Temperature monitoring and control for negative pressure wound therapy systems

Abstract

A negative pressure wound therapy may include: a negative pressure source configured to provide negative pressure to a wound of a patient covered by a wound dressing; a first sensor and a second sensor configured to measure the temperature of the negative pressure system; an electronic control circuit configured to control the operation of the negative pressure source in response to the temperature measured by the first sensor; and a programmable controller configured to control the operation of the negative pressure source in response to the temperature measured by the second sensor, the controller being configured to control the operation of the negative pressure source independently of the electronic control circuit.

Description

Technical Field

[0001] The embodiments described herein relate to devices, systems, and methods for treating wounds, for example, using a combination of dressings and negative pressure wound therapy. Background Technology

[0002] The treatment of large, non-healing, or otherwise unhealable open or chronic wounds by applying negative pressure to the wound site is well known in the art. Currently known negative pressure wound therapy (“NPWT”) systems typically involve placing a fluid-impermeable or semi-permeable covering over the wound, sealing the covering to the patient’s tissues surrounding the wound using various means, and connecting a negative pressure source (such as a vacuum pump) to the covering in a manner that generates and maintains negative pressure beneath it. It is believed that this type of negative pressure promotes wound healing by facilitating granulation tissue formation at the wound site and aiding the body’s normal inflammatory processes while removing excess fluid that may contain harmful cytokines and / or bacteria. However, further improvements to NPWT are needed to fully realize the therapeutic benefits. Summary of the Invention

[0003] A negative pressure wound therapy system may include a negative pressure source configured to provide negative pressure to a patient wound covered by a wound dressing. The negative pressure system may include a first sensor configured to measure the temperature of at least a first portion of the negative pressure system. The negative pressure system may include a second sensor configured to measure the temperature of at least one of the patient or at least a second portion of the negative pressure system. The negative pressure system may include electronic control circuitry configured to control the operation of the negative pressure source in response to the temperature measured by the first sensor. The negative pressure system may include a controller configured to control the operation of the negative pressure source in response to the temperature measured by the second sensor. The controller may be programmable. The controller may be configured to control the operation of the negative pressure source independently of the electronic control circuitry.

[0004] Any of the negative pressure wound therapy systems described in the preceding paragraphs and / or the negative pressure wound therapy systems, devices, or apparatuses disclosed herein may include one or more of the following features. The controller may be configured to reduce the activity of the negative pressure source in response to a temperature measured by the second sensor satisfying a second temperature threshold below a first temperature threshold and not satisfying the first temperature threshold. Reducing the activity of the negative pressure source may include decreasing the duty cycle of the negative pressure source. The negative pressure wound therapy system may include a wound dressing. At least one of the negative pressure source, the first sensor, the second sensor, the electronic control circuitry, or the controller may be at least partially supported by the wound dressing. The temperature measured by the first sensor may indicate the temperature of the negative pressure source. The electronic control circuitry may be configured to deactivate the negative pressure source in response to determining that the temperature measured by the first sensor satisfies a temperature threshold indicating unsafe operation. The electronic control circuitry may include a comparator configured to output a determination that the temperature measured by the first sensor satisfies the temperature threshold indicating unsafe operation. The comparator may accept the temperature measured by the first sensor as a first input. The comparator may accept the temperature threshold as a second input. The comparator may be configured to operate in the presence of noise due to at least one of the following: one or more inputs of the comparator are filtered, or feedback is provided between a first or second input of the comparator and the output of the comparator. The first and second inputs of the comparator may be low-pass filtered. Feedback may include a resistor positioned between a non-inverting input of the comparator and the output of the comparator. The negative pressure wound therapy system may include a power supply configurable to provide power to at least a negative pressure source. The negative pressure wound therapy system may include a boost converter configurable to increase the power provided by the power supply and provide the increased power to the negative pressure source. A first sensor may be configured to measure the temperature of the boost converter. The first sensor may be located adjacent to the boost converter.

[0005] Any of the negative pressure wound therapy systems described in the preceding paragraphs and / or any of the negative pressure wound therapy systems, devices, or apparatuses disclosed herein may include one or more of the following features. The second sensor may include a pair of sensors. The controller may be configured to determine the temperature of at least one of the negative pressure source or another component of the negative pressure system based on the difference between measurements from the first and second sensors of the pair. The first and second sensors of the pair may be configured to measure pressure and temperature. The first sensor of the pair may be located at the inlet of the negative pressure source, and the second sensor of the pair may be located at the outlet of the negative pressure source. The controller may be configured to control the operation of the negative pressure source in response to the temperature measured by the second sensor by at least one of the following: deactivating the negative pressure source in response to the temperature measured by the second sensor meeting a first temperature threshold indicating unsafe operation; reducing the activity of the negative pressure source in response to the temperature measured by the second sensor meeting a second temperature threshold less than the first temperature threshold and not meeting the first temperature threshold; or taking no action in response to the temperature measured by the second sensor not meeting the second temperature threshold. Reducing the activity of the negative pressure source may include reducing the duty cycle of the negative pressure source. The controller can be configured to store in memory a first indication that at least one of the first or second temperature thresholds has been met, and a second indication that the temperature measured by the first sensor meets the temperature threshold indicating unsafe operation.

[0006] Any negative pressure wound therapy system described in any of the preceding paragraphs and / or any negative pressure wound therapy system, device, or apparatus disclosed herein may include one or more of the following features. The controller may be configured to disable activation of the negative pressure source in response to determining that a temperature measured by at least one of the first or second sensors meets a temperature threshold indicating unsafe operation. The first and second portions of the negative pressure system may be identical. The negative pressure wound therapy system may include a switch configurable to allow activation of the negative pressure source. The switch may be configured to deactivate in response to determining that a temperature measured by at least one of the first or second sensors meets a temperature threshold indicating unsafe operation. The second sensor may be configured to measure the patient's temperature. The controller may be configured to deactivate the negative pressure source in response to determining that a temperature measured by the second sensor meets a temperature threshold indicating a high patient temperature. The controller may be configured to execute instructions to control the operation of the negative pressure source in response to a temperature measured by the second sensor.

[0007] Disclosed are methods for operating any of the negative pressure wound therapy systems described in the preceding paragraphs and / or any of the negative pressure wound therapy systems, devices or apparatuses disclosed herein. Attached Figure Description

[0008] Figure 1A-1C A wound dressing is shown, which incorporates a negative pressure source and / or other electronic components within the wound dressing.

[0009] Figure 2A-2B An electronic device unit that may be incorporated into a wound dressing is shown;

[0010] Figure 3 It is an exploded perspective view of an electronic component assembly that encloses the electronic component units within a housing;

[0011] Figure 4A It shows Figure 3 Bottom perspective view of the electronic component assembly;

[0012] Figure 4B It shows Figure 3 Top perspective view of the electronic component assembly;

[0013] Figure 5A An exploded view of a wound dressing that includes electronic components within a wound dressing layer is shown.

[0014] Figure 5B A cross-sectional layout of the material layers of a wound dressing that includes electronic components within the dressing is shown.

[0015] Figures 6A-6B 7A-7B show components of an electronic device assembly;

[0016] Figure 8 The pump outlet mechanism is shown;

[0017] Figure 9 A block diagram of the electronic components of the TNP system is shown;

[0018] Figures 10A-10B The electronic components and other parts of the TNP system are shown; and

[0019] Figure 11 A circuit diagram of a portion of the TNP system is shown. Detailed Implementation

[0020] The embodiments disclosed herein relate to devices and methods for treating wounds under decompression, including negative pressure sources and wound dressing assemblies and devices. These devices and components (including, but not limited to, wound coverings, backing layers, overlays, drapes, sealing layers, spacers, absorbent layers, delivery layers, wound contact layers, filler materials, fillers, and / or fluid connectors) are sometimes collectively referred to herein as dressings.

[0021] It should be recognized that the term "wound" is used throughout this instruction manual. It should be understood that the term "wound" should be interpreted broadly to include and encompass both open and closed wounds where the skin is torn, cut, or punctured, or where trauma has caused contusion, or any other surface or other condition or defect on the patient's skin, or those wounds that have benefited from decompression treatment. Therefore, a wound is broadly defined as any area of ​​damaged 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 open wounds that result from surgery, trauma, sternotomy, fasciotomy, or other conditions, lacerations, acute wounds, chronic wounds, subacute and lacerated wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers, and venous ulcers.

