PRESSURE WOUND THERAPY SYSTEMS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 62/401 ,728, filed September 29, 2016, and U.S. Provisional Application No. 62/468,258, filed March 7, 2017; the disclosures of which are hereby incorporated by reference in their entirety.

BACKGROUND

[0002] Embodiments of the present disclosure relate to methods and apparatuses for dressing and treating a wound with negative or reduced pressure therapy or topical negative pressure (TNP) therapy, in particular, but without limitation, embodiments disclosed herein relate to negative pressure therapy devices, methods for controlling the operation of TNP systems, and methods of using TNP systems.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] Features and advantages of the present disclosure will be apparent from the following detailed description, taken in conjunction with the accompanying drawings of which:

[0004] FIGURE 1 illustrates a reduced pressure wound therapy system according to some embodiments.

[0005] FIGURES 2A, 2B, and 2C illustrate a pump assembly and canister according to some embodiments.

[0006] FIGURE 3 illustrates an electrical component schematic of a pump assembly according to some embodiments.

[0007] FIGURES 4A, 4B, 4C, 4D, 4E, and 4F illustrate a pump assembly according to some embodiments. [0008] FIGURES 5A, 5B, 5C, 5D, and 5E illustrate a pump assembly according to some embodiments.

[0009] FIGURES 6A and 6B illustrate a front and back of a main circuit board assembly according to some embodiments.

[0010] FIGURES 7A, 7B, 7C, and 7D illustrate a communications circuit board assembly according to some embodiments.

[0011] FIGURES 8A and 8B illustrate a top layer and bottom film of a communications circuit board assembly according to some embodiments.

[0012] FIGURES 8C and 8D illustrate an internal ground plane and an internal power plane of the communications circuit board assembly of FIGURES 8A and 8B according to some embodiments.

[0013] FIGURE 9 illustrates a pump assembly communicating using an antenna according to some embodiments.

DETAILED DESCRIPTION

[0014] The present disclosure relates to methods and apparatuses for dressing and treating a wound with reduced pressure therapy or topical negative pressure (TNP) therapy. In particular, but without limitation, embodiments of this disclosure relate to negative pressure therapy apparatuses, methods for controlling the operation of TNP systems, and methods of using TNP systems. The methods and apparatuses can incorporate or implement any combination of the features described below.

[0015] Many different types of wound dressings are known for aiding in the healing process of a human or animal. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads or multi-layer wound dressings. TNP therapy, sometimes referred to as vacuum assisted closure, negative pressure wound therapy, or reduced pressure wound therapy, can be a beneficial mechanism for improving the healing rate of a wound. Such therapy is applicable to a broad range of wounds such as incisional wounds, open wounds and abdominal wounds or the like. [0016] TNP therapy can assist in the closure and healing of wounds by reducing tissue oedema, encouraging blood flow, stimulating the formation of granulation tissue, removing excess exudates, and reducing bacterial load and thus, infection to the wound. Furthermore, TNP therapy can permit less outside disturbance of the wound and promote more rapid healing,

[0017] As is used herein, reduced or negative pressure levels, such as -X mmHg, represent pressure levels that are below atmospheric pressure, which typically corresponds to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure value of -X mmHg reflects pressure that is X mmHg below atmospheric pressure, such as a pressure of (760-X) mmHg. in addition, negative pressure that is less" or "smaller" than -X mmHg corresponds to pressure that is closer to atmospheric pressure (for example, -40 mmHg is less than -60 mmHg). Negative pressure that is "more" or "greater than -X mmHg corresponds to pressure that is further from atmospheric pressure (for example, -80 mmHg is more than -60 mmHg).

System Overview

[0018] A pump assembly can include one or more features that improve the tolerance of the pump assembly to environmental conditions, such as high temperature, high altitude, electromagnetic radiation, or electrostatic discharge (ESD). The improved tolerance of the pump assembly can, for example, enable the pump assembly to function despite non-ideal environmental conditions or function more safely in the presence of certain environmental conditions. The pump assembly can be small, compact, and light and capable of transmitting and receiving wireless communications and able to meet stringent electrical immunity standards. Although one or more features are described separately, in some instances, one or more of the features can be combined in particular implementations of pump assemblies.

[0019] FIGURE 1 illustrates an embodiment of a negative or reduced pressure wound treatment (or TNP) system 100 comprising a wound filler 130 placed inside a wound cavity 1 10, the wound cavity sealed by a wound cover 120. The wound filler 130 in combination with the wound cover 120 can be referred to as wound dressing. A single or multi lumen tube or conduit 140 is connected the wound cover 120 with a pump assembly 150 configured to supply reduced pressure. The wound cover 120 can be in fiuidic communication with the wound cavity 1 10. in any of the system embodiments disclosed herein, as in the embodiment illustrated in FIGURE 1 , the pump assembly can be a canisterless pump assembly (meaning that exudate is collected in the wound dressing or is transferred via tube 140 for collection to another location). However, any of the pump assembly embodiments disclosed herein can be configured to include or support a canister. Additionally, in any of the system embodiments disclosed herein, any of the pump assembly embodiments can be mounted to or supported by the dressing, or adjacent to the dressing.

