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Title:
STATUS INDICATION USING A DISPOSABLE ACCESSORY FOR NEGATIVE PRESSURE WOUND THERAPY AND TREATMENT
Document Type and Number:
WIPO Patent Application WO/2024/033313
Kind Code:
A1
Abstract:
A negative pressure wound therapy apparatus can include a device housing and a canister including at least one exterior surface defining an interior volume configured to store fluid removed from a wound. The canister can be configured to be removably attached to the device housing and provide a visual indication that the canister has been correctly attached. A handpiece for a wound debridement system can include a housing configured to be coupled to a console and treat a wound by applying a liquid jet to the wound and a visual indicator supported by the housing and configured to provide: a first indication that the housing has been correctly coupled to the console, a second indication responsive to a duration of time following activation of treatment of the wound satisfying a duration threshold, and a third indication responsive to a pressure level of the liquid jet satisfying a threshold pressure level.

Inventors:
QUINTANAR FELIX (GB)
Application Number:
PCT/EP2023/071838
Publication Date:
February 15, 2024
Filing Date:
August 07, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
SMITH & NEPHEW (GB)
International Classes:
A61M1/00; A61B17/3203; A61M3/02
Domestic Patent References:
WO2021122454A12021-06-24
WO2018150268A12018-08-23
WO2018167199A12018-09-20
Foreign References:
US20210386925A12021-12-16
US8801685B22014-08-12
US20120116334A12012-05-10
US20110213287A12011-09-01
US20110282309A12011-11-17
US20120136325A12012-05-31
US9084845B22015-07-21
EP2020078376W2020-10-09
US20210386925A12021-12-16
US9737649B22017-08-22
US20170216501A12017-08-03
US20200069850A12020-03-05
EP2022060459W2022-04-20
Attorney, Agent or Firm:
GUY, Mark (GB)
Download PDF:
Claims:
WHAT IS CLAIMED IS:

1. A negative pressure wound therapy apparatus comprising: a device housing supporting a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing; a canister comprising at least one exterior surface defining an interior volume configured to store at least some fluid removed from the wound, the canister configured to be removably attached to the device housing, and the canister configured to provide a visual indication that the canister has been correctly attached to the device housing; and a light sensor configured to detect ambient light after it has at least partially passed through the canister, the visual indication being adjusted responsive to an intensity of ambient light detected by the light sensor.

2. The negative pressure wound therapy apparatus of any of the preceding claims, wherein the canister comprises a light source configured to transmit light associated with the visual indication through at least a portion of the interior volume, thereby causing a provision of the visual indication to a user via the canister.

3. The negative pressure wound therapy apparatus of any of the preceding claims, further comprising at least one light guide supported by the canister and configured to guide ambient light to the light sensor.

4. The negative pressure wound therapy apparatus of claim 3, wherein the at least one light guide is positioned at least partially along the at least one exterior surface of the canister.

5. The negative pressure wound therapy apparatus of any of claims 3 or 4, wherein the at least one light guide comprises a plurality of light guides positioned at least partially along opposing exterior surfaces of the canister.

6. The negative pressure wound therapy apparatus of any of the preceding claims, wherein the canister is configured to provide a plurality of visual indications associated with normal operation, improper attachment of the canister, estimated amount of fluid stored in the interior volume of the canister, or negative pressure level.

7. A canister for using with a negative pressure wound therapy device, the canister comprising: a housing comprising at least one exterior surface defining an interior volume configured to store at least some fluid removed from a wound, the housing configured to be removably attached to a negative pressure wound therapy device, the housing configured to provide a visual indication that the housing has been correctly attached to the device; and a light sensor configured to detect ambient light after it has at least partially passed through the housing, the visual indication being adjusted based on an intensity of ambient light detected by the light sensor.

8. The canister of any of the preceding claims, wherein the housing comprises a light source configured to transmit light associated with the visual indication through at least a portion of the interior volume, thereby causing a provision of the visual indication to a user via the housing.

9. The canister of any of the preceding claims, further comprising at least one light guide supported by the housing and configured to guide ambient light to the light sensor.

10. The canister of claim 9, wherein the at least one light guide is positioned at least partially along the at least one exterior surface of the housing.

11. The canister of any of claims 9 or 10, wherein the at least one light guide comprises a plurality of light guides positioned at least partially along opposing exterior surfaces of the housing.

12. The canister of any of the preceding claims, wherein the housing is configured to provide a plurality of visual indications associated with normal operation, improper atachment of the housing, estimated amount of fluid stored in the interior volume of the housing, or negative pressure level.

