Changing treatment devices or wound dressings during reduced pressure wound therapy

Abstract

A device for applying negative pressure to a wound is disclosed. The device may include a housing, a pressure source, a canister, and a controller. The pressure source may be supported by the housing and provide negative pressure to a wound dressing located on the wound via a fluid flow path. The canister may collect exudate from the wound. The controller may monitor a parameter indicating that the pressure source provides negative pressure to the wound dressing, determine based on the parameter that the wound is treatable with a canister-free wound therapy device, and output a notification indicating that the wound is treatable with the canister-free wound therapy device for presentation to a user.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to UK Provisional Application No. 1820388.5 filed on December 14, 2018, the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0003] Embodiments of the present disclosure relate to methods and apparatus for dressing and treating wounds with negative pressure or reduced pressure therapy or topical negative pressure (TNP) therapy. In particular, but not limited to, 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

[0004] In some aspects, a device for applying negative pressure to a wound is disclosed. The device may include a housing, a pressure source, a canister, and a controller. The pressure source may be supported by the housing and provide negative pressure to a wound dressing located on the wound via a fluid flow path. The canister may be in fluid communication with the wound dressing via the fluid flow path and collect fluid from the wound. The controller may: monitor a parameter indicating that negative pressure is provided to the wound dressing with the pressure source, determine based on the parameter that the wound is treatable with a canister-free wound therapy device, and output a notification indicating that the wound is treatable with the canister-free wound therapy device for presentation to a user.

[0005] The device described in the previous paragraph may include one or more of the following features: The parameter may include one or more of the following: the duration of treatment delivered with the pressure source, the pressure in the fluid flow path, the flow rate in the fluid flow path, the blockage in the fluid flow path, the fill level of the wound dressing, the activity level of the pressure source, the fill level of the canister, the depth of the wound, or the frequency of exudate collection. The device may include a sensor to detect the parameter. The controller may determine that the wound is treatable with the canisterless wound treatment device based on the change in the parameter over time. The controller may determine that the wound is treatable with the canisterless wound treatment device based on the comparison of the parameter with a threshold value. The canister may be supported by the housing. The canisterless wound treatment device may include an accompanying pressure source and operate in combination with an accompanying wound dressing having a different fluid capacity than the wound dressing. The notification may include a visual indication, an audio indication, or a tactile indication. The device may include a display supported by the housing and presenting the notification. The controller may determine a prediction of exudate collection from the wound and output the prediction for presentation to the user. The controller may update the user's profile in response to determining that the wound is treatable with the canless wound therapy device. The parameters may include a flow rate in the fluid flow path and a pressure in the fluid flow path, and the controller may determine that the wound is treatable with the canless wound therapy device based on a comparison of the flow rate in the fluid flow path with a flow threshold and based on a comparison of a difference between the pressure in the fluid flow path and a pressure setting with a pressure threshold. The controller may determine that the wound is treatable with the canless wound therapy device based on information received about a patient having the wound. The controller may determine that the wound dressing is full of the fluid based on the parameters. The controller may output the notification wirelessly to an electronic device.

[0006] A method of making or operating the apparatus described in the preceding two paragraphs is disclosed.

[0007] In some aspects, a method of operating a wound treatment device is disclosed. The method may include: collecting fluid from a fluid flow path by a canister in fluid communication with a wound dressing located on a wound via the fluid flow path; monitoring a parameter indicating that a pressure source is used to provide negative pressure to the wound dressing; determining that the wound is treatable with a canless wound treatment device based on the parameter; and outputting a notification indicating that the wound is treatable with the canless wound treatment device for presentation to a user.

[0008] The method described in the preceding paragraph may include one or more of the following features: The parameter may include one or more of the following: duration of treatment delivered with the pressure source, pressure in the fluid flow path, flow rate in the fluid flow path, blockage in the fluid flow path, fill level of the wound dressing, activity level of the pressure source, fill level of the canister, depth of the wound, or frequency of exudate collection. The method may also include detecting the parameter with a sensor. The determining may include determining that the wound is treatable with the canisterless wound therapy device based on changes in the parameter over time. The determining may include determining that the wound is treatable with the canisterless wound therapy device based on a comparison of the parameter with a threshold value. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Features and advantages of the present disclosure will become apparent by considering the following detailed description in conjunction with the accompanying drawings, in which:

[0010] Figure 1 A wound treatment system is shown.

[0011] Figure 2A , 2B and 2C show the pump assembly and tank.

[0012] Figure 3 A schematic diagram of the electrical components of the pump assembly is shown.

[0013] Figure 4 A process for monitoring wound status and determining a treatment plan is shown.

[0014] Figure 5 A method for use with a pump assembly (e.g. Figure 3 A tank for use with a pump assembly).

[0015] Fig. 6A and 6B A canisterless pump assembly is shown connected to different wound dressings.

[0016] Figure 7 A non-negative pressure therapy wound dressing is shown.

