Device operation monitoring and control in wound therapy systems

Abstract

Disclosed are embodiments of a negative pressure wound therapy system and a method for operating the system. In one embodiment, the apparatus includes a housing, a pressure source supported by the housing, a controller, and an output device. The pressure source couples to a wound dressing via a fluid flow path and provides negative pressure to the wound dressing. The controller operates the pressure source to provide negative pressure to the wound dressing. The output device provides identification data to an electronic device, the identification data being usable by the electronic device to access a label associated with the housing or one or more components supported by the housing. [Selection diagram] Figure 7

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 563,889, filed September 27, 2017, and U.S. Provisional Patent Application No. 1811494.2, filed July 13, 2018, the disclosures of which are incorporated herein by reference in their entireties. [Background technology]

[0002] Embodiments of the present disclosure relate to methods and apparatus for dressing and treating wounds using negative or reduced pressure therapy or topical negative pressure (TNP) therapy. Specifically, but not by way of limitation, the embodiments disclosed herein relate to negative pressure therapy devices, methods for controlling the operation of TNP systems, and methods of using TNP systems. Summary of the Invention

[0003] In some embodiments, an apparatus for applying negative pressure to a wound is disclosed. The apparatus may include a housing, a pressure source supported by the housing and coupled to a wound dressing placed on the wound via a fluid flow path and configured to provide negative pressure to the wound, a controller supported by the housing and configured to operate the pressure source to provide negative pressure to the wound, and an output device supported by the housing and configured to provide identification data to an electronic device. The identification data is usable by the electronic device to access a label associated with the housing or one or more components supported by the housing.

[0004] The apparatus described in the preceding paragraph may include one or more of the following features: The identification data may be available to the electronic device to access the label from a remote database via a computer network; The output device may include a display capable of presenting the identification data as an optical, machine-readable representation of the identification data; The optical, machine-readable representation of the identification data may include a two-dimensional barcode; The output device may include a transmitter configured to wirelessly transmit the identification data to the electronic device; The electronic device may execute an application that receives the identification data from the output device and sends a request for a label according to the identification data; The electronic device may execute an application that receives the identification data from the output device, requests a label according to the identification data via the computer network, presents the label to a user on the display, and enables a user of the electronic device to command a controller to operate a pressure source to provide negative pressure to the wound dressing; The electronic device may execute an application that sends confirmation or verification of the presentation of the label on the display; The controller may determine the location of the housing and automatically select identification data from a plurality of identification data according to the location; The controller may deactivate the pressure source until the output device provides the identification data to the electronic device. The electronic device may include a mobile personal computer that communicates over a cellular communications network.

[0005] In some embodiments, a method of operating a negative pressure wound therapy device is disclosed. The method may include obtaining identification data from a memory device of the wound therapy device, outputting the identification data from the wound therapy device to an electronic device, receiving the identification data by the electronic device, generating by the electronic device a request from the identification data, the request being a request to access a label associated with the wound therapy device, sending the request by the electronic device to a remote database via a computer network, receiving the label via the computer network, and outputting the label for presentation to a user of the electronic device.

[0006] The method described in the above paragraph may include one or more of the following features. The method may include transmitting confirmation or verification of the output over a computer network. Outputting the identification data may include presenting the identification data as an optical, machine-readable representation of the identification data on a display of the negative pressure wound therapy device, and receiving the identification data may include receiving the identification data by an image sensor of the electronic device. Outputting the identification data may include wirelessly transmitting the identification data by a transmitter of the negative pressure wound therapy device, and receiving the identification data may include receiving the identification data by a receiver of the electronic device. Outputting a label may include displaying the label on a display of the electronic device.

[0007] In some embodiments, a device for applying negative pressure to a wound is disclosed. The device may include a pressure source coupled to a wound dressing via a fluid flow path and configured to provide negative pressure to the wound dressing. A controller receives input data, determines a control value from the input data, and adjusts an action performed by the controller according to the control value such that the action is performed differently than if the action were not performed according to the control value.

[0008] The device described in the above paragraph may include one or more of the following features: The controller may send a verification or confirmation adjustment of the operation to a remote device via a computer network; The control value may indicate operation of the pressure source at an altitude above a threshold, and the operation may be a therapy performed using the pressure source; The fluid flow path includes multiple lumens; The method may further include monitoring pressure in the wound dressing at one or more lumens of the fluid flow path or near an inlet of the pressure source; The controller may activate and deactivate the pressure source.

[0009] In some embodiments, a device for applying negative pressure to a wound is disclosed. The device may include a housing, a motion sensor supported by the housing and configured to output motion data indicative of motion of the housing, a pressure source supported by the housing, and a controller. The pressure source is capable of coupling to a wound dressing positioned on the wound via a fluid flow path and providing negative pressure to the wound. The controller is capable of detecting an error condition associated with providing negative pressure to the wound with the pressure source, determining a cause of the error condition from the motion data, and outputting an alert for presentation to a user notifying the user of the cause of the error condition.

[0010] The device described in the above paragraph may include one or more of the following features. The error condition may include a blockage in the fluid flow path or a low pressure level at the wound. The controller may determine the blockage or the activation level of the pressure source from flow in the fluid flow path. The device may include a canister supported by the housing and configured to collect fluid aspirated from the wound, and the cause of the error condition may be rotation of the housing, which likely saturates a filter in the canister with fluid. The controller may output user instructions to a user indicating how to correct the cause of the error condition. The user instructions may indicate replacing the filter in the canister, and the canister may be supported by the housing and collect fluid aspirated from the wound. The controller may output user instructions to a user indicating how to prevent future occurrences of the error condition. The user instructions may indicate not to rotate the housing when detected from motion. In response to detecting the error condition, the controller may operate the pressure source differently than before detecting the error condition. The motion sensor may include an accelerometer. The controller may add an entry to a log indicating the occurrence of the error condition, determine from the log the frequency of occurrence of the error condition, and operate the pressure source. The device may include a display, which may visually present the alert to the user, and a speaker, which may audibly present the alert to the user.

[0011] In some embodiments, a method of operating a negative pressure wound therapy device is disclosed. The method may include operating a pressure source of the wound therapy device to provide negative pressure to a wound dressing positioned on a wound via a fluid flow path, the pressure source being supported by a housing of the wound therapy device, generating motion data indicative of motion of the housing, detecting an error condition associated with providing negative pressure to the wound with the pressure source, determining a cause of the error condition from the motion data, and outputting an alert for presentation to a user notifying the user of the cause of the error condition.

[0012] The method described in the above paragraph may include one or more of the following features. The wound therapy device may be a negative pressure therapy device. The wound therapy device may include a canister supported by a housing and configured to collect fluid aspirated from the wound, and the cause of the error condition may be rotation of the housing, which likely saturates a filter in the canister with fluid. The method may include outputting user instructions to a user indicating how to correct the cause of the error condition. The user instructions may indicate replacing a filter in the canister, the canister supported by the housing and capable of collecting fluid aspirated from the wound. The method may include outputting user instructions to a user indicating how to prevent future occurrences of the error condition or operating the pressure source differently than determining the cause of the error condition. [Brief explanation of the drawings]

[0013] Embodiments of the present disclosure are herein described, by way of example only, with reference to the accompanying drawings, in which:

[0014] [Figure 1] FIG. 1 illustrates a negative pressure wound therapy system, according to some embodiments. [Figure 2A] FIG. 2A shows a diagram of a TNP device, according to some embodiments. [Figure 2B] FIG. 2B shows a diagram of a TNP device, according to some embodiments. [Figure 2C] FIG. 2C shows a diagram of a TNP device, according to some embodiments. [Figure 3A] FIG. 3A shows components of a negative pressure therapy system, according to some embodiments. [Figure 3B] FIG. 3B shows components of a negative pressure therapy system, according to some embodiments. [Figure 3C] FIG. 3C illustrates components of a negative pressure therapy system, according to some embodiments. [Figure 3D]FIG. 3D shows components of a negative pressure therapy system, according to some embodiments. [Figure 3E] FIG. 3E shows components of a negative pressure therapy system, according to some embodiments. [Figure 3F] FIG. 3F shows components of a negative pressure therapy system, according to some embodiments. [Figure 3G] FIG. 3G shows components of a negative pressure therapy system, according to some embodiments. [Figure 4] FIG. 4 shows components of a negative pressure therapy system including multiple wound dressings, according to some embodiments. [Figure 5] FIG. 5 illustrates a negative pressure wound therapy system, according to some embodiments. [Figure 6] FIG. 6 illustrates a negative pressure wound therapy system, according to some embodiments. [Figure 7] FIG. 7 illustrates a label access process according to some embodiments. [Figure 8A] FIG. 8A illustrates a user interface for managing the label access process and performing other operations, according to some embodiments. [Figure 8B] FIG. 8B illustrates a user interface for managing the label access process and performing other operations, according to some embodiments. [Figure 8C] FIG. 8C illustrates a user interface for managing the label access process and performing other operations, according to some embodiments. [Figure 8D] FIG. 8D illustrates a user interface for managing the label access process and performing other operations, according to some embodiments. [Figure 9A] FIG. 9A illustrates a user interface for accessing intellectual property related information, according to some embodiments. [Figure 9B] FIG. 9B illustrates a user interface for accessing intellectual property related information, according to some embodiments. [Figure 10]FIG. 10 illustrates a control process according to some embodiments. [Figure 11] FIG. 11 illustrates a monitoring process according to some embodiments. [Figure 12] FIG. 12 illustrates a TNP device, according to some embodiments. [Figure 13A] FIG. 13A shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13B] FIG. 13B shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13C] FIG. 13C shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13D] FIG. 13D shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13E] FIG. 13E shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13F] FIG. 13F shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13G] FIG. 13G shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13H] FIG. 13H shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13I] FIG. 13I shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. [Figure 13J] FIG. 13J shows a plot of motion data over time collected as the TNP device of FIG. 12 was moved. DETAILED DESCRIPTION OF THE INVENTION

[0015] The present disclosure relates to methods and devices for dressing and treating wounds using reduced pressure or topical negative pressure (TNP) therapy. Specifically, but not exclusively, embodiments of the present disclosure relate to negative pressure therapy devices, methods for controlling the operation of TNP systems, and methods of using TNP systems. The methods and devices may incorporate or implement any combination of the features described below. Additionally, features of the present disclosure may be incorporated or implemented in other wound therapy devices, such as positive pressure therapy devices, or other medical devices that can be used to treat patients.

