Respiratory assistance device

Abstract

To provide an improved respiration assisting device.SOLUTION: There is provided a head-mounted respiration assisting device configured so as to supply a user with a respiratory gas flow. The head-mounted respiration assisting device includes a body that can be fixed to the head of the user and a blower unit for generating a pressurized gas flow from the gas supplied from ambient air. The body is provided with a patient interface having a gas inlet that is fluid-connected to the blower unit, which is configured so as to deliver the pressured gas to the nose and / or the mouth of the user.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] The present invention relates to a respiratory assistance device for providing a flow of gas to a user for therapeutic purposes, specifically but not exclusively capable of providing respiratory assistance to a patient or user in need of a supply of gas for respiratory therapy, such as positive airway pressure (PAP) therapy, typically used to treat conditions such as obstructive sleep apnea (OSA), snoring or chronic obstructive pulmonary disease (COPD), including but not limited to continuous positive airway pressure (CPAP) therapy, bilevel positive airway pressure (B1-PAP) therapy and oral positive airway pressure (OPAP) therapy. [Background technology]

[0002] Respiratory or inhalation assistance devices or systems that provide a humidified and heated gas flow to a patient for therapeutic purposes are well known in the art. Typically, a system for providing this type of therapy (e.g., respiratory humidification) is structured to deliver gas from a gas source, such as a blower (also known as a compressor, assisted breathing unit, fan unit, flow generator or pressure generator), to a humidification chamber. The gas becomes saturated with water vapor as it passes over hot water or through heated and humidified air that is in the humidification chamber. The heated and humidified gas is then delivered to a user or patient downstream of the humidification chamber via a patient interface that includes a flexible gas conduit and a patient interface.

[0003] In one form, such a breathing assistance system can be a modular system with separate (modular) elements, a humidification unit and a blower unit. These modules are connected in series via a connecting conduit so that gas can pass from the blower unit to the humidification unit. For example, FIG. 1 shows a schematic diagram of a user 1 receiving a heated and humidified air flow from a modular breathing assistance system. Pressurized air is supplied from the assisted breathing unit or blower unit 2a via a connector conduit 7 to a humidification chamber 4a. From the humidification chamber 4a, the humidified, heated and pressurized air flow is exhausted via a flexible hose or gas conduit 3 and supplied to the patient or user 1 via a patient interface 5.

[0004] Alternatively, the breathing assistance system may be an integrated system in which the blower unit and the humidifier unit are contained within the same housing. A typical integrated system consists of a main blower or auxiliary breathing unit providing a pressurized gas flow and a humidifier unit integrated or otherwise tightly connected to the blower unit. Figure 2 shows a schematic diagram of a user 1 receiving heated and humidified air from an integrated breathing assistance system 6. This system operates similarly to the modular system shown in Figure 1, except that the humidifier chamber 4b is integrated with the blower unit to form the integrated system 6.

[0005] The patient interface 5 shown in Figures 1 and 2 is a nasal mask that covers the nose of the user 1. However, in these types of systems, a mouth and nose mask, a full face mask, a nasal cannula, or any other suitable patient interface could be used instead of the nasal mask shown. A mouth-only interface or an oral mask could also be used. The patient or user end of the conduit could also be connected to a tracheal opening fitting or to an endotracheal intubation.

[0006] Impeller type fans or blowers are most commonly used in this type of respiratory assistance system. The impeller housing contains an impeller vane unit. The impeller vane unit is connected to some form of drive by a central spindle. A typical impeller housing is shown in Figures 3 and 4. A typical rotating impeller unit 10 is shown in Figures 5 and 6, having a number of vanes 11 and a shroud 12 that reside inside the housing in use. Air is drawn into the centre of the impeller unit through an opening, and the air is then forced outwards from the centre of the housing towards an outlet passage (usually located to one side of the housing) by the vanes of the rotating impeller unit. The vanes 11 are coupled to a central spindle 13 that is rotated, for example, by a motor.

[0007] Respiratory assistance systems of the type described above typically present manufacturers with a variety of design issues or challenges, some of which are briefly outlined below.