[0017] Fig. 8A and 8B A notification screen that may be presented in a wound therapy system is shown. DETAILED DESCRIPTION

[0018] The present disclosure relates to methods and apparatus for dressing and treating wounds with reduced pressure therapy or topical negative pressure (TNP) therapy. In particular, but not limited to, 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 apparatus may include or implement any combination of the features described below.

[0019] Many different types of wound dressings are known for aiding the healing process of humans or animals. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads or multi-layer wound dressings. TNP therapy is sometimes referred to as vacuum assisted closure, negative pressure wound therapy or reduced pressure wound therapy, which may be a beneficial mechanism for promoting the healing rate of wounds. This therapy is suitable for a wide range of wounds, such as incisions, open wounds and abdominal wounds, etc.

[0020] TNP therapy can help close and heal wounds by: reducing tissue edema; promoting blood flow; stimulating the formation of granulation tissue; removing excess exudate, and reducing bacterial load, and therefore wound infection. Furthermore, TNP therapy can allow the wound to be less disturbed by external factors, promoting more rapid healing.

[0021] As used herein, a reduced pressure level or negative pressure level (such as -X mmHg) represents a pressure level below atmospheric pressure, which generally corresponds to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Therefore, a negative pressure value of -X mmHg reflects a pressure below atmospheric pressure X mmHg, such as a pressure of (760-X) mmHg. In addition, a negative pressure that is "less" or "smaller" than -X mmHg corresponds to a pressure that is closer to atmospheric pressure (e.g., -40 mmHg is smaller than -60 mmHg). A negative pressure that is "more" or "larger" than -X mmHg corresponds to a pressure that is further away from atmospheric pressure (e.g., -80 mmHg is larger than -60 mmHg).

[0022] Figure 1 A negative pressure or reduced pressure wound therapy (or TNP) system 100 is shown, which includes a wound filler 130 placed inside a wound cavity 110, which is sealed by a wound cover 120. The wound filler 130 and the wound cover 120 in combination can be referred to as a wound dressing. A single-lumen or multi-lumen tube or conduit 140 connects the wound cover 120 to a pump assembly 150, which is configured to supply a reduced pressure. The wound cover 120 can be in fluid communication with the wound cavity 110.

[0023] In the systems disclosed herein, the pump assembly 150 may be a canisterless pump assembly (which, in addition to its usual meaning, may also mean that exudate removed by the canisterless pump assembly is collected in the wound dressing rather than by an accompanying canister for collecting exudate), or used in combination with a canister for collecting exudate removed by the pump assembly 150. In addition, the pump assembly may be mounted to or supported by the wound dressing, or adjacent to the wound dressing.

[0024] The wound filler 130 may be of any suitable type, for example, a hydrophilic or hydrophobic foam, gauze, an inflatable bag, etc. The wound filler 130 may be conformable to the wound cavity 110 such that it substantially fills the cavity. The wound cover 120 may provide a substantially fluid-impermeable seal over the wound cavity 110. The wound cover 120 may have a top side and a bottom side, with the bottom side adhesively (or in any other suitable manner) sealed to the wound cavity 110. The conduit 140 or lumen or any other conduit or lumen disclosed herein may be formed of polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0025] Some embodiments of the wound cover 120 may have a port (not shown) configured to receive an end of the conduit 140. For example, the port may be a Renays Soft Port available from Smith & Nephew. In other embodiments, the conduit 140 may otherwise pass through or under the wound cover 120 to supply reduced pressure to the wound cavity 110 so as to maintain a desired reduced pressure level in the wound cavity. The conduit 140 may be any suitable article configured to provide an at least substantially sealed fluid flow path between the pump assembly 150 and the wound cover 120 so as to supply the reduced pressure provided by the pump assembly 150 to the wound cavity 110.

[0026] The wound cover 120 and wound filler 130 may be provided as a single article or in an integral single unit. In some aspects, no wound filler is provided, and the wound cover itself may be considered a wound dressing. The wound dressing may then be connected to a negative pressure source, such as a pump assembly 150, via a conduit 140. The pump assembly 150 may be miniaturized and portable, but larger conventional pumps may also be used.

[0027] The wound cover 120 may be positioned over a wound site to be treated. The wound cover 120 may form a substantially sealed cavity or enclosure over the wound site. In some aspects, the wound cover 120 may be configured with a membrane having a high water vapor permeability to enable excess fluid to evaporate, and may have a superabsorbent material contained therein to safely absorb wound exudate. It will be appreciated that throughout this specification, reference is made to wounds. In this sense, it will be understood that the term wound is to be broadly interpreted as, and encompasses, open wounds and closed wounds, where the skin is torn, cut or punctured, or where trauma has caused a contusion, or any other superficial or other condition or defect on the patient's skin, or those wounds that would benefit from reduced pressure treatment. Thus, a wound is broadly defined as any damaged tissue area where fluid may or may not be produced. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical and other incisions, subacute and dehiscent wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure sores, ostomies, surgical wounds, traumatic and venous ulcers, etc. The components of the TNP system described herein may be particularly suitable for incisional wounds that shed small amounts of wound exudate.

