Intelligent disposable devices for wound therapy and treatment

Abstract

The present disclosure is directed to the use of intelligent disposables in wound treatment devices and systems, such as negative pressure wound therapy devices and systems, and liquid jet debridement devices and systems for wound preparation. The intelligent disposables can collect, maintain, and store data to manage the entire lifecycle of the device or system. The intelligent disposables may include control or processing circuitry, a transceiver, memory, and a power source. The transceiver may be configured to wirelessly communicate with a computing device, such as a phone or tablet. Any of a variety of data may be stored by the intelligent disposables, such as operational statistics, regulatory information, and past usage information.

Description

[Technical field]

[0001] The embodiments described herein relate to the use of intelligent disposable or consumable accessories with devices, systems, and methods for the treatment of wounds, for example, by negative pressure wound therapy or liquid jet debridement and wound bed preparation systems.

[0002] 2. Description of Related Art Conventional consumables or disposable accessories used in connection with negative pressure wound therapy or liquid jet debridement and wound bed preparation devices and systems lack intelligence. These conventional disposables function when connected and interfaced with the devices and systems. However, information regarding one or more characteristics of the disposable is not recorded and subsequently used to adjust the delivery of therapy or treatment. Summary of the Invention

[0003] A canister for negative pressure wound therapy may include a housing defining an interior volume for storing fluid aspirated from a wound during delivery of negative pressure wound therapy. The canister may include electronic circuitry at least partially enclosed by the housing. The electronic circuitry may include a memory configured to store data related to one or more parameters of the canister. The electronic circuitry may include a transceiver configured to wirelessly communicate with a computing device. The electronic circuitry may include a processing circuitry coupled to the memory and the transceiver. The processing circuitry may be configured to store data in the memory and to cause the transceiver to provide at least a portion of the data stored in the memory in response to a request from the computing device.

[0004] The negative pressure canister of any of the preceding paragraphs and / or any of the canisters disclosed herein may include one or more of the following features: The memory may be configured to store code for updating firmware or software of a computing device, which may be a negative pressure wound therapy device configured to removably support the housing. The memory may be configured to store an indication for the negative pressure wound therapy device to determine that the firmware or software needs to be updated with the code. The indication may include a firmware version of the software stored in the memory and configured to be executed by the processing circuit. The transceiver may be configured to communicate with the computing device using a wireless communication protocol such as near field communication (NFC). The computing device may be a negative pressure wound therapy device configured to removably support the housing. The data may include a canister capacity stored in the memory before the canister is used for negative pressure wound therapy. The data may include instructions to recycle the canister. The data may include an indication that the canister has reached its end of life. The data may include an indication of the canister being used to provide negative pressure to the patient. The data may include a canister orientation or a canister fill status determined during the delivery of negative pressure wound therapy and stored in memory during the delivery of negative pressure wound therapy. The canister orientation may include a reversed orientation determined during the delivery of negative pressure wound therapy. Storing the reversed orientation in memory may prevent the canister from being used for further delivery of negative pressure wound therapy. The electronic circuit may include a power source configured to provide power to at least one of the memory, the transceiver, or the processing circuit. The power source may include one or more of a capacitor or a battery. The data may include a manufacturing date stored as read-only data. The manufacturing date may facilitate a determination that the shelf life of the canister has not been exceeded. The data may include an indication that the canister is full. The indication may be stored in response to a determination that a level of fluid aspirated from the wound has reached a threshold level for a duration of time.

[0005] A handpiece for a wound debridement system may include a housing coupled to a console and configured to apply a liquid jet to a wound. The handpiece may include electronic circuitry at least partially enclosed by the housing. The electronic circuitry may include a memory configured to store data related to one or more parameters of the handpiece. The electronic circuitry may include a transceiver configured to communicate with the console. The electronic circuitry may include a processing circuitry coupled to the memory and the transceiver. The processing circuitry may be configured to store data in the memory and cause the transceiver to provide at least a portion of the data stored in the memory in response to a request from the console. The handpiece may include a mechanism configured to provide an indication that the handpiece has lost sterility.

[0006] The handpiece of any of the preceding paragraphs and / or any of the handpieces disclosed herein may include one or more of the following features: The mechanism may include a material configured to become non-conductive in response to exposure to the atmosphere for a duration. The mechanism may include a photodiode coupled to a material configured to change an optical property in response to exposure to the atmosphere for a duration. The data may include a fluid pressure value or range that the handpiece is capable of providing. Data related to the fluid pressure value or range may be stored in the memory prior to use of the handpiece to debride a wound. The console may be configured to alert a user of a fluid pressure value or out of range fluid pressure. The data may include instructions for recycling the handpiece. The data may include an indication that the handpiece has reached the end of its useful life. The data may include an indication of the handpiece being used to debride a wound of a patient.

[0007] A disposable device for use in a wound treatment or monitoring system may include a substrate or housing. The device may include electronic circuitry supported at least in part by the substrate or housing. The electronic circuitry may include a memory configured to store data relating to one or more parameters of the disposable device. The electronic circuitry may include a transceiver configured to wirelessly communicate with a computing device. The electronic circuitry may include a processing circuitry coupled to the memory and the transceiver. The processing circuitry may be configured to store data in the memory and to cause the transceiver to provide at least a portion of the data stored in the memory in response to a request from the computing device.

[0008] The disposable device of any of the preceding paragraphs and / or any of the disposable devices disclosed herein may include one or more of the following features: The disposable device may include a mechanism configured to provide an indication that the disposable device has lost sterility. The mechanism may include a photodiode coupled to a material configured to become non-conductive in response to exposure to the atmosphere for a first duration, or to a material configured to change an optical property in response to exposure to the atmosphere for a second duration. The transceiver may be configured to communicate with the computing device using a wireless communication protocol, such as near field communication (NFC) or radio frequency identification (RFID). At least a portion of the data may be stored in the memory before the device is used for wound treatment or monitoring. At least a portion of the data may be stored in the memory in response to the device being used for wound treatment or monitoring. The data may include an indication of whether the disposable device has been used for wound treatment or monitoring. The data may include instructions to recycle the device. The data may include an indication that the life of the device has been reached. The electronic circuitry may include a power source configured to power at least one of the memory, the transceiver, or the processing circuitry. The power source can be one or more of a capacitor or a battery. The disposable device can be a sensor integrated substrate, a wound dressing configured to provide vibration therapy, or a wound dressing that supports a negative pressure source.

[0009] A method of using any of the disposable devices of the preceding paragraphs and / or any of the disposable devices disclosed herein may include transferring data stored in a memory of the disposable device to a computing device and displaying the data on the computing device.

[0010] The method of the above paragraph and / or any of the methods disclosed herein may include one or more of the following features: At least a portion of the data may be stored in the memory before the disposable device is used to treat or monitor a wound. At least a portion of the data may be stored in the memory in response to the disposable device being used to treat or monitor a wound.

[0011] Disclosed herein are methods of using and / or operating the canister, debridement system, or disposable apparatus of any of the preceding paragraphs, and / or any of the devices, canisters, apparatus, or systems disclosed herein.

[0012] Disclosed herein is a kit comprising a canister of any of the preceding paragraphs and / or any of the canisters disclosed herein, and a negative pressure wound therapy device.

[0013] Disclosed is a kit comprising a canister of the negative pressure wound therapy apparatus of any of the preceding paragraphs, and / or any of the devices, apparatus, or systems disclosed herein, and one or more wound dressings.

[0014] Any of the features, components, or details of any of the arrangements or embodiments disclosed in the present application, including but not limited to any of the device embodiments disclosed herein and any of the negative pressure wound therapy embodiments disclosed herein, can be combined with any other features, components, or details of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments. [Brief description of the drawings]

[0015] [Figure 1A] FIG. 1A shows a negative pressure wound therapy system. [Figure 1B] FIG. 1B illustrates another negative pressure wound therapy system. [Figure 2A]FIG. 2A is an isometric view of a negative pressure wound therapy device and canister, showing the canister detached from the pump assembly of the device. [Figure 2B] FIG. 2B is a rear view of the negative pressure wound therapy device shown in FIG. 2A. [Figure 2C] FIG. 2C shows the top surface of the negative pressure wound therapy device shown in FIG. 2A, showing the user interface. [Diagram 3] FIG. 3 shows a schematic diagram of the control system of the negative pressure wound therapy device. [Figure 4A] FIG. 4A shows a perspective view of a substrate supporting electronic components. [Figure 4B] FIG. 4B shows a perspective view and a top view of a perforated substrate supporting electronic components. [Figure 4C] FIG. 4C shows a perspective view and a top view of a perforated substrate supporting electronic components. [Diagram 5] FIG. 5 shows a liquid jet debridement and wound bed preparation system. [Figure 6A] FIG. 6A shows the console of the liquid jet debridement and wound bed preparation system. [Figure 6B] FIG. 6B shows the console of the liquid jet debridement and wound bed preparation system. [Figure 7] FIG. 7 shows a schematic diagram of an intelligent disposable. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] overview Intelligent or smart disposables for use in wound therapy or treatment systems can advantageously store status data that facilitates more effective and efficient operation of the system. The status data can be stored in memory of the smart disposable and can be accessed by another component of the system. The status data can be used to manage the lifecycle of the smart disposable or system, for example, set-up, adjustment of operation, or disposal of the smart disposable or system. As described herein, wound therapy or treatment can be improved.

[0017] Smart disposables may be used in a variety of applications, including, but not limited to, negative pressure wound therapy devices, debridement devices, wearable devices, health devices, therapy applicators, radiation applicators, measurement assembly devices, implantable devices, or semi-implantable devices. Smart disposables can be an integral part of devices and systems when connected, activated, and identified. Smart disposables can communicate status data via wired or wireless communication protocols, such as radio frequency identification (RFID), near field wireless protocols (such as Near Field Communication (NFC)), infrared (such as IrDA), vibration, and the like.

