Self-testing for negative pressure wound therapy devices

Abstract

A negative pressure wound therapy device can include a negative pressure source configured to be connected, via a fluid flow path, to a wound and a pressure sensor configured to measure in the fluid flow path. The device can include a control circuitry configured to perform a combined flow test and leak test irrespective of the size of a canister or wound dressing positioned in the fluid flow path. The control circuitry can be configured to perform an excessive pressure test.

Description

SELF-TESTING FOR NEGATIVE PRESSURE WOUND THERAPY DEVICESTechnical Field

[0001] Embodiments described herein relate to apparatuses, systems, and methods for the treatment of wounds, for example using dressings in combination with negative pressure wound therapy.Description of the Related Art

[0002] Many different types of wound dressings are known for aiding in the healing process of a human or animal. 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. Topical negative pressure (TNP) therapy, sometimes referred to as vacuum assisted closure, negative pressure wound therapy, or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving the healing rate of a wound. Such therapy is applicable to a broad range of wounds such as incisional wounds, open wounds, and abdominal wounds or the like. TNP therapy assists in the closure and healing of wounds by reducing tissue edema, encouraging blood flow, stimulating the formation of granulation tissue, removing excess exudates and may reduce bacterial load. Thus, reducing infection to the wound. Furthermore, TNP therapy permits less outside disturbance of the wound and promotes more rapid healing.SUMMARY

[0003] A negative pressure wound therapy device can include a negative pressure source configured to be connected, via a fluid flow path, to a wound covered by a wound dressing and supply negative pressure to the wound. The device can include at least one pressure sensor configured to measure pressure in the fluid flow path. The device can include a control circuitry configured to in a normal operational mode in which negative pressure can be provided to the wound, permit supply of negative pressure from the negative pressure source to the wound covered by the wound dressing. The control circuitry can be configured to in a test mode, in which performance of the device can be being verified, perform a combined flow test and leak test. The combined flow and leak test can include the control circuitry being configured to determine that at least one of a canister or the wound dressing has been positionedin the fluid flow path. The control circuitry can be configured to, in response to determining that at least one of the canister or the wound dressing has been positioned in the fluid flow path, activate the negative pressure source to establish a first negative pressure level in the fluid flow path, monitor a flow in the fluid flow path using at least one of measurements of the at least one pressure sensor or activity of the negative pressure source, and indicate that the flow test has been completed successfully in response to at least one of determining that the flow in the fluid flow path satisfies a flow threshold or that the first negative pressure level has been established in the fluid flow path. The control circuitry can be configured to, subsequent to at least one of determining that the flow in the flow path satisfies the flow threshold or the first negative pressure level has been established in the fluid flow path, pause operation of the negative pressure source for a first duration of time, monitor a negative pressure decay in the fluid flow path using measurements by the at least one pressure sensor, and indicate that the leak test has been completed successfully in response to determining that the negative pressure decay over a second duration of time subsequent to the first duration of time satisfies a negative pressure decay threshold.

[0004] The negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein can include one or more of the following features. The control circuitry can be configured to, in the test mode, perform an excessive pressure test by being configured to, subsequent to completion of the leak test, activate the negative pressure source to establish a second negative pressure level in the fluid flow path that exceeds the first negative pressure level and corresponds to an unsafe level of negative pressure and indicate that the excessive pressure test has been performed successfully in response to determining that the negative pressure source has been deactivated subsequent to establishing the second negative pressure level. The control circuitry can be configured to, in the test mode, perform the excessive pressure test subsequent to completion of the leak test and prior to pressure in the fluid flow path reaching atmospheric pressure. The control circuitry can be configured to determine that at least one of the canister or the wound dressing has been positioned in the fluid flow path in response to receiving data from at least one of the canister or the wound dressing. The control circuitry can be configured to determine a volume of at least one of the canister or the wound dressing from the data; and adjust a parameter of the flow test based on the volume, the parameter of the flow test including a timeduration for determining that the first negative pressure level has been established in the fluid flow path. The control circuitry can be configured to determine a volume of at least one of the canister or the wound dressing from the data and adjust a parameter of the leak test based on the volume. The parameter of the leak test can include the negative pressure decay threshold.

[0005] The negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein can include one or more of the following features. The control circuitry can be configured to, in the test mode, indicate that the flow test and the leak test have not been completed successfully in response to determining that the flow in the fluid flow path does not satisfy the flow threshold or that the first negative pressure level has not been established in the fluid flow path. The control circuitry can be configured to, in the test mode, provide an indication to a user to position at least one of the canister or the wound dressing in the fluid flow path. The indication can be a visual indication provided on a display. The control circuitry can be configured to, in the test mode, indicate that the flow test has been completed successfully in response to determining that an electric current provided to an actuator of the negative pressure source is indicative of the flow that satisfies the flow threshold. The device can include a flow restrictor positioned in the fluid flow path, wherein the at least one pressure sensor can be configured to measure a pressure differential across the flow restrictor. The control circuitry can be configured to, in the test mode, indicate that the flow test has been completed successfully in response to determining that the pressure differential across the flow restrictor is indicative of the flow that satisfies the flow threshold. The control circuitry can be configured to, in the test mode, operate the negative pressure source without operating any valve positioned in the fluid flow path.

[0006] The negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein can include one or more of the following features. The flow threshold can be indicative of a duration of time from activation of the negative pressure source to establishing the first negative pressure level in the fluid flow path. Determining that the flow in the fluid flow path satisfies the flow threshold can include determining that a duration of time from activation of the negative pressure source to providing peak electrical power to the negative pressure source satisfied the flow threshold. The control circuitry can determine that at least one of the canister or thewound dressing has not been positioned in the fluid flow path and terminate the test mode in response to determining that at least one of the canister or the wound dressing has not been positioned in the fluid flow path. The control circuitry can, subsequent to terminating the test mode, prevent the negative pressure source from supplying negative pressure wound therapy.

[0007] A negative pressure wound therapy device can include a negative pressure source configured to be connected, via a fluid flow path, to a wound covered by a wound dressing and supply negative pressure to the wound. The device can include at least one pressure sensor configured to measure pressure in the fluid flow path. The device can include a control circuitry configured to, in a normal operational mode, cause the negative pressure source to supply negative pressure to the wound. The control circuitry can be configured to, in a test mode in which performance of the device is being verified, determine that a canister has been positioned in the fluid flow path. The control circuitry can be configured to, in response to determining that the canister has been positioned in the fluid flow path, activate the negative pressure source to establish a first negative pressure level in the fluid flow path, monitor a flow in the fluid flow path using at least one of measurements of the at least one pressure sensor or activity of the negative pressure source, and indicate that a flow test has been completed successfully in response to at least one of determining that the flow in the fluid flow path satisfies a flow threshold or that the first negative pressure level has been established in the fluid flow path. The control circuitry can be configured to, subsequent to at least one of determining that the flow in the flow path satisfies the flow threshold or the first negative pressure level has been established in the fluid flow path and without allowing pressure in the fluid flow path to reach atmospheric pressure, pause operation of the negative pressure source for a first duration of time, monitor a negative pressure decay in the fluid flow path using measurements by the at least one pressure sensor, and indicate that a leak test has been completed successfully in response to determining that the negative pressure decay over a second duration of time subsequent to the first duration of time satisfies a negative pressure decay threshold.

[0008] The negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein can include one or more of the following features. The control circuitry can be configured to, in the test mode, subsequent to completion of the leak test, activate the negative pressure source to establish asecond negative pressure level in the fluid flow path that exceeds the first negative pressure level and corresponds to an unsafe level of negative pressure and indicate that an excessive pressure test has been performed successfully in response to determining that the negative pressure source has been deactivated subsequent to establishing the second negative pressure level. The control circuitry can be configured to, in the test mode, perform the excessive pressure test subsequent to completion of the leak test and prior to pressure in the fluid flow path reaching atmospheric pressure. The control circuitry can be configured to determine that the canister has been positioned in the fluid flow path in response to receiving data from the canister. The control circuitry can be configured to determine a volume of the canister from the data and adjust a parameter of the flow test based on the volume, the parameter of the flow test can include a time duration for determining that the first negative pressure level has been established in the fluid flow path.

[0009] The negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein can include one or more of the following features. The control circuitry can be configured to determine a volume the canister from the data and adjust a parameter of the leak test based on the volume, the parameter of the leak test can include the negative pressure decay threshold. The control circuitry can be configured to, in the test mode, indicate that the flow test and the leak test have not been completed successfully in response to determining that the flow in the fluid flow path does not satisfy the flow threshold or that the first negative pressure level has not been established in the fluid flow path. The control circuitry can be configured to, in the test mode, guide a user to position the canister in the fluid flow path. The control circuitry can be configured to, in the test mode, indicate that the flow test has been completed successfully in response to determining that a pressure differential measured by the at least one pressure sensor across a flow restrictor positioned in the fluid flow path is indicative of the flow that satisfies the flow threshold. The control circuitry can be configured to indicate that the flow test has been completed successfully in response to determining that an electric current provided to an actuator of the negative pressure source is indicative of the flow that satisfies the flow threshold. The control circuitry can be configured to, in the test mode, operate the negative pressure source without operating any valve positioned in the fluid flow path.

[0010] The negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein can include one or more of the following features. The flow threshold is indicative of a duration of time from activation of the negative pressure source to establishing the first negative pressure level in the fluid flow path. Determining that the flow in the fluid flow path satisfies the flow threshold can include determining that a duration of time from activation of the negative pressure source to providing peak electrical power to the negative pressure source satisfied the flow threshold. The control circuitry can determine that the canister has not been positioned in the fluid flow path and terminate the test mode in response to determining that the canister has not been positioned in the fluid flow path. The control circuitry can, subsequent to terminating the test mode, prevent the negative pressure source from supplying negative pressure wound therapy.

[0011] Disclosed are methods of operating a negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein. Discloses are kits that include the negative pressure wound therapy device of any of the preceding paragraphs and / or any of the devices, apparatuses, or systems disclosed herein and one or more wound dressings or canisters.

