Patent Description:
The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders. In particular, the present technology relates to medical devices or apparatus, their use, and updating the same.

The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the air into the venous blood and carbon dioxide to move out. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See "<NPL>.

Some examples of respiratory disorders include: Obstructive Sleep Apnea (OSA), Cheyne Stokes Respiration (CSR), Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) or chest wall disorders.

Otherwise healthy individuals may take advantage of systems and devices to prevent respiratory disorders from arising.

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The hypothesis is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall.

Non-invasive ventilation (NIV) provides ventilator support to a patient through the upper airways to assist the patient in taking a full breath and/or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilator support is provided via a patient interface. NIV has been used to treat CSR, OHS, COPD, MD and Chest Wall disorders.

Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and is provided using a tracheostomy tube.

Ventilators may control the timing and pressure of breaths pumped into the patient and monitor the breaths taken by the patient. The methods of control and monitoring patients typically include volume-cycled and pressure-cycled methods. The volume-cycled methods may include among others, Pressure-Regulated Volume Control (PRVC), Volume Ventilation (VV), and Volume Controlled Continuous Mandatory Ventilation (VC-CMV) techniques. The pressure-cycled methods may involve, among others, Assist Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV), Controlled Mechanical Ventilation (CMV), Pressure Support Ventilation (PSV), Continuous Positive Airway Pressure (CPAP), or Positive End Expiratory Pressure (PEEP) techniques.

A treatment system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

A patient interface may be used to interface respiratory equipment to its user, for example by providing a flow of breathable gas. The flow of breathable gas may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of the user. Depending upon the therapy to be applied, the patient interface may form a seal, e.g. with a face region of the patient, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g. a positive pressure of about 10cmH2O. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10cmH2O.

The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being one or more of obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use and uncomfortable especially when worn for long periods of time or when a patient is unfamiliar with a system. For example, masks designed solely for aviators, mask designed as part of personal protection equipment (e.g. filter masks), SCUBA masks or for the administration of anaesthetics may be tolerable for their original application, but nevertheless be undesirably uncomfortable to be worn for extended periods of time, e.g. several hours. This is even more so if the mask is to be worn during sleep.

Nasal CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g. difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

For these reasons, masks for delivery of nasal CPAP during sleep form a distinct field.

Patient interfaces may include a seal-forming portion. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming portion can have a direct impact the effectiveness and comfort of the patient interface.

A patient interface may be partly characterised according to the design intent of where the seal-forming portion is to engage with the face in use. In one form of patient interface, a seal-forming portion may comprise two sub-portions to engage with respective left and right nares. In one form of patient interface, a seal-forming portion may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming portion may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal-forming portion may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

A seal-forming portion that may be effective in one region of a patient's face may be in appropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient's face. For example, a seal on swimming goggles that overlays a patient's forehead may not be appropriate to use on a patient's nose.

Certain seal-forming portions may be designed for mass manufacture such that one design fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient's face, and the seal-forming portion of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.

One type of seal-forming portion extends around the periphery of the patient interface, and is intended to seal against the user's face when force is applied to the patient interface with the seal-forming portion in confronting engagement with the user's face. The seal-forming portion may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming portion, if the fit is not adequate, there will be gaps between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

Another type of seal-forming portion incorporates a flap seal of thin material so positioned about the periphery of the mask so as to provide a self-sealing action against the face of the user when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to affect a seal, or the mask may leak. Furthermore, if the shape of the seal-forming portion does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

Another type of seal-forming portion may comprise a friction-fit element, e.g. for insertion into a naris.

Another form of seal-forming portion may use adhesive to affect a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.

A range of patient interface seal-forming portion technologies are disclosed in the following patent applications, assigned to ResMed Limited: <CIT>; <CIT>; <CIT>.

One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of <CIT>.

ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFT nasal pillows mask, SWIFT II nasal pillows mask, SWIFT LT nasal pillows mask, SWIFT FX nasal pillows mask and LIBERTY full-face mask. The following patent applications, assigned to ResMed Limited, describe nasal pillows masks: International Patent Application <CIT> (describing amongst other things aspects of ResMed SWIFT nasal pillows), <CIT> (describing amongst other things aspects of ResMed SWIFT LT nasal pillows); International Patent Applications <CIT> and <CIT> (describing amongst other things aspects of ResMed LIBERTY full-face mask); International Patent Application <CIT> (describing amongst other things aspects of ResMed SWIFT FX nasal pillows).

A seal-forming portion of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming portion, and to maintain it in sealing relation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US Patent publication <CIT>.

Another technique is the use of one or more straps and stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.

One known RPT device used for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar™ Series of Adult and Paediatric Ventilators may provide support for invasive and non-invasive non-dependent ventilation for a range of patients for treating a number of conditions such as but not limited to NMD, OHS and COPD. RPT devices have also been known as flow generators.

The ResMed Elisée™ <NUM> ventilator and ResMed VS III™ ventilator may provide support for invasive and non-invasive dependent ventilation suitable for adult or paediatric patients for treating a number of conditions. These ventilators provide volumetric and barometric ventilation modes with a single or double limb circuit.

RPT devices typically comprise a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be supplied to the airway of the patient at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

RPT devices typically also include an inlet filter, various sensors and a microprocessor-based controller. A blower may include a servo-controlled motor, a volute and an impeller. In some cases a brake for the motor may be implemented to more rapidly reduce the speed of the blower so as to overcome the inertia of the motor and impeller. The braking can permit the blower to more rapidly achieve a lower pressure condition in time for synchronization with expiration despite the inertia. In some cases the pressure generator may also include a valve capable of discharging generated air to atmosphere as a means for altering the pressure delivered to the patient as an alternative to motor speed control. The sensors measure, amongst other things, motor speed, mass flow rate and outlet pressure, such as with a pressure transducer or the like. The controller may include data storage capacity with or without integrated data retrieval and display functions.

Table of noise output levels of prior devices (one specimen only, measured using test method specified in ISO3744 in CPAP mode at 10cmH<NUM>O).

Delivery of a flow of breathable gas without humidification may cause drying of airways. Medical humidifiers are used to increase humidity and/or temperature of the flow of breathable gas in relation to ambient air when required, typically where the patient may be asleep or resting (e.g. at a hospital). As a result, a medical humidifier is preferably small for bedside placement, and it is preferably configured to only humidify and/or heat the flow of breathable gas delivered to the patient without humidifying and/or heating the patient's surroundings. Room-based systems (e.g. a sauna, an air conditioner, an evaporative cooler), for example, may also humidify air that is breathed in by the patient, however they would also humidify and/or heat the entire room, which may cause discomfort to the occupants.

The use of a humidifier with a flow generator or RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. In addition, in cooler climates warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.

Respiratory humidifiers are available in many forms and may be a standalone device that is coupled to a respiratory apparatus via an air circuit, is integrated with or configured to be coupled to the relevant respiratory apparatus. While known passive humidifiers can provide some relief, generally a heated humidifier may be used to provide sufficient humidity and temperature to the air so that the patient will be comfortable. Humidifiers typically comprise a water reservoir or tub having a capacity of several hundred milliliters (ml), a heating element for heating the water in the reservoir, a control to enable the level of humidification to be varied, a gas inlet to receive gas from the flow generator or RPT device, and a gas outlet adapted to be connected to an air circuit that delivers the humidified gas to the patient interface.

