WO2021032707A1 - Systems and methods for operating negative pressure wound therapy using text messaging - Google Patents

Systems and methods for operating negative pressure wound therapy using text messaging Download PDF

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Publication number
WO2021032707A1
WO2021032707A1 PCT/EP2020/073051 EP2020073051W WO2021032707A1 WO 2021032707 A1 WO2021032707 A1 WO 2021032707A1 EP 2020073051 W EP2020073051 W EP 2020073051W WO 2021032707 A1 WO2021032707 A1 WO 2021032707A1
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WIPO (PCT)
Prior art keywords
negative pressure
text message
therapy
wound
operational parameter
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PCT/EP2020/073051
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French (fr)
Inventor
Yeswanth Gadde
Original Assignee
T.J.Smith And Nephew, Limited
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Publication date
Application filed by T.J.Smith And Nephew, Limited filed Critical T.J.Smith And Nephew, Limited
Publication of WO2021032707A1 publication Critical patent/WO2021032707A1/en

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    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • Embodiments described herein relate to apparatuses, systems, and methods the treatment of wounds, for example using dressings in combination with negative pressure wound therapy.
  • TNP 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.
  • TNP therapy permits less outside disturbance of the wound and promotes more rapid healing.
  • a negative pressure wound therapy device can include a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing in accordance with a plurality of operational parameters and electronic control circuitry configured to receive and send text messages over a communications network.
  • the electronic control circuitry can be configured to, in response to receiving a first text message from a remote computing device, transmit to the remote computing device a second text message including one or more of therapy status data or at least some of the operational parameters.
  • the electronic control circuitry can be configured to, in response to receiving a third text message from the remote computing device including at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter.
  • the negative pressure wound therapy device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices described herein can include one or more of the following features.
  • the first text message can include a status request.
  • Therapy status data can include data indicating status of the wound.
  • At least some of the operational parameters can include one or more of negative pressure set point, therapy mode, or therapy duration.
  • the electronic control circuitry can be configured to, in response to receiving the third text message from the remote computing device including the at least one updated operational parameter, transmit to the remote computing device a fourth text message including the at least one updated operational parameter.
  • the electronic control circuitry can be configured to, in response to receiving a fifth text message from the remote computing device confirming the at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter. Confirmation can, for example, be confirmation of correctly receiving the at least one updated operational parameter by the remote computing device.
  • the negative pressure wound therapy device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices described herein can include one or more of the following features.
  • the electronic control circuitry can be configured to transmit to the remote computing device a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be transmitted as a text message.
  • the device can include a housing at least partially enclosing the negative pressure source and the electronic control circuitry.
  • a method of operating the negative pressure wound therapy device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices described herein is disclosed.
  • the method can be performed by electronic control circuitry configured to receive and send text messages over a communications network.
  • the method can include, in response to receiving a first text message from a remote computing device, transmitting to the remote computing device a second text message including therapy status data and at least some operational parameters from a plurality of operational parameters in accordance with which negative pressure is provided to a wound covered by a wound dressing.
  • the method can include, in response to receiving a third text message from the remote computing device including at least one updated operational parameter, causing negative pressure to be provided in accordance with the at least one updated operational parameter.
  • the method of any of the preceding paragraphs and/or any of the methods described herein can include one or more of the following features.
  • the first text message can include a status request.
  • Therapy status data can include data indicating status of the wound.
  • the at least some of the operational parameters can include one or more of negative pressure set point, therapy mode, or therapy duration.
  • the method can include, in response to receiving the third text message from the remote computing device including the at least one updated operational parameter, transmitting to the remote computing device a fourth text message including the at least one updated operational parameter.
  • the method can include, in response to receiving a fifth text message from the remote computing device confirming the at least one updated operational parameter, causing negative pressure to be provided in accordance with the at least one updated operational parameter.
  • the method can include transmitting to the remote computing device a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be transmitted as a text message.
  • a non-transitory computer readable medium can store instructions that, when executed by electronic processing circuitry of a computing device, cause the electronic processing circuitry to transmit a first text message to a negative pressure wound therapy device configured to treat a wound.
  • the instructions can be for negative pressure wound therapy device.
  • the instructions can cause the electronic circuitry to, in response to transmission of the first text message, receive a second text message including one or more of therapy status data or at least one operational parameter of the negative pressure wound therapy device.
  • the instructions can cause the electronic circuitry to transmit a third text message to the negative pressure wound therapy device, the third text message including at least one updated operational parameter, thereby causing the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
  • the computer readable medium of any of the preceding paragraphs and/or any of the computer readable media described herein can include one or more of the following features.
  • the first text message can include a status request.
  • Therapy status data can include data indicating status of the wound.
  • At least one operational parameter can include at least one of negative pressure set point, therapy mode, or therapy duration.
  • the instructions can be configured to cause the electronic processing circuitry to receive a fourth text message from the negative pressure wound therapy device.
  • the instructions can be configured to cause the electronic processing circuitry to, in response to confirming that the fourth text message includes the at least one updated operational parameter, transmit to the negative pressure wound therapy device a fifth text message that causes the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
  • the instructions can be configured to cause the electronic processing circuitry to, in response to confirming that the fourth text message does not includes the at least one updated operational parameter, not transmit the fifth text message.
  • the computer readable medium of any of the preceding paragraphs and/or any of the computer readable media described herein can include one or more of the following features.
  • the instructions can be configured to cause the electronic processing circuitry to receive a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be received as a text message.
  • a computing device and/or method of operating the computing device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices and/or computer readable media described herein is disclosed.
  • a method of operating a negative pressure wound therapy device can be performed by electronic processing circuitry of a computing device.
  • the method can include transmitting a first text message to a negative pressure wound therapy device configured to treat a wound.
  • the method can include, in response to transmission of the first text message, receiving a second text message including therapy status data and at least one operational parameter of the negative pressure wound therapy device.
  • the method can include transmitting a third text message to the negative pressure wound therapy device.
  • the third text message can include at least one updated operational parameter, thereby causing the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
  • the method of any of the preceding paragraphs and/or any of the methods described herein can include one or more of the following features.
  • the first text message can include a status request.
  • Therapy status data can include data indicating status of the wound.
  • the at least one operational parameter can include at least one of negative pressure set point, therapy mode, or therapy duration.
  • the method can include, by electronic processing circuitry, receiving a fourth text message from the negative pressure wound therapy device.
  • the method can include, in response to confirming that the fourth text message includes the at least one updated operational parameter, transmitting to the negative pressure wound therapy device a fifth text message that causes the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
  • the method can include, in response to confirming that the fourth text message does not includes the at least one updated operational parameter, not transmitting the fifth text message.
  • the method can include, by the electronic processing circuitry, receiving a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be received as a text message.
  • Figure 1 illustrates a reduced pressure wound therapy system
  • Figures 2A-2B illustrate a pump assembly and canister.
  • Figure 3 illustrates a schematic of a reduced pressure wound therapy system.
  • Figure 4 illustrates a process of operating a reduced pressure wound therapy system using text messaging.
  • Embodiments disclosed herein relate to systems and methods of monitoring and/or treating a wound. It will be appreciated that throughout this specification reference is made to a wound. It is to be understood that 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 reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.
  • 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.
  • TNP topical negative pressure
  • 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, and/or removing excess exudate and can reduce bacterial load (and thus infection risk).
  • 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.
  • reduced or negative pressure levels 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).
  • 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 and/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 (sometimes referred to as HCP), such as a clinician, nurse, or the like, can provide a TNP prescription specifying, for example, the pressure level and/or time of application.
  • HCP a healthcare provider
  • 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, and/or methods of efficiently adjusting TNP prescriptions and delivering effective TNP therapy.
  • Figure I illustrates a negative or reduced pressure wound treatment (or TNP) system 100 comprising a wound filler 130 placed inside a wound cavity 110, the wound cavity sealed by a wound cover 120.
  • the wound filler 130 in combination with the wound cover 120 can be referred to as wound dressing.