[0028] In some aspects, configuring pump assembly 150 and catheter 140 so that catheter 140 can be quickly and easily removed from pump assembly 150 can facilitate or improve the process of dressing or pump replacement, if necessary. Pumps disclosed herein can be configured with any suitable connection between tubing and the pump.

[0029] In some embodiments, the pump assembly 150 can be configured to deliver a negative pressure of about -80 mmHg, or about -20 mmHg to -200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure, so -200 mmHg will actually be about 560 mmHg. The pressure range can be between about -40 mmHg and -150 mmHg. Alternatively, a pressure range of up to -75 mmHg, up to -80 mmHg, or above -80 mmHg can be used. In addition, a pressure range below -75 mmHg can be suitable. Alternatively, the pump assembly 150 can supply a pressure range above about -100 mmHg or even -150 mmHg.

[0030] In operation, the wound filler 130 is inserted into the wound cavity 110 and the wound cover 120 is placed to seal the wound cavity 110. The pump assembly 150 provides a negative pressure source to the wound cover 120, which is transmitted to the wound cavity 110 via the wound filler 130. Fluid (e.g., wound exudate) can be drawn into the wound cover 120, the wound filler 130, or another absorbent layer (not shown) and stored or passed through the conduit 140 and stored in a canister.

[0031] Wound dressings that can be used with the pump assembly and other aspects of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Other descriptions of such wound dressings and other components of the negative pressure wound therapy system that can be used with the pump assembly and other aspects 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 herein by reference in their entirety. In other aspects, other suitable wound dressings can be used.

[0032] Figure 2A A front view of a pump assembly 230 and canister 220 is shown. As shown, the pump assembly 230 and canister 220 are connected to form a wound treatment device. The pump assembly 230 can be similar or identical to the pump assembly 150.

[0033] The pump assembly 230 includes one or more indicators, for example, an indicator 202 configured to visually indicate an alarm and an indicator 204 configured to visually indicate the status of the TNP system. The indicators 202, 204 can be configured to alert a user (e.g., a patient or a medical care provider) of various operating or fault conditions, including alerting the user to a normal or correct operating state, a pump failure, power supply to the pump or power failure, detection of a leak in the wound cover or flow path, a suction blockage, or any other similar or suitable state or combination thereof. The pump assembly 230 can include additional indicators. The pump assembly 230 can use a single indicator or multiple indicators. Any suitable indicator can be used, such as visual, audio, tactile indicators, etc. The indicator 202 can be configured to signal an alarm state, such as a full tank, low power, disconnected catheter 140, a broken seal in wound seal 120, etc. The indicator 202 can be configured to display a flashing red light to attract the user's attention. The indicator 204 may be configured to signal the status of the TNP system, such as treatment delivery is normal, a leak is detected, etc. The indicator 204 may be configured to display one or more different colors of light, such as green, yellow, etc. For example, green light may be emitted when the TNP system is operating properly, and yellow light may be emitted to indicate a warning.

[0034] The pump assembly 230 includes a display or screen 206 mounted in a recess 208 formed in the housing of the pump assembly. The display 206 may be a touch screen display. The display 206 may support playback of audio-visual (AV) content, such as an instructional video. As described below, the display 206 may be configured to present multiple screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the TNP system. The pump assembly 230 includes a gripping portion 210 formed in the housing of the pump assembly. The gripping portion 210 may be configured to assist a user in holding the pump assembly 230, such as during removal of the tank 220. The tank 220 may be replaced by another tank, such as when the tank 220 is filled with fluid.

[0035] The pump assembly 230 includes one or more keys or buttons 212, which are configured to allow a user to operate and monitor the operation of the TNP system. As shown, three buttons 212a, 212b, and 212c are included. Button 212a can be configured as a power button to turn on / off the pump assembly 230. Button 212b can be configured as a play / pause button for delivering negative pressure therapy. For example, pressing button 212b can cause the therapy to start, and pressing button 212b can then cause the therapy to pause or end. Button 212c can be configured to lock the display 206 or button 212. For example, button 212c can be pressed so that the user does not inadvertently change the delivery of the therapy. Button 212c can be pressed to unlock the control. In other aspects, additional buttons can be used, or one or more of the buttons 212a, 212b, or 212c shown can be omitted. Multiple key presses or key sequences can be used to operate the pump assembly 230.

[0036] The pump assembly 230 includes one or more latch recesses 222 formed in the cover. As shown, two latch recesses 222 may be formed on the side of the pump assembly 230. The latch recesses 222 may be configured to allow the canister 220 or another canister to be attached and detached using one or more latches 221. The pump assembly 230 includes an air outlet 224 for allowing air removed from the wound cavity 110 to escape. The air entering the pump assembly may pass through one or more suitable filters, such as an antibacterial filter. This can maintain the reusability of the pump assembly. The pump assembly 230 includes one or more belt mounts 226 for connecting a carrying belt to the pump assembly 230 or for attaching a bracket. Two belt mounts 226 may be formed on the side of the pump assembly 230. In some aspects, various of these features are omitted, or various additional features are added to the pump assembly 230.