[0012] Any of the features, components, or details of any of the arrangements or embodiments disclosed in this application, including without limitation any of the apparatus embodiments and any of the negative pressure wound therapy embodiments disclosed herein, are interchangeably combinable with any other features, components, or details of any of the arrangements or embodiments disclosed herein to form new arrangements and embodiments.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 A illustrates a negative pressure wound therapy system.

[0014] Figure IB illustrates another negative pressure wound therapy system.

[0015] Figure 2A is an isometric view of a negative pressure wound therapy device and canister, showing the canister detached from the pump assembly of the device.

[0016] Figure 2B is a back view of the negative pressure wound therapy device shown in Figure 2 A.

[0017] Figure 2C illustrates a top surface of the negative pressure wound therapy device shown in Figure 2A, showing a user interface.

[0018] Figure 3 illustrates a schematic of a control system of a negative pressure wound therapy device.

[0019] Figure 4 illustrates another negative pressure wound therapy system.

[0020] Figure 5 illustrates a negative pressure wound therapy device configured to perform self-testing.

[0021] Figures 6 to 8 illustrate flow charts of various tests that can be performed by the negative pressure wound therapy device of Figure 5.

[0022] Figures 9 to 12 illustrates graphs associated with performing various tests by the negative pressure wound therapy device of Figure 5.DETAILED DESCRIPTION

[0023] Embodiments disclosed herein relate to systems and methods of treating and / or monitoring a wound. Some embodiments of the negative pressure wound therapy devices disclosed herein can include a negative pressure source configured to be connected and / or fluidically coupled, via a fluid flow path, to a wound covered by a wound dressing and provide negative pressure to a wound.

[0024] Throughout this specification reference is made to a wound. The term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, bums, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.

[0025] Embodiments of systems and methods disclosed herein can be used with topical negative pressure (“TNP”) or reduced pressure therapy systems. Briefly, negative pressure wound therapy assists in the closure and healing of many forms of “hard to heal” wounds by reducing tissue oedema, encouraging blood flow and granular tissue formation, orremoving excess exudate and can reduce bacterial load (and thus infection risk). In addition, the therapy allows for less disturbance of a wound leading to more rapid healing. TNP therapy systems can also assist in the healing of surgically closed wounds by removing fluid. TNP therapy can help to stabilize the tissue in the apposed position of closure. A further beneficial use of TNP therapy can be found in grafts and flaps where removal of excess fluid is important and close proximity of the graft to tissue is required in order to ensure tissue viability.

[0026] As used herein, reduced or negative pressure levels, such as -X mmHg, represent pressure levels relative to normal ambient atmospheric pressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure value of-X mmHg reflects pressure that is X mmHg below 760 mmHg or, in other words, a pressure of (760-X) mmHg. In addition, negative pressure that is “less” or “smaller” than X mmHg corresponds to pressure that is closer to atmospheric pressure (for example, -40 mmHg is less than -60 mmHg). Negative pressure that is “more” or “greater” than -X mmHg corresponds to pressure that is further from atmospheric pressure (for example, -80 mmHg is more than -60 mmHg). In some cases, local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.

[0027] Systems and methods disclosed herein can be used with other types of treatment in addition to or instead of reduced pressure therapy, such as irrigation, ultrasound, heat or cold, neuro stimulation, or the like. In some cases, disclosed systems and methods can be used for wound monitoring without application of additional therapy. Systems and methods disclosed herein can be used in conjunction with a dressing, including with compression dressing, reduced pressure dressing, or the like.

[0028] A healthcare provider, such as a clinician, nurse, or the like, can provide a TNP prescription specifying, for example, the pressure level or time of application. However, the healing process is different for each patient and the prescription may affect the healing process in a way the clinician or healthcare provider did not expect at the time of devising the prescription. A healthcare provider may try to adjust the prescription as the wound heals (or does not heal), but such process may require various appointments that can be time consuming and repetitive. Embodiments disclosed herein provide systems, devices, or methods of efficiently adjusting TNP prescriptions and delivering effective TNP therapy.Wound Therapy System

[0029] Figure 1A schematically illustrates a negative pressure wound treatment system 100 (sometimes referred to as a reduced or negative pressure wound therapy system, a TNP system, or a wound treatment system). In any implementations disclosed herein, though not required, the negative pressure wound treatment system 100 can include a wound filler 102 placed on or inside a wound 104 (which may be a cavity). The wound 104 can be sealed by a wound cover 106, which can be a drape, such that the wound cover 106 can be in fluidic communication with the wound 104. The wound filler 102 in combination with the wound cover 106 can be referred to as a wound dressing. A tube or conduit 108 (also referred to herein as a flexible suction adapter or a fluidic connector) can be used to connect the wound cover 106 with a wound therapy device 110 (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure. The conduit 108 can be a single or multi lumen tube. A connector 112 can be used to removably and selectively couple a conduit or tube 142 with the conduit 108.

[0030] In any of the systems disclosed herein, a wound therapy device can be canisterless, wherein, for example and without limitation, wound exudate is collected in the wound dressing or is transferred via a conduit for collection at another location. However, any of the wound therapy devices disclosed herein can include or support a canister.

[0031] Additionally, with any of the wound therapy systems disclosed herein, any of the wound therapy devices can be mounted to or supported by the wound dressing or adjacent to the wound dressing. The wound filler 102 can be any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, and so on. The wound filler 102 can be conformable to the wound 104 such that the wound filler 102 substantially fills the cavity of the wound 104. The wound cover 106 can provide a substantially fluid impermeable seal over the wound 104. The wound cover 106 can have a top side and a bottom side. The bottom side can adhesively (or in any other suitable manner) seal with the wound 104, for example by sealing with the skin around the wound 104. The conduit 108 or any other conduit disclosed herein can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0032] The wound cover 106 can have a port (not shown) configured to receive an end of the conduit 108. In some cases, the conduit 108 can otherwise pass through or under the wound cover 106 to supply reduced pressure to the wound 104 so as to maintain a desired level of reduced pressure in the wound 104. The conduit 108 can be any suitable article configured to provide at least a substantially sealed fluid flow pathway or path between the wound therapy device 110 and the wound cover 106, so as to supply the reduced pressure provided by the wound therapy device 110 to wound 104.

[0033] The wound cover 106 and the wound filler 102 can be provided as a single article or an integrated single unit. In some cases, no wound filler is provided and the wound cover by itself may be considered the wound dressing. The wound dressing can then be connected, via the conduit 108, to a source of negative pressure of the wound therapy device 110. In some cases, though not required, the wound therapy device 110 can be miniaturized and portable, although larger conventional negative pressure sources (or pumps) can also be used.

[0034] The wound cover 106 can be located over a wound site to be treated. The wound cover 106 can form a substantially sealed cavity or enclosure over the wound. The wound cover 106 can have a film having a high water vapour permeability to enable the evaporation of surplus fluid, and can have a superabsorbing material contained therein to safely absorb wound exudate. In some cases, the components of the TNP systems described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.

[0035] The wound therapy device 110 can operate with or without the use of an exudate canister. In some cases, as is illustrated, the wound therapy device 110 can include an exudate canister. In some cases, configuring the wound therapy device 110 and conduit 108 so that the conduit 108 can be quickly and easily removed from the wound therapy device 110 can facilitate or improve the process of wound dressing or pump changes, if necessary. Any of the pump assemblies disclosed herein can have any suitable connection between the conduit 108 and the pump.

[0036] The wound therapy device 110 can deliver 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 thus, -200 mmHg would be about 560 mmHg in practical terms. In some cases, 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 over -80 mmHg can be used. Also in some cases a pressure range of below -75 mmHg can be used. Alternatively, a pressure range of over approximately -100 mmHg, or even -150 mmHg, can be supplied by the wound therapy device 110.

[0037] As will be described in greater detail below, the negative pressure wound treatment system 100 can be configured to provide a connection 332 to a separate or remote computing device 334. The connection 332 can be wired or wireless (such as, Bluetooth, NFC, WiFi, or cellular). The remote computing device 334 can be a smartphone, a tablet, a laptop or another standalone computer, a server (such as, a cloud server), another pump device, or the like.

[0038] Figure IB illustrates another negative pressure wound treatment system 100’. The negative pressure wound treatment system 100’ can have any of the components, features, or other details of any of the other negative pressure wound treatment system disclosed herein, including without limitation the negative pressure wound treatment system 100 illustrated in Figure 1A or the negative pressure wound treatment system 400 illustrated in Figure 4, in combination with or in place of any of the components, features, or other details of the negative pressure wound treatment system 100’ shown in Figure IB and / or described herein. The negative pressure wound treatment system 100’ can have a wound cover 106 over a wound 104 that can seal the wound 104. A conduit 108’, such as a single or multi lumen tube can be used to connect the wound cover 106 with a wound therapy device 110’ (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure. The wound cover 106 can be in fluidic communication with the wound 104.

[0039] With reference to Figure IB, the conduit 108’ can have a bridge portion 130 that can have a proximal end portion and a distal end portion (the distal end portion being closer to the wound 104 than the proximal end portion, and an applicator 132 at the distal end of the bridge portion 130 forming the flexible suction adapter (or conduit) 108’. A connector 134 can be disposed at the proximal end of the bridge portion 130, so as to connect to at least one of the channels that can extend along a length of the bridge portion 130 of the conduit 108 shown in Figure IB. A cap 140 can be coupled with a portion of the conduit 108 and can, in some cases, as illustrated, be attached to the connector 134. The cap 140 can be useful in preventing fluids from leaking out of the proximal end of the bridge portion 130. The conduit108’ can be a Soft Port manufactured by Smith & Nephew. As mentioned, the negative pressure wound treatment system 100’ can include a source of negative pressure, such as the device 110’, capable of supplying negative pressure to the wound 104 through the conduit 108’. Though not required, the device 110’ can also include a canister or other container for the storage of wound exudates and other fluids that can be removed from the wound.

[0040] The device 110’ can be connected to the connector 134 via a conduit or tube 142. In use, the applicator 132 can be placed over an aperture formed in a cover 106 that is placed over a suitably-prepared wound or wound 104. Subsequently, with the wound therapy device 110’ connected via the tube 142 to the connector 134, the wound therapy device 110’ can be activated to supply negative pressure to the wound. Application of negative pressure can be applied until a desired level of healing of the wound is achieved.