  • a single or multi lumen tube or conduit 140 is connected the wound cover 120 with a pump assembly 150 configured to supply reduced pressure.
  • the wound cover 120 can be in fluidic communication with the wound cavity HO.
  • a negative pressure wound therapy device (sometimes as a whole or partially referred to as a “pump assembly”) can be a canisterless (meaning that exudate is collected in the wound dressing or is transferred via tube 140 for collection to another location).
  • any of the pump assemblies disclosed herein can be configured to include or support a canister. Additionally, with any of the systems disclosed herein, any of the pump assemblies can be mounted to or supported by the dressing, or adjacent to the dressing.
  • the wound filler 130 can be any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, and so on.
  • the wound filler 130 can be conformable to the wound cavity 110 such that it substantially fills the cavity.
  • the wound cover 120 can provide a substantially fluid impermeable seal over the wound cavity 110. In some cases, the wound cover 120 has a top side and a bottom side, and the bottom side adhesively (or in any other suitable manner) seals with wound cavity 110.
  • the conduit 140 or any other conduit disclosed herein can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.
  • the wound cover 120 can have a port (not shown) configured to receive an end of the conduit 140.
  • the conduit 140 can otherwise pass through and/or under the wound cover 120 to supply reduced pressure to the wound cavity 110 so as to maintain a desired level of reduced pressure in the wound cavity.
  • the conduit 140 can be any suitable article configured to provide at least a substantially sealed fluid flow pathway or path between the pump assembly 150 and the wound cover 120, so as to supply the reduced pressure provided by the pump assembly 150 to wound cavity 110.
  • the wound cover 120 and the wound filler 130 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 may then be connected, via the conduit 140, to a source of negative pressure, such as the pump assembly 150.
  • the pump assembly 150 can be miniaturized and portable, although larger conventional negative pressure sources (or pumps) can also be used.
  • the wound cover 120 can be located over a wound site to be treated.
  • the wound cover 120 can form a substantially sealed cavity or enclosure over the wound site.
  • the wound cover 120 can be configured to 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.
  • a wound it is to be understood that 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 surficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced pressure treatment.
  • a wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.
  • wounds include, but are not limited to, acute wounds, chronic wounds, surgical incisions and other incisions, 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.
  • the components of the TNP system described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.
  • the system can be designed to operate without the use of an exudate canister.
  • the system can be configured to support an exudate canister.
  • configuring the pump assembly 150 and tubing 140 so that the tubing 140 can be quickly and easily removed from the pump assembly 150 can facilitate or improve the process of dressing or pump changes, if necessary.
  • Any of the pump assemblies disclosed herein can be configured to have any suitable connection between the tubing and the pump.
  • the pump assembly 150 can be configured to 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 pump assembly 150.
  • the pump assembly 150 can be configured to provide continuous or intermittent negative pressure therapy.
  • Continuous therapy can be delivered at above -25 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg.
  • Intermittent therapy can be delivered between low and high negative pressure set points.
  • Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, 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, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg.
  • 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.
  • the first and second durations can be selected from the following range: less than 2 minutes, 2 minutes, 3 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, or greater than 10 minutes.
  • switching between low and high set points and vice versa can be performed according to a step waveform, square waveform, sinusoidal waveform, and the like.
  • the wound filler 130 is inserted into the wound cavity 110 and wound cover 120 is placed so as to seal the wound cavity 110.
  • the pump assembly 150 provides a source of a negative pressure to the wound cover 120, which is transmitted to the wound cavity 110 via the wound filler 130.
  • Fluid (such as, wound exudate) is drawn through the conduit 140, and can be stored in a canister. In some cases, fluid is absorbed by the wound filler 130 or one or more absorbent layers (not shown).
  • Wound dressings that may 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 may 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 and U.S. Patent No. 9,084,845, each of which is incorporated by reference in its entirety. In some cases, other suitable wound dressings can be utilized.
  • Pump Assembly and Canister can be utilized.
  • FIGS 2A-B illustrates a negative pressure wound therapy device 200 including a pump assembly 230 and canister 220. As is illustrated, the pump assembly 230 and the canister are connected, thereby forming the device 200.
  • the pump assembly 230 comprises one or more indicators, such as visual indicator 202 configured to indicate alarms and visual indicator 204 configured to indicate status of the TNP system.
  • the indicators 202 and 204 can be configured to alert a user to a variety of operating and/or failure conditions of the system, including alerting the user to normal or proper operating conditions, pump failure, power supplied to the pump or power failure, detection of a leak within the wound cover or flow pathway (sometimes referred to as fluid flow path), suction blockage in the flow pathway, canister full, overpressure, or any other similar or suitable conditions or combinations thereof.
  • any one or more of the indicators 202 and 204 can be configured to alert a user that the current operation is compliant or non-compliant with a therapy prescription, which can be stored in a remote computing device (sometimes referred to a “remote computing system” or “remote computer”).
  • the remote computing device can be any one or more computing devices with at least one processor and/or database, such as one or more cloud servers (sometimes referred to as “the cloud”).
  • the pump assembly 230 can comprise additional indicators. In some cases, a single indicator is used. In some cases, multiple indicators are used. Any one or more suitable indicators can be used such as visual, audio, tactile indicator, and so on.
  • the indicator 202 can be configured to signal alarm conditions, such as canister full, power low, conduit 140 disconnected, seal broken in the wound seal, and so on.
  • the indicator 202 can be configured to display red flashing light to draw user’s attention.
  • the indicator 204 can be configured to signal status of the TNP system, such as therapy delivery is ok, leak detected, and so on.
  • the indicator 204 can be configured to display one or more different colors of light, such as green, yellow, etc. For example, green light can be emitted when the TNP system is operating properly and yellow light can be emitted to indicate a warning.
  • the pump assembly 230 comprises a display or screen 206 mounted in a recess formed in a case of the pump assembly.
  • the display 206 can be a touch screen display.
  • the display 206 can support playback of audiovisual (AY) content, such as instructional videos.
  • AY audiovisual
  • the display 206 can be configured to render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the TNP system.
  • the pump assembly 230 comprises a gripping portion formed in the case of the pump assembly. The gripping portion can be configured to assist the user to hold the pump assembly 230, such as during removal of the canister 220.
  • the pump assembly 230 includes one or more strap mounts for connecting a carry strap to the pump assembly 230 or for attaching a cradle.
  • the canister 220 can be replaced with another canister, such as when the canister 220 has been filled with fluid.
  • the pump assembly 230 comprises one or more keys or buttons 212 configured to allow the user to operate and monitor the operation of the TNP system. As is illustrated, there can be a plurality of buttons. One button can be configured as a power button to turn on/off the pump assembly 230. Another button can be configured as a play/pause button for the delivery of negative pressure therapy. For example, pressing the button can cause therapy to start, and pressing the button afterward can cause therapy to pause or end. A button can be configured to lock the display 206 and/or the buttons 212. For instance, a button can be pressed so that the user does not unintentionally alter the delivery of the therapy. In some cases, multiple key presses and/or sequences of key presses can be used to operate the pump assembly 230.
  • the canister 220 is configured to hold fluid (such as, exudate) removed from the wound cavity 110.
  • the canister 220 includes one or more latches for attaching the canister to the pump assembly 230.
  • the exterior of the canister 220 can formed from frosted plastic so that the canister is substantially opaque and the contents of the canister and substantially hidden from plain view.
  • the canister 220 includes a substantially transparent window, which can also include graduations of volume.
  • the illustrated 300 mL canister 220 includes graduations of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL.
  • the canister can hold different volume of fluid and can include different graduation scale.
  • the canister 220 comprises a tubing channel for connecting to the conduit 140.
  • FIG. 2B illustrates a rear view 200B of the pump assembly 230 and canister 220.
  • the pump assembly 230 comprises a speaker 232 for producing sound.
  • the speaker 232 can be used to 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 232 can be used to generate audio feedback to user input.