13. A handpiece for a wound debridement system, the handpiece comprising: a housing configured to be coupled to a console and treat a wound by applying a liquid jet to the wound, the liquid jet provided at positive pressure; and at least one first visual indicator supported by the housing, the at least one first visual indicator configured to: provide a first indication that the housing has been correctly coupled to the console; provide a second indication responsive to a duration of time following activation of treatment of the wound satisfying a duration threshold; and provide a third indication responsive to a pressure level of the liquid jet satisfying a threshold pressure level.

14. The handpiece of any of the preceding claims, wherein the first, second, and third indications are different.

15. A kit comprising the handpiece of any of the preceding claims and the console, the console comprising at least one second visual indicator configured to provide at least one of the first indication, second indication, or third indication.

16. The kit of claim 15, wherein the at least one second visual indicator comprises a ring.

Description:
STATUS INDICATION USING A DISPOSABUE ACCESSORY FOR NEGATIVE PRESSURE WOUND THERAPY AND TREATMENT

Technical Field

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

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

A negative pressure wound therapy apparatus can includes a device housing supporting a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing. The apparatus can include a canister with at least one exterior surface defining an interior volume configured to store at least some fluid removed from the wound. The canister can be configured to be removably attached to the device housing. The canister can be configured to provide a visual indication that the canister has been correctly attached to the device housing.

The negative pressure wound therapy apparatus of any of the preceding paragraphs and/or any of the apparatuses, systems, or devices disclosed herein can include one or more of the following features. The canister can include a light source configured to transmit light associated with the visual indication through at least a portion of the interior volume, thereby causing a provision of the visual indication to a user via the canister. The apparatus can include light sensor configured to detect ambient light after it has at least partially passed through the canister. The visual indication can be adjusted based on an intensity of ambient light detected by the light sensor. The apparatus can include at least one light guide supported by the canister and configured to guide ambient light to the light sensor. The at least one light guide can be positioned at least partially along the at least one exterior surface of the canister. The at least one light guide can include a plurality of light guides positioned at least partially along opposing exterior surfaces of the canister. The canister can be configured to provide a plurality of visual indications associated with normal operation, improper attachment of the canister, estimated amount of fluid stored in the interior volume of the canister, or negative pressure level.

A handpiece for a wound debridement system can include a housing configured to be coupled to a console and treat a wound by applying a liquid jet to the wound, the liquid jet provided at positive pressure. The handpiece can include at least one visual indicator supported by the housing. The at least one visual indicator can be configured to provide a first indication that the housing has been correctly coupled to the console. The at least one visual indicator can be configured to provide a second indication responsive to a duration of time following activation of treatment of the wound satisfying a duration threshold. The at least one visual indicator can be configured to provide a third indication responsive to a pressure level of the liquid jet satisfying a threshold pressure level. The first, second, and third indications can be different.

A kit can include the handpiece of any of the preceding paragraphs and/or any of the handpieces described herein and a console. The console can include at least one second visual indicator configured to provide at least one of the first indication, second indication, or third indication. At least one second visual indicator can be a ring.

A canister for using with a negative pressure wound therapy device can include a housing with at least one exterior surface defining an interior volume configured to store at least some fluid removed from a wound. The housing can be configured to be removably attached to a negative pressure wound therapy device. The housing can be configured to provide a visual indication that the housing has been correctly attached to the device. The canister of any of the preceding paragraphs and/or any of the canisters, systems, or devices disclosed herein can include one or more of the following features. The housing can include a light source configured to transmit light associated with the visual indication through at least a portion of the interior volume, thereby causing a provision of the visual indication to a user via the housing. The canister can include a light sensor configured to detect ambient light after it has at least partially passed through the housing. The visual indication can be adjusted based on an intensity of ambient light detected by the light sensor. The canister can include at least one light guide supported by the housing and configured to guide ambient light to the light sensor. The at least one light guide can be positioned at least partially along the at least one exterior surface of the housing. The at least one light guide can include a plurality of light guides positioned at least partially along opposing exterior surfaces of the housing. The housing can be configured to provide a plurality of visual indications associated with normal operation, improper attachment of the housing, estimated amount of fluid stored in the interior volume of the housing, or negative pressure level.

Disclosed herein are methods of operating a negative pressure wound therapy device, handpiece, or canister of any of the preceding paragraphs and/or any of the devices, apparatuses, systems, handpieces, or canisters disclosed herein.

Disclosed herein 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.

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

Figure 1 A illustrates a negative pressure wound therapy system.

Figure IB illustrates another negative pressure wound therapy system.