[0018] In general, smart disposables can allow access to status data before or after the disposable is used to provide therapy or wound care. Status data can include, for example, who used the disposable, what, where, when, and how it was used. Status data can be used to adjust therapy, pre-set alarms and alerts, control basic safety with pre-measured data (e.g., component temperature, electrical insulation, operating temperature, etc.), measure data used as a reference or compensation, measure radio frequency (RF) antenna parameters, measure individual data of RF radio power and sensitivity, or measure impedance, capacitance, inductance, or temperature. Status data can include pre-calibration parameters such as maximum pressure level, vacuum source level, or leak level. Smart disposables can track shelf life status, manufacturing time, location or country of manufacture, shipping conditions, storage location, duration of use, etc.

[0019] The status data can be used to adjust system-level regulatory behavior. For example, one or more of therapy parameters, safety and electromagnetic compatibility (EMC) deviations, waste management regulatory data, biohazard regulatory data, and location and privacy regulations. The status data can include system-level functional usage data, such as data related to faults, alarms and alerts, misuse, extreme operational use, and warranty interruptions or failures. The status data can include an indication that the disposable is used, which can be used to ensure and enforce single-patient use while also allowing reuse after an approved sterilization process. The status data can include instructions for use or instructions for disposal of one or more of the smart disposable or wound therapy or treatment system.

[0020] A smart disposable may include one or more processors, memory, sensors, or communication interfaces. A smart disposable may be remotely powered or may have a power source. An embodiment of a smart disposable may function as an accessory. A smart disposable may be capable of communicating with other devices, systems, trackers, beacons, mesh networks, locators, waste disposal devices, software applications, smartphones, tablets, personal computers (PCs), and the like. Communication to and from the disposable may be established via wires and connectors, wirelessly, acoustically, optically, fluidically, using mechanical vibrations, pressure fluctuations, and the like. The incorporation of smart disposables can create an effective integrated system that can fully control the life cycle of the disposable. The use of smart disposables that store status data may be advantageous over the use of labels, quick response (QR) codes, bar codes, or the like, as they may be removed or damaged.

[0021] Wound treatment and monitoring The embodiments disclosed herein relate to smart disposables, and treatment or monitoring systems and methods that interface with smart disposables. Some examples relate to a negative pressure wound therapy system including a negative pressure source configured to provide negative pressure to a wound covered with a wound dressing via a fluid flow path. Some examples relate to a wound debridement system used to prepare a wound. Some examples relate to a sensor-integrated wound dressing. Some examples relate to a wound dressing that can provide vibration therapy (such as ultrasound). Some examples relate to a wound dressing that supports a negative pressure source, such as that described in International Patent Publication No. WO2020 / 187641, which is incorporated by reference in its entirety.

[0022] Throughout this specification, reference is made to wounds. The term wound is broadly interpreted to include open and closed wounds where the skin is torn, incised, or perforated, or where trauma causes bruising, or any other surface or other pathology or incomplete condition in the skin of a patient, or others that benefit from reduced pressure treatment. Thus, a wound is broadly defined as any damaged area of ​​tissue where fluid may or may not be produced. 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 wounds and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, bruises, burns, diabetic ulcers, decubitus ulcers, stomas, surgical wounds, traumatic ulcers, and venous ulcers.

[0023] The embodiments of the devices, systems and methods disclosed herein may be used with topical negative pressure ("TNP") or reduced pressure therapy systems. Simply put, negative pressure wound therapy may assist in the closure and healing of many forms of "hard to heal" wounds by reducing tissue edema, promoting blood flow and granular tissue formation, or removing excess exudate, and may reduce bacterial load (and thus infection risk). Furthermore, this therapy may lead to less wound injury and more rapid healing. TNP therapy systems may also assist in the healing of surgically closed wounds by removing fluids. TNP therapy may help stabilize tissues in opposition to closure. Further beneficial uses of TNP therapy may be found in grafts and flaps, where removing excess fluid is important and grafts are required to be in close proximity to tissue to ensure tissue viability.

[0024] As used herein, a reduced pressure or negative pressure level, such as -XmmHg, represents a pressure level relative to normal ambient atmospheric pressure, which may correspond to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -XmmHg reflects a pressure that is XmmHg lower than 760mmHg, or in other words, a pressure of (760-X)mmHg. Additionally, a negative pressure that is "lower" or "less" than XmmHg corresponds to a pressure that is closer to atmospheric pressure (e.g., -40mmHg is lower than -60mmHg). A negative pressure that is "higher" or "greater" than -XmmHg corresponds to a pressure that is further from atmospheric pressure (e.g., -80mmHg is higher than -60mmHg). In some cases, the local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.

[0025] The systems and methods disclosed herein may be used in addition to or in place of reduced pressure therapy, such as irrigation, ultrasound, heating or cooling, nerve stimulation, or the like, with other types of treatments. In some cases, the disclosed systems and methods may be used for wound monitoring without the application of additional therapy. The systems and methods disclosed herein may be used with dressings, including compression dressings, reduced pressure dressings, or the like.

[0026] A healthcare provider, such as a doctor, nurse, or the like, can provide a TNP prescription that specifies, for example, pressure levels or application times. However, the healing process varies from patient to patient, and the prescription may affect the healing process in ways that the clinician or healthcare provider did not anticipate when devising the prescription. The healthcare provider may attempt to adjust the prescription as the wound heals (or does not heal), but such a process may require various appointments that may be time-consuming and repetitive. The embodiments disclosed herein provide a system, device, or method that efficiently adjusts the TNP prescription and delivers an effective TNP therapy.

[0027] Negative Pressure Wound Therapy with Smart Disposables Any of the embodiments of the wound therapy systems or devices described herein may be configured with smart disposables to provide any of the benefits described herein.

[0028] FIG. 1A illustrates a schematic of a negative pressure wound treatment system 100′ (also referred to as a reduced pressure or negative pressure wound therapy system, TNP system, or wound treatment system). Although not required in any implementation disclosed herein, the negative pressure wound treatment system 100′ may include a wound packing 102 placed on or within a wound 104 (which may be a cavity). The wound 104 may be sealed by a wound cover 106, which may be a drape, such that the wound cover 106 may be in fluid communication with the wound 104. The wound packing 102 in combination with the wound cover 106 may be referred to as a wound dressing. A tube or conduit 108′ (also referred to herein as a flexible suction adapter or fluid connector) may be used to connect the wound cover 106 to a wound therapy device 110′ (which may be referred to in whole or in part as a “pump assembly”) configured to deliver reduced pressure or negative pressure. The conduit 108' can be a single lumen tube or a multi-lumen tube. Referring to Figure 1B, a connector 134 can be used to removably and selectively couple a conduit or tube 142 to the conduit 108'.

[0029] In any of the systems disclosed herein, the wound therapy device may be canister-less, for example and without limitation, wound exudate is collected in a wound dressing or transferred via a conduit for collection elsewhere, however, any of the wound therapy devices disclosed herein may include or support a canister.

[0030] Additionally, in any of the wound therapy systems disclosed herein, any of the wound therapy devices may be attached to or supported by a wound dressing or adjacent to a wound dressing. The wound filler 102 may be of any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, or the like. The wound filler 102 may be conformable to the wound 104 such that the wound filler 102 substantially fills the cavity of the wound 104. The wound cover 106 may provide a substantially fluid impermeable seal over the wound 104. The wound cover 106 may have a top side and a bottom side. The bottom side may be adhesively (or in any other suitable manner) sealed to the wound 104, for example, by sealing with the skin around the wound 104. The conduit 108' or any other conduit disclosed herein may be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0031] The wound cover 106 may have a port (not shown) configured to receive an end of the conduit 108'. In some cases, the conduit 108' may otherwise pass through or under the wound cover 106 to supply reduced pressure to the wound 104 to maintain a desired level of reduced pressure within the wound 104. The conduit 108' may be any suitable article configured to provide at least a substantially sealed fluid flow path or passage between the wound therapy device 110' and the wound cover 106 to supply reduced pressure provided by the wound therapy device 110' to the wound 104. The pressure provided may be stored as state data by a smart disposable, such as the smart disposable 1000, as shown in FIG. 7.

[0032] The wound cover 106 and wound packing 102 may be provided as a single item or integral single unit. In some cases, no wound packing is provided and the wound cover itself may be considered a wound dressing. The wound dressing may then be connected via conduit 108' to a negative pressure source of wound therapy device 110'. In some cases, although not required, the wound therapy device 110' may be miniaturized and portable, although a larger conventional negative pressure source (or pump) may also be used.

[0033] The wound cover 106 may be placed over the wound site to be treated. The wound cover 106 may form a substantially sealed cavity or enclosure over the wound. The wound cover 106 may have a film with high water vapor permeability to allow evaporation of excess fluids, and may have a superabsorbent material contained therein to safely absorb wound exudate. In some cases, the components of the TNP system described herein may be particularly suitable for incised wounds that exude a small amount of wound exudate.

[0034] The wound therapy device 110' can be operated with or without the use of an exudate canister. In some cases, as shown, the wound therapy device 110' may include an exudate canister. In some cases, the wound therapy device 110' and the conduit 108' may be configured to allow the conduit 108' to be quickly and easily detached from the wound therapy device 110', thereby facilitating or improving the process of changing wound dressings or pumps, if desired. Any of the pump assemblies disclosed herein may have any suitable connection between the conduit 108' and the pump. When an exudate canister is used with the wound therapy device 110' (or any of the other wound therapy devices disclosed herein), it may be configured as a smart disposable, such as smart disposable 1000, as shown in FIG. 7.