Heated passover humidification is one common form of humidification used with a RPT device. In such humidifiers the heating element may be incorporated in a heater plate which sits under, and is in thermal contact with, the water tub. Thus, heat is transferred from the heater plate to the water reservoir primarily by conduction. The air flow from the RPT device passes over the heated water in the water tub resulting in water vapour being taken up by the air flow. The ResMed H4i™ and H5i™ Humidifiers are examples of such heated passover humidifiers that are used in combination with ResMed S8 and S9 CPAP devices respectively.

Other humidifiers may also be used such as a bubble or diffuser humidifier, a jet humidifier or a wicking humidifier. In a bubble or diffuser humidifier the air is conducted below the surface of the water and allowed to bubble back to the top. A jet humidifier produces an aerosol of water and baffles or filters may be used so that the particles are either removed or evaporated before leaving the humidifier. A wicking humidifier uses a water absorbing material, such as sponge or paper, to absorb water by capillary action. The water absorbing material is placed within or adjacent at least a portion of the air flow path to allow evaporation of the water in the absorbing material to be taken up into the air flow.

An alternative form of humidification is provided by the ResMed HumiCare™ D900 humidifier that uses a CounterStream™ technology that directs the air flow over a large surface area in a first direction whilst supplying heated water to the large surface area in a second opposite direction. The ResMed HumiCare™ D900 humidifier may be used with a range of invasive and non-invasive ventilators. <CIT> and <CIT> disclose systems for updating patient devices in providing medical treatment. They do not disclose a transmitted instruction set update data which include instructions for the instruction set update not to be applied until patient treatment is stopped.

Aspects of the disclosure provide a computer implemented method for updating a patient device over a network. The method may include accessing configuration data relating to a plurality of patient devices, wherein the plurality of patient devices each implements a set of instructions. The method may also include identifying one or more patient devices, from the plurality of patient devices, having configuration data that meets one or more criteria and selecting, in the case where more than one updates are provided, an instruction update to be provided to the one or more patient devices, wherein the configuration data indicates that the instruction update is not currently installed on the one or more patient devices. The method may also include transmitting the instruction update to the one or more patient devices, as well as determining whether each of the one or more patient devices successfully installed the instruction update. In addition the configuration data may be updated for each of the one or more patient devices that successfully installed the instruction update.

In another aspect, the instruction update may include at least one of the following: data specifying a location of an instruction update file; instructions as to which component of the device should the update be applied to; schedule time for performing the update for each device; instructions on whether or not to request confirmation that the update should be applied; instructions for the update not be applied until patient treatment is stopped, if applicable; data structure and functionality enabling cancelling upgrades that have not yet occurred; batch capability to request bulk upgrades in a single operation; and an ability to check a status of these upgrades in a single operation indicating the status of the upgrades.

Selecting the one or more criteria and the instruction update may be based on received one or more transmissions from a remote computing device, e.g. the computer of a clinician or service personnel. In addition, the step of selecting the instruction update may be based on receiving input from a user of the remote computing device indicating the instruction update, from a plurality of instruction updates. Transmitting the instruction update may further include transmitting verification data, wherein the verification data is used by the patient device to verify that the received instruction update is complete. In this case the expression that the update is "complete" is also meant to indicate that the update is without corruption or alteration in any way. The instruction update may be retransmitted to each device for which it is determined that the instruction update was not successfully installed.

In accordance with yet another aspect, an indication from each of the one or more patient devices indicates that the instruction set was successfully installed, and a message may be transmitted to a computing device, wherein the message identifies successful installation of the instruction update for the one or more patient devices. The configuration data may include at least one of a) a serial number, b) a version of the set of instructions that is currently installed on the patient device, c) a hardware version, d) a region in which the patient device is being used, and e) a record of the instruction updates that have previously been successfully or unsuccessfully applied to the patient device.

In accordance with still another aspect, the plurality of patient devices may be respiratory pressure therapy devices. The configuration data may include at least one of a) a serial number, b) a version of the set of instructions that is currently installed on the patient device, and c) a hardware version. In addition, the instruction update may include a first portion and a second portion, herein a first component of the patient device operates in accordance with the first portion of the instruction update and a second component operates in accordance with the second portion of the instruction update.

In another aspect, a method for updating a device for providing medical may include accessing a first set of instructions for operation of a patient device; performing a first set of operations in accordance with the first instruction set; receiving update data from a remote computing device over a network; updating the first set of instructions in accordance with the update data so as to generate an updated set of instructions; transmitting confirmation to the remote computing device that an update of the first set of instructions has occurred; and performing a second set of operations in accordance with the updated set of instructions.

The method may also include receiving verification data, and further comprising determination of whether the received update data is complete. If the received update data is determined to be incomplete, the patient device may transmit an error notification to the remote computing device and receive a second transmission of update data.

<FIG> is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermillion, lower vermillion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion.

<FIG> shows an example of a patient interface known in the prior art.

<FIG> shows a humidifier in accordance with one aspect of the present technology.

<FIG> shows a model typical breath waveform of a person while sleeping, the horizontal axis is time, and the vertical axis is respiratory flow. While the parameter values may vary, a typical breath may have the following approximate values: tidal volume, Vt, <NUM>, inhalation time, Ti, <NUM>, peak inspiratory flow, Qpeak, <NUM>/s, exhalation time, Te, <NUM>, peak expiratory flow, Qpeak, -<NUM>/s. The total duration of the breath, Ttot, is about <NUM>. The person typically breathes at a rate of about <NUM> breaths per minute (BPM), with Ventilation, Vent, about <NUM>/s. A typical duty cycle, the ratio of Ti to Ttot is about <NUM>%.

<FIG> shows an example communications system <NUM> that may be used in the collection and transmission of patient data. Each patient device <NUM>, <NUM>, and <NUM> may comprise an RPT <NUM>, humidifier <NUM>, and patient interface <NUM>. <FIG> shows flow diagram <NUM> of operations that may be performed by patient devices disclosed herein in connection with updating instruction sets that are implemented by the patient device. <FIG> shows flow diagram <NUM> operations that may be performed by computing devices, such as servers, disclosed herein.

In one form, the present technology comprises apparatus for treating a respiratory disorder. The apparatus may comprise a flow generator or blower for supplying pressurised respiratory gas, such as air, to the patient <NUM> via an air delivery tube leading to a patient interface <NUM>.

In one form, the present technology comprises a method of treating Obstructive Sleep Apnea in a patient by applying nasal continuous positive airway pressure to the patient.

A non-invasive patient interface <NUM> in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure <NUM>, a plenum chamber <NUM>, a positioning and stabilising structure <NUM>, a vent <NUM> and a connection port <NUM> for connection to air circuit <NUM>. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure <NUM> is arranged to surround an entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways.

