Patent Application
20240165318
This application claims priority to Patent Application No. EP 21382346.1, filed on Apr. 21, 2021, which are hereby incorporated by reference in its entirety and made part of this disclosure.
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.
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.
A negative pressure wound therapy device can include a device housing, a negative pressure source supported by the device housing, the negative pressure source configured to provide negative pressure to a wound covered by a wound dressing, and a canister configured to be in fluid communication with the negative pressure source and the wound dressing, the canister can comprise a canister housing configured to store fluid aspirated from the wound, a cap connected to the canister housing and configured to be connected to the device housing when the canister is removably attached to the device housing, and a fluid level sensor supported by the cap, the fluid level sensor comprising a pair of arms extending into an interior of the canister housing and configured to be in fluid communication with fluid aspirated from the wound, wherein the fluid level sensor is configured to detect a completed electrical circuit when the fluid aspirated from the wound comes into contact with the pair of arms of the fluid level sensor, and wherein the fluid level sensor is configured to detect a canister full condition when the electrical circuit is completed, and an electronic circuitry configured to detect a state of the fluid level sensor and provide an indication of a status of the canister.
The negative pressure wound therapy device 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 status of the canister can comprise the canister full condition. The electronic circuitry can be supported by the device housing. The fluid level sensor can be configured to communicate with the electronic circuitry using Near Field Communication (NFC). The fluid level sensor can comprise a Near Field Communication (NFC) tamper detection circuitry, and wherein responsive to the fluid aspirated from the wound completing a circuit in the NFC tamper detection circuitry, the fluid level sensor is configured to detect the canister full condition. The electronic circuitry can comprise an antenna configured to communicate with the NFC tamper detection circuitry and facilitate transmission and reception of data.
A canister for negative pressure wound therapy can include a canister housing configured to store fluid removed from a wound and a fluid level sensor comprising a pair of arms extending into an interior of the canister housing and configured to be in fluid communication with fluid removed from the wound, wherein the fluid level sensor is configured to detect a completed electrical circuit when fluid within the interior of the canister comes in contact with the pair of arms of the fluid level sensor, and wherein the fluid level sensor is configured to detect a canister full condition when the electrical circuit is closed, wherein a reader is configured to wirelessly detect a state of the fluid level sensor and provide an indication of a status of the canister.
The negative pressure wound therapy device or canister for negative pressure wound therapy 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 status of the canister can comprise the canister full condition. The fluid level sensor can be configured to communicate with the reader using Near Field Communication (NFC). The fluid level sensor can comprise a Near Field Communication (NFC) tamper detection circuitry, wherein responsive to the fluid removed from the wound completing a circuit in the NFC tamper detection circuitry, the fluid level sensor is configured to detect the canister full condition. The reader can comprise an antenna configured to wirelessly communicate with the NFC tamper detection circuitry. The canister can further comprise a cap connected to the canister housing and configured to be connected to a negative pressure wound therapy device when the canister housing is removably attached to the negative pressure wound therapy device, wherein the fluid level sensor is supported by the cap.
A negative pressure wound therapy device can include a device housing, a negative pressure source supported by the device housing, the negative pressure source configured to provide negative pressure to a wound covered by a wound dressing, a device coil supported by the device housing, and a canister comprising a canister housing configured to collect fluid removed from the wound, a plurality of electrodes extending into the canister housing, and a canister coil connected to the plurality of electrodes and configured to be in electrical communication with fluid within the canister, wherein the canister coil is configured to conduct a current when the fluid in the canister comes into contact with the plurality of electrodes, and wherein the current in the canister coil causes a change of current in the device coil indicating a fluid level of fluid collected in the canister housing, and an electronic circuitry configured to detect the change of current and generate an indication of the fluid level.
The negative pressure wound therapy device 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 electronic circuitry can be supported by the device housing.
A canister fluid level detection system can include a device electronic circuitry comprising a device coil, and a canister comprising a canister housing configured to collect fluid removed from a wound, and a canister coil configured to be in electrical communication with fluid within the canister, wherein the canister coil is configured to conduct a current when the fluid in the canister reaches a fluid level threshold, and wherein the current in the canister coil causes a change in a current conducted by the device coil indicating a fluid level within the canister, wherein the device electronic circuitry is configured to detect the change in the current conducted by the device coil and generate an indication of the fluid level.