[0020] The wound filler 130 can be any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, and so on. The wound filler 130 can be conformable to the wound cavity 1 10 such that it substantially fills the cavity. The wound cover 120 can provide a substantially fluid impermeable seal over the wound cavity 1 10. The wound cover 120 can have a top side and a bottom side, and the bottom side adhesively (or in any other suitable manner) seals with wound cavity 1 10. The conduit 140 or lumen or any other conduit or lumen disclosed herein can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0021] Some embodiments of the wound cover 120 can have a port (not shown) configured to receive an end of the conduit 140. For example, the port can be Renays Soft Port available from Smith & Nephew. In other embodiments, the conduit 140 can otherwise pass through and/or under the wound cover 120 to supply reduced pressure to the wound cavity 1 10 so as to maintain a desired level of reduced pressure in the wound cavity. The conduit 140 can be any suitable article configured to provide at least a substantially sealed fluid flow pathway between the pump assembly 150 and the wound cover 120, so as to supply the reduced pressure provided by the pump assembly 150 to wound cavity 1 10. [0022] The wound cover 120 and the wound filler 130 can be provided as a single article or an integrated single unit. In some embodiments, no wound filler is provided and the wound cover by itself may be considered the wound dressing. The wound dressing may then be connected, via the conduit 140, to a source of negative pressure, such as the pump assembly 150. The pump assembly 150 can be miniaturized and portable, although larger conventional pumps such can also be used.

[0023] The wound cover 120 can be located over a wound site to be treated. The wound cover 120 can form a substantially sealed cavity or enclosure over the wound site. In some embodiments, the wound cover 120 can be configured to have a film having a high water vapor permeability to enable the evaporation of surplus fluid, and can have a superabsorbing material contained therein to safely absorb wound exudate, it will be appreciated that throughout this specification reference is made to a wound. In this sense it is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other surficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced pressure treatment, A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical incisions and other incisions, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure uicers, stoma, surgical wounds, trauma and venous uicers or the like. The components of the TNP system described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.

[0024] Some embodiments of the system are designed to operate without the use of an exudate canister. Some embodiments can be configured to support an exudate canister, in some embodiments, configuring the pump assembly 150 and tubing 140 so that the tubing 140 can be quickly and easily removed from the pump assembly 150 can facilitate or improve the process of dressing or pump changes, if necessary. Any of the pump embodiments disclosed herein can be configured to have any suitable connection between the tubing and the pump.

[0025] The pump assembly 150 can be configured to deliver negative pressure of approximately -80 mmHg, or between about -20 mmHg and 200 mmHg in some implementations. Note that these pressures are relative to normal ambient atmospheric pressure thus, -200 mmHg would be about 560 mmHg in practical terms. The pressure range can be between about -40 mmHg and -150 mmHg. Alternatively a pressure range of up to -75 mmHg, up to -80 mmHg or over -80 mmHg can be used. Also a pressure range of below -75 mmHg can be used. Alternatively a pressure range of over approximately -100 mmHg, or even 150 mmHg, can be supplied by the pump assembly 150.

[0026] In operation, the wound filler 130 is inserted into the wound cavity 1 10 and wound cover 120 is placed so as to seal the wound cavity 1 10. The pump assembly 150 provides a source of a negative pressure to the wound cover 120, which is transmitted to the wound cavity 1 10 via the wound filler 130. Fluid (e.g., wound exudate) is drawn through the conduit 140, and can be stored in a canister. In some embodiments, fluid is absorbed by the wound filler 130 or one or more absorbent layers (not shown).

[0027] Wound dressings that may be utilized with the pump assembly and other embodiments of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Further description of such wound dressings and other components of a negative pressure wound therapy system that may be used with the pump assembly and other embodiments of the present application are found in U.S. Patent Publication Nos. 201 1/0213287, 201 1/0282309, 2012/01 18334, 2012/0136325, and 2013/01 10058, which are incorporated by reference in their entirety, in other embodiments, other suitable wound dressings can be utilized.

[0028] FIGURE 2A illustrates a front view of a pump assembly 230 and canister 220 according to some embodiments. As is illustrated, the pump assembly 230 and the canister are connected, thereby forming a negative pressure wound therapy device. The pump assembly 230 can be similar to or the same as the pump assembly 150 in some embodiments.

[0029] The pump assembly 230 includes one or more indicators, such as visual indicator 202 configured to indicate alarms and visual indicator 204 configured to indicate status of the TNP system. The indicators 202 and 204 can be configured to alert a user, such as patient or medical care provider, to a variety of operating and/or failure conditions of the system, including alerting the user to normal or proper operating conditions, pump failure, power supplied to the pump or power failure, detection of a leak within the wound cover or flow pathway, suction blockage, or any other similar or suitable conditions or combinations thereof. The pump assembly 230 can comprise additional indicators. The pump assembly can use a single indicator or multiple indicators. Any suitable indicator can be used such as visual, audio, tactile indicator, and so on. The indicator 202 can be configured to signal alarm conditions, such as canister full, power low, conduit 140 disconnected, seal broken in the wound seal 120, and so on. The indicator 202 can be configured to display red flashing light to draw user ^' s attention. The indicator 204 can be configured to signal status of the TNP system, such as therapy delivery is ok, leak detected, and so on. The indicator 204 can be configured to display one or more different colors of light, such as green, yellow, etc. For example, green light can be emitted when the TNP system is operating properly and yellow light can be emitted to indicate a warning.

[0030] The pump assembly 230 includes a display or screen 206 mounted in a recess 208 formed in a case of the pump assembly. The display 206 can be a touch screen display. The display 206 can support playback of audiovisual (AV) content, such as instructional videos. As explained below, the display 206 can be configured to render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the TNP system. The pump assembly 230 comprises a gripping portion 210 formed in the case of the pump assembly. The gripping portion 210 can be configured to assist the user to hold the pump assembly 230, such as during removal of the canister 220. The canister 220 can be replaced with another canister, such as when the canister 220 has been filled with fluid.

