor is positioned proximal to the boost converter.

10. the controller responding to the patient's temperature measured by the second sensor: deactivating the negative pressure source in response to the patient's temperature measured by the second sensor meeting a first temperature threshold indicative of unsafe operation; reducing activity of the negative pressure source in response to the patient's temperature measured by the second sensor meeting a second temperature threshold that is less than the first temperature threshold and not meeting the first temperature threshold; or taking no action in response to the patient's temperature measured by the second sensor not meeting the second temperature threshold; 10. The negative pressure wound therapy system of claim 1, configured to control operation of the negative pressure source by at least one of:

11. The negative pressure wound therapy system of claim 10, wherein reducing the activity of the negative pressure source comprises reducing the duty cycle of the negative pressure source.

12. 12. A negative pressure wound therapy system according to any one of claims 1 to 11, wherein the controller is further configured to disable activation of the negative pressure source in response to a determination that the temperature of the negative pressure source or the temperature of the patient measured by at least one of the first sensor or the second sensor meets a temperature threshold indicative of unsafe operation.

13. 13. The negative pressure wound therapy system of any one of claims 1 to 12, further comprising a switch configured to enable activation of the negative pressure source, the switch configured to be deactivated in response to a determination that the temperature of the negative pressure source or the patient's temperature measured by at least one of the first sensor or the second sensor meets a temperature threshold indicative of unsafe operation.

14. 14. A negative pressure wound therapy system according to any one of claims 1 to 13, wherein the controller is configured to execute instructions for controlling operation of the negative pressure source in response to the patient's temperature measured by the second sensor.

15. A negative pressure wound therapy system as described in claim 14, wherein the controller is configured to stop the negative pressure source in response to a determination that the patient's temperature measured by the second sensor meets a temperature threshold indicating a high patient temperature.

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