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

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

Figure 2D illustrates a canister for use with a negative pressure wound therapy device.

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

Figure 4 illustrates another negative pressure wound therapy system.

Figure 5 illustrates a liquid jet debridement and wound bed preparation system.

Figure 6A-6B illustrate a console of a liquid jet debridement and wound bed preparation system.

DETAILED DESCRIPTION

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.

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.

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, or removing 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.

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.

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.

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

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 can be used to removably and selectively couple a conduit or tube of the device 110’ with the conduit 108’.

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.

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. 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.

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.

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.

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.

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’.

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, Bluetooth low energy (BLE), Near-Field Communication (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.

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.

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 conduit 108 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.

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.

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.

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 or occlusion 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.

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.

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.

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 lower channel of the bridge portion 130 by passing through the apertures through the distal ends of the upper, intermediate, and lower layers. 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.

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, -125 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, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -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.

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).

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.

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 or pause 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.

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. For example, therapy setting adjustment can be locked/unlocked via the lock/unlock control 188. 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.

The display 172, which can be a screen such as an LCD 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.

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.

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 therapy delivery, 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.

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.

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 142 (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 142 can be used to connect with the conduit 108.

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.

Figure 2D illustrates a canister 162 that is configured to be illuminated. One or more light guides or light pipes 250, 251, 252, and 253 can protrude into the canister 162. The light pipes can be the same types or can be a combination of different types of light pipes. One or more light pipes can transmit light generated by one or more light sources mounted on the bottom surface of the pump assembly 160 (or another suitable surface) into another portion or location in the canister. For example, one or more light pipes can transmit the generated light into the canister so that the entire or substantially entire surface of the canister lights up to provide one or more visual indications to the user. In some cases, lights pipes can transmit the light to each of the side surfaces of the canister and the bottom surface of the canister. In some cases, multiple light pipes can be used to transmit light to multiple locations on larger surfaces of the canister.

The one or more light pipes 250, 251, 252, or 253 can be located on the canister-device interface. The one or more light pipes can be positioned at least partially along the one or more exterior surfaces of the canister housing. For example, the one or more light pipes can be positioned in the interior volume of the canister 162 along the one or more exterior surfaces. The one or more light pipes can comprise a plurality of light pipes positioned at least partially along opposing one or more exterior surfaces of the canister. The one or more light pipes can additionally or alternatively include optical diffusers to scatter the light on the sidewalls of the canister. The one or more light pipes can additionally or alternatively connect directly with the sidewalls to prevent the exudate obscuring the light. Further details of providing status indication using the canister 162 are described in U.S. Patent Publication No. 2021/0386925, which is incorporated by reference in its entirety.

The canister 162 can be configured to indicate proper attachment of the canister to the pump assembly 160. For instance, properly attached canister could be illuminated green (or another suitable color). As another example, an improperly attached canister could be illuminated orange (or another suitable color) or not illuminated at all. Canister illumination can be used to indicate or corroborate when the canister 162 has been properly attached to the pump assembly 160 (including during application if negative pressure wound therapy). The color indication may be different to the standardized yellow/cyan/red indication specified in IEC 60601-1-8 standard.

Light sensing and dimming capability can be implemented by the canister 162. For instance, illumination can be dimmed at night (to not disrupt rest or sleep) or increased in bright, sunny environments. Ambient light can be captured as it passes through the canister and funneled by one or more light pipes to an ambient light sensor. Such optical interface of capturing ambient light can be more accurate than having a light sensing behind a top display of the pump assembly 162 or transparent front enclosure of the pump assembly 162. The angle of light captured by the ambient light sensor can be augmented with a large canister housing acting as a light pipe. Dimming control can be implemented when the device is at least partially enclosed in a carry bag provided that a visual opening for viewing the device (or at least the canister 162) is available. The opening can serve as the main light pipe for ambient light sensing.

The canister 162 can be configured to indicate operational status, such as level of exudate collected in the canister. For example, use of different colors can provide indication of the canister 162 being full, half full, or empty. The canister 162 can be configured to indicate negative pressure level provided to the wound (or detected at the wound). This can be accomplished by using different colors.

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 is not 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.

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.

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.

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.

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, and the main controller 310 can coordinate the activity of other processors, such as the pump controller 370, one or more communications controllers 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.

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. A control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump controller 370 can perform flow rate calculations and detect alarms. The pump controller 370 can communicate information to the main controller 310. The pump controller 370 can be a low- power processor.