[0041] The bridge portion 130 can comprise an upper channel material or layer positioned between an upper layer and an intermediate layer, with a lower channel material or layer positioned between the intermediate layer and a bottom layer. The upper, intermediate, and lower layers can have elongate portions extending between proximal and distal ends and can include a material that is fluid-impermeable, for example polymers such as polyurethane. It will of course be appreciated that the upper, intermediate, and lower layers can each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper, intermediate, and lower layers can be at least partially transparent. In some instances, the upper and lower layers can be curved, rounded or outwardly convex over a majority of their lengths.

[0042] The upper and lower channel layers can be elongate layers extending from the proximal end to the distal end of the bridge 130 and can each preferably comprise a porous material, including for example open-celled foams such as polyethylene or polyurethane. In some cases, one or more of the upper and lower channel layers can be comprised of a fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.) or a nonwoven material, or terry-woven or loop-pile materials. The fibers may not necessarily be woven, and can include felted and flocked (including materials such as Flotex.RTM.) fibrous materials. The materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure or vented air to the wound site, and can also confer a degree of kinking orocclusion resistance to the channel layers. In one example, the upper channel layer can include an open-celled foam such as polyurethane, and the lower channel layer can include a fabric. In another example, the upper channel layer is optional, and the system can instead be provided with an open upper channel. The upper channel layer can have a curved, rounded or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer can have a curved, rounded or downwardly convex lower surface and a substantially flat upper surface.

[0043] The fabric or material of any components of the bridge 130 can have a three- dimensional (3D) structure, where one or more types of fibers form a structure where the fibers extend in all three dimensions. Such a fabric can in some cases aid in wicking, transporting fluid or transmitting negative pressure. In some cases, the fabric or materials of the channels can include several layers of material stacked or layered over each other, which can in some cases be useful in preventing the channel from collapsing under the application of negative pressure. The materials used in some implementations of the conduit 108’ can be conformable and pliable, which can, in some cases, help to avoid pressure ulcers and other complications which can result from a wound treatment system being pressed against the skin of a patient.

[0044] The distal ends of the upper, intermediate, and lower layers and the channel layers can be enlarged at their distal ends (to be placed over a wound site), and can form a "teardrop" or other enlarged shape. The distal ends of at least the upper, intermediate, and lower layers and the channel layers can also be provided with at least one through aperture. This aperture can be useful not only for the drainage of wound exudate and for applying negative pressure to the wound, but also during manufacturing of the device, as these apertures can be used to align these respective layers appropriately.

[0045] In some implementations, a controlled gas leak 146 (sometimes referred to as gas leak, air leak, or controlled air leak) can be disposed on the bridge portion 130, for example at the proximal end thereof. This air leak 146 can comprise an opening or channel extending through the upper layer of the bridge portion 130, such that the air leak 146 is in fluidic communication with the upper channel of the bridge portion 130. Upon the application of suction to the conduit 108, gas (such, as air) can enter through the gas leak 146 and move from the proximal end of the bridge portion 130 to the distal end of the bridge portion along the upper channel of the bridge portion 130. The gas can then be suctioned into the lowerchannel of the bridge portion 130 by passing through the apertures through the distal ends of the upper, intermediate, and lower layers.

[0046] The air leak 146 can include a filter. Preferably, the air leak 146 is located at the proximal end of the bridge portion 130 so as to minimize the likelihood of wound exudate or other fluids coming into contact and possibly occluding or interfering with the air leak 146 or the filter. In some instances, the filter can be a microporous membrane capable of excluding microorganisms and bacteria, and which may be able to filter out particles larger than 45 pm. Preferably, the filter can exclude particles larger than 1.0 pm, and more preferably, particles larger than 0.2 pm. Advantageously, some implementations can provide for a filter that is at least partially chemically-resistant, for example to water, common household liquids such as shampoos, and other surfactants. In some cases, reapplication of vacuum to the suction adapter or wiping of the exposed outer portion of the filter may be sufficient to clear any foreign substance occluding the filter. The filter can be composed of a suitably-resistant polymer such as acrylic, poly ethersulfone, or polytetrafluoroethylene, and can be oleophobic or hydrophobic. In some cases, the gas leak 146 can supply a relatively constant gas flow that does not appreciably increase as additional negative pressure is applied to the conduit 108’. In instances of the negative pressure wound treatment system 100 where the gas flow through the gas leak 146 increases as additional negative pressure is applied, preferably this increased gas flow will be minimized and not increase in proportion to the negative pressure applied thereto. Further description of such bridges, conduits, air leaks, and other components, features, and details that can be used with any implementations of the negative pressure wound treatment systems disclosed herein are found in U.S. Patent No. 8,801,685, which is incorporated by reference in its entirety as if fully set forth herein.

[0047] Any of the wound therapy devices (such as, the device 110 or 110’) disclosed herein can provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, - 70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. Intermittent therapy can be delivered between low and high negative pressure set points (sometimes referred to as setpoint). Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, orbelow -180 mmHg. High set point can be set at above -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. During intermittent therapy, negative pressure at low set point can be delivered for a first time duration, and upon expiration of the first time duration, negative pressure at high set point can be delivered for a second time duration. Upon expiration of the second time duration, negative pressure at low set point can be delivered. The first and second time durations can be same or different values.

[0048] In operation, the wound filler 102 can be inserted into the cavity of the wound 104, and wound cover 106 can be placed so as to seal the wound 104. The wound therapy device 110’ can provide negative pressure to the wound cover 106, which can be transmitted to the wound 104 via the wound filler 102. Fluid (such as, wound exudate) can be drawn through the conduit 108’ and stored in a canister. In some cases, fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown).

[0049] Wound dressings that can be utilized with the pump assembly and systems of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Further description of such wound dressings and other components of a negative pressure wound therapy system that can be used with the pump assembly and systems of the present application are found in U.S. Patent Publication Nos. 2012 / 0116334, 2011 / 0213287, 2011 / 0282309, 2012 / 0136325, U.S. Patent No. 9,084,845, and International App. No. PCT / EP2020 / 078376, each of which is incorporated by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings can be utilized.

[0050] Figures 2A-2C show the negative pressure wound therapy device 110’. As illustrated, a pump assembly 160 and canister 162 can be connected, thereby forming the wound therapy device 110’. With reference to Figure 2C, the pump assembly 160 can include an interface panel 170 having a display 172, one or more indicators 174, or one or more controls or buttons, including, for example and without limitation, a therapy start and pause button 180 or an alarm / alert mute button 182. The interface panel 170 can have one or more input controls or buttons 184 (three being shown) that can be used to control any functions of the pump assembly 160 or the interface panel 170. For example and without limitation, one or more of the buttons 184 can be used to turn the pump assembly 160 on or off, to start orpause therapy, to operate and monitor the operation of the pump assembly 160, to scroll through menus displayed on the display 172, or to control or perform other functions. In some cases, the command buttons 184 can be programmable, and can be made from a tactile, soft rubber.

[0051] Additionally, the interface panel 170 can have visual indicators 186 that can indicate which of the one or more buttons 184 is active. The interface panel 170 can also have a lock / unlock control or button 188 that can be configured to selectively lock or unlock the functionality of the various buttons (e.g., buttons 184) or the display 172. When the lock / unlock button 188 is in the locked state, depressing one or more of the various other buttons or the display will not cause the pump assembly 160 to change any display functions or performance functions of the device. This way, the interface panel 170 will be protected from inadvertent bumping or touching of the various buttons or display. The interface panel 170 can be located on an upper portion of the pump assembly 160, for example and without limitation on an upward facing surface of the pump assembly 160.

[0052] The display 172, which can be a screen such as an LED screen, can be mounted in a middle portion of the interface panel 170. The display 172 can be a touch screen display. The display 172 can support playback of audiovisual (AV) content, such as instructional videos, and render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the pump assembly 160.

[0053] The one or more indicators 174 can be lights (such as, LEDs) and can be configured to provide a visual indication of alarm conditions and or a status of the pump. For example and without limitation, the one or more indicators 174 can be configured to provide a visual indication of a status of the pump assembly 160 or other components of the negative pressure wound treatment system 100’, including without limitation the conduit 108’ or the wound cover 106 (such as, to provide an indication of normal operation, low battery, a leak, canister full, blockage, overpressure, or the like). Any one or more suitable indicators can be additionally or alternatively used, such as visual, audio, tactile indicator, and so on.

[0054] Figure 2B shows a back or rear view of the wound therapy device 110’ shown in the Figure 2A. As shown, the pump assembly 160 can include a speaker 192 for producing sound. For example and without limitation, the speaker 192 can generate an acoustic alarm in response to deviations in therapy delivery, non-compliance with therapydelivery, or any other similar or suitable conditions or combinations thereof. The speaker 192 can provide audio to accompany one or more instructional videos that can be displayed on the display 172.

[0055] The pump assembly 160 can be configured to provide easy access (such as, an access door on the casing of the pump assembly) to one or more filters of the pump assembly 160, such as antibacterial filters. This can enable a user (such as, a healthcare provider or patient) to more easily access, inspect or replace such filters. The pump assembly 160 can also include a power jack 196 for providing power to the pump assembly 160 or for charging and recharging an internal power source (such as, a battery). Some implementations of the pump assembly 160 can include a disposable or renewable power source, such as one or more batteries, so that no power jack is needed. The pump assembly 160 can have a recess 198 formed therein to facilitate gripping of the pump assembly 160.

[0056] The canister 162 can hold fluid aspirated from the wound 104. For example, the canister 162 can have an 800 mL (or approximately 800 mL) capacity, or from a 300 mL or less capacity to a 1000 mL or more capacity, or any capacity level in this range. The canister 162 can include a tubing for connecting to the conduit 108’ in order to form a fluid flow path. The canister 162 can be replaced with another canister, such as when the canister 162 has been filled with fluid. With reference to Figure 2A, the wound therapy device 110’ can include a canister inlet tube 200 (also referred to herein as a dressing port connector) in fluid communication with the canister 162. For example and without limitation, the canister inlet tube 200 can be used to connect with the conduit 108’.