Disclosed herein 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.
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.
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, burns, 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.
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.
With reference to
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®, or Gehring 879®) 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®) 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 μm. Preferably, the filter can exclude particles larger than 1.0 μm, and more preferably, particles larger than 0.2 μm. 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, polyethersulfone, 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. Pat. 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. Pat. 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.
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. In some cases, when the lock/unlock button 188 is in the locked state, some buttons or portions of the display may be available and able to cause the pump assembly 160 to change any display functions or performance functions of the device while other buttons or portion of the display are not able to cause the pump assembly 160 to change any display functions or performance functions of the device. For example and without limitation, when the lock/unlock button 188 is in the locked state, the menu navigation may still be available and able to be used or activated, but the commands that adjust therapy settings are greyed out, and not able to be used or not able to cause a change of function 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.
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
The canister 162 can be selectively coupleable and removable from the pump assembly 160. With reference to
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′.
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 (MIRAM), 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 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.
Any of the negative pressure wound therapy devices described herein can include one or more features disclosed in U.S. Pat. No. 9,737,649 or U.S. Patent Publication No. 2017/0216501, each of which is incorporated by reference in its entirety.
The system 400 can be similar to the system 100′ with the exception that multiple wounds 104a and 104b 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
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
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.
A negative pressure therapy system can utilize a canister status detection system. The canister status detection system can function as a fluid detection system to detect the volume of fluid (or liquid) within the canister (or fill level of the canister) or whether the canister has reached a full or almost full level of fluid (or liquid). One or more alarms or alerts can be generated responsive to the detection. A canister full or nearly full alert can be important for a negative pressure therapy system because it can allow a healthcare professional or a user to replace their canister and continue therapy with the least amount of interruptions (such as, not having to worry about the device suddenly sounding a canister full or canister blockage alarm).
Canister fluid detection systems may rely on comparing peak-to-peak voltage measurements obtained from a pressure sensor to threshold values over a certain period to then trigger the canister full or nearly full alert. In some cases, this approach can be unreliable and can have a low tolerance for variations in conditions. For instance, nuisance alarms may be generated when the canister is empty but there are restrictions in flow from the filter assembly.
Accordingly, it can be useful to have a more accurate detection method for detecting a full canister condition or a nearly full canister condition that reduces the nuisance alarms. The canister can have a canister detection system that allows for fluid detection that uses a device that communicates with fluid within the canister to detect when the fluid reaches a threshold level within the canister. The canister can incorporate the fluid level sensor device within a surface of the canister. For example, the canister can incorporate a fluid level detector (also referred to as a fluid level sensor) within a cap portion of the canister system.
The canister cap 510 can include a housing formed from a cap top 512 and a cap bottom 514. The canister cap 510 can include a filter 516 positioned between the cap top 512 and the cap bottom 514. A fluid level sensor 518 can be included within the canister cap 510 to communicate with the interior of the canister. The fluid level sensor 518 can include two arms 520 that extend from the cap bottom 514 into the interior of the canister. The arms 520 can be made of conductive material (such as, conductive metal). The arms 520 can be used to interact with the fluid within the canister and create a completed circuit when the arms of the fluid level sensor 518 are in communication with fluid in the canister, which can thereby detect a canister full condition. The fluid level sensor can detect a completed electrical circuit when fluid within the interior of the canister is in contact with the arms of the fluid level sensor. For example, the fluid level sensor can detect fluid collection capacity within the canister when the circuit is open and a canister full condition when the circuit is closed. In other examples, the fluid level sensor can detect fluid collection capacity within the canister when the circuit is closed and a canister full condition when the circuit is open. A reader within the negative pressure wound therapy device can communicate with the fluid level sensor and, responsive to the canister full condition being detected, can provide an indication of a condition of the canister. The reader can also cause a change in the provision of negative pressure wound therapy (such as, cease application of negative pressure) or cause an alert (such as, a canister full alert) in response to the canister full condition being detected by the fluid level sensor. The reader can be positioned within a housing of the negative pressure wound therapy device, such as the pump assembly 160.