[0016] TNP therapy can assist in the closure and healing of many forms of "difficult-to-heal" wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, and removing excess exudate, as well as reducing bacterial load (and the resulting risk of infection). Furthermore, TNP therapy can result in less wound trauma, which may lead to more rapid healing. TNP systems can also assist in the healing of surgically closed wounds by removing fluid and helping to stabilize tissue in an apposed position for closure. Further beneficial uses of TNP therapy can be found in grafts and flaps, where removal of excess fluid is important and graft proximity to tissue is required to ensure tissue viability.

[0017] As used herein, a reduced pressure or negative pressure level, such as -X mmHg, represents a pressure level below atmospheric pressure, typically corresponding to 760 mmHg (or 1 atmosphere, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -X mmHg represents a pressure X mmHg below atmospheric pressure, such as a pressure of (760-X) mmHg. Furthermore, a negative pressure "lower" or "less" than -X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). A negative pressure "higher" or "greater" than -X mmHg corresponds to a pressure further from atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg).

[0018] overview In some instances, updating the label for a TNP device may be desirable or required. For example, the label may be updated when indicators of use for the TNP device are added or changed, or when changes occur in the standards that the TNP device is expected or required to meet (e.g., IEC 60601-1, FCC, etc., and when the device is released or operated in a new country in accordance with the regulations of that particular country).

[0019] In some instances, it can be difficult to reliably provide patients with the latest labeling of a TNP device. For example, the ability of a TNP device to receive and present updated labels may be limited or unreliable. Some features disclosed herein address this technical challenge by facilitating the TNP device to instruct another electronic device to quickly access and present the latest labels, thereby relieving the TNP device of the burden of providing the latest labels. Advantageously, in certain embodiments, these features can reduce the memory or hardware requirements of the TNP device because they allow the TNP device to access the latest labels but do not themselves receive or present the latest labels. Furthermore, this can increase the robustness and security of the TNP device because the TNP device cannot receive malicious or inappropriate code by updating the label information on the TNP device.

[0020] Additionally, some features disclosed herein relate to techniques that make TNP devices faster and more intelligent when dealing with various conditions or environments.

[0021] Wound Therapy System Overview FIG. 1 illustrates an embodiment of a negative pressure or reduced pressure wound therapy (or TNP) system 100 comprising a wound cavity 110 with a wound packing 130 placed within the wound cavity sealed by a wound cover 120. The wound packing 130 in combination with the wound cover 120 may be referred to as a wound dressing. A single or multiple lumen tube or conduit 140 connects the wound cover 120 to a TNP device 150 configured to deliver reduced pressure. The wound cover 120 may be in fluid communication with the wound cavity 110. In any of the system embodiments disclosed herein, the TNP device may be a canisterless TNP device (meaning that exudate is collected in the wound dressing or transported via tubing 140 to another location for collection), as in the embodiment shown in FIG. 1. However, any of the TNP device embodiments disclosed herein may be configured to include or support a canister. Additionally, in any of the system embodiments disclosed herein, any of the TNP device embodiments may be attached to or supported by or adjacent to the dressing.

[0022] The wound packing 130 can be of any suitable type, such as, for example, hydrophilic or hydrophobic foam, gauze, an inflatable bag, etc. The wound packing 130 can conform to the wound cavity 110 so that it substantially fills the cavity. The wound cover 120 can provide a substantially fluid-impermeable seal over the wound cavity 110. The wound cover 120 can have a top side and a bottom side, where the bottom side adhesively seals (or in any other suitable manner) the wound cavity 110. The conduit 140 or lumen disclosed herein or some other conduit or lumen can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0023] Some embodiments of the wound cover 120 may have a port (not shown) configured to receive the end of the conduit 140. For example, the port may be a Renasys Soft Port available from Smith & NepHew. Alternatively, in other embodiments, the conduit 140 may pass through or under the wound cover 120 to supply reduced pressure to the wound cavity 110 to maintain a desired reduced pressure level within the wound cavity. The conduit 140 may be any suitable article configured to provide at least a substantially sealed fluid flow path between the TNP device 150 and the wound cover 120 to supply reduced pressure provided by the TNP device 150 to the wound cavity 110.

[0024] The wound cover 120 and wound packing 130 may be provided as a single item or an integral single unit. In some embodiments, no wound packing is provided and the wound cover may be considered a wound dressing in its own right. The wound dressing may then be connected via conduit 140 to a source of negative pressure, such as a TNP device 150. The TNP device 150 may be miniaturized and portable, although larger conventional pumps may also be used.

[0025] The wound cover 120 may be placed over the wound site to be treated. The wound cover 120 may form a substantially sealed cavity or enclosure that covers the wound site. In some embodiments, the wound cover 120 may be configured with a film that has high water vapor permeability to allow evaporation of excess fluid and may have a superabsorbent material contained therein to safely absorb wound exudate. It will be understood that references will be made to wounds throughout this specification. In this regard, it should be understood that the term wound is to be broadly interpreted to include open and closed wounds where the skin is torn, incised, or perforated, or where trauma has caused bruising, or any other surface or other condition or defect in a patient's skin, or otherwise that would benefit from reduced pressure treatment. Thus, a wound is broadly defined as any damaged area of ​​tissue that may or may not produce fluid. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical and other incisions, subacute and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers, etc. The components of the TNP system described herein may be particularly suitable for incisional wounds that exude small amounts of wound exudate.

[0026] Some embodiments of the system are designed to operate without the use of an exudate canister. Some embodiments may be configured to support an exudate canister. In some embodiments, configuring the TNP device 150 and tubing 140 so that the tubing 140 can be quickly and easily removed from the TNP device 150 can facilitate or improve the process of replacing the dressing or pump, if necessary. Some pump embodiments disclosed herein may be configured with any suitable connection between the tubing and the pump.

[0027] In some implementations, the TNP device 150 may be configured to provide 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 be approximately 560 mmHg in practical terms. The pressure range may be between approximately -40 mmHg and -150 mmHg. Alternatively, a pressure range up to -75 mmHg, up to -80 mmHg, or greater than -80 mmHg may be used. A pressure range below -75 mmHg may also be used. Alternatively, a pressure range of approximately -100 mmHg or even above 150 mmHg may be provided by the TNP device 150.

[0028] In operation, the wound packing 130 is inserted into the wound cavity 110 and the wound cover 120 is placed to seal the wound cavity 110. The TNP device 150 provides a source of negative pressure to the wound cover 120, which is delivered to the wound cavity 110 through the wound packing 130. Fluid (e.g., wound exudate) may be drawn through the conduit 140 and stored in the canister. In some embodiments, the fluid is absorbed by the wound packing 130 or one or more absorbent layers (not shown).

[0029] Wound dressings that may be utilized with the TNP device and other embodiments of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico dressings available from Smith & NepHew. Further descriptions of such wound dressings and other components of negative pressure wound therapy systems that may be used with the TNP device and other embodiments of the present application can be found in U.S. Patent Publication Nos. 2011 / 0213287, 2011 / 0282309, 2012 / 0116334, 2012 / 0136325, and 2013 / 0110058, which are incorporated by reference in their entireties. In other embodiments, other suitable wound dressings may be utilized.

[0030] 2A shows a front view of pump assembly 230 and canister 220, according to some embodiments. As shown, pump assembly 230 and canister 220 are connected, thereby forming a TNP device. Pump assembly 230 can be similar to or identical to TNP device 150 in some embodiments.

[0031] The pump assembly 230 includes one or more indicators, such as a visual indicator 202 configured to indicate an alarm and a visual indicator 204 configured to indicate a status of the TNP system. The indicators 202 and 204 may be configured to alert a user, such as a patient or a healthcare provider, of various operational or shutdown conditions of the system, including alerting the user of a normal or proper operating condition, a pump shutdown, a loss of power supplied to the pump or a power outage, the detection of a leak in the wound cover or flow path, a suction blockage, or some other similar or suitable condition or combination thereof. The pump assembly 230 may include additional indicators. The pump assembly may use a single indicator or multiple indicators. Any suitable indicator may be used, for example, a visual, audible, tactile indicator, etc. The indicator 202 may be configured to indicate an alarm condition, such as a full canister, low power, a disconnected conduit 140, a broken seal in the wound seal 120, etc. The indicator 202 may be configured to display a red flashing light to attract the user's attention. Indicator 204 may be configured to indicate the status of the TNP system, e.g., therapy delivery is normal, a leak is detected, etc. Indicator 204 may be configured to display one or more different colored lights, e.g., green, yellow, etc. For example, a green light may be emitted when the TNP system is operating properly, and a yellow light may be emitted to indicate a warning.

[0032] The pump assembly 230 includes a display or screen 206 mounted in a recess 208 formed in the pump assembly case. The display 206 may be a touchscreen display. The display 206 may support playback of audiovisual (AV) content, such as instructional videos. As described below, the display 206 may be configured with several screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the TNP system. The pump assembly 230 includes a grip portion 210 formed in the pump assembly case. The grip portion 210 may be configured to support a user's holding of the pump assembly 230, such as during removal of the canister 220. The canister 220 may be replaced with another canister, such as when the canister 220 is filled with fluid.

[0033] Pump assembly 230 includes one or more keys or buttons configured to allow a user to operate and monitor the operation of the TNP system. As shown, this includes buttons 212a, 212b, and 212c (collectively referred to as buttons 212). Button 212a may be configured as a power button for turning pump assembly 230 on and off. Button 212b may be configured as a play / pause button for the delivery of negative pressure therapy. For example, pressing button 212b can start therapy, and then pressing button 212b can stop or end therapy. Button 212c may be configured to lock display 206 or buttons 212. For example, button 212c can be pressed to prevent a user from unintentionally altering the delivery of therapy. Button 212c can be pressed to unlock controls. In other embodiments, additional buttons may be used, or one or more of the illustrated buttons 212a, 212b, or 212c may be omitted. Multiple key presses or sequential key presses can be used to operate the pump assembly 230 .

[0034] The pump assembly 230 includes one or more latch recesses 222 formed in the cover. In an exemplary embodiment, two latch recesses 222 may be formed in the side of the pump assembly 230. The latch recesses 222 may be configured to allow attachment and detachment of the canister 220 using one or more canister latches 221. The pump assembly 230 includes an air outlet 224 to allow air to escape from the wound cavity 110. Air entering the pump assembly may pass through one or more appropriate filters, such as an antibacterial filter. This may maintain the reusability of the pump assembly. The pump assembly 230 includes one or more strap attachments 226 for connecting a carrying strap to the pump assembly 230 or for attaching a cradle. In an exemplary embodiment, two strap attachments 226 may be formed in the side of the pump assembly 230. In some embodiments, various of these features are omitted, or various additional features are added to the pump assembly 230.