[0057] The canister 162 can be selectively coupleable and removable from the pump assembly 160. With reference to Figure 2A, in some cases, a canister release button 202 can be configured to selectively release the canister 162 from the pump assembly 160. With reference to Figure 2B, the canister 162 can have one or more fill lines or graduations 204 to indicate to the user and amount of fluid or exudate stored within the canister 162.

[0058] The wound therapy device 110’ can have a handle 208 that can be used to lift or carry the wound therapy device 110’. The handle 208 can be coupled with the pump assembly 160 and can be rotatable relative to the wound therapy device 110’ so that the handle can be rotated upward for lifting or carrying the wound therapy device 110’ or the pump assembly 160, or rotated into a lower profile in a more compact position when the handle isnot being used. In some cases, the handle 208 can be coupled with the pump assembly 160 in a fixed position. The handle 208 can be coupled with an upper portion of the pump assembly 160 or can be removable from the wound therapy device 110’.

[0059] Figure 3 illustrates a schematic of a control system 300 that can be employed in any of the wound therapy devices described herein, such as in the wound therapy device 110’. Electrical components can operate to accept user input, provide output to the user, operate the pressure source, provide connectivity, and so on. A first processor (such as, a main controller 310) can be responsible for user activity, and a second processor (such as, a pump controller 370) can be responsible for controlling another device, such as a pump 390.

[0060] An input / output (I / O) module 320 can be used to control an input and / or output to another component or device, such as the pump 390, one or more sensors (for example, one or more pressure sensors 325 configured to monitor pressure in one or more locations of the fluid flow path), or the like. For example, the I / O module can receive data from one or more sensors through one or more ports, such as serial (for example, I2C), parallel, hybrid ports, and the like. Any of the pressure sensors can be part of the wound therapy device or the canister. In some cases, any of the pressure sensors 325 can be remote to the wound therapy device, such as positioned at or near the wound (for example, in the dressing or the conduit connecting the dressing to the wound therapy device). In such implementations, any of the remote pressure sensors can communicate with the I / O module over a wired connection or with one or more transceivers 340 over a wireless connection.

[0061] The main controller 310 can receive data from and provide data to one or more expansion modules 360, such as one or more USB ports, SD ports, Compact Disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, and the like. The main controller 310, along with other controllers or processors, can store data in memory 350 (such as one or more memory modules), which can be internal or external to the main controller 310. Any suitable type of memory can be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, Magnetoresistive random-access memory (MRAM), and the like.

[0062] The main controller 310 can be a general purpose controller, such as a low- power processor or an application specific processor. The main controller 310 can be configured as a “central” processor in the electronic architecture of the control system 300, andthe main controller 310 can coordinate the activity of other processors, such as the pump controller 370, communications controller 330, and one or more additional processors 380. The main controller 310 can run a suitable operating system, such as a Linux, Windows CE, VxWorks, etc.

[0063] The pump controller 370 can control the operation of a pump 390, which can generate negative or reduced pressure. The pump 390 can be a suitable pump, such as a diaphragm pump, peristaltic pump, rotary pump, rotary vane pump, scroll pump, screw pump, liquid ring pump, diaphragm pump operated by a piezoelectric transducer, voice coil pump, and the like. The pump controller 370 can measure pressure in a fluid flow path, using data received from one or more pressure sensors 325, calculate the rate of fluid flow, and control the pump. The pump controller 370 can control the pump actuator (such as, a motor) so that a desired level of negative pressure is achieved in the wound 104. The desired level of negative pressure can be pressure set or selected by the user. The pump controller 370 can control the pump (for example, pump motor) using pulse-width modulation (PWM) or pulsed control, which can control the flow rate supplied by the pump (or intensity of the negative pressure supplied by the pump). For instance, higher PWM value can correspond to a higher flow rate (or higher intensity). A control signal for driving the pump can be a 0-100% duty cycle PWM signal, which can control the flow rate (or intensity) of the pump. The pump controller 370 can perform flow rate calculations and detect alarms. The pump controller 370 can communicate information to the main controller 310. The pump controller 370 can be a low- power processor.

[0064] A communications controller 330 can provide connectivity (such as, a wired or wireless connection 332). The communications controller 330 can utilize one or more transceivers 340 for sending and receiving data. The one or more transceivers 340 can include one or more antennas, optical sensors, optical transmitters, vibration motors or transducers, vibration sensors, acoustic sensors, ultrasound sensors, or the like. The communications controller 330 can provide one or more of the following types of connections: Global Positioning System (GPS), cellular connectivity (for example, 2G, 3G, LTE, 4G, 5G, or the like), near field communication (NFC), Bluetooth connectivity, radio frequency identification (RFID), wireless local area network (WLAN), wireless personal area network (WPAN), WiFi connectivity, Internet connectivity, optical connectivity (for example, using infrared light,barcodes, such as QR codes, etc.), acoustic connectivity, ultrasound connectivity, or the like. Connectivity can be used for various activities, such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading of logs, alarms, and other operational data, and adjustment of therapy settings, upgrading of software or firmware, pairing, and the like.

[0065] The communications controller 330 can provide dual GPS / cellular functionality. Cellular functionality can, for example, be 3G, 4G, or 5G functionality. The communications controller 330 can communicate information to the main controller 310. The communications controller 330 can include internal memory or can utilize memory 350. The communications controller 330 can be a low-power processor.

[0066] The control system 300 can store data, such as GPS data, therapy data, device data, and event data. This data can be stored, for example, in memory 350. This data can include patient data collected by one or more sensors. The control system 300 can track and log therapy and other operational data. Such data can be stored, for example, in the memory 350.

[0067] Using the connectivity provided by the communications controller 330, the control system 300 can upload any of the data stored, maintained, or tracked by the control system 300 to a remote computing device, such as the device 334. The control system 300 can also download various operational data, such as therapy selection and parameters, firmware and software patches and upgrades, and the like (for example, via the connection to the device 334). The one or more additional processors 380, such as processor for controlling one or more user interfaces (such as, one or more displays), can be utilized. In some cases, any of the illustrated or described components of the control system 300 can be omitted depending on an embodiment of a wound monitoring or treatment system in which the control system 300 is used.

[0068] Any of the negative pressure wound therapy devices described herein can include one or more features disclosed in U.S. Patent No. 9,737,649 or U.S. Patent Publication No. 2017 / 0216501, each of which is incorporated by reference in its entirety.Multiple Dressing Negative Wound Therapy

[0069] Figure 4 illustrates another negative pressure wound treatment system 400. The system 400 can include a wound therapy device capable of supplying negative pressure to the wound site or sites, such as wound therapy device 110’. The wound therapy device 110’ can be in fluidic communication with one or more wound dressings 406a, 406b (collectively referred to as 406) so as to supply negative pressure to one or more wounds, such as the wounds 104a and 104b. A first fluid flow path can include components providing fluidic connection from the wound therapy device 110’ to the first wound dressing 406a. As a non-limiting example, the first fluid flow path can include the path from the wound dressing 406a to the wound therapy device 110’ or the path from the first wound dressing 406a to an inlet 446 of a branching attachment (or connector) 444 in fluidic connection with the wound therapy device 110’. Similarly, a second fluid flow path can include components providing fluidic connection from the wound therapy device 110’ to the second wound dressing 406b.

[0070] The system 400 can be similar to the system 100’ with the exception that multiple wounds 104a and 140b are being treated by the system 400. The system 400 can include any one or more of the components of the system 100’, which are illustrated in Figure 4 with appended letter “a” or “b” to distinguish between the first and second wounds (such as, the wounds 104a and 104b, the covers 106a and 106b). As illustrated, the system 400 can include a plurality of wound dressings 406a, 406b (and corresponding fluid flow paths) in fluidic communication with the wound therapy device 110’ via a plurality of suction adapters, such as the adapter 108’. The suction adapters can include any one or more of the components of the adapter 108’, which are illustrated in Figure 4 with appended letter “a” or “b” to distinguish between the first and second wounds (such as, the bridge portions 130a and 130b, the connectors 134a and 134b, and the caps 140a and 140b).

[0071] The wound therapy device 110’ can be fluidically coupled via the tube 142 with the inlet 446 of the connector 444. The connector 444 can be fluidically coupled via branches 445a, 445b and tubes or conduits 442a, 442b with the connectors 134a, 134b, which can be fluidically coupled with the tubes or conduits 130a, 130b. The tubes or conduits 130a, 130b can be fluidically coupled with the dressings 406a, 406b. Once all conduits and dressing components are coupled and operably positioned, the wound therapy device 110’ can be activated, thereby supplying negative pressure via the fluid flow paths to the wounds 430a,430b. Application of negative pressure can be applied until a desired level of healing of the wounds 430 is achieved. Although two wounds and wound dressing are illustrated in Figure 4, some implementations of the wound therapy device 110’ can provide treatment to a single wound (for instance, by closing the unused branch 445a or 445b of the connector 444) or to more than two wounds (for instance, by adding branches to the connector 444).

[0072] The system 400 can include one or more features disclosed in U.S. Patent Publication No. 2020 / 0069850 or International Publication No. WO2018 / 167199, each of which is incorporated by reference in its entirety.Self-Testing of Negative Pressure Devices

[0073] In some cases, a negative pressure wound therapy device (such as, the device 110) may need to be tested to ensure that it is capable of providing negative pressure wound therapy safely and effectively. Such testing may involve verifying one or more of: that the leak rate of the device is within acceptable limits, that the negative pressure source provides adequate flow, that an excessive pressure safety system is operational, or the like. The testing can additionally or alternatively involve one or more of: prompting the user to press one or more of the buttons (such as, the buttons 184) of the user interface to confirm normal operation, confirm that the display (such as the display 172) is illuminated, confirm that one or more of the status indicators (such as, the status indicators 174) are illuminated, confirm that the speaker (such as, the speaker 192) is operational, or the like. The testing may be performed when the device is used with a new patient, periodically (such as, semi-annually), or the like. The testing parameters, such as the timing and pressure settings, can be varied to accommodate different self-test hardware designs. For example, the pressure can be varied from about -40 mmHg to about -250 mmHg. Existing devices are typically sent by the user (such as, a patient or health care provider (HCP), or the like), to the device manufacturer or a third-party for testing. However, this approach is time consuming, expensive, and disruptive.