[0035] The wound therapy device 110' may deliver a negative pressure of approximately -80 mmHg, or between about -20 mmHg and -200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure, i.e., -200 mmHg may actually be about 560 mmHg. In some cases, the pressure range may be between about -40 mmHg and -150 mmHg. Alternatively, a pressure range of -75 mmHg or less, -80 mmHg or less, or greater than -80 mmHg may be used. Also, in some cases, a pressure range below -75 mmHg may be used. Alternatively, a pressure range of approximately -100 mmHg, or even greater than -150 mmHg may be provided by the wound therapy device 110'.

[0036] As described in more detail below, the negative pressure wound treatment system 100′ may be configured to provide a connection 332 to a separate or remote computing device 334. The connection 332 may be wired or wireless (such as Bluetooth, Bluetooth Low Energy (BLE), NFC, WiFi, or cellular). The remote computing device 334 may be a smartphone, tablet, laptop or another standalone computer, a server (such as a cloud server), another pump device, etc. The remote computing device 334 may be incorporated into any wound therapy or treatment system disclosed herein and configured to communicate with smart disposables as described herein.

[0037] FIG. 1B illustrates another negative pressure wound treatment system 100. The negative pressure wound treatment system 100 may have any of the components, features, or other details of any of the other negative pressure wound treatment systems disclosed herein, including, but not limited to, the negative pressure wound treatment system 100′ shown in FIG. 1A or the negative pressure wound treatment system 400 shown in FIG. 4, in combination with or in place of any of the components, features, or other details of the negative pressure wound treatment system 100 shown in FIG. 1B and / or described herein. The negative pressure wound treatment system 100 may have a wound cover 106 over the wound 104 that may seal the wound 104. A conduit 108, such as a single lumen or multi-lumen tubing, may be used to connect the wound cover 106 to a wound therapy device 110 (sometimes referred to as a “pump assembly” in whole or in part) configured to provide reduced pressure or negative pressure. The wound cover 106 may be in fluid communication with the wound 104.

[0038] 1B, the conduit 108 may have a bridge portion 130, which may have a proximal end and a distal end (the distal end being closer to the wound 104 than the proximal end), and an applicator 132 at the distal end of the bridge portion 130, which forms a flexible suction adapter (or conduit) 108. A connector 134 may be disposed at the proximal end of the bridge portion 130 to extend along the length of the bridge portion 130 of the conduit 108 shown in FIG. 1B and connect to at least one of the channels. A cap 140 may be coupled to a portion of the conduit 108, and in some cases may be attached to the connector 134, as shown. The cap 140 may be useful in preventing fluid from leaking out the proximal end of the bridge portion 130. The conduit 108 may be a Soft Port manufactured by Smith & Nephew. As mentioned above, the negative pressure wound treatment system 100 may include a negative pressure source, such as device 110, capable of supplying negative pressure to the wound 104 through conduit 108. Although not required, the canister or device 110 may also include other containers for storing wound exudate and other fluids that may be removed from the wound.

[0039] The device 110 may be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 may be placed over a suitably prepared wound or an opening formed in the cover 106 placed over the wound 104. With the wound therapy device 110 connected to the connector 134 via the tube 142, the wound therapy device 110 may then be operated to provide negative pressure to the wound. The application of negative pressure may be applied until a desired level of healing of the wound is achieved.

[0040] The bridge portion 130 may include an upper channel material or layer positioned between the upper and middle layers, with a lower channel material or layer positioned between the middle and bottom layers. The upper, middle, and lower layers may have elongated portions extending between the proximal and distal ends and may include a fluid impermeable material, e.g., a polymer such as polyurethane. Of course, it will be understood that the upper, middle, and lower layers may each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper, middle, and lower layers may be at least partially transparent. In some instances, the upper and lower layers may be curved, rounded, or outwardly convex over a majority of the length of the upper and lower layers.

[0041] The upper and lower channel layers may be elongated layers extending from the proximal end to the distal end of the bridge 130, and each may preferably comprise a porous material including an open cell foam such as, for example, polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers may be comprised of, for example, a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.), or a nonwoven material, or a terry or loop pile material. The fabric is not necessarily woven and may include felt and floppy fabric materials (including materials such as Flotex.RTM.). The material selected is preferably positioned to direct wound exudate away from the wound and transmit negative pressure or evacuated air to the wound site, and may also provide the channel layer with some degree of kink or occlusion resistance. In one example, the upper channel layer may include an open cell foam such as polyurethane, and the lower channel layer may include a fabric. In another example, the upper channel layer is optional and the system may instead include an open upper channel. The upper channel layer may have a curved, rounded, or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer may have a curved, rounded, or downwardly convex lower surface and a substantially flat upper surface.

[0042] The fabric or material of any component of the bridge 130 may have a three-dimensional (3D) structure, with one or more types of fibers forming a structure in which the fibers extend in all three dimensions. Such fabrics may aid in wicking, fluid transport, or negative pressure transmission in some cases. In some cases, the fabric or material of the channel may include several layers of material stacked or layered on top of each other, which may be useful in some cases in preventing the channel from collapsing under the application of negative pressure. The materials used in some implementations of the conduit 108 may be conformable and flexible, which may help in some cases to avoid bed sores and other complications that may arise from a wound treatment system pressed against a patient's skin.

[0043] The distal ends of the top, middle and bottom layers, as well as the channel layer, may be expanded at the distal ends of the layers (placed over the wound site) to form a "teardrop" or other expanded shape. At least the distal ends of the top, middle and bottom layers, as well as the channel layer, may also include at least one aperture therethrough. This aperture may be useful during manufacture of the device, as it may be used to properly align the respective layers, as well as to drain wound exudate and apply negative pressure to the wound.

[0044] In some implementations, a controlled gas leak 146 (which may also be referred to as a gas leak, air leak, or controlled air leak) may be disposed on the bridge portion 130, for example, at a proximal end of the bridge portion 130. This air leak 146 may include an opening or channel extending through an upper layer of the bridge portion 130 such that the air leak 146 is in fluid communication with the upper channel of the bridge portion 130. Upon application of suction to the conduit 108, gas (such as air) may enter through the gas leak 146 and travel along the upper channel of the bridge portion 130 from the proximal end of the bridge portion 130 to the distal end of the bridge portion. Gas may then be drawn into the lower channel of the bridge portion 130 by passing the opening through the upper layer, the middle layer, and the distal end of the lower layer. Data related to the air leak 146, such as the flow rate (or flow range) provided by the air leak 146, may be part of the status data stored by a smart disposable, such as the smart disposable 1000, as shown in FIG.

[0045] The air leak 146 may include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 to minimize the possibility of wound exudate or other fluids contacting the air leak 146 or filter and blocking or impeding the air leak 146 or filter. In some instances, the filter may be a microporous membrane that may be capable of excluding microorganisms and bacteria and filtering particles larger than 45 μm. Preferably, the filter may be capable of filtering out particles larger than 1.0 μm, and more preferably, particles larger than 0.2 μm. Advantageously, some implementations may provide a filter that is at least partially chemically resistant, for example, to water, common household liquids such as shampoo, and other surfactants. In some cases, reapplication of vacuum to the suction adapter or wiping the exposed outer portion of the filter may be sufficient to clear out any foreign matter that blocks the filter. The filter may be constructed of a suitably resistant polymer, such as acrylic, polyethersulfone, or polytetrafluoroethylene, and may be oil-based or hydrophobic. In some cases, the gas leak 146 may provide a relatively constant gas flow that does not increase appreciably when additional negative pressure is applied to the conduit 108. In instances of negative pressure wound treatment systems 100 where the gas flow through the gas leak 146 increases when additional negative pressure is applied, preferably this increased gas flow will be minimized and will not increase proportionately to the negative pressure applied thereto. Further description of such bridges, conduits, air leaks, and other components, features, and details that may be used in any implementation of the negative pressure wound treatment system disclosed herein may be found in U.S. Patent No. 8,801,685, the entirety of which is incorporated by reference herein as if fully set forth herein.

[0046] Any of the wound therapy devices disclosed herein (such as device 110 or 110') may provide continuous or intermittent negative pressure therapy. Continuous therapy may be delivered above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. Intermittent therapy may be delivered between a low negative pressure set point and a high negative pressure set point (sometimes referred to as set points). The lower set point may be set above 0mmHg, -25mmHg, -40mmHg, -50mmHg, -60mmHg, -70mmHg, -80mmHg, -90mmHg, -100mmHg, -120mmHg, -125mmHg, -140mmHg, -160mmHg, -180mmHg, or below -180mmHg. The high set point can be set above -25mmHg, -40mmHg, -50mmHg, -60mmHg, -70mmHg, -80mmHg, -90mmHg, -100mmHg, -120mmHg, -125mmHg, -140mmHg, -160mmHg, -180mmHg, -200mmHg, or below -200mmHg. During intermittent therapy, negative pressure at the low set point can be delivered for a first period of time, and at the end of the first period of time, negative pressure at the high set point can be delivered for a second period of time. At the end of the second period of time, negative pressure at the low set point can be delivered. The first and second periods of time can be the same or different values.

[0047] In operation, the wound packing 102 may be inserted into the cavity of the wound 104 and the wound cover 106 may be placed to seal the wound 104. The wound therapy device 110' may provide negative pressure to the wound cover 106, which may be transmitted to the wound 104 via the wound packing 102. Fluid (such as wound exudate) may be drawn through the conduit 108 and stored in the canister. In some cases, the fluid is absorbed by the wound packing 102 or one or more absorbent layers (not shown).

[0048] Wound dressings that may be used with the pump assembly and system of the present application may include Renasys-F, Renasys-G, Renasys AB, and Pico Dressing available from Smith & Nephew. Further description of wound dressings and other components of the negative pressure wound therapy system that may be used with the pump assembly and system of the present application can be found in U.S. Patent Publication Nos. 2012 / 0116334, 2011 / 0213287, 2011 / 0282309, 2012 / 0136325, U.S. Patent No. 9,084,845, and International Patent No. PCT / EP2020 / 078376, each of which is incorporated herein by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings may be used.