While the fluid level sensor 518 is shown with two downwardly extending arms, the fluid level sensor can include only one arm or any number of arms that extend into the interior of the canister to detect fluid within the canister. In some cases, the fluid level sensor can have any number or extensions or arms as long as at least two separate tracks of conductive material (or electrodes) are present to form the completed electrical circuit.
The cap assembly 1820 can include an upper filter 1826 and an odor filter 1828. The upper filter 1826 can be a hydrophobic filter and/or a dust filter. The odor filter 1828 can also be configured to filter out bacteria from the air flowing through the filter 1828. The upper filter 1826 can be used to prevent any liquids from escaping from the canister body 1902 through the opening 1824 in the first cap member 1822 and can be positioned on either or both sides of the odor filter 1828. The odor filter 1828 can include any suitable filter membrane or material, including carbon. For example and without limitation, some arrangements of the odor filter 1828 can include compressed carbon.
The cap assembly 1820 can also include a base cap support 1830 that can be configured to provide a support surface for one or more of the filters 1826, 1828 and/or other components of the cap assembly 1820. The base cap support 1830 be configured to block or shield the one or more filters 1826, 1828 from exudate and/or other liquids within the canister. In some arrangements, the base cap support 1830 can have a main surface 1840 that can overlap or cover at least a portion of the filter 1828 so as to inhibit or prevent liquid or exudate within the canister 1902 from splashing onto at least a portion of the odor filter 1828 and/or the upper filter 1826. For example and without limitation, the main surface 1840 can overlap at least 80% of a surface area of a lower main surface of the odor filter 1828, or at least 90% of a surface area of the lower main surface of the filter 1828, or from at least 60% or approximately 60% to 90% or approximately 90% of a surface area of the first main surface of the filter 1828.
The base cap support 1830 can have one or more openings 1844 formed therein that air and/or other gases can pass through as the air and/or other gases are being drawn through the cap assembly 1820 when the pump is in operation. The cap assembly 1820 can be configured such that all air or gas or substantially all air or gas coming from the canister body 1802, 1902 must pass through the filter 1828 before passing through the opening 1844 in the cap assembly 1820. In some arrangements, there can be 3 or more, 4 or more, 5 or more openings 1844 formed in the base cap support 1830. The openings 1844 can be formed in walls that are perpendicular to a top main surface of the canister body 1802, 1902 so that exudate is less likely to splash or otherwise pass through the openings 1844—e.g., the openings 1844 can be formed in vertical walls of the base cap support 1830.
The cap assembly 1820 can include a fluid level sensor 1834 to detect the fluid level within the canister and/or if the canister is full or nearly full. The fluid level sensor 1834 can include two downwardly extending arms 1832. The fluid level sensor 1834 and arms 1832 can be similar to the fluid level sensor 518 and arms 520 described with reference to
The filter assembly 1620 can be supported at a lower end or interior end by a base support 1650 that can be configured to provide a support surface for the hydrophobic filter 1640 and/or other components of the filter assembly 1620. The base support 1650 can have one or a plurality of openings 1652 through a main surface 1653 thereof through which air/or other gases can pass as air and/or other gases are being drawn by the pump through the filter assembly 1620.
Some arrangements of the base support 1650 can optionally be configured to support a sensor or sensors and/or other electronics components. With reference to
The support tabs 1655 can extend away from the support surface 1654 toward a bottom of the canister. The support tabs 1655 can have a flange or shield 1657 at a distal end of each of the support tabs 1655 to inhibit liquid (e.g., wound exudate) within the canister from splashing onto the support tabs 1655 and/or the electronics components 1658 (such as, electrodes) and from exposure to a gel packet 1622 or a mound of gelling agent. In some arrangements, the flanges 1657 can each extend at an angle (e.g., at a perpendicular angle) away from the support tabs 1655. In other arrangements, the flanges 1657 can extend at an angle that is greater than or less than 90 degrees relative to the support tabs 1655.