[0074] Figure 5 illustrates a negative pressure wound therapy device 500 configured to perform self-testing. Device 500 can include one or more features of any of the devices described herein, such as the device 110. Device 500 may be capable of performing self-testing in the field without the need to send the device to the manufacturer or third-party. For example, the user can cause the device 500 to perform self-testing. Self-testing can be activated, for instance, via the user interface of the device, such as via the display 206. Self-testing can be initiated remotely. Device 500 can provide an indication to the user (who may be local or remote) or a remote computing system that self-testing has completed successfully or unsuccessfully. The indication can be provided using any of the approaches described herein, such as visually, audibly, tactilely, via remote transmission, or the like. The indication can include information regarding which particular test or tests have been completed successfully or failed. In some cases, responsive to a determination that self-testing has completed unsuccessfully, the indication can include disabling provision of negative pressure wound therapy. In case of unsuccessful completion of self-testing, the device can be taken out of the field and serviced, repaired, or discarded.

[0075] Device 500 can include an inlet 510, an exudate collector 520 (which can be a canister or dressing), and a negative pressure source (positioned in the direction indicated by the arrow 560). The exudate collector 520 can be a canister of varying sizes, for example with a volume size of 300 mL or 800 mL, or a dressing of varying sizes. In a canisterless system, the inlet 510 can be similar to the connector 430 illustrated in Figure 4A.

[0076] Exudate collector 520, such as the canister or the dressing, can include electronic circuitry that supports connectivity. Such electronic circuitry can include one or more controllers, transceivers, or antennas. The retrieval of data from the exudate collector 520 can be performed by or under control of one or more controllers of the device 500, such as via the communications controller 330. The retrieval of data can be performed via a wired connection or wirelessly, such as using one or more transceivers (for example, one or more transceivers 340). For instance, one or more controllers of the device 500 can transmit and retrieve data wirelessly using a near-field protocol (such as, NFC), RFID, Bluetooth, or the like. In a canister mode, the one or more controllers can retrieve data from the canister, including one or more of identification data (such as canister identifier, batch code, or serial number), canister capacity or size (such as, 300 mL or 800 mL), canister fill detection (such as, whether the canister is full or the level of fluid in the canister), date of manufacture (which can be a timestamp), or canister first use date / time (which can be a timestamp stored in a canister memory responsive to the canister being connected to the device and / or responsive to initiation of negative pressure wound therapy).

[0077] The one or more processors can detect whether the exudate collector 520 is positioned in the fluid flow path (such as, whether the canister is connected to the devicehousing). For instance, the one or more processors can attempt to communicate with the exudate collector 520 and determine whether a response has been received. As another example, the device 500 can utilize a sensor, such as optical sensor, resistive sensor, capacitive sensor, electromagnetic sensor (such as, Hall effect sensor), or the like, to determine presence of the exudate collector 520 in the fluid flow path. In a similar vein, the device 500 can detect whether the exudate collector 520 is disconnected.

[0078] Additional details of communicating with the canister or dressing and retrieving data are disclosed in International Patent Application No. PCT / EP2022 / 060464, filed on April 20, 2022, and titled “Communication Systems and Methods for Negative Pressure Wound Therapy Devices,” International Patent Application No. PCT / EP2022 / 060463, filed on April 20, 2022, and titled “Canister Status Determination for Negative Pressure Wound Therapy Devices,” and International Patent Application No. PCT / EP2022 / 060459, filed on April 20, 2022, and titled “Intelligent Disposable Devices for Wound Therapy and Treatment,” each of which is incorporated by reference in its entirety.

[0079] A one-way valve or check valve 550 can be included to ensure that the fluid flows downstream toward the negative pressure source (in the direction indicated by the arrow 560) and not in the opposite direction, for example, when the negative pressure source is deactivated or stopped. The check valve 550 can stop any reverse flow when the negative pressure source is stopped. The device 500 can include a flow restrictor 540, and pressure sensors 532 and 534 positioned in the fluid flow path upstream and downstream of the flow restrictor 540. In some cases, the pressure sensors 532 and 534 can be replaced with a differential pressure sensor configured to measure pressure across the flow restrictor 540 and pressure in the fluid flow path. The fluid flow path can include the negative pressure source and other components that are internal to or integral with the negative pressure source, such as one or more connectors, manifolds, lumens, tubes, valves (for example, one or more valves of the negative pressure source), or the like. In some implementations, the flow restrictor 540 can be a valve, such as a solenoid valve (or solenoid) or a manually operated valve. The flow restriction produced by the flow restrictor 540 can result in a pressure drop across the pressure measured by the pressure sensors 532 and 534. As explained herein, such pressure drop can be indicative of the flow rate. In some instances, the flow restrictor 540 may not be not activated or operated (so that it may only be passively present in the fluid flow path) whenperforming one or more self-tests or may be omitted entirely. For instance, assuming that the flow restrictor 540 is a solenoid valve, the solenoid valve may be passively present by being open.

[0080] During normal operation in which the device 500 provides negative pressure to a wound covered by a wound dressing fluidically connected to the inlet 510, the fluid flow path can remain open. Device 500 can regulate negative pressure in the fluid flow path based on a pressure signal from the pressure sensor 532 (and / or the pressure sensor 534). During self-testing operation, the fluid flow path can be closed, for instance, by applying a cap or otherwise sealing canister or dressing tubing (in order to ensure that there is a fixed fluid flow path volume for self-testing).

[0081] Figure 6 illustrates a process 600 for performing self-testing. The process 600 can be implemented by the device 500, such as performed under control of a controller (or one or more controllers) of the device 500. In block 602, the process 600 can verify that the exudate collector 520 (such as, canister or wound dressing) is connected to the device 500 (or positioned in the fluid flow path). The process 600 can verify in block 602 that one or more of the wound dressing (for instance, in a canisterless system) or canister (for example, in a system with a canister) has been connected. As described herein, this can be performed via one or more of a sensor, such as, an optical sensor, electromagnetic sensor (for example, a Hall effect sensors), electrical switch, mechanical switch, interrogation via wireless or wired communications channel, or the like. The connection of the canister or wound dressing can establish a fixed volume in the fluid flow path subjected to self-testing.

[0082] In some cases, the process 600 can prompt the user to connect one or more of the canister or wound dressing. The prompt can be a user interface screen 603 displayed on the display of the device 500. The prompt 603 can direct a user to close off the fluid flow path, such as by placing a cap or otherwise sealing the canister or wound dressing. In some cases, the process 600 can terminate self-testing in response to determining in block 602 that one or more of the wound dressing or canister has not been connected. In some cases, the device can be prevented from providing negative pressure wound therapy to a patient as a result of termination of the self-testing. For instance, the process 600 can transition from block 603 to block 614 after a passage of a duration of time.

[0083] In some instances, the process 600 can verify that one or more of the wound dressing or canister has been connected in response to the user confirming such connection. The confirmation can be made via the user interface (such as, via a user interface screen).

[0084] In response to verifying that one or more of the wound dressing or canister has been connected, the process 600 can transition to block 604 in which it can determine the volume of the connected canister or wound dressing. The identification of the volume (such as 300 mL or 800 mL canister) can provide more accurate performance of self-testing. As described above, a canister or dressing can include communication capabilities and the volume of the canister or dressing can be determined using such communication capabilities. For instance, the canister or dressing can include memory that stores the volume, and in block 604 the process 600 can retrieve the volume from memory. In some cases, the user can input the volume of the canister or dressing, for example, via the user interface (such as, via a user interface screen).

[0085] In some implementations, a canister or dressing may be partially filled with exudate. In block 604, the process 600 can determine the remaining volume of the canister or dressing, for instance, by retrieving the volume size of the canister and the current fill level.

[0086] After determining the volume of the canister or dressing, the process 600 can transition to block 606 in which it can perform a leak test of the device. The leak test can be used to verify that the leak rate of the device is within acceptable limits for the application of negative pressure wound therapy. If the leak test fails, the process 600 can transition to block 614. If the leak test passes, the process 600 can transition to block 608 and perform a flow test of the device. The flow test can be used to verify that the negative pressure source of the device provides adequate flow for the application of negative pressure wound therapy. If the flow test fails, the process 600 can transition to block 614. If the flow test passes, the process 600 can transition to block 610 and verify that excessive pressure safety system of the device is operational. Excessive pressure safety system can prevent application of unsafe level(s) of negative pressure to the wound (for example, negative pressure of about -235 mmHg or less, about -240 mmHg or less or more, about -245 mmHg or less or more, about -250 mmHg or more, or the like). In some cases, excessive pressure safety system can include a valve or another mechanism that configured to release negative pressure in response to detection of excessive negative pressure level(s). For example, a valve can be opened to release excessnegative pressure to the atmosphere. Excessive pressure safety system can alternatively or additionally include deactivating the negative pressure source or the device 500 in response to detection of excessive negative pressure level(s). The negative pressure source can be deactivated, for instance, by deactivating the pump controller 370 or otherwise instructing the pump controller 370 to deactivate the negative pressure source. If an excessive pressure test fails, the process 600 can transition to block 614. If the excessive pressure test passes, the process 600 can transition to block 612. In block 612, the process 600 can provide an indication that self-testing has completed successfully. In some cases, the order of the tests 606 to 610 can be different. For example, the flow test in block 608 can be performed before the leak test in block 606.

[0087] In some instances, the flow test can be combined with the leak test or be part of the leak test. A relatively large volume of the canister, such as 300 m or 800 mL, (or, in some cases, dressing) can allow for application of negative pressure at high intensity (such as, about 100% PWM) for the leak test, as explained in more detail in connection with Figure 7. Such initial pump down cycle to establish a target level of negative pressure for performing the leak test, which can test negative pressure decay characteristics, can form the basis for the flow test, as explained in more detail in connection with Figure 7. Advantageously, combining the flow test and the leak test can simplify and speed up self-testing of the device.