[0049] 2A, 2B, and 2C illustrate a negative pressure wound therapy device 110'. As shown, a pump assembly 160 and a canister 162 can be connected, thereby forming the wound therapy device 110'. With reference to FIG. 2C, the pump assembly 160 can include an interface panel 170 having a display 172, one or more indicators 174, or one or more controls or buttons, including, for example, but not limited to, a start and pause therapy button 180 or an alarm / warning mute button 182. The interface panel 170 can have one or more input controls or buttons 184 (three shown) that can be used to control any function of the pump assembly 160 or the interface panel 170. For example, and without limitation, one or more of the buttons 184 can be used to turn the pump assembly 160 on or off, start or pause therapy, operate and monitor the operation of the pump assembly 160, scroll through menus displayed on the display 172, or control or perform other functions. In some cases, the command buttons 184 may be programmable and may be made from a tactile soft rubber.

[0050] Additionally, the interface panel 170 may have a visual indicator 186 that may indicate which of the one or more buttons 184 is active. The interface panel 170 may also have a lock / unlock control or button 188 that may be configured to selectively lock or unlock the functionality of the various buttons (e.g., buttons 184) or display 172. For example, adjustments to therapy settings may be locked / unlocked via the lock / unlock control 188. When the lock / unlock button 188 is in a locked state, pressing one or more of the various other buttons or displays will not cause the pump assembly 160 to change any display or performance functions of the device. In this manner, the interface panel 170 will protect the various buttons or displays from being accidentally bumped or touched. The interface panel 170 may be located on a top portion of the pump assembly 160, for example, and without limitation, on an upwardly facing surface of the pump assembly 160.

[0051] A display 172, which may be a screen such as an LCD screen, may be mounted in a central portion of the interface panel 170. The display 172 may be a touch screen display. The display 172 supports the playback of audiovisual (AV) content, such as instructional videos, and can render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the pump assembly 160.

[0052] The one or more indicators 174 may be lights (e.g., LEDs) and may be configured to provide a visual indication of an alarm condition and / or a status of the pump. For example, and without limitation, the one or more indicators 174 may be configured to provide a visual indication of a status of the pump assembly 160 or other components of the negative pressure wound therapy system 100, including, but not limited to, the conduit 108 or wound cover 106 (e.g., providing an indication of normal operation, low battery, leakage, canister full, blockage, overpressure, etc.). Any suitable indicator or indicators may additionally or alternatively be used, such as visual, audible, tactile indicators, etc.

[0053] FIG. 2B illustrates a rear or back view of the wound therapy device 110' shown in FIG. 2A. As shown, the pump assembly 160 may include a speaker 192 for generating audio. For example, and without limitation, the speaker 192 may generate an audio alarm in response to deviations in therapy delivery, non-compliance with therapy delivery, or any other similar or suitable medical condition, or combinations thereof. Either the alarm or alert may be part of the status data stored by the smart disposable. The speaker 192 may provide audio to accompany one or more instructional videos that may be displayed on the display 172.

[0054] The pump assembly 160 may be configured to provide easy access (such as an access door on the casing of the pump assembly) to one or more filters of the pump assembly 160, such as an antibacterial filter. This allows a user (such as a healthcare provider or patient) to more easily access, inspect, or replace such filters. The pump assembly 160 may also include a power jack (or socket) 196 for providing power to the pump assembly 160 or for charging and recharging an internal power source (such as a battery). Some implementations of the pump assembly 160 may include a disposable or renewable power source, such as one or more batteries, such that a power jack is not required. The pump assembly 160 may have a recess 198 formed therein to facilitate gripping the pump assembly 160.

[0055] The canister 162 may hold fluid aspirated from the wound 104. For example, the canister 162 may have a capacity of 800 mL (or approximately 800 mL), or a capacity of 300 mL or less to 1000 mL or more, or any capacity level within this range. The canister 162 may include tubing for connection to the conduit 108' to form a fluid flow path. The canister 162 may be replaced with another canister, such as when the canister 162 is filled with fluid. With reference to FIG. 2A, the wound therapy device 110' may include a canister inlet tube 200 (also referred to herein as a dressing port connector) in fluid communication with the canister 162. For example, but not limited to, the canister inlet tube 200 may be used to connect to the conduit 108'.

[0056] The canister 162 may be selectively connectable and removable to the pump assembly 160. With reference to FIG. 2A, in some cases a canister release button 202 may be configured to selectively release the canister 162 from the pump assembly 160. With reference to FIG. 2B, the canister 162 may have one or more fill lines or markings 204 to indicate to a user and to indicate the amount of fluid or exudate stored within the canister 162.

[0057] The canister 162 may be configured as a smart disposable, such as the smart disposable 1000. For example, the canister 162 may include electronics having memory and processing capabilities. The electronics may be located partially or completely within the canister housing. The electronics may be powered by a power source, such as a coin cell battery or one or more capacitors. In some cases, external power may be provided, such as via NFC, RFID, or other wireless charging protocols. The canister 162 may facilitate system-level start-up and shut-down after the canister 162 is connected to the pump assembly 160. As described herein, the canister 162 may store status data. The status data may include an identifier (which may be unique), type, or capacity (such as a 350 mL or 700 mL canister) of the canister 162. This data may be used by the pump assembly 160 to adjust the delivery of negative pressure wound therapy.

[0058] In some instances, the duration for establishing a negative pressure set point may be adjusted based on the volume (or size) of the canister. For larger canisters, the flow rate may be increased (e.g., by increasing the speed or pump motor) to draw gas from the canister faster and establish the negative pressure set point. One or more of the charging or performance may be adjusted based on the canister capacity. For example, a user may expect a larger canister to allow the user to be ambulatory for a longer period of time. The device may respond by one or more of charging the power source faster or performing one or more power saving techniques (such as turning the display). Alarm or alert delays and behavior may change based on the canister capacity. For example, the canister fill or total threshold may be adjusted in response to the detected canister volume. As another example, the device may operate in a vertical orientation with a smaller canister and in a horizontal orientation with a larger canister (or vice versa). The alarm or alert may be adjusted based on the position of the device during the delivery of therapy. Where irrigation may be provided with negative pressure, the amount or volume of infusion fluid provided may be adjusted based on the capacity of the canister, e.g., for smaller volumes of fluid, smaller canisters may be provided.

[0059] An indication may be provided to a user in response to detecting the canister volume. For example, an ambulatory patient may recognize the limitation of mobility due to a larger canister. As another example, an indication may be provided that a larger canister is a better option when the user is mobile. An indication of an appropriate set of accessories, such as a carrier bag, straps, bed crumbs, IV pole, or transport case, may be provided based on the detected canister volume. Any of these accessories may also be smart accessories.

[0060] The condition data can be used to adjust one or more tests performed during manufacturing. For example, detection of a larger canister may cause adjustment of one or more thresholds for a drop (or impact) test to account for the additional weight of the larger canister. For heavier systems, assurance or acceptance of drop (or impact) requirements may be more sensitive than for systems with smaller canisters.

[0061] The status data may include vacuum levels detected during manufacturing or testing. This data may be used by the pump assembly during delivery of therapy to, for example, verify that the canister 162 is intact (e.g., free of cracks or damage). Such verification may be performed by comparing pressure measurements from one or more pressure sensors during delivery of therapy to vacuum levels stored as part of the status data.

[0062] The status data may include an indication that the canister 162 has been used during therapy. This may facilitate ensuring that the canister is not used to provide therapy to a different patient (e.g., without being cleaned and sterilized). An indication that the canister has been used may be stored in the memory of the canister 162, for example, in response to detecting connection of the canister 162 to the pump assembly 160 or activation of the pump assembly 160 to provide negative pressure. The status data may include an indication that the canister 162 has been tilted or inverted (which may damage the canister's filter and render the canister 1620 unusable for providing negative pressure wound therapy). An indication that the canister 162 has been tilted or inverted may be stored in the memory of the canister 162, for example, in response to detecting a change in orientation of the pump assembly 160 and the canister. Such detection may be performed using one or more motion sensors (such as an accelerometer or gyroscope) of the pump assembly 160.

[0063] The status data may include an indication that the canister 162 has reached the end of its life as a result of being used for a particular period of time indicative of its operational life. For example, the pump assembly 160 may track the cumulative duration of negative pressure wound therapy provided to the canister 162. In response to detecting that the cumulative duration has reached a particular period of time, an indication that the canister's life has been reached may be stored as part of the canister's status data. As another example, a timestamp (as described herein) may be used for end of life detection. The status data may include location, hospital, use or misuse condition, environmental use, exposure of the canister (e.g., remote or ambulatory), transport use, and the like.

[0064] The pump assembly 160 can retrieve status data from the canister 162. The retrieval can be performed by or under the control of one or more controllers of the pump assembly 160. The status data can be retrieved prior to initiating negative pressure wound therapy. The pump assembly 160 can retrieve the status data using any of the approaches described in co-pending International Patent Application No. ____________ (Attorney Docket No. SMNPH.654WO), entitled "Communication System and Method for a Negative Pressure Wound Therapy Apparatus," and co-pending International Application No. ____________ (Attorney Docket No. SMNPH.672WO), entitled "Canister Status Determination for a Negative Pressure Wound Therapy Apparatus," each of which is incorporated by reference in its entirety. For example, the pump assembly 160 can retrieve the status data using a short-range wireless protocol (such as NFC). The pump assembly 160 can adjust therapy in response to the status data. For example, the pump assembly 160 may not permit the delivery of therapy in response to a determination that the status data indicates that the canister 162 was already in use or was tilted or upside down. The use or misuse data may be used to manage or resolve complaints, warranties, or costs for the canister 162 or any of the smart disposables disclosed herein.