In some arrangements, the electronics components 1658 can optionally be a fill level sensor or a canister full sensor as described herein. For example, the fill level sensor can have a wireless transmitter thereon (that can optionally be a near field communication transmitter) that can be configured to communicate status information (such as, detected fill level or whether the canister is full) to a wireless receiver in the pump assembly or otherwise, or can have a wired connection through the canister in communication with the pump assembly. The flanges or shields 1657 can reduce or prevent fluid from splashing onto the fill level sensor or canister full sensor to prevent false detection. In some cases, the flanges or shields 1657 can be utilized to shield the electronics from the gelling agent bag or fluid solidifier within the canister. The fill level sensor or canister full sensor can be adhered to or otherwise fixed or attached to the support surface 1654 and/or the support tabs 1655. In other cases, the fill level sensor or canister full sensor can rest on at least a portion of the support surface 1654 and/or the support tabs 1655.
The base support 1650 can have an annular flange 1660 around a perimeter thereof and a recessed portion 1662 that can be configured to receive and support at least the hydrophobic filter 1640. The base support 1650 can be welded, adhered, or otherwise coupled within an inside surface of the first body portion 1702a of the canister body 1702 of the canister assembly 1700, optionally, before the first and second portions 1702a, 1702b of the body 1607 are coupled together.
The fill level sensor or canister full sensor can be overmoulded into the canister assembly. In other cases, the fill level sensor or canister full sensor can be insert moulded into the canister assembly. The fill level sensor or canister full sensor can be screen printed onto the canister assembly, for example, the electrical tracks can be screen printed onto the canister assembly. These techniques can be helpful during assembly and manufacture because these methods can eliminate the need to put the fill level sensor or canister full sensor into the canister. The fill level sensor or canister full sensor can be adhered to the support surface and/or the support tabs by ultrasonic welding or an adhesive. This method can take advantage of manufacturing methods for ultrasonic welding and adhesive application that are used for other components of the canister.
The fluid level sensor can include or be part of a detection system configured to communicate wired or wirelessly (such as, using NFC, RFID, etc.). The detection system can utilize fluid level sensor that incorporates a communication device to communicate information from the canister to the device or another remote computing device 334 (such as, the remote computing device 334). The detection system can utilize a communication device for communicating the information from the canister to the device using NFC. NFC is a set of short-range wireless technologies, typically requiring a separation of 10 cm or less (in some cases, 4 cm or less). NFC can involve an initiator (or active tag) and a target (or passive tag). The initiator can actively generate a radio frequency (RF) field that can power the passive tag. In some cases, NFC communication can utilize an NFC reader communicating with a passive NFC tag. The NFC reader can retrieve information stored in the passive NFC tag. The pump assembly 160 can include an NFC reader (which can be located at or near the bottom of the pump assembly 160 housing) and the detection system of the canister can include a passive NFC tag. When the conductive portions of the NFC tag are in contact with fluid within the canister and the circuit is closed, information (such as, a flag) can be stored in memory of the NFC tag. The NFC reader can read such information by communicating with the NFC tag. The NFC reader and NFC tag can include one or more antennas to facilitate wireless communication (for example, facilitate transmission and reception of data). In some cases, the range of communication between the NFC reader and the NFC tag can be about 20 mm (or less or more), which can exceed the distance between the NFC reader and the NFC tag. Additional details of utilizing NFC communication for determining canister status are disclosed in co-pending International Patent Application No. ______ (Atty. Docket SMNPH.654WO) titled “COMMUNICATION SYSTEMS AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY DEVICES,” filed on the same day as the present patent application, and incorporated by reference in its entirety.
As described herein, a negative pressure wound therapy device, such as the pump assembly 160, or a remote computing device can include an NFC reader. The NFC reader can have an antenna configured to facilitate communication with the canister, such as the canister 162. The pump assembly 160 can receive data relating to the status of the canister, such as whether the canister is full, the level of fluid in the canister, or the like. Additional approaches for communicating the with the pump assembly are disclosed in the above-referenced International Patent Application No. ______ (Atty. Docket SMNPH.654WO) titled “COMMUNICATION SYSTEMS AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY DEVICES.”