[0088] In block 614, the process 600 can provide an indication that self-testing has not completed successfully. Such indication can include information about which of the one or more tests have not completed successfully, as described herein. As described herein, in case of unsuccessful completion of self-testing, the device can be taken out of the field and serviced, repaired, or discarded. The device can be prevented from providing negative pressure wound therapy to a patient until self-testing has been completed successfully.

[0089] Upon completion of the process 600 (either in block 612 or 614), the process 600 can provide an indication to disconnect the canister or dressing. For instance, this can be performed by displaying a user interface screen 617.

[0090] Figure 7 illustrates a process 700 for the flow test (block 606 of Figure 6) and the leak test (block 608 of Figure 6). The process 700 can be implemented by the device 500, such as performed under control of a controller (or one or more controllers) of the device 500. The process 700 can begin in block 704 by activating the negative pressure source toattempt to establish a target negative pressure in the fluid flow path and perform the flow test. As described herein, the process 700 can cause the negative pressure source to run at high flow rate or intensity (such as, about 100% PWM). The process 700 can remain in block 704 until a first threshold level of negative pressure has been established in the fluid flow path. This can be verified by the pressure sensor 532 (or the pressure sensor 534). The first threshold level of negative pressure can be at least about -100 mmHg, about -150 mmHg or less or more, about -160 mmHg or less or more, about -170 mmHg or less or more, about -180 mmHg or less or more, about -190 mmHg or less or more, about -200 mmHg or more, or the like. The first threshold level of negative pressure can be dependent on various factors, such as the type of negative pressure source being utilized by the device 500, type of wounds that the device 500 is configured to treat (for example, treating large wounds may necessitate that the device 500 be configured to provide greater levels of negative pressure and greater flow rates than treating small wounds), or the like.

[0091] In some cases, activating the negative pressure source and deactivating (or lowering the flow rate or intensity of) the negative pressure source when the first threshold level of negative pressure has been established (as may be normally performed during application of negative pressure wound therapy to a wound) can cause the negative pressure in the fluid flow path to reach a level that satisfies excessive negative pressure level(s). This may undesirably cause the excessive pressure safety system to be activated. To avoid such outcome, the negative pressure source may be activated for a fixed period of time or a fixed duty cycle, after which pressure in the fluid flow path can be verified. Subsequently, the negative pressure source can be activated again (or the flow rate or intensity can be increased) if it is determined that the threshold level of negative pressure has not been established in the fluid flow path. For example, the actuator of the negative pressure source can be a motor that can be pulsed for a fixed period of time or pulsed for a single rotation (or multiple rotations). Subsequently, pressure in the fluid flow path can be verified, and the motor can be pulsed again if the first threshold level of negative pressure has not been established.

[0092] In block 706, the process 700 can determine if the threshold level of negative pressure has been established in the fluid flow path. If so, it can be concluded that the flow test has been performed successfully, and the process 700 can transition to block 718. Otherwise, the process 700 can transition to block 714 and indicate that the flow test has failed.In case when the flow and leak tests have been combined, transition from block 706 to block 714 can indicate failure of both the flow test and the leak test. The process 700 can utilize a time duration threshold over which it can determine whether the threshold level of negative pressure has been established. For example, assuming that the threshold level of negative pressure is -150 mmHg, the time duration threshold can be about 2 seconds for 300 mL canister and about 4 seconds for 800 mL canister. Accordingly, the flow test (or any other test described herein, such as the leak test or excessive pressure test) can adjust its operation based on the volume of the canister or dressing. Should the process 700 determine that the threshold level of negative pressure has not been established over a time period that does not exceed the time duration threshold, the process can transition to block 714 and indicate that the flow test has failed.

[0093] Parameters or metrics that are additional or alternative to time to establish the threshold level of negative pressure can be utilized in some implementations of flow testing. In some cases, activity of the negative pressure source can be indicative of the flow rate. Activity of the negative pressure source can be monitored by monitoring power level or duty cycle of electric signal supplied to the actuator of the negative pressure source, speed of the actuator, duty cycle of the actuator, or the like. For instance, power level supplied to the actuator of the negative pressure source (such as, motor current) can be utilized by the process 700. Such power level can be indicative of the flow rate provided by the negative pressure source. As an example, assuming that the threshold level of negative pressure is -150 mmHg, the average motor current for a successful flow test can be about 300 mA for 300 mL or 800 mL canister. Average motor current can be used to filter out any errant noise in the measurement.

[0094] As another indicator of the flow rate, pressure difference or differential between the sensors 532 and 534 can be utilized. As described herein, the flow restrictor 540 can be passively present in the fluid flow path. At a high flow rate of intensity (such as, when the negative pressure source is operated at high PWM levels), even a passive flow restriction can cause a pressure differential across the flow restriction, as described herein. Such pressure differential can be indicative of the flow rate and can be monitored by the pressure sensors 532 and 534. Several metrics of the pressure differential can be used for performing the flow test, such as the average pressure differential (which can be filtered to remove any errant noise inthe measurement) or peak pressure differential (which can be indicative of instantaneous flow in the fluid flow path). As an example, assuming that the threshold level of negative pressure is -150 mmHg, the average pressure differential for a successful flow test can be about 25 mmHg for 300 mL and about 28 mmHg for 800 mL canister. As another example, assuming that the threshold level of negative pressure is -150 mmHg, the peak pressure differential for a successful flow test can be about 36 mmHg for 300 mL or 800 mL canister.

[0095] Utilizing activity of the negative pressure source (such as, the average motor current) or pressure differential (such as, average or peak pressure differential) can provide for a threshold level that is not dependent on the size of the canister.

[0096] Additional details of monitoring the flow rate using flow restrictors are disclosed in U.S. Patent Nos. 8,974,429 and 9,636,440, each of which is incorporated by reference in its entirety.

[0097] After completion of the flow test, the process 700 can perform the leak test, which can verify that the rate of decay of negative pressure in the fluid flow path satisfies an expected rate of decay. Because performing the leak test may necessitate establishing a certain level of negative pressure in the fluid flow path (for instance, the first threshold level of negative pressure) before allowing pressure to decay in order to assess the leak level in the fluid flow path, flow testing can be performed during such initial phase of establishing the certain level of negative pressure in the fluid flow path. After the flow testing has been performed and before allowing depressurization of the flow path to atmospheric pressure, leak testing can be performed.

[0098] If the verification in block 706 is successful, the process 700 can transition to block 708. The process 700 can also transition to block 708 from block 718. In block 708, the process 700 can implement a delay for a threshold period of time. The threshold period of time can be, for example, 1 second or less, 2 seconds or less or more, 5 seconds or less or more, 10 seconds or more, or the like. In block 708, the negative pressure source can be deactivated in order to allow negative pressure in the fluid flow path to decrease (or become more positive). Such negative pressure decay may be due to presence of one or more inherent leaks in the fluid flow path (for example, one or more connectors, manifolds, or the fluid flow path may have an inherent leak). As described herein, the threshold period of time for the delay can be dependenton various factors, such as type of negative pressure source being utilized by the device 500, the type of wounds that the device 500 is configured to treat, or the like.

[0099] After the threshold period of time has elapsed, the process 700 can transition to block 710 where it can verify that negative pressure decrease in the fluid flow path satisfies a pressure decay threshold. Even though one or more inherent leaks may be present in the fluid flow path, such leaks should not be too large or severe to cause a large negative pressure drop in the fluid flow path during the delay in block 708. The pressure decay threshold can be set to a relatively small value, such as 1 mmHg or less, 2 mmHg or less, 3 mmHg or less, 4 mmHg or less, 5 mmHg or less or more, 10 mmHg or less or more, 20 mmHg or less or more, 25 mmHg or less or more, or the like. For example, assuming a delay of 5 seconds in block 708, a pressure decay threshold can be around -3 mmHg for 300 mL canister and around -1 mmHg for 800 mL canister. As described herein, the pressure decay threshold can be dependent on various factors, such as the type of negative pressure source being utilized by the device 500, type of wounds that the device 500 is configured to treat, or the like. In block 710, the process 700 can utilize readings of the pressure sensor 532 or 534 to determine pressure in the fluid flow path.

[0100] If the process 700 verifies in block 710 that the negative pressure in the fluid flow path satisfies the pressure decay threshold, the process 700 can transition to block 712 where it can indicate successful completion of the leak test. For example, in block 710, the process 700 can verify that negative pressure in the fluid flow path is greater than (or more negative) or equal to the difference between the first threshold level of negative pressure and the pressure decay threshold. If the verification in block 710 is unsuccessful, the process 700 can transition to block 714 where it can provide indication that the leak test has failed. This may be due to one or more leaks in the flow path causing the pressure decay to be too steep or excessive.

[0101] While the flow test can be combined with the leak test as shown in Figure 7, in some implementations, the flow test can be performed separately.

[0102] Figure 8 illustrates a process 900 for the excessive pressure test. The process 900 can be performed in block 610 of Figure 6. The process 900 can be implemented by the device 500, such as performed under control of a controller (or one or more controllers) of the device 500. The process 900 can begin in block 904 by activating the negative pressuresource, similar to block 704 of Figure 7. For example, the process 900 can cause the negative pressure source to operate at a maximum flow rate or intensity (such as, 100% PWM). Same or different intensity level or high activity level can be used as in block 704.

[0103] The process 900 can remain in block 904 until a second threshold level of negative pressure has been established in the fluid flow path. This can be verified by the pressure sensor 532 (or pressure sensor 534).

[0104] In some cases, the second threshold level of negative pressure can correspond to negative pressure that is just less than (or more positive) than an excess (or excessive) pressure threshold indicative or unsafe level(s) of negative pressure (for example, negative pressure of about -235 mmHg or less, about -240 mmHg or less or more, about -245 mmHg or less or more, about -250 mmHg or more, or the like). For instance, the second threshold level of negative pressure can be about -200 mmHg or less, about -210 mmHg or less or more, about -220 mmHg or less or more, about -230 mmHg or less or more, -250 mmHg or less or more, or the like.