[0065] The wound therapy device 110 may have a handle 208 that can be used to lift or carry the wound therapy device 110. The handle 208 may be coupled to the pump assembly 160 and may be rotatable relative to the wound therapy device 110 so that the handle can be rotated upwards for lifting or carrying the wound therapy device 110 or pump assembly 160, or rotated to a lower profile for a more compact position when the handle is not in use. In some cases, the handle 208 may be coupled to the pump assembly 160 in a fixed position. The handle 208 may be coupled to an upper portion of the pump assembly 160 or may be detachable from the wound therapy device 110.

[0066] 3 shows a schematic diagram of a control system 300 that may be used with any of the wound therapy devices described herein, such as wound therapy device 110' or 110. The electrical components may operate to accept user input, provide output to a user, operate a pressure source, provide connections, etc. A first processor (such as main controller 310) may be responsible for user activity, and a second processor (pump controller 370) may be responsible for controlling another device, such as a pump 390.

[0067] The input / output (I / O) module 320 can be used to control input and / or output to another component or device, such as a pump 390, one or more sensors (e.g., one or more pressure sensors 325 configured to monitor pressure at one or more locations in the fluid flow path), etc. For example, the I / O module can receive data from one or more sensors via one or more ports, such as serial (e.g., I2C), parallel, hybrid ports, and the like. Any of the pressure sensors can be part of the wound therapy device or the canister. In some cases, any of the pressure sensors 325 can be remote to the wound therapy device, such as positioned at or near the wound (e.g., in a dressing or a conduit connecting the dressing to the wound therapy device). In such implementations, any of the remote pressure sensors can communicate with the I / O module via a wired connection or with one or more transceivers 340 via a wireless connection.

[0068] The main controller 310 can receive and provide data to and from one or more expansion modules 360, such as one or more USB ports, SD ports, compact disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, etc. The main controller 310, along with other controllers or processors, can store data in memory 350 (e.g., one or more memory modules), which can be internal or external to the main controller 310. Any suitable type of memory can be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, magnetoresistive random access memory (MRAM), etc.

[0069] The main controller 310 may be a general-purpose controller, such as a low-power processor or an application-specific processor. The main controller 310 may be configured as the "central" processor within the electronic architecture of the control system 300, and the main controller 310 may coordinate the activities of other processors, such as a pump controller 370, one or more communication controllers 330, and one or more additional processors 380. The main controller 310 may run a suitable operating system, such as Linux, Windows CE, VxWorks, or the like.

[0070] The pump controller 370 can control the operation of a pump 390 that can generate negative pressure or reduced pressure. The pump 390 can be any suitable pump, such as a diaphragm pump, a peristaltic pump, a rotary pump, a rotary vane pump, a scroll pump, a screw pump, a liquid ring pump, a diaphragm pump operated by a piezoelectric transducer, a voice coil pump, and the like. The pump controller 370 can measure the pressure in the fluid flow path, calculate the fluid flow rate, and control the pump using data received from the one or more pressure sensors 325. The pump controller 370 can control a pump actuator (e.g., a motor) such that a desired level of negative pressure is achieved in the wound 104. The desired level of negative pressure can be selected by a pressure setting or a user. The pump controller 370 can control the pump (e.g., a pump motor) using pulse width modulation (PWM) or pulse control. The control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump controller 370 can perform flow rate calculations and detect alarms. The pump controller 370 can communicate information to the main controller 310. The pump controller 370 can be a low power processor.

[0071] Any of the one or more communication controllers 330 may provide a connection (such as a wired or wireless connection 332). The one or more communication controllers 330 may utilize one or more transceivers 340 to transmit and receive data. The one or more transceivers 340 may include one or more antennas, optical sensors, optical transmitters, vibration motors or transducers, vibration sensors, acoustic sensors, ultrasonic sensors, and the like. Any of the one or more transceivers 340 may function as a communication controller. In such cases, the one or more communication controllers 330 may be omitted. Any of the one or more transceivers 340 may be connected to one or more antennas that facilitate wireless communication. The one or more communication controllers 330 may provide one or more of the following types of connections: Global Positioning System (GPS), cellular connectivity (e.g., 2G, 3G, LTE, 4G, 5G, etc.), NFC, Bluetooth (or BLE) connectivity, radio frequency identification (RFID), wireless local area network (WLAN), wireless personal area network (WPAN), WiFi connectivity, internet connectivity, optical connectivity (e.g., using infrared, barcodes such as QR codes, etc.), acoustic connectivity, ultrasonic connectivity, etc. The connectivity may be used for a variety of activities such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading logs, alarms, and other operational data, as well as adjusting therapy settings, software or firmware upgrades, pairing, etc.

[0072] Any of the one or more communication controllers 330 may provide dual GPS / cellular functionality. The cellular functionality may be, for example, 3G, 4G, or 5G functionality. The one or more communication controllers 330 may communicate information to the main controller 310. Any of the one or more communication controllers 330 may include internal memory or may utilize memory 350. Any of the one or more communication controllers 330 may be a low power processor.

[0073] The control system 300 can store data such as GPS data, therapy data, device data, and event data. This data can be stored, for example, in memory 350. This data can include patient data collected by one or more sensors. The control system 300 can track and log therapy and other operational data. Such data can be stored, for example, in memory 350.

[0074] Using connections provided by one or more communications controllers 330, the control system 300 can upload any of the data stored, maintained, or tracked by the control system 300 to a remote computing device, such as device 334. The control system 300 can also download (e.g., via connections to device 334) various operational data, such as therapy selections, parameters, firmware and software patches and upgrades. One or more additional processors 380 can be utilized, such as a processor for controlling one or more user interfaces (such as one or more displays). In some cases, any of the illustrated or described components of the control system 300 can be omitted depending on the embodiment of the wound monitoring or treatment system in which the control system 300 is used.

[0075] Any of the negative pressure wound therapy devices described herein may include one or more features disclosed in U.S. Patent No. 9,737,649 or U.S. Patent Publication WO 2017 / 0216501, each of which is incorporated by reference in its entirety.

[0076] Sensor-integrated wound dressings in smart disposables Wound dressings incorporating several electronic components, including one or more sensors, may be utilized to monitor wound characteristics. Collecting and analyzing data from the wound may provide useful insight into determining whether the wound is on a healing curve, selecting appropriate therapy, determining whether the wound has healed, etc. Any of the sensor-integrated wound dressings disclosed herein may be configured as smart disposables.

[0077] In some embodiments, some sensor technologies may be used in one or more components that form part of the wound dressing or the entire wound dressing device. For example, as shown in Figures 4A, 4B, 4C, one or more sensors may be incorporated on or in a substrate (such a substrate may be referred to as a "sensor-integrated substrate"). Although the substrate is shown to have a square shape, it will be understood that the substrate may have other shapes, such as a rectangle, a circle, an oval, etc. In some cases, the substrate supporting the one or more sensors may be provided as a separate layer of material that is placed directly or indirectly on or in the wound. The sensor-integrated substrate may be part of a larger wound dressing device. In some cases, the sensor-integrated substrate is part of a single unit dressing. Additionally or alternatively, the sensor-integrated substrate may be placed directly or indirectly on or in the wound and then covered by a secondary wound dressing which may include one or more of gauze, foam or other wound packing material, a superabsorbent layer, a drape, a fully integrated dressing such as Pico or Allevyn Life dressings manufactured by Smith & Nephew, and the like.

[0078] The sensor-integrated substrate may be placed in contact with the wound and allow fluid to pass through the substrate without causing any or little damage to the tissue in the wound. The substrate may be flexible, elastic, stretchable, or stretchable, or substantially flexible, elastic, stretchable, or stretchable, to conform to or cover the wound. For example, the substrate may be made of a stretchable or substantially stretchable material, such as one or more of polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polyethylene tetraphthalate (PET), polybutene tetraphthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymer (FEP) and copolymer materials, or another suitable material.

[0079] In some cases, the substrate may include one or more flexible circuit boards, which may be formed of flexible polymers including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymers (FEP) and copolymers, etc. The one or more sensors may be incorporated into a two-layer flexible circuit board. In some scenarios, the one or more circuit boards may be a multi-layer flexible circuit board.

[0080] In some cases, the sensor-integrated substrate may incorporate an adhesive, such as the wound contact layer described herein, that adheres to wet or dry tissue. In some cases, one or more sensors, on which one or more flexible circuit boards may be positioned, may be incorporated into any layer of the wound dressing. For example, the wound contact layer may have cutouts or slits that allow one or more sensors to protrude from the lower surface of the wound contact layer and directly contact the wound. In some situations, one or more sensors may be incorporated into or encapsulated in other components of the wound dressing, such as, for example, the absorbent layer.

[0081] As shown in FIG. 4A, the sensor-integrated substrate 500A may support a number of electronic components and a number of electronic connections that interconnect at least some of the components. The electronic components may be one or more of any electronic components described herein, such as sensors, amplifiers, capacitors, resistors, inductors, controllers, processors, etc. The electronic connections may electrically connect one or more of the electronic components. The electronic connections may be tracks printed on the substrate, such as using copper, conductive inks (silver ink, graphite ink, etc.). At least some of the electronic connections may be flexible or stretchable, or substantially flexible or stretchable.

[0082] The electronic components may include one or more impedance or conductivity sensors 510, which may be arranged in an outer 4×4 grid and an inner 4×4 grid as shown in FIGS. 4A, 4B, 4C. The sensors 510 are illustrated as pads configured to measure tissue impedance or conductivity across any pair of pads. Two (or more) excitation pads 515 may be arranged as shown to provide an excitation signal across the pads, which is conducted by the tissue, and in response, tissue impedance or conductance may be measured across the pads 510. Electrical components such as one or more amplifiers 520 may be used to measure tissue impedance or conductance. Impedance or conductance measurements may be used to distinguish between live and dead tissue, monitor healing progress, and the like. Arrangement of the pads 510 in the inner and outer grids may be used to measure wound impedance or conductance, wound circumference, or tissue or area surrounding the wound. Additional approaches for measuring impedance or conductivity are described in International Patent Publication No. WO2020 / 187643, entitled "Systems and Methods for Measuring Tissue Impedance," which is incorporated by reference in its entirety.