[0035] The canister 220 is configured to hold fluid (e.g., exudate) to be removed from the wound cavity 110. The canister 220 includes one or more latches 221 for attaching the canister to the pump assembly 230. In an exemplary embodiment, the canister 220 includes two latches 221 on the sides of the canister. The exterior of the canister 220 may be formed from a matte plastic such that the canister is substantially opaque and the contents of the canister are substantially hidden in a plan view. The canister 220 includes a grip portion 214 formed on the canister's casing. The grip portion 214 may be configured to allow a user to hold the pump assembly 220, such as during removal of the canister from the device 230. The canister 220 includes a substantially transparent window 216, which may also include volume markings. For example, the 300 mL canister 220 shown includes graduations of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. Other embodiments of the canister may hold different amounts of fluid and include different graduation scales. For example, the canister may be an 800 mL canister. The canister 220 includes a tubular channel 218 for connecting to the conduit 140. In some embodiments, various of these features, such as the grip portion 214, are omitted, or various additional features are added to the canister 220. Some of the disclosed canisters may include a solidifying agent or may omit a solidifying agent.

[0036] FIG. 2B shows a rear view of the pump assembly 230 and canister 220, according to some embodiments. The pump assembly 230 includes a speaker port 232 for generating sound. The pump assembly 230 includes a filter access door 234 with screws for removing the access door 234 and communicating with and replacing one or more filters, such as antibacterial or odor filters. The pump assembly 230 includes a grip portion 236 formed on the pump assembly's case. The grip portion 236 may be configured to allow a user to hold the pump assembly 230, for example, during removal of the canister 220. The pump assembly 230 includes one or more covers 238 configured as screw covers, feet, or protectors for positioning the pump assembly 230 on a surface. The covers 230 may be formed of rubber, silicone, or any other suitable material. The pump assembly 230 includes a power jack 239 for charging and recharging the pump assembly's internal battery. The power jack 239 may be a direct current (DC) jack. In some embodiments, the pump assembly may include a disposable power source, such as a battery, so that a power jack is not required.

[0037] The canister 220 includes one or more feet 244 for positioning the canister on a surface. The feet 244 may be formed of rubber, silicone, or any other suitable material and may be angled at an appropriate angle to keep the canister 220 stable when placed on a surface. The canister 220 includes a tube mounting relief 246 configured to allow one or more tubes to exit to the front of the device. The canister 220 includes a stand or kickstand 248 for supporting the canister when placed on a surface. As described below, the kickstand 248 can pivot between an open position and a closed position. In the closed position, the kickstand 248 can be latched to the canister 220. In some embodiments, the kickstand 248 can be made from an opaque material, such as plastic. In other embodiments, the kickstand 248 can be made from a transparent material. The kickstand 248 includes a grip portion 242 formed thereon. Grip portion 242 may be configured to allow a user to position kickstand 248 in a closed position. Kickstand 248 includes hole 249, which allows a user to position the kickstand in an open position. Hole 249 may be sized to allow a user to extend the kickstand with their finger.

[0038] 2C shows the pump assembly 230 separated from the canister 220, according to some embodiments. The pump assembly 230 includes a vacuum attachment, connector, or inlet 252 through which a vacuum pump transmits negative pressure to the canister 220. The pump assembly draws fluids, such as gas, from the wound via the inlet 252. The pump assembly 230 includes a USB access door 256 configured to provide access to one or more USB ports. In some embodiments, the USB access door is omitted, and the USB ports are accessed through the door 234. The pump assembly 230 can include additional access doors configured to provide access to additional serial, parallel, or hybrid data transfer interfaces, such as, for example, SD, compact disc (CD), DVD, Firewire, Thunderbolt, PCI Express, etc. In other embodiments, one or more of these additional ports are accessed through the door 234.

[0039] 3A illustrates a negative pressure therapy system 300A including a TNP device 310 and a remote data processing system 320, according to some embodiments. The TNP device 310 can be used to treat a wound using a wound dressing in fluid communication with the TNP device 310 via a fluid flow path. The TNP device 310 can include a controller 311, a memory device 312, a negative pressure source 313, a user interface 314, a power source 315, a pressure sensor 316, a transceiver 317, and one or more other sensors 318 configured to electrically communicate with each other. The power source 315 can provide power to one or more components of the TNP device 310. The TNP device 310 can operate at pressure levels and using control techniques similar to those described herein or in U.S. Patent Publication Nos. 2016 / 0136339 and 2016 / 0184496, which are incorporated by reference in their entireties. TNP device 310 may be similar to or identical to TNP device 150 in some embodiments.

[0040] Controller 311 may control the operation of one or more other components of TNP apparatus 310 at least according to instructions stored in memory device 312. For example, controller 311 may control the operation and thereby the supply of negative pressure of negative pressure source 313. Negative pressure source 313 may include a pump, such as, but not limited to, a rotary diaphragm pump or other diaphragm pump, a piezoelectric pump, a peristaltic pump, a piston pump, a rotary vane pump, a liquid ring pump, a scroll pump, a diaphragm pump operated by a piezoelectric transducer, or any other suitable pump or micropump, or any combination of the above.

[0041] The user interface 314 may include one or more elements that receive user input or provide user output to the patient or caregiver. The one or more elements that receive user input may include buttons, switches, dials, a touchscreen, or the like. The user interface 314 may be used, for example, to generate and display reports or other information reflecting therapy use data, non-compliant use data, or a comparison of therapy use to non-compliant use data. As another example, the user interface 314 may receive user input providing a patient reference number or another unique identifier; the TNP device 310 may then be activated for use by the patient; and data collected and stored as described herein may be associated with the patient reference number for use in monitoring the particular patient. The user interface 314 may also provide alerts to the user. For example, the user interface 314 may include a screen that visually presents an alert or a speaker that audibly presents an alert.

[0042] The pressure sensor 316 may be used to monitor the pressure below the wound dressing, such as (i) the pressure in a fluid flow path connecting the negative pressure source 313 and the wound dressing as shown in Figure 3B, (ii) the pressure at the wound dressing as shown in Figure 3C, or (iii) the pressure at or within the negative pressure source 313 as shown in Figure 3D. As the negative pressure source 313 provides negative pressure, it may generate pressure pulses that propagate through the fluid flow path and are detected by the pressure sensor 316. These pressure pulses may be manifested as changes or bounces in the magnitude or frequency of the signal from the pressure sensor 316.

[0043] The controller 311 can analyze the signal output by the pressure sensor 316 to thereby determine the pressure within the fluid flow path. The controller 311 can examine the signal using one or more techniques, including time domain or frequency domain calculations, such as with a digital signal processor.

[0044] The controller 311 or other circuitry of the TNP device 310 may process one or more signals output by the pressure sensor 316 by filtering noise and then dynamically amplifying the filtered one or more signals. Dynamic amplification may be performed without filtering, which may allow the features described herein to be applied to small wounds or weak pressure signals. For example, amplification may be performed by a programmable gain amplifier, which may be controlled by software or hardware.

[0045] The detection of pressure by pressure sensor 316 may, in some instances, be enhanced by changing one or more settings of negative pressure source 313, such as increasing or decreasing the vacuum level provided by negative pressure source 313, stopping negative pressure source 313, changing the operating speed of negative pressure source 313, changing the cadence of negative pressure source 313, combinations thereof, etc. Controller 311 may, for example, automatically manage the adjustment of one or more settings.

[0046] In some implementations, the pressure sensor 316 may be used in combination with another pressure sensor, such that at least two pressure sensors positioned in or fluidly connected to the fluid flow path enable differential pressure measurements, as shown in FIG. 3E. For example, a first pressure sensor may be positioned upstream of the wound (e.g., at or near the inlet of the negative pressure source 313C), and a second pressure sensor may be positioned to detect pressure at or near the wound, or at or near the canister. This configuration may be further achieved by incorporating one or more lumens forming a second fluid flow path, including a first fluid flow path connecting the negative pressure source 313 to the wound, one or more lumens connecting the TNP device 310 to the wound, and through which a second pressure sensor can monitor pressure at or near the wound, or at or near the canister. The first and second fluid flow paths may be fluidly isolated from each other. When at least two pressure sensors are used, the rate of pressure change (e.g., peak-to-peak or maximum pressure) in the first and second fluid flow paths may be determined, and the pressure difference detected between the first and second pressure sensors may be determined. These values ​​may be used individually or together to detect various operating conditions, such as leaks, blockages, canister fill conditions, the presence of blood, etc., in the first or second fluid flow paths. In some implementations, multiple redundant pressure sensors may be provided to protect against failure of one or more of the pressure sensors.

[0047] The transceiver 317 may be used to communicate with the data processing system 320 via the network 330. The transceiver 317 may transmit device usage data to the data processing system 320, such as alarms, measured pressures, or changes to a therapy program administered by the TNP device 310. The network 330 may be a communications network, such as a wireless communications network, such as a cellular communications network. The memory device 312 may be used to store device usage data that may be transmitted by the transceiver 317.

[0048] The one or more other sensors 318 may be or include one or more motion sensors (e.g., accelerometers, gyroscopes, inertial measurement units, or orientation detectors). The TNP device 310 can adjust its operation according to one or more outputs from the one or more other sensors 318. The one or more other sensors 318 can be mounted outside the housing of the TNP device 310. The one or more other sensors 318 can be removable so that they can be interchangeably replaced with another type of sensor. Additionally or alternatively, the one or more other sensors 318 can be located or disposed within the housing of the TNP device 310.

[0049] The one or more other sensors 318 can detect multiple parameters, such as the x, y, and z directions, or the angle between the orientation of the TNP device 310 and the direction of gravity. Furthermore, by measuring multiple times within an interval, the one or more other sensors 318 can provide information regarding changes in acceleration in the x, y, and z directions, or changes in the angle between the orientation of the TNP device 310 and the direction of gravity. In some implementations, the one or more other sensors 318 can take measurements 50 times per second, more than 50 times per second, more than 100 times per second, or more than 200 times per second. If data is taken more frequently, changes in acceleration or orientation can be calculated more accurately. The one or more other sensors 318 can wirelessly communicate sensor data to the controller 311 or other components of the TNP device 310, such as via the Bluetooth protocol.