[0037] The canister 220 is configured to hold fluid removed from the wound cavity 110. The canister 220 includes one or more latches 221 for attaching the canister to the pump assembly 230. The canister 220 may include two latches 221 on the side of the canister. The exterior of the canister 220 may be formed of frosted plastic so that the canister is substantially opaque and the canister and contents are substantially hidden from a plan view. The canister 220 includes a gripping portion 214 formed in the shell of the canister. The gripping portion 214 may be configured to allow a user to hold the pump assembly 230, such as during removal of the canister from the pump assembly 230. The canister 220 includes a substantially transparent window 216, which may also include volume scales. For example, the canister 220 has a fluid capacity of 300 mL and includes scales of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. Other aspects of the canister may hold different volumes of fluid and may include different scales. For example, Figure 5 The canister 500 shown in the figure can be used in place of the canister 220 with the pump assembly 230, and the canister 500 has an 800 mL fluid capacity canister with graduations from 50 mL to 800 mL in 50 mL increments. The canister 220 includes a tubing channel 218 for connecting to the catheter 140. In some aspects, various of these features (e.g., the gripping portion 214) are omitted, or various additional features are added to the canister 220. Any of the disclosed canisters may include or may omit a curing agent.

[0038] Figure 2B A rear view of a pump assembly 230 and a tank 220 is shown. The pump assembly 230 includes a speaker port 232 for generating sound. The pump assembly 230 includes a filter access door 234 having a screw 235 for removing the access door 234, accessing and replacing one or more filters (e.g., antibacterial or deodorizing filters). The pump assembly 230 includes a gripping portion 236 formed in the housing of the pump assembly. The gripping portion 236 may be configured to allow a user to hold the pump assembly 230, such as during the removal of the tank 220. The pump assembly 230 includes one or more covers 238 configured as screw covers or feet or protectors for placing the pump assembly 230 on a surface. The cover 230 may be formed of rubber, silicone, or any other suitable material. The pump assembly 230 includes a power socket 239 for charging and recharging the internal battery of the pump assembly. The power socket 239 may be a direct current (DC) socket. In some aspects, the pump assembly may include a disposable power source, such as a battery, so that a power socket is not required.

[0039] The tank 220 includes one or more feet 244 for placing the tank on a surface. The feet 244 may be formed of rubber, silicone, or any other suitable material, and may be angled at a suitable angle so that the tank 220 remains stable when placed on a surface. The tank 220 includes a tube mounting release 246 configured to allow one or more tubes to leave the front of the device. The tank 220 includes a rack or bracket 248 for supporting the tank when it is placed on a surface. As described below, the bracket 248 may pivot between an open position and a closed position. In the closed position, the bracket 248 may be latched to the tank 220. The bracket 248 may be made of an opaque material such as plastic, or a transparent material. The bracket 248 includes a gripping portion 242 formed in the bracket. The gripping portion 242 may be configured to allow a user to place the bracket 248 in a closed position. The bracket 248 includes a hole 249 to allow a user to place the bracket in an open position. The hole 249 may be sized to allow a user to extend the bracket using a finger.

[0040] Figure 2C A view of the pump assembly 230 separated from the canister 220 is shown. The pump assembly 230 includes a vacuum attachment, connector, or inlet 252 through which the vacuum pump transmits negative pressure to the canister 220. The pump assembly aspirates fluid, such as gas, from the wound through the inlet 252. The pump assembly 230 may include an access door 256 configured to allow access to one or more serial, parallel, or hybrid data transmission interfaces, such as USB, SD, compact disk (CD), DVD, FireWire, Thunderbolt, PCI Express, etc. Additionally or alternatively, one or more serial, parallel, or hybrid data transmission connector interfaces may be accessed through the access door 234. The connector interface may be a connector port.

[0041] Figure 3 Pump assembly 300 is shown, for example, an electrical component schematic diagram of pump assembly 230. The electrical component is operable to accept user input, provide output to the user, operate pump system and TNP system, provide network connection, etc. The electrical component can be installed on one or more printed circuit boards (PCBs), and the printed circuit board mechanically supports the electronic components and uses conductive tracks, pads and other features of copper sheet etching laminated to non-conductive substrates to electrically connect the electronic components. For example, components such as capacitors, resistors or active devices can be welded on the PCB or embedded in the substrate. The PCB can be single-sided (a copper layer), double-sided (two copper layers) or multilayer (outer layer and inner layer), and the conductors on different layers can be connected with through holes. As shown in the figure, the pump assembly may include multiple processors.

[0042] The pump assembly may include a user interface processor or controller 310, which may serve as a main processor and is configured to operate one or more components for accepting user input and providing output to the user, such as display 206, button 212, etc. Input to and output from the pump assembly may be controlled by an input / output (I / O) module 320. For example, the I / O module 320 may receive data from one or more ports, such as serial, parallel, hybrid ports, etc. The processor 310 also receives data from and provides data to one or more expansion modules 360, such as one or more USB ports, SD ports, CD drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, etc. The processor 310, along with other controllers or processors, stores data in one or more memory modules 350, which may be internal and / or external to the processor 310. Any suitable type of memory may be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, magnetoresistive random access memory (MRAM), etc.