In one form of the present technology, a seal-forming structure <NUM> provides a sealing-forming surface, and may additionally provide a cushioning function.

A seal-forming structure <NUM> in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

In one form, the seal-forming structure <NUM> comprises a sealing flange and a support flange. Preferably the sealing flange comprises a relatively thin member with a thickness of less than about <NUM>, for example about <NUM> to about <NUM>, that extends around the perimeter <NUM> of the plenum chamber <NUM>. Support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge of the plenum chamber <NUM>, and extends at least part of the way around the perimeter <NUM>. The support flange is or includes a spring-like element and functions to support the sealing flange from buckling in use. In use the sealing flange can readily respond to system pressure in the plenum chamber <NUM> acting on its underside to urge it into tight sealing engagement with the face.

In one form the seal-forming portion of the non-invasive patient interface <NUM> comprises a pair of nasal puffs, or nasal pillows, each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient.

Nasal pillows in accordance with an aspect of the present technology include: a frusto-cone, at least a portion of which forms a seal on an underside of the patient's nose; a stalk, a flexible region on the underside of the cone and connecting the cone to the stalk. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent the base of the stalk. The flexible regions can act in concert to facilitate a universal joint structure that is accommodating of relative movement-both displacement and angular- of the frusto-cone and the structure to which the nasal pillow is connected. For example, the frusto-cone may be axially displaced towards the structure to which the stalk is connected.

In one form the non-invasive patient interface <NUM> comprises a seal-forming portion that forms a seal in use on an upper lip region (that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface <NUM> comprises a seal-forming portion that forms a seal in use on a chin-region of the patient's face.

Preferably the plenum chamber <NUM> has a perimeter <NUM> that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber <NUM> is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure <NUM>. Preferably the seal-forming structure <NUM> extends in use about the entire perimeter <NUM> of the plenum chamber <NUM>.

In one form, the plenum chamber <NUM> may surround and/or be in fluid communication with the nares of the patient where the plenum chamber <NUM> is a part of a nasal mask (e.g. shown in <FIG>). In another form, the plenum chamber <NUM> may surround and/or be in fluid communication with the nares and the mouth of the patient where the plenum chamber <NUM> is a part of a full-face mask (e.g., shown in <FIG>). In yet another form, the plenum chamber <NUM> may engage and/or be in fluid communication with one or more of the nares of the patient where the plenum chamber <NUM> is a part of nasal pillows (e.g., shown in Fig. <NUM>).

Preferably the seal-forming structure <NUM> of the patient interface <NUM> of the present technology is held in sealing position in use by the positioning and stabilising structure <NUM>.

An example RPT device <NUM> that may be suitable for implementing aspects of the present technology may include mechanical and pneumatic components <NUM>, electrical components <NUM> and may be programmed to execute one or more of the control methodologies or algorithms described throughout this specification. The RPT device may have an external housing <NUM>, preferably formed in two parts, an upper portion <NUM> of the external housing <NUM>, and a lower portion <NUM> of the external housing <NUM>. In alternative forms, the external housing <NUM> may include one or more panel(s) <NUM>. Preferably the RPT device <NUM> comprises a chassis <NUM> that supports one or more internal components of the RPT device <NUM>. In one form a pneumatic block <NUM> is supported by, or formed as part of the chassis <NUM>. The RPT device <NUM> may include a handle <NUM>.

The pneumatic path of the RPT device <NUM> preferably comprises an inlet air filter <NUM>, an inlet muffler <NUM>, a controllable pressure device <NUM> capable of supplying air at positive pressure (preferably a blower <NUM>), and an outlet muffler <NUM>. One or more pressure transducers <NUM> and flow sensors <NUM> are included in the pneumatic path.

The preferred pneumatic block <NUM> comprises a portion of the pneumatic path that is located within the external housing <NUM>.

The RPT device <NUM> preferably has an electrical power supply <NUM>, one or more input devices <NUM>, a central controller <NUM>, a therapy device controller <NUM> and/or any of the controllers previously described, a pressure device <NUM>, one or more protection circuits <NUM>, memory <NUM>, transducers <NUM>, data communication interface <NUM> and one or more output devices <NUM>. Electrical components <NUM> may be mounted on a single Printed Circuit Board Assembly (PCBA) <NUM>. In an alternative form, the RPT device <NUM> may include more than one PCBA <NUM>.

The central controller <NUM> of the RPT device <NUM>, which may include one or more processors, can be programmed to execute one or more algorithm modules, preferably including a pre-processing module, a therapy engine module, a pressure control module, and further preferably a fault condition module. It may further include a vent control module that may be configured with one or more of the vent control methodologies described throughout this specification.

A RPT device in accordance with one form of the present technology may include an air filter <NUM>, or a plurality of air filters <NUM>.

In one form, an inlet air filter <NUM> is located at the beginning of the pneumatic path upstream of a blower <NUM>.

In one form, an outlet air filter <NUM>, for example an antibacterial filter, is located between an outlet of the pneumatic block <NUM> and a patient interface <NUM>.

In one form of the present technology, an inlet muffler <NUM> is located in the pneumatic path upstream of a blower <NUM>.

In one form of the present technology, an outlet muffler <NUM> is located in the pneumatic path between the blower <NUM> and a patient interface <NUM>.

In a preferred form of the present technology, a pressure device <NUM> for producing a flow of air at positive pressure is a controllable blower <NUM>. For example the blower may include a brushless DC motor <NUM> with one or more impellers housed in a volute. The blower may be preferably capable of delivering a supply of air, for example about <NUM> litres/minute, at a positive pressure in a range from about <NUM> cmH<NUM>O to about <NUM> cmH<NUM>O, or in other forms up to about <NUM> cmH<NUM>O.

The pressure device <NUM> is under the control of the therapy device controller <NUM>.

In one form of the present technology, one or more transducers <NUM> are located upstream of the pressure device <NUM>. The one or more transducers <NUM> are constructed and arranged to measure properties of the air at that point in the pneumatic path.

In one form of the present technology, one or more transducers <NUM> are located downstream of the pressure device <NUM>, and upstream of the air circuit <NUM>. The one or more transducers <NUM> are constructed and arranged to measure properties of the air at that point in the pneumatic path.

In one form of the present technology, one or more transducers <NUM> are located proximate to the patient interface <NUM>.

In one form of the present technology, an anti-spill back valve is located between the humidifier <NUM> and the pneumatic block <NUM>. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier <NUM>, for example to the motor <NUM>.

An air circuit <NUM> in accordance with an aspect of the present technology is constructed and arranged to allow a flow of air or breathable gasses between the pneumatic block <NUM> and the patient interface <NUM>.

In one form of the present technology, supplemental oxygen <NUM> is delivered to a point in the pneumatic path.

In one form of the present technology, supplemental oxygen <NUM> is delivered upstream of the pneumatic block <NUM>.

In one form of the present technology, supplemental oxygen <NUM> is delivered to the air circuit <NUM>.

In one form of the present technology, supplemental oxygen <NUM> is delivered to the patient interface <NUM>.