[0050] The output from the one or more other sensors 318 can provide information about various conditions or situations surrounding the TNP device 310 so that the TNP device 310 can act in response to such conditions or situations. For example, from the output of the one or more other sensors 318, it may be determined that the TNP device 310 is oriented upside down, has been subjected to an impact, is being used by a user who may be walking, or is positioned in a vehicle or airplane.

[0051] The controller 311 can analyze signals output by one or more sensors 318, such as one or more motion sensors, to determine the motion or orientation of a device described herein.

[0052] In some implementations, the data processing system 320 can analyze the pressure data received from the transceiver 317 to determine whether the received pressure data is indicative of the negative pressure source 313 in use on a patient, such as using analytical techniques as described with respect to the TNP device 310. The data processing system 320 can generate and display reports or other information reflecting, for example, therapy use data, non-compliant use data, or a comparison of therapy use to non-compliant use data. In one example, a user of the data processing system 320 may enter a patient reference number or a TNP device number associated with a TNP device, and the data processing system 320 can then provide or display data, such as therapy use data or non-compliant use data, related to the patient reference number or TNP device number.

[0053] 3B shows a negative pressure therapy system 300B including the TNP device 310 of FIG. 3A as well as a first fluid flow path 340A, a wound dressing 350, and a wound 360, according to some embodiments. The TNP device 310 may be used to treat the wound 360 using the wound dressing 350 in fluid communication with a negative pressure source 313 via the first fluid flow path 340A. In particular, FIG. 3B shows that a pressure sensor 316 may be positioned in the first fluid flow path 340A, for example, at or near the inlet of the TNP device 310, to measure the pressure within the first fluid flow path 340A.

[0054] FIG. 3C shows a negative pressure therapy system 300C that differs from negative pressure therapy system 300B in that pressure sensor 316 may instead be positioned to measure pressure at or near wound dressing 350, such as the pressure under wound dressing 350 when wound dressing 350 is coupled to wound 360.

[0055] 3D shows negative pressure therapy system 300D, which differs from negative pressure therapy system 300B in that pressure sensor 316 may instead be positioned to measure the pressure at negative pressure source 313. In one embodiment, pressure sensor 316 is part of and within negative pressure source 313, thereby being able to measure the pressure generated by negative pressure source 313. In another embodiment, pressure sensor 316 may be separate from negative pressure source 313 and positioned to measure the pressure at or near the inlet of negative pressure source 313.

[0056] 3E shows negative pressure therapy system 300E, which differs from negative pressure therapy system 300B in that negative pressure therapy system 300E further includes a second fluid flow path 340B and pressure sensor 316 may be a differential pressure sensor or may include two pressure sensors. If pressure sensor 316 includes two pressure sensors, one of the two pressure sensors of pressure sensor 316 may be positioned in first fluid flow path 340A to measure the pressure within first fluid flow path 340A, and the other of the two pressure sensors of pressure sensor 316 may be positioned in second fluid flow path 340B to measure the pressure within second fluid flow path 340B. If pressure sensor 316 may be a differential pressure sensor, pressure sensor 316 may be fluidly connected to first fluid flow path 340A and second fluid flow path 340B. The first fluid flow path 340A may therefore be used by the negative pressure source 313 to provide negative pressure to the wound dressing 350, and the second fluid flow path 340B may be used primarily by the pressure sensor 316 to measure the pressure at or near the wound dressing 350, such as beneath the wound dressing 360. The pressure sensor 316 may thereby be used by the TNP device 310 to perform a differential pressure measurement between the pressure supplied by the negative pressure source 313 and the pressure at or near the wound dressing 350.

[0057] 3F shows negative pressure therapy system 300F, which differs from negative pressure therapy system 300B in that negative pressure therapy system 300F may further include an additional pressure sensor 370 positioned to measure pressure at or near wound dressing 350, such as the pressure under wound dressing 350 when wound dressing 350 is coupled to wound 360. Additional pressure sensor 370 may generate and output a signal to TNP device 310 in response to the pressure measured at wound dressing 350. Pressure sensor 316 and additional pressure sensor 370 may thus be used by TNP device 310 to perform a differential pressure measurement between the pressure supplied by negative pressure source 313 and the pressure at or near wound dressing 350.

[0058] 3G illustrates negative pressure therapy system 300G, which differs from negative pressure therapy system 300B in that canister 380 may be coupled between negative pressure source 313 and wound dressing 350 in first fluid flow path 340A. Canister 380 may collect exudate removed from wound 360. The embodiments of FIGS. 3C-3F may similarly be modified to further include canister 380 in some implementations.

[0059] 4 shows a negative pressure therapy system 400 including a TNP device 410 and wound dressings 420A, 420B, ..., 420N, according to some embodiments. The wound dressings 420A, 420B, ..., 420N can be in fluid communication with the TNP device 410 and can be used to treat different wounds 430A, 430B, ..., 430N on a patient. The TNP device 410 can be similar to or identical to the TNP device 310 in some embodiments.

[0060] The TNP device 310 can monitor each of the wound dressings 420A, 420B, ..., 420N individually, such that the TNP device 310 can generate an alarm for a subset of the wounds 430A, 430B, ..., 430N (e.g., one, two, or three of the wounds) without having to generate an alarm for one or more other wounds 430A, 430B, ..., 430N. As a result, control can be consolidated into the TNP device 310, and multiple TNP devices need not be used to treat the wounds 430A, 430B, ..., 430N.

[0061] In further implementations, the negative pressure therapy system 400 may include two of the TNP devices 410 that communicate with each other to further promote wound treatment. The negative pressure therapy system 400 in some such implementations may also include a central hub device (not shown) that operates one or both of the TNP devices 410 and provides a communication interface for the two of the TNP devices 410 to communicate with.

[0062] 5 illustrates communications within a negative pressure wound therapy system 500, according to some embodiments. The negative pressure therapy system 500 includes the TNP device 310 of FIG. 3 as well as an electronic device 510 and a server 530. The TNP device 310 can communicate wirelessly with the electronic device 510 via electromagnetic radiation, such as optical radiation (e.g., visible to a user). The electronic device 510 can then wirelessly communicate with the server 530 via a network 520, such as a computer network. The electronic device 510 may be, for example, a smartphone, tablet, personal computer, or the like.

[0063] The electronic device 510 may include an image sensor 512, control circuitry 514, a user interface 516, and a transceiver 518. The image sensor 512 may be configured to detect optical radiation, such as in the form of a barcode, displayed by the user interface 314. The control circuitry 514 may process the optical radiation from the user interface 314 and determine to communicate with a server 530 over a network 520 using the transceiver 518. The user interface 316 may be used to display information, such as a label for the TNP device 310, received from the server 530. Additionally, the operation of the electronic device 510 and the TNP device 310 may be controlled by a user via the user interface 516.

[0064] 6 illustrates communications within a negative pressure wound therapy system 600, according to some embodiments. The negative pressure therapy system 600 includes the TNP device 310 of FIG. 3 as well as an electronic device 610 and a server 630. The negative pressure wound therapy system 600 may be similar to the negative pressure therapy system 500, except that the TNP device 310 and the electronic device 610 may be configured to communicate via the transceiver 316 and the transceiver 612 of the electronic device 610 using ultra-high frequency (UHF) radiation (e.g., approximately 2.4 GHz radiation) or super high frequency (SHF) radiation (e.g., approximately 5 GHz radiation) rather than optical radiation. The transceiver 316 and the transceiver 612 may communicate, for example, via data packets and using a communication protocol such as Bluetooth®. The electronic device 610, network 620, and server 630 may operate similarly to the electronic device 510, network 520, and server 530, respectively, and the transceiver 612 may communicate with the server 530 via the network 620. The control circuitry 614 of the electronic device 610 may be used to display information, such as a label for the TNP device 310, received from the server 630, and the operation of the electronic device 610 and the TNP device 310 may be controlled by a user via a user interface 616.

[0065] 7 illustrates a label access process 700, according to some embodiments. The label access process 700 may be performed by a therapy system, such as negative pressure therapy system 500 or negative pressure therapy system 600. The label access process 700 may be initiated, for example, when a user selects the device label area 802 on a menu screen 800, which is displayed on the user interface of a TNP device, such as TNP device 310, as shown in FIG. 8A.

[0066] For convenience, label access process 700 is described in the context of negative pressure wound therapy system 500 and negative pressure wound therapy system 600, but may alternatively be implemented in other systems described herein or by other systems not shown. Advantageously, label access process 700, in certain embodiments, provides a way for a TNP device to provide up-to-date labels without the TNP device itself receiving or presenting updated label information.

[0067] At block 702, the label access process 700 may retrieve identification data from a memory device of the therapy device. For example, the TNP device 310 may retrieve the identification data from the memory device 312. The identification data may be data that can be used to access the latest label of the TNP device 310.

[0068] At block 704, the label access process 700 can output identification data from the therapy device. For example, the user interface 314 can output the identification data by presenting the identification data as a two-dimensional barcode on the display of the user interface 314. The two-dimensional barcode may be displayed, for example, in the barcode area 812 of the label access screen 810 shown in FIG. 8B and displayed on the user interface of a TNP device, such as the TNP device 310. As another example, the user interface 314 can output the identification data by outputting the identification data wirelessly via the transceiver 316. In some implementations, the two-dimensional barcode or identification data can include information such as an identifier associated with the TNP device 310 or that type of device, as well as an address or other instructions for contacting the server 530 to request an updated label.

[0069] At block 706, the label access process 700 can receive the identification data output by the therapy device using an electronic device. For example, the electronic device 510 can detect the two-dimensional barcode output via the image sensor 512 and the user interface 314. As another example, the electronic device 610 can detect the identification data output wirelessly via the transceiver 316 to the transceiver 612.

[0070] At block 708, the label access process 700 can generate a request from the identification data by the electronic device. For example, the control circuitry 516 can generate a request from a two-dimensional barcode to access the most recent label of the TNP device 310. As another example, the control circuitry 614 can generate a request from wirelessly received identification data to access the most recent label of the TNP device 310.

[0071] At block 710, the label access process 700 may send a request by the electronic device. For example, the transceiver 518 may send the request to the server 530 over the network 520, or the transceiver 612 may send the request to the server 630 over the network 620. The request may be used by the server 530 or the server 630 to obtain and provide the latest label for the TNP device 310 to the electronic device 510 or the electronic device 610.

[0072] At block 712, label access process 700 may receive a label associated with the electronic device request. For example, electronic device 510 may receive the latest label over the network from server 530, or electronic device 610 may receive the latest label over the network from server 630. Server 530 may provide the latest label to electronic device 510 in response to a request from electronic device 510, and server 630 may provide the latest label to electronic device 610 in response to a request from electronic device 610.