[0031] The pump assembly 230 includes one or more keys or buttons 212 configured to allow the user to operate and monitor the operation of the TNP system. As is illustrated, there buttons 212a, 212b, and 212c are included. Button 212a can be configured as a power button to turn on/off the pump assembly 230. Button 212b can be configured as a play/pause button for the delivery of negative pressure therapy. For example, pressing the button 212b can cause therapy to start, and pressing the button 212b afterward can cause therapy to pause or end. Button 212c can be configured to lock the display 206 and/or the buttons 212. For instance, button 212c can be pressed so that the user does not unintentionally alter the delivery of the therapy. Button 212c can be depressed to unlock the controls, in other embodiments, additional buttons can be used or one or more of the illustrated buttons 212a, 212b, or 212c can be omitted. Multiple key presses and/or sequences of key presses can be used to operate the pump assembly 230.

[0032] The pump assembly 230 includes one or more latch recesses 222 formed in the cover, in the illustrated embodiment, two latch recesses 222 can be formed on the sides of the pump assembly 230. The latch recesses 222 can be configured to allow attachment and detachment of the canister 220 using one or more canister latches 221. The pump assembly 230 comprises an air outlet 224 for allowing air removed from the wound cavity 1 10 to escape. Air entering the pump assembly can be passed through one or more suitable filters, such as antibacterial filters. This can maintain reusability of the pump assembly. The pump assembly 230 includes one or more strap mounts 226 for connecting a carry strap to the pump assembly 230 or for attaching a cradle. In the illustrated embodiment, two strap mounts 226 can be formed on the sides of the pump assembly 230. in some embodiments, various of these features are omitted and/or various additional features are added to the pump assembly 230.

[0033] The canister 220 is configured to hold fluid (e.g., exudate) removed from the wound cavity 1 10. The canister 220 includes one or more latches 221 for attaching the canister to the pump assembly 230. in the illustrated embodiment, the canister 220 comprises two latches 221 on the sides of the canister. The exterior of the canister 220 can formed from frosted plastic so that the canister is substantially opaque and the contents of the canister and substantially hidden from plain view. The canister 220 comprises a gripping portion 214 formed in a case of the canister. The gripping portion 214 can be configured to allow the user to hold the pump assembly 220, such as during removal of the canister from the apparatus 230. The canister 220 includes a substantially transparent window 216, which can also include graduations of volume. For example, the illustrated 300 mL canister 220 includes graduations of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. Other embodiments of the canister can hold different volume of fluid and can include different graduation scale. For example, the canister can be an 800 mL canister. The canister 220 comprises a tubing channel 218 for connecting to the conduit 140. In some embodiments, various of these features, such as the gripping portion 214, are omitted and/or various additional features are added to the canister 220. Any of the disclosed canisters may include or may omit a solidifier,

[0034] FIGURE 2B illustrates a rear view of the pump assembly 230 and canister 220 according to some embodiments. The pump assembly 230 comprises a speaker port 232 for producing sound. The pump assembly 230 includes a filter access door 234 with a screw 235 for removing the access door 234, accessing, and replacing one or more filters, such as antibacterial or odor filters. The pump assembly 230 comprises a gripping portion 236 formed in the case of the pump assembly. The gripping portion 236 can be configured to allow the user to hold the pump assembly 230, such as during removal of the canister 220. The pump assembly 230 includes one or more covers 238 configured to as screw covers and/or feet or protectors for placing the pump assembly 230 on a surface. The covers 230 can be formed out of rubber, silicone, or any other suitable material. The pump assembly 230 comprises a power jack 239 for charging and recharging an internal battery of the pump assembly. The power jack 239 can be a direct current (DC) jack. In some embodiments, the pump assembly can comprise a disposable power source, such as batteries, so that no power jack is needed. [003S] The canister 220 includes one or more feet 244 for placing the canister on a surface. The feet 244 can be formed out of rubber, silicone, or any other suitable material and can be angled at a suitable angle so that the canister 220 remains stable when placed on the surface. The canister 220 comprises a tube mount relief 246 configured to allow one or more tubes to exit to the front of the device. The canister 220 includes a stand or kickstand 248 for supporting the canister when it is placed on a surface. As explained below, the kickstand 248 can pivot between an opened and closed position. In closed position, the kickstand 248 can be latched to the canister 220. In some embodiments, the kickstand 248 can be made out of opaque material, such as plastic. In other embodiments, the kickstand 248 can be made out of transparent material. The kickstand 248 includes a gripping portion 242 formed in the kickstand. The gripping portion 242 can be configured to allow the user to place the kickstand 248 in the closed position. The kickstand 248 comprises a hole 249 to allow the user to place the kickstand in the open position. The hole 249 can be sized to allow the user to extend the kickstand using a finger.

[0036] FIGURE 2C illustrates a view of the pump assembly 230 separated from the canister 220 according to some embodiments. The pump assembly 230 includes a vacuum attachment, connector, or inlet 252 through which a vacuum pump communicates negative pressure to the canister 220. The pump assembly aspirates fluid, such as gas, from the wound via the inlet 252. The pump assembly 230 comprises a USB access door 256 configured to allow access to one or more USB ports. In some embodiments, the USB access door is omitted and USB ports are accessed through the door 234. The pump assembly 230 can include additional access doors configured to allow access to additional serial, parallel, and/or hybrid data transfer interfaces, such as SD, Compact Disc (CD), DVD, FireWire, Thunderbolt, PCI Express, and the like, in other embodiments, one or more of these additional ports are accessed through the door 234.