In one form of the present technology power supply <NUM> is internal of the external housing <NUM> of the RPT device <NUM>. In another form of the present technology, power supply <NUM> is external of the external housing <NUM> of the RPT device <NUM>.

In one form of the present technology power supply <NUM> provides electrical power to the RPT device <NUM> only. In another form of the present technology, power supply <NUM> provides electrical power to both RPT device <NUM> and humidifier <NUM>. The power supply may also optionally provide power to any actuator, controller and/or sensors for a vent arrangement as described throughout this specification.

In one form of the present technology, a RPT device <NUM> includes one or more input devices <NUM> in the form of buttons, switches or dials to allow a person to interact with the device. These may be implemented for entering settings for operation of the components of the RPT device such as the vent arrangement. The buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing <NUM>, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller <NUM>.

In one form the input device <NUM> may be constructed and arranged to allow a person to select a value and/or a menu option.

In one form of the present technology, the central controller <NUM> is a dedicated electronic circuit configured to receive input signal(s) from the input device <NUM>, and to provide output signal(s) to the output device <NUM> and / or the therapy device controller <NUM>.

In one form, the central controller <NUM> is an application-specific integrated circuit. In another form, the central controller <NUM> comprises discrete electronic components.

In another form of the present technology, the central controller <NUM> is a processor suitable to control a RPT device <NUM> such as an x86 INTEL processor.

A processor of a central controller <NUM> suitable to control a RPT device <NUM> in accordance with another form of the present technology includes a processor based on ARM Cortex-M processor from ARM Holdings. For example, an STM32 series microcontroller from ST MICROELECTRONICS may be used.

Another processor suitable to control a RPT device <NUM> in accordance with a further alternative form of the present technology includes a member selected from the family ARM9-based <NUM>-bit RISC CPUs. For example, an STR9 series microcontroller from ST MICROELECTRONICS may be used.

In certain alternative forms of the present technology, a <NUM>-bit RISC CPU may be used as the processor for the RPT device <NUM>. For example a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS, may be used.

The processor is configured to receive input signal(s) from one or more transducers <NUM>, and one or more input devices <NUM>.

The processor is configured to provide output signal(s) to one or more of an output device <NUM>, a therapy device controller <NUM>, a data communication interface <NUM> and humidifier controller <NUM>.

In some forms of the present technology, the processor of the central controller <NUM>, or multiple such processors, is configured to implement the one or more methodologies described herein such as the one or more algorithms <NUM> expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory <NUM>. In some cases, as previously discussed, such processor(s) may be integrated with a RPT device <NUM>. However, in some forms of the present technology the processor(s) may be implemented discretely from the flow generation components of the RPT device <NUM>, such as for purpose of performing any of the methodologies described herein without directly controlling delivery of a respiratory treatment. For example, such a processor may perform any of the methodologies described herein for purposes of determining control settings for a ventilator or other respiratory related events by analysis of stored data such as from any of the sensors described herein. Similarly, such a processor may perform any of the methodologies described herein for purposes controlling operation of any vent arrangement described in this specification.

Preferably RPT device <NUM> includes a clock <NUM> that is connected to processor.

In one form of the present technology, therapy device controller <NUM> is a pressure control module <NUM> that forms part of the algorithms <NUM> executed by the processor of the central controller <NUM>.

In one form of the present technology, therapy device controller <NUM> is a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used.

Preferably a RPT device <NUM> in accordance with the present technology comprises one or more protection circuits <NUM>.

One form of protection circuit <NUM> in accordance with the present technology is an electrical protection circuit.

One form of protection circuit <NUM> in accordance with the present technology is a temperature or pressure safety circuit.

In accordance with one form of the present technology the RPT device <NUM> includes memory <NUM>, preferably non-volatile memory. In some forms, memory <NUM> may include battery powered static RAM. In some forms, memory <NUM> may include volatile RAM.

Preferably memory <NUM> is located on PCBA <NUM>. Memory <NUM> may be in the form of EEPROM, or NAND flash.

Additionally or alternatively, RPT device <NUM> includes removable form of memory <NUM>, for example a memory card made in accordance with the Secure Digital (SD) standard.

In one form of the present technology, the memory <NUM> acts as a non-transitory computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms <NUM>.

Transducers may be internal of the device, or external of the RPT device. External transducers may be located for example on or form part of the air delivery circuit, e.g. the patient interface. External transducers may be in the form of non-contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

A flow transducer <NUM> in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION. The differential pressure transducer is in fluid communication with the pneumatic circuit, with one of each of the pressure transducers connected to respective first and second points in a flow restricting element.

In use, a signal representing total flow Qt from the flow transducer <NUM> is received by the processor.

A pressure transducer <NUM> in accordance with the present technology is located in fluid communication with the pneumatic circuit. An example of a suitable pressure transducer is a sensor from the HONEYWELL ASDX series. An alternative suitable pressure transducer is a sensor from the NPA Series from GENERAL ELECTRIC.

In use, a signal from the pressure transducer <NUM>, is received by the central controller processor. In one form, the signal from the pressure transducer <NUM> is filtered prior to being received by the central controller <NUM>.

In one form of the present technology a motor speed signal <NUM> is generated. A motor speed signal <NUM> is preferably provided by therapy device controller <NUM>. Motor speed may, for example, be generated by a speed sensor, such as a Hall effect sensor.

In one preferred form of the present technology, a data communication interface <NUM> is provided, and is connected to central controller processor. Data communication interface <NUM> is preferably connectable to remote external communication network <NUM>. Data communication interface <NUM> is preferably connectable to local external communication network <NUM>. Preferably remote external communication network <NUM> is connectable to remote external device <NUM>. Preferably local external communication network <NUM> is connectable to local external device <NUM>.

In one form, data communication interface <NUM> is part of processor of central controller <NUM>. In another form, data communication interface <NUM> is an integrated circuit that is separate from the central controller processor.

In one form, remote external communication network <NUM> is the Internet. The data communication interface <NUM> may use wired communication (e.g. via Ethernet, or optical fibre) or a wireless protocol to connect to the Internet.

In one form, local external communication network <NUM> utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol.

In one form, remote external device <NUM> is one or more computers, for example a cluster of networked computers. In one form, remote external device <NUM> may be virtual computers, rather than physical computers. In either case, such remote external device <NUM> may be accessible to an appropriately authorised person such as a clinician.

Preferably local external device <NUM> is a personal computer, mobile phone, tablet or remote control.

An output device <NUM> in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.

A display driver <NUM> receives as an input the characters, symbols, or images intended for display on the display <NUM>, and converts them to commands that cause the display <NUM> to display those characters, symbols, or images.

A display <NUM> is configured to visually display characters, symbols, or images in response to commands received from the display driver <NUM>. For example, the display <NUM> may be an eight-segment display, in which case the display driver <NUM> converts each character or symbol, such as the figure "<NUM>", to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.