[0073] The label may include information such as the intended use of the therapy device, general therapy device warnings, associated therapy device supplies and materials, therapy device components, therapy device usage status, user preparation information, regulatory numbers or codes for the therapy device or its components, the manufacturer's or distributor's name and place of business, a unique therapy device identifier, combinations thereof, or for other TNP devices 310. The label may include information in the form of symbols, pictures, alphanumeric characters, identical combinations, etc. Some or all of the information on the label may be encrypted before being communicated to the electronic device due to the potential security importance of the information, e.g., to prevent tampering with the information by others. In some embodiments, the electronic or therapy device may maintain one or more encryption keys that decrypt the message header.

[0074] At block 714, the label access process 700 can output the label by the electronic device for presentation to the user. For example, the electronic device 510 can present the label to the user on the display of the user interface 514, or the electronic device 610 can present the label to the user on the display of the user interface 616.

[0075] The label is displayed, for example, in label area 821 of label display screen 820 shown in FIG. 8C and displayed on a user interface of an electronic device, such as electronic device 510 or electronic device 610. The displayed label may include a therapy device name section 822 presenting the therapy device name, a therapy device provider name section 823 presenting the therapy device provider name, a provider contact information section 824 presenting provider contact information, a usage information section 825 presenting usage information, a regulatory or serial number section 826 presenting the therapy device's regulatory or serial number, a symbol section 827 presenting symbols indicative of or related to device features, and a machine-readable code section 828 presenting a barcode or the like. In some implementations, the label displayed in label area 821 may include one or more other sections not shown, a subset of the sections shown in FIG. 8C, or multiple repeats or similar sections of those shown in FIG. 8C.

[0076] The label display screen 820 may also include a navigation control section 829 that, when selected by the user, may navigate within an application running on the electronic device to another screen, such as the control screen 830 shown in FIG. 8D. The control screen 830 may include an activation area 832 that the user can select to activate a therapy device, such as the TNP device 310, a break-in area 834 that the user can select to stop the therapy device, and an adjustment area 836 that the user can select to adjust settings of the therapy device, such as the pressure set point. The control screen 830 may also include a navigation control section 838 that, when selected by the user, may navigate within an application running on the electronic device to another screen, such as the label display screen 820.

[0077] At block 716, the label access process 700 can transmit confirmation or verification with the electronic device. For example, the transceiver 518 can transmit the confirmation or verification to the server 530 over the network 520, or the transceiver 612 can transmit the confirmation or verification to the server 630 over the network 620. The confirmation or verification can include a code that can be used to confirm or verify that some or all of the label's information is being presented by the display, or that the correct or latest version of the label is being presented by the display. Additionally, the confirmation or verification can indicate the readiness of the TNP device 310 (e.g., for use to administer a therapy) and can be used to monitor therapy compliance for the TNP device 310 (e.g., by the device manufacturer, prescribing physician, or insurance provider). In one example, the confirmation or verification can include a combination of the device serial number and software / data file update version, which may be recorded in a database for regulatory or post-market monitoring and maintenance use. The confirmation or verification can be encrypted or unique to a particular type of device, thereby enhancing cybersecurity protection. The confirmation or verification can be generated in at least some implementations from at least the label file. In some embodiments, one or more features of the TNP device 310 or electronic device 510 or electronic device 610 may be disabled until confirmation or verification is generated or transmitted.

[0078] The label access process 700 may further include one or more other features in particular implementations. For example, the therapy device may not operate to provide therapy until the identification data is output by the therapy device. In another example, the therapy device may not operate to provide therapy until the identification data is output by the therapy device, and the therapy device may receive confirmation from the electronic device receiving the identification data that the identification data was used to present the latest label.

[0079] An electronic or therapy device may include one or more cybersecurity mechanisms to protect the integrity of its operation. For example, the electronic or therapy device may store data received from a remote server (updated labels or other information) in memory physically separated from other memory used to manage or operate the therapy, so that even if communications with the remote server are compromised, malicious code cannot be deployed to adjust operation. In some instances, the control software of the electronic or therapy device can verify the data received from the remote server. When therapy settings are received remotely, the settings may be stored in a memory separate from the control software so that the control software can check the memory of the settings against any predetermined protocols or other restrictions. If the protocols or other restrictions are not met, the control software may not operate the electronic or therapy device.

[0080] FIGURE 9A illustrates a menu screen 900 that may be displayed on the user interface of a therapy device, such as TNP device 310. Menu screen 900 may include a user-selectable patents area 902 for viewing patents or other intellectual property information related to the therapy device. Additionally, upon selection of patents area 902, patents screen 910, illustrated in FIGURE 9B, may become visible in place of menu screen 900. Patents screen 910 may include a user-selectable patent links area 912, which may load links, such as uniform resource locators (URLs), as an example of a browser-like application.

[0081] Therapy Device Control Process 10 illustrates a control process 1000 that may be performed by a device such as the TNP device 150 of FIG. 1, the pump assembly 230 of FIGS. 2A-2C, the TNP device 310 of FIG. 3A, or other TNP devices similar to those described in U.S. Patent Publication Nos. 2016 / 0136339 and 2016 / 0184496, which are incorporated herein by reference in their entireties. For convenience, the control process 1000 is described in the context of the TNP device 310 of FIG. 3A, but may instead be implemented in other systems described herein or not shown.

[0082] The control process 1000 may advantageously enable the TNP device 310 to perform more efficiently, effectively, or safely than other TNP devices by dynamically and intelligently functioning to prevent degradation of therapy performance, prevent device misuse, assist in the completion of therapy, maintain performance of the negative pressure source 313, or allow the negative pressure source 313 to adapt to changing external environments.

[0083] At block 1002, the controller 311 can receive input data. The input data can include, for example, device operation information, information about the environment surrounding the TNP device 310, information about the current condition of a patient using the TNP device 310, or prescribed therapy and information. The input data can be collected using a sensor (e.g., pressure sensor 316 or one or more other sensors 318), user input (e.g., via the user interface 314), or received control input (e.g., a communication received by the transceiver 317 from another device over the network 330), among other possible sources such as those described herein.

[0084] In block 1004, the controller 311 may determine a control value from the input data. The control value may be, for example, a control parameter that can be used to adjust an operation controlled by the controller 311.

[0085] In block 1006, the controller 311 can adjust device operation according to the control value. For example, the controller 311 can change processing by the TNP device 310 (such as alarms, applied pressure control algorithms, when or how data is reported, inputs used to change processing, device power usage, or when or how noise suppression of the signal is collected) according to the control value.

[0086] In block 1008, the controller 311 may indicate or send a notification of the adjustment of the device operation. The controller 311 may, for example, set a flag in a memory device indicating the success or failure of the adjustment, or send a confirmation or verification indicating the success or failure of the adjustment to another device, such as over a communications network.

[0087] Example of remote programming and local verification The control process 1000 can be a process by which remote programming is verified locally at the TNP device 310. The data processing system 320 can provide instruction messages to the TNP device 310 via the network 330 to function according to specific instructions, such as prescribed treatments, for a patient assigned to use the TNP device 310. However, to ensure that the functionality provided by the specific instructions is appropriate and safe for the patient, a caregiver can use the user interface 314 to review and confirm the functionality and provide authorization to activate the functionality. Without local authorization by the appropriate caregiver, the TNP device 310 may receive the specific instructions but not function according to the specific instructions. In one implementation, the caregiver may be responsible for causing the data processing system 320 to provide the specific instructions, and the local authorization can provide confirmation that the specific instructions were correctly received and implemented by the TNP device 310. Once the local authorization is received, the TNP device 310 can further send confirmation or verification of receipt of the local authorization, such as to another device via the communications network. For example, the confirmation or verification may indicate the readiness of the TNP device 310 (e.g., for use to administer therapy) and may indicate that the TNP device 310 can be used to monitor therapy compliance. In one implementation, the confirmation or verification may include a combination of a device serial number and software / data file update version as described herein, which may be cryptographically unique to a particular type of device. Additionally or alternatively, upon failure to successfully perform local authentication, the TNP device 310 may send a failure notification, such as to another device via a communications network.

[0088] The authentication described in the above paragraph may additionally or alternatively be implemented using one or more techniques. For example, authentication may be performed via a radio frequency identification (RFID) tag, or a caregiver's handheld device (such as a smartphone) using a verification code entered via user interface 314. Furthermore, in certain embodiments, the authentication described in the above paragraph may be desirable if a clinician in the patient's home can review and confirm certain instructions.

[0089] Example of two-way control of negative pressure source The control process 1000 may be a process by which the TNP device 310 may be remotely configured into a different mode, such as a home mode (e.g., when the pressure setting for use of the TNP device 310 cannot be changed) or a hospital mode (e.g., when the pressure setting for use of the TNP device 310 is changed). The data processing system 320 may provide instructions to the TNP device 310 via the network 330. The TNP device 310 may then adjust its mode according to the instructions. In some implementations, the change of mode by the TNP device 310 may trigger an alarm in the user interface 314 or an alarm in the data processing system 320 via communication from the TNP device 310 over the network 330.

[0090] Example of alarm setting The control process 1000 may be a process by which the TNP device 310 changes its alarms (such as (i) increasing or decreasing alarm sensitivity, such as an alarm threshold that audibly or visually alarms depending on a particular mode, or (ii) adjusting a help screen displayed to the patient depending on a particular mode) depending on whether the patient using the TNP device 310 is in a particular location, moving around, or in a particular environment.

[0091] For example, the TNP device 310 can have an ambulatory mode or a stationary mode. The mode of the TNP device 310 can be set by user input to the user interface 314 or by sensor input using sensors such as motion sensors (e.g., accelerometers or gyroscopes) or orientation detectors. The TNP device 310 can activate an audible or visual alarm on the user interface 314 or display a specific help screen depending on both the device's operating parameters and the device's mode. In another example, the TNP device 310 can suppress or alternatively present one or more alarms presented by the TNP device 310 if the TNP device 310 determines (using GPS data or Wi-Fi or location triangulation data collected by the TNP device 310, etc.) that its location is within an area where a caregiver is expected to be present, such as a hospital. In yet another example, when the TNP device 310 determines that the local time at which the TNP device 310 is located (which may be determined automatically by the TNP device 130 using GPS data or Wi-Fi or location communication triangulation data collected by the TNP device 310) is within a suppression period in the alarm suppression schedule (e.g., late at night when the patient is expected to be asleep), the TNP device 310 may suppress or alternatively present one or more alarms presented by the TNP device 310, which may be programmed at the time of manufacture or set or adjusted by user input to the user interface 314.