[0043] The processor 310 can be a general purpose controller (e.g., a low power processor) or a dedicated processor. The processor 310 can be configured as a "central" processor in the electronic architecture of the pump assembly, and the processor 310 can coordinate the activities of other processors, such as a pump control processor 370, a communication processor 330, and one or more additional processors 380 (e.g., a processor for controlling the display 206, a processor for controlling the buttons 212, etc.). The processor 310 can run a suitable operating system, such as Linux, Windows CE, VxWorks, etc.

[0044] The processor 310 may communicate with and receive sensor data from one or more sensors 362. The one or more sensors 362 may include a pressure sensor, a flow rate sensor, an optical sensor, a magnetic field sensor, an inductive sensor, and the like. The sensor data from the one or more sensors 362 may be used by the processor 310 to monitor one or more parameters indicative of treatment progress, wound status, information about fluid from the wound, and other information. The one or more sensors 362 may be positioned in the housing of the pump assembly 300, proximate to a fluid flow path connecting the pump assembly 300 to a wound dressing, in or around a wound dressing used in combination with the pump assembly 300, or at another suitable location to detect activity of the pump assembly 300 or information indicative of treatment or status of the wound.

[0045] The pump control processor 370 can be configured to control the operation of a pump 390 (e.g., a negative pressure pump). The pump 390 can be a suitable pump, such as a diaphragm pump, a peristaltic pump, a rotary pump, a rotary vane pump, a scroll pump, a screw pump, a liquid ring pump, a diaphragm pump operated by a piezoelectric transducer, a voice coil pump, etc. The pump control processor 370 can measure the pressure in the fluid flow path using data received from one or more pressure sensors (e.g., one or more sensors 362), calculate the rate of fluid flow, and control the pump. The pump control processor 370 can control the pump motor so that a desired negative pressure level is achieved in the wound cavity 110. The desired negative pressure level can be a pressure set or selected by a user. The pump control processor 370 controls the pump (e.g., a pump motor) using pulse width modulation (PWM). The control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump control processor 370 can perform flow rate calculations and detect various conditions in the flow path. The pump control processor 370 can transmit information to the processor 310. The pump control processor 370 may include internal memory or may utilize the memory 350. The pump control processor 370 may be a low power processor.

[0046] The communication processor 330 can be configured to provide a wired or wireless connection. The communication processor 330 can use one or more antennas 340 to send and receive data. The communication processor 330 can provide one or more of the following types of connections: global positioning system (GPS) technology, cellular connection (e.g., 2G, 3G, LTE, 4G), WiFi connection, Internet connection, etc. The connection can be used for various activities, such as pump component location tracking, asset tracking, compliance monitoring, remote selection, log upload, alarm and other operational data, as well as adjustment of treatment settings, software or firmware upgrades, etc. The communication processor 330 can provide dual GPS / cellular functionality. The cellular function can be, for example, 3G function. The pump component can include a SIM card, and SIM-based location information can be obtained.

[0047] The communication processor 330 may also be electrically coupled to one or more serial, parallel, or hybrid data transmission connector interfaces, through which the communication processor 330 may directly receive data or commands without passing through or receiving data or commands from the processor 310. For example, the data transmission connector interface may include one or more USB ports, SD ports, CD drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, etc.

[0048] The communication processor 330 may communicate information to and receive information from the processor 310. The communication processor 330 may include internal memory or may utilize the memory 350. The communication processor 330 may be a low power processor.

[0049] Using the connection provided by the communication processor 330, the device can upload any data stored, maintained or tracked by the pump assembly. The device can also download various operational data, such as treatment selections and parameters, firmware and software patches and upgrades, etc.

[0050] Figure 4 A process 400 is shown for supporting wound treatment by automatically determining a treatment plan for a wound. The process 400 can be applied to any of the pump assemblies described herein, other pump assemblies, or other wound treatment devices. In certain aspects, the process 400 can advantageously provide information about the nature of a wound or the progress of wound healing during wound treatment, and be used to alert an individual to negative or positive developments in a wound, and enable informed and timely decisions regarding treatment.

[0051] At block 402, application of negative pressure can be controlled. For example, the pump control processor 370 can control the generation and application of negative pressure with the pump 390. The pressure can be provided as part of a wound therapy for treating a wound, and a wound dressing can be positioned over the wound and in fluid communication with the pump 390 as described herein.

[0052] At box 404, the pump assembly can monitor one or more parameters indicative of the negative pressure provided to the wound dressing. The one or more parameters may include: pressure in a flow path connecting the wound dressing to the pump assembly, flow rate in the flow path, blockage in the flow path, dressing fill rate or amount, tank fill rate or amount, duration of treatment with the pump assembly, pump activity level of the pump assembly, depth of the wound, fluid viscosity in the flow path, tissue granulation at the wound, tissue tunneling at the wound, or other patient information and other possible conditions. The one or more parameters can indicate the progress of healing of a wound treated with the wound dressing and can be used to monitor and predict the release of fluid from the wound or the healing of the wound during treatment. For example, the processor 310 can monitor the one or more parameters based on sensor data collected by the one or more sensors 362 during the provision of negative pressure with the pump 390, during wound treatment, or at other times.