  • the pump assembly 230 can include a filter access door 234 for accessing and replacing one or more filters, such as antibacterial filters.
  • the pump assembly 230 can comprise a power jack 239 for charging and recharging an internal battery of the pump assembly.
  • the power jack 239 is a direct current (DC) jack.
  • the pump assembly can comprise a disposable power source, such as batteries, so that no power jack is needed.
  • one of the power supplies (primary) can deliver power to operate and control the pump.
  • a secondary power source can deliver power to one or more of the user interface, alert system, and/or communication system for uploading usage data to the cloud.
  • FIG. 3 illustrates a schematic of a control system 300 which can be employed in any of the embodiments of wound monitoring and/or treatment systems described herein.
  • Electrical components can operate to accept user input, provide output to the user, operate the negative pressure source of a TNP system, provide network connectivity, and so on. It may be advantageous to utilize multiple processors in order to allocate or assign various tasks to different processors.
  • a first processor can be responsible for user activity and a second processor can be responsible for controlling another device, such as a pump 390.
  • I/O input/output
  • 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.
  • the processor 310 can also 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 processor 310 along with other controllers or processors, can store data in one or more memory modules 350, which can be internal and/or external to the processor 310.
  • Any suitable type of memory can be used, including volatile and/or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, Magnetoresistive random-access memory (MRAM), and the like.
  • the processor 310 can be a general purpose controller, such as a low- power processor. In other cases, the processor 310 can be an application specific processor. In some cases, the processor 310 can be configured as a “central” processor in the electronic architecture of the system 300, and the processor 310 can coordinate the activity of other processors, such as a pump control processor 370, communications processor 330, and one or more additional processors 380.
  • the processor 310 can run a suitable operating system, such as a Linux, Windows CE, VxWorks, etc.
  • the pump control processor 370 (if present) can be configured to control the operation of a negative pressure pump 390.
  • 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 control processor 370 can measure pressure in a fluid flow path, using data received from one or more pressure sensors, calculate the rate of fluid flow, and control the pump.
  • the pump control processor 370 controls the pump motor so that a desired level of negative pressure in achieved in the wound cavity 110.
  • the desired level of negative pressure can be pressure set or selected by the user.
  • the pump control processor 370 can control the pump (for example, pump motor) using pulse- width modulation (PWM).
  • a control signal for driving the pump can be a 0-100% duty cycle PWM signal.
  • the pump control processor 370 can perform flow rate calculations and detect alarms.
  • the pump control processor 370 can communicate information to the processor 310.
  • the pump control processor 370 can include internal memory and/or can utilize memory 350.
  • the pump control processor 370 can be a low-power processor.
  • a communications processor 330 can be configured to provide wired and/or wireless connectivity.
  • the communications processor 330 can utilize one or more antennas or transceivers 340 for sending and receiving data.
  • the communications processor 330 can provide one or more of the following types of connections: Global Positioning System (GPS) technology, cellular connectivity (for example, 2G, 3G, LTE, 4G, 5G, or the like), WiFi connectivity, Internet connectivity, and the like.
  • GPS Global Positioning System
  • 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 and/or firmware, and the like.
  • the communications processor 330 can provide dual GPS/cellular functionality.
  • Cellular functionality can, for example, be 3G (or 4G or 5G) functionality.
  • the GPS module is not able to establish satellite connection due to various factors including atmospheric conditions, building or terrain interference, satellite geometry, and so on, the device location can be determined using the 3G (or 4G or 5G) network connection, such as by using cell identification, triangulation, forward link timing, and the like.
  • the system 300 can include a SIM card, and SIM- based positional information can be obtained.
  • the communications processor 330 can communicate information to the processor 310.
  • the communications processor 330 can include internal memory and/or can utilize memory 350.
  • the communications processor 330 can be a low-power processor.
  • the system 300 can store data illustrated in Table 1. This data can be stored, for example, in memory 350. This data can include patient data (such as, data collected by one or more sensors). In various cases, different or additional data can be stored by system 300. In some cases, location information can be acquired by GPS or any other suitable method, such as cellular triangulation, cell identification forward link timing, and the like.
  • the system 300 can track and log therapy and other operational data. Such data can be stored, for example, in the memory 350.
  • the system 300 can store log data illustrated in Table 2.
  • Table 3 illustrates an example event log. One or more such event logs can be stored by the system 300.
  • the event log can include time stamps indicating the time of occurrence of a particular event.
  • Table 3 illustrates that the negative pressure source was activated at 1:31:02 UTC on 4/22/2012 to provide therapy at a set point of -120 mmHg (with medium ramp-up intensity) in a continuous mode of operation and that at 1 :44:20 UTC on the same day a high flow leak was detected and therapy was stopped at 1:44:24 UTC on the same day.
  • additional and/or alternative data can be logged.
  • the system 300 can upload any of the data stored, maintained, and/or tracked by the system 300 to a remote computing device.
  • the following information can be uploaded to the remote computing device: activity log(s), which includes therapy delivery information, such as therapy duration, alarm log(s), which includes alarm type and time of occurrence; error log, which includes internal error information, transmission errors, and the like; therapy duration information, which can be computed hourly, daily, and the like; total therapy time, which includes therapy duration from first applying a particular therapy program or programs; lifetime therapy information; device information, such as the serial number, software version, battery level, etc.; device location information; patient information; and so on.
  • therapy delivery information such as therapy duration, alarm log(s), which includes alarm type and time of occurrence
  • error log which includes internal error information, transmission errors, and the like
  • therapy duration information which can be computed hourly, daily, and the like
  • total therapy time which includes therapy duration from first applying a particular therapy program or programs
  • device information such as the serial number, software version, battery level, etc.
  • the system 300 can also download various operational data, such as therapy selection and parameters, firmware and software patches and upgrades, and the like.
  • the system 300 can provide Internet browsing functionality using one or more browser programs, mail programs, application software (for example, apps), etc.
  • Additional processors 380 such as processor for controlling one or more user interfaces (such as, one or more displays), can be utilized.
  • any of the illustrated and/or described components of the system 300 can be omitted depending on an embodiment of a wound monitoring and/or treatment system in which the 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.
  • any of the NPWT devices described herein can be monitored and/or configured (sometimes referred to as programmed) remotely.
  • Remote monitoring and/or configuration of an NPWT device can promote more accurate adjustment of negative pressure wound therapy prescription parameters (for example, as a wound is healing), improve safety of the therapy (for example, by monitoring progress of therapy and timely adjusting one or more therapy parameters as the wound is healing), promote compliant use of the NPWT device by the patient, provide flexibility and convenience (for example, by obviating the need for a patient to come into HCP’s office for monitoring and adjustment of therapy), or the like.
  • Remote monitoring and/or configuration of an NPWT device can allow for responding to patient’s concerns about the delivery of therapy (such as, negative pressure levels causing inconvenience) by remotely adjusting one or more therapy parameters without requiring a physical visit.
  • Remote monitoring and/or configuration can be performed using text messaging.
  • SMS short message service
  • the SMS protocol can be supported by the cellular network.
  • Text messaging can allow for data of limited size to be transmitted (such as, 67 16-bit characters, 134 8-bit characters, 153 7-bit characters, or the like).
  • text messaging can be used in cases when one or more of the NPWT device or a remote computing device used by the HCP to communicate with the NPWT device only supports commutation with basic features.
  • one or more of the NPWT device or the remote computing device can be located in area of poor network coverage (for example, too poor to support higher speed cellular communication that enables more data intensive communication features), can be a device that supports only the basic communication features (which include text messaging), or the like. Even in cases when communication with only basic features is supported, the NPWT device and the remote computing device may be able to exchange text messages (which can be of limited size as described herein).
  • the remote computing device can be a mobile phone, tablet, computer, another NPWT device, or the like.
  • the remote computing device can include one or more of a number pad or keyboard (which can be physical or displayed on the user interface, such as on a touchscreen display) to permit the HCP to enter data.
  • Figure 4 illustrates a process 400 of operating (such as, monitoring and/or configuring) a negative pressure wound therapy device using text messaging.