[0092] As another example, the TNP device 310 can determine the transport environment in which the TNP device 310 is located (e.g., transport in a car, train, or airplane). The transport environment can be set by user input to the user interface 314 or by sensor output from one or more other sensors 318 (e.g., a motion sensor or an audio sensor that detects vibration or noise frequencies). In one example, if the one or more other sensors 318 includes a motion sensor, the motion sensor output can be used to detect movement patterns indicative of a particular transport, and the audio sensor can detect a particular noise or vibration, such as in the 1 Hz to 1 KHz range, that exceeds a threshold level. The TNP device 310 can also adjust certain settings, such as alarm sensitivity (e.g., lowering the sensitivity) or volume (e.g., increasing the volume). In environments where low noise or vibration levels are detected, the alarm sensitivity can be increased or the volume can be decreased, for example.

[0093] The alarm sensitivity adjustment described in the above paragraph can, in some implementations, be used to adjust the threshold for triggering an alarm indicating an occlusion. Peak-to-peak measurements can be used to detect occlusion, as described in U.S. Patent Publication No. 2016 / 0184496, the entire disclosure of which is incorporated herein by reference in its entirety. In one example, triggering an occlusion alarm under one condition can be counting the number of peak-to-peak measurements that exceed a threshold level over a certain period of time. If alarm sensitivity is decreased, the peak-to-peak threshold can be increased, for example, for a certain period of time. As a result, a therapy device alarm may be less sensitive when the patient is walking than when the patient is driving in a moving vehicle.

[0094] Examples of noise removal or suppression The control process 1000 may be a process by which the TNP device 310 adjusts its functions to remove or suppress noise so that the TNP device 310 can continue to function accurately. The TNP device 310 may cease operation, for example, if the TNP device 310 detects a high interference environment (such as high temperature, humidity, location, or acceleration) or if it operates more continuously and there is less reliability that commanded actions will be carried out. When the TNP device 310 detects that the interference level around the TNP device 310 or the network 330 falls below an interference threshold, the TNP device 310 may communicate data to the data processing system 320 via the network 330.

[0095] Power management example The control process 1000 may be a process by which the TNP device 310 shuts down one or more components or services provided by the TNP device 310 depending on the remaining energy or operating temperature of the power source 315. This may desirably allow the TNP device 310 to conserve power to operate the negative pressure source 313 in certain embodiments.

[0096] Location service selection example The control process 1000 may be a process by which the TNP device 310 selects from one or more location information. For example, in response to the TNP device 310 determining (using a motion sensor or orientation sensor, etc.) that the patient is moving, the TNP device 310 may attempt to determine the location of the TNP device 310 using Wi-Fi or location triangulation data rather than GPS data. Further, in response to the TNP device 310 determining (using a motion sensor or orientation sensor, etc.) that the patient is stationary, the TNP device 310 may attempt to determine the location of the TNP device 310 using GPS data rather than Wi-Fi or location triangulation data.

[0097] Example of using analog control instead of digital control The control process 1000 may be a process by which the TNP device 310 selects to use analog or digital data to control the negative pressure source 313. For example, when operating in certain environments, such as noisy environments (such as when the therapy device may be exposed to a great deal of motion, electromagnetic radiation, or heat), an analog pressure sensor may provide a more accurate pressure reading than a digital pressure sensor for use in the controller 311 controlling the negative pressure source 313.

[0098] Example of user interface menu configuration The control process 1000 may be a process by which the TNP device 310 configures the behavior of the user interface 314 according to environmental conditions detected by the TNP device 310 .

[0099] The TNP device 310 can automatically display a particular help screen on the user interface 314 in response to, for example, detection (e.g., using a motion sensor, an orientation sensor, or other sensor) of a particular detected environmental condition associated with the particular help screen. The particular help screen can present information usable by a user of the TNP device 310 to diagnose and resolve the detected environmental condition. Thus, the TNP device 310 can present a particular help screen on the user interface 314 in a timely manner because the user desires to seek out the particular help screen to address the environmental condition.

[0100] In yet another example, if the TNP device 310 detects environmental conditions associated with a less favorable environment for operating the TNP device 310, such as when it is determined (e.g., using a motion or orientation sensor) that the TNP device 310 is moving, or when the detected ambient temperature falls below a first temperature threshold (e.g., 30°F, 40°F, or 50°F) or exceeds a second temperature threshold (e.g., 100°F, 110°F, or 120°F), the TNP device 310 may simplify one or more user interfaces displayed to the user (e.g., by reducing the amount of data presented, reducing the number of available inputs, or changing the presentation scheme, such as different colors, sizes of interface elements, or presentation times of interface elements).

[0101] In yet another example, the TNP device 310 can vary the amount of user interface interaction required from the user in response to a determined patient health or activity level (e.g., determined from user input indicative of the patient's health or activity level, or inferred from one or more past user inputs or detected conditions surrounding the TNP device 310 or the user). If the TNP device 310 detects an amount of movement below a threshold, or if the TNP device 310 receives other information, such as vital signs, that indicates the patient is not healthy enough to provide much user input, the TNP device can simplify one or more user interface elements displayed to the user (e.g., by reducing the amount of data presented, reducing the number of available inputs, or changing the presentation scheme, such as different colors, sizes of interface elements, or presentation time of interface elements).

[0102] Example of flow-based pressure control The control process 1000 may be a process by which the TNP device 310, in response to determining that fluid flow from the wound to which negative pressure is being provided, automatically increases the pressure provided by the negative pressure source 313. This increase desirably, in certain embodiments, helps prevent a decrease in the effectiveness of the therapy provided by the TNP device 310 as fluid flow from the wound increases.

[0103] Example of time configuration The control process 1000 can be a process by which the TNP device 310 automatically determines and adjusts its settings for local time, date, or daylight saving time data. The TNP device 310 can include a communications module, such as a 3G module, that enables the TNP device 310 to obtain local time, date, and daylight saving time data from a computer network, such as a cellular network. In response to the TNP device 310 determining the local time, date, or daylight saving time data, the TNP device 310 can adjust its display or use of the time, date, or any other time or date associated with the TNP device 310. As a result, a user of the TNP device 310 may or may not need to manually provide time information, thereby reducing the possibility of usage errors. Additionally, the TNP device 310 may or may not need to have an internal clock that is user-activated or continues to run from the time of the TNP device's manufacture. In some implementations, the TNP device 310 can use GPS data to obtain the TNP device's location and automatically determine the local time described herein.

[0104] Example of advanced configuration The control process 1000 may be a process in which the TNP device 310 determines the altitude at which the TNP device 310 is located and adjusts one or more therapy parameters according to the determined altitude. For example, the TNP device 310 may include a sensor, such as an altimeter, a barometric sensor, an accelerometer, or a GPS sensor, that can be used to detect the altitude at which the TNP device 310 is located. If the TNP device 310 determines that the detected altitude is within one or more altitude ranges or exceeds a threshold (e.g., an altitude of 10,000 feet), the TNP device 310 may adjust one or more therapy parameters, such as a pressure set level, a pressure fluctuation pattern, an operating mode of the pressure source, an alarm threshold, an alarm sensitivity, or a sensor sensitivity.

[0105] Example of a high-pressure chamber The control process 1000 may be a process by which the TNP device 310 detects the presence of a nearby hyperbaric chamber and adjusts the operation of the TNP device 310 when a hyperbaric chamber is detected. For example, the TNP device 310 may include one or more sensors to detect high ambient pressure levels or high ambient oxygen levels, which may result from the use of a hyperbaric chamber. In response to detecting a hyperbaric chamber, the TNP device 310 may adjust its operation (e.g., by turning off the TNP device 310, reducing operating power levels, or disabling certain functions) to reduce the risk of fire.

[0106] Motion detection example The control process 1000 may be a process by which the TNP device 310 detects movement or orientation of the TNP device 310 and adjusts its movement according to the motion or orientation. In some instances, the TNP device 310 may use one or more other sensors 318, including one or more motion sensors, to determine the acceleration or orientation of the TNP device 310. The TNP device 310 further selects an operating mode based at least on the detected acceleration or orientation and adjusts the operation of the controller 311 according to the operating mode.

[0107] The control process 1000 can be useful for adjusting the operation of the TNP device 310 in various situations. For example, the TNP device 310 may experience an error condition that can trigger an alarm, where the error condition can be caused by an inversion of the TNP device 310, causing a filter positioned between the canister and the TNP device's 310 negative pressure source to saturate with fluid stored in the canister. In another example, if the TNP device 310 detects an aircraft environment, the TNP device 310 can automatically turn off certain wireless data communication functions (e.g., 3G-GPS communication) so that the user does not have to manually turn off functions that may be required by regulatory authorities. The TNP device 310 can additionally or alternatively change the volume of an alarm according to the operating mode or change an occlusion alarm threshold based at least on the acceleration or orientation of the TNP device 310.

[0108] FIG. 11 illustrates a monitoring process 1100, according to some embodiments. The monitoring process 1100 may be performed by a therapy system, such as negative pressure therapy system 300A. The therapy system may include a TNP device having a motion sensor, such as TNP device 310 having one or more other sensors 318, including one or more motion sensors. The monitoring process 1100 may be initiated, for example, when a user selects a motion detection on / off area (not shown) on a user interface of the TNP device, such as menu screen 800 shown in FIG. 8A. In some instances, the monitoring process 1100 may be initiated automatically when the TNP device is started or powered on.

[0109] For convenience, the monitoring process 1100 is described in the context of the negative pressure wound therapy system 300A, but may instead be implemented by other systems described herein or not shown. Advantageously, the monitoring process 1100, in certain embodiments, provides a method for the TNP device to determine the cause of an error condition and provide information about the cause of the error condition.

[0110] At block 1102, the monitoring process 1100 can activate a pressure source of a therapy device. For example, the TNP device 310 can activate a negative pressure source 313.

[0111] At block 1104, the monitoring process 1100 can generate motion data indicative of motion of the therapy device using a motion sensor. For example, the TNP device 310 can generate motion data indicative of motion of the housing of the TNP device 310 using one or more sensors 318. The motion data can include, among other information, acceleration, direction of acceleration, change in acceleration, or angle formed with the direction of gravity. Various motion data and determining device motion from the motion data are further described herein. The motion data can be saved or recorded by the TNP device 310 in a log in the memory device 312 to allow for later access to the motion data.