[0037] FIGURE 3 illustrates an electrical component schematic 300 of a pump assembly, such as the pump assembly 230, according to some embodiments. Electrical components can operate to accept user input, provide output to the user, operate the pump assembly and the TNP system, provide network connectivity, and so on. Electrical components can be mounted on one or more printed circuit boards (PCBs). As is illustrated, the pump assembly can include multiple processors.

[0038] The pump assembly can comprise a user interface processor or controller 310 configured to operate one or more components for accepting user input and providing output to the user, such as the display 206, buttons 212, etc. Input to the pump assembly and output from the pump assembly can controlled by an input/output (I/O) module 320. For example, the I/O module can receive data from one or more ports, such as serial, parallel, hybrid ports, and the like. The processor 310 also receives data from and provides data to one or more expansion modules 360, such as one or more USB ports, SD ports, Compact Disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, and the like. The processor 310, along with other controllers or processors, stores data in one or more memory modules 350, which can be internal and/or external to the processor 310. Any suitable type of memory can be used, including volatile and/or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, magnetoresistive random-access memory (MRAM), and the like.

[0039] In some embodiments, the processor 310 can be a general purpose controller, such as a low-power processor, in other embodiments, the processor 310 can be an application specific processor. The processor 310 can be configured as a "central" processor in the electronic architecture of the pump assembly, and the processor 310 can coordinate the activity of other processors, such as a pump control processor 370, communications processor 330, and one or more additional processors 380 (e.g., processor for controlling the display 206, processor for controlling the buttons 212, etc.). The processor 310 can run a suitable operating system, such as a Linux, Windows CE, VxWorks, etc.

[0040] The pump control processor 370 can be configured to control the operation of a negative pressure pump 390. The pump 390 can be a suitable pump, such as a diaphragm pump, peristaltic pump, rotary pump, rotary vane pump, scroll pump, screw pump, liquid ring pump, diaphragm pump operated by a piezoelectric transducer, voice coil pump, and the like. The pump control processor 370 can measure pressure in a fluid flow path, using data received from one or more pressure sensors, calculate the rate of fluid flow, and control the pump. The pump control processor 370 can control a pump motor so that a desired level of negative pressure is achieved in the wound cavity 1 10. The desired level of negative pressure can be pressure set or selected by the user. In various embodiments, the pump control processor 370 controls the pump (e.g., pump motor) using pulse-width modulation (PWM). A control signal for driving the pump can be a 0-100% duty cycle PWM signal. The pump control processor 370 can perform flow rate calculations and detect various conditions in a flow path. The pump control processor 370 can communicate information to the processor 310. The pump control processor 370 can include internal memory and/or can utilize memory 350. The pump control processor 370 can be a low-power processor.

[0041] A communications processor 330 can be configured to provide wired and/or wireless connectivity. The communications processor 330 can utilize one or more antennas 340 for sending and receiving data. The communications processor 330 can provide one or more of the following types of connections: Global Positioning System (GPS) technology, cellular connectivity (e.g., 2G, 3G, LTE, 4G), WiFi connectivity, Internet connectivity, and the like. Connectivity can be used for various activities, such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading of logs, alarms, and other operational data, and adjustment of therapy settings, upgrading of software and/or firmware, and the like. The communications processor 330 can provide dual GPS/cellular functionality. Cellular functionality can, for example, be 3G functionality. The pump assembly can include a SIM card, and SIM-based positional information can be obtained.

[0042] The communications processor 330 can communicate information to the processor 310. The communications processor 330 can include internal memory and/or can utilize memory 350. The communications processor 330 can be a low-power processor.

[0043] In some embodiments, using the connectivity provided by the communications processor 330, the device can upload any of the data stored, maintained, and/or tracked by the pump assembly. The device can also download various operational data, such as therapy selection and parameters, firmware and software patches and upgrades, and the like.

[0044] FIGURE 4A illustrates exploded view of a pump assembly 400, such as the pump assembly 230, according to some embodiments. The illustrated view can correspond to the front portion of the pump assembly 400. The components of the pump assembly 400 can include: a front enclosure 401 , a GPS antenna 402, a status light pipe 403, adhesives 404, a liquid crystal display (LCD) 405, a chassis and LCD circuit board assembly 406, screws 407, a main circuit board assembly 408, screws 409, standoffs 410, a communications circuit board assembly 41 1 (including a communications antenna), a negative pressure source 412, a power entry cable 413, a universal serial bus (USB) cable assembly 414, a subscriber identity module (SIM) card 415, a bottom enclosure 416, a canister connector 417, a canister connector O-ring 418, and a keypad 419. FIGURES 4B- 4F illustrate multiple views of the pump assembly 400 according to some embodiments. The dimensions included in FIGURES 4B-4F are provided in inches.

[0045] Although FIGURES 4A-4F show particular components included as part of the pump assembly 400, some components may be removed or other components may be added in other implementations.

[0046] FIGURE 5A illustrates exploded view of a pump assembly 500, such as the pump assembly 230, according to some embodiments. The illustrated view can correspond to the back portion of the pump assembly 500. The illustrated components of the pump assembly 500 can be configured to couple to the components of the pump assembly 400 to form an integral pump assembly. The components of the pump assembly 500 can include: an access door 501 (which can be the same as access door 234), a filter enclosure gasket 502, a filter 503 (for example, antibacterial filter, odor filter, and the like), a mini USB port cover 504, a back enclosure 505, a power entry light pipe 506, a power entry circuit board assembly 507, a USB circuit board assembly 508, a tubing outlet 509, a dip 510, a battery bracket 51 1 , a battery 512, a speaker assembly 513, a speaker filter 514, a push nut 515, a screw 516 (which can be the same as the screw 235), screws 517, screws 518, and foam tape 519. FIGURES 5B-5E illustrate multiple views of the pump assembly 500 according to some embodiments. The dimensions included in FIGURES 5B-5E are provided in inches.