[0083] The substrate 500A may be configured as a smart disposable and may store status data. The impedance or conductance of one or more components of the substrate 500A, such as one or more of the impedance sensors 510, may be measured and stored in the memory of the substrate 500A as part of the status data. This may be performed during manufacture or calibration of the substrate 500A. In use, the impedance or conductance stored as part of the status data may be used to accurately measure the impedance or conductance of the wound or tissue. For example, the impedance or conductance provided by the status data may be taken into account (or otherwise ignored) when determining the impedance or conductance of the wound or tissue.

[0084] The electronic components may include one or more temperature sensors 530 configured to measure the temperature of the wound or surrounding tissue. For example, nine temperature sensors were positioned around the periphery of the substrate 500A. The one or more temperature sensors may include one or more thermocouples or thermostats. The one or more temperature sensors may be calibrated and data obtained from the one or more sensors may be processed to provide information about the wound environment. In some cases, an ambient sensor measuring ambient air temperature may be used to help eliminate problems associated with environmental temperature shifts.

[0085] The electronic components may include one or more optical sensors 550. The one or more optical sensors 550 may be configured to measure the appearance of the wound or image the wound. In some cases, a light source or illumination source that emits light and a light sensor or detector that detects the light reflected by the wound are used as the one or more optical sensors. The light source may be a light emitting diode (LED), such as one or more white LEDs, red, green, blue (RGB) LEDs, ultraviolet (UV) LEDs, etc. The light sensor may be one or more of an RGB sensor configured to detect color, an infrared (IR) color sensor, a UV sensor, etc. In some cases, both the light source and the detector will be pressed against the skin, which will cause the light to penetrate into the tissue and exhibit the spectral characteristics of the tissue itself. In some scenarios, the one or more optical sensors may include an imaging device, such as a charge-coupled device (CCD), a CMOS image sensor, etc.

[0086] In some cases, ultra-bright LEDs, RGB sensors, and polyester optical filters can be used as components of one or more optical sensors to measure through tissue color differentiation. For example, color can be measured from light that first passes through tissue for a given geometry, as surface color can be measured from reflected light. This can include color sensing from diffuse light, such as that diffused from an LED in contact with the skin. In some cases, an LED can be used with a proximal RGB sensor to detect light diffused through tissue. The optical sensor can image using diffuse internal light or surface reflected light.

[0087] The status data may include calibration data (such as thresholds) for any sensors supported by the substrate 500A. For example, the sensitivity, color, or power of an optical sensor may be included in the status data. As another example, the impedance or conductance of an impedance sensor may be included in the status data. As yet another example, the temperature threshold of a temperature sensor may be included in the status data. As yet another example, absolute pressure or humidity thresholds may be included in the status data. Such status data may be used to compensate for any variations between different substrates 500A.

[0088] The calibration data can be used to obtain accurate measurements of the wound or tissue during use. As described herein, the status data can include an indication of the substrate 500 that has been used on a patient. In response to such an indication, a notification can be provided to a healthcare provider. This can facilitate ensuring that the substrate 500A is not used together with different patients (e.g., without being cleaned and sterilized).

[0089] The status data may include data related to the capabilities of the board 500A. For example, a particular board may only include a temperature sensor. This data may be used to adjust one or more of the collection of data or the delivery of therapy. A verification of the data collection or therapy prescription may be performed. For example, assume that collection of wound impedance is part of the prescription, but the status data of the board indicates that the board does not include an impedance sensor. In such a case, an indication (such as an alarm) may be generated. Such verification may be performed for any of the smart disposables described herein.

[0090] As described herein, the status data may include an indication that the life of the substrate 500A has been reached. The status data may facilitate ensuring and enforcing that the substrate 500A (or any other smart disposable described herein) is used only with a single patient. For example, when the smart disposable is connected to a therapy or monitoring device (such as the pump assembly 160 or control module), the device may store its real-time clock in the memory of the smart disposable. Any future parameters stored in the memory of the smart disposable may include a timestamp with the real-time clock. If there is a mismatch in the timestamps (e.g., the real-time clock does not indicate the passage of a particular duration), a determination may be made that there is an attempt to use the smart disposable with a different therapy or monitoring device (and possibly a different patient). Such attempted use with a different patient may be prevented. The timestamp may be written periodically. The timestamp may be written in response to disconnection of the smart disposable from the therapy or monitoring device. The timestamp may be used to determine that the life of the smart disposable has been reached.

[0091] One or more of the electronic components may be controlled by a control module. The control module may receive and process one or more measurements taken by one or more sensors. An external control module may be connected to at least some of the electronic components via a connector 540. In some cases, the connector 540 may be located at the end of the conductive track portion as shown in FIG. 4B, or attached to the conductive track portion at a location away from the end as shown in FIG. 4A or FIG. 4C (e.g., attached to the top of the track portion with an adhesive). The control module may include one or more controllers or microprocessors, memory, etc. In some cases, the one or more controllers may be located on the board and the connector 540 is not used. In some cases, data and commands may be communicated wirelessly, such as by a transceiver located on the board, and the connector 540 is not used.

[0092] In some cases, additional or alternative sensors may be positioned on the substrate, such as one or more pH sensors, pressure sensors, perfusion sensors, etc.

[0093] In some cases, the substrate may be perforated as shown in FIG. 4B and FIG. 4C. A plurality of perforations 560 may be formed in the substrate 500B to allow fluid to pass through the substrate. It may be advantageous to use a perforated substrate in conjunction with the application of negative pressure wound therapy, during which reduced pressure is applied to a wound covered by a dressing to cause removal of fluid (such as wound exudate) from the wound. The perforations 560 may be formed around a plurality of electronic components and connections as shown in FIG. 4B and FIG. 4C. The perforations 560 may be formed as slits or holes. In some cases, the perforations 560 may be small enough to help prevent tissue ingrowth while allowing fluid to pass through the substrate.

[0094] In some cases, any of the wound dressings or wound dressing components described herein may be part of a kit that also includes a negative pressure wound therapy device. One or more components of the kit, such as the sensor-integrated substrate, the secondary dressing, or the negative pressure wound therapy device, may be sterilized.

[0095] Any of the embodiments disclosed herein may be used in conjunction with any of the embodiments described in International Patent Publication No. WO2017 / 195038, entitled "Sensor Enabled Wound Monitoring and Therapy Apparatus", International Patent Publication No. WO2018 / 189265, entitled "Component Stress Reduction for Sensor Enabled Negative Pressure Wound Therapy Bandages", International Patent Publication No. WO2020 / 157103, entitled "Sensor Integrated Bandages and Systems", International Patent Application No. PCT / EP2018 / 069886, entitled "Skewing Pad for Impedance Measurements", International Patent Application No. PCT / EP2018 / 075815, entitled "Sensor Positioning and Optical Sensing for Sensor Enabled Wound Therapy Bandages and Systems", and International Patent Application No. PCT / EP2018 / 069883, entitled "Biocompatible Encapsulation and Component Stress Reduction for Sensor Enabled Negative Pressure Wound Therapy Bandages", each of which is incorporated by reference in its entirety.

[0096] Wound debridement with smart disposables Debridement systems can be used to promote wound healing. Debridement systems, such as the Smith & Nephew Versajet Hydrosurgery system, can utilize high pressure water or other liquids for debridement. In some cases, the debridement system can use a high pressure saline water jet for debridement and wound bed preparation. With reference to FIG. 5, a liquid jet debridement and wound bed preparation system can include two saline tubes 800, 802 extending from an inlet 804 of a pump handle 806. The pump can be a piston pump. A handpiece (or handpiece or handset) 812 can extend from an inlet 814 of the pump handle 806. The handpiece 812 can be configured to treat the wound with liquid pressure from a liquid jet of fluid. For example, a pressurized liquid jet (or stream) can be emitted from the handpiece 812. The saline tube 800 can terminate in a spike 807 that connects to a saline bag 808. The saline tube 802 may be open to atmosphere or may include a spike that connects to a second saline bag. In the system of FIG. 5, if there is an airlock in the system, the clamp 811 in the open position allows air to be evacuated from the open tube 802. With reference to FIGS. 6A and 6B, the console 950 of the liquid jet debridement and wound bed preparation system includes a display 952 (such as an LCD screen) for displaying device status information, e.g., power level, procedure run time, outside patient / operating room mode, and service reminders. The console 950 may include an interface 954 for receiving a pump 956 (which may be a piston pump), and a reader 958 and antenna 960 capable of identifying a tag 962 attached to a handpiece (such as handpiece 812). Identification may be performed using RFID or near-field radio (such as NFC), in which case the tag 962 may be an RFID or NFC tag. As described herein, identification may be performed using infrared (such as IrDA), vibration, or the like.

[0097] The handpiece 812 may be configured as a smart disposable and may store status data. Such a handpiece 812 may facilitate system-level start-up and shutdown when connected to the console 950. The status data may include the exact pressure of the liquid jet of the handpiece 812. Such pressure may be used for calibration to provide more accurate pressure during use or to ensure patient safety. For example, if the status data indicates that the handpiece pressure is not compatible with the console 950, debridement may be disabled. This may prevent use of liquid jet debridement with improper pressure. As described herein, the status data may include an indication of the handpiece 812 that has been used on a patient. In response to such an indication, the console 950 may disable debridement. This may facilitate ensuring that the handpiece 812 is not used to provide debridement to a different patient (e.g., without being cleaned and sterilized). End of life of the handpiece 812 may be monitored and detected as described herein.