[0112] At block 1106, the monitoring process 1100 can detect an error condition associated with providing negative pressure to the wound with the pressure source. For example, the error condition could be an obstruction in the fluid flow path or a low pressure level at the wound. The TNP device 310 can determine an obstruction from flow in the fluid path or an activation level of the negative pressure source 313 from a pressure value determined using the pressure sensor 316. The error condition may or may not trigger an alarm by the TNP device 310. Examples of error conditions, including leaks or obstructions, are described in U.S. Patent Publication Nos. 2015 / 0025482, 2016 / 0184496, and 2017 / 0216501, which are incorporated by reference in their entireties. The TNP device 310 can additionally create or add a log entry indicating the occurrence of the error condition. The log is stored in the memory device 312. In some instances, the TNP device 310 can determine the frequency of the error condition from the log. The TNP device 310 may operate the negative pressure source 313 differently than before the detection of the error condition. For example, the TNP device 310 may shut down the negative pressure source 313 or change the setpoint or operating mode of the negative pressure source 313, among other possibilities.

[0113] At block 1108, the monitoring process 1100 can determine a cause of the error condition from the motion data. The cause of the error condition may be determined from motion data generated before or after the occurrence of the error condition. The TNP device 310 can, for example, analyze the motion data for one or more features indicative of a particular cause of the error condition or compare the motion data to model motion data indicative of a particular cause of the error condition. If the TNP device 310 determines motion data over a period of time (e.g., 0.2, 0.5, 1, 1.5, 2, 3, 5, 10, 20, or 30 seconds), meets a threshold associated with a feature indicative of a particular cause, or has a threshold degree of similarity with model motion data associated with a particular cause, the TNP device 310 can determine that a particular or specific cause is the cause of the error condition.

[0114] In one embodiment, the TNP device 310 can include a canister, such as the canister 220 of FIGS. 2A-2C, supported by the housing of the TNP device 310, which can collect fluid aspirated from the wound. Mishandling of the housing of the TNP device 310, such as by improperly rotating or vibrating it, can cause a filter between the canister and the device's pump assembly to become saturated with fluid within the canister. The monitoring process 1100 can detect a threshold magnitude of rotation or vibration from the motion data and determine that rotation or vibration may have saturated the canister with fluid, resulting in a blockage detected by the TNP device 310. As another example, an abnormal impact to the TNP device 310 can be detected from the motion data, and it can be determined that the impact is the cause of the blockage or leak. Other examples of improper handling of the TNP device 310 are described further herein.

[0115] At block 1110, the monitoring process 1100 can output an alert for presentation to a user notifying the user of the cause of the error condition. The alert may be presented together with or separately from the alarm associated with the error condition. The alert may identify improper rotation, vibration, impact, or other motion of the housing of the TNP device 310, or how motion of the housing led to the error condition associated with one or more components of the TNP device 310. The alert may be presented to the user visually or audibly. In one example, the TNP device 310 can output a warning or alarm, such as for presentation via the user interface 314, notifying the user that rotation or vibration of the housing of the TNP device 310 may cause saturation of the canister filter.

[0116] Additionally or alternatively, the TNP device 310 may output user instructions to the user, such as for presentation via the user interface 314, indicating how to remedy the error condition. For example, the TNP device 310 may output user instructions to replace a canister filter in response to detecting rotation or vibration that likely causes the canister filter to become saturated with fluid. In some instances, the TNP device 310 may output user instructions to the user indicating how to prevent future occurrences of the error condition, such as how to not repeat the cause of the error condition. For example, the TNP device 310 may indicate not to rotate or vibrate the housing of the TNP device 310, as detected from the motion data, such as by outputting for presentation to the user one or more images or videos indicating proper or improper device handling corresponding to the cause of the error condition.

[0117] In addition to, or instead of, outputting an alert or user instruction, the monitoring process 1100 can act differently in response to determining the cause of the error condition, for example, by operating the negative pressure source 313 differently than before determining the cause of the error condition. For example, the TNP device 310 can shut down the negative pressure source 313 or change the setpoint or operating mode of the negative pressure source 313, among other possibilities.

[0118] 12 shows a TNP device 1210, which may be similar to the pump assembly 230 and canister 220 of FIG. 2A and may further include a motion sensor 1230, which may be similar to one or more other sensors 318 of FIG. 3A. The motion sensor 1230 may be attached to a housing of the TNP device 1210. The motion sensor 1230 may detect movement or orientation of the TNP device 1210.

[0119] 13A-13J show plots of measurements from a motion sensor attached to a TNP device, such as the motion sensor 1230 of FIG. 12 or another motion sensor described herein. In FIGS. 13A-13J, "step" may be determined and output by the motion sensor 1230. "Pitch" may indicate the orientation of the TNP device and may be determined by the angle formed by the motion sensor 1230 with respect to the direction of gravity. "RMS" may be determined by the root mean square of the acceleration measured by the motion sensor 1230 in the x, y, and z directions. "Shock" may be determined and output by the motion sensor 1230 and may indicate a large change in acceleration.

[0120] FIG. 13A shows a plot of motion data over time collected when the TNP device was moved from a standing position to a supine position, and FIG. 13A shows the corresponding change in pitch. FIG. 13B shows a plot of motion data over time collected when the TNP device was returned. FIG. 13C shows a plot of motion data over time collected when the TNP device was carried by a user while walking, and the timing of each of the user's steps is shown in FIG. 13C. FIG. 13D shows a plot of motion data over time collected when the TNP device was positioned on an angled stand. FIG. 13E shows a plot of motion data over time collected when the TNP device was suddenly lowered and an impact was detected, as shown in FIG. 13E. FIG. 13F shows a plot of motion data over time collected when the TNP device was moved from an angled stand to a standing position. FIG. 13G shows a plot of motion data over time collected when the TNP device was moved from a supine position to a frontal position. Figure 13H shows a plot of motion data over time collected when the TNP device was placed on its left side. Figure 13I shows a plot of motion data over time collected when the TNP device was placed on its right side. Figure 13J shows a plot of motion data over time collected when the TNP device was moved from an upright position to an upside-down position. As in Figure 13J, the pitch increased from approximately 0° to 180°, indicating that the TNP device was inverted.

[0121] 13A-13J, the orientation of the TNP device, as well as movement of the TNP device, such as walking or impact, can be detected by a motion sensor. Determinations from motion data, such as the motion data plotted in Figures 13A-13J, are described herein as being used by the TNP device to determine the cause of an error condition in the TNP device, or to provide an alarm, notification, or instruction, or the like.

[0122] Other variations Although specific embodiments have been described, these embodiments are presented by way of example only 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. Additionally, various omissions, substitutions, and modifications may be made to the methods and systems described herein. Those skilled in the art will recognize that, in some embodiments, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the figures. In some embodiments, certain steps described above may be removed, and others may be added. For example, the actual steps or order of steps performed in the disclosed processes may differ from those shown in the figures. In some embodiments, certain steps described above may be removed, and others may be added. For example, various components shown in the figures may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as a processor, ASIC, FPGA, etc., may include logic circuitry. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in various ways to form additional embodiments, all of which are within the scope of the present disclosure.

[0123] The user interface screens shown and described herein may include additional 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, etc. The user interface screens may include additional or alternative information. The components may be arranged, grouped, and labeled in any suitable order.

[0124] While the present disclosure includes particular embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses, and obvious modifications and equivalents thereof, including embodiments that may 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.

[0125] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context of use, is typically intended to convey that certain embodiments include certain features, elements, or steps, while other embodiments do not. Thus, such conditional language is not necessarily intended to suggest that the features, elements, or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instruction, whether those features, elements, or steps are included in or should be performed in any particular embodiment. Terms such as "comprising," "including," and "having" are synonymous and used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in an inclusive sense (as opposed to an exclusive sense), such as when used to connect a list of elements, to mean one, some, or all of the listed elements. Further, the term "each," as used herein, in addition to having its ordinary meaning, can also refer to any subset of the list of elements to which the term "each" is applied.

[0126] Conjunctive phrases such as the term "at least one of X, Y, and Z," unless specifically stated otherwise, are to be construed in conjunction with the context in which they are generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive phrases are not generally intended to suggest that a particular embodiment requires including at least one of X, at least one of Y, and at least one of Z.

[0127] As used herein, language expressing degrees, such as "approximately," "about," "generally," and "substantially," refers 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 refer to 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 being exactly parallel by 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, or 0.1 degrees or less.