Any of the one or more communications controllers 330 can provide connectivity (such as, a wired or wireless connection 332). The one or more communications controllers 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. Any of the one or more transceivers 340 can function as a communications controller. In such case, the one or more communications controllers 330 can be omitted. Any of the one or more transceivers 340 can be connected to one or more antennas that facilitate wireless communication. The one or more communications controllers 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), NFC, Bluetooth connectivity (or BLE), 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.

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

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. Using the connectivity provided by the one or more communications controllers 330, the control system 300 can upload any of the data stored, maintained, or tracked by the control system 300 to a remote computing device, such as 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.

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

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.

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).

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).

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.

Wound Debridement with Smart Disposable

A wound debridement system can be used to promote wound healing. A debridement system, such as Smith & Nephew Versajet Hydrosurgery system, can utilize a high pressure water or other liquid for debridement. In some cases, a debridement system can use a high pressure saline waterjet for debridement and wound bed preparation. Referring to Figure 5, a liquid jet debridement and wound bed preparation system can include two saline tubes 800, 802 extending from an inlet 804 of a pump handle 806. The pump can be a piston pump. A handpiece (or hand piece or handset) 812 can extend from an inlet 814 of the pump handle 806. The handpiece 812 can be configured to treat a wound with liquid pressure from a liquid jet of a fluid. For example, a pressurized liquid jet (or stream) can be emitted from the handpiece 812. Saline tube 800 can terminate in a spike 807 that connects to a saline bag 808. Saline tube 802 can be open to atmosphere or include a spike that connects to a second saline bag. In the system of Figure 5, air can be expelled from the open tube 802 with a clamp 811 in an open position when there is an airlock in the system. Referring to Figures 6A-6B, a console 950 of a liquid jet debridement and wound bed preparation system includes a display 952 (such as, an LCD screen) for displaying device state information, for example, power level, procedure running time, out-patient/operating room mode, and service reminders. The console 950 can include an interface 954 for receiving the pump 956 (which can be a piston pump), and a reader 958 and antenna 960, which can identify a tag 962 installed in a handpiece (such as, the handpiece 812). The identification can be performed using RFID or near-field (such as, NFC), in which case the tag 962 can be an RFID or NFC tag. As described herein, identification can be performed using infrared (such as, IrDA), vibration, or the like

The handpiece 812 can be configured as a smart disposable and store status data. Such handpiece 812 can facilitate system level activation and deactivation when connected to the console 950. The status data can include the exact pressure of the liquid jet of the handpiece 812. Such pressure can be used for calibration to provide a more precise pressure during use or to ensure patient safety. For instance, in the event that the status data indicates that the pressure of the handpiece is incompatible with the console 950, debridement can be disabled. This can prevent use of the liquid jet debridement with an improper pressure. As described herein, status data can include an indication of the handpiece 812 having been used on a patient. Responsive to such indication, the console 950 can disable debridement. This can facilitate ensuring that the handpiece 812 is not used for providing debridement to a different patient (for instance, without having been cleaned and sterilized). As described herein, end of life of the handpiece 812 can be monitored and detected.

The status data can include the exact procedure running time of disposal of the liquid jet from the handpiece 812. Such time can be used for calibration to provide a more precise duration of time to ensure patient safety. For instance, in the event that the status data indicates that the duration of time is greater than a predetermined maximum time, a visual indicator and/or an acoustic indicator can alert the user to the exact duration of time of the procedure. For instance, in the event that the status data indicates that the duration of time of procedure is outside a maximum allowed time of procedure, debridement can be disabled.

The handpiece 812 can communicate status via one or more visual indications. For example, the handpiece 812 or a portion of the handpiece 812 can be illuminated when is fully engaged with the console 950. For instance, the handpiece 812 can include a ring. As another example, the handpiece 812 can change the color to reflect time of use or a pressure failure. Pressure levels can be indicated through the handpiece 812. The tubing and/or the saline water with optical termination can be illuminated from the console 950 (such as, via the interface 954 providing illumination). One or more time of use, pressure, or end of life of the handpiece 812 can be indicated. Advantageously, user (such as, doctor) would not need to remember the pressure level and the time of use, but instead determine the pressure level in real time by observing the color of the handpiece 812.

In some instances, visual indication can be additional or alternatively provided by the console 950. For example, a ring 955 on the console 950 can light up in different colors.

Console can store as part of status data one or more of system failures with the handpiece, priming problems by measuring the time prior to proper procedure, duration of setting up, temperature during procedure, location, hand vibration level (which can be relevant safety of the user), procedure duration, failure(s) or intermittence(s), pressure decay, confirmation of pressure settings for a type of handpiece, noise acoustic value, flow, exhaust flow, misuse data, or the like.