<FIG> depicts an example system <NUM> in which aspects of the disclosure may be implemented. This example should not be considered as limiting the scope of the disclosure or usefulness of the features described herein. In this example, system <NUM> includes server <NUM>, patient devices <NUM>, <NUM>, and <NUM>, storage systems <NUM>, as well as computing device <NUM>. These devices may each communicate over network <NUM>. System <NUM> may be scaled to any size network. For example, while only three patient devices <NUM>, <NUM>, and <NUM> are shown, system <NUM> may include any number of patient devices.

Each patient device <NUM>, <NUM>, and <NUM> may include one or more devices, including RPT <NUM>, humidifier <NUM>, and patient interface <NUM>. In addition, each patient device <NUM>, <NUM>, and <NUM> may be operated at remote locations and by different patients. While only controller <NUM> and memory <NUM> are shown in patient device <NUM>, each patient device may include any of the components discussed above in connection with RPT <NUM>, humidifier <NUM>, and patient interface <NUM>. In addition, while patient devices <NUM>, <NUM>, and <NUM> are shown as communicating directly with the server <NUM> or the computing device <NUM> over <NUM>, each patient device may also communicate over network <NUM> via an external computing device (not shown). For example, patient device <NUM> may communicate with a personal computer that transmits data over network <NUM>.

Servers <NUM> may contain one or more processors <NUM>, memory <NUM> and may be incorporated with other components typically present in general purpose computing devices. Memory <NUM> of server <NUM> may store information accessible by processor <NUM>, including instructions <NUM> that can be executed by the processor <NUM>. Memory <NUM> may also include data <NUM> that can be retrieved, manipulated or stored by processor <NUM>. The memory can be of any non-transitory type capable of storing information accessible by the processor. The instructions <NUM> may include instructions that are directly or indirectly executed by processor <NUM>. In that regard, the terms "instructions," "application," "steps" and "programs" can be used interchangeably herein.

Data <NUM> may be retrieved, stored or modified by processor <NUM> in accordance with the instructions <NUM>. For instance, although the subject matter described herein is not limited by any particular data structure, the data can be stored in computer registers, in a relational database as a table having many different fields and records, or XML documents. Data <NUM> may also be any information sufficient to identify or calculate relevant information, such as numbers, descriptive text, proprietary codes, pointers, references to data stored in other memories such as at other network locations. The one or more processors <NUM> may include conventional processors, such as a CPU, or may be a hardware-based component, such as an ASIC.

Although <FIG> functionally illustrates the processor, memory, and other elements of server <NUM>, computing device <NUM> and patient devices <NUM>, <NUM>, and <NUM> as each being within one block, the various components of each device may be stored within the different physical housings. For example, memory <NUM> may be a hard drive or other storage media located in a housing different from that of server <NUM>. Similarly, processor <NUM> may include a plurality of processors, some or all of which are located in a housing different from that of server <NUM>. Accordingly, references to a processor, computer, computing device, or memory will be understood to include references to a collection of processors, computers, computing devices, or memories that may or may not operate in parallel. Although some functions are described herein as taking place on a single computing device having a single processor, various aspects of the disclosure may be implemented by a plurality of computing devices communicating information with one another, such as by communicating over network <NUM>.

In many instances, it is preferable for patient devices <NUM>, <NUM>, and <NUM> to communicate with network <NUM> using wireless communication. However, network <NUM> and intervening nodes described herein can be interconnected using various protocols and systems, such that the network can be part of the Internet, World Wide Web, specific intranets, wide area networks, local networks, or cell phone networks. The network can utilize standard communications protocols, such as Ethernet, Wi-Fi and HTTP, protocols that are proprietary to one or more companies, and various combinations of the foregoing. Although certain advantages are obtained when information is transmitted or received as noted above, other aspects of the subject matter described herein are not limited to any particular manner of transmission of information.

Servers <NUM> may include one or more communication servers that are capable of communicating with storage system <NUM>, computing device <NUM>, and patient devices <NUM>, <NUM>, and <NUM> via network <NUM>. As will be described in greater detail below, servers <NUM> may transmit updates <NUM> of software and firmware over network <NUM> to patient devices <NUM>, <NUM>, and <NUM>. In turn, patient devices <NUM>, <NUM>, and <NUM> may transmit data to server <NUM> in accordance with software and firmware in the form of the instruction sets <NUM>.

The computing device <NUM> may be configured similarly to the server <NUM>, with one or more processors <NUM>, memory <NUM> and instructions as described above. Each such computing device may be a personal computing device intended for use by a clinician and have all of the components normally used in connection with a personal computing device such as a central processing unit (CPU), memory (e.g., RAM and internal hard drives) storing data and instructions, a display such as a display <NUM> (e.g., a monitor having a screen, a touch-screen, a projector, a television, or other device that is operable to display information), and user input device <NUM> (e.g., a mouse, keyboard, touch-screen or microphone).

As discussed above, each patient device <NUM>, <NUM>, and <NUM> shown in <FIG> may include one or more medical devices, including RPT <NUM>, humidifier <NUM>, and patient interface <NUM>. In performing the operations described above, patient devices <NUM>, <NUM>, and <NUM> may implement instruction sets <NUM>, which may include software or firmware. As discussed above in connection with <FIG>, RPT <NUM> may include multiple controllers, such as humidifier controller <NUM> and therapy device controller <NUM>. Each of these controllers may operate in connection with a specific instruction set <NUM>. Accordingly, each instruction set may relate to a specific component of the patient device, including the components discussed above. For example, returning to <FIG>, patient device <NUM> is shown as including a number of modules, including communications module <NUM>, humidifier module <NUM>, and alarm module <NUM>. Each of these modules may access and implement a distinct instruction set <NUM>. In another example, a particular instruction set <NUM> may be implemented by more than one module, including any of the modules discussed above.

As patient devices <NUM>, <NUM>, <NUM> are used by their respective patients, updates to instruction sets <NUM> may become available and necessary. Such updates may be associated with improving specific functions or fixing identified problems with operational aspects of one or more modules of the device. Thus, in some instances an update may be essential for the efficient administration of the patient treatment and even for the safety of the patient. In accordance with one aspect of the disclosure, one or more instruction sets <NUM> may be automatically updated over communication network <NUM>. In particular, servers <NUM> may transmit one or more instruction set updates <NUM> to one or more of the patient devices <NUM>, <NUM>, and <NUM>. Upon receiving an instruction set update <NUM>, each patient device <NUM>, <NUM>, and <NUM> may alter instruction sets <NUM> in a manner indicated by the transmitted instruction set update <NUM>. In this way, patient device may be easily upgraded and otherwise customized remotely, without requiring a patient to bring the patient device to a clinician or to a service center.