[0128] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims set forth in this section or elsewhere herein or presented hereafter. The claim language is to be interpreted broadly based on the language used in the claims, and is not limited to the examples described herein or described during the prosecution of this application, which examples are to be construed as non-exclusive. [Additional note 1] 1. A device for applying negative pressure to a wound, comprising: Housing and a pressure source supported by the housing and coupled to a wound dressing placed on a wound via a fluid flow path, the pressure source configured to provide negative pressure to the wound; a controller supported by the housing and configured to operate the pressure source to provide negative pressure to the wound; an output device supported by the housing and configured to provide identification data to an electronic device, the identification data usable by the electronic device to access a label associated with the housing or one or more components supported by the housing. [Additional note 2] 10. The apparatus of claim 1, wherein the identification data is usable by the electronic device to access the label from a remote database via a computer network. [Additional note 3] 3. The apparatus of claim 1 or 2, wherein the output device comprises a display configured to present the identification data as an optical, machine-readable representation of the identification data. [Additional note 4] 4. The device of claim 3, wherein the optical, machine-readable representation of the identification data comprises a two-dimensional barcode. [Additional note 5] 5. The apparatus of any one of clauses 1 to 4, wherein the output device includes a transmitter configured to wirelessly transmit the identification data to the electronic device. [Additional note 6] The apparatus according to any one of appended items 1 to 5, in combination with the electronic device. [Additional note 7] 7. The apparatus of claim 6, wherein the electronic device is configured to execute an application that receives the identification data from the output device and sends a request for the label according to the identification data. [Additional note 8] The apparatus of claim 6, wherein the electronic device is configured to receive the identification data from the output device, request the label according to the identification data via a computer network, present the label to a user on a display, and execute an application that enables the user of the electronic device to instruct the controller to operate the pressure source to provide negative pressure to the wound dressing. [Additional note 9] 9. The apparatus of claim 8, wherein the electronic device is configured to execute an application that sends confirmation or verification of the presentation of the label on the display. [Additional Note 10] 10. The apparatus of any one of clauses 1 to 9, wherein the controller is configured to determine a location of the housing and automatically select the identification data from a plurality of identification data according to the location. [Additional Note 11] 11. The apparatus of any one of claims 1 to 10, wherein the controller is configured to deactivate the pressure source until the output device provides the identification data to the electronic device. [Additional Note 12] The electronic device is configured to communicate over a cellular communication network. 12. The device according to any one of claims 1 to 11, including a personal computer. [Additional Note 13] 1. A method of operating a wound therapy system, comprising: obtaining identification data from a memory device of the wound therapy device; outputting the identification data from the wound therapy device to an electronic device; receiving, by the electronic device, the identification data; generating, by the electronic device, a request from the identification data, the request being a request to access a label associated with the wound therapy device; sending the request by the electronic device to a remote database over a computer network; receiving the label via the computer network; and outputting the label for presentation to a user of the electronic device. [Additional Note 14] 14. The method of claim 13, further comprising transmitting confirmation or verification of the output via the computer network. [Additional Note 15] and wherein outputting the identification data comprises presenting the identification data as an optical, machine-readable representation of the identification data on a display of the negative pressure wound therapy device. 15. The method of claim 13 or 14, wherein receiving the identification data comprises receiving the identification data by an image sensor of the electronic device. [Additional Note 16] outputting the identification data includes wirelessly transmitting the identification data by a transmitter of the negative pressure wound therapy device; 16. The method according to any one of claims 13 to 15, wherein receiving the identification data comprises receiving the identification data by a receiver of the electronic device. [Additional Note 17] 17. The method according to any one of appended claims 13 to 16, wherein outputting the label includes displaying the label on a display of the electronic device. [Additional Note 18] 1. A device for applying negative pressure to a wound, comprising: a pressure source coupled to the wound dressing via a fluid flow path and configured to provide negative pressure to the wound dressing; a controller, Receives input data, determining a control value from the input data; a controller configured to adjust an action performed by the controller in accordance with the control value such that the action is performed differently than if the action were not performed in accordance with the control value. [Additional Note 19] 20. The apparatus of claim 18, wherein the controller is configured to send a verification or confirmation adjustment of the operation to a remote device via a computer network. [Additional Note 20] 20. The device of claim 18 or 19, wherein the control value indicates operation of a pressure source at an altitude above a threshold, and the operation is wound therapy performed using the pressure source. [Additional Note 21] 21. The device according to any one of claims 18 to 20, wherein the fluid flow path comprises a plurality of lumens. [Additional Note 22] 22. The device of any one of claims 18 to 21, wherein the sensor is configured to monitor the pressure in the wound dressing in one or more lumens of the fluid flow path or near the inlet of the pressure source. [Additional Note 23] 23. The apparatus of any one of clauses 18 to 22, wherein the controller is configured to start and stop the pressure source. [Additional note 24] 1. A device for applying pressure to a wound, comprising: Housing and a motion sensor supported by the housing and configured to output motion data indicative of motion of the housing; a pressure source supported by the housing, the pressure source coupled to a wound dressing disposed on a wound via a fluid flow path and configured to provide negative pressure to the wound; a controller, detecting an error condition associated with providing negative pressure to the wound with the pressure source; determining a cause of the error condition from the motion data; a controller configured to output an alert for presentation to a user notifying the user of the cause of the error condition. [Additional note 25] 25. The device of claim 24, wherein the error condition includes a blockage in the fluid flow path or a low pressure level in the wound. [Additional note 26] 26. The device of claim 24 or 25, wherein the controller is configured to determine an obstruction from flow in the fluid flow path or an activation level of the pressure source. [Additional note 27] 27. The device of any one of clauses 24 to 26, further comprising a canister supported by the housing and configured to collect fluid aspirated from the wound, and wherein the cause of the error condition is rotation of the housing, which is likely to cause the fluid to saturate a filter in the canister. [Additional note 28] 28. The device of any one of clauses 24 to 27, further comprising a canister supported by the housing and configured to collect fluid aspirated from the wound, and wherein the cause of the error condition is vibration of the housing causing the fluid to be likely to saturate a filter in the canister. [Additional note 29] 29. The apparatus of any one of clauses 24 to 28, wherein the controller is configured to output user instructions to the user indicating how to correct the cause of the error condition. [Additional note 30] 30. The device of claim 29, wherein the user instruction indicates replacing a filter in a canister, the canister being supported by the housing and configured to collect fluid aspirated from the wound. [Additional Note 31] 31. The apparatus of any one of clauses 24 to 30, wherein the controller is configured to output user instructions to a user indicating how to prevent future occurrences of the error condition. [Additional note 32] 32. The device of claim 31, wherein the user command indicates not to rotate the housing when detected from the motion. [Additional note 33] 33. The method of claim 24, wherein the controller is configured to operate the pressure source differently in response to detecting the error condition than before detecting the error condition. The device. [Additional note 34] 34. The device of any one of clauses 24 to 33, wherein the motion sensor includes an accelerometer. [Additional note 35] 35. The apparatus of any one of clauses 24 to 34, wherein the controller is configured to add an entry to a log indicating the occurrence of the error condition. [Additional note 36] 36. The apparatus of claim 35, wherein the controller is configured to determine a frequency of occurrence of the error condition from the log. [Additional note 37] 37. The apparatus of any one of clauses 24 to 36, wherein the controller is configured to operate the pressure source. [Additional note 38] 38. The device of any one of clauses 24 to 37, further comprising a display configured to visually present the alert to the user. [Additional note 39] 39. The device of any one of clauses 24 to 38, further comprising a speaker configured to audibly present the alert to the user. [Additional note 40] 1. A method of operating a wound therapy device, comprising: activating a pressure source of the wound therapy device to provide negative pressure to a wound dressing positioned on the wound via a fluid flow path, the pressure source being supported by a housing of the wound therapy device; generating motion data indicative of motion of the housing; detecting an error condition associated with providing negative pressure to the wound with the pressure source; determining a cause of the error condition from the motion data; outputting an alert for presentation to a user notifying the user of the cause of the error condition. [Additional note 41] 41. The method of claim 40, wherein the wound therapy device is a negative pressure therapy device. [Additional note 42] 42. The method of claim 40 or 41, wherein the wound therapy device includes a canister supported by the housing and configured to collect fluid aspirated from the wound, and the cause of the error condition is rotation of the housing, which is likely to cause the fluid to saturate a filter in the canister. [Additional note 43] 43. The method of any one of clauses 40 to 42, further comprising outputting user instructions to the user indicating how to correct the cause of the error condition. [Additional note 44] 44. The method of claim 43, wherein the user instruction indicates replacing a filter in a canister, the canister being supported by the housing and configured to collect fluid aspirated from the wound. [Additional note 45] 45. The method of any one of clauses 40 to 44, further comprising outputting user instructions to the user indicating how to prevent future occurrences of the error condition. [Additional note 46] 46. ​​The method of any one of clauses 40 to 45, further comprising operating the pressure source differently than determining the cause of the error condition.

Claims

1. 1. A device for applying negative pressure to a wound, comprising: Housing and a pressure source supported by the housing and coupled to a wound dressing placed on a wound via a fluid flow path, the pressure source configured to provide negative pressure to the wound; a controller supported by the housing, a controller configured to operate the pressure source to provide negative pressure to the wound; an output device supported by the housing and configured to output identification data to an electronic device, the identification data being an identifier of the device for applying negative pressure to a wound, the output device causing the electronic device to receive a label having information about the device for applying negative pressure to a wound from a remote database over a network and display the label on the electronic device; and Equipped with The controller: receiving confirmation that the electronic device has received the identification data; The apparatus is further configured to receive user input from the electronic device regarding operation of the apparatus to apply negative pressure to a wound.

2. The apparatus of claim 1 , wherein the output device comprises a display configured to display the identification data as an optical, machine-readable representation of the identification data.

3. The apparatus of claim 2 , wherein the optical, machine-readable representation of the identification data comprises a two-dimensional barcode.

4. The apparatus of any one of claims 1 to 3, wherein the output device comprises a transmitter configured to wirelessly transmit the identification data to the electronic device.

5. The apparatus of any one of claims 1 to 4, wherein the controller is configured to deactivate the pressure source until the output device provides the identification data to the electronic device.

6. A system comprising the apparatus according to any one of claims 1 to 5 and an electronic device.

7. The system of claim 6 , wherein the electronic device is configured to execute an application that receives the identification data from the output device and sends a request for the label to the remote database according to the identification data.

8. 8. The system of claim 6 or 7, wherein the identification data causes the electronic device to receive the label from the remote database over a computer network.

9. 8. The system of claim 7, wherein the electronic device is configured to receive the identification data from the output device, send a request for the label to the remote database via a computer network according to the identification data, display the label on the electronic device, and execute an application that enables a user of the electronic device to command the controller to operate the pressure source to provide negative pressure to the wound dressing.

10. 10. The system of claim 9, wherein the electronic device is configured to execute an application that transmits a code to the remote database for confirmation or verification of the display of the label on the electronic device.

11. The system of any one of claims 6 to 10, wherein the electronic device comprises a mobile personal computer configured to communicate over a cellular communications network.

12. 1. A method of operating a wound therapy system having a wound therapy device that applies negative pressure to a wound and an electronic device, comprising: the wound therapy device obtaining identification data from a memory device of the wound therapy device, the identification data being an identifier of the wound therapy device; the wound therapy device outputting the identification data from the wound therapy device to the electronic device; receiving the identification data by the electronic device; generating, by the electronic device, a request from the identification data, the request being a request to receive a label having information about the wound therapy device from a remote database and to display the label on the electronic device; sending the request by the electronic device to the remote database via a computer network; receiving the label from the remote database via the computer network by the electronic device; displaying the label by the electronic device for presentation to a user of the electronic device; receiving confirmation that the electronic device has received the identification data; transmitting, by the electronic device, user input to a wound therapy device regarding operation of the wound therapy device; A method comprising:

13. 13. The method of claim 12, further comprising the step of the electronic device transmitting a code to the remote database via the computer network for validation or verification of the label output.

14. wherein the step of outputting the identification data comprises presenting the identification data on a display of the wound therapy device as an optical, machine-readable representation of the identification data; 14. The method of claim 12 or 13, wherein said receiving said identification data comprises receiving said identification data by an image sensor of said electronic device.

15. the step of outputting the identification data includes a transmitter of the wound therapy device wirelessly transmitting the identification data; The method of any one of claims 12 to 14, wherein said receiving said identification data comprises receiving said identification data by a receiver of said electronic device.

Images