[0098] The console may store as part of the status data one or more of the following: system failures in the handpiece, priming issues by measuring time before proper treatment, duration of set up, temperature during treatment, location, hand vibration level (which may be of user safety relevance), treatment duration, failure or intermittency, pressure decay, confirmation of pressure setting for handpiece type, noise acoustic values, flow, exhaust flow, misuse data, etc.

[0099] In some cases, it may be important to ensure that the hand piece 812 is sterilized when it is used to treat a wound. The hand piece 812 may be positioned in a sterile package and thus remains sterile while packaged. However, when the hand piece 812 is removed from the package, it may lose sterility after being exposed to the environment outside the package (such as air) for a period (or duration) after the package is opened. For example, the period may be about 15 minutes (or less or more) at room temperature. As a smart disposable, the hand piece 812 may implement one or more mechanisms that monitor for a period and provide a loss of sterility indication. One such mechanism may be a chemical-based trigger. For example, the hand piece 812 may include a reactive element or material that changes its state when exposed to air (as a result of one or more of exposure to oxidation or humidity). In some cases, oxidation is preferred because the oxygen content of a room typically does not change as much as humidity or temperature.

[0100] The reactive material may be conductive, such as aluminum or iron. When the reactive material is exposed to air, it may lose its conductivity as a result of being oxidized (or exposed to humidity). In response to the expiration of a period of time, the reactive material may become non-conductive (e.g., conductive iron may become non-conductive iron rust). The reactive material may be part of an electronic circuit that changes its state (e.g., becomes an open circuit) as a result of the material's transition from conductive to non-conductive. In some cases, oxidation (or humidity) may cause mechanical disruption of the conductive pathway. For example, a conductive wire, membrane, or the like may break. Such a change in the state of the electronic circuit may be detected by the console 950. As a result, a connection of the non-sterile handpiece 812 (such as an open circuit) may be detected by the console, treatment may be disabled, and any indication may be provided to the user.

[0101] In some implementations, another such mechanism may be an enzyme-based trigger. For example, the electronic circuitry may include one or more photodiodes coated with (or otherwise coupled to) a material that changes one or more properties (such as transparency, color, etc.) in response to exposure to the environment. The material may change one or more properties as a result of being hardened when exposed to the environment. For example, the material may be silicone. In response to expiration of a period of time (which may be the same or different than the period of time described in the previous paragraph), the material may change one or more properties that cause the photodiodes to detect (or stop detecting) light leading to a change in state of the electronic circuitry. The material may be a color or polarizing filter of the one or more diodes. As a result, a connection of the non-sterile handpiece 812 (such as an open or closed circuit) may be detected by the console, treatment may be disabled, and any indication may be provided to the user.

[0102] Although detection of loss of sterility is described with respect to handpiece 812, the approaches disclosed herein may be applied to any sensor-integrated substrate (such as 500A or 500B), canister, or other smart disposable described herein.

[0103] Smart disposables structure FIG. 7 shows a schematic diagram of a smart disposable 1000. The smart disposable 1000 may include a processing circuit 1002 (such as one or more controllers), a transceiver 1004 for wired or wireless communication, one or more memories 1006, and a power source 1008. The memory 1006 may be a non-volatile or persistent memory such as an EPROM or flash memory. Status data may be stored in the memory 1006. The transceiver may facilitate wireless communication using NFC, RFID, Bluetooth, WiFi, or the like. Communication between the transceiver 1004 and an external computing device (such as a medical or diagnostic device, including any such device described herein) may be bidirectional. The control circuit 1002 may be connected to the memory 1006 and the transceiver 1004 and configured to store data in the memory 1006 and provide the transceiver 1004 with status data to the external computing device. The external computing device may be a wound therapy or treatment device, or another computing device (such as a phone, tablet, PC, etc.).

[0104] The power source 1008 is configured to provide power to the control circuitry 1002, the transceiver 1004, and the memory 1006. The power source 1008 may include one or more capacitors or batteries (such as a coin cell battery). The power source 1008 may be small because communications with the smart disposable are short and infrequent, so a bulk power source may not be needed. In some cases, the smart disposable 1000 may be powered by an external power source and the power source 1008 may be omitted. For example, external power may be provided via NFC or RFID (such as when the smart disposable 1000 is a passive tag).

[0105] The smart disposable 1000 may include a housing. For example, in the case of a canister (such as canister 162), the housing may store fluid aspirated from the wound. One or more of the processing circuit 1002, the transceiver 1004, the one or more memories 1006, or the power source 1008 may be partially or completely enclosed by or located within the housing.

[0106] The external computing device can store, modify, and retrieve status data. As described herein, the status data can include, but is not limited to, instructions on how to recycle the smart disposable 1000, disassembly instructions, instructions for use, indications of past use of the smart disposable, regulatory information, or legal information. Recycling instructions can facilitate waste reduction. For example, recycling instructions can be provided automatically (or on request) in response to a determination that the smart disposable 1000 has reached the end of its life. The transfer of information to the computing device can supplement or replace any conventional label (text label, bar code label, QR code label, etc.). This is advantageous because conventional labels can be damaged or destroyed. The external computing device can communicate at least a portion of the status data to a user. For example, instructions can be displayed.

[0107] The smart disposable 1000 may facilitate writing status data to one or more memories 1006. The status data may be communicated by an external computing device (such as via wireless or wired communication protocols) and stored in the one or more memories.

[0108] As an example, during manufacturing, data can be written to one or more memories 1006. For a canister, for example, the data can include a coded value representing one or more of the canister's manufacturing date and lot code. Device identification data (such as a serial number) can be included in the data. The manufacturing data can be set with a permanent write lock after it is written. When attached to the negative pressure wound therapy device, such manufacturing data can be read from and compared to the current date. A check can be performed to ensure that the canister has not passed its indicated shelf life. If the canister's shelf life is exceeded, the negative pressure wound therapy device can generate an indication that can include one or more of: alerting the user of the expired canister or refusing to operate with the expired canister. The manufacturing data (or any other data described herein) can be read by the negative pressure wound therapy device as well as by another external computing device that implements the communication protocol.

[0109] In some cases, the identity of the smart disposable 1000 may be represented as a capacitive impedance (such as a resistor or capacitor) in addition to, or instead of, the data stored in one or more memories 1006.

[0110] Continuing with the canister example, during the delivery of therapy, the negative pressure wound therapy device can write data (e.g., in the form of coded values) indicative of therapy performance. Such data can include one or more of negative pressure set points, other therapy settings, alarms or alerts, fluid flow rates in use (e.g., can indicate flow rates over a duration, such as an hour), leak rates in use (e.g., can indicate leak rates over a duration, such as an hour), self-test results (which can include a subset of the last self-tests, such as the last one, the last two, or the last three), motion data, and the like. One or more parameters of the alarms or alerts can be stored in one or more memories 1006, such as one or more parameters of canister full detection, leak detection, or the like. This can facilitate seamless delivery of therapy with canisters of different sizes, volumes, or the like. Self-test results can include leak rates, flow rates, power requirements for flow rates, and the like. Motion data can include data related to the smart disposable or device, such as detection of any sudden acceleration against an acceleration threshold (which may indicate a drop or another impact), reversals, vibrations, and the like. For a handpiece (such as handpiece 812), the data written may include motor current, speed data, pressure data, etc. Data written to smart disposables can facilitate determination of misuse, therapy or treatment failure, etc.

[0111] The negative pressure wound therapy device may also write data indicating whether the canister was full or was removed before it became full. Such data may be important to determine whether the canister is permitted to be reconnected with the negative pressure wound therapy device to continue therapy and may therefore be written with a write lock. For example, reconnecting a canister to continue therapy may not be permitted for a canister that has been detected as full.

[0112] Additionally, data indicating that the canister is full may be written in response to detecting that the canister has been full for an appropriate percentage of a particular period of time, thereby preventing false positives. Such data may be written with a write lock.

[0113] Additionally, the negative pressure wound therapy device can write data indicative of loss of sterility (such as a biological hazard) in response to initiation of therapy. This data can be used to prevent the use of non-sterile canisters for different patients.

[0114] Additionally, the negative pressure wound therapy device may identify write-locked areas of one or more of the memories 1006. For example, the device may write a random code to one or more memory areas (or in some cases each memory area) and attempt to read back the value. This may be performed in response to a canister being connected to the device.

[0115] In some implementations, the smart disposable 1000 may utilize one or more antennas for wireless communication. To achieve redundancy, there may be multiple conductive paths to a single antenna (e.g., from the transceiver 1004) or multiple antennas (and multiple transceivers 1004). Multiple antennas may utilize different frequencies (or frequency bands) to avoid or minimize interference. For example, as described herein, the NFC protocol may be used for wireless communication. Transmission may be accomplished at a frequency of 13.56 MHz and the EPC Gen2 protocol frequency 865-868 MHz (or 902-928 MHz). Communication with such a smart disposable 1000 may be accomplished using multiple readers (each supporting a particular frequency or frequency band), multiple frequency readers, or a single reader with multiple communication circuits (that can rotate, vibrate, etc.).

[0116] In some cases, the smart disposable 1000 may be utilized to update firmware or software on a medical or diagnostic device in which the smart disposable 1000 is used. For example, a firmware or software patch (or code) may be stored in one or more memories 1006 of the smart disposable 1000. This may be performed during manufacturing. In the field, when the device connects to the smart disposable 1000, the device may obtain and install the patch. The device may obtain and install the patch in response to reading information stored in the one or more memories 1006 indicating the firmware (or software) version of the device required to operate with the disposable 1000. If the current version of the firmware (or software) running on the device does not match the information indicating the required firmware (or software) version, the device obtains and installs the patch. As another example, the device obtains and installs the patch in response to determining that the firmware (or software) version of the device is earlier (e.g., lower) than the firmware (or software) version of the smart disposable or the version of the smart disposable. The patch may include one or more of the following data related to firmware (or software) upgrades or calibration data for the smart disposable 1000 or the device (negative pressure set point, alerts, last self-test value, etc.). Advantageously, firmware (or software) updates for the device may be performed efficiently even for devices that do not support connection to the Internet or another network to complete remote updates. The need to perform local updates of the device or to transport the device for updates may be avoided.