[0047] Although FIGURES 5A-5F show particular components included as part of the pump assembly 500, some components may be removed or other components may be added in other implementations.

Device Electronics

[0048] The electronics of a pump assembly can be constructed and positioned to improve the tolerance of the pump assembly to environmental conditions. The pump assembly desirably can operate electrically or mechanically properly or safely in various non-controlled environments like home healthcare, airborne, automobile, boats, train, metal detectors, active implantable device, and the like.

[0049] The pump assembly can be configured to withstand high levels of ESD and in multiples steps, such as contact: ±2 kV (or lower), ±4 kV, ±6 kV, ±8 kV or higher and air: ±2 kV (or lower), ±4 kV, ±6 kV, ±8 kV ±15 kV, ±30 kV or higher. The pump assembly can additionally or alternatively be configured to have high levels of magnetic immunity, for example for magnetic field strengths of 100 A/m (or lower), 150 A/m, 200 A/m, 400 A/m or higher, as well as high levels of RF immunity, for example for RF signal strengths of 10 V/m (or lower), 20 V/m and higher. Additionally or alternatively, the pump assembly can withstand high levels of mechanical strain (for example, shock, vibration, drop, or the like) and high altitude environments (for example, airborne mechanical). In some embodiments, the pump assembly complies with one or more of IEC 81000 family standards relating to electromagnetic compatibility for electrical and electronic equipment or one or more other applicable industry standards.

[0050] The pump assembly can, in some implementations, be defibriilafion-proof (for instance, defibriliation-proof as an entire applied part), such as is defined under the IEC 60601 -1 standard, another standard, or other industry- accepted criteria. The pump assembly can, for example, continue normal operation when monophasic or biphasic defibrillation shock is applied. The pump assembly may not change its performance or present false alarms under such conditions. Such a defibrillation-proof construction can be desirable because the pump assembly can then survive an external defibrillation shock in case a patient using the pump assembly goes into cardiac arrest. Moreover, the pump assembly can be defibriilator-proof while retaining usability.

[0051] One or more of the features described herein can enable the pump assembly to withstand high levels of ESD, have magnetic immunity or RF immunity, withstand high levels of mechanical strain, withstand high altitude environment, or be defibrillation-proof.

[0052] The pump assembly can include one or more PCBs that mechanically support and electrically connect electronic components using conductive tracks, pads and other features etched from copper sheets laminated onto a non-conductive substrate. Components, such as capacitors, resistors, or active devices, can be soldered on the PCBs or embedded in the substrate. PCBs can be single sided (one copper layer), double sided (two copper layers) or multilayer (outer and inner layers). Conductors on different layers are connected with vias. Multi-layer PCBs allow for much higher component density, in one implementation, the pump assembly can include one or more PCBs with one or two layers, in yet another implementation, the pump assembly can include one or more PCBs with three or more layers, such as six layers. The one or more PCBs can each include components, such as one or more controllers, configured to perform one or more device functions, such as operating a negative pressure source, controlling power distribution in the pump assembly, communicating with other electronic devices, or operating as a user interface, among other functions.

[0053] The pump assembly can be constructed to electrically isolate certain internal device components and provide electromagnetic interference shielding (EMI) shielding, ESD protection, and other forms of electrical isolation.

[00S4] The pump assembly can include a PCB positioned so that there is a gap between the edges of the PCB and a housing, such as a plastic housing, of the pump assembly. Additionally or alternatively, the pump assembly can include a PCB constructed so that components (such as one or more microcontrollers or memories) coupled to the PCB are more than a threshold distance (for example, around 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm) from an edge of the PCB. This can protect the PCB and its components from interference as a result of ESD applied to the housing.

[0055] The pump assembly can include a software input-output bus that is configured to be substantially noise immune, including with respect to analog inputs. The pump assembly can include an EMI shield on top of one or more components such as a microcontroller or memory.

[0056] The pump assembly can include one or more nylon screws rather than metal screws to provide better ESD protection for the pump assembly. One or more nylon screws can be positioned on the external surface of the housing. A nylon screw can, for example, be used to access a filter of the pump assembly, such as screw 235 or screw 501.

[00S7] The pump assembly can include one or more internal gaskets to provide better ESD protection for the pump assembly. The pump assembly may also include no exposed metal or limit an amount of exposed metal by covering metal parts to prevent arcing. For instance, a plug for a charging cable can be electrically isolated and ears for connecting a clamp for the pump assembly can be electrically isolated.

[0058] The pump assembly can include a capacitor electrically coupled to one or more individual connectors (for example, a USB connector or an antenna connector) and an ESD clamp (such as a circuit with one or more diodes). The pump assembly can include conformal coating, relatively short cable assemblies, relatively short layout traces, or encapsulate specific layout traces between planes. The pump assembly can also include planes and traces from an edge of a PCB or grounded metal shielding.

[0059] The pump assembly can include no gap or change of material which could be an electrical channel to a PCB at energy and current level experienced under defibrillation conditions. One or more light-emitting diodes (LEDs) of the pump assembly can be behind a solid, unbroken, and translucent front cover rather than having a light-pipe, lens, or other means to transmit the light. [0060] In view of the device structures described herein, the pump assembly may not protect against overvacuum or another erroneous operational mode in the event of an electrical short because the pump assembly may have alternative capabilities to handle the electrical short.