  • the process 400 can be implemented by a remote computing device 420 and a NPWT device 430, such as by one or more processors of the remote computing device and the NPWT device (for instance, one or more of the communications processor 330 or the processor 310).
  • the NPWT device 430 can be the same or similar to any of the NPWT devices described herein.
  • the remote computing device 420 can be the same or similar to any of the remote computing devices described herein.
  • Direction of the illustrated arrows can indicate a sender and receiver of a text message.
  • the remote computing device 420 can query status of the NPWT device 430.
  • the remote computing device 420 can transmit a text message (or plurality of text messages) indicating the status query.
  • the NPWT device 430 can respond with wound status (sometimes referred to as therapy status) and device operational parameters (sometimes referred to as operational parameters).
  • Wound status can include data stored in one or more logs, as described herein in connection with any of Tables 1 to 3.
  • wound status can include log data illustrated in Table 3 and described herein.
  • wound status can include a summary of the log data (rather than entirety of the log data).
  • Device operational parameters can include one or more parameters of the therapy prescription.
  • device operational parameters can include data for one or more parameters listed in Table 2 under the Therapy category (such as, negative pressure set point, therapy mode (continuous or intermittent), therapy duration, or the like).
  • Wound status and/or device operational parameters can be transmitted by the NPWT device 430 in one or more text messages. Any of the blocks 404 or 406 can be optional in some cases.
  • the HCP can assess the wound. Such assessment can be performed based on one or more of the wound status or device operational parameters received from the NPWT device 430. For example, the HCP can determine that the wound is healing as expected based on the assessment of duration of therapy included in the wound status. Based on such determination, the HCP can decide to lower the negative pressure set point, decrease the therapy duration, or the like. As another example, the HCP can determine that insufficient amount of therapy is being applied in the continuous mode based on the assessment of the duration of therapy. The HCP can decide to switch the therapy mode to intermittent mode in order to cycle between higher and lower negative pressure set points, which may be more comfortable to the patient.
  • the remote computing device 420 can transmit one or more updated device operational parameters to the NPWT device 430 (for example, updated negative pressure set point, therapy duration, therapy mode, or the like). Such transmission can be performed using one or more text messages.
  • the NPWT device 430 can apply the one or more updated device operational parameters received from the remote computing device 420 and provide therapy according to the one or more updated device operational parameters.
  • the NPWT device 430 can, in block 412, transmit the one or more updated device operational parameters to the remote computing device 420.
  • the NPWT device 430 can, in block 412, transmit the device operational parameters including the one or more updated device operational parameters. Such transmission can be performed using one or more text messages.
  • the remote computing device 420 (and/or the HCP) can confirm that the one or more updated operational parameters have been correctly received by the NPWT device 430.
  • the remote computing device 420 can transmit a confirmation in block 414. The confirmation can be transmitted using one or more text messages.
  • the NPWT device 430 Upon receiving the confirmation, the NPWT device 430 can apply the one or more updated device operational parameters received from the remote computing device 420 and provide therapy according to the one or more updated device operational parameters. In some cases, in block 416, the NPWT device 430 can transmit an acknowledgement that the one or more device operational parameters have been updated. If the confirmation is not received from the remote computing device 420, the NPWT device 430 can continue to provide therapy according to the previous set of device operational parameters.
  • the remote computing device 420 can be registered with the NPWT device 430 before the process 400 is executed. For example, a mobile number of the remote computing device 420 can be registered with the NPWT device 430. The NPWT device 430 may not respond to messages received from an unregistered remote computing device. Additionally or alternatively, the communication session of process 400 can be authenticated using one or more passwords (which can be static or dynamically changing), encrypted, or the like. For example, the message transmitted in block 402 can include a password, which can be verified by the NPWT device 430.
  • NFC near field communication
  • Bluetooth Zigbee
  • Wi-Fi Wireless Fidelity
  • the remote computing device 420 may be placed in the proximity of the NPWT device 430.
  • the process 400 can be performed via a voice call.
  • An intermediate telecommunication service which can be automated, manual, or a combination of both, can convert the voice communication into messages, which can be transmitted via text messaging.
  • the telephone number pad can be used to enter data.
  • any of the remote monitoring and/or configuration approaches described herein can be advantageously used in case of emergency.
  • any of the NPWT devices described herein can include an emergency feature that can be activated by a user.
  • the emergency feature can be a button.
  • the NPWT device can communicate information to one or more of the HCP, hospital, emergency personnel, or the like.
  • the communicated information can include the location of the NPWT device.
  • the information can be transmitted using text messaging, voice call, Wi-Fi, or the like.
  • 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.
  • 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.
  • 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.
  • any threshold, limit, duration, etc. provided herein can be fixed or varied either automatically or by a user.
  • 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.
  • 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.
  • the various components illustrated in the figures may be implemented as software and/or firmware on a processor, controller, ASIC, FPGA, and/or dedicated hardware.
  • 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.
  • the instructions can be stored in a non-transitory computer readable memory (or medium), such as on a data storage device (for example, a flash drive), in persistent memory of a computing device, on CD-ROM, DVD, or the like.
  • the instructions may be stored in a non-transitory computer readable memory that can direct a computing device, such as one or more processors of the computing device, to operate in a particular manner (for example, such that the instructions stored in the computer readable memory produce an article of manufacture including instruction means which implement the acts described herein and/or illustrated in the figures).
  • the instructions may also be loaded to a computing device or other programmable data processing apparatus to cause operations to be performed on the computing device or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computing device or other programmable apparatus provide steps for implementing the acts described herein and/or illustrated in the figures.
  • 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.
  • 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.

Abstract

A negative pressure wound therapy device can include a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing in accordance with a plurality of operational parameters and electronic control circuitry configured to receive and send text messages over a communications network. Electronic control circuitry can be further configured to, in response to receiving a first text message from a remote computing device, transmit to the remote computing device a second text message including therapy status data and at least some of the operational parameters and, in response to receiving a third text message from the remote computing device comprising at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter.

Description

SYSTEMS AND METHODS FOR OPERATING NEGATIVE PRESSURE WOUND
THERAPY USING TEXT MESSAGING
Technical Field
Embodiments described herein relate to apparatuses, systems, and methods 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 device can include a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing in accordance with a plurality of operational parameters and electronic control circuitry configured to receive and send text messages over a communications network. The electronic control circuitry can be configured to, in response to receiving a first text message from a remote computing device, transmit to the remote computing device a second text message including one or more of therapy status data or at least some of the operational parameters. The electronic control circuitry can be configured to, in response to receiving a third text message from the remote computing device including at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter.
The negative pressure wound therapy device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices described herein can include one or more of the following features. The first text message can include a status request. Therapy status data can include data indicating status of the wound. At least some of the operational parameters can include one or more of negative pressure set point, therapy mode, or therapy duration. The electronic control circuitry can be configured to, in response to receiving the third text message from the remote computing device including the at least one updated operational parameter, transmit to the remote computing device a fourth text message including the at least one updated operational parameter. The electronic control circuitry can be configured to, in response to receiving a fifth text message from the remote computing device confirming the at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter. Confirmation can, for example, be confirmation of correctly receiving the at least one updated operational parameter by the remote computing device.
The negative pressure wound therapy device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices described herein can include one or more of the following features. The electronic control circuitry can be configured to transmit to the remote computing device a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be transmitted as a text message. The device can include a housing at least partially enclosing the negative pressure source and the electronic control circuitry.
A method of operating the negative pressure wound therapy device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices described herein is disclosed. The method can be performed by electronic control circuitry configured to receive and send text messages over a communications network. The method can include, in response to receiving a first text message from a remote computing device, transmitting to the remote computing device a second text message including therapy status data and at least some operational parameters from a plurality of operational parameters in accordance with which negative pressure is provided to a wound covered by a wound dressing. The method can include, in response to receiving a third text message from the remote computing device including at least one updated operational parameter, causing negative pressure to be provided in accordance with the at least one updated operational parameter.
