Devices and methods for negative pressure wound therapy

Abstract

Devices and related aspects for providing reduced pressure to a wound site are disclosed. The device includes a negative pressure source configured to provide negative pressure via a fluid flow path from an inlet of the negative pressure source to the wound site. The apparatus further includes one or more transceivers and one or more antennas, where the one or more transceivers are configured to transmit data to and receive data from an external device via the one or more antennas. The apparatus further includes a user interface including an input device and one or more output devices, and a control circuit operatively connected to the negative pressure source, the user interface, and the one or more transceivers. The control circuit is configured to receive data from an external device, where the received data includes one or more parameter settings of the apparatus. Further, in response to receiving data from an external device (50), the control circuit is configured to output a signal to a user of the apparatus via the one or more output devices, and in response to detecting a confirmation action from the user of the apparatus via the input device, the control circuit is configured to output a signal to the user of the apparatus via the one or more output devices. The control circuit is configured to update one or more settings of the device based on the received one or more parameter settings.

Description

Technical Field

[0001] The technology disclosed herein relates to negative pressure wound therapy (NPWT). In particular, but not exclusively, the disclosed technology relates to apparatus and methods for providing decompression to a wound site, as well as associated computer program products, computer-readable storage media, and systems. Background Technology

[0002] Negative pressure wound therapy (NPWT) is a technique that promotes the healing of wounds, such as surgical wounds, acute wounds, and chronic wounds, by applying sub-atmospheric pressure (“negative pressure”) to the wound using a negative pressure pump. Wound healing is achieved by applying negative pressure (e.g., a “vacuum”) to the wound through dressings or coverings. This removes excess wound exudate, increasing blood flow to the area and promoting granulation tissue formation. NPWT also reduces external disturbance to the wound and removes excess fluid from the wound site. NPWT is suitable for a wide variety of wounds, such as open wounds, incision wounds, and skin grafts.

[0003] NPWT devices (which may be referred to as pump devices) typically operate based on a set of treatment parameters carefully considered to ensure the effectiveness and safety of the treatment. An example of such treatment parameters is the pressure setting, which defines the pressure level or range that the device should maintain at the wound site. Typically, NPWT is performed at pressure settings ranging from -20 mmHg to -300 mmHg, and specifically, the NPWT device operates within sub-ranges of this range depending on the type of wound, such as -50 mmHg to -75 mmHg, -100 mmHg to -150 mmHg, -115 mmHg to -135 mmHg, or -150 mmHg to -200 mmHg. Other treatment parameters may include time intervals for different operating modes, treatment duration, pump motor settings, etc. Summary of the Invention

[0004] The techniques disclosed herein seek to mitigate, alleviate, or eliminate the deficiencies and disadvantages of the prior art in order to address various issues related to the safe operation of devices that provide decompression to wound sites.

[0005] Therefore, the purpose of the technology disclosed herein is to provide apparatus, methods, computer program products, computer-readable storage media, and systems that mitigate all or at least some of the disadvantages of currently known products and methods.

[0006] Furthermore, the purpose of the technology disclosed herein is to provide apparatus, methods, computer program products, and computer-readable storage media that provide means for ensuring that the parameters of the apparatus are reliable and accurate, so as to ensure the full functionality of the apparatus for providing decompression to the wound site and to improve the overall safety of such apparatus.

[0007] The various aspects and implementations of the technology disclosed herein are defined below and in the appended independent and dependent claims.

[0008] A first aspect of the disclosed technology includes a device for providing decompression to a wound site. The device includes a negative pressure source configured to provide negative pressure via a fluid flow path from an inlet of the negative pressure source to the wound site. The device also includes one or more transceivers and one or more antennas, wherein the transceivers are configured to transmit data to and receive data from an external device via the antennas. The device further includes a user interface and control circuitry, the user interface including an input device, and the control circuitry operatively connected to the negative pressure source, the user interface, and the transceivers. The control circuitry is configured to receive data from the external device, wherein the received data includes one or more parameter settings of the device. Furthermore, in response to detecting a user confirmation action from the device via the input device, the control circuitry is configured to update one or more settings of the device based on the received parameter settings.

[0009] Therefore, NPWT devices with improved functionality are provided, particularly when configuring or updating the operating parameters of the NPWT device (e.g., pressure settings). More specifically, the NPWT device is equipped with communication capabilities (e.g., Bluetooth Low Energy (BLE)) to send and receive data from external devices. This allows users of external devices (e.g., smartphones or tablets) (e.g., patients or doctors) to change various operating settings of the NPWT device (e.g., treatment-related operating parameters such as pressure settings). However, it should be recognized that when settings are changed via external devices, especially when multiple NPWT devices are within the communication range of the external device (e.g., in a hospital environment), there is a potential risk that the changed settings may be erroneous. More specifically, the changed operating settings themselves may be incorrect, or the settings of one NPWT device may be unintentionally assigned to another. In either case, incorrect operating settings may reduce the efficiency of treatment and, in some cases, even cause discomfort to the patient. Furthermore, NPWT devices whose operating settings can be changed via external devices also face cybersecurity threats that malicious actors may attempt to alter their settings.

[0010] Therefore, some embodiments of this document incorporate a configuration protocol that requires a confirmation action (preferably a physical interaction) via the NPWT device's user interface (e.g., a button) before updating or otherwise configuring the settings of the NPWT device. This reduces the risk of applying incorrect operational settings to the NPWT device. In particular, it reduces the risk of setting operational parameters for a first NPWT device that were originally intended for a second NPWT device. The confirmation action also gives users of external devices the opportunity to reconsider new settings before actually updating them. Thus, some embodiments of this document improve the reliability and operational safety of the NPWT device.

[0011] A second aspect of the disclosed technology includes a method for controlling the application of decompression to a wound site using an apparatus. The method includes receiving data from an external device via one or more antennas and one or more transceivers of the apparatus, wherein the received data includes one or more parameter settings of the apparatus. The method further includes updating one or more settings of the apparatus based on the received parameter settings in response to the detection of a confirmation action from a user via an input device of the apparatus's user interface. This aspect of the disclosed technology possesses similar advantages and preferred features to those discussed previously.