[0117] Data stored in the one or more memories 1006 of the smart disposable 1000 may be displayed (or otherwise communicated to a user) via one or more user interfaces of the device (such as the display 172). For example, a message related to the need to install a firmware (or software) patch may be displayed. The displayed data may include information regarding new products or other marketing information.

[0118] The data stored in the one or more memories 1006, which may include patient data, may be encrypted. For a canister, patient data may include a canister full indication (which may indicate that the patient is not healthy), a time period for changing the canister, time to alarm, configuration of the system (such as delivering therapy to multiple wounds using a Y connection), parameters of exudate stored in the canister, etc. For a handpiece (such as handpiece 812), such patient data may include pressure, treatment time, etc. An event log may be stored in the one or more memories 1006. A key may be required to decrypt the encrypted data. The stored data may be used to determine compliance, post-treatment market monitoring, etc.

[0119] Smart disposables may store status data that can be accessed by a computing device (which may be a therapy or monitoring device). As a result, the entire life cycle of the smart disposable (from manufacturing to disposal) can be effectively and efficiently managed. Patient safety and integrity of medical treatment can be improved. Complaints (including regulatory complaints) can be efficiently resolved and compliance with treatment or monitoring prescriptions can be improved.

[0120] Other Variations Any one or more features of a particular embodiment of a smart disposable may be used with any of the other embodiments of a smart disposable.

[0121] Although some embodiments describe negative pressure wound therapy, the systems, devices, and / or methods disclosed herein may be applied to other types of therapy that can be used standalone or in addition to TNP therapy. The systems, devices, and / or methods disclosed herein may be extended to any medical device, particularly any wound treatment or wound care device. For example, the systems, devices, and / or methods disclosed herein may be used with devices that provide one or more of ultrasound therapy, oxygen therapy, neurostimulation, microwave therapy, active agents, antibiotics, antimicrobial agents, wound debridement, or the like. Such devices may further provide TNP therapy. The systems and methods disclosed herein are not limited to medical devices and may be utilized by any electronic device.

[0122] Any transmission of data described herein may be performed securely, for example utilizing one or more of encryption, https protocol, secure VPN connection, error checking, delivery confirmation, or the like.

[0123] Any values ​​of thresholds, limits, periods, etc. provided herein are not intended to be absolute values ​​and may therefore be approximate values. In addition, any thresholds, limits, periods, etc. provided herein may be fixed or changed automatically or by a user. Furthermore, as used herein, terms expressing a relative degree, such as exceeding, over, or under, in relation 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 exceeding, over, or under, in relation to a reference value, are intended to encompass the inverse of the disclosed relationship, such as under, under, or over, in relation to a reference value.

[0124] It is to be understood that a property, substance, feature, 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 incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The subject matter is not limited to the details of any of the foregoing embodiments. The subject matter extends to any novel, or any novel combination, of the properties disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or to any novel, or any novel combination, of the steps of any method or process similarly disclosed.

[0125] Although specific embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and changes may be made in the form of the methods and systems described herein. Those skilled in the art will recognize that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the figures. In some embodiments, certain of the steps described above may be omitted or others may be added. For example, the actual steps and / or order of steps performed in the disclosed processes may differ from those shown in the figures. In some embodiments, certain of the steps described above may be omitted or others may be added. For example, various components shown in the figures or disclosed herein may be implemented as software and / or firmware on a processor, controller, ASIC, FPGA, and / or dedicated hardware. The software or firmware may include instructions stored in a non-transitory computer-readable memory. The 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 fall within the scope of the present disclosure.

[0126] The user interface screens illustrated and described herein may include additional and / or alternative components. These components may include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, check boxes, combo boxes, status bars, dialog boxes, windows, and the like. The user interface screens may include additional and / or alternative information. The components may be arranged, grouped, and labeled in any suitable order.

[0127] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context in which it is used, is typically intended to convey that certain embodiments include certain features, elements, and / or conditions, while other embodiments do not. Thus, such conditional language is not necessarily intended to suggest that the features, elements, and / or conditions are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without author input or instruction, whether those features, elements, and / or conditions are included in or should be implemented in any particular embodiment. Terms such as "include," "comprise," and "having" are synonymous and are 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 (not an exclusive sense), e.g., when used to join a list of elements, it means one, some, or all of the elements in the list. Additionally, the term "each" as used herein, in addition to having its ordinary meaning, can also refer to any subset of the set of elements to which the term "each" applies. Furthermore, as used herein, the words "herein," "above," "below," and similar words, when used in this application, are meant to refer to the specification as a whole and not to specific portions of the specification.

[0128] Unless otherwise indicated, conjugated language such as the phrase "at least one of X, Y, and Z" should be understood in the context in which it is used to generally convey that an item, term, etc. can be either X, Y, or Z, or combinations thereof. Thus, such conjugated language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0129] As used herein, degree-expressing phrases such as "approximately," "about," "generally," and "substantially" refer to a value, amount, or characteristic that is close to a given value, amount, or characteristic that still performs a desired function or produces a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can mean an amount that is within 10%, 5%, 1%, 0.1%, and 0.01% of a given amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exactly parallel by 15 degrees or less, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0130] Unless expressly stated otherwise, articles such as "a" or "an" should generally be construed to include one or more of the listed items. Thus, phrases such as "an apparatus configured to" are intended to include one or more of the listed apparatus. Such one or more listed apparatuses may also be collectively configured to perform the stated enumeration.

[0131] While the present disclosure includes certain embodiments, examples, and applications, it should be understood by those skilled in the art that the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and obvious modifications 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.

Claims

1. 1. A canister for negative pressure wound therapy, comprising: a housing defining an interior volume for storing fluid aspirated from the wound during delivery of negative pressure wound therapy; an electronic circuit at least partially enclosed by the housing, a memory configured to store data relating to one or more parameters of the canister; a transceiver configured to wirelessly communicate with a computing device; and a processing circuit coupled to the memory and to the transceiver, the processing circuit configured to store the data in the memory and to cause the transceiver to provide at least a portion of the data stored in the memory in response to a request from the computing device.

2. 10. The canister of claim 1, wherein the memory is further configured to store code for updating firmware or software of the computing device, the computing device including a negative pressure wound therapy device configured to removably support the housing.

3. The canister of claim 2 , wherein the memory is further configured to store an indication for the negative pressure wound therapy device to determine that firmware or software should be updated with the code.

4. The canister of claim 3 , wherein the indication comprises a firmware version of software stored in the memory and configured to be executed by the processing circuitry.

5. A canister according to any one of claims 1 to 4, wherein the transceiver is configured to communicate with the computing device using Near Field Communication (NFC), and the computing device includes a negative pressure wound therapy device configured to removably support the housing.

6. 3. The canister of claim 1 or 2, wherein the data includes a canister volume stored in the memory before the canister is used for negative pressure wound therapy.

7. the data including a canister orientation or a canister fill state determined during delivery of negative pressure wound therapy and stored in the memory during delivery of negative pressure wound therapy; and optionally The canister of claim 1 or 2, wherein the canister orientation includes a reversed orientation determined during the delivery of negative pressure wound therapy, and storing the reversed orientation in the memory prevents the canister from being used for further delivery of negative pressure wound therapy.

8. the electronic circuitry further comprises a power source configured to provide power to at least one of the memory, the transceiver, or the processing circuitry, and optionally 3. The canister of claim 1 or 2, wherein the power source comprises one or more of a capacitor or a battery.

9. 3. A canister according to claim 1 or 2, wherein the data includes a manufacturing date stored as read-only data to facilitate determining that the manufacturing date has not exceeded the shelf life of the canister.

10. 3. The canister of claim 1 or 2, wherein the data includes an indication that the canister is full, the indication being stored in response to a determination that the level of fluid aspirated from the wound has reached a threshold level for a duration of time.

11. 1. A disposable device for use in a wound treatment or monitoring system, comprising: A substrate or a housing; an electronic circuit at least partially supported by the substrate or the housing, a memory configured to store data relating to one or more parameters of the disposable device; a transceiver configured to wirelessly communicate with a computing device; and a processing circuit coupled to the memory and to the transceiver, the processing circuit configured to store the data in the memory and to cause the transceiver to provide at least a portion of the data stored in the memory in response to a request from the computing device.

12. and optionally further comprising a mechanism configured to provide an indication that the disposable device has lost sterility.

12. The disposable device of claim 11, wherein the mechanism includes a photodiode coupled to a material configured to become non-conductive in response to exposure to the atmosphere for a first duration or to a material configured to change an optical property in response to exposure to the atmosphere for a second duration.

13. 13. The disposable device of claim 11 or 12, wherein the transceiver is configured to communicate with the computing device using Near Field Communication (NFC) or Radio Frequency Identification (RFID).

14. 13. The device of claim 11 or 12, wherein the data includes an indication of whether the device has been used for wound treatment or monitoring.

15. the electronic circuitry further comprises a power source configured to provide power to at least one of the memory, the transceiver, or the processing circuitry, and optionally 13. The disposable device of claim 11 or 12, wherein the power source comprises one or more of a capacitor or a battery.

16. 13. The disposable device of claim 11 or 12, wherein the disposable device comprises a sensor-integrated substrate, a wound dressing configured to provide vibration therapy, or a wound dressing that supports a negative pressure source.

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