The method of any of the preceding paragraphs and/or any of the methods described herein can include one or more of the following features. The first text message can include a status request. Therapy status data can include data indicating status of the wound. The at least some of the operational parameters can include one or more of negative pressure set point, therapy mode, or therapy duration. The method can include, in response to receiving the third text message from the remote computing device including the at least one updated operational parameter, transmitting to the remote computing device a fourth text message including the at least one updated operational parameter. The method can include, in response to receiving a fifth text message from the remote computing device confirming the at least one updated operational parameter, causing negative pressure to be provided in accordance with the at least one updated operational parameter. The method can include transmitting to the remote computing device a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be transmitted as a text message.
A non-transitory computer readable medium can store instructions that, when executed by electronic processing circuitry of a computing device, cause the electronic processing circuitry to transmit a first text message to a negative pressure wound therapy device configured to treat a wound. The instructions can be for negative pressure wound therapy device. The instructions can cause the electronic circuitry to, in response to transmission of the first text message, receive a second text message including one or more of therapy status data or at least one operational parameter of the negative pressure wound therapy device. The instructions can cause the electronic circuitry to transmit a third text message to the negative pressure wound therapy device, the third text message including at least one updated operational parameter, thereby causing the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
The computer readable medium of any of the preceding paragraphs and/or any of the computer readable media described herein can include one or more of the following features. The first text message can include a status request. Therapy status data can include data indicating status of the wound. At least one operational parameter can include at least one of negative pressure set point, therapy mode, or therapy duration. The instructions can be configured to cause the electronic processing circuitry to receive a fourth text message from the negative pressure wound therapy device. The instructions can be configured to cause the electronic processing circuitry to, in response to confirming that the fourth text message includes the at least one updated operational parameter, transmit to the negative pressure wound therapy device a fifth text message that causes the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter. The instructions can be configured to cause the electronic processing circuitry to, in response to confirming that the fourth text message does not includes the at least one updated operational parameter, not transmit the fifth text message.
The computer readable medium of any of the preceding paragraphs and/or any of the computer readable media described herein can include one or more of the following features. The instructions can be configured to cause the electronic processing circuitry to receive a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be received as a text message.
A computing device and/or method of operating the computing device of any of the preceding paragraphs and/or any of the negative pressure wound therapy devices and/or computer readable media described herein is disclosed.
A method of operating a negative pressure wound therapy device can be performed by electronic processing circuitry of a computing device. The method can include transmitting a first text message to a negative pressure wound therapy device configured to treat a wound. The method can include, in response to transmission of the first text message, receiving a second text message including therapy status data and at least one operational parameter of the negative pressure wound therapy device. The method can include transmitting a third text message to the negative pressure wound therapy device. The third text message can include at least one updated operational parameter, thereby causing the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
The method of any of the preceding paragraphs and/or any of the methods described herein can include one or more of the following features. The first text message can include a status request. Therapy status data can include data indicating status of the wound. The at least one operational parameter can include at least one of negative pressure set point, therapy mode, or therapy duration. The method can include, by electronic processing circuitry, receiving a fourth text message from the negative pressure wound therapy device. The method can include, in response to confirming that the fourth text message includes the at least one updated operational parameter, transmitting to the negative pressure wound therapy device a fifth text message that causes the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter. The method can include, in response to confirming that the fourth text message does not includes the at least one updated operational parameter, not transmitting the fifth text message. The method can include, by the electronic processing circuitry, receiving a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter. Confirmation can be received as a text message.
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 illustrates a reduced pressure wound therapy system.
Figures 2A-2B illustrate a pump assembly and canister.
Figure 3 illustrates a schematic of a reduced pressure wound therapy system. Figure 4 illustrates a process of operating a reduced pressure wound therapy system using text messaging.
DETAILED DESCRIPTION
Embodiments disclosed herein relate to systems and methods of monitoring and/or treating a wound. It will be appreciated that throughout this specification reference is made to a wound. It is to be understood that 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 reduced 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, and/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 is 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 and/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 (sometimes referred to as HCP), such as a clinician, nurse, or the like, can provide a TNP prescription specifying, for example, the pressure level and/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, and/or methods of efficiently adjusting TNP prescriptions and delivering effective TNP therapy.
Negative Pressure System
Figure I illustrates a negative or reduced pressure wound treatment (or TNP) system 100 comprising a wound filler 130 placed inside a wound cavity 110, the wound cavity sealed by a wound cover 120. The wound filler 130 in combination with the wound cover 120 can be referred to as wound dressing. A single or multi lumen tube or conduit 140 is connected the wound cover 120 with a pump assembly 150 configured to supply reduced pressure. The wound cover 120 can be in fluidic communication with the wound cavity HO. With any of the systems disclosed herein, as is illustrated in Figure 1, a negative pressure wound therapy device (sometimes as a whole or partially referred to as a “pump assembly”) can be a canisterless (meaning that exudate is collected in the wound dressing or is transferred via tube 140 for collection to another location). However, any of the pump assemblies disclosed herein can be configured to include or support a canister. Additionally, with any of the systems disclosed herein, any of the pump assemblies can be mounted to or supported by the dressing, or adjacent to the dressing. The wound filler 130 can be any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, and so on. The wound filler 130 can be conformable to the wound cavity 110 such that it substantially fills the cavity. The wound cover 120 can provide a substantially fluid impermeable seal over the wound cavity 110. In some cases, the wound cover 120 has a top side and a bottom side, and the bottom side adhesively (or in any other suitable manner) seals with wound cavity 110. The conduit 140 or any other conduit disclosed herein can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.
The wound cover 120 can have a port (not shown) configured to receive an end of the conduit 140. In some cases, the conduit 140 can otherwise pass through and/or under the wound cover 120 to supply reduced pressure to the wound cavity 110 so as to maintain a desired level of reduced pressure in the wound cavity. The conduit 140 can be any suitable article configured to provide at least a substantially sealed fluid flow pathway or path between the pump assembly 150 and the wound cover 120, so as to supply the reduced pressure provided by the pump assembly 150 to wound cavity 110.
The wound cover 120 and the wound filler 130 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 may then be connected, via the conduit 140, to a source of negative pressure, such as the pump assembly 150. In some cases, though not required, the pump assembly 150 can be miniaturized and portable, although larger conventional negative pressure sources (or pumps) can also be used.
The wound cover 120 can be located over a wound site to be treated. The wound cover 120 can form a substantially sealed cavity or enclosure over the wound site. In some cases, the wound cover 120 can be configured to 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. It will be appreciated that throughout this specification reference is made to a wound. In this sense it is to be understood that 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 surficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced 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, acute wounds, chronic wounds, surgical incisions and other incisions, 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. In some cases, the components of the TNP system described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.
The system can be designed to operate without the use of an exudate canister. The system can be configured to support an exudate canister. In some cases, configuring the pump assembly 150 and tubing 140 so that the tubing 140 can be quickly and easily removed from the pump assembly 150 can facilitate or improve the process of dressing or pump changes, if necessary. Any of the pump assemblies disclosed herein can be configured to have any suitable connection between the tubing and the pump.
The pump assembly 150 can be configured to 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 pump assembly 150.
The pump assembly 150 can be configured to provide continuous or intermittent negative pressure therapy. Continuous therapy can be delivered at above -25 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg. Intermittent therapy can be delivered between low and high negative pressure set points. Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, 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, -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. The first and second durations can be selected from the following range: less than 2 minutes, 2 minutes, 3 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, or greater than 10 minutes. In some cases, switching between low and high set points and vice versa can be performed according to a step waveform, square waveform, sinusoidal waveform, and the like.
In operation, the wound filler 130 is inserted into the wound cavity 110 and wound cover 120 is placed so as to seal the wound cavity 110. The pump assembly 150 provides a source of a negative pressure to the wound cover 120, which is transmitted to the wound cavity 110 via the wound filler 130. Fluid (such as, wound exudate) is drawn through the conduit 140, and can be stored in a canister. In some cases, fluid is absorbed by the wound filler 130 or one or more absorbent layers (not shown).