In one aspect, specific patient devices may be selected as being able to receive, or otherwise suitable to receive, a particular update. For example, server <NUM> may determine that patient device <NUM> should receive a particular instruction set update <NUM>, while patient devices <NUM> and <NUM> should not. In order to identify the specific patient device that will receive a particular update, server <NUM> may maintain configuration data <NUM> for each patient device <NUM>, <NUM>, and <NUM>. Configuration data <NUM> may include any information that may be used to identify a particular patient device, including a serial number, identification of the software and firmware versions that are currently being implemented by the patient device, and hardware version numbers. Configuration data <NUM> may also include a record of the instruction set updates that have previously been transmitted to a patient device and an indication of whether each transmitted instruction set update was successfully or unsuccessfully applied to patient device. In addition, configuration data <NUM> is not limited to information that is distinct with respect to one particular patient device but may include information that is applicable to a number of patient devices. For example, configuration data <NUM> may include identification of the patient device's supplier or retailer, as well as the location or region in which the patient device is being used. Alternatively, an update may be triggered by other factors, such as a fault condition that can be fixed by a specific update.

Configuration data <NUM> may be provided by the patient devices <NUM>, <NUM>, and <NUM> through a registration process. For example, patient device <NUM> may transmit configuration data <NUM> over network <NUM> to server <NUM>. Server <NUM> may then store the received configuration data <NUM> in memory <NUM> as configuration data <NUM>. Registration of a patient device's configuration data <NUM> may occur upon the patient's initial use of the patient device. In addition, configuration data <NUM> may be updated on server <NUM> upon any change that occurs in the configuration data <NUM>. For example, patient device <NUM> may transmit a notification to server <NUM> that it has successfully updated the firmware for its humidifier module <NUM> from a first version to a second version. Server <NUM> may then update configuration data <NUM> so as to indicate that patient device <NUM> is currently implementing the second version of the humidifier module firmware. In one example, patient device <NUM> may check its current configuration data <NUM> each time it is started and report any changes in configuration data <NUM> to server <NUM>.

In accordance with one aspect, a user of computing device <NUM> may select particular patient devices to update by communicating with server <NUM>. For example, a user of computing device <NUM> may access a website that provides an interface with server <NUM> by which computing device <NUM> may designate a particular update <NUM> for particular patient devices <NUM>, <NUM> and <NUM>. In order to identify the patient devices for which an update should be performed, computing device <NUM> may search memory <NUM> of server <NUM> for patient devices that meet certain criteria. For example, a user of computing device <NUM> may request that server <NUM> identify all patient devices that are implementing a specific software version or have a serial number within a particular range. In another example, computing device <NUM> may request a list of all patient devices that have been purchased from a particular retailer.

The user of the computing device <NUM> may identify, via server <NUM>, the patient devices that are to be updated. If there are more than one possible updates, the user may also have to identify or select the specific update <NUM> to be provided to the patient devices. In identifying a particular update, the user may identify which components of the patient devices are to be updated, as well as the particular version of the software or firmware that is to be implemented by the component. For example, the user of computing device <NUM> may request that server <NUM> provide patient devices <NUM> and <NUM> with an update <NUM> for humidifier module <NUM> and that the update be for version <NUM> of humidifier firmware. Server <NUM> may then transmit the selected update <NUM> to patient devices <NUM> and <NUM>. Version <NUM> of the firmware may include new or different settings than the settings being currently implemented by patient devices <NUM> and <NUM>. These new settings may be implemented once patient devices <NUM> and <NUM> have installed version <NUM> of the firmware. While the process of selecting an update <NUM> and transmitting the selected update <NUM> may be performed by a single server <NUM>, it may alternatively be performed by more than one server <NUM>. For example, computing device <NUM> may make an update request with a communications server. The communications server may then transmit the request to a download server that, in turn, transmits the selected update to the designated patient devices.

The instruction update data may also include any one of the following; data specifying where to get the instruction update from, e.g. host server, port, filename; the schedule time for performing the update for each device so that large volumes of device updates can be effectively managed; whether or not to request the patient to confirm that the update should be applied; instructions for the update not be applied until patient treatment is stopped, if applicable; data structure and functionality enabling cancelling upgrades that have not yet occurred, if necessary; a batch capability to request bulk upgrades in a single operation as well as the ability to check the status of these upgrades afterwards in a single operation indicating which upgrades in the list succeeded, which failed, which have not started etc..

In providing updates <NUM> to patient devices <NUM>, <NUM> and <NUM>, server <NUM> may also transmit verification data that can be used to verify that the update has been downloaded successfully. Each update <NUM> may include verification data. The verification data may take the form of a checksum, a cyclic redundancy check, or identification of the size of the update file. For example, server <NUM> may transmit to patient device <NUM> an update <NUM> that includes a checksum. Patient device <NUM> may compare the checksum against the received update <NUM> to determine if the entire update has been received. If the downloaded update matches the checksum, patient device may install the update and transmit an indication to server <NUM> that installation was successful. However, if the downloaded update does not match the checksum, patient device may not install the update and may transmit an indication to server <NUM> that installation did not occur.

A transmission from server <NUM> to patient device <NUM> may include an update for more than one component. For example, a particular update <NUM> may be transmitted from server <NUM> to patient device <NUM> that modifies multiple instruction sets <NUM> for multiple components, such as instruction sets <NUM> for communications module <NUM> and humidifier module <NUM>. In another example, a particular instruction set <NUM> may be implemented by multiple components, so that a modification of that instruction set <NUM> causes a modification of those multiple components. Multiple updates may also be transmitted and applied to a single patient device <NUM>. If multiple updates <NUM> are included in a transmission, server <NUM> may identify the order in which the updates are to occur. The patient device in receipt of the transmission may then implement the updates <NUM> in accordance with the order designated by server <NUM>. A single component of the patient device may need to be updated more than once, in order for the final version of the instruction set to be implemented. For example, patient device <NUM> may need to download and install version <NUM> of an instruction set before version <NUM> may be installed. Accordingly, configuration data <NUM> may include identification of patient devices <NUM>, <NUM> and <NUM> that are currently capable of installing a particular update <NUM>, as well as identification of other updates that must be installed in order for the particular update <NUM> to be installed. In another example, a transmitted update <NUM> may include an identification of the version or versions of instruction sets <NUM> that are needed in order for update <NUM> to be installed. Prior to installing update <NUM>, patient device <NUM> may compare the required versions identified in update <NUM> with the version that it is currently implementing. Patient device <NUM> may avoid installing update <NUM> if patient device <NUM> is not currently implementing one of the required versions.

Patient device <NUM> may determine whether it satisfies a specified build standard identified by update <NUM>, and perform or avoid installation of update <NUM> based on the determination. For example, the identified build standard may include the combination of components that are needed for the update to be installed. Patient device <NUM> may determine whether it meets the identified build standard, such as by determining if it is using the identified combination of components. If the identified components are being used by patient device <NUM>, those components may be updated in accordance with update <NUM>. However, patient device <NUM> may avoid installing update <NUM> if patient device <NUM> does not contain one or more of the identified components. In one example, patient device <NUM> may avoid installing only the portions of update <NUM> that relate to the components that patient device <NUM> does not contain or use, but proceed with installing other portions of update <NUM>.