To detect the fluid level within the canister, the detection system can utilize a tamper detection system to detect when the fluid in the canister reaches a threshold level. The tamper detection system can detect a change in impedance or resistance in the circuit to determine if the system has been tampered with. For example, when used in packaging, detection of an open circuit in the tamper detection system can indicate tampering of the device such as the opening of a parcel. The fluid detection system can utilize the tamper detection system to detect canister full when the tamper detection system detects a closed circuit caused by the fluid level in the canister reaching (or exceeding) a threshold fluid level. Accordingly, the tamper detection system can detect canister full responsive to a closed circuit, which can be indicative of no tampering (rather than tampering detected with the open circuit as used in the case of packaging solutions).
The tamper detection system can detect that the circuit is closed based on monitoring the impedance or resistance between nodes TD0 and TD1. In some cases, a threshold impedance for detecting a closed circuit should correspond to the impedance of the fluid (such as, wound exudate) expected to fill the canister. Testing of various fluids, including tap water, saturated salt water, and stimulated exudate (0.9% saline), has revealed impedances of about 460K, about 342, and about 662, respectively. The threshold impedance can be set to a value that equals or exceeds these impedances. For instance, the threshold impedance can be set to about 352 (or more), about 50K (or less or more), about 70K (or less or more), about 1002 (or less or more), about 0.5 kΩ (or less or more), about 1 kΩ (or less or more), about 2 kΩ (or less or more), about 3 kΩ (or less or more), about 4 kΩ (or less or more), about 5 kΩ (or less or more), about 6 kΩ (or less or more), or less than about 7.5 kΩ. In some cases, the threshold impedance can correspond to an average impedance of at least some of the fluids expected to fill the canister.
In some instances, the threshold impedance can be a preset value. The area of one or more of the electrodes of the fluid level sensor can be adjusted to ensure that the impedance of the closed circuit matches such present threshold impedance. For example, suppose that the preset threshold impedance is no more than 50K. In such case, the area of the one or more of the electrodes can be increased to ensure that closed circuit impedance does not exceed 50K.
In some cases, a reliable canister detection can be implemented. The fluid detection system can communicate an identifier, which can be a unique value (such as, a unique canister identifier). For instance, when NFC protocol is used (which operates over a short range), the negative pressure wound therapy device can be configured to disallow provision of therapy unless the identifier has been received from the canister (indicating that the canister has been attached to the device).
In some cases, the pump assembly can be used with canisters of various volumes or sizes. In such cases, the canisters of different volumes or sizes can be identified by changing the location (or number) of the fluid level sensor (for example, NFC tag) within the canister on the different types of fluid containment canister. For example, a canisters of a first size can have a fluid level sensor or NFC tag in a first location (such as the center top of the canister body) while a second canister of a second size can have a fluid level sensor or NFC tag positioned in a second location (such as the top side of the canister body). This can be identified by the reader on the pump assembly to indicate the type of canister that has been attached to the pump assembly, rather than reading a coded message on the sensor to determine the canister type. Additionally, using sensors positioned at different locations for canisters for determining the canister volumes or sizes can allow for identification of the canister type even if data written to the sensor is written incorrectly.