[0105] When the second threshold level of negative pressure has been established in the fluid flow path, the process 900 can transition to block 906 in which it can verify that the excessive pressure safety system has not been activated. Unless there is a fault, the excessive pressure safety system should not be activated because negative pressure in the fluid flow path has not reached the excess pressure threshold. If such verification fails, the process 900 can transition to block 914 where it can provide indication that the excessive pressure test has failed.

[0106] If the verification in block 906 is successful, the process 900 can transition to block 908 and activate the negative pressure source. Block 908 can be similar to block 904 except that the process 900 can remain in block 908 (with the negative pressure source being active) until the negative pressure level in the fluid flow path satisfies the excess pressure threshold. For example, the process 900 can remain in block 908 until negative pressure in the fluid flow path reaches or exceeds the excess pressure threshold. This verification can be performed by pressure sensor 532 (or pressure sensor 534). Subsequently, the process 900 can transition to block 910 where it can verify that the excessive pressure safety system or mechanism has been activated (for example, the negative pressure source has been deactivated). The process 900 can verify that the safety mechanism has been activated withina threshold time duration, such as 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, or the like. For instance, the process 900 can verify that the negative pressure source has been deactivated within a threshold time duration after the excess pressure threshold has been established in the fluid flow path.

[0107] In case the excessive pressure safety system includes a valve configured to vent excessive pressure into the surrounding environment, the process 900 can include activating the negative pressure source in block 908 at a different level of intensity (such as, the maximum level of intensity) to verify that the excess pressure threshold cannot be achieved. If such verification fails, the process 900 can transition to block 914. If the verification in block 910 is successful, the process 900 can transition to block 912 where it can indicate successful completion of the excessive pressure test.

[0108] In some implementations, the process 900 can omit blocks 904 and 906. Instead, the process 900 can begin in block 908 and activate the negative pressure source to reach the excess pressure threshold in the fluid flow path.

[0109] In some instances, excessive pressure test can be performed immediately after one or more of the flow test or leak test and without allowing release of negative pressure in the fluid flow path (such as, release to atmospheric pressure). This way, excessive pressure testing can take advantage of the pump down that has been performed for the flow testing or leak testing. Advantageously, time for completing self-testing can be reduced.

[0110] In some cases, the process 900 can additionally or alternatively execute the flow test of the process 700. If the flow test fails (such as, the process 700 reaching block 714), it can be concluded that the excessive pressure safety system has been activated. If the flow test is successfully completed (such as, the process 700 reaching block 718), it can be concluded that the excessive pressure safety system has not been activated. In some instances, the flow test can be executed before transitioning from block 910 to 912. Executing the flow test can provide additional or alternative verification regarding activation of the excessive safety system.

[0111] Figure 9A illustrates graphs that capture the flow testing when the device 500 is connected to a 300 m canister. Figure 9B illustrates graphs that capture the flow testing when the device is connected to an 800 m canister. X-axis can represent time (in msec), and y-axis can represent the pressure (in mmHg), motor current (in mA), and duty cycle (inPWM%). Figures 9A and 9B illustrate response of the device 500 when the negative pressure source is operated at a maximum flow rate or intensity (such as, 100% PWM), which can correspond to the execution of block 704. Figure 9A illustrates graph 1002 that captures readings of the pressure sensor 532, graph 1004 that captures readings of the pressure sensor 534, graph 1006 that captures the average motor current, graph 1008 that captures the PWM value, graph 1010 that captures the peak pressure differential between the pressure sensors 532 and 534, and graph 1012 that captures the average pressure differential between the pressure sensors 532 and 534. Figure 9B illustrates graph 1022 that captures readings of the pressure sensor 532, graph 1024 that captures readings of the pressure sensor 534, graph 1026 that captures the average motor current, graph 1028 that captures the PWM value, graph 1030 that captures the peak pressure differential between the pressure sensors 532 and 534, and graph 1032 that captures the average pressure differential between the pressure sensors 532 and 534. The graphs in Figures 9A and 9B confirm that any of the pressure sensor readings, pressure differential values, or motor current value can serve as viable indicators of the flow rate for performing the flow rate test, regardless of the volume of the canister (or dressing) positioned in the fluid flow path. In fact, changes over time of the motor current, average pressure differential, and peak pressure differential are almost identical between the two canisters.

[0112] Figure 10 illustrates a graph that captures leak testing of the device 500 connected to a 300 mL canister. X-axis can represent time (in sec), and y-axis can represent pressure (in mmHg). The graph illustrates a pressure decay over time, which shows a gradual loss of negative pressure due to inherent leaks in the fluid flow path. The illustrated pressure decay can be approximated by the linear equation y = -0.2547x + 120.89.

[0113] Figure 11 illustrates a graph that captures excessive pressure testing of the device 500 connected to a 300 mL canister. X-axis can represent time (in msec), and y-axis can represent pressure (in mmHg) and the duty cycle percentage (in PWM%). As shown, over the course of approximately 2 seconds there is a smooth transition from the first threshold level of negative pressure (such as, -150 mmHg) used during the flow and leak tests to the second threshold level of negative pressure (such as, -250 mmHg) used for excessive pressure testing. The time for such transition may differ for different volumes of the canister or dressing. For instance, with an 800 mL canister, it may take approximately 4 seconds.

[0114] Figure 12 illustrates another graph that captures flow testing when the device 500 is connected to a 300 mL canister. Similar to Figure 9A, the x-axis can represent time (in msec), and the y-axis can represent the pressure (in mmHg), motor current (in mA), and duty cycle (in PWM%). Figure 12 illustrates response of the device 500 when the negative pressure source is operated at a maximum flow rate or intensity (such as, 100% PWM), which can correspond to the execution of block 704. Figure 12 illustrates graph 1210 that captures readings of the pressure sensor 532, graph 1204 that captures readings of the pressure sensor 534, graph 1206 that captures the average motor current, graph 1208 that captures the PWM value, and graph 1202 that captures the average pressure differential between the pressure sensors 532 and 534 (which can be indicative of a pressure drop across the flow restrictor).

[0115] With reference to Figure 12, point 1220 illustrates activation of the negative pressure source. Point 1222 illustrates reaching the maximum motor current (which can correspond to 100% PWM). Point 1224 illustrates reaching the maximum flow in the fluid flow path (including across the flow restrictor). Point 1226 illustrates that pressure sensors 532 and 534 follow each other closely until the negative pressure source has been deactivated. Point 1228 illustrates deactivation of the negative pressure source. Point 1230 illustrates that after the negative pressure source has been deactivated, pressure sensors 532 and 534 read the same pressure.

[0116] Figure 12 can illustrate the following sequence of events for performing the flow test. First, the device 500 can be connected to a 300mL canister with a closed tubing end (such as, by placing a cap or otherwise sealing the canister). Next, the negative pressure source can be activated (at 1220) to deliver negative pressure (for instance, at the maximum duty cycle). Progress toward a target negative pressure (such as, -200 mHg in the illustrated example) can be measured in real-time (such as, every 10 msec or less or more). The timing to the inflection point in the graph 1202 indicates the device’s ability to overcome the volume of fluid (such as, air) contained in the canister. The time between 1220 and 1224 reflects the device’s ability to evacuate the fluid from the canister and confirms that the flow rate test is successful. In some cases, the timing of the change in the slope of the graph 1202 can be measured to confirm acceptable flow. For instance, the duration of time between 1220 (when the negative pressure source has been activated) and 1224 (when the peak motor current is being provided to the motor of the negative pressure source, as illustrated at 1222) can bemonitored and compared against a threshold to confirm that the flow test has been completed successfully. In the illustrated example, the duration of time between 1220 and 1224 is about 3 seconds.

[0117] In some implementations, pressure drop across the flow restrictor as plotted in graph 1202 can be monitored and compared against a pressure drop (or flowrate) threshold to confirm that the flow test has been completed successfully.

[0118] Peak current (indicated by the point 1222) consumed in order to achieve the flow (1222) can indicate the mechanical resistance of the negative pressure source. After the negative pressure source has been deactivated (at about -210 mmHg, as illustrated at 1228), flow testing can confirm that the pressure sensors are both in agreement in the absence of air flow through the system (1230).

[0119] Additional or alternative approaches for self-testing are disclosed in U.S. Patent Publication 2023 / 0037943, which is incorporated by reference in its entirety.Other Variations

[0120] Although some embodiments describe negative pressure wound therapy, the systems, devices, and / or methods disclosed herein can be applied to other types of therapies usable standalone or in addition to TNP therapy. Systems, devices, and / or methods disclosed herein can be extended to any medical device, and in particular any wound monitoring and / or treatment device. For example, systems, devices, and / or methods disclosed herein can be used with devices that provide one or more of ultrasound therapy, oxygen therapy, neurostimulation, microwave therapy, active agents, antibiotics, antimicrobials, or the like. Such devices can in addition provide TNP therapy. As another example, systems, devices, and / or methods disclosed herein can be used with a wound debridement system, patient monitoring system, or the like. The systems and methods disclosed herein are not limited to medical devices and can be utilized by any electronic device.

[0121] Any of the controllers or processors disclosed herein can include electronic circuitry (sometimes referred to as control circuity). Electronic circuitry can be configured to implement programmable control or hardwired control.

[0122] Any value of a threshold, limit, duration, etc. provided herein is not intended to be absolute and, thereby, can be approximate. In addition, any threshold, limit, duration, etc. provided herein can be fixed or varied either automatically or by a user. Furthermore, asis used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass being equal to the reference value. For example, exceeding a reference value that is positive can encompass being equal to or greater than the reference value. In addition, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass an inverse of the disclosed relationship, such as below, less than, greater than, etc. in relations to the reference value.

[0123] Features, materials, characteristics, or groups 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 of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0124] While certain embodiments have been described, these embodiments have been 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. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For example, the actual steps and / or order of steps taken in the disclosed processes may differ from those shown in the figure. Various components illustrated in the figures or described herein may be implemented as software and / or firmware on a processor, controller, ASIC, FPGA, and / or dedicated hardware. The software or firmware can include instructions stored in a non-transitory computer-readable memory. The instructions can be executed by a processor, controller, ASIC, FPGA, ordedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, and the like, can include logic circuitry. Furthermore, 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.