Wound dressings that may 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 may 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 and U.S. Patent No. 9,084,845, each of which is incorporated by reference in its entirety. In some cases, other suitable wound dressings can be utilized. Pump Assembly and Canister
Figures 2A-B illustrates a negative pressure wound therapy device 200 including a pump assembly 230 and canister 220. As is illustrated, the pump assembly 230 and the canister are connected, thereby forming the device 200. The pump assembly 230 comprises one or more indicators, such as visual indicator 202 configured to indicate alarms and visual indicator 204 configured to indicate status of the TNP system. The indicators 202 and 204 can be configured to alert a user to a variety of operating and/or failure conditions of the system, including alerting the user to normal or proper operating conditions, pump failure, power supplied to the pump or power failure, detection of a leak within the wound cover or flow pathway (sometimes referred to as fluid flow path), suction blockage in the flow pathway, canister full, overpressure, or any other similar or suitable conditions or combinations thereof. In some cases, any one or more of the indicators 202 and 204 can be configured to alert a user that the current operation is compliant or non-compliant with a therapy prescription, which can be stored in a remote computing device (sometimes referred to a “remote computing system” or “remote computer”). In some cases, the remote computing device can be any one or more computing devices with at least one processor and/or database, such as one or more cloud servers (sometimes referred to as “the cloud”). In some cases, the pump assembly 230 can comprise additional indicators. In some cases, a single indicator is used. In some cases, multiple indicators are used. Any one or more suitable indicators can be used such as visual, audio, tactile indicator, and so on. The indicator 202 can be configured to signal alarm conditions, such as canister full, power low, conduit 140 disconnected, seal broken in the wound seal, and so on. The indicator 202 can be configured to display red flashing light to draw user’s attention. The indicator 204 can be configured to signal status of the TNP system, such as therapy delivery is ok, leak detected, and so on. The indicator 204 can be configured to display one or more different colors of light, such as green, yellow, etc. For example, green light can be emitted when the TNP system is operating properly and yellow light can be emitted to indicate a warning.
The pump assembly 230 comprises a display or screen 206 mounted in a recess formed in a case of the pump assembly. In some cases, the display 206 can be a touch screen display. In some cases, the display 206 can support playback of audiovisual (AY) content, such as instructional videos. As explained below, the display 206 can be configured to render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the TNP system. The pump assembly 230 comprises a gripping portion formed in the case of the pump assembly. The gripping portion can be configured to assist the user to hold the pump assembly 230, such as during removal of the canister 220. The pump assembly 230 includes one or more strap mounts for connecting a carry strap to the pump assembly 230 or for attaching a cradle. In some cases, the canister 220 can be replaced with another canister, such as when the canister 220 has been filled with fluid.
The pump assembly 230 comprises one or more keys or buttons 212 configured to allow the user to operate and monitor the operation of the TNP system. As is illustrated, there can be a plurality of buttons. One button can be configured as a power button to turn on/off the pump assembly 230. Another button can be configured as a play/pause button for the delivery of negative pressure therapy. For example, pressing the button can cause therapy to start, and pressing the button afterward can cause therapy to pause or end. A button can be configured to lock the display 206 and/or the buttons 212. For instance, a button can be pressed so that the user does not unintentionally alter the delivery of the therapy. In some cases, multiple key presses and/or sequences of key presses can be used to operate the pump assembly 230.
The canister 220 is configured to hold fluid (such as, exudate) removed from the wound cavity 110. The canister 220 includes one or more latches for attaching the canister to the pump assembly 230. The exterior of the canister 220 can formed from frosted plastic so that the canister is substantially opaque and the contents of the canister and substantially hidden from plain view. The canister 220 includes a substantially transparent window, which can also include graduations of volume. For example, the illustrated 300 mL canister 220 includes graduations of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. In some cases, the canister can hold different volume of fluid and can include different graduation scale. The canister 220 comprises a tubing channel for connecting to the conduit 140.
Figure 2B illustrates a rear view 200B of the pump assembly 230 and canister 220. The pump assembly 230 comprises a speaker 232 for producing sound. The speaker 232 can be used to 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 232 can be used to generate audio feedback to user input.
The pump assembly 230 can include a filter access door 234 for accessing and replacing one or more filters, such as antibacterial filters. The pump assembly 230 can comprise a power jack 239 for charging and recharging an internal battery of the pump assembly. In some cases, the power jack 239 is a direct current (DC) jack. In some cases, the pump assembly can comprise a disposable power source, such as batteries, so that no power jack is needed. In some cases, one of the power supplies (primary) can deliver power to operate and control the pump. In some cases, a secondary power source can deliver power to one or more of the user interface, alert system, and/or communication system for uploading usage data to the cloud.
Control System
Figure 3 illustrates a schematic of a control system 300 which can be employed in any of the embodiments of wound monitoring and/or treatment systems described herein. Electrical components can operate to accept user input, provide output to the user, operate the negative pressure source of a TNP system, provide network connectivity, and so on. It may be advantageous to utilize multiple processors in order to allocate or assign various tasks to different processors. In some cases, a first processor can be responsible for user activity and a second processor can be responsible for controlling another device, such as a pump 390. This way, the activity of controlling the other device, such as the pump 390, which may necessitate a higher level of responsiveness (corresponding to higher risk level), can be offloaded to a dedicated processor and, thereby, will not be interrupted by user interface tasks, which may take longer to complete because of interactions with the user.
Input and output to the other device, such as a pump 390, one or more sensors (for example, one or more pressure sensors configured to monitor pressure in one or more locations of the fluid flow path), or the like, can be controlled by an input/output (I/O) module 320. 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.
The processor 310 can also 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 processor 310, along with other controllers or processors, can store data in one or more memory modules 350, which can be internal and/or external to the processor 310. Any suitable type of memory can be used, including volatile and/or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, Magnetoresistive random-access memory (MRAM), and the like.
In some cases, the processor 310 can be a general purpose controller, such as a low- power processor. In other cases, the processor 310 can be an application specific processor. In some cases, the processor 310 can be configured as a “central” processor in the electronic architecture of the system 300, and the processor 310 can coordinate the activity of other processors, such as a pump control processor 370, communications processor 330, and one or more additional processors 380. The processor 310 can run a suitable operating system, such as a Linux, Windows CE, VxWorks, etc.
The pump control processor 370 (if present) can be configured to control the operation of a negative pressure pump 390. 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. In some cases, the pump control processor 370 can measure pressure in a fluid flow path, using data received from one or more pressure sensors, calculate the rate of fluid flow, and control the pump. In some cases, the pump control processor 370 controls the pump motor so that a desired level of negative pressure in achieved in the wound cavity 110. The desired level of negative pressure can be pressure set or selected by the user. The pump control processor 370 can control the pump (for example, pump motor) using pulse- width modulation (PWM). A control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump control processor 370 can perform flow rate calculations and detect alarms. The pump control processor 370 can communicate information to the processor 310. The pump control processor 370 can include internal memory and/or can utilize memory 350. The pump control processor 370 can be a low-power processor.
A communications processor 330 can be configured to provide wired and/or wireless connectivity. The communications processor 330 can utilize one or more antennas or transceivers 340 for sending and receiving data. In some cases, the communications processor 330 can provide one or more of the following types of connections: Global Positioning System (GPS) technology, cellular connectivity (for example, 2G, 3G, LTE, 4G, 5G, or the like), WiFi connectivity, Internet connectivity, and 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 and/or firmware, and the like. In some cases, the communications processor 330 can provide dual GPS/cellular functionality. Cellular functionality can, for example, be 3G (or 4G or 5G) functionality. In such cases, if the GPS module is not able to establish satellite connection due to various factors including atmospheric conditions, building or terrain interference, satellite geometry, and so on, the device location can be determined using the 3G (or 4G or 5G) network connection, such as by using cell identification, triangulation, forward link timing, and the like. In some cases, the system 300 can include a SIM card, and SIM- based positional information can be obtained. The communications processor 330 can communicate information to the processor 310. The communications processor 330 can include internal memory and/or can utilize memory 350. The communications processor 330 can be a low-power processor.