The state of the tamper detection system 502 that supports NFC communications (such as, functions as a passive NFC tag) can be detected with an NFC reader 504 as illustrated in
In some cases, the tamper detection system can include memory that stores additional information related to the status of the canister. For example, the additional information may include information about the canister size (such as, 300 ml or 800 ml). In some cases, the additional information can include an indication whether the same canister had been previously attached to the negative pressure wound therapy device. For example, a unique canister identifier can indicate if the same canister is being removed and put back on the negative pressure system. The unique canister identifier can allow for tracking of the use of the canister. In some cases, the additional information stored in the tamper detection device in the canister can include tracking information entered into the device, such as the time and/or date when the canister was connected to the pump assembly, when the canister was removed from the pump assembly, and/or the number of hours of operating time. Additional details of the status of the canister are disclosed in International Patent Application No. ______ (Atty. Docket SMNPH.683WO), titled “INTELLIGENT DISPOSABLE DEVICES FOR WOUND THERAPY AND TREATMENT,” filed on the same day as the present patent application, and incorporated by reference in its entirety
In some cases, the tamper detection system can be used in combination with other canister full detection methods. Using two or more redundant systems can promote accuracy. For example, the tamper detection system can be used in combination with using a peak-to-peak voltage measurement from pressure pulses to avoid false positive alarms from the peak-to-peak voltage measurement system. This can be particularly advantageous when estimating the fill rate of the canister. For example, in some cases, the peak-to-peak voltage measurements can give a crude indication of the fill level and therefore the flow rate of the wound drainage. The tamper detection system could be used to ensure the alarm will trigger when the canister is near a full level or is full. Further, a third check by the user could be implemented to increase accuracy of the system. This third check can consist of a user interface input of the canister level (for example, ‘low’, ‘half-full’, ‘nearly full’). In some cases, the user interface can utilize buttons or other modes of user input, as described herein. For example, pictures or text can be used on the buttons (e.g. using three buttons with each corresponding to a certain fluid level—each with a picture and/or text).
The fluid detection system can include a fill level sensor or canister full sensor that includes multiple sets of electrode pairs. In some cases, the multiple sets of electrode pairs can be positioned on multiple arms. Additionally or alternatively, the fluid detection system can utilize multiple fill level sensors or canister full sensors (for example, multiple NFC tags) within the canister. For example, in some cases, rather than a single pair of arms or a single sensor extending into the canister as shown in
For example, there can be three pairs of arms positioned at or extending into the canister body to different locations within the canister. A first pair of arms (longest pair of arms) can extend into the canister to a position the would indicate the canister is half filled with liquid. A second pair of arms can be shorter than the first pair but longer than the third pair and can extend into the canister to a position between a position that would indicate the canister is half filled and a position that would indicate the canister is full. A third pair of arms can be the shortest pair of arms and is positioned in a location that would indicate the canister is full or nearly full. If only the first pair of arms detect fluid, then the canister is half full. If the second pair of arms detect fluid then the canister can be ¾th of the way full or some volume between halfway full and full or nearly full. If the third pair of arms detect fluid, then the canister is full or nearly full. The multiple pairs of arms can also be used to measure a “time to full” of the canister as described further herein. The pairs of arms can be on the same sensor device (or same support substrate) or can be in the form of multiple sensors (for example, multiple NFC tags) each having pairs of arms and each pair of arms differs in length from another pair of arms. While three pairs of arms are described, any number of pairs of arms or any number of sensor devices can be used to detect any number of levels within the canister. The fill level resolution can be increased with more sensors or pairs of arms at various levels.
In some cases, multiple sensor devices can be positioned at the same distance from the filter in the canister top but in multiple axes. The multiple sensors can generate redundancy against failure of a tag. Multiple sensors also offer the capability to mount the sensors offset to generate a fill gauge. The spacing of the tag read paths to generate the fill gauge can be set to a fixed increment of fluid or in a spacing appropriate for an expected time increment (e.g. wider spaced towards the start or as the bottom of the canister fills to cope with a bolus of fluid delivered to the canister and then the tags can be more closely spaced later as it would be expected that the fluid rate tails off as the canister fills). The latter would give the greatest granularity of whether the wound is following an ‘expected’ path with the minimum number of track paths. In some cases, the multiple sensors or sensor with multiple arms can be set at different lateral positions within the canister.
It can be advantageous to detect and indicate the fill rate of a canister, such as the canister 162, in the negative pressure system. This detection can be performed in addition to or as an alternative to the canister full or near full detection described herein.
The canister fill rate can be used to infer the wound drainage or how much exudate is flowing out of the wound. The flow rate of fluid from the wound can be calculated using the time taken to fill the canister based on the duration of time between an empty canister being installed and the time canister full is detected. The volume of the canister can then be divided by the time taken to fill the canister to calculate the flow rate of wound fluid. For example, the following equation can be used:
flow rate=(canister volume)/(time taken to fill) (1)
In some cases, the volume of the canister can be input by the user or can be detected (such as, retrieved from the memory of the canister as described herein). An accurate flow rate can be calculated using the fluid level sensor described herein. Time duration for filling the canister can be accurately determined by taking into account any stoppages or pausing of therapy, determination that the same canister is still attached there when therapy is resumed, and determination that the canister has been removed and reapplied. As described herein, these determinations can be made using the unique canister identifier.