[0061] The pump assembly can include electrical isolation to isolate water, urine, or blood ingress from short-circuiting the pump assembly.

[0062] The pump assembly can, in some instances, use a tuned receiver for communication and perform shorting and capacitor protection of the receiver. Interference outside of a frequency of interest can be shorted to ground. The pump assembly may still have some vulnerability at the frequency of interest, but the vulnerability may notably be acceptable if the frequency is different from the spectrum of interference.

[0063] Features of the pump assembly to protect against electrical shock, ESD, and the like can desirably protect a pump assembly from damage or malfunction or protect a patient or clinician from being shocked.

[0064] FIGURE 6A illustrates a front of a main PCB 600 of a pump assembly, such as the pump assembly 230, according to some embodiments. The main PCB 600 can, for example, be an embodiment of the main circuit board assembly 408. The main PCB 600 can include a digital signal processor 610 for controlling a source of negative pressure, an electromagnetic compatibility shield 620 for an LED backlight (for example, to protect against high voltages like 12 V rather than 3 V), a shielded battery charger 630, a shielded memory and main microcontroller 640, a battery connector 650, and a shielded regulator 660 for digital circuitry. FIGURE 6B illustrates a back of the main PCB 600.

[0065] FIGURES 7A and 7B illustrate a front and back of a wireless communication PCB assembly 700 of a pump assembly, such as the pump assembly 230, according to some embodiments. The wireless communication PCB 700 assembly can, for example, be an embodiment of the communications circuit board assembly 41 1. The wireless communication PCB assembly 700 can include an antenna board 710 and a PCB 705 with a shielded wireless communication controller 720 and a shielded voltage regulator 730. The antenna board 710 can be wireless mobile communications antenna, such a single-, dual-, tri-, quad-, or the like band antenna for communicating via 2G, 3G, LTE, 4G, or the like and be mounted to the communications PCB 705 with mounting brackets 712. The wireless communication PCB assembly 700 can be electrically coupled via a path 740 to a GPS antenna 750, which can be an embodiment of the GPS antenna 402.

[0066] FIGURE 7C illustrates a side of the wireless communication PCB assembly 700 with the path 740 and the GPS antenna 750 removed. As can be seen, the antenna board 710 can be mounted to extend along a line A at an angle ζθ° relative to a line B that extends perpendicular to a line C that extends parallel to a direction in which the PCB 705 extends. The angle ζθ° can be non-zero in some implementations, but zero in other implementations. For instance, the angle ζθ° can be between a minimum of z1 °, z5°, z10°, z15°, z20°, z25°, z30°, or z35° and a maximum of z45°, z50°, z55°, z60°, z85°, z70°, z75°, z80°, z85°, or z89°. The angle ζθ° can, for example, be z15°, z20°, z25°, z30°, z35°, z40°, or z45° or approximately so. In other implementations, the antenna board 710 can be mounted to angle in the opposite direction and yet face downward such that the angle ζθ° can instead be between a minimum of z-45°, z-50°, z-55°, z-60°, z-65°, z-70°, z-75°, z-80°, z-85°, or z-89° and a maximum of z-1 °, z-5°, z-10°, z-15°, z-20°, z-25°, z- 30°, or z-35° and, for example, have a value of z- 5°, z-20°, z-25°, z-30°, z-35°, z- 40°, or z-45° or approximately so. The angle ζθ° may be selected, in some implementations, so that the antenna board 710 does not face directly downwards at the orientations at which the pump assembly may be used (for example, when the pump assembly may be positioned on a canister on a fiat surface, position at an angle resting on a kickstand of the pump assembly or canister, or coupled to a pole using a clamp).

[0067] As is illustrated in FIGURES 7A-7C, the antenna board 710 can be mechanically coupled to the PCB 705. The antenna board 710 can, for example, be mounted to the PCB 705 (or at another suitable orientation) using one or more fasteners (for instance, two fasteners) and one or more brackets (for instance, two brackets), as illustrated in FIGURES 7A-7C. The antenna board 710 can transmit electromagnetic signals downward, such as toward the ground (of the earth) or a surface on which the pump assembly is positioned. The antenna board 710 can thereby communicate by reflecting signal electromagnetic signals off of one or more surfaces below the antenna board 710.

[0068] FIGURE 7D illustrates a perspective view of components of the wireless communication PCB assembly 700 according to some embodiments. The antenna board 710 can be mounted to the communications PCB 705 with the mounting brackets 712 secured to the PCB 705 with pins, screws, or rivets 716. Although two brackets 712 are illustrated, in some embodiments, one bracket or more than two brackets can be used. The brackets 712 can be secured to the antenna board 710 using tape 714 alone or in combination with pegs or pins 724 being aligned with (and when assembled fitting through) the holes 770, 772, 780, and 782 of the antenna board 710. Pegs or protrusions 762 and 792 of the PCB 705 also can be aligned with (and when assembled fit through) the holes 760 and 790 of the antenna board 710. The antenna can be oriented at any desired angle to the PCB 705. In some implementations, desired orientation can be achieved by rotating or pivoting the brackets 712 about the rivets 716.