In some cases, the system 300 can store data illustrated in Table 1. This data can be stored, for example, in memory 350. This data can include patient data (such as, data collected by one or more sensors). In various cases, different or additional data can be stored by system 300. In some cases, location information can be acquired by GPS or any other suitable method, such as cellular triangulation, cell identification forward link timing, and the like.
Figure imgf000017_0001
Table 1: Example Data Stored
The system 300 can track and log therapy and other operational data. Such data can be stored, for example, in the memory 350. In some cases, the system 300 can store log data illustrated in Table 2. Table 3 illustrates an example event log. One or more such event logs can be stored by the system 300. As is illustrated, the event log can include time stamps indicating the time of occurrence of a particular event. For example, Table 3 illustrates that the negative pressure source was activated at 1:31:02 UTC on 4/22/2012 to provide therapy at a set point of -120 mmHg (with medium ramp-up intensity) in a continuous mode of operation and that at 1 :44:20 UTC on the same day a high flow leak was detected and therapy was stopped at 1:44:24 UTC on the same day. In some cases, additional and/or alternative data can be logged.
Figure imgf000018_0001
Table 2: Example Data Tracked
Figure imgf000018_0002
Table 3 : Example Event Log In some cases, using the connectivity provided by the communications processor 330, the system 300 can upload any of the data stored, maintained, and/or tracked by the system 300 to a remote computing device. In some cases, the following information can be uploaded to the remote computing device: activity log(s), which includes therapy delivery information, such as therapy duration, alarm log(s), which includes alarm type and time of occurrence; error log, which includes internal error information, transmission errors, and the like; therapy duration information, which can be computed hourly, daily, and the like; total therapy time, which includes therapy duration from first applying a particular therapy program or programs; lifetime therapy information; device information, such as the serial number, software version, battery level, etc.; device location information; patient information; and so on. The system 300 can also download various operational data, such as therapy selection and parameters, firmware and software patches and upgrades, and the like. The system 300 can provide Internet browsing functionality using one or more browser programs, mail programs, application software (for example, apps), etc. 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 and/or described components of the system 300 can be omitted depending on an embodiment of a wound monitoring and/or treatment system in which the 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.
Wound Pressure Monitoring Sensor
Any of the NPWT devices described herein can be monitored and/or configured (sometimes referred to as programmed) remotely. Remote monitoring and/or configuration of an NPWT device can promote more accurate adjustment of negative pressure wound therapy prescription parameters (for example, as a wound is healing), improve safety of the therapy (for example, by monitoring progress of therapy and timely adjusting one or more therapy parameters as the wound is healing), promote compliant use of the NPWT device by the patient, provide flexibility and convenience (for example, by obviating the need for a patient to come into HCP’s office for monitoring and adjustment of therapy), or the like. Remote monitoring and/or configuration of an NPWT device can allow for responding to patient’s concerns about the delivery of therapy (such as, negative pressure levels causing inconvenience) by remotely adjusting one or more therapy parameters without requiring a physical visit.
Remote monitoring and/or configuration can be performed using text messaging. For example, short message service (SMS) protocol for exchanging text messages can be used. The SMS protocol can be supported by the cellular network. Text messaging can allow for data of limited size to be transmitted (such as, 67 16-bit characters, 134 8-bit characters, 153 7-bit characters, or the like).
Among other advantages, text messaging can be used in cases when one or more of the NPWT device or a remote computing device used by the HCP to communicate with the NPWT device only supports commutation with basic features. For example, one or more of the NPWT device or the remote computing device can be located in area of poor network coverage (for example, too poor to support higher speed cellular communication that enables more data intensive communication features), can be a device that supports only the basic communication features (which include text messaging), or the like. Even in cases when communication with only basic features is supported, the NPWT device and the remote computing device may be able to exchange text messages (which can be of limited size as described herein). The remote computing device can be a mobile phone, tablet, computer, another NPWT device, or the like. The remote computing device can include one or more of a number pad or keyboard (which can be physical or displayed on the user interface, such as on a touchscreen display) to permit the HCP to enter data.
Figure 4 illustrates a process 400 of operating (such as, monitoring and/or configuring) a negative pressure wound therapy device using text messaging. The process 400 can be implemented by a remote computing device 420 and a NPWT device 430, such as by one or more processors of the remote computing device and the NPWT device (for instance, one or more of the communications processor 330 or the processor 310). The NPWT device 430 can be the same or similar to any of the NPWT devices described herein. The remote computing device 420 can be the same or similar to any of the remote computing devices described herein. Direction of the illustrated arrows can indicate a sender and receiver of a text message.
In block 402, the remote computing device 420 can query status of the NPWT device 430. For example, the remote computing device 420 can transmit a text message (or plurality of text messages) indicating the status query. In blocks 404 and 406, the NPWT device 430 can respond with wound status (sometimes referred to as therapy status) and device operational parameters (sometimes referred to as operational parameters). Wound status can include data stored in one or more logs, as described herein in connection with any of Tables 1 to 3. For example, wound status can include log data illustrated in Table 3 and described herein. In some cases, wound status can include a summary of the log data (rather than entirety of the log data). Device operational parameters can include one or more parameters of the therapy prescription. For example, device operational parameters can include data for one or more parameters listed in Table 2 under the Therapy category (such as, negative pressure set point, therapy mode (continuous or intermittent), therapy duration, or the like). Wound status and/or device operational parameters can be transmitted by the NPWT device 430 in one or more text messages. Any of the blocks 404 or 406 can be optional in some cases.
In block 408, the HCP can assess the wound. Such assessment can be performed based on one or more of the wound status or device operational parameters received from the NPWT device 430. For example, the HCP can determine that the wound is healing as expected based on the assessment of duration of therapy included in the wound status. Based on such determination, the HCP can decide to lower the negative pressure set point, decrease the therapy duration, or the like. As another example, the HCP can determine that insufficient amount of therapy is being applied in the continuous mode based on the assessment of the duration of therapy. The HCP can decide to switch the therapy mode to intermittent mode in order to cycle between higher and lower negative pressure set points, which may be more comfortable to the patient.
In block 410, the remote computing device 420 can transmit one or more updated device operational parameters to the NPWT device 430 (for example, updated negative pressure set point, therapy duration, therapy mode, or the like). Such transmission can be performed using one or more text messages. The NPWT device 430 can apply the one or more updated device operational parameters received from the remote computing device 420 and provide therapy according to the one or more updated device operational parameters.
In some cases, to promote accuracy and security, the NPWT device 430 can, in block 412, transmit the one or more updated device operational parameters to the remote computing device 420. Alternatively or additionally, the NPWT device 430 can, in block 412, transmit the device operational parameters including the one or more updated device operational parameters. Such transmission can be performed using one or more text messages. In response, the remote computing device 420 (and/or the HCP) can confirm that the one or more updated operational parameters have been correctly received by the NPWT device 430. In response to making the confirmation, the remote computing device 420 can transmit a confirmation in block 414. The confirmation can be transmitted using one or more text messages. Upon receiving the confirmation, the NPWT device 430 can apply the one or more updated device operational parameters received from the remote computing device 420 and provide therapy according to the one or more updated device operational parameters. In some cases, in block 416, the NPWT device 430 can transmit an acknowledgement that the one or more device operational parameters have been updated. If the confirmation is not received from the remote computing device 420, the NPWT device 430 can continue to provide therapy according to the previous set of device operational parameters.
To promote security, the remote computing device 420 can be registered with the NPWT device 430 before the process 400 is executed. For example, a mobile number of the remote computing device 420 can be registered with the NPWT device 430. The NPWT device 430 may not respond to messages received from an unregistered remote computing device. Additionally or alternatively, the communication session of process 400 can be authenticated using one or more passwords (which can be static or dynamically changing), encrypted, or the like. For example, the message transmitted in block 402 can include a password, which can be verified by the NPWT device 430.