In some cases, the flow rate can then be used by the healthcare provider to determine the best route of care and if the patient can be moved to another system, for example a Pico Single Use Negative Pressure Wound Therapy System from Smith & Nephew.
In some cases, the canister can be removed before the canister is full. In these situations, an inference can be made about the flow rate by providing a manual input to the user interface to state the level of fluid within the canister. In some cases, this input could be an input noting: ‘low’, ‘half-full’, ‘nearly full’, if the canister is removed before the canister is full or before the canister full alarm is triggered. This input can be used to adjust the canister volume variable in Equation 1.
In some cases, the information obtained from the canister, the canister fill rate, and/or canister use and therapy use can provide information to the healthcare practitioner and to allow for an understanding of trends and behaviors for a single patient or among various patients to assist in making healthcare decisions.
In some cases, a flow meter can be positioned in the fluid flow path (such as, in the conduit 108 or 108′) to determine the flow rate. For example, a venturi tube can be used.
A canister full detection system can use an inductively coupled fluid detection system. The inductively coupled fluid detection system can detect a full or nearly full canister and consequently provide an alert to the user. As described herein, the canister full or nearly full alert can be important for a negative pressure therapy system because it can allow a healthcare professional or a user to replace the canister and continue therapy with the least amount of interruptions (such as, not having to worry about the device suddenly sounding a canister full/blockage alarm).
The negative pressure wound therapy system can use an inductively coupled fluid detection system to determine if the canister is near full. To do this, the system can use spaced-apart electrodes in the canister, which can detect fluid presence by the change in electrical properties when the fluid within the canister is at a certain level and the electrodes are submerged. The canister fluid level information can then be relayed back to the negative pressure therapy system, for instance, through inductive coupling (such as, NFC) or another wireless or wired communications protocol. For example, the inductively coupled fluid detection system can include one coil in a device (device side) and the other coil in the canister (canister side) as shown in
In some cases, the coils 702 and 711 can be inductively coupled and information (in the form of electric current) can be relayed between the coils. The configuration with one coil in the device and the other in the canister can be ideal as it provides isolation by avoiding direct electrical connections between a canister, a device and ultimately the user.
The device coil 702 can be excited by an alternating current (A.C.) signal of a certain frequency. The canister coil 711 and the fluid in the canister can form a LC circuit that includes the coil 711 (inductor) and the capacitor 712, which represents the capacitance of the fluid. The impedance (or the effective opposition to the alternating current) of the capacitor 712 decreases as frequency increases. The impedance of the inductor 711 increases as the frequency increases, as shown in
When the device coil 702 is inductively coupled to the canister coil 711, alternating current is coupled between two circuits. When there is no fluid within the canister (or the fluid has not reached the electrodes), the canister coil is in an open circuit and no current is flowing through the canister coil. This can cause very little current to flow though the device coil as shown in
An inductively coupled fluid detection system can include a device side 1001 with a device coil 1002 shown in section 1034 and a canister side 1010 with a canister coil 1011 shown in section 1036. The device side 1001 and the canister side 1010 can be similar to the device side 701 and canister side 710 described with reference to
A transimpedance amplifier in section 1038 can be used to convert the current into a voltage which can then be interpreted more easily by the MCU or similar device. A comparison can be conducted between the output voltage generated from the transimpedance amplifier in section 1038 and a threshold value indicative of the canister being full. The comparison can be conducted with the condition that if the threshold value is satisfied (such as, reached or exceeded), a full canister has been achieved. Once it has been established that a full canister has been achieved an alarm can be triggered.
In some cases, having direct electrical connections from the negative pressure wound therapy device though the canister interface may be undesirable (for instance, for patient safety). As a result, using the isolated inductively coupled circuit of
While canister full detection is described in this section, detection of the canister being nearly full can be similarly performed.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21382346.1 | Apr 2021 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/060463 | 4/20/2022 | WO |