[0053] At block 406, a treatment plan for the wound may be determined based on one or more parameters (e.g., using one, two, three, four, or more different parameters). The treatment plan may be determined based on a comparison of (i) one or more parameters or (ii) changes in one or more parameters over time to a threshold, parameter model, or parameter pattern, among other possibilities. The threshold, parameter model, or parameter pattern may depend on patient or wound information (e.g., information provided by a caregiver, such as wound size, depth, or color) or treatment device information (e.g., canister size or treatment settings).

[0054] For example, the comparison can be used to characterize the current condition of the wound or changes in the condition of the wound over time. When the wound is characterized as being healing or likely to be emitting less exudate, the treatment plan can include positive progress recommendations, such as one or more of the following: (i) changing the size of the can used to treat the wound, such as by changing the can size from Figure 5 The tank is reduced to 500 Figure 2A (ii) changing the pressure source used to treat the wound, such as by reducing the size or power of the pressure source; (iii) from using a pump assembly and a canister (e.g., Figure 2A The pump assembly 230 and canister 220) of the present invention is changed to treating the wound with a canister-free treatment device (e.g., Fig. 6A or the tankless pump assembly system 600A, 600B shown in 6B, or Figure 7 (iv) changing the size of the wound dressing used to treat the wound, for example by changing the size of the wound dressing from Fig. 6A The size shown in Figure 6B (v) ceasing to apply further pressure to the wound with the pressure source, such as by removing the pressure source from the wound with Figure 6B The tankless pump assembly system 600B treatment transition to use Figure 7 ; (vi) starting or stopping the use of a medical device other than a pump assembly and using the pump assembly to treat the wound; or (vii) changing the treatment schedule or pressure setting of the pump assembly when the pump assembly is used to treat the wound, among other possibilities. When the wound is characterized as not healing or as likely to exude more exudate, the treatment plan may include enhanced treatment recommendations, such as one or more of the following: (i) changing the canister size used to treat the wound, such as by changing the canister size from Figure 2A The tank 220 is increased to Figure 5 (ii) changing the pressure source used to treat the wound, such as by increasing the size or power of the pressure source; (iii) changing from using a canisterless pump assembly (e.g., Fig. 6A or 6B) to treat wounds with a pump assembly and a canister (e.g., Figure 2A(iv) changing the size of a wound dressing used to treat the wound, such as by changing the size of the wound dressing from Figure 6B The size shown in Fig. 6A ; (v) continue to apply further pressure to the wound with the pressure source beyond the scheduled end time; (vi) start or stop using a medical device other than the pump assembly and using the pump assembly to treat the wound; or (vii) change the treatment schedule or pressure setting of the pump assembly when the pump assembly is used to treat the wound, among other possibilities. The treatment plan can indicate an action that may be desired to be taken at the current time or at some time in the future, so that a plan or consideration can be made to prepare for the action. The processor 310 can determine the treatment plan, for example, based on one or more parameters.

[0055] In one example, where one or more parameters may include flow rate, a relatively high flow rate may indicate a large amount of exudate collection, while a relatively low flow rate may indicate a smaller amount of exudate collection. Therefore, the magnitude of the flow rate or the change in flow rate over time may be used to determine the amount of exudate collected from the wound and the change or trend of the exudate collection. If the amount, change or trend indicates that the wound is healing or may discharge less exudate from the wound (e.g., if the flow rate of the fluid in the fluid flow path is less than 20, 30, 40, 50, 60, 70, 80 or 100 mL / day), the treatment plan may include one or more active progress suggestions. If the amount, change or trend indicates that the wound is no longer healing or may discharge more exudate from the wound (e.g., if the flow rate of the fluid in the fluid flow path is at least 20, 30, 40, 50, 60, 70, 80 or 100 mL / day), the treatment plan may include one or more enhanced treatment suggestions.

[0056] In another example, where one or more parameters may include a dressing fill rate or a canister fill rate, a relatively high fill rate may indicate a large amount of exudate collection, while a relatively low fill amount may indicate a smaller amount of exudate collection. Thus, the magnitude of the fill rate or the change in fill rate over time may be used to determine the amount of exudate collected from the wound and the change or trend in exudate collection. If the amount, change or trend indicates that the wound is healing or may be discharged from the wound less exudate (e.g., if the fill rate is less than 20, 30, 40, 50, 60, 70, 80 or 100 mL / day, or expected to be changed 1 or 2 times a week for dressings or canisters), the treatment plan may include one or more positive progress suggestions. If the amount, change or trend indicates that the wound is not healing or may be discharged from the wound more exudate (e.g., if the fill rate is at least 20, 30, 40, 50, 60, 70, 80 or 100 mL / day, or expected to be changed at least 3 times a week for dressings or canisters), the treatment plan may include one or more enhanced treatment suggestions.