[0125] User interface screens illustrated and described herein can include additional and / or alternative components. These components can include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, checkboxes, combo boxes, status bars, dialog boxes, windows, and the like. User interface screens can include additional and / or alternative information. Components can be arranged, grouped, displayed in any suitable order.

[0126] Conditional language used herein, such as, among others, “can,” “could”, “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or states. Thus, such conditional language is not generally intended to imply that features, elements and / or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or states are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. Additionally, the words “herein,” “above,” "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0127] Conjunctive language, such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is to be understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z, or a combination thereof. Thus, suchconjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0128] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

[0129] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations.

[0130] Although the present disclosure includes certain 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 and / or uses and obvious modifications and equivalents thereof, including embodiments which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments herein, and may be defined by claims as presented herein or as presented in the future.

Claims

WHAT IS CLAIMED IS:

1. A negative pressure wound therapy device comprising: a negative pressure source configured to be connected, via a fluid flow path, to a wound covered by a wound dressing and supply negative pressure to the wound; at least one pressure sensor configured to measure pressure in the fluid flow path; and a control circuitry configured to: in a normal operational mode in which negative pressure is provided to the wound, permit supply of negative pressure from the negative pressure source to the wound covered by the wound dressing; and in a test mode in which performance of the device is being verified, perform a combined flow test and leak test during which the control circuitry is further configured to: determine that at least one of a canister or the wound dressing has been positioned in the fluid flow path; and in response to determining that at least one of the canister or the wound dressing has been positioned in the fluid flow path: activate the negative pressure source to establish a first negative pressure level in the fluid flow path, monitor a flow in the fluid flow path using at least one of measurements of the at least one pressure sensor or activity of the negative pressure source, and indicate that the flow test has been completed successfully in response to at least one of determining that the flow in the fluid flow path satisfies a flow threshold or that the first negative pressure level has been established in the fluid flow path; and subsequent to at least one of determining that the flow in the flow path satisfies the flow threshold or the first negative pressure level has been established in the fluid flow path, pause operation of the negative pressure source for a first duration of time, monitor a negative pressure decay in the fluid flow path using measurements by the at least one pressure sensor, and indicate that the leak test has been completed successfully in response to determining that the negative pressure decayover a second duration of time subsequent to the first duration of time satisfies a negative pressure decay threshold.

2. The device of any one of the preceding claims, wherein the control circuitry is further configured to, in the test mode, perform an excessive pressure test by being further configured to: subsequent to completion of the leak test, activate the negative pressure source to establish a second negative pressure level in the fluid flow path that exceeds the first negative pressure level and corresponds to an unsafe level of negative pressure and indicate that the excessive pressure test has been performed successfully in response to determining that the negative pressure source has been deactivated subsequent to establishing the second negative pressure level.

3. The device of claim 2, wherein the control circuitry is configured to, in the test mode, perform the excessive pressure test subsequent to completion of the leak test and prior to pressure in the fluid flow path reaching atmospheric pressure.

4. The device of any one of the preceding claims, wherein the control circuitry is configured to determine that at least one of the canister or the wound dressing has been positioned in the fluid flow path in response to receiving data from at least one of the canister or the wound dressing.

5. The device of claim 4, wherein the control circuitry is further configured to: determine a volume of at least one of the canister or the wound dressing from the data; and adjust a parameter of the flow test based on the volume, the parameter of the flow test comprising a time duration for determining that the first negative pressure level has been established in the fluid flow path.

6. The device of claim 4 or 5, wherein the control circuitry is further configured to: determine a volume of at least one of the canister or the wound dressing from the data; andadjust a parameter of the leak test based on the volume, the parameter of the leak test comprising the negative pressure decay threshold.

7. The device of any one of the preceding claims, wherein the control circuitry is further configured to, in the test mode: indicate that the flow test and the leak test have not been completed successfully in response to determining that the flow in the fluid flow path does not satisfy the flow threshold or that the first negative pressure level has not been established in the fluid flow path.

8. The device of any one of the preceding claims, wherein the control circuitry is further configured to, in the test mode: provide an indication to a user to position at least one of the canister or the wound dressing in the fluid flow path.

9. The device of claim 8, wherein the indication is a visual indication provided on a display.

10. The device of any one of the preceding claims, wherein the control circuitry is configured to, in the test mode: indicate that the flow test has been completed successfully in response to determining that an electric current provided to an actuator of the negative pressure source is indicative of the flow that satisfies the flow threshold.

11. The device of any one of the preceding claims, further comprising a flow restrictor positioned in the fluid flow path, wherein the at least one pressure sensor is configured to measure a pressure differential across the flow restrictor, and wherein the control circuitry is configured to, in the test mode: indicate that the flow test has been completed successfully in response to determining that the pressure differential across the flow restrictor is indicative of the flow that satisfies the flow threshold.

12. The device of any one of the preceding claims, wherein the control circuitry is configured to, in the test mode: operate the negative pressure source without operating any valve positioned in the fluid flow path.

13. The device of any one of the preceding claims, wherein: the flow threshold is indicative of a duration of time from activation of the negative pressure source to establishing the first negative pressure level in the fluid flow path; and determining that the flow in the fluid flow path satisfies the flow threshold comprises determining that a duration of time from activation of the negative pressure source to providing peak electrical power to the negative pressure source satisfied the flow threshold.

14. The device of any one of the preceding claims, wherein the control circuitry is further configured to, in the test mode: determine that at least one of the canister or the wound dressing has not been positioned in the fluid flow path; and terminate the test mode in response to determining that at least one of the canister or the wound dressing has not been positioned in the fluid flow path.

15. The device of claim 14, wherein the control circuitry is further configured to: subsequent to terminating the test mode, prevent the negative pressure source from supplying negative pressure wound therapy.

16. A negative pressure wound therapy device comprising: a negative pressure source configured to be connected, via a fluid flow path, to a wound covered by a wound dressing and supply negative pressure to the wound; at least one pressure sensor configured to measure pressure in the fluid flow path; and a control circuitry configured to: in a normal operational mode, cause the negative pressure source to supply negative pressure to the wound; and in a test mode in which performance of the device is being verified:determine that a canister has been positioned in the fluid flow path; and in response to determining that the canister has been positioned in the fluid flow path: activate the negative pressure source to establish a first negative pressure level in the fluid flow path, monitor a flow in the fluid flow path using at least one of measurements of the at least one pressure sensor or activity of the negative pressure source, and indicate that a flow test has been completed successfully in response to at least one of determining that the flow in the fluid flow path satisfies a flow threshold or that the first negative pressure level has been established in the fluid flow path; and subsequent to at least one of determining that the flow in the flow path satisfies the flow threshold or the first negative pressure level has been established in the fluid flow path and without allowing pressure in the fluid flow path to reach atmospheric pressure, pause operation of the negative pressure source for a first duration of time, monitor a negative pressure decay in the fluid flow path using measurements by the at least one pressure sensor, and indicate that a leak test has been completed successfully in response to determining that the negative pressure decay over a second duration of time subsequent to the first duration of time satisfies a negative pressure decay threshold.

17. The device of claim 16, wherein the control circuitry is further configured to, in the test mode: subsequent to completion of the leak test, activate the negative pressure source to establish a second negative pressure level in the fluid flow path that exceeds the first negative pressure level and corresponds to an unsafe level of negative pressure and indicate that an excessive pressure test has been performed successfully in response to determining that the negative pressure source has been deactivated subsequent to establishing the second negative pressure level.

18. The device of claim 17, wherein the control circuitry is configured to, in the test mode, perform the excessive pressure test subsequent to completion of the leak test and prior to pressure in the fluid flow path reaching atmospheric pressure.

19. The device of any claims 16 to 18, wherein the control circuitry is configured to determine that the canister has been positioned in the fluid flow path in response to receiving data from the canister.

20. The device of claim 19, wherein the control circuitry is further configured to: determine a volume of the canister from the data; and adjust a parameter of the flow test based on the volume, the parameter of the flow test comprising a time duration for determining that the first negative pressure level has been established in the fluid flow path.

21. The device of claim 19 or 20, wherein the control circuitry is further configured to: determine a volume the canister from the data; and adjust a parameter of the leak test based on the volume, the parameter of the leak test comprising the negative pressure decay threshold.

22. The device of any of claims 16 to 21, wherein the control circuitry is further configured to, in the test mode: indicate that the flow test and the leak test have not been completed successfully in response to determining that the flow in the fluid flow path does not satisfy the flow threshold or that the first negative pressure level has not been established in the fluid flow path.

23. The device of any of claims 16 to 22, wherein the control circuitry is further configured to, in the test mode, provide an indication to a user to position the canister in the fluid flow path.

24. The device of any of claims 16 to 23, wherein the control circuitry is configured to, in the test mode:indicate that the flow test has been completed successfully in response to determining that a pressure differential measured by the at least one pressure sensor across a flow restrictor positioned in the fluid flow path is indicative of the flow that satisfies the flow threshold; or indicate that the flow test has been completed successfully in response to determining that an electric current provided to an actuator of the negative pressure source is indicative of the flow that satisfies the flow threshold.

25. The device of any of any of claims 16 to 24, wherein the control circuitry is configured to, in the test mode: operate the negative pressure source without operating any valve positioned in the fluid flow path.

26. The device of any of claims 16 to 25, wherein: the flow threshold is indicative of a duration of time from activation of the negative pressure source to establishing the first negative pressure level in the fluid flow path; and determining that the flow in the fluid flow path satisfies the flow threshold comprises determining that a duration of time from activation of the negative pressure source to providing peak electrical power to the negative pressure source satisfied the flow threshold.

27. The device of any claims 16 to 26, wherein the control circuitry is further configured to, in the test mode: determine that the canister has not been positioned in the fluid flow path; and terminate the test mode in response to determining that the canister has not been positioned in the fluid flow path.

28. The device of claim 27, wherein the control circuitry is further configured to: subsequent to terminating the test mode, prevent the negative pressure source from supplying negative pressure wound therapy.

29. A method of operating the negative pressure wound therapy device of any one of the preceding claims.

30. A non-transitory computer readable medium storing instructions that, when executed by at least one processor, cause the at least one processor to operate the negative pressure wound therapy device of any one of the preceding claims.

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