In some cases, one or more of near field communication (NFC), Bluetooth, Zigbee, Wi-Fi, or the like protocols can be used in addition to or instead of text messaging to perform the process 400. In case of NFC, for example, the remote computing device 420 may be placed in the proximity of the NPWT device 430. In some cases, the process 400 can be performed via a voice call. An intermediate telecommunication service, which can be automated, manual, or a combination of both, can convert the voice communication into messages, which can be transmitted via text messaging. When a landline telephone is being used by the HCP, the telephone number pad can be used to enter data.
In some cases, any of the remote monitoring and/or configuration approaches described herein can be advantageously used in case of emergency. For example, any of the NPWT devices described herein can include an emergency feature that can be activated by a user. For instance, the emergency feature can be a button. Upon activation of the emergency feature by the user, the NPWT device can communicate information to one or more of the HCP, hospital, emergency personnel, or the like. The communicated information can include the location of the NPWT device. The information can be transmitted using text messaging, voice call, Wi-Fi, or the like.
Other Variations
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, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
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 may be implemented as software and/or firmware on a processor, controller, ASIC, FPGA, and/or dedicated hardware. 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.
One or more features of any of the disclosed embodiments can be implemented as computer program instructions. The instructions can be stored in a non-transitory computer readable memory (or medium), such as on a data storage device (for example, a flash drive), in persistent memory of a computing device, on CD-ROM, DVD, or the like. The instructions may be stored in a non-transitory computer readable memory that can direct a computing device, such as one or more processors of the computing device, to operate in a particular manner (for example, such that the instructions stored in the computer readable memory produce an article of manufacture including instruction means which implement the acts described herein and/or illustrated in the figures). The instructions may also be loaded to a computing device or other programmable data processing apparatus to cause operations to be performed on the computing device or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computing device or other programmable apparatus provide steps for implementing the acts described herein and/or illustrated in the figures.
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 ofZ 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.

Claims

WHAT IS CLAIMED IS:
1. A negative pressure wound therapy device comprising: a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing in accordance with a plurality of operational parameters; and electronic control circuitry configured to receive and send text messages over a communications network, the electronic control circuitry further configured to: in response to receiving a first text message from a remote computing device, transmit to the remote computing device a second text message including therapy status data and at least some of the operational parameters; and in response to receiving a third text message from the remote computing device comprising at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter.
2. The device of any of the preceding claims, wherein the first text message comprises a status request.
3. The device of any of the preceding claims, wherein the therapy status data comprises data indicating status of the wound.
4. The device of any of the preceding claims, wherein the at least some of the operational parameters include one or more of negative pressure set point, therapy mode, or therapy duration.
5. The device of any of the preceding claims, wherein the electronic control circuitry is further configured to, in response to receiving the third text message from the remote computing device comprising the at least one updated operational parameter: transmit to the remote computing device a fourth text message comprising the at least one updated operational parameter; and in response to receiving a fifth text message from the remote computing device confirming the at least one updated operational parameter, cause the negative pressure source to provide negative pressure to the wound in accordance with the at least one updated operational parameter.
6. The device of any of the preceding claims, wherein the electronic control circuitry is further configured to transmit to the remote computing device a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter.
7. The device of claim 6, wherein the confirmation is transmitted as a text message.
8. The device of any of the preceding claims, further comprising a housing at least partially enclosing the negative pressure source and the electronic control circuitry.
9. A method of operating the device of any of the preceding claims.
10. A non-transitory computer readable medium storing instructions for operating a negative pressure wound therapy device, the instructions when executed by electronic processing circuitry of a computing device, cause the electronic processing circuitry to: transmit a first text message to a negative pressure wound therapy device configured to treat a wound; in response to transmission of the first text message, receive a second text message including therapy status data and at least one operational parameter of the negative pressure wound therapy device; and transmit a third text message to the negative pressure wound therapy device, the third text message including at least one updated operational parameter, thereby causing the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
11. The computer readable medium of any of the preceding claims, wherein the first text message comprises a status request.
12. The computer readable medium of any of the preceding claims, wherein the therapy status data comprises data indicating status of the wound.
13. The computer readable medium of any of the preceding claims, wherein the at least one operational parameter includes at least one of negative pressure set point, therapy mode, or therapy duration.
14. The computer readable medium of any of the preceding claims, wherein the instructions are further configured to cause the electronic processing circuitry to: receive a fourth text message from the negative pressure wound therapy device; in response to confirming that the fourth text message includes the at least one updated operational parameter, transmit to the negative pressure wound therapy device a fifth text message that causes the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter; and in response to confirming that the fourth text message does not includes the at least one updated operational parameter, not transmit the fifth text message.
15. The computer readable medium of any of the preceding claims, wherein the instructions are further configured to cause the electronic processing circuitry to receive a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter.
16. The computer readable medium of claim 15, wherein the confirmation is received as a text message.
17. A method of operating a negative pressure wound therapy device, the method comprising: by electronic control circuitry configured to receive and send text messages over a communications network: in response to receiving a first text message from a remote computing device, transmitting to the remote computing device a second text message including therapy status data and at least some operational parameters from a plurality of operational parameters in accordance with which negative pressure is provided to a wound covered by a wound dressing; and in response to receiving a third text message from the remote computing device comprising at least one updated operational parameter, causing negative pressure to be provided in accordance with the at least one updated operational parameter.
18. The method of claim 17, wherein the first text message comprises a status request.
19. The method of any of the claims 17 to 18, wherein the therapy status data comprises data indicating status of the wound.
20. The method of any of the claims 17 to 19, wherein the at least some of the operational parameters include one or more of negative pressure set point, therapy mode, or therapy duration.
21. The method of any of the claims 17 to 20, further comprising, by the electronic control circuitry: in response to receiving the third text message from the remote computing device comprising the at least one updated operational parameter: transmitting to the remote computing device a fourth text message comprising the at least one updated operational parameter; and in response to receiving a fifth text message from the remote computing device confirming the at least one updated operational parameter, causing negative pressure to be provided in accordance with the at least one updated operational parameter.
22. The method of any of the claims 17 to 21, further comprising, by the electronic control circuitry, transmitting to the remote computing device a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter.
23. The method of claim 22, wherein the confirmation is transmitted as a text message.
24. A method of operating a negative pressure wound therapy device, the method comprising: by electronic processing circuitry of a computing device: transmitting a first text message to a negative pressure wound therapy device configured to treat a wound; in response to transmission of the first text message, receiving a second text message including therapy status data and at least one operational parameter of the negative pressure wound therapy device; and transmitting a third text message to the negative pressure wound therapy device, the third text message including at least one updated operational parameter, thereby causing the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter.
25. The method of claim 24, wherein the first text message comprises a status request.
26. The method of any of claims 24 to 25, wherein the therapy status data comprises data indicating status of the wound.
27. The method of any of claims 24 to 26, wherein the at least one operational parameter includes at least one of negative pressure set point, therapy mode, or therapy duration.
28. The method of any of claims 24 to 27, further comprising, by the electronic processing circuitry: receiving a fourth text message from the negative pressure wound therapy device; in response to confirming that the fourth text message includes the at least one updated operational parameter, transmitting to the negative pressure wound therapy device a fifth text message that causes the negative pressure wound therapy device to apply negative pressure wound therapy in accordance with the at least one updated operational parameter; and in response to confirming that the fourth text message does not includes the at least one updated operational parameter, not transmitting the fifth text message.
29. The method of any of claims 24 to 28, further comprising, by the electronic processing circuitry, receiving a confirmation that negative pressure is provided in accordance with the at least one updated operational parameter.
30. The method of claim 29, wherein the confirmation is received as a text message.
PCT/EP2020/073051 2019-08-21 2020-08-18 Systems and methods for operating negative pressure wound therapy using text messaging WO2021032707A1 (en)

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