[0057] As another example, where one or more parameters may include a pump activity level, a relatively high activity level of a fixed speed pump may indicate a large amount of exudate collection, while a relatively low activity level of a fixed speed pump may indicate a smaller amount of exudate collection. Thus, the magnitude of the speed of the pump or the change in the magnitude of the speed of the pump over time may be used to determine the amount of exudate collected from the wound and the change or trend in the exudate collection. If the amount, change, or trend indicates that the wound is healing or that less exudate may be discharged from the wound, the treatment plan may include one or more positive progress recommendations. If the amount, change, or trend indicates that the wound is not healing or that more exudate may be discharged from the wound, the treatment plan may include one or more enhanced treatment recommendations.

[0058] In another example, where one or more parameters may include the depth of the wound, a relatively deep wound may indicate a large amount of exudate collection, while a relatively shallow wound may indicate a smaller amount of exudate collection. Thus, the depth of the wound or changes in the depth of the wound over time may be used to determine the amount of exudate collected from the wound and changes or trends in the exudate collection. If the amount, change, or trend indicates that the wound is healing or that less exudate may be discharged from the wound (e.g., if the wound depth is determined to be less than 1.0, 1.2, 1.4, 1.5, 1.6, 1.8, 2.0, 2.2, 2.4, 2.5, 2.6, 2.8, or 3.0 cm), the treatment plan may include one or more positive progress recommendations. If the amount, change, or trend indicates that the wound is not healing or that more exudate may be discharged from the wound (e.g., if the wound depth is determined to be at least 1.0, 1.2, 1.4, 1.5, 1.6, 1.8, 2.0, 2.2, 2.4, 2.5, 2.6, 2.8, or 3.0 cm), the treatment plan may include one or more enhanced treatment recommendations.

[0059] Information about the start and duration of treatment can be stored in a memory, such as memory 350. Similarly, information about the frequency and amount of exudate collected can be stored in a memory, such as memory 350. Such information can be used to prepare an initial treatment plan and then update the treatment plan. For example, based on the start date of treatment and other information about the patient or his wound (e.g., patient age, weight, height, gender, medical history, expected patient activity level, location of the wound, treatment settings, etc.), an initial treatment plan can be prepared. This initial treatment plan can then be adjusted based on a comparison with one or more parameters.

[0060] At block 408, the pump assembly can output a notification indicating the treatment plan. The notification can include one or more positive progress recommendations, one or more enhanced treatment recommendations, or indicate the availability of a treatment plan determined based on one or more parameters (e.g., for viewing by a caregiver rather than the patient, so that the patient can be made aware of the need for attention rather than being directly informed of the details of the treatment plan). The notification can be output, for example, via a display (e.g., Figure 2A 206), the indicator lights of the pump components (such as Figure 2A The notification may be output for storage in a memory, such as memory 350, or output to another electrical device via a communication interface, such as output to a computer, server, or smartphone via a computer network or other communication.

[0061] Fig. 8A A notification screen 800A is shown. The notification screen 800A may be used to display a notification of a treatment plan as described with reference to block 408 of process 400. The notification screen 800A may present a treatment plan message 810A, which may indicate that the pump assembly has determined a treatment plan for display. The treatment plan message 810A may not specifically indicate what treatment plan has been determined, but may indicate to consult a caregiver. The notification screen 800A may include a menu 820 for navigating to other screens, such as for controlling the application of pressure.

[0062] Figure 8B A notification screen 800B is shown. The notification screen 800B may be used to display notifications of a treatment plan as described with reference to block 408 of process 400. The notification screen 800B may present a progress message 810B that may provide a positive progress recommendation, such as that treatment may be transitioned from using a pump assembly and a canister to using a canister-free treatment device. The progress message 810B may also provide one or more reasons for the positive progress recommendation, such as an indication that the fluid flow rate has met a threshold for using a canister-free treatment device.

[0063] Any values ​​of threshold values, limits, durations, etc. provided herein are not intended to be absolute values, and therefore may be approximate values. In addition, any threshold values, limits, durations, etc. provided herein may be fixed or automatically or changed by a user. In addition, relative terms such as exceeding, greater than, less than, etc. relative to a reference value as used herein are intended to also encompass equal to a reference value. For example, exceeding a positive reference value may include being equal to or greater than a reference value. In addition, relative terms such as exceeding, greater than, less than, etc. relative to a reference value as used herein are also intended to encompass the opposite of the disclosed relationship, such as being lower than, less than, greater than, etc. relative to a reference value. In addition, although the boxes of various processes may be described in terms of determining whether a value meets or does not meet a particular threshold, these boxes may be understood similarly, for example, in terms of values ​​(i) being lower than or higher than a threshold or (ii) meeting or not meeting a threshold.

[0064] Features, materials, characteristics or combinations described in conjunction with a particular aspect, embodiment or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except for combinations where at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiments. Protection extends to any novelty or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novelty or any novel combination of steps of any method or process so disclosed.