In some cases, it may be important to ensure that the handpiece 812 is sterile when it is being used to treat a wound. The handpiece 812 can be positioned in a sterile package and thus remain sterile while packaged. However, when the handpiece 812 is taken out of the packaging, it can lose sterility after being exposed to environment outside of packaging (such as, atmosphere) for a period (or duration) of time following opening of the packaging. For instance, the period of time can be about 15 minutes (or less or more) at room temperature. As a smart disposable, the handpiece 812 can implement one or more mechanisms that monitor the period of time and provide a loss of sterility indication. One such mechanism can be a chemical-based trigger. For example, the handpiece 812 can include a reactive element or material that changes its state when exposed to air (as a result of one or more of oxidation or being exposed to humidity). In some cases, oxidation be preferable as the oxygen content of a room typically does not vary as much as humidity or temperature.

The reactive material can be conductive, such as aluminum or iron. When the reactive material is exposed to air, it can lose its conductivity as a result of being oxidized (or being exposed to humidity). Responsive to the expiration of the period of time, the reactive material can become non-conductive (for instance, conductive iron can become non-conductive iron rust). The reactive material can be part of an electronic circuit that changes its state (such as, becomes an open circuit) as a result of the transition of the material from being conductive to becoming non-conductive. In some cases, oxidation (or humidity) can cause a mechanical break in a conductive pathway. For instance, a conductive wire, membrane, or the like can become broken. Such change of the state of the electronic circuit can be detected by the console 950. As a result, connection with of a non-sterile handpiece 812 (such as, open circuit) can be detected by the console, treatment can be disabled, and an optional indication can be provided to the user.

In some implementations, another such mechanism can be an enzymatic-based trigger. For example, an electronic circuit can include one or more photodiodes coated (or otherwise coupled) with a material that changes one or more properties (such as, transparency, color, or the like) responsive to being exposed to the environment. The material can change the one or more properties as a result of being cured when exposed to the environment. For example, the material can be silicone. Responsive to the expiration of a period of time (which may the same or different as the period of time in described in the preceding paragraph), the material can change the one or more properties that would cause the photodiode to detect (or stop detecting) light, which would lead to the change of the state of the electronic circuit. The material can be a color or polarizing filter for the one or more diodes. As a result, connection with of a non- sterile handpiece 812 (such as, open or closed circuit) can be detected by the console, treatment can be disabled, and an optional indication can be provided to the user.

While detection of loss of sterility is described in connection with the handpiece 812, approaches disclosed herein can be applied to any sensor-integrated substrates (such as, 500A or 500B), canisters, or other smart disposables described herein. The wound debridement system can include one or more features disclosed International Application No. PCT/EP2022/060459, which is incorporated by reference in its entirety.

Conclusion

Any of the smart disposables described herein, such as the canister 162 or the handpiece 812, can include one or more memories and a communication circuitry. One or more memories can store information related to provision of therapy (such as, operational status, history, or the like), instructions or information related to troubleshooting, or instructions or information related to disposing a smart disposable after provision of therapy. The communication circuitry can implement one or more short range communication protocols that facilitate rapid retrieval (or storage) of information, such as RFID, NFC, or the like. These protocols can operate via a tap or the like.

Advantageously, smart disposable implementations described herein can improve patient safety (for instance, by facilitating provision of alert(s)), facilitate compliance with therapy protocols(s) and applicable regulation(s) (for instance, by maintaining history of use of a smart disposable), improve waste management (for instance, by storing instructions for disposing in memory), or facilitate troubleshooting (for instance, by providing information about the state of the smart disposable).

Any of the smart disposables described herein, such as the canister 162 or the handpiece 812, can be configured for use with a single patient. One or more memories can store an indicator that a smart disposable has been used on a patient, thereby indicating that the smart disposable cannot be used on a different patient. In other example, one or more memories can store an indicator that a smart disposable is reusable and can be used with multiple patients.

One or more memories can store information indicating a smart disposable is not a counterfeit. This information can be used to verify that the smart disposable can be used for treatment prior to initiation of the treatment.

Other Variations

In some implementations, dressing with fiber optics can augment or replace one or more user interface described herein. 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 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. The systems and methods disclosed herein are not limited to medical devices and can be utilized by any electronic device.

Any of transmission of data described herein can be performed securely. For example, one or more of encryption, https protocol, secure VPN connection, error checking, confirmation of delivery, or the like can be utilized.

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, 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 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.

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, can 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.

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. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For instance, the 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, or dedicated 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.

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.

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.

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, such conjunctive 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.

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.

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. 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.