In accordance with one aspect, the patient devices may be updated in accordance with a schedule. For example, a user of computing device <NUM> may provide server <NUM> with a schedule of updates, such as by identifying the dates on which particular patient devices are to receive particular updates <NUM>. Server <NUM> may then transmit updates <NUM> in accordance with the schedule. In one example, the schedule may be incorporated into the configuration data <NUM> for each patient device. In this way, an update that applies to a large number of patient devices may be applied over an extended period of time, such as over a period of weeks or months, in order to decrease the load that network <NUM> must transmit at any given time. When a patient device is scheduled to receive an update <NUM>, server <NUM> may transmit an update request. The update request may take the form of an SMS message or some other shoulder tap transmission. Upon receiving the update request from server <NUM>, patient device <NUM> may respond with an indication that it is prepared to receive the update. The update may then be transmitted to and installed by patient device <NUM>. Server <NUM> may also cancel updates <NUM> that are scheduled to occur. For example, a user of computing device <NUM> may send a request that a particular update <NUM> be cancelled for one or more patient devices <NUM>, <NUM>, and <NUM>. In response to the request of computing device <NUM>, server <NUM> may remove the particular update <NUM> from a list of scheduled updates. If the update has already been transmitted to one or more of the patient devices, but not yet installed, server <NUM> may transmit au update cancellation to the one or more patient devices. Upon receiving the update cancellation, patient devices <NUM>, <NUM>, and <NUM> may delete the received update <NUM> from memory before it is installed.

Alternatively, the transmission may occur on a specific suitable day, but the respective device may be instructed to implement the update on a specific later date. After receiving an update from server <NUM>, patient device <NUM> may wait before installing the update for various reasons. For example, if a patient is receiving treatment from patient device <NUM> when the update is received, patient device <NUM> may wait until the patient's treatment has ended before installing the update. This may prevent a patient's therapy from being interrupted or otherwise negatively affected by the installation of the update. In one aspect, the update may indicate whether it may be installed while the patient device is being used. In particular, the update may indicate specific operations that may be performed by the patient device while the update is being performed. For example, update <NUM> may relate solely to communications module <NUM>, which does not relate to operations that are performed while the patient device provides respiratory therapy. Accordingly, update <NUM> may indicate that it may be installed while patient device <NUM> is being used to provide respiratory therapy. During installation, patient device <NUM> may display a notice indicating that patient device <NUM> is being updated. The notice may include displaying a message stating that the patient should not turn off the patient device and that the patient should wait until the update has been completed before using the patient device in particular manners. In one example, patient device <NUM> may require confirmation from the patient before an update is installed. Also, new software may be downloaded by many devices over a period of time, however the downloaded update can be installed on all devices at the same day for marketing or communication purposes.

In accordance with one aspect, a user of computing device <NUM> may query server <NUM> for the status of updates <NUM>. For example, computing device <NUM> may request identification of those patient devices that have not received or have not yet installed a particular update <NUM>. In addition, computing device <NUM> may request a list of all patient devices for which one or more updates <NUM> have been installed, as well as information regarding any errors that have occurred in connection with the transmission and installation of updates <NUM>. In addition, server <NUM> may provide computing device <NUM> with a list of current instruction sets, such as versions of software and firmware, that particular patient devices are currently implementing. For example, computing device <NUM> may query server <NUM> for a list of instruction sets <NUM> being implemented by patient device <NUM>. Sever <NUM> may access configuration data <NUM> in order to identify the queried information and transmit the information to computing device <NUM>. Computing device <NUM> may make the query and receive the queried information from server <NUM> by accessing a website or some other server interface. Server <NUM> may require that computing device <NUM> provide identification information or a password in connection with the query, so as to maintain the confidentiality of patient information.

<FIG> shows a flow diagram <NUM> that may be performed by a patient device, such as patient device <NUM> of system <NUM>. As described above, a patient device may store and implement sets of instructions. In block <NUM>, the patient device may implement a set of instructions, such as software or firmware that is currently accessible to the patient device. The set of instructions may relate to the operation of a plurality of components within the patient device and need not be stored at a single location. In implementing the set of instructions, the patient device may transmit data over a network to one or more external devices (Block <NUM>). For example, patient device <NUM> may transmit, over network <NUM>, data relating to a patient's use of patient device <NUM> in accordance with one or more sets of instructions. This transmission may include information about the dates and times for which the patient has used the patient device. The patient device may also receive transmissions from external devices, such as server <NUM>, and may determine whether the received transmission is related to an update to one or more instruction sets. (Block <NUM>). For example, the patient device may receive a transmission indicating that update data may be accessed at a particular location, such as at a particular address of a server. If no update has been received, the patient device may continue to implement the current instruction set (Block <NUM>). If an indication of an update is received, the patient device may receive the update data, such as by requesting or accessing update files at an identified address.

The patient device may determine if there is an error in relation to the update data (Block <NUM>). For example, as described above, patient device may compare the update with a checksum to determine that the entire update has been received. In addition, patient device may determine whether the version of the instruction set that it is currently implemented matches one of the versions that are needed in order for the update to be installed. If it is determined that an error exists in relation to the update, the patient device may transmit an error notification (Block <NUM>). For example, patient device <NUM> may transmit a notification to server <NUM> indicating that the update did not match the checksum that was provided. The notification may also include a request for the update to be retransmitted.

If no error is detected in relation to the update, the patient device may install the update (Block <NUM>). As described above, the update may include modifying one or more sets of instructions. The modification may include deleting a portion of an instruction set and adding to the instruction set, as well as replacing an original instruction set with an entirely new instruction set. As set forth above, an update may include modifications to various instruction sets, including instruction sets for different components of the patient device. Upon installing the update, the patient device may perform a check to determine if the installation was successful, including performing a check of each updated component (Block <NUM>). If the installation was not successful, the patient device may transmit an error notification (Block <NUM>). In addition the patient device may revert back to and implement the original instruction set in accordance with Block <NUM>. If installation is determined to be successful, the patient device may transmit a notification to an external device, such as server <NUM>, indicating that the update has been installed (Block <NUM>). The patient device may also access and implement the current instruction sets, including the updated instruction sets, in accordance with Block <NUM>.

<FIG> shows flow diagram <NUM> that may be performed by computing devices of the disclosed system, including server <NUM> of system <NUM>. In Block <NUM>, a server may receive a query for identification of patient devices that meet one or more criteria. For example, as described above, server <NUM> may receive a query from computing device <NUM>. This query may seek identification of all patient devices that meet one or more criteria provided by a user of computing device <NUM>. The criteria may be based on any number of aspects or features of the patient device, such the region in which the patient device is located, the patient device's serial numbers, as well as software and firmware versions that are currently being implemented by the patient device. The server may access configuration data in response to the received query (Block <NUM>), and may respond to the query by transmitting data that identifies the patient devices for which the identified criteria are met (Block <NUM>).