[0012] A third aspect of the disclosed technology includes a computer program product comprising instructions that, when executed by a computing device for providing decompression to a wound site, cause the device to perform a method according to any of the embodiments disclosed herein. This aspect of the disclosed technology possesses similar advantages and preferred features to those discussed previously.

[0013] A fourth aspect of the disclosed technology includes a (non-transitory) computer-readable storage medium comprising instructions that, when executed by a computing device of the apparatus, cause the computing device to perform a method according to any of the embodiments disclosed herein. This aspect of the disclosed technology possesses similar advantages and preferred features to those previously discussed.

[0014] As used herein, the term "non-transitory" is intended to describe computer-readable storage media (or "memory") that exclude the propagation of electromagnetic signals, but is not intended to otherwise limit the types of physical computer-readable storage devices covered by the phrase computer-readable media or memory. For example, the terms "non-transitory computer-readable media" or "tangible memory" are intended to cover types of storage devices that do not necessarily permanently store information, including, for example, random access memory (RAM). Program instructions and data stored on tangible computer-accessible storage media in non-transitory form can also be transmitted via transmission media or signals (e.g., electrical signals, electromagnetic signals, or digital signals), which can be transmitted via communication media such as networks and / or wireless links. Therefore, as used herein, the term "non-transitory" is a limitation on the medium itself (i.e., tangible media, not signals), rather than a limitation on the persistence of data storage (e.g., RAM and ROM).

[0015] A fifth aspect of the disclosed technology includes a wound treatment system comprising an apparatus according to any of the embodiments disclosed herein, a wound covering for creating a sealed space partially defined by the wound site, and a piping assembly defining a fluid flow path. This aspect of the disclosed technology offers similar advantages and preferred features to those previously discussed.

[0016] The disclosed aspects and preferred embodiments may be suitably combined with each other in any manner obvious to any person skilled in the art, such that one or more features or embodiments disclosed with respect to one aspect may also be considered as disclosed with respect to another aspect or embodiments of another aspect.

[0017] Further embodiments are defined in the dependent claims. It should be emphasized that the term "comprises" or "comprising," as used in this specification, is used to specify the presence of the stated features, elements, steps, or components. This does not preclude the presence or addition of one or more other features, elements, steps, components, or groups thereof.

[0018] One advantage of some implementations is that they reduce the risk of wirelessly setting incorrect operating parameters for the NPWT device when using external devices, thereby improving the operational safety of the NPWT device.

[0019] One advantage of some implementation methods is that they can reduce network security risks associated with NPWT devices that have communication capabilities.

[0020] One advantage of some implementations is that they reduce the risk of wirelessly updating or configuring a set of operating parameters for the wrong NPWT device in an environment where multiple NPWT devices are adjacent to each other.

[0021] One advantage of some implementations is that the reliability of the NPWT device's operating parameter update processing can be more reliable and robust, thereby improving the efficiency of NPWT treatment.

[0022] One advantage of some implementations is that they can reduce the risk of patient discomfort caused by incorrect operation settings for the NPWT device.

[0023] These and other features and advantages of the disclosed technology will be further explained below with reference to the embodiments described herein. Attached Figure Description

[0024] The above aspects, features, and advantages of the disclosed technology will be more fully understood by referring to the following illustrative and non-limiting detailed description of exemplary embodiments of the present disclosure, in conjunction with the accompanying drawings, in which:

[0025] Figure 1 This is a schematic diagram of a wound treatment system according to some implementation methods.

[0026] Figure 2 This is a schematic diagram of a wound treatment system according to some implementation methods.

[0027] Figure 3a This is a schematic diagram of a device for providing pressure reduction according to some embodiments.

[0028] Figure 3b This is a schematic diagram of a device for providing pressure reduction according to some embodiments.

[0029] Figure 4a This is a schematic diagram of several devices for providing decompression to a wound site, according to some embodiments.

[0030] Figure 4b This is a schematic diagram of the confirmation action according to some implementation methods.

[0031] Figure 5a This is a schematic diagram of several devices for providing decompression to a wound site, according to some embodiments.

[0032] Figure 5b This is a schematic diagram of the confirmation action according to some implementation methods.

[0033] Figure 6 It is a schematic flowchart representing a method for controlling a device for providing decompression to a wound site according to some embodiments. Detailed Implementation

[0034] The techniques disclosed herein will now be described in detail with reference to the accompanying drawings, in which some exemplary embodiments of the disclosed techniques are illustrated. However, the disclosed techniques may be implemented in other forms and should not be construed as limited to the exemplary embodiments disclosed. The exemplary embodiments disclosed are provided to fully convey the scope of the disclosed techniques to those skilled in the art. The same reference numerals always refer to the same elements. Those skilled in the art will understand that the steps, services, and functions described herein can be implemented using separate hardware circuitry, using software that works in conjunction with hardware circuitry such as a programmable microprocessor or a general-purpose computer, using one or more application-specific integrated circuits (ASICs), using one or more field-programmable gate arrays, and / or using one or more digital signal processors (DSPs).

[0035] It will also be understood that, when this disclosure is described in terms of method, it can also be embodied in an apparatus comprising one or more processors and one or more memories coupled to one or more processors, wherein computer code is loaded to implement the method. For example, in some embodiments, one or more memories may store one or more computer programs that, when executed by one or more processors, cause the apparatus to perform the steps, services, and functions disclosed herein.

[0036] It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. It should be noted that when used in the specification and appended claims, unless the context clearly specifies otherwise, the terms "a", "an", "the", and "described" are intended to mean one or more elements. Thus, for example, a reference to "unit" or "the unit" may refer to more than one unit in some contexts. Furthermore, the words "comprising," "including," and "containing" do not exclude other elements or steps. It should be emphasized that the terms "comprises" / "comprising," when used in this specification, are used to specify the presence of the stated features, elements, steps, or components. This does not exclude the presence or addition of one or more other features, elements, steps, components, or groups thereof. The term "and / or" should be interpreted as also meaning "both" and alternatively. Similarly, "at least one of A and B" should be interpreted as only A, only B, or both A and B.

[0037] It will also be understood that although the terms first, second, etc., may be used herein to describe various elements or features, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of the embodiments, a first signal may be referred to as a second signal, and similarly, a second signal may be referred to as a first signal. Both the first signal and the second signal are signals, but they are not the same signal.

[0038] As used herein, the term "in response to" can be interpreted, depending on the context, as meaning "when," "at," or "if." Similarly, the phrases "if determined," "when determined," or "in the case of," can be interpreted, depending on the context, as meaning "when determined," "in response to determination," "when the occurrence of an event is detected and identified," or "in response to the detection of an event." Therefore, the phrase "if X equals Y" can be interpreted, depending on the context, as "when X equals Y," "when determined to be Y," "in response to X equals Y," or "in response to the detection / determination of X equals Y."

[0039] For NPWT devices, several operating parameters (or processing parameters) need to be carefully considered to ensure the effectiveness and safety of the treatment. These parameters can be adjusted based on the specific needs of the wound and the patient. Some modern NPWT devices have wireless communication capabilities, and for such NPWT devices, at least some of these operating parameters can usually be set, updated, or changed using an external device such as a smartphone or tablet. Using an external handheld device to set or update the operating parameters of the NPWT device can cause problems in some situations. For example, the user of the external device may mistakenly change the operating parameters.

[0040] Another potential problem scenario is in a hospital environment where multiple patients may be present and NPWT devices are closely adjacent to each other. Here, an external device may be within communication range of multiple NPWT devices, and even paired with multiple NPWT devices, potentially unintentionally assigning one patient's desired set of processing parameters to another patient. Another scenario is when multiple NPWT devices are arranged on a table or tray, where the operating settings of each device need to be configured or updated before active use. As mentioned earlier, the intended operating settings of one device may be incorrectly assigned to another. Yet another potential problem scenario is when a malicious actor attempts to alter various settings of the NPWT devices, thereby exposing them to cybersecurity risks.

[0041] By utilizing some of the embodiments disclosed herein, the aforementioned complexities or problems can be at least partially mitigated. Turning now to the accompanying drawings and particularly to... Figure 1The diagram schematically illustrates a wound treatment system 1 according to some embodiments. The wound treatment system 1 includes a device 10 for providing decompression to a tissue site 27 (or otherwise referred to as a wound site 27). The wound treatment system 1 also includes a wound dressing 22 adapted to create a sealed space 23 at or around the user's wound, the sealed space 23 being partially defined by the wound surface (e.g., at the user's skin). Furthermore, the device 10 (also referred to as NPWT device 10) is fluidly connected to the wound dressing 22 using, for example, a conduit 21. The conduit 21 can be any suitable flexible conduit made of an elastomeric or polymeric material. The conduit 21 can be connected to a wound dressing 20, or more specifically, to the wound dressing 22 of the wound dressing 20, via a suitable connector 25. The connector 25 can be adhesively or otherwise attached to the wound dressing 22. In particular, the connector 25 can be attached around an opening (not shown) formed in the wound dressing 22. The conduit 21 can include one or two separate tubes.

[0042] As used herein, the term "wound covering" should be interpreted broadly as any wound site component, such as a membrane sealing the periphery of wound site 27, wherein wound filler can be used to fill the wound volume prior to the application of such a wound covering. Wound covering may also refer to the backing layer of wound dressing 20, which includes additional layers such as absorbent layers and / or spacer layers.

[0043] The device 10 includes a negative pressure source 14 configured to provide negative pressure (i.e., subatmospheric pressure) via a fluid flow path from the inlet of the negative pressure source 14 to the wound dressing 20, or more specifically, configured to provide negative pressure beneath the wound covering. The negative pressure source 14 is indicated in the figures as “VP” (“vacuum pump”). In some embodiments, the negative pressure source 14 includes a negative pressure pump adapted, together with a motor, to establish negative pressure when the negative pressure source 14 is in operation (i.e., when it is active or simply “on”). The negative pressure source can include any type of pump and motor that is biocompatible or otherwise adapted for use in an NPWT setup and capable of maintaining or drawing a sufficient therapeutic vacuum level. Preferably, the negative pressure level to be achieved is in the range of about -20 mmHg to about -300 mmHg. In some embodiments, a negative pressure range of about -80 mmHg to about -140 mmHg is used. In some implementations, the negative pressure pump is a diaphragm pump, a peristaltic pump, etc., in which a motor causes a moving part to draw fluid from the wound site 27.

[0044] In the context of this disclosure, it should be understood that the terms “negative pressure,” “subatmospheric pressure,” “decompression,” or even “vacuum,” as used interchangeably herein, generally refer to pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment provided by the wound covering 22 or dressing 20. In many cases, the local ambient pressure may also be the atmospheric pressure in which the patient is located. Unless otherwise indicated, the pressure values ​​stated herein are gauge pressures. Similarly, references to an increase in negative pressure generally refer to a decrease in absolute pressure, while a decrease in negative pressure generally refers to an increase in absolute pressure.

[0045] Furthermore, in some embodiments, device 10 includes a can 16 fluidly connected to negative pressure source 14. Can 16 may be formed of, for example, molded plastic and may be a removable component of device 10. Additionally, can 16 may be at least partially transparent / semi-transparent to allow observation of the interior of can 16, thereby helping the user determine the remaining capacity of can 16. As used herein, the term "fluid connection" should be interpreted broadly and may include, for example, any form of tubing, conduit, or channel providing fluid connection / communication between can 16 and negative pressure source 14 and dressing 20.

[0046] In some embodiments, tank 16 includes an inlet port 28 for allowing connection to conduit 21. Inlet port 28 may also be formed elsewhere on device 10, yet still fluidly connected to tank 16. The connection between inlet port 28 and conduit 21 is a sealed connection, thus ensuring no leakage occurs at inlet port 28 during normal operation of device 10. Conduit 21 is preferably detachably connected to inlet port 28 by conventional means including friction fits, bayonet connections, snap-fit ​​connections, barbed connectors, etc. Inlet port 28 may be molded / formed from the same material as forming tank 16 and / or simultaneously molded / formed with forming tank 16. A similar sealed connection (e.g., using a flange insulating seal / “O-ring”) is formed between tank 16 (at outlet port 29) and negative pressure source 14.

[0047] In some embodiments, the device includes a housing 19 surrounding the negative pressure source 14. The can 16 may be detachably connected to the housing 19 including the negative pressure source 14, thereby allowing, for example, the removal of a full can and replacement with an empty (new) can. In such embodiments, it may be desirable to provide, for example, some form of engagement mechanism to the can 16 and the housing 19, for securing the can 16 to the housing so that the can 16 cannot be accidentally removed from the housing 19. In one embodiment, the engagement mechanism may include a pair of flexible protrusions extending from the can 16 and adapted to engage, for example, corresponding locking recesses provided on the housing 19.

[0048] However, in some embodiments, the wound treatment system 1 is a canisterless wound treatment system (not shown), in which wound exudate is collected in the absorbent layer of the wound dressing 20, etc. In such embodiments, as will be readily understood by those skilled in the art, the fluid flow path from the wound dressing 20 to the negative pressure source 14 is provided with one or more suitable filters (not shown), said one or more suitable filters being adapted to allow gas to flow from the wound site 27 to the negative pressure source 14 and to block liquid from flowing from the wound site 27 to the negative pressure source 14.

[0049] In some embodiments, device 10 includes a power source, such as battery 13, for powering device 10. Battery 13 may preferably be rechargeable, but may alternatively be arranged as disposable and therefore need to be replaced once discharged. In some embodiments, specially adapted battery packs may be used. Device 10 may be of single-use type (allowing use during a single treatment duration) or multiple-use type (allowing use during several different treatment sessions).

[0050] The device 10 also includes a control circuit 11 (also referred to as a "control unit", "controller", etc.) electrically connected to the battery 13 and the negative pressure source 14. The control circuit 11 is configured to control the operation of the negative pressure source 14. The control circuit 11 may include a microprocessor, a microcontroller, a programmable digital signal processor, or another programmable device. The control circuit 11 may also include, or alternatively include, an application-specific integrated circuit (ASIC), a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the control circuit 11 includes a programmable device such as a microprocessor, microcontroller, or programmable digital signal processor as mentioned above, the control circuit 11 may also include computer-executable code that controls the operation of the programmable device. Thus, in some embodiments, the control circuit 11 includes one or more processors and a memory, wherein the memory contains instructions executable by the processor, thereby operating the device 10 to perform any of the method steps or functions disclosed herein.

[0051] Furthermore, in some embodiments, the device 10 includes one or more pressure sensors 15 arranged in fluid connection to the inlet of the negative pressure source 14, the tank 16, and / or the sealed space 23. In the depicted... Figure 1 In this embodiment, device 10 includes a pressure sensor 15 disposed in the fluid flow path between the canister 16 and the negative pressure source 14. However, as will be readily understood by those skilled in the art, the pressure sensor 15 may be located at any other suitable location to sense or detect pressure within the fluid flow path between the negative pressure source 14 and the wound site. For example, the pressure sensor 15 may be disposed inside the canister or under the wound dressing 22.

[0052] During use of the device 10, a wound dressing 22 is placed over the user / patient's wound site 27, forming a sealed space 23. A conduit 21 is provided to fluidly connect the wound dressing 22 to the inlet port 28 of the device 10. The device 10 is then activated, for example by the user pressing the start / pause button 31a on the user interface 60 of the device 10. The negative pressure source 14 is thus activated. When activated, the negative pressure source 14 begins to expel air through the canister 16, the inlet port 28, the conduit 21, and the sealed space 23 formed by the wound dressing 22. Thus, a negative pressure is generated within the sealed space 23. If fluid has already formed at the wound site 27, this fluid from the wound site 27 can be at least partially "drawn" from the wound site, through the conduit 21, the inlet port 28, and into the canister 16. The amount of fluid (possibly defined as exudate) drawn from the wound and collected in the canister 16 will depend on the type of wound being treated, the duration of treatment, and the type of wound dressing 20 used. For example, when using an absorbent dressing, the fluid can be absorbed and collected in both the can 16 and the wound dressing 20, while if a dressing with no or low absorbency is used, most or all of the fluid from the wound site 27 can be collected in the can 16. A suitable filter element (not shown) is typically arranged at the outlet port 29 of the can 16 to ensure that fluid is not allowed to pass from the can 16 to the negative pressure source 14.

[0053] In some embodiments, the wound treatment system 1 also includes an air inlet port 26 or a controlled leak port 26 for providing a small, controlled inflow of air (as indicated by the arrow) beneath the wound covering 22. As schematically shown, the air inlet port 26 may be provided, for example, via a secondary lumen extending from the connector 25. However, in some embodiments, the air inlet port 26 may be additionally or alternatively located at the connector 25 and / or at any suitable location on the conduit 21.

[0054] Therefore, in some embodiments, the wound treatment system 1 can be arranged to ensure a small amount of leakage, thereby ensuring that flow from the sealed space 23 can be achieved (assuming, for example, no overall blockage within the conduit 21). Additionally, some leakage related to the wound covering 22 can be anticipated during use of the wound treatment system 1. In some embodiments, the air inlet port 26 includes means for supplying / providing air to the wound site 27 at a predetermined supply rate, which is from 2 ml / min to 7 ml / min at a predetermined negative pressure level, preferably from 3 ml / min to 5 ml / min. The predetermined negative pressure level can be from -80 mmHg to -180 mmHg, preferably from -100 mmHg to -150 mmHg, more preferably from -110 mmHg to -140 mmHg or from -115 mmHg to -135 mmHg. The means for supplying air to the wound site 27 (i.e., below the wound covering 22) at the predetermined supply rate can be, for example, in the form of an air filter (not shown).

[0055] In some embodiments, the air filter comprises a hydrophobic and porous material, wherein the pore size ranges from 2 µm to 20 µm, preferably from 5 µm to 12 µm. The pore size of the filter is measured in an uncompressed state. In some embodiments, the air filter comprises polyethylene or sintered polyethylene.

[0056] Transfer to Figure 2 The diagram schematically illustrates a wound treatment system 1' according to some embodiments. Figure 2 Many functions, features and components of the wound treatment system 1' described in the text are similar to those of the wound treatment system 1'. Figure 1 The wound treatment system 1 described herein is identical or similar, and will not be repeated for the sake of brevity and simplicity. Instead, the focus will be on distinguishing the differences in function, features, or components between the two wound treatment systems. Therefore, as will be readily understood by those skilled in the art, unless specifically instructed otherwise, the foregoing references are not intended to be used in this context. Figure 1 The discussion of the components of wound treatment system 1 applies as indicated by the reference numerals in the accompanying drawings. Figure 2 The corresponding components are depicted in the text.

[0057] generally, Figure 1 The wound treatment system described in the text 1 and Figure 2 The difference between the wound treatment system 1' described in the text is that wound treatment system 1 is generally referred to as a "single-lumen" NPWT system 1, while wound treatment system 1' is generally referred to as a "double-lumen" NPWT system 1'. Therefore, although Figure 1 The wound treatment system 1 depicted in the text features "controlled airflow" (also known as controlled leakage), but... Figure 2The wound treatment system 1' depicted in the image precisely controls or regulates the air supply to the wound site 27 by means of device 10.

[0058] Therefore, with Figure 1 Compared to the wound treatment system described in [the text], Figure 2 The wound treatment system 1' includes a second fluid flow path that connects the sealed space 23 created by the wound dressing 22 to the ambient atmosphere or a "fluid reservoir" (not shown) via an electronically controllable valve 40. This second fluid flow path (also referred to as an "air lumen") is defined by a second conduit 41, which can be any suitable flexible conduit made of an elastomeric or polymeric material. Here, the fluid flow path from the inlet of the negative pressure source 14 to the wound dressing 20 can be interpreted as a "first" fluid flow path or an "exudate lumen."

[0059] Here, control circuit 11 is electrically connected to electronically controllable valve 40, and control circuit 11 is also configured to control the operation of electronically controllable valve 40 to release negative pressure from the wound site via a second fluid flow path (or "air cavity") 41. In other words, control circuit 11 is configured to open electronically operable valve 40 when there is sub-atmospheric pressure below wound covering 22 to introduce fluid (e.g., air) to wound site 27. This operation may also be referred to as "flushing". Figure 2 The wound treatment system 1' depicted does not have any "controlled leakage flow," thus posing a risk that once a negative pressure is established under the wound dressing 22 due to a lack of airflow through system 1', the device 10 will be unable to draw any "exudate" from the wound site 27 to the canister 16, or at least only a suboptimal amount of "exudate" from the wound site 27 to the canister 16. Therefore, in order to be able to draw the desired amount of wound exudate from the wound site, fluid (e.g., air from the ambient atmosphere) is controllably introduced by opening the electronically operable valve 40 at defined time intervals or in response to pressure measurements. Once sufficient fluid has been introduced (e.g., in response to a lower threshold of negative pressure within the first and / or second fluid flow paths), the control circuit 11 is configured to close the electronically operable valve 40 and activate the negative pressure source 14.

[0060] The ability to controllably “flush” system 1’ by injecting air via electronically operable valve 40 provides the advantage of a longer pressure regulation cycle, which reduces the opening time of negative pressure source 14 and thus reduces the energy consumption of device 10.

[0061] Furthermore, regardless of whether wound treatment system 1 or wound treatment system 1' is a single lumen ( Figure 1 ) or double lumen ( Figure 2Each device 10 includes a communication interface 56 with suitable components (e.g., transceivers, antennas, filters, power amplifiers, etc.) and suitable communication protocols (e.g., Wi-Fi, Bluetooth, Bluetooth Low Energy, Zigbee, etc.) to establish a connection with an external device 50 and to transmit and receive wireless signals from the external device 50. The communication interface 56, labeled “CI”, is connected to a control circuit 11 labeled “CTRL”. The communication interface 56 is configured to transmit and receive wireless signals from the external handheld device 50. More specifically, the communication interface 56 includes one or more transceivers and one or more antennas connected to the transceivers. The transceivers are correspondingly configured to transmit signals to and receive signals from the external device 50 via one or more antennas. For example, the communication interface 56 may include a Wi-Fi transceiver for communication via a wireless communication network or a cellular or mobile phone communication transceiver. In another example, communication interface 56 may include a short-range wireless transceiver (e.g., a Bluetooth wireless transceiver, etc.) for communicating via a short-range wireless communication transceiver.

[0062] External devices may be external handheld devices 50, such as mobile phones (e.g., smartphones), that are operatively connected to device 10. The term "operatively connected" in the context of this disclosure should be understood to mean that entities or units "operatively connected" can send signals to and / or receive signals from each other.

[0063] The received signals / data may include information about or otherwise indicating one or more parameter settings (or parameter setting values) of device 10. Specifically, control circuitry 11 is configured to receive data from external device 50 via communication interface 56, wherein the received data includes one or more parameter settings of device 10. The parameter settings of device 10 may include various values ​​for one or more operating parameters of device 10. For example, parameter settings may include one or more of the following: a negative pressure setting value to be maintained by the device, a negative pressure range to be maintained by the device, one or more pump motor settings, pressure cycle settings (e.g., duration of a pressure cycle), flushing settings (e.g., flushing interval, pressure range, control valve parameters, etc.), and operating modes of the device (e.g., silent mode, night mode, or day mode). For example, the currently set negative pressure range of device 10 may be configured between -50 mmHg and -75 mmHg, in which case the received data includes a new pressure range setting for the device, which is -110 mmHg to -140 mmHg.

[0064] Furthermore, device 10 includes a user interface 60 labeled “UI”, which includes an input device 31. The input device 31 can be interpreted as any user input device through which a user of device 10 can interact. More specifically, control circuitry 11 (e.g., via a wired connection) is operatively connected to the user interface 60 and thereby capable of sending signals to and receiving signals from the user interface 60. In some embodiments, device 10 includes a housing 19 surrounding the negative pressure source 14 and control circuitry 11, wherein the input device 31 is an integrated portion of the housing 19. In some embodiments, the input device includes a button 31a and / or a touchscreen 31b. In this context, “user of device 10” will be interpreted broadly and may include patients and / or caregivers applying NPWT.

[0065] Figure 3a A schematic diagram of a device 10 according to some embodiments is shown. The device 10 includes a button 31a, which may be an integrated part of a housing 19. The button 31a is arranged relative to the housing 19 such that it is accessible to a user of the device 10. Furthermore, Figure 3b A schematic diagram of a device 10 according to some embodiments is shown. Here, the device 10 has a user interface 60, which includes a touchscreen 31b. The touchscreen 31b may be an integrated part of the housing 19. The housing 19 and the touchscreen 41 may be arranged such that the touchscreen 41 can be touched by a user of the device 10.

[0066] As mentioned, the potential risk of device 10, whose settings can be updated via an external device, is that the settings of device 10 may be changed incorrectly or unintentionally.

[0067] To this end, this document proposes to provide a device 10 configured to receive one or more parameter settings from an external device 50 and, in response to detecting a confirmation action from a user via an input device 31, update one or more settings of the device 10 based on the received one or more parameters. Therefore, the user interface 60 includes an input device 31 configured to receive confirmation actions from the user. In some embodiments, the confirmation action may include physical interaction between the user and the input device 31. Therefore, before any changes are made to the settings of such a device 10, a confirmation action (e.g., a response action) needs to be received from the user of the device 10.

[0068] As mentioned, input device 31 may include button 31a, and control circuitry 11 may be configured to update one or more settings of device 10 (based on received data) in response to detecting a confirmation action from the user of device 10 via button 31a. The confirmation action may be a physical interaction between the user and button 31a. For example, the physical interaction may be pressing or turning button 31a. The button 31a used for the confirmation action may be the same button 31a that initially activates device 10, such as the aforementioned start / pause button 31a. However, the button used for the confirmation action may be a second button (not shown) dedicated to the confirmation action and different from the start / pause button 31a.

[0069] As mentioned, input device 31 may include touchscreen 31b, and control circuitry may be configured to update one or more settings of device 10 (based on received data) in response to a confirmation action detected via touchscreen 31b from a user of device 10. The confirmation action may be a physical interaction between the user and touchscreen 31b. Physical interaction may be a swipe, press, or any interaction performed on touchscreen 31b.

[0070] Although the illustrated embodiment specifies an input device 31 in the form of a button 31a and a touchscreen 31b, the input device 31 may include any suitable unit configured to receive a confirmation action from a user of the device 10. For example, the input device 31 may include one or more accelerometers. Therefore, a confirmation action may include moving or clicking / touching the device 10. In other words, one or more accelerometers may be configured to detect a confirmation action including moving or clicking / touching the device 10.

[0071] Furthermore, in some embodiments, the input device 31 may include one or more (wireless) proximity detectors / sensors (e.g., NFC tags, RFID tags, etc.). Therefore, the confirmation action may include moving the device 10 or otherwise placing the device 10 near the external device 50. In other words, one or more proximity sensors may be configured to detect a confirmation action that includes moving the device 10 or otherwise placing the device 10 near the external device 50. "Near" in this context may be interpreted as being positioned within 20 cm, 10 cm, or 5 cm of each other, as defined by the applicable technology or protocol for the proximity sensors.

[0072] Furthermore, in some embodiments, the user interface 60 also includes one or more output devices 62. Therefore, the control circuitry 11 can also be configured to output signals to the user of the device 10 via one or more output devices 62 in response to receiving data from the external device 50. This means that pending updates in the parameter settings of the device 10 can be communicated to the user by outputting signals from the device 10. In other words, the output signal can serve as an indication to the user of the device 10 to confirm pending updates in the parameter settings of the device 10. This characteristic of the output signal can facilitate the identification of a device 10 that has received data from the external device 50 in the presence of multiple devices 10 closely adjacent to each other. In some embodiments, the signal is an auditory signal, a visual signal, and / or a tactile signal. In some embodiments, the control circuitry 11 can be configured to output signals by activating one or more LEDs to illuminate the button 31a (i.e., input device 31) of the device 10 (e.g., by flashing intermittently or continuously). This guides the user to confirm pending updates by interacting with the button 31a.

[0073] Furthermore, in some embodiments, the output signal is output only for a set duration. Specifically, the output signal may be output only for a set duration after data is received from the external device 50. For example, the output signal may be output for 10 seconds, 20 seconds, 30 seconds, or 60 seconds. Then, when the set duration expires and in response to no confirmation action from the user detected via the input device during the set duration, the control circuit 11 may be configured to discard the received data including one or more parameter settings of the device 10. Therefore, the received data including one or more parameter settings of the device 10 is temporarily stored during the set duration and discarded when the set duration expires without any confirmation action from the user during the set duration. However, if the control circuit 11 detects a confirmation action from the user of the device 10 during the set duration, it updates one or more settings of the device 10 based on the received one or more parameter settings. In other words, the currently stored corresponding parameter settings may be overwritten by the received one or more parameter settings.

[0074] By providing an output signal only for a set duration, the time that device 10 waits for confirmation is limited. Therefore, in a scenario where data from external device 50 is broadcast to multiple devices 10 that are closely adjacent to each other, and the intention is only to update the parameter settings of one of these devices 10, the remaining devices remain "standby" for a limited duration to be used for the update, in order to avoid consuming excessive energy.

[0075] For example, output device 62 may include a vibration unit. The vibration unit may be configured to cause device 10 to vibrate when receiving data from external device 50. Control circuitry 11 may be configured to control the operation of the vibration unit and activate the vibration unit when receiving data from external device 50 to send a tactile signal to the user of device 10.

[0076] Alternatively or additionally, output device 62 may include a speaker. The speaker may be configured to emit audible sound to the user of device 10 when data is received from external device 50. Control circuitry 11 may be configured to control the operation of the speaker and activate the speaker when data is received from external device 50 to emit an auditory signal to the user of device 10.

[0077] In some implementations, output device 62 may include an illumination unit, such as a light-emitting diode (LED). The illumination unit may be configured to emit light when data is received from external device 50. Control circuitry 11 may be configured to control the operation of the illumination unit and activate the illumination unit when data is received from external device 50 to provide a visual signal to the user of device 10.

[0078] Furthermore, in some embodiments, the device includes two or more output devices of different types. These two or more different types of output devices may be selected from vibration units, loudspeakers, and lighting units. In some embodiments, the type of output device used to output an output signal in response to receiving data from external device 50 is selected based on the current operating / working mode of the device 10. For example, if the device is in "silent mode" (e.g., night mode), a non-auditory output device type (e.g., lighting unit or vibration unit) may be selected.

[0079] Figure 4aMultiple devices 10, 10', 10'' for providing decompression to a wound site according to some embodiments are shown. Each device 10, 10', 10'' includes a user interface having an input device 31a and an output device 62, the input device having a button 31a and the output device 62 having one or more light-emitting diodes (LEDs). The control circuit 11 of the first device 10 receives data from an external device 50 including one or more parameter settings of the device 10. Upon receiving data from the external device 50, the first device 10 outputs a signal in the form of emitting light (e.g., by activating one or more LEDs of the device 10). In response to detecting the output signal from the device 10, a user can perform a confirmation action by interacting with the button 31 of the emitting light device 10, thereby allowing the device 10 to update its settings. As mentioned, the device 10 may include other input devices, such as one or more accelerometers and / or one or more proximity sensors (e.g., NFC tags or RFID tags), and confirmation can then be achieved by moving or clicking the device 10, and / or moving the device 10 closer to the external device 50.

[0080] Therefore, device 10 assists the user in identifying / detecting pending updates to one or more settings of device 10. Then, in response to detecting a confirmation action by the user in the form of a button press (e.g., ... Figure 4b As shown), the control circuit 11 of device 10 updates one or more settings of device 10 based on parameter settings received from external device 50. The advantage of having device 10 output a signal when receiving data from external device 50 is that device 10 receiving data from external device 50 can be more easily identified by users handling many devices.

[0081] Furthermore, by having the device 10 that receives one or more parameter settings output a signal, the user can manually verify that the device 10 receiving the parameter settings is the intended device 10. Additionally, in some cases, the external device 50 can broadcast one or more parameter settings to multiple devices 10, 10', 10''. In this case, the user can select the device 10 or these devices 10 from the multiple devices 10, 10', 10'' by interacting with the user interface of the device that should perform the update of one or more settings for the device. The output of the signal from the device 10 also indicates to the user that the parameter settings have been received by that specific device 10, thereby providing guided human-machine interaction.

[0082] Figure 5a Several devices 10 for providing decompression to a wound site, according to some embodiments, are shown. Each device 10 includes a user interface with an input device having a button 31a. Here, with Figures 4a to 4bCompared to the example implementations depicted, the device is not necessarily configured to output a signal in response to receiving data from the external device 50. Instead, the external device 50, including one or more processors and a display device operatively connected to one or more processors, can be configured to instruct a user (i.e., a patient or caregiver) to perform a confirmation action by interacting with the input device of the device 10. As will be readily understood by those skilled in the art, the external device 50 also includes a suitable communication interface for sending data to and receiving data from the device 10.

[0083] More specifically, one or more processors of external device 50 can be configured to send data including one or more parameter settings to device 10. One or more processors can also be configured to display a graphical user interface (GUI) via a display device, including a confirmation action on device 10. Thus, the user can be guided to perform a confirmation action on device 10 via the GUI of external device 50. The GUI may, for example, instruct the user to press a button on device 10, such as... Figure 5b As depicted. However, the GUI can instruct the user to perform any applicable confirmation action on device 10.

[0084] For example, in some embodiments, control circuitry 11 may be configured to receive data from external device 50, wherein the received data includes one or more parameter settings of device 10. Furthermore, control circuitry 11 may be configured to, in response to receiving data from external device 50, output a first signal to a user of device 10 via one or more output devices of device 10, and send a second signal to external device 50, the second signal prompting external device to display a graphical user interface (GUI) including a graphical representation via display device of external device 50, the graphical representation including instructions for performing a confirmation action on device 10 that is outputting the first signal. Then, in response to detecting a confirmation action from the user of the device via input device 31, control circuitry is configured to update one or more settings of device 10 based on the received one or more parameter settings. Optionally, control circuitry 11 may also be configured (when parameter settings are updated) to send a third signal to external device, the third signal prompting external device to display a graphical user interface (GUI) including a graphical representation via display device of external device 50, the graphical representation including an indication that the parameter settings of device 10 have been updated.

[0085] Furthermore, in some embodiments, device 10 includes a matrix barcode (e.g., a QR code) disposed on the outer surface of the housing 19 of device 10. The matrix barcode is specific to device 10, meaning each device 10 has a unique matrix barcode. Therefore, the confirmation action may include scanning the matrix barcode of device 10 by means of an external device 50. It is assumed here that the external device includes one or more camera devices and suitable applications to read the matrix barcode and send a confirmation signal to the device in response to reading the matrix barcode. The confirmation action is detected by device 10 based on the confirmation signal sent from the external device 50. Therefore, in some embodiments, detecting the confirmation action includes receiving a confirmation signal from the external device 50, wherein the confirmation signal is sent in response to the matrix barcode of device 10 being read by the external device 50.

[0086] Furthermore, the graphical representation may include an ID element (e.g., a device ID) of the device 10 that received one or more parameter settings, enabling the user to identify the correct device 10 for the confirmation action. Additionally, one or more processors of the external device 50 may be configured to receive an acknowledgment signal from the device 10 that received one or more parameter settings. This acknowledgment signal may include the device ID.

[0087] Therefore, an external (handheld) device 50 (which may be a smartphone or tablet computer) can provide a GUI that guides the user to confirm the correct update of one or more settings of the device 10, thereby reducing the risk that incorrect parameter setting updates are applied to the device 10.

[0088] Next, Figure 6 This is a schematic flowchart illustrating a method S100 for controlling a device for providing decompression to a wound site, according to some embodiments.

[0089] Method S100 includes the step of receiving data from an external device via one or more antennas and one or more transceivers of the device, S101. The received data includes one or more parameter settings of the device. In response to an input device detecting an acknowledgment action from the user of the device via the user interface of the device, S103, method S100 includes updating one or more settings of the device based on the received one or more parameter settings, S104.

[0090] In some embodiments, method S100 includes: in response to receiving data from an external device, outputting a signal S102 to a user of the device via one or more output devices of the user interface. In some other embodiments, the signal is an auditory signal, a visual signal, and / or a tactile signal. However, as mentioned, in some embodiments, the external device is configured to guide the user to perform a confirmation action via a graphical user interface (GUI) of the external device.

[0091] In some implementations, the confirmation action includes physical interaction with the input device. Therefore, method S100 may include detecting a confirmation action, such as physical interaction between the user and the input device or with the device as a whole.

[0092] In some implementations, the input device includes buttons and / or a touchscreen. Therefore, method S100 may include detecting physical interaction between the user and the buttons and / or touchscreen of the input device, and / or with the device as a whole.

[0093] In addition, method S100 may include means for providing any of the embodiments disclosed herein.

[0094] Executable instructions for performing these functions may optionally be included in other computer program products or non-transitory computer-readable storage media configured for execution by one or more processors of a device for providing decompression to a wound site.

[0095] The techniques disclosed herein have been presented above with reference to specific embodiments. However, other embodiments besides those described above are also possible and within the scope of the claims. Within the scope of the claims, method steps different from those described above for performing the method by hardware or software may be provided. Thus, according to some embodiments, a non-transitory computer-readable storage medium is provided storing one or more programs configured to be executed by one or more processors of a means for providing decompression to a wound site, said one or more programs including instructions for performing the method according to any of the embodiments described above.

[0096] Processor 11 (associated with device 10) may be or include any number of hardware components for performing data or signal processing or for executing computer code stored in memory. Therefore, device 10 may have associated memory, and memory may be one or more devices for storing data and / or computer code for performing or facilitating the implementation of the various methods described herein. Memory may include volatile or non-volatile memory. Memory may include database components, object code components, script components, or any other type of information structure for supporting the various activities of this specification. According to some embodiments, any distributed or local memory device may be used with the systems and methods of this specification. According to some embodiments, memory (e.g., via circuitry or any other wired, wireless, or network connection) may be communicatively connected to processor 11 and includes computer code for performing one or more of the processes described herein.

[0097] It should be noted that any reference numerals in the drawings do not limit the scope of the claims, some embodiments can be implemented at least in part by means of both hardware and software, and several “apparatus” or “units” can be represented by the same piece of hardware.

[0098] Although the accompanying drawings may show a specific order of method steps, the order of steps may differ from the depicted order. Furthermore, two or more steps may be performed simultaneously or partially simultaneously. Such variations will depend on the chosen software and hardware system and the designer's choices. All such variations are within the scope of the appended claims. Similarly, software implementations can be achieved using rule-based logic and other logic through standard programming techniques to perform steps such as generation, activation, operation, and initiation. The embodiments mentioned and described above are given by way of example only and should not limit the appended claims. Other solutions, uses, purposes, and functions within the scope of the patent claims described below should be apparent to those skilled in the art.

Claims

1. A device (10) for providing pressure relief to a wound site, the device comprising: A negative pressure source (14) is configured to provide negative pressure via a fluid flow path from the inlet of the negative pressure source to the wound site; One or more transceivers and one or more antennas, wherein the one or more transceivers are configured to transmit data to and receive data from an external device (50) via the one or more antennas; User interface (60), the user interface including an input device (31) and one or more output devices (62); A control circuit (11) is operatively connected to the negative pressure source (14), the user interface (60), and the one or more transceivers; The control circuit (11) is configured as follows: Data is received from the external device (50), wherein the received data includes one or more parameter settings for the device; In response to receiving the data from the external device (50), a signal is output to the user of the device via the one or more output devices; and In response to the detection of a confirmation action from the user of the device via the input device (31), one or more settings of the device (10) are updated based on one or more received parameter settings.

2. The apparatus according to claim 1, wherein, The signal is an auditory signal, a visual signal, and / or a tactile signal.

3. The apparatus according to any one of claims 1 or 2, wherein, The confirmation action includes physical interaction with the input device.

4. The apparatus according to any one of claims 1 to 3, wherein, The input device includes buttons and / or a touchscreen.

5. The apparatus according to any one of claims 1 to 4, wherein, The device includes a housing surrounding the negative pressure source and the control circuit, wherein the input device is an integrated part of the housing.

6. The apparatus according to any one of claims 1 to 5, wherein, The fluid flow path is a first fluid flow path, and the device further includes an electronically controllable valve configured to release negative pressure from the wound site via a second fluid flow path.

7. A method for controlling the application of pressure relief to a wound site, the method comprising: Data is received from an external device via one or more antennas and one or more transceivers of the device, wherein the received data includes one or more parameter settings for the device; In response to receiving the data from the external device, a signal is output to the user of the device via one or more output devices of the user interface; and In response to the user's confirmation action detected by the input device via the user interface of the device, one or more settings of the device are updated based on one or more received parameter settings.

8. The method according to claim 7, wherein, The signal is an auditory signal, a visual signal, and / or a tactile signal.

9. The method according to any one of claims 7 to 8, wherein, The confirmation action includes physical interaction with the input device.

10. The method according to any one of claims 7 to 9, wherein, The device for providing decompression to the wound site is the device according to any one of claims 1 to 6.

11. A computer program product comprising instructions that, when executed by a computing device for providing decompression to a wound site, cause the device to perform the method according to any one of claims 7 to 10.

12. A computer-readable storage medium comprising instructions that, when executed by a computing device for providing decompression to a wound site, cause the device to perform the method according to any one of claims 7 to 10.

13. A system comprising: The apparatus according to any one of claims 1 to 6; A wound covering for creating a sealed space partially defined by the wound site; Piping assembly that defines the fluid flow path.

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