[0022] It should be understood that the embodiments of this disclosure are generally suitable for use in NPWT or localized negative pressure (“TNP”) therapy systems. In simple terms, negative pressure wound therapy aids in the closure and healing of various forms of “refractory” wounds by: reducing tissue edema, promoting blood flow and granulation tissue formation, removing excess exudate, and reducing bacterial load (thereby lowering the risk of infection). Furthermore, this therapy allows for less disturbance to the wound, enabling faster healing. TNP therapy systems can also aid in the healing of surgically closed wounds by removing fluid and helping to stabilize tissue in the relative position of the closure. Another beneficial use of TNP therapy can be found in grafts and flaps, where removing excess fluid is important and close proximity of the graft to the tissue is necessary to ensure tissue viability.

[0023] As used herein, a decompression level or negative pressure level (e.g., -X mmHg) represents a pressure level relative to normal ambient atmospheric pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, 1013.25 mbar, etc.). Therefore, a negative pressure value of -X mmHg reflects an absolute pressure X mmHg lower than 760 mmHg, or in other words, reflects an absolute pressure of (760-X) mmHg. Furthermore, a negative pressure "lower" or "smaller" than X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40 mmHg is smaller than -60 mmHg). A negative pressure "higher" or "larger" than -X mmHg corresponds to a pressure further away from atmospheric pressure (e.g., -80 mmHg is larger than -60 mmHg). In some cases, local ambient atmospheric pressure is used as a reference point, which does not necessarily have to be, for example, 760 mmHg.

[0024] The negative pressure range can be approximately -80 mmHg, or between approximately -20 mmHg and -200 mmHg. It should be noted that these pressures are based on normal ambient atmospheric pressure (which can be 760 mmHg). Therefore, -200 mmHg would practically be around 560 mmHg. In some cases, the pressure range can be between approximately -40 mmHg and -150 mmHg. Alternatively, pressure ranges up to -75 mmHg, up to -80 mmHg, or above -80 mmHg can be used. Additionally, in some cases, pressure ranges below -75 mmHg can be used. As an alternative, negative pressure equipment can supply pressure ranges exceeding approximately -100 mmHg, or even -150 mmHg.

[0025] wound dressing

[0026] The negative pressure source (such as a pump) and some or all other components of the TNP system (such as power supplies, sensors, connectors, user interface components (such as buttons, switches, speakers, screens, etc.)) can be integrated with the wound dressing. The material layers may include a wound contact layer, one or more absorbent layers, one or more delivery layers or spacers, and a backing or covering layer that covers one or more absorbent layers and delivery or spacer layers. The wound dressing can be placed over and sealed to the wound, with the pump and / or other electronic components housed beneath the covering layer within the wound dressing. The dressing can be supplied as a single article, where all wound dressing elements (including the pump) are pre-attached and integrated into a single unit. Figure 1A-1C As shown, the periphery of the wound contact layer can be attached to the periphery of the covering layer that surrounds all wound dressing elements.

[0027] The pump and / or other electronic components may be configured to be positioned adjacent to or immediately adjacent to the absorbent and / or transport layers, such that the pump and / or other electronic components remain part of a single article to be applied to the patient. The pump and / or other electronic components may be positioned remotely from the wound site. Although certain features disclosed herein can be described as relating to systems and methods for controlling the operation of a negative pressure wound therapy system in which the pump and / or other electronic components are positioned in or on a wound dressing, the systems and methods disclosed herein are applicable to any negative pressure wound therapy system or any medical device. Figure 1A-1C A wound dressing is shown, which incorporates a negative pressure source and / or other electronic components. Figure 1A-1C A wound dressing 100 is shown in which the pump and / or other electronic components are positioned away from the wound site. The wound dressing may include an electronics region 161 and an absorbent region 160. The dressing may include a wound contact layer 110. Figure 1A-1B (not shown in the image), and water vapor permeable membrane, overlay, or backing layer 113 positioned above the contact layer and other layers of the dressing. For example... Figure 1A-1CAs shown, the wound dressing layer, as well as the components of the electronic device area and the absorption area, can be covered by a continuous covering layer 113.

[0028] A porous material layer 111 may be located above the wound contact layer 110. As used herein, the terms porous material, spacer layer, and / or transport layer can be used interchangeably to refer to a material layer in a dressing configured to distribute negative pressure throughout the wound area. This porous layer or transport layer 111 allows fluids, including liquids and gases, to be transported away from the wound site to the upper layer of the wound dressing. Specifically, the transport layer 111 preferably ensures that open air channels remain open to deliver negative pressure over the wound area even when the absorbent layer has absorbed a considerable amount of exudate. Layer 111 should preferably remain open under the typical pressure that will be applied during negative pressure wound therapy as described above, so that the entire wound site is subjected to uniform negative pressure. Layer 111 may be formed of a material having a three-dimensional structure. For example, knitted or woven spacer fabrics (e.g., Baltex 7970 weft-knitted polyester) or nonwoven fabrics may be used.

[0029] Additionally, one or more absorbent layers (such as layers 122, 151) can be used to absorb and retain exudate aspirated from the wound. Superabsorbent materials can be used in absorbent layers 122, 151. One or more absorbent material layers 122, 151 can be disposed above transport layer 111. Since each of the absorbent layers experiences negative pressure during use, the material of the absorbent layer can be selected to absorb liquid under these conditions. Absorbent layers 122, 151 may include composites comprising superabsorbent powder, fibrous materials such as cellulose, and bound fibers. The composite may be an air-laid thermally bonded composite.

[0030] Electronics area 161 may include a negative pressure source (e.g., a pump) that can be integrated with wound dressings and some or all other components of the TNP system (e.g., power supply, sensors, connectors, user interface components (e.g., buttons, switches, speakers, screens, etc.)). For example, electronics area 161 may include buttons or switches ( Figure 1A-1B (The image shown is covered by a pull tab). A button or switch can be used to operate the pump (e.g., turn the pump on / off).

[0031] The electronic component region 161 of the dressing may include one or more transport or spacer material layers and / or absorbent material layers, and electronic components may be embedded within one or more transport or spacer material layers and / or absorbent material layers. The transport or absorbent material layers may have recesses or cutouts to embed the electronic components internally while providing a structure to prevent collapse. Figure 1C As shown, recesses 128 and 129 can be provided in absorption layers 151 and 122, respectively.

[0032] As used herein, the upper layer, top layer, or overlying layer refers to the layer furthest from the surface of the skin or wound when the dressing is in use and positioned on the wound. Therefore, the lower surface, lower layer, bottom layer, or underlying layer refers to the layer closest to the surface of the skin or wound when the dressing is in use and positioned on the wound. Additionally, these layers may have a proximal side facing the wound, referring to the side or face of the layer closest to the skin or wound, and a distal side, referring to the side or face of the layer furthest from the skin or wound.

[0033] The cover layer may include a cut 172 positioned above at least a portion of an opening 128 in the absorbent layer 122 to allow access to and fluid communication with at least a portion of the absorbent layers 122 and 151, the transport layer 111, and the underlying wound contact layer 110. Electronic device assemblies, as described below, may be positioned in the openings 128, 129, and 172 of the first absorbent material 151, the second absorbent material 122, and the cover layer 113. (See reference...) Figure 3 and 4A As described in -4B, electronic device components may include pumps, power supplies, and printed circuit boards.

[0034] Prior to use, the dressing may include one or more delivery layers 146 adhered to the bottom surface of the wound contact layer 110. Delivery layers 146 may cover adhesive or openings on the bottom surface of the wound contact layer 110. Delivery layers 146 may provide support for the dressing and may assist in the sterile and proper placement of the dressing on the patient's wound and skin. Delivery layers 146 may include a handle that can be used by the user to detach the delivery layer 146 from the wound contact layer 110 before applying the dressing to the patient's wound and skin.

[0035] Electronic components included in wound dressings

[0036] Figure 2A-2B An electronic device unit 267 that may be incorporated into a wound dressing is shown. Figure 2A A top view of the electronic device unit is shown. Figure 2B The bottom or wound-facing surface of the electronic device unit is shown. The electronic device unit 267 may include a pump 272 and one or more power sources 268, such as a battery. The electronic device unit 267 may include a circuit board 276 configured to be electrically connected to the pump 272 and / or the power source 268. The circuit board 276 may be flexible or substantially flexible.

[0037] like Figure 2A As shown, the electronic device unit 267 may include a single button or switch 265 on its upper surface. The single button or switch 265 can be used as an on / off button or switch to stop and start the operation of the pump and / or electronic components. The electronic device unit 267 may also include one or more vents or exhaust ports 264 on the circuit board 276 for discharging air discharged from the pump. Figure 2BAs shown, pump outlet discharge mechanism 274 (sometimes referred to as pump discharge mechanism or pump outlet mechanism) may be attached to the outlet of pump 272.