[0069] FIGURE 8A illustrates a top layer 800 of a wireless communication PCB assembly, such as the wireless communication assembly PCB 700, according to some embodiments. The top layer 800 can, for instance, be a top film layer. The top layer 800 includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The top layer 800 moreover includes multiple features including at least ground (GND) plane, mounting pads 802A-D for mounting the wireless communication PCB assembly, a connector or connection 804 between the antenna board 710 and the PCB 705. The connection 804 can provide a transmit signal feed from a controller (for example, the communication controller 720) and the antenna board 710 when antenna is transmitting (or is in a transmit mode). The connection 804 can provide a receive signal feed from the antenna board 710 to the controller when the antenna is receiving (or is in a receive mode). The connection 804 can, in some implementations, be the sole connection point for transmitting and receiving signals via the antenna board 710. Antenna trace 806, which includes first and second portions 860 and 862, is connected to the ground plane 8 0 at or near location 870. The trace 806 includes conductive material, such as copper, and can serve as a ground plane for the antenna board 710. Connection between the trace 806 and the ground plane 810 of the PCB 705 can be accomplished with a shunt or another suitable component.

[0070] In certain implementations, the top side of the antenna board 710 can be placed facing down toward the ground and facing away from the PCB 705 when the antenna board is mounted to the PCB 705. Connection 760 can be located on the bottom side of the antenna board, which faces the PCB 705 when the antenna board is mounted to the PCB 705. In this configuration, connection 804 on the PCB 705 faces connection 760 on the antenna board 710. As is explained herein, protrusion 762 of the PCB 705 can be placed in the hole 760 of the antenna board 710. Electrical connection between connection 804 and 760 can be made, for example, using soldering or another suitable mechanism.

[0071] FIGURE 8B illustrates a bottom layer 820 of the wireless communication PCB assembly of FIGURE 8A according to some embodiments. The bottom layer 820 can, for instance, be a bottom film layer. The bottom layer 820 includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The bottom layer 820 includes multiple features including at least a ground (GND) plane and an antenna connector or connection 822. Connection 822 can be used as a mechanical connection for securing the antenna board 710. For instance, when the antenna board is positioned top side facing downward as explained herein, because connection 822 is positioned on the opposite side of the board with respect to connection 804, more reliable or secure mechanical connection can be made by soldering (or using another suitable attachment) a portion of the top surface of the antenna board (for example, area on the top side including and/or surrounding the whole 760) to the connection 822. In such instances, connection 822 does not provide any electrical connectivity, but is used soieiy for mechanical support. As explained herein, protrusion 762 of the PCB 705 can be placed in the hole 760 of the antenna board 710 so that connection 822 is located proximal the top surface of the antenna board Soldering the antenna board connection 760 on the opposite, bottom side of the antenna board 710 to the connection 804 can provide electrical connection and, optionally, additional mechanical support. In some embodiments, the locations of the antenna connection 822 and the connection 804 can be switched (for example, the antenna connection 822 can be placed on the top layer 800) particularly when the antenna board is positioned top side facing upward away from the ground,

[0072] FIGURE 8C illustrates an internal ground plane 840 of the wireless communication PCB assembly of FIGURE 8A according to some embodiments. The internal ground plane 840 includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The internal ground plane 840 includes a ground extending around a perimeter of the PCB, as well as a ground area 842 proximate the antenna, which can help with for reducing noise (such as EMI) associated with the antenna. The ground area 842 can have a thickness that is greater (for example, more than 2, 3, 4, 5, 6, 7, or 8 times the thickness) than a thickness of the other parts of the ground extending around a perimeter of the PCB. The internal ground plane 840 further includes grounding at the locations of the mounting pads so that the mounting holes for the wireless communication PCB assembly may be grounded.

[0073] FIGURE 8D illustrates an internal power plane 860 of the wireless communication PCB assembly of FIGURE 8A according to some embodiments. The internal power plane 860 includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The internal power plane 860 includes multiple features including at least ground, mounting pads, and voltage supply areas +V1 , +V2, +V3, +V4.

[0074] With the structures depicted in FIGURES 8A-8D, the wireless communication PCB assembly can experience one or more benefits in some implementations. The wireless communication PCB assembly can, for example, be protected from interference (such as EMI) where noise in the transmission band may be fed back to the antenna, in addition, the wireless communication PCB assembly may not include long traces on the bottom some layer or top film layer, which may act as transmitters, and signal traces instead may be moved inward where they are shielded from radiating noise by ground. In some embodiments, one or more capacitors are utilized to provide noise immunity or suppression. For example, the one or more capacitors can be used to construct a low-pass filter (such as a RC filter, LC filter, etc.) that suppresses high-frequency interference. The one or more capacitors can be used to protect one or more input signals.

Device Antenna

[0075] A pump assembly, such as the pump assembly 230, can communicate using an antenna, such as the antenna board 710 of FIGURE 7A, with one or more other electronic devices. The antenna can be positioned near a base of the pump assembly or near a canister coupled to the pump assembly. The position of the antenna proximate the canister can enable the canister to function as an electromagnetic shield or insulator from EMI, ESD, or electric shock (such as from a defibrillator) and protect the antenna from ESD and internal noise from other electronic components of the pump assembly. Such positioning may also desirably afford additional space for increasing a size of the antenna to improve a signal strength obtained with the antenna, as well as to enable the canister to function as a spacer to space the antenna off of the ground or other surface on which the pump assembly is positioned.

[0076] The antenna can be oriented to face downward (for example, toward the ground, floor, desk, bed, or other surface on which the pump assembly is positioned) rather than upward (for example, toward a ceiling or sky) or sideward (for example, toward side wall of a room) when the pump assembly is oriented for delivery of negative pressure therapy. . This orientation can allow the antenna to reflect a communication signal (for example, a strongest signal or most of the energy of the signal received or output by the antenna) off the ground or another surface on which the pump assembly is positioned.

[0077] In some implementations, the antenna can be positioned as far as possible from a ground plane or another plane of the PCB 705 to which it is connected. The antenna however can still be positioned inside the pump assembly housing to prevent the antenna from picking up any undesirable PCB noise or being shielded by the PCB or other board components.