The server may then receive a request for one or more updates to be transmitted to one or more patient devices (Block <NUM>). For example, as described above, computing device <NUM> may receive a list from server <NUM> of patient devices <NUM>, <NUM> and <NUM> that meet criteria provided by the user of computing device <NUM>. The user may then select specific updates <NUM> to be transmitted to patient devices <NUM>, <NUM>, and <NUM>. Upon receiving the request of Block <NUM>, the server may access update data (Block <NUM>) and transmit the update data to the patient devices identified in the received request (Block <NUM>). The functions in items <NUM>-<NUM> may be implemented in a different order. For example, the server may receive the request for identifying devices with specific configurations at the same time (or even before) it receives the update request and send the updates only to the devices that fulfil the specified criteria. In addition, Block <NUM> need not be performed in order for the update data to be transmitted to the patient device in accordance with Block <NUM>. For example, server <NUM> may transmit update data as an address that indicates the location of where the update files are stored. The location identified by the address may be on server <NUM> or elsewhere. In this way, the address for update files may be provided to the patient device without requiring server <NUM> to access the actual update file data that is stored at the identified location.

The server may also determine if the transmission and/or installation of the update was successful (Block <NUM>). For example, the server may receive from each patient device either an error notification or a message that the update was successfully installed. If an error occurred in the transmission of the update, the server may transmit the update data again for each patient device for which the error occurred (Block <NUM>). Alternatively, the actual update file (new software) can be requested by the treatment device itself from the file server, rather than being pushed by server <NUM> down to the device. The update of a patient device may not occur immediately, in that the update may be contingent on the occurence of one or more conditions. For example, the update data may indicate that the patient device is to install the update after the device has provided treatment for a period of <NUM> hours. Accordingly, a substantial amount of time may lapse between Block <NUM> and Block <NUM>. However, if the transmission and installation are successful, the server may revise the stored configuration data to indicate that the one or more patient devices are currently implementing instruction sets that correspond to the transmitted updates (Block <NUM>) and report that the update was successful (Block <NUM>). For example, if the one or more of the patient devices have been successfully updated, server <NUM> may transmit a message to computing device <NUM> to notify a user, such as technical personnel, that the update is complete. This message may identify the specific patient devices, or group of patient devices, that have successfully installed the update.

While the operations set forth in <FIG> and <FIG> may each be performed by a single device, the operations may alternatively be performed by more than one device. For example, a patient device may communicate with a personal computer over a wireless network, so that the personal computer may perform one or more of the operations described above. The server referenced in connection with <FIG> and <FIG> may also include a plurality of servers. Regarding the specific operations shown in <FIG> and <FIG>, various operations may be added or removed from flow diagrams <NUM> and <NUM>. In addition, various operations need not be performed in the same order as set forth in flow diagrams <NUM> and <NUM>. For example, the server may transmit update information to the treatment devices indicating what update is required, where to obtain it (host, port, filename) and how to verify it (e.g. checksum/CRC). The treatment device comms module may then requests the update file (instructions) from the specified host (server). This slightly different functional diagram allows distributing the load of downloading large volumes of software over many servers if necessary i.e. not just from Server <NUM>, as shown in the <FIG>. In addition, the treatment device can re-request the update file (i.e. the new software) from the specified server itself if there is a transmission error without interaction with server <NUM>. It is also possible that the server, upon being notified of an error, could re-try the operation as described above.

In certain forms of the present technology, one or more of the following definitions may apply.

Air: Air will be taken to include breathable gases, for example air with supplemental oxygen.

Continuous Positive Airway Pressure (CPAP): CPAP treatment will be taken to mean the application of a supply of air or breathable gas to the entrance to the airways at a pressure that is continuously positive with respect to atmosphere, and preferably approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will vary by a few centimeters of water within a single respiratory cycle, for example being higher during inhalation and lower during exhalation. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

Silicone or Silicone Elastomer: A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, a preferred form of LSR has a Shore A (or Type A) indentation hardness in the range of about <NUM> to about <NUM> as measured using ASTM D2240.

Polycarbonate: a typically transparent thermoplastic polymer of Bisphenol-A Carbonate.

Anti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO<NUM> rebreathing by a patient.

Elbow: A conduit that directs an axis of flow of air to change direction through an angle. In one form, the angle may be approximately <NUM> degrees. In another form, the angle may be less than <NUM> degrees. The conduit may have an approximately circular cross-section. In another form the conduit may have an oval or rectangular cross-section.

Frame: Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear. A mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.

Headgear: Headgear will be taken to mean a form of positioning and stabilizing structure designed for use on a head. Preferably the headgear comprises a collection of one or more struts, ties and stiffeners configured to locate and retain a patient interface in position on a patient's face for delivery of respiratory therapy. Some ties are formed of a soft, flexible, elastic material such as a laminated composite of foam and fabric.

Membrane: Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.

Plenum chamber: a patient interface plenum chamber will be taken to mean a portion of a patient interface having walls enclosing a volume of space, such as for a full-face mask (e.g., nose and mouth mask), a nasal mask or a nasal pillow, the volume having air therein pressurised above atmospheric pressure in use by the patient. A shell may form part of the walls of a patient interface plenum chamber. In one form, a region of the patient's face abuts one of the walls of the plenum chamber, such as via a cushion or seal.

Seal: The noun form ("a seal") will be taken to mean a structure or barrier that intentionally resists the flow of air through the interface of two surfaces. The verb form ("to seal") will be taken to mean to resist a flow of air.

Shell: A shell will preferably be taken to mean a curved structure having bending, tensile and compressive stiffness, for example, a portion of a mask that forms a curved structural wall of the mask. Preferably, compared to its overall dimensions it is relatively thin. In some forms, a shell may be faceted. Preferably such walls are airtight, although in some forms they may not be airtight.

Stiffener: A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

Strut: A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.

Swivel: (noun) A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least <NUM> degrees. In another form, the swivel may be constructed to rotate through an angle less than <NUM> degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. Preferably there is little or no leak flow of air from the swivel in use.

Tie: A tie will be taken to be a structural component designed to resist tension.

Vent: (noun) the structure that allows a deliberate controlled rate leak of air from an interior of the mask, or conduit to ambient air, to allow washout of exhaled carbon dioxide (CO<NUM>) and supply of oxygen (O<NUM>).

When a particular material is identified as being preferably used to construct a component, obvious alternative materials with similar properties may be used as a substitute.

All publications mentioned herein are used to disclose and describe the methods and/or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest reasonable manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

Although the technology herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and/or aspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the scope of the appended claims.

Claim 1:
A system for updating a patient device in providing medical treatment, the system comprising one or more computing devices including one or more servers (<NUM>), the one or more computing devices being configured to:
maintain configuration data in the one or more servers (<NUM>) for each of a plurality of patient devices (<NUM>), wherein the plurality of patient devices (<NUM>) each implement a set of instructions;
receive, by the one or more servers (<NUM>), a query for identification of one or more patient devices of the plurality of patient devices (<NUM>) that have configuration data that meet one or more criteria;
access configuration data in response to the received query;
identify one or more patient devices, from the plurality of patient devices (<NUM>), having configuration data that meets the one or more criteria;
transmit an instruction set update data to the identified one or more patient devices; and
update the configuration data for each of the one or more patient devices that has installed an instruction set update of the instruction set update data,
wherein the transmitted instruction set update data includes instructions for the instruction set update not to be applied until patient treatment is stopped.