[0065] Although certain embodiments have been described, these embodiments are presented only as examples and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein may be embodied in various other forms. In addition, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made. It will be appreciated by those skilled in the art that in some embodiments, the actual steps taken in the process shown or disclosed may be different from the steps shown in the accompanying drawings. According to an embodiment, some of the above steps may be removed and other steps may be added. For example, the actual steps or sequence of steps taken in the disclosed process may be different from those shown in the figure. According to an embodiment, some of the above steps may be removed and other steps may be added. For example, the various components shown in the figure may be implemented as software or firmware on a processor, a controller, an ASIC, an FPGA, or dedicated hardware. Hardware components such as a processor, an ASIC, an FPGA, etc. may include a logic circuit. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0066] Although the present disclosure includes certain embodiments, examples, and applications, those skilled in the art will appreciate 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 do not provide all of the features and advantages described herein. Therefore, the scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein, and may be limited by the claims set forth herein or claims set forth in the future.

[0067] Conditional language, such as "can", "may", "possibly", or "can", unless otherwise expressly stated or otherwise understood in the context of use, is generally intended to express that certain embodiments include (and other embodiments do not include) certain functions, elements, or steps. Therefore, such conditional language is generally not intended to imply that one or more embodiments require features, elements, or steps in any way, or that one or more embodiments must include logic for determining whether these features, elements, or steps are included in or executed in any particular embodiment with or without user input or prompting. The terms "include", "comprise", "have", etc. are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in its inclusive sense (rather than in its exclusive sense) so that when used, for example, to connect a list of elements, the term "or" represents one, some, or all of the elements in the list. In addition, in addition to having its ordinary meaning, the term "each" used herein can represent any subset of a set of elements to which the term "each" is applied.

[0068] Unless expressly stated otherwise, conjunctive language such as the phrase "at least one of X, Y, and Z" is understood in context as generally used to indicate that an item, term, etc. can be X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0069] Language of degree as used herein, such as the terms "about," "approximately," "substantially," and "roughly" as used herein, refers to a value, amount, or feature that is close to a stated value, amount, or feature that still performs a desired function or achieves a desired result. For example, the terms "about," "approximately," "substantially," and "roughly" may refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a specified amount. As another example, in certain embodiments, the terms "substantially parallel" and "roughly parallel" refer to a value, amount, or feature that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0070] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, and may be limited by the claims in this section or elsewhere in this specification or in the future. The language of the claims will be interpreted broadly based on the language employed in the claims, and not limited to examples described in this specification or during the prosecution of the application, which examples should be interpreted as non-exclusive.

Claims

1. A device for applying negative pressure to a wound, the device comprising: case; a pressure source supported by the housing and configured to provide negative pressure to a wound dressing positioned over the wound via the fluid flow path; a canister configured to be in fluid communication with the wound dressing via the fluid flow path and to collect fluid from the wound; as well as A controller, the controller being configured to: monitoring a parameter indicative of providing negative pressure to the wound dressing with the pressure source, wherein the parameter comprises a flow rate in the fluid flow path and a pressure in the fluid flow path, determining that the wound is treatable with a canless wound therapy device based on the parameters, wherein the controller is configured to determine that the wound is treatable with the canless wound therapy device based on a comparison of a flow rate in the fluid flow path with a flow threshold and based on a comparison of a difference between a pressure in the fluid flow path and a pressure setting with a pressure threshold, and A notification is output for presentation to a user indicating that the wound is treatable with the canisterless wound therapy device.

2. The apparatus of claim 1, wherein the parameters further comprise one or more of: duration of therapy delivered with the pressure source, blockage in the fluid flow path, fill level of the wound dressing, activity level of the pressure source, fill level of the canister, depth of the wound, or frequency of exudate collection.

3. The device according to claim 1 or 2, further comprising a sensor configured to detect the parameter.

4. The device according to claim 1 or 2, wherein the controller is further configured to determine that the wound can be treated with the canless wound treatment device based on the change of the parameter over time.

5. The apparatus of claim 1 or 2, wherein the tank is supported by the housing.

6. The device of claim 1 or 2, wherein the canisterless wound therapy device comprises an accompanying pressure source and is configured to operate in combination with an accompanying wound dressing having a different fluid capacity than the wound dressing.

7. The device of claim 1 or 2, wherein the notification comprises a visual indication, an audio indication, or a tactile indication.

8. The device of claim 1 or 2, further comprising a display supported by the housing and configured to present the notification.

9. The apparatus of claim 1 or 2, wherein the controller is configured to determine a prediction of exudate collection from the wound and output the prediction for presentation to the user.

10. The device of claim 1 or 2, wherein the controller is configured to update the user's profile in response to determining that the wound is treatable with the canisterless wound treatment device.

11. The device of claim 1 or 2, wherein the controller is configured to determine that the wound is treatable with the canless wound therapy device further based on information received about the patient having the wound.

12. The apparatus of claim 1 or 2, wherein the controller is configured to determine that the wound dressing is filled with the fluid based on the parameter.

13. The apparatus of claim 1 or 2, wherein the controller is configured to wirelessly output the notification to an electronic device.

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