[0078] FIGURE 9 illustrates a pump assembly 900, such as the pump assembly 230, communicating using an antenna according to some embodiments. The antenna can, for example, be an embodiment of the antenna board 710. As illustrated, the antenna of the pump assembly 900 can be positioned so that the antenna may not be planar with a bulk head of the pump assembly 900. This may advantageously enable the antenna to angle forwards or backwards (for instance, toward a GUI like a display screen) when the pump assembly 900 may be sat on a flat base of a canister. The electromagnetic radiation from the antenna may thus not have a tendency to bounce back toward the pump assembly 900 but may instead bounce away from the pump assembly 900.

Device User Interface

[0079] A pump assembly can include a user interface that improves the tolerance of the pump assembly to environmental conditions. The pump assembly can include one or more buttons, such as buttons 212a, 212b, and 212c, or other components (for example, a power supply or battery or shielding or waterproofing) constructed to handle pressure variations at different altitudes, including relatively high altitudes. The button or other components can be or include a membrane or formed of molded rubber. The buttons or other components can include a vent, valve, or be breathable to allow the membrane to accept and release air to prevent the buttons from changing size at various altitude (such as, growing in size and potentially exploding at higher altitudes, such as at a flying altitude of in a helicopter, airplane, etc.). The flying altitude can be 1500 feet or higher, such as 2000 feet, 3000 feet, 8000 feet, 20000, 30000 feet. Moreover, any elastomeric key, membrane switch, or any user interface of the pump assembly that includes an enclosure filled with gas can be similarly vented, in the absence of a pressure relief, the buttons or other components may become so full of air that the components are unable to be usable until the pump assembly is operated under more typical pressure conditions. The vents or values in moreover can include a filter to prevent passage of liquid, such as a filter that is hydrophobic. In some implementations, components compliant for use in aircraft's can be used as part of the pump assembly to ensure appropriate pressure tolerance.

[0080] The pump assembly can include one or more switches that are able to withstand extreme temperature conditions. A pump assembly can additionally or alternatively include one or more hardware buttons, relays, rotary switches, or touch controls.

[0081] The pump assembly can include a reinforced liquid crystal display (LCD) screen with a non-conductive gasket in the LCD. The LCD screen can have EMC/ESD shield protection via a high hardness glass, which can also provide resistance against force (for example, to additional increase patient safety). Additionally or aiternativeiy, a LCD screen can include a vent to allow pressure normalization and to prevent cracking if the LCD is exposed to different pressure environments.

Other Variations

[0082] In one embodiment, an apparatus for applying negative pressure to a wound is disclosed. The apparatus can include a housing, a negative pressure source, a canister, a user interface, and one or more controllers. The negative pressure source can provide negative pressure via a fluid flow path to a wound dressing. The canister can be positioned in the fluid flow path and collect fluid removed from the wound dressing. The one or more controllers can: activate and deactivate the negative pressure source, and output an alarm indicating presence of a leak in the fluid flow path or that pressure in the fluid flow path failed to satisfy a desired pressure threshold. The one or more controllers can continue to activate and deactivate the negative pressure source subsequent to the wound dressing being exposed to a defibrillation shock while the negative pressure source is maintaining negative pressure below a negative pressure threshold, or the one or more controllers may not erroneously output the alarm as a result of the wound dressing being exposed to a defibrillation shock while the negative pressure source is maintaining negative pressure below the negative pressure threshold. The apparatus can be performing negative pressure therapy when the magnitude is maintained below the negative pressure threshold. The apparatus, moreover can function correctly and safely after a monophasic or biphasic electrical pulse of 5 KV/250J (or another suitable intensity) from an external defibrillator.

[0083] Any value of a threshold, limit, duration, etc. provided herein is not intended to be absolute and, thereby, can be approximate, in addition, any threshold, limit, duration, etc. provided herein can be fixed or varied either automatically or by a user. Furthermore, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass being equal to the reference value. For example, exceeding a reference value that is positive can encompass being equal to or greater than the reference value. In addition, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass an inverse of the disclosed relationship, such as below, less than, greater than, etc. in relations to the reference value. Moreover, although blocks of the various processes may be described in terms of determining whether a value meets or does not meet a particular threshold, the blocks can be similarly understood, for example, in terms of a value (i) being below or above a threshold or (ii) satisfying or not satisfying a threshold.

[0084] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. Ail of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or ail of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. [008S] While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection, indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For example, the actual steps or order of steps taken in the disclosed processes may differ from those shown in the figure. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For instance, the various components illustrated in the figures may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as processors, ASICs, FPGAs, and the like, can include logic circuitry. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0086] User interface screens illustrated and described herein can include additional or alternative components. These components can include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, checkboxes, combo boxes, status bars, dialog boxes, windows, and the like. User interface screens can include additional or alternative information. Components can be arranged, grouped, displayed in any suitable order.

[0087] Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments which do not provide ail of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments herein, and may be defined by claims as presented herein or as presented in the future.

[0088] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, or steps. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, or steps are included or are to be performed in any particular embodiment The terms "comprising," "including," "having," and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term "or" is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Further, the term "each," as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term "each" is applied.

[0089] Conjunctive language such as the phrase "at least one of X, Y, and Z," unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z, Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0090] Language of degree used herein, such as the terms "approximately," "about," "generally," and "substantially" as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately", "about", "generally," and "substantially" may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1 % of, within less than 0.1 % of, and within less than 0.01 % of the stated amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

[0091] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The Ianguage of the claims is to be interpreted broadly based on the Ianguage employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive.