Patent Description:
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. An example of a prior art device is disclosed in <CIT>.

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

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. The disclosed methods do not form part of the invention as claimed.

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.

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.

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 <NUM> mmHg (or <NUM> atm, <NUM> inHg, <NUM> kPa, <NUM> psi, etc.). Accordingly, a negative pressure value of -X mmHg reflects pressure that is X mmHg below atmospheric pressure, such as a pressure of (<NUM>-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, -<NUM> mmHg is less than -<NUM> mmHg). Negative pressure that is "more" or "greater" than -X mmHg corresponds to pressure that is further from atmospheric pressure (for example, -<NUM> mmHg is more than -<NUM> mmHg).

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.

<FIG> illustrates an embodiment of a negative or reduced pressure wound treatment (or TNP) system <NUM> comprising a wound filler <NUM> placed inside a wound cavity <NUM>, the wound cavity sealed by a wound cover <NUM>. The wound filler <NUM> in combination with the wound cover <NUM> can be referred to as wound dressing. A single or multi lumen tube or conduit <NUM> is connected the wound cover <NUM> with a pump assembly <NUM> configured to supply reduced pressure. The wound cover <NUM> can be in fluidic communication with the wound cavity <NUM>. In any of the system embodiments disclosed herein, as in the embodiment illustrated in <FIG>, the pump assembly can be a canisterless pump assembly (meaning that exudate is collected in the wound dressing or is transferred via tube <NUM> 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.

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

Some embodiments of the wound cover <NUM> can have a port (not shown) configured to receive an end of the conduit <NUM>. For example, the port can be Renays Soft Port available from Smith & Nephew. In other embodiments, the conduit <NUM> can otherwise pass through and/or under the wound cover <NUM> to supply reduced pressure to the wound cavity <NUM> so as to maintain a desired level of reduced pressure in the wound cavity. The conduit <NUM> can be any suitable article configured to provide at least a substantially sealed fluid flow pathway between the pump assembly <NUM> and the wound cover <NUM>, so as to supply the reduced pressure provided by the pump assembly <NUM> to wound cavity <NUM>.

The wound cover <NUM> and the wound filler <NUM> 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 <NUM>, to a source of negative pressure, such as the pump assembly <NUM>. The pump assembly <NUM> can be miniaturized and portable, although larger conventional pumps such can also be used.

The wound cover <NUM> can be located over a wound site to be treated. The wound cover <NUM> can form a substantially sealed cavity or enclosure over the wound site. In some embodiments, the wound cover <NUM> 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 ulcers, stoma, surgical wounds, trauma and venous ulcers or the like. The components of the TNP system described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.

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 <NUM> and tubing <NUM> so that the tubing <NUM> can be quickly and easily removed from the pump assembly <NUM> 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.

The pump assembly <NUM> can be configured to deliver negative pressure of approximately -<NUM> mmHg, or between about -<NUM> mmHg and <NUM> mmHg in some implementations. Note that these pressures are relative to normal ambient atmospheric pressure thus, -<NUM> mmHg would be about <NUM> mmHg in practical terms. The pressure range can be between about -<NUM> mmHg and -<NUM> mmHg. Alternatively a pressure range of up to -<NUM> mmHg, up to -<NUM> mmHg or over -<NUM> mmHg can be used. Also a pressure range of below -<NUM> mmHg can be used. Alternatively a pressure range of over approximately -<NUM> mmHg, or even <NUM> mmHg, can be supplied by the pump assembly <NUM>.

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

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 <CIT>,<CIT>, <CIT>,<CIT>, and<CIT>, which are incorporated by reference in their entirety. In other embodiments, other suitable wound dressings can be utilized.

<FIG> illustrates a front view of a pump assembly <NUM> and canister <NUM> according to some embodiments. As is illustrated, the pump assembly <NUM> and the canister are connected, thereby forming a negative pressure wound therapy device. The pump assembly <NUM> can be similar to or the same as the pump assembly <NUM> in some embodiments.

The pump assembly <NUM> includes one or more indicators, such as visual indicator <NUM> configured to indicate alarms and visual indicator <NUM> configured to indicate status of the TNP system. The indicators <NUM> and <NUM> 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 <NUM> 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 <NUM> can be configured to signal alarm conditions, such as canister full, power low, conduit <NUM> disconnected, seal broken in the wound seal <NUM>, and so on. The indicator <NUM> can be configured to display red flashing light to draw user's attention. The indicator <NUM> can be configured to signal status of the TNP system, such as therapy delivery is ok, leak detected, and so on. The indicator <NUM> can be configured to display one or more different colors of light, such as green, yellow, etc. For example, green light can be emitted when the TNP system is operating properly and yellow light can be emitted to indicate a warning.

The pump assembly <NUM> includes a display or screen <NUM> mounted in a recess <NUM> formed in a case of the pump assembly. The display <NUM> can be a touch screen display. The display <NUM> can support playback of audiovisual (AV) content, such as instructional videos. As explained below, the display <NUM> 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 <NUM> comprises a gripping portion <NUM> formed in the case of the pump assembly. The gripping portion <NUM> can be configured to assist the user to hold the pump assembly <NUM>, such as during removal of the canister <NUM>. The canister <NUM> can be replaced with another canister, such as when the canister <NUM> has been filled with fluid.

The pump assembly <NUM> includes one or more keys or buttons <NUM> 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 <NUM>. 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 <NUM> and/or the buttons <NUM>. 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 <NUM>.

The pump assembly <NUM> includes one or more latch recesses <NUM> formed in the cover. In the illustrated embodiment, two latch recesses <NUM> can be formed on the sides of the pump assembly <NUM>. The latch recesses <NUM> can be configured to allow attachment and detachment of the canister <NUM> using one or more canister latches <NUM>. The pump assembly <NUM> comprises an air outlet <NUM> for allowing air removed from the wound cavity <NUM> 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 <NUM> includes one or more strap mounts <NUM> for connecting a carry strap to the pump assembly <NUM> or for attaching a cradle. In the illustrated embodiment, two strap mounts <NUM> can be formed on the sides of the pump assembly <NUM>. In some embodiments, various of these features are omitted and/or various additional features are added to the pump assembly <NUM>.

The canister <NUM> is configured to hold fluid (e.g., exudate) removed from the wound cavity <NUM>. The canister <NUM> includes one or more latches <NUM> for attaching the canister to the pump assembly <NUM>. In the illustrated embodiment, the canister <NUM> comprises two latches <NUM> on the sides of the canister. The exterior of the canister <NUM> 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 <NUM> comprises a gripping portion <NUM> formed in a case of the canister. The gripping portion <NUM> can be configured to allow the user to hold the pump assembly <NUM>, such as during removal of the canister from the apparatus <NUM>. The canister <NUM> includes a substantially transparent window <NUM>, which can also include graduations of volume. For example, the illustrated <NUM> canister <NUM> includes graduations of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>. Other embodiments of the canister can hold different volume of fluid and can include different graduation scale. For example, the canister can be an <NUM> canister. The canister <NUM> comprises a tubing channel <NUM> for connecting to the conduit <NUM>. In some embodiments, various of these features, such as the gripping portion <NUM>, are omitted and/or various additional features are added to the canister <NUM>. Any of the disclosed canisters may include or may omit a solidifier.

<FIG> illustrates a rear view of the pump assembly <NUM> and canister <NUM> according to some embodiments. The pump assembly <NUM> comprises a speaker port <NUM> for producing sound. The pump assembly <NUM> includes a filter access door <NUM> with a screw <NUM> for removing the access door <NUM>, accessing, and replacing one or more filters, such as antibacterial or odor filters. The pump assembly <NUM> comprises a gripping portion <NUM> formed in the case of the pump assembly. The gripping portion <NUM> can be configured to allow the user to hold the pump assembly <NUM>, such as during removal of the canister <NUM>. The pump assembly <NUM> includes one or more covers <NUM> configured to as screw covers and/or feet or protectors for placing the pump assembly <NUM> on a surface. The covers <NUM> can be formed out of rubber, silicone, or any other suitable material. The pump assembly <NUM> comprises a power jack <NUM> for charging and recharging an internal battery of the pump assembly. The power jack <NUM> 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.

The canister <NUM> includes one or more feet <NUM> for placing the canister on a surface. The feet <NUM> can be formed out of rubber, silicone, or any other suitable material and can be angled at a suitable angle so that the canister <NUM> remains stable when placed on the surface. The canister <NUM> comprises a tube mount relief <NUM> configured to allow one or more tubes to exit to the front of the device. The canister <NUM> includes a stand or kickstand <NUM> for supporting the canister when it is placed on a surface. As explained below, the kickstand <NUM> can pivot between an opened and closed position. In closed position, the kickstand <NUM> can be latched to the canister <NUM>. In some embodiments, the kickstand <NUM> can be made out of opaque material, such as plastic. In other embodiments, the kickstand <NUM> can be made out of transparent material. The kickstand <NUM> includes a gripping portion <NUM> formed in the kickstand. The gripping portion <NUM> can be configured to allow the user to place the kickstand <NUM> in the closed position. The kickstand <NUM> comprises a hole <NUM> to allow the user to place the kickstand in the open position. The hole <NUM> can be sized to allow the user to extend the kickstand using a finger.

<FIG> illustrates a view of the pump assembly <NUM> separated from the canister <NUM> according to some embodiments. The pump assembly <NUM> includes a vacuum attachment, connector, or inlet <NUM> through which a vacuum pump communicates negative pressure to the canister <NUM>. The pump assembly aspirates fluid, such as gas, from the wound via the inlet <NUM>. The pump assembly <NUM> comprises a USB access door <NUM> 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 <NUM>. The pump assembly <NUM> 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 <NUM>.

<FIG> illustrates an electrical component schematic <NUM> of a pump assembly, such as the pump assembly <NUM>, 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.

The pump assembly can comprise a user interface processor or controller <NUM> configured to operate one or more components for accepting user input and providing output to the user, such as the display <NUM>, buttons <NUM>, etc. Input to the pump assembly and output from the pump assembly can controlled by an input/output (I/O) module <NUM>. 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 <NUM> also receives data from and provides data to one or more expansion modules <NUM>, 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 <NUM>, along with other controllers or processors, stores data in one or more memory modules <NUM>, which can be internal and/or external to the processor <NUM>. Any suitable type of memory can be used, including volatile and/or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, magnetoresistive random-access memory (MRAM), and the like.

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

The pump control processor <NUM> can be configured to control the operation of a negative pressure pump <NUM>. The pump <NUM> 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 <NUM> 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 <NUM> can control a pump motor so that a desired level of negative pressure is achieved in the wound cavity <NUM>. The desired level of negative pressure can be pressure set or selected by the user. In various embodiments, the pump control processor <NUM> controls the pump (e.g., pump motor) using pulse-width modulation (PWM). A control signal for driving the pump can be a <NUM>-<NUM>% duty cycle PWM signal. The pump control processor <NUM> can perform flow rate calculations and detect various conditions in a flow path. The pump control processor <NUM> can communicate information to the processor <NUM>. The pump control processor <NUM> can include internal memory and/or can utilize memory <NUM>. The pump control processor <NUM> can be a low-power processor.

A communications processor <NUM> can be configured to provide wired and/or wireless connectivity. The communications processor <NUM> can utilize one or more antennas <NUM> for sending and receiving data. The communications processor <NUM> can provide one or more of the following types of connections: Global Positioning System (GPS) technology, cellular connectivity (e.g., <NUM>, <NUM>, LTE, <NUM>), 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 <NUM> can provide dual GPS/cellular functionality. Cellular functionality can, for example, be <NUM> functionality. The pump assembly can include a SIM card, and SIM-based positional information can be obtained.

The communications processor <NUM> can communicate information to the processor <NUM>. The communications processor <NUM> can include internal memory and/or can utilize memory <NUM>. The communications processor <NUM> can be a low-power processor.

In some embodiments, using the connectivity provided by the communications processor <NUM>, 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.

<FIG> illustrates exploded view of a pump assembly <NUM>, such as the pump assembly <NUM>, according to some embodiments. The illustrated view can correspond to the front portion of the pump assembly <NUM>. The components of the pump assembly <NUM> can include: a front enclosure <NUM>, a GPS antenna <NUM>, a status light pipe <NUM>, adhesives <NUM>, a liquid crystal display (LCD) <NUM>, a chassis and LCD circuit board assembly <NUM>, screws <NUM>, a main circuit board assembly <NUM>, screws <NUM>, standoffs <NUM>, a communications circuit board assembly <NUM> (including a communications antenna), a negative pressure source <NUM>, a power entry cable <NUM>, a universal serial bus (USB) cable assembly <NUM>, a subscriber identity module (SIM) card <NUM>, a bottom enclosure <NUM>, a canister connector <NUM>, a canister connector O-ring <NUM>, and a keypad <NUM>. <FIG> illustrate multiple views of the pump assembly <NUM> according to some embodiments. The dimensions included in <FIG> are provided in inches.

Although <FIG> show particular components included as part of the pump assembly <NUM>, some components may be removed or other components may be added in other implementations.

<FIG> illustrates exploded view of a pump assembly <NUM>, such as the pump assembly <NUM>, according to some embodiments. The illustrated view can correspond to the back portion of the pump assembly <NUM>. The illustrated components of the pump assembly <NUM> can be configured to couple to the components of the pump assembly <NUM> to form an integral pump assembly. The components of the pump assembly <NUM> can include: an access door <NUM> (which can be the same as access door <NUM>), a filter enclosure gasket <NUM>, a filter <NUM> (for example, antibacterial filter, odor filter, and the like), a mini USB port cover <NUM>, a back enclosure <NUM>, a power entry light pipe <NUM>, a power entry circuit board assembly <NUM>, a USB circuit board assembly <NUM>, a tubing outlet <NUM>, a clip <NUM>, a battery bracket <NUM>, a battery <NUM>, a speaker assembly <NUM>, a speaker filter <NUM>, a push nut <NUM>, a screw <NUM> (which can be the same as the screw <NUM>), screws <NUM>, screws <NUM>, and foam tape <NUM>. <FIG> illustrate multiple views of the pump assembly <NUM> according to some embodiments. The dimensions included in <FIG> are provided in inches.

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.

The pump assembly can be configured to withstand high levels of ESD and in multiples steps, such as contact: ±<NUM> kV (or lower), ±<NUM> kV, ±<NUM> kV, ±<NUM> kV or higher and air: ±<NUM> kV (or lower), ±<NUM> kV, ±<NUM> kV, ±<NUM> kV ±<NUM> kV, ±<NUM> 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 <NUM> A/m (or lower), <NUM> A/m, <NUM> A/m, <NUM> A/m or higher, as well as high levels of RF immunity, for example for RF signal strengths of <NUM> V/m (or lower), <NUM> 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 <NUM> family standards relating to electromagnetic compatibility for electrical and electronic equipment or one or more other applicable industry standards.

The pump assembly can, in some implementations, be defibrillation-proof (for instance, defibrillation-proof as an entire applied part), such as is defined under the IEC <NUM>-<NUM> 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 defibrillator-proof while retaining usability.

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.

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 multi-layer (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.

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.

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 <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>) 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.

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.

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 <NUM> or screw <NUM>.

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.

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.

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.

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.

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

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.

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.

<FIG> illustrates a front of a main PCB <NUM> of a pump assembly, such as the pump assembly <NUM>, according to some embodiments. The main PCB <NUM> can, for example, be an embodiment of the main circuit board assembly <NUM>. The main PCB <NUM> can include a digital signal processor <NUM> for controlling a source of negative pressure, an electromagnetic compatibility shield <NUM> for an LED backlight (for example, to protect against high voltages like <NUM> V rather than <NUM> V), a shielded battery charger <NUM>, a shielded memory and main microcontroller <NUM>, a battery connector <NUM>, and a shielded regulator <NUM> for digital circuitry. <FIG> illustrates a back of the main PCB <NUM>.

<FIG> and <FIG> illustrate a front and back of a wireless communication PCB assembly <NUM> of a pump assembly, such as the pump assembly <NUM>, according to some embodiments. The wireless communication PCB <NUM> assembly can, for example, be an embodiment of the communications circuit board assembly <NUM>. The wireless communication PCB assembly <NUM> can include an antenna board <NUM> and a PCB <NUM> with a shielded wireless communication controller <NUM> and a shielded voltage regulator <NUM>. The antenna board <NUM> can be wireless mobile communications antenna, such a single-, dual-, tri-, quad-, or the like band antenna for communicating via <NUM>, <NUM>, LTE, <NUM>, or the like and be mounted to the communications PCB <NUM> with mounting brackets <NUM>. The wireless communication PCB assembly <NUM> can be electrically coupled via a path <NUM> to a GPS antenna <NUM>, which can be an embodiment of the GPS antenna <NUM>.

<FIG> illustrates a side of the wireless communication PCB assembly <NUM> with the path <NUM> and the GPS antenna <NUM> removed. As can be seen, the antenna board <NUM> can be mounted to extend along a line A at an angle ∠θ° relative to a line B that extends perpendicular to a line C that extends parallel to a direction in which the PCB <NUM> extends. The angle ∠θ° can be non-zero in some implementations, but zero in other implementations. For instance, the angle ∠θ° can be between a minimum of ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, or ∠<NUM>° and a maximum of ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, or ∠<NUM>°. The angle ∠θ° can, for example, be ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, ∠<NUM>°, or ∠<NUM>° or approximately so. In other implementations, the antenna board <NUM> can be mounted to angle in the opposite direction and yet face downward such that the angle ∠θ° can instead be between a minimum of ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, or ∠-<NUM>° and a maximum of ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, or ∠-<NUM>° and, for example, have a value of ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, ∠-<NUM>°, or ∠-<NUM>° or approximately so. The angle ∠θ° may be selected, in some implementations, so that the antenna board <NUM> 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 flat surface, position at an angle resting on a kickstand of the pump assembly or canister, or coupled to a pole using a clamp).

As is illustrated in <FIG>, the antenna board <NUM> can be mechanically coupled to the PCB <NUM>. The antenna board <NUM> can, for example, be mounted to the PCB <NUM> (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 <FIG>. The antenna board <NUM> 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 <NUM> can thereby communicate by reflecting signal electromagnetic signals off of one or more surfaces below the antenna board <NUM>.

<FIG> illustrates a perspective view of components of the wireless communication PCB assembly <NUM> according to some embodiments. The antenna board <NUM> can be mounted to the communications PCB <NUM> with the mounting brackets <NUM> secured to the PCB <NUM> with pins, screws, or rivets <NUM>. Although two brackets <NUM> are illustrated, in some embodiments, one bracket or more than two brackets can be used. The brackets <NUM> can be secured to the antenna board <NUM> using tape <NUM> alone or in combination with pegs or pins <NUM> being aligned with (and when assembled fitting through) the holes <NUM>, <NUM>, <NUM>, and <NUM> of the antenna board <NUM>. Pegs or protrusions <NUM> and <NUM> of the PCB <NUM> also can be aligned with (and when assembled fit through) the holes <NUM> and <NUM> of the antenna board <NUM>. The antenna can be oriented at any desired angle to the PCB <NUM>. In some implementations, desired orientation can be achieved by rotating or pivoting the brackets <NUM> about the rivets <NUM>.

<FIG> illustrates a top layer <NUM> of a wireless communication PCB assembly, such as the wireless communication assembly PCB <NUM>, according to some embodiments. The top layer <NUM> can, for instance, be a top film layer. The top layer <NUM> includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The top layer <NUM> 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 <NUM> between the antenna board <NUM> and the PCB <NUM>. The connection <NUM> can provide a transmit signal feed from a controller (for example, the communication controller <NUM>) and the antenna board <NUM> when antenna is transmitting (or is in a transmit mode). The connection <NUM> can provide a receive signal feed from the antenna board <NUM> to the controller when the antenna is receiving (or is in a receive mode). The connection <NUM> can, in some implementations, be the sole connection point for transmitting and receiving signals via the antenna board <NUM>. Antenna trace <NUM>, which includes first and second portions <NUM> and <NUM>, is connected to the ground plane <NUM> at or near location <NUM>. The trace <NUM> includes conductive material, such as copper, and can serve as a ground plane for the antenna board <NUM>. Connection between the trace <NUM> and the ground plane <NUM> of the PCB <NUM> can be accomplished with a shunt or another suitable component.

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

<FIG> illustrates a bottom layer <NUM> of the wireless communication PCB assembly of <FIG> according to some embodiments. The bottom layer <NUM> can, for instance, be a bottom film layer. The bottom layer <NUM> includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The bottom layer <NUM> includes multiple features including at least a ground (GND) plane and an antenna connector or connection <NUM>. Connection <NUM> can be used as a mechanical connection for securing the antenna board <NUM>. For instance, when the antenna board is positioned top side facing downward as explained herein, because connection <NUM> is positioned on the opposite side of the board with respect to connection <NUM>, 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 <NUM>) to the connection <NUM>. In such instances, connection <NUM> does not provide any electrical connectivity, but is used solely for mechanical support. As explained herein, protrusion <NUM> of the PCB <NUM> can be placed in the hole <NUM> of the antenna board <NUM> so that connection <NUM> is located proximal the top surface of the antenna board Soldering the antenna board connection <NUM> on the opposite, bottom side of the antenna board <NUM> to the connection <NUM> can provide electrical connection and, optionally, additional mechanical support. In some embodiments, the locations of the antenna connection <NUM> and the connection <NUM> can be switched (for example, the antenna connection <NUM> can be placed on the top layer <NUM>) particularly when the antenna board is positioned top side facing upward away from the ground.

<FIG> illustrates an internal ground plane <NUM> of the wireless communication PCB assembly of <FIG> according to some embodiments. The internal ground plane <NUM> includes conductive portions (shown as darkened or shaded areas) and nonconductive portions or voids (shown as undarkened or white areas). The internal ground plane <NUM> includes a ground extending around a perimeter of the PCB, as well as a ground area <NUM> proximate the antenna, which can help with for reducing noise (such as EMI) associated with the antenna. The ground area <NUM> can have a thickness that is greater (for example, more than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times the thickness) than a thickness of the other parts of the ground extending around a perimeter of the PCB. The internal ground plane <NUM> further includes grounding at the locations of the mounting pads so that the mounting holes for the wireless communication PCB assembly may be grounded.

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

With the structures depicted in <FIG>, 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.

A pump assembly, such as the pump assembly <NUM>, can communicate using an antenna, such as the antenna board <NUM> of <FIG>, 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.

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.

In some implementations, the antenna can be positioned as far as possible from a ground plane or another plane of the PCB <NUM> 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.

<FIG> illustrates a pump assembly <NUM>, such as the pump assembly <NUM>, communicating using an antenna according to some embodiments. The antenna can, for example, be an embodiment of the antenna board <NUM>. According to the invention as claimed, the antenna of the pump assembly <NUM> is positioned so that the antenna is not planar with a bulk head of the pump assembly <NUM>. This may advantageously enable the antenna to angle forwards or backwards (for instance, toward a GUI like a display screen) when the pump assembly <NUM> 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 <NUM> but may instead bounce away from the pump assembly <NUM>.

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 <NUM> feet or higher, such as <NUM> feet, <NUM> feet, <NUM> feet, <NUM>, <NUM> 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.

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.

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 alternatively, a LCD screen can include a vent to allow pressure normalization and to prevent cracking if the LCD is exposed to different pressure environments.

In one embodiment useful for understanding the disclosure, 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 <NUM> KV/250J (or another suitable intensity) from an external defibrillator.

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.

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. For example, the actual steps or order of steps taken in the disclosed processes may differ from those shown in the figure. 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.

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.

Although the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments herein, the invention is defined by the appended claims.

Claim 1:
A pump assembly (<NUM>, <NUM>) for applying negative pressure to a wound, the pump assembly comprising:
a housing;
a negative pressure source (<NUM>) configured to provide negative pressure via a fluid flow path to a wound dressing;
a canister (<NUM>) positioned in the fluid flow path and configured to collect fluid removed from the wound dressing;
an antenna including an antenna board (<NUM>) supported by the housing and configured to wirelessly communicate with an electronic device, the antenna being positioned proximate to the canister and
oriented in the housing to face downward toward the floor or a surface on which the pump assembly is positioned when the negative pressure source is providing negative pressure; one or more controllers configured to:
activate and deactivate the negative pressure source, and transmit first data to the electronic device using the antenna or receive second data from the electronic device using the antenna; and
characterized in that
the antenna is positioned so that the antenna is not planar with a bulk head of the pump assembly and wherein the canister is configured to provide electromagnetic shielding to the antenna.