[0038] like Figure 2B As shown, the electronic device unit 267 may include a pump inlet protection mechanism 280 positioned on the portion of the electronic device unit closest to the absorbent region and aligned with the inlet of the pump 272. The pump inlet protection mechanism 280 is positioned between the pump inlet and the absorbent region or absorbent layer of the dressing. The pump inlet protection mechanism 280 may include a hydrophobic material to prevent fluid from entering the pump 272. The pump inlet protection mechanism 280 (or any inlet protection mechanism disclosed herein) may include a filter.

[0039] The upper surface of the electronic device unit 267 may include one or more indicators 266 for indicating the status of the pump and / or the pressure level within the dressing. The indicators may be small LED lights or other light sources, visible through a through-hole in the dressing component or above the indicator. The indicators may be green, yellow, red, orange, or any other color. For example, two lights may be present, one green and one orange. The green light indicates that the device is functioning normally, and the orange light indicates that there is a problem with the pump (e.g., leakage, dressing saturation level, blockage downstream of the pump, drain blockage, low battery, etc.).

[0040] Power supply 268 may be electrically connected to circuit board 276. One or more power connectors are connected to the surface of circuit board 276. Circuit board 276 may have other electronic devices included therein. For example, circuit board 276 may support various sensors, including but not limited to one or more pressure sensors, temperature sensors, optical sensors and / or cameras, and / or saturation indicators.

[0041] Figure 3 An electronic device assembly 300 is shown, in which electronic device units are enclosed within a housing. For example... Figure 3 As shown, the housing of the electronic device assembly 300 may include a plate 301 and a flexible membrane 302 that surrounds the electronic device unit 303 therein. The electronic device unit 303 may include a pump 305, an inlet protection mechanism 310, a pump discharge mechanism 306, a power supply 307, and a circuit board 309. The circuit board 309 may be flexible or substantially flexible.

[0042] As shown, the pump discharge mechanism 306 can be a housing such as a chamber. The electronic unit 303 and the pump 305 can be used without the inlet protection mechanism 310. However, the pump discharge mechanism 306 and the pump 305 can be located within an extended housing 316.

[0043] The flexible membrane 302 can be attached to the plate 301 to form a fluid-impermeable seal and enclosure around the electronic components. The flexible membrane 302 can be attached to the periphery of the plate by thermal welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technology.

[0044] The flexible membrane 302 may include an aperture 311. The aperture 311 allows the inlet protection mechanism 310 to be in fluid communication with the absorbent layer and / or transport layer of the wound dressing. The periphery of the aperture 311 of the flexible membrane 303 may be sealed or attached to the inlet protection mechanism 310, thereby forming a fluid-impermeable seal and closure around the inlet protection mechanism 310, allowing the electronic components 303 to remain protected from fluids within the dressing. The flexible membrane 302 may be attached to the periphery of the inlet protection mechanism 310 by thermal welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique. The inlet protection mechanism 310 prevents wound exudate or fluid from the wound and collected in the absorbent area 160 of the wound dressing from entering the pump and / or electronic components of the electronic device assembly 300.

[0045] As described in this article, Figure 3 The electronic component 300 shown may be included within the wound dressing such that once the dressing is applied to the patient's body, air from within the dressing may pass through the inlet protection mechanism 310 to be pumped out toward the pump discharge mechanism 306, which communicates with the orifices in the housing 316 and the flexible circuit board 309.

[0046] Figure 4A -B shows the reference Figure 3 The description similarly includes an electronic component assembly 400 of a pump inlet protection mechanism 410 sealed to the outside of a flexible membrane 402. An emission mechanism 406, which may be similar to an emission mechanism 306, is also shown.

[0047] Figure 4A The lower surface of the electronic device assembly 400 facing the wound is shown. Figure 4B The upper surface of a plate 401 of an electronic device assembly 400 (which may face a patient or user) is shown. The upper surface of plate 401 may include an on / off switch or button cover 443 (shown as a pull tab), an indicator 444, and / or one or more ventilation holes 442. Removal of the pull tab 443 may activate the electronic device assembly 400, such as by supplying power from a power source to the electronic device assembly. Further details of the operation of the pull tab 443 are described in PCT International Application No. PCT / EP2018 / 079745, filed October 30, 2018, entitled “SAFE OPERTATION OF INTEGRATED NEGATIVE PRESSURE WOUNDTREATMENT APPARATUSES,” which is incorporated herein by reference in its entirety.

[0048] like Figure 1C As shown, an electronic component assembly 400 having a pump inlet protection mechanism 410 extending from and sealing the membrane 402 can be positioned within an orifice 172 in the cover layer 113 and the absorber layers (122, 151). Figure 1C As shown and referenced in this article Figures 5A-5B In more detail, the periphery of the electronic component assembly 400 can be sealed to the top surface of the outer periphery of the orifice 172 in the cover layer 113. The electronic component assembly 400 can be sealed to the cover layer 113 using gaskets, adhesives, thermal welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique. The electronic component assembly 400 can be permanently sealed to the cover layer 113 and cannot be removed from the cover layer without damaging the dressing.

[0049] The electronic component assembly 400 can be used in a single dressing and disposed of with the dressing. In other cases, the electronic component assembly 400 can be used in a series of dressings.

[0050] Figure 5A This illustrates a wound dressing that includes an electronic component 500 within a wound dressing layer 590, such as... Figure 1C Wound dressings. Figure 5B It shows including Figure 5A A cross-sectional view of a wound dressing with an electronic component assembly. The electronic component assembly 500 may be disposed within orifices 172 in a cover layer and orifices 129 and 128 in a first absorbent layer 122 and a second absorbent layer 151. The electronic component assembly 500 may be sealed to the outer periphery of the orifices 172 in the cover layer. The dressing may include a wound contact layer 110 and a water vapor permeable membrane, cover layer, or backing layer 113 positioned above the contact layer 110 and other layers of the dressing. A porous material layer 111 may be located above the wound contact layer 110. As used herein, the terms porous material, spacer layer, and / or transport layer can be used interchangeably to refer to material layers in a dressing configured to distribute negative pressure throughout the wound area. This porous layer or transport layer 111 allows fluids, including liquids and gases, to be transported away from the wound site to the upper layers of the wound dressing. Additionally, one or more absorbent layers (such as layers 122, 151) may be used to absorb and retain exudate absorbed from the wound. One or more absorbent material layers 122, 151 may be disposed above the delivery layer 111. A small-aperture absorbent layer 151 and a large-aperture absorbent layer 122 may be present. The small-aperture absorbent layer 151 may be positioned on top of the large-aperture absorbent layer 122. In some cases, the small-aperture absorbent layer 151 may be positioned below the large-aperture absorbent layer 122. Before use, the dressing may include one or more delivery layers 146 adhered to the bottom surface of the wound contact layer. The delivery layers 146 may cover the adhesive or openings on the bottom surface of the wound contact layer 110.

[0051] Figures 6A-6B Figures 7A-7B show an electronic device assembly 1500 having a pump inlet protection mechanism 1710 and a pump discharge mechanism 1074 on a pump 1072. Assembly 1500 may include cavities 1082 and 1083 respectively located on the pump inlet protection mechanism 1710 and the pump discharge mechanism 1074. Figures 7A-7B (As shown in the diagram). The inlet protection mechanism and pump discharge mechanism can be adhered to the inlet and outlet of the pump as described herein. Component 1500 can be assembled using adhesives and is allowed to cure before being incorporated into the electronic component assembly.

[0052] The pump inlet may be covered or equipped with a pump inlet protection mechanism 1710. For example, by Figure 7A As indicated by the arrow, the pump inlet protection mechanism 1710 can be pushed onto the pump inlet. This can be a friction fit. The port of the pump inlet protection mechanism 1710, which receives a portion of the pump inlet, can be sized and shaped to complementarily fit around the pump inlet. The pump inlet protection mechanism 1710 can be attached to the pump inlet using silicone sealant or any other sealant or sealing technology. Figure 7B A pump inlet protection mechanism 1710 covering the pump inlet and a pump discharge mechanism 1074 covering the pump outlet are shown. The pump discharge mechanism 1074 may include one or more orifices or vents 1084 to allow gas drawn by the pump to be discharged from the pump discharge mechanism 1074. In some cases, a check valve and / or filter diaphragm of the pump discharge mechanism are included in the pump discharge mechanism 1074.

[0053] Figures 7A-7B A pump inlet protection mechanism 1710 and a pump discharge mechanism 1074 with cavities 1082 and 1083 are shown. The pump assembly including the pump inlet protection mechanism 1710 and the pump discharge mechanism 1074 can be placed above the surface of the circuit board 1081. Figure 6B As shown, when the pump assembly contacts the surface of the circuit board 1081, cavities 1082 and 1083 can at least partially enclose sensors on the circuit board 1081, such as pressure sensors 1091 and 1092 on the circuit board 1081.

[0054] Figure 6B The pressure sensors 1091 and 1902 shown can be used to measure and / or monitor the pressure level and atmospheric pressure at the wound site. Pressure sensor 1091 can be used to measure and / or monitor the pressure at the wound site (e.g., under a wound dressing), which can be achieved by measuring and / or monitoring the pressure in the fluid flow path connecting the negative pressure source or pump 1072 to the wound. Pressure sensor 1091 can measure and / or monitor... Figures 7A-7B The pressure in chamber 1082 of the pump inlet protection mechanism 1710 shown. Power supply 1068 (in Figure 6A(The two batteries shown in the middle) can provide power to the negative pressure source 1072 and electronic devices.

[0055] Pressure sensor 1092 can be used to measure and / or monitor pressure outside the wound dressing. Figures 7A-7B The pressure in chamber 1083 of the pump discharge mechanism 1074 shown is illustrated. Pressure sensor 1092 measures the pressure outside the wound dressing, which can be relative to atmospheric pressure, as atmospheric pressure can vary depending on factors such as the altitude at which it is used or the pressurized environment where a TNP device can be used. These measurements can be used to establish the desired negative pressure differential (or set point) at the wound site relative to the external pressure.

[0056] Circuit board 1081 (including any circuit board described herein) may include control circuitry, such as one or more processors or controllers, which can control the negative pressure supplied by negative pressure source 1072 based on a comparison between the pressure monitored by pressure sensor 1091 and the pressure monitored by pressure sensor 1092. The control circuitry can operate negative pressure source 1072 in a first mode (which may be referred to as the initial pump-down mode), in which negative pressure source 1072 is activated to establish a negative pressure setpoint at the wound site. The setpoint may be set to a value in, for example, a range from about -70 mmHg to about -90 mmHg, etc. Once a setpoint that can be verified based on the difference between the pressure measured by pressure sensor 1091 (or wound pressure) and the pressure measured by pressure sensor 1092 (or external pressure) has been established, the control circuitry can deactivate (or pause) the operation of negative pressure source 1072. The control circuitry can operate the negative pressure source 1072 in a second mode (which may be referred to as the maintenance pump depressurization mode), in which the negative pressure source 1072 is periodically activated to re-establish the negative pressure setpoint when the wound is depressurized due to one or more leaks. The control circuitry can activate the negative pressure source 1072 in response to the pressure at the wound (as monitored by pressure sensor 1091) becoming more positive than a negative pressure threshold, which can be set to the same negative pressure as the setpoint or a lower negative pressure.

[0057] The embodiments of wound dressings, wound treatment devices, and methods described herein may also be combined with or supplemented by one or more features described in PCT International Application No. PCT / EP2017 / 060464, filed May 3, 2017, entitled NEGATIVE PRESSURE WOUND THERAPY DEVICE ACTIVATION AND CONTROL, U.S. Patent Nos. 8,734,425 and 8,905,985, each of which is incorporated herein by reference in its entirety.

[0058] One or more self-adhesive gaskets may be applied to the pump inlet protection mechanism 1710 and the pump discharge mechanism 1074 to seal the cavities 1082 and 1083 of the pump inlet and pump discharge ports around the sensor on the circuit board 1081, and to seal around the discharge mechanism vent and the corresponding vent in the circuit board 1081 (as described herein). Pre-formed adhesive sheets may be used to form sealing gaskets between the cavities 1082 and 1083 of the pump inlet and pump discharge mechanisms and the sensor on the circuit board 1081, and between the discharge mechanism vent and the vent in the circuit board 1081. In some cases, adhesive may be used to seal the cavities 1082 and 1083 of the pump inlet protection mechanism 1710 and the pump discharge mechanism 1074 around the sensor on the circuit board 1081, and around the discharge mechanism vent 1084 and the corresponding vent in the circuit board (see [link to relevant documentation]). Figure 10B (1094) Sealing. As described herein, the electronic component 1500 may be embedded within the layers of the dressing, such as in the cuts or recesses therein.

[0059] The pump inlet protection mechanism 1710 provides a large surface area that can be used to draw vacuum from the pump inlet. The pump inlet (at...) Figure 7A The protrusion shown in the center (circular) can fit into the recess in the pump inlet protection mechanism 1710. The pump inlet can be attached to and / or form a complementary fit with the recess of the pump inlet protection mechanism by friction fit.

[0060] Pump inlet protection mechanism 1710 allows air or gas to pass through but prevents liquid from reaching a negative pressure source. Pump inlet protection mechanism 1710 may include a porous material. Pump inlet protection mechanism 1710 may include one or more porous polymer molded parts. Pump inlet protection mechanism 1710 may include a hydrophobic or substantially hydrophobic material. The material included in pump inlet protection mechanism 1710 may have a pore size ranging from about 5 micrometers to about 40 micrometers. In some cases, the pore size may be about 10 micrometers. Pump inlet protection mechanism 1710 may include a polymer that may be one of hydrophobic polyethylene or hydrophobic polypropylene. In some cases, pump inlet protection mechanism may include Porvair Vyon material with a pore size of 10 micrometers. Any pump inlet protection mechanism described herein may include one or more features of pump inlet protection mechanism 1710.

[0061] Pump discharge mechanism 1074 (or any of the pump discharge mechanism or outlet mechanism described herein) may include, for example: Figure 8The check valve or check valve 1210 shown is an example. Check valve 1210 can be any suitable mechanical check valve, such as a reed valve, duckbill valve, ball valve, hinged valve, or umbrella valve. The check valve can be similar to any check valve described in PCT International Application No. PCT / EP2017 / 055225, filed March 6, 2017, entitled "WOUNDTREATMENT APPARATUSES AND METHODS WITH NEGATIVE PRESSURE SOURCE INTEGRATEDINTO WOUND DRESSING," which is incorporated herein by reference in its entirety. Pump discharge mechanism 1074 may be bonded to the pump outlet using a sealant such as a silicone sealant. The outlet or discharge port of pump discharge mechanism 1074 may include an antimicrobial membrane and / or other filter membranes that filter gases discharged from outside the NPWT system, such as gases discharged into the atmosphere. As shown in the figure, the pump discharge mechanism 1074 may be a housing or chamber that is substantially sealed to prevent gas or fluid from entering through the vent 1084.

[0062] Any embodiment described herein may additionally or alternatively include international application number PCT / EP2018 / 074694, filed September 13, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; international application number PCT / EP2018 / 074701, filed September 13, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; international application number PCT / EP2018 / 079345, filed October 25, 2018, entitled "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS"; and international application number PCT / EP2018 / 079345, filed March 10, 2020, entitled "EXHAUST BLOCKAGE DETECTION FOR NEGATIVE PRESSURE". The WOUND TREATMENT APPARATUSES contains one or more features described in International Patent Application No. PCT / EP2020 / 056317, each of which is incorporated herein by reference in its entirety.

[0063] Temperature monitoring and control

[0064] Figure 9 A block diagram of electronics 2000 for a TNP system (which may be any of the TNP systems described herein) is shown. The electronics (or electronic components) may include a power supply 2010, a latching circuit 2020, a controller 2030 (which may be programmable), a memory 2012, a boost converter (or regulator) 2040 (sometimes referred to as a boost converter circuit or boost regulator circuit), a drive circuit 2050, and a negative pressure source 2060. The negative pressure source 2060 may include a piezoelectric pump (such as a pump operated by a piezoelectric actuator or transducer). In some cases, the drive circuit 2050 may include an H-bridge circuit. The power supply 2010 may include one or more batteries (such as two 3V batteries). The power supply 2010 may provide power to other electronic components.

[0065] The latching circuit 2020 may include one or more active components (such as transistors) that are activated in response to activation of the TNP device (such as removal of the pull tab). Figure 9 Any one or more of the other components shown. Activation allows latch circuit 2020 to facilitate the supply of power from power source 2010 to one or more other components, such as controller 2030. In some cases, in response to activation, latch circuit 2020 may provide indication or signal 2022 to controller 2030. Latch circuit 2020 may transition from an inactive state (which may be the default state) to an active state in response to activation. In response to receiving signal 2022, controller 2030 may operate negative voltage source 2060. For example, controller may operate boost converter 2040 via signal 2032 (such as reference voltage or current) and drive circuit 2050 via signal 2034 (such as pulse width modulation signal). Further details of the operation of the latching circuit are described in International Application No. PCT / EP2018 / 079745, filed on October 30, 2018, entitled “SAFE OPERTATION OF INTEGRATED NEGATIVEPRESSURE WOUND TREATMENT APPARATUSES”, which is incorporated herein by reference in its entirety.

[0066] The power supplied by power source 2010 (e.g., 3V or less or greater, 4V or less or greater, 5V or less or greater, 6V or less or greater, 7V or less or greater, 8V or less or greater, 9V or less or greater, etc.) may need to be increased to power negative voltage source 2060. Boost converter 2040 can increase the power supplied by power source 2010 to a power level sufficient to power negative voltage source 2060. Boost converter 2040 may include electronic circuitry configured to generate a higher power level (e.g., a higher DC voltage) from a lower input power (e.g., battery power). In some cases, boost converter 2040 may be a switch-mode power supply device. Boost converter 2040 may be a DC-DC converter having an output voltage greater than the input voltage or source voltage. Boost converter 2040 can increase or boost the power level of power source 2010 to a power level suitable for operating negative voltage source 2060. For example, power supply 2010 can provide 6V DC power (or less or more), while negative voltage source 2060 may require DC power between 30V (or less or more) and 22V (or less or more).

[0067] The negative pressure source 2060 can be controlled by alternating cycles of activation and deactivation. The duty cycle of the negative pressure source 2060 reflects the portion of time the negative pressure source is in operation relative to a given time interval (e.g., 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, etc.). For example, if the negative pressure source 2060 operates for 15 seconds within a 30-second time interval, the duty cycle is 50%. In some cases, an increase in the duty cycle of the negative pressure source 2060 may indicate the presence of one or more leaks (e.g., in the seal between the dressing and the patient). This may be because the negative pressure source 2060 operates longer in the presence of one or more leaks to establish or maintain a negative pressure setpoint. Further details of the operation of the boost converter and the negative pressure source are described in International Application No. PCT / EP2020 / 064601, filed April 26, 2020, entitled “SYSTEMS AND METHODS FOR EXTENDING OPERATIONAL TIME OF NEGATIVEPRESSURE WOUND TREATMENT APPARATUSES”, which is incorporated herein by reference in its entirety.

[0068] One or more electronic components of a TNP system may be located on the top side of the system (see example). Figure 5A , 6A and Figure 10A As a result, the top side of the system (facing away from the patient), especially the portion where one or more electronic components are located, may be the hottest part of the system during operation. Figure 9One or more of the components shown may experience a temperature increase during operation. For example, the temperature of at least one of the boost converter 2040, drive circuit 2050, or negative pressure source 2060 may increase during operation. The negative pressure source 2060 (or power supply 2010 or another component) may be designed to operate safely and efficiently at temperatures below maximum temperature thresholds (e.g., about 40 degrees Celsius or less, 41 degrees Celsius or less, 42 degrees Celsius or less, 48 ​​degrees Celsius or less, 50 degrees Celsius or less, 60 degrees Celsius or less, 70 degrees Celsius or less, 80 degrees Celsius or less, 90 degrees Celsius or less, etc.). Additionally or alternatively, because the electronics may be positioned close to the patient (e.g., supported by a wound dressing positioned on the patient's body), a temperature increase in one or more of the electronic components may cause patient discomfort or injury (e.g., burns). In some cases, an increase in patient temperature may lead to a temperature increase in one or more electronic components. To address these issues, the electronic device 2000 can monitor the temperature of one or more electronic components. The electronic device 2000 can take one or more remedial actions in response to detecting that a temperature meets (e.g., reaches or exceeds) one or more temperature thresholds. As described herein, one or more remedial actions may include disabling one or more electronic components, adjusting the operation of one or more electronic components, etc.

[0069] Electronic device 2000 may include sensor 2070 and circuitry 2080, the circuitry being able to perform one or more remedial actions in response to measurements taken by sensor 2070 (and provided to circuitry 2080 via signal 2072). Sensor 2070 may be a temperature sensor (e.g., a thermistor). In some cases, sensor 2070 may be located near one or more components that may experience increased temperatures. For example, sensor 2070 may be located near boost converter 2040, which may be the electronic component whose temperature increases the most during operation. Figure 9 As shown, in some cases, sensor 2070 may be positioned at a distance of no more than "d" from boost converter 2040. In some cases, sensor 2070 may be positioned approximately 4 mm away from boost converter 2040. In some embodiments, the distance between sensor 2070 and boost converter 2040 may be less than or greater than approximately 4 mm. A thermal path (such as a conductive trace) may connect sensor 2070 to boost converter 2040. One or more of these positioning of sensor 2070 or the presence of a thermal path may improve temperature monitoring by sensor 2070.

[0070] Circuit 2080 may include comparators, etc. (in combination) Figure 11Further description), it is configured to provide an indication (sometimes referred to as overheat detection) in response to a temperature measured by sensor 2070 meeting (e.g., reaching or exceeding) a maximum temperature threshold. This indication may enable the provision of one or more remedial measures, such as disabling negative pressure source 2060 (e.g., ...). Figure 9 As shown by signal 2084, the boost converter 2040 can be disabled. For example, circuit 2080 may include switches (e.g., transistors) that are activated (or deactivated) in response to a comparator providing an indication. Figure 9 As shown, activation (or deactivation) of the switch can cause latching circuit 2020 to stop supplying signal 2022 to controller 2030 via signal 2082. For example, in response to activation (or deactivation) of the switch, latching circuit can transition from an active state to an inactive state. In response to no longer receiving signal 2022, controller 2030 can deactivate negative pressure source 2060 (e.g., by stopping the supply of one or more of signals 2032 or 2034, or by modifying any of these signals). In some cases, circuit 2080 does not include a programmable processor or controller.

[0071] The negative pressure source may additionally or alternatively include a deactivation switch (such as switch 265) in response to any deactivation that meets the highest temperature threshold described herein, said switch being configured to allow the user to control the provision of negative pressure wound therapy. Deactivation of such a switch may be performed by controller 2030. In some cases, multiple comparators may be present to facilitate the detection of multiple temperature thresholds.

[0072] Controller 2030 may independently (or in some cases, additionally to circuitry 2080) perform one or more remedial actions in response to temperature. Sensor 2090 may sense or monitor the temperature of one or more electronic components and / or one or more patient components. Sensor 2090 may provide the measured value to controller 2030 via signal 2092. As described herein, the controller may perform one or more remedial actions based on comparing the sensed temperature to one or more temperature thresholds. For example, controller 2030 may deactivate negative pressure source 2060 in response to determining that the sensed temperature meets a maximum temperature threshold (e.g., by stopping the supply of one or more of signals 2032 or 2034 or by modifying any of these signals). Including independent and redundant mechanisms for responding to temperature increases may be advantageous for ensuring the safe and effective delivery of negative pressure wound therapy to the patient.

[0073] Sensor 2090 may include multiple sensors capable of monitoring pressure and temperature, such as pressure sensors 1091 and 1092. As described herein and further referenced, the electronics and other components 2100 of the TNP system are shown. Figures 10A-10BPressure sensor 1091 can be positioned to measure the pressure of the fluid being drawn in by negative pressure source 2060. For example, pressure sensor 1091 can be positioned at negative pressure source (e.g., in...). Figures 10A-10B The entry specified as 1072 in (e.g., in) Figure 10A The pressure sensor 1091 is located in or near the inlet (shown as 1710). Pressure sensor 1091 measures the internal temperature of the TNP system. As described herein, pressure sensor 1092 can be positioned to measure the pressure of the surrounding environment. Pressure sensor 1092 can measure the external temperature. As described herein and further referenced... Figures 10A-10B The pressure sensor 1092 can be located at the outlet of the negative pressure source (e.g., Figure 10A The location is shown as 1074) in or near the emission outlet, and is therefore in fluid communication with the surrounding environment. Figure 10A As shown, to facilitate communication with the surrounding environment, the emission mechanism 1074 may have one or more vents 1084. Additionally, as... Figure 10B As shown, one or more vents 1094 may be present in the circuit board 1081.

[0074] Due to its positioning, pressure sensor 1091 can monitor the patient's temperature (e.g., by monitoring the temperature of a dressing). For example, pressure sensor 1091 can monitor the temperature of fluid aspirated from the patient's wound (e.g., when fluid enters the inlet of a negative pressure source), which can indicate the patient's temperature. Alternatively or additionally, pressure sensor 1091 can monitor the temperature of at least some of the electronic components, including at least one of the boost converter 2040, drive circuitry 2050, or negative pressure source 2060 (whose temperature may increase during operation). Due to the positioning of pressure sensor 1092 adjacent to the negative pressure source (see...), Figures 10A-10B Therefore, the pressure sensor can monitor the temperature of at least some of the electronic components. The temperature monitored by the pressure sensor 1092 can reflect a contribution from at least one of the boost converter 2040, the drive circuit 2050, or the negative pressure source 2060. Figure 10B As shown, the covers of the inlet and outlet mechanisms have been removed, and pressure sensor 1092 is positioned adjacent to boost converter 2040 (the pressure sensor may be located on circuit board 1081 under the cover of negative pressure source 1072, in the area indicated by reference numeral 2040). Because pressure sensor 1092 is positioned in the fluid flow path of fluid aspirated from the wound, pressure sensor 1092 can additionally monitor the temperature contribution due to the patient.

[0075] The difference between the temperature monitored by pressure sensor 1092 and the temperature monitored by pressure sensor 1091 may reflect the temperature of one or more electronic components, such as boost converter 2040, drive circuit 2050, or negative pressure source 2060. This can be attributed to pressure sensor 1091, which monitors the patient's temperature, and pressure sensor 1092, which monitors the temperature of one or more electronic components and the patient. Controller 2030 may compare the temperature difference to one or more thresholds and take one or more remedial actions. As described herein, controller 2030 may compare the temperature difference to a maximum temperature threshold and, in response to determining that the temperature difference meets the maximum temperature threshold, deactivate negative pressure source 2060.

[0076] Alternatively or additionally, the controller 2030 may induce one or more modifications to the negative pressure source 2060 during operation in response to a temperature difference that does not meet the maximum temperature threshold but meets one or more other thresholds. For example, one or more of the operating time or operating intensity (sometimes referred to individually or collectively as activity) of the negative pressure source 2060 may be adjusted. For example, the activity of the negative pressure source 2060 may be reduced in response to a detected increase in temperature. In some cases, the maximum temperature threshold may be set at 40 degrees Celsius, 41 degrees Celsius, or 42 degrees Celsius.

[0077] A second temperature threshold, indicating a temperature below a maximum temperature threshold, can be used to reduce one or more of the operating time or operating intensity of the negative pressure source 2060 in response to a detected temperature increase. For example, the second temperature threshold may be set at 35 degrees Celsius (or less or greater). The controller 2030 may reduce the duty cycle of the negative pressure source 2060 in response to a temperature difference satisfying the second threshold (but not the maximum temperature threshold). Alternatively or additionally, the operating intensity of the negative pressure source 2060 may be reduced (e.g., the negative pressure level or setpoint provided by the negative pressure source may be lowered). Alternatively or additionally, the controller 2030 may deactivate the negative pressure source 2060 for a period of time. The temperature increase may be attributed to the presence of one or more leaks, which may cause the negative pressure source 2060 to operate more frequently and / or at a higher intensity to overcome the negative pressure loss due to one or more leaks. Adjusting the operation of the negative pressure source 2060 can facilitate reducing the temperature of one or more electronic components. In some cases, one or more additional temperature thresholds may be used to further adjust the operation of the negative pressure source 2060 in response to a temperature increase. Such control of the operation of the negative pressure source 2060 in response to an increase in temperature can particularly advantageously improve patient comfort, enhance safety, and conserve the capacity of the power supply 2010 (e.g., by not depleting the power supply when attempting to overcome negative pressure losses due to one or more leaks).

[0078] Alternatively or additionally, controller 2030 may perform one or more remedial actions in response to a temperature measured by pressure sensor 1091. As described herein, pressure sensor 1091 monitors the patient's temperature. To promote patient safety and comfort, controller 2030 may deactivate (e.g., permanently or temporarily) negative pressure source 2060 in response to a temperature measured by pressure sensor 1091 meeting a first temperature threshold indicating a high patient temperature. For example, the first temperature threshold may correspond to a patient temperature of 37.5 degrees Celsius (or less or greater). For example, the first temperature threshold may be the same as a maximum temperature threshold (e.g., 41 degrees Celsius). Controller 2030 may perform one or more such remedial actions to prevent further discomfort or harm to the patient due to an increase in the temperature of one or more electronic components during the provision of negative pressure wound therapy. Alternatively or additionally, controller 2030 may reduce one or more of the operating time or intensity of negative pressure source 2060 in response to a detected increase in temperature monitored by pressure sensor 1091. This can be performed using any of the methods described above, such as reducing the duty cycle of the negative pressure source 2060 in response to meeting a second temperature threshold. The second temperature threshold may correspond to a temperature lower than the first temperature threshold. For example, the second temperature threshold may be 40 degrees Celsius (or less or more). In some cases, the temperature measured by the pressure sensor 1091 may differ from the patient's temperature because the aspirated fluid flow may be colder than the patient's temperature and / or may cool the pressure sensor 1091. The temperature measured by the pressure sensor 1091 can still indicate the patient's temperature, such that an increase in temperature sensed by the pressure sensor 1091 indicates an increase in the patient's temperature.

[0079] In some cases, a hysteresis may be implemented to control the negative pressure source 2060 in response to an increase in temperature. For example, a delay may be implemented to take one or more remedial measures in response to determining that a maximum temperature threshold (or a second temperature threshold or any other temperature threshold) has been met. This prevents adjustments to the delivery of negative pressure wound therapy in response to one or more erroneous temperature detections or determinations.

[0080] One or more determinations that one or more temperature thresholds have been met can be recorded by the electronic device 2000 (e.g., stored in memory 2012). Advantageously, this can help to comply with the IEC 60601-1 standard for the safe and efficient operation of medical devices, or another applicable standard. For example, the controller 2030 can store one or more determinations in memory 2012. The controller 2030 can store overheat detection of circuit 2080 and overheat detection of controller 2030 separately in memory 2012. The controller 2030 can also store determinations that a second temperature threshold (or any other temperature threshold) has been met separately in memory 2012. The controller 2030 can store temperatures detected by one or more of sensors 2070 or 2080 (e.g., one or more of sensors 1091 and 1092) in memory. This facilitates the debugging of the electronic device 2000. For example, if it is determined that sensor 2070 has met a maximum temperature threshold, but sensor 2080 has not (or vice versa), it can be concluded that one of the sensors (and / or electrical connections) may be damaged.

[0081] Detecting overheating can disable the negative pressure source 2060 in electronic device 2000 (e.g., temporarily or permanently). In some cases, electronic device 2000 may transition to an unrecoverable error state (or end-of-life state), in which the negative pressure source 2060 may be disabled. For example, controller 2030 may transition to an unrecoverable state (or end-of-life state). In an unrecoverable error state (or end-of-life state), the operation (e.g., activation) of the negative pressure source 2060 may be permanently disabled. Further details of the disabling operation of the negative pressure source are described in International Application No. PCT / EP2020 / 064601, which is disclosed as WO2020 / 239781 and is incorporated herein by reference in its entirety.

[0082] In some cases, power supply 2010 may be depleted in response to a transition to an unrecoverable fault state (or end-of-life state). Electronic device 2000 may include circuitry (not shown) for depleting power supply 2010. Such circuitry may include one or more resistors grounded. In some cases, depleting power supply 2010 may involve monitoring temperature and controlling the depletion rate to avoid causing discomfort or harm to the patient (such as burns). Any of the approaches disclosed herein (such as using one or more sensors for monitoring the temperature of the power supply) may be used to monitor temperature and control the depletion rate of power supply 2010. In some cases, power supply 2010 may be considered discharged when its capacity meets a capacity threshold. For example, assuming power supply 2010 comprises one or more 3V lithium batteries, power supply 2010 may be considered discharged once the voltage of one or more batteries reaches 2V or lower. Depleting power supply 2010 may be advantageous for patient safety, safe disposal, etc.

[0083] In some variations, Figure 9 One or more components shown may be omitted or replaced with alternative components. In some cases, one or more remedies described herein may be taken in response to a decrease in temperature (such as when the temperature meets (e.g., reaches or falls below) a minimum temperature threshold and / or any other threshold described herein).

[0084] Figure 11 A diagram shows a circuit 2200 configured to perform overheat detection in a TNP system (which may be any of the TNP systems described herein). Circuit 2200 may correspond at least partially to circuit 2080. A temperature sensor 2210 (which may be similar to sensor 2070) may monitor the temperature of one or more components of the TNP system. For example, temperature sensor 2210 may monitor the temperature of a boost converter. Temperature sensor 2210 may be a thermistor. The temperature monitored by temperature sensor 2210 (which may output a voltage signal) may be provided to comparator 2220 (e.g., as input 2224). Comparator 2220 may be an operational amplifier. Another input 2222 of comparator 2220 may correspond to a temperature threshold, such as a maximum temperature threshold. The output 2226 of comparator 2220 may indicate whether the temperature monitored by temperature sensor 2210 meets the temperature threshold. Output 2226 may be used to control switch 2240, such as a transistor (in this case, output 2226 may control the gate of the transistor). The output of switch 2240 can be used to override the output of a latch-up circuit (such as latch-up circuit 2020). If the temperature monitored by temperature sensor 2210 meets a temperature threshold, switch 2240 will be turned on. As described herein, this overrides the output of the latch-up circuit and disables the negative voltage source. For example, activation of switch 2240 can cause output 2202 to be low (e.g., grounded), which can provide an indication to a controller (such as controller 2030) to disable the negative voltage source. For example, as in combination Figure 9 The overclock output 2202 may correspond to providing signal 2084. In some cases, the overclock output 2202 may disable a boost converter (such as boost converter 2040).

[0085] As described herein, the controller can independently perform one or more remedial actions in response to temperature. This can be achieved via signal 2204, which may correspond to an overload signal from the controller. (In conjunction with...) Figure 9 The signal 2204 may correspond to one or more of the signals 2032 provided to the boost converter 2040 or 2034 provided to the drive circuit 2050. In some cases, the signal 2204 may be used to control the switch 2250, such as a transistor (in which case the signal 2204 may control the gate of the transistor). As described above in conjunction with the switch 2240, the output of the switch 2250 may be used as the output of the overclocking latch circuit.

[0086] In some cases, comparator 2220 may malfunction due to noise in one or more of inputs 2222 or 2224. For example, noise in the operation of a negative pressure source can affect the grounding of circuit 2200 (e.g., echoes through the ground plane), which can adversely affect the operation of comparator 2220. As another example, external noise (e.g., ambient noise caused by microwave radiation, travel in a helicopter or airplane, travel in an elevator, etc.) may adversely affect the operation of comparator 2220. Due to the presence of noise, comparator 2220 may not respond correctly to a monitored temperature that meets (or does not meet) a temperature threshold (e.g., generating output 2226 at temperatures higher or lower than the temperature threshold). This can impair patient comfort, safety, etc.

[0087] To address these issues, circuit 2200 may include one or more filters 2232 and 2234 at the input of comparator 2220. Filters 2232 and 2234 may be low-pass filters configured to remove high-frequency noise (such as transient spikes). Figure 11 As shown, filters 2232 and 2234 may include resistors and capacitors (or RC low-pass filters) connected in parallel. Alternatively, feedback may be created across comparator 2220. Figure 11 As shown, resistor 2238 can be positioned across the non-inverting input 2222 and output 2226 of comparator 2220. Resistor 2238 can be referred to as a feedback resistor. Resistor 2238 can introduce hysteresis into output 2224 of comparator 2220 (or keep output 2226 in its current state even though one or more input changes caused by transient noise).

[0088] The methods for monitoring temperature and taking one or more remedial measures described herein are generally applicable to any negative pressure wound therapy device configured for wear by a patient. This facilitates the safe and effective delivery of negative pressure wound therapy. Negative pressure wound therapy devices may include electronic components, such as a negative pressure source and control circuitry. As described herein, there is a risk of patient discomfort or injury (such as burns) due to increased temperature from one of the multiple electronic components. Implementing one or more of the described techniques for detecting elevated temperature and taking one or more remedial measures (such as adjusting or stopping the delivery of negative pressure wound therapy) may be advantageous. This may be particularly important in cases where the patient is unresponsive or has other impairments, and therefore it may be impossible to stop the delivery of negative pressure wound therapy or remove the negative pressure wound therapy device attached to the patient. Alternatively or additionally, since negative pressure wound therapy devices can be used in various environments, such as locations with high ambient temperatures, the described techniques for detecting elevated temperature and taking one or more remedial measures may be advantageous in ensuring the safe and effective delivery of negative pressure wound therapy.

[0089] Other variations

[0090] While some embodiments described herein relate to integrated negative pressure wound therapy systems in which the negative pressure source is supported by a dressing, the systems and methods described herein are applicable to any negative pressure wound therapy system or medical system, particularly systems positioned on a patient (worn by the patient). For example, the systems and methods described herein for controlling operation can be used in fluid-protected (e.g., waterproof) negative pressure wound therapy systems or medical systems. Such systems may be configured with a negative pressure source and / or electronics located outside the wound dressing, such as a negative pressure source and / or electronics positioned within a fluid-protected housing. Additionally, such systems are generally configured for use within ultrasonic delivery devices, negative pressure devices powered by an external power supply, negative pressure devices with a separate pump, and medical devices.

[0091] Any of the embodiments disclosed herein may be used in conjunction with one or more of the following features: U.S. Patent No. 7,779,625, entitled “DEVICE AND METHOD FOR WOUND THERAPY”, issued August 24, 2010; U.S. Patent No. 7,964,766, entitled “WOUND CLEANSING APPARATUS IN SITU”, issued June 21, 2011; U.S. Patent No. 8,235,955, entitled “WOUND TREATMENT APPARATUS AND METHOD”, issued August 7, 2012; U.S. Patent No. 7,753,894, entitled “WOUND CLEANSING APPARATUS WITHSTRESS”, issued July 13, 2010; U.S. Patent No. 8,764,732, entitled “WOUND DRESSING”, issued July 1, 2014; and U.S. Patent No. 8,764,732, entitled “WOUND DRESSING”, issued August 19, 2014. U.S. Patent No. 8,808,274, entitled "WOUND DRESSING AND METHOD OF USE", issued June 23, 2015; U.S. Patent No. 9,061,095, entitled "WOUND DRESSING AND METHOD OF USE", issued September 18, 2018; U.S. Patent Application No. 14 / 418908, entitled "WOUND DRESSING AND METHOD OF TREATMENT", filed January 30, 2015, and published July 9, 2015, as U.S. Publication No. 2015 / 0190286; U.S. Patent No. 10,231,878, entitled "TISSUE HEALING", issued March 19, 2019; and U.S. Patent Application No. 10,231,878, entitled "WOUND DRESSING AND METHOD OF USE", filed July 12, 2012. PCT international application for “TREATMENT”, PCT / GB2012 / 000587; international application for “APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUNDTHERAPY”, filed on May 22, 2013, PCT / IB2013 / 001469; international application for “WOUND DRESSING AND METHOD OF TREATMENT”, filed on July 31, 2013, PCT / IB2013 / 002102;The following are PCT international applications filed on July 31, 2013, entitled “WOUND DRESSING AND METHOD OF TREATMENT” (PCT / IB2013 / 002060); on March 12, 2013, entitled “REDUCED PRESSURE APPARATUS AND METHODS” (PCT / IB2013 / 00084); on April 26, 2016, entitled “REDUCED PRESSURE APPARATUSES” (PCT / EP2016 / 059329); and on April 26, 2017, entitled “WOUND DRESSINGS AND METHODS OF USE WITH INTEGRATED NEGATIVE PRESSURE SOURCE HAVINGA FLUID INGRESS INHIBITION”. PCT international application for "Component" (PCT / EP2017 / 059883); PCT international application for "WOUND TREATMENT APPARATUSES AND METHODS WITH NEGATIVE PRESSURE SOURCE INTEGRATED INTO WOUND DRESSING" (PCT / EP2017 / 055225), filed on March 6, 2017; PCT international application for "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS" (PCT / EP2018 / 074694), filed on September 13, 2018; PCT international application for "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED" (PCT / EP2018 / 074694), filed on September 13, 2018; The PCT international application for "ELECTRONICS" is PCT / EP2018 / 074701; the PCT international application for "NEGATIVE PRESSURE WOUND TREATMENT APPARATUSES AND METHODS WITH INTEGRATED ELECTRONICS" filed on October 25, 2018 is PCT / EP2018 / 079345.PCT international application No. PCT / EP2018 / 079745, filed on October 30, 2018, entitled “SAFE OPERTATION OF INTEGRATEDNEGATIVE PRESSURE WOUND TREATMENT APPARATUSES”, is incorporated herein by reference in its entirety.

[0092] While some embodiments described herein relate to wound dressings, the systems and methods disclosed herein are not limited to wound dressings or medical applications. The systems and methods disclosed herein are generally applicable to electronic devices, such as those that can be worn by or applied to a user.

[0093] Any values ​​of thresholds, limits, durations, etc., provided herein are not intended to be absolute values ​​and are therefore approximate values. Furthermore, any thresholds, limits, durations, etc., provided herein may be fixed or automatically or by the user. Additionally, relative terms such as exceeding, greater than, less than, etc., used herein relative to a reference value are intended to also cover being equal to the reference value. For example, exceeding a positive reference value may include being equal to or greater than the reference value. Furthermore, relative terms such as exceeding, greater than, less than, etc., used herein relative to a reference value are also intended to cover the opposite relationships disclosed, such as being below, less than, greater than, etc., relative to the reference value. Moreover, although various processes may be described in boxes regarding determining whether a value meets or does not meet a particular threshold, these boxes can be understood similarly, for example, regarding values ​​(i) below or above a threshold or (ii) meeting or not meeting a threshold.

[0094] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example shall be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except for at least some mutually exclusive combinations of such features or steps. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel or any novel combination of steps of any method or process so disclosed.

[0095] Although certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be embodied in various other forms. Moreover, various omissions, substitutions, and changes can be made to the form of the methods and systems described herein. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated or disclosed process may differ from those shown in the accompanying drawings. According to embodiments, some of the above steps may be removed, and other steps may be added. For example, the actual steps or the order of steps taken in the disclosed process may differ from those shown in the figures.

[0096] The various components shown in the figures or described herein may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components such as controllers, processors, ASICs, FPGAs, etc., may include logic circuitry. Software or firmware may include instructions stored in a non-transitory computer-readable memory. These instructions may be executed by a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components such as controllers, processors, ASICs, FPGAs, etc., may include logic circuitry. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form other embodiments, all of which fall within the scope of this disclosure.

[0097] While this disclosure includes certain embodiments, examples, and applications, those skilled in the art will understand that the scope of this disclosure extends beyond the specific disclosed embodiments to other alternative embodiments or uses, as well as obvious modifications and equivalents thereof, including embodiments that do not provide all the features and advantages set forth herein. Therefore, the scope of this disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein, but may be defined by the claims set forth herein or forthcoming.

[0098] Unless otherwise specifically stated or understood in the context of use, conditional languages ​​such as “may,” “possibly,” or “may” are generally intended to indicate that certain embodiments include certain features, elements, or steps that are not included in other embodiments. Therefore, such conditional languages ​​are not generally intended to imply that one or more embodiments require features, elements, or steps in any way, or that one or more embodiments must include logic for determining whether such features, elements, or steps are included in or performed in any particular embodiment, with or without user input or prompting. The terms “comprising,” “including,” “having,” etc., are synonymous and used in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (but not in its proprietary sense) so that, when used, for example, to connect lists of elements, the term “or” indicates one, some, or all of the elements in the list. In addition, besides having its ordinary meaning, the term “each” as used herein can mean any subset of the set of elements to which the term “each” is applied.

[0099] Unless otherwise explicitly stated, union language such as the phrase “at least one of X, Y, and Z” is understood in context as generally used to indicate that an item, term, etc., may be X, Y, or Z. Therefore, such union language generally does not imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0100] The degree language used in this document, such as the terms “approximately,” “about,” “generally,” and “basically”, refers to a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic and still performs the expected function or achieves the expected result. For example, the terms “approximately,” “about,” “generally,” and “approximately” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the specified quantity.

[0101] The scope of this disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, but may be defined by the claims in this section or elsewhere in this specification or future. The language of the claims will be interpreted broadly based on the language used in the claims and is not limited to the examples described in this specification or during the examination of the application, which should be interpreted as non-exclusive.

Claims

1. A negative pressure wound therapy system, comprising: A negative pressure source configured to provide negative pressure to a wound of a patient covered by a wound dressing; A first sensor, configured to measure the temperature of at least a first portion of the negative pressure wound therapy system; A second sensor, configured to measure the temperature of at least one of the patient or at least a second part of the negative pressure wound therapy system; A non-programmable electronic control circuit configured to deactivate the negative pressure source in response to determining that the temperature measured by the first sensor meets a first temperature threshold indicating unsafe operation, the electronic control circuit including a comparator configured to output the determination that the temperature measured by the first sensor meets the first temperature threshold, and the comparator accepting the temperature measured by the first sensor as a first input and accepting the first temperature threshold as a second input; as well as A programmable controller configured to control the operation of the negative pressure source in response to a temperature measured by the second sensor, the controller being configured to control the operation of the negative pressure source independently of the electronic control circuitry.

2. The system of claim 1, wherein the controller is configured to reduce the activity of the negative pressure source in response to a temperature measured by the second sensor that is below a second temperature threshold and does not meet the first temperature threshold.

3. The system of claim 2, wherein reducing the activity of the negative pressure source includes reducing the duty cycle of the negative pressure source.

4. The system according to any one of claims 1 to 3, further comprising the wound dressing, wherein at least one of the negative pressure source, the first sensor, the second sensor, the electronic control circuit, or the controller is at least partially supported by the wound dressing.

5. The system according to any one of claims 1 to 3, wherein the temperature measured by the first sensor indicates the temperature of the negative pressure source.

6. The system of claim 1, wherein the comparator is configured to operate in the presence of noise due to at least one of the following: one or more of the first and second inputs of the comparator are filtered, or feedback is provided between the first or second input of the comparator and the output of the comparator.

7. The system of claim 6, wherein the first and second inputs of the comparator are low-pass filtered.

8. The system of claim 6 or 7, wherein the feedback comprises a resistor positioned between the non-inverting input of the comparator and the output of the comparator.

9. The system according to any one of claims 1 to 3, further comprising a power supply configured to at least provide power to the negative pressure source, and a boost converter configured to increase the power provided by the power supply and provide the increased power to the negative pressure source, wherein the first sensor is configured to measure the temperature of the boost converter.

10. The system of claim 9, wherein the first sensor is located adjacent to the boost converter.

11. The system according to any one of claims 1 to 3, wherein the second sensor comprises a pair of sensors, and wherein the controller is configured to determine the temperature of at least one of the negative pressure source or another component of the negative pressure wound therapy system based on the difference between measurements taken by the first and second sensors in the pair of sensors.

12. The system of claim 11, wherein the first and second sensors of the pair of sensors are configured to measure pressure and temperature.

13. The system of claim 11, wherein the first sensor of the pair of sensors is located at the inlet of the negative pressure source, and the second sensor of the pair of sensors is located at the outlet of the negative pressure source.

14. The system according to any one of claims 1 to 3, wherein the controller is configured to control the operation of the negative pressure source in response to a temperature measured by the second sensor by at least one of the following: The negative pressure source is deactivated in response to the temperature measured by the second sensor meeting the first temperature threshold. The activity of the negative pressure source is reduced in response to the temperature measured by the second sensor being less than a second temperature threshold and not meeting the first temperature threshold; or No action is taken in response to the temperature measured by the second sensor not meeting the second temperature threshold.

15. The system of claim 14, wherein reducing the activity of the negative pressure source includes reducing the duty cycle of the negative pressure source.

16. The system of claim 2 or 3, wherein the controller is further configured to store in memory: A first indication has been met, indicating that at least one of the first temperature threshold or the second temperature threshold has been satisfied; and The temperature measured by the first sensor meets a second indication that indicates a temperature threshold for unsafe operation.

17. The system according to any one of claims 1 to 3, wherein the controller is further configured to disable the activation of the negative pressure source in response to determining that the temperature measured by at least one of the first sensor or the second sensor meets the first temperature threshold.

18. The system according to any one of claims 1 to 3, wherein the first and second parts of the negative pressure wound therapy system are identical.

19. The system according to any one of claims 1 to 3, further comprising a switch configured to allow activation of the negative pressure source, wherein the switch is configured to deactivate in response to determining that a temperature measured by at least one of the first sensor or the second sensor satisfies the first temperature threshold.

20. The system of claim 2 or 3, wherein the second sensor is configured to measure the patient's temperature, and wherein the controller is configured to deactivate the negative pressure source in response to determining that the temperature measured by the second sensor meets a second temperature threshold indicating a high patient temperature.

21. The system according to any one of claims 1 to 3, wherein the controller is configured to execute instructions to control the operation of the negative pressure source in response to a temperature measured by the second sensor.

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