[0008] In many cases, users will need to use the above-mentioned type of respiratory support system daily for long periods of time for effective respiratory therapy. Treating OSA requires the user to use the respiratory support system while sleeping at night. Patient comfort and convenience while using such a respiratory support system are paramount for compliant and effective treatment. A common complaint of users of the above-mentioned type of respiratory support system is mask leaks. Mask leaks are usually caused by the flexible gas conduit 3 pulling on the patient interface or mask 5 when the user moves during sleep.

[0009] Most of the above-mentioned types of respiratory support systems for treating OSA with PAP therapy deliver gas to the patient interface but do not have a return path for the gas from the interface. The patient interface needs a gas outlet to vent exhaled gas to the atmosphere to eliminate carbon dioxide buildup in the patient interface, which is often called "bias flow". Bias flow means losses in the gas delivery circuit, and the blower unit must have a powerful enough motor to maintain the bias flow while also creating the desired gas pressure at the patient interface. The gas outlet can also be a source of noise and a noticeable draft. Excessive noise can be uncomfortable for the patient and bed companions. Drafts can be irritating to the patient depending on their location.

[0010] Humidification of gases in respiratory assistance systems also adds design complexity, for example it often requires heating of the gas conduit 3 of the patient interface to prevent condensation from forming within the gas conduit.

[0011] References to patents, other external documents or other sources are made herein for the purpose of generally providing a context for describing the features of the present invention, and unless specifically stated otherwise, the reference to such external documents should not be construed as an admission that such documents or such sources are prior art in any jurisdiction or form part of the common general knowledge in the art. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] International Application No. 2012 / 140514 [Patent Document 2] US Patent Application Publication No. 2010 / 0006101 Summary of the Invention [Problem to be solved by the invention]

[0013] It is an object of the present invention to provide an improved respiratory assistance apparatus, or at least to give the public a useful choice. [Means for solving the problem]

[0014] In a first aspect, the invention broadly resides in a head-mounted respiratory aid arranged to supply a flow of respiratory gas to a user, the head-mounted respiratory aid comprising a body securable to a user's head, a blower unit provided on the body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurised gas flow at a gas outlet, and a patient interface provided on the body having a gas inlet fluidly connected to the gas outlet of the blower unit via a gas flow path and arranged to deliver the pressurised gas to the user's nose and / or mouth via one or more gas outlets, the gas flow path from the gas inlet of the blower unit to the gas outlet(s) of the patient interface being substantially sealed such that there is zero bias flow along the gas flow path, the blower unit including a lightweight impeller and a motor having a rotatable drive shaft arranged to rotate the impeller.

[0015] The device may be preferably configured to passively humidify and warm the pressurized breathing gas in the gas flow path via accumulation of accumulated heat and moisture within at least a portion of the gas flow path. In one form, the gas flow path may be configured to accumulate heat and moisture within at least a portion of the air flow path from accumulated heat and moisture from a user's exhaled gases flowing back into the gas flow path from the patient interface.

[0016] Preferably, the apparatus may further comprise one or more heat and moisture exchangers (HME) in the gas flow path of the respiratory aid apparatus.

[0017] Preferably, a gas or air flow path is provided within the respiratory apparatus between a gas inlet of the blower unit and an outlet or opening in the patient interface.

[0018] Preferably, this air flow path allows excess exhaled air from the user to be expelled counter to the pressurized gas flow and out the gas inlet of the ventilation unit of the respiratory assistance device into the atmosphere. The volume or "dead space" of the gas flow path between the gas inlet of the ventilation unit and the gas outlet of the patient interface can be preferably less than about 200 mL, and more preferably between about 50 mL and about 150 mL.

[0019] Preferably, the device can be configured to be operatively connected to an independent base station which includes a power supply system for providing power to the respiratory assistance device, a data transfer system for transmitting data to and from the respiratory assistance device, and a control system for controlling the respiratory assistance device via control signals.

[0020] Preferably, the device may further comprise headgear including one or more head straps configured to secure or attach the body to the user's head. In one form, the headgear may include an upper head strap connected to an upper portion of the respiratory aid apparatus and configured to extend around an upper portion of the user's head, and a lower head strap connected to a lower portion of the respiratory aid apparatus and configured to extend around a lower portion of the user's head, the headgear configured to position the body of the respiratory aid apparatus within the area of ​​the user's face.

[0021] In one form, the headgear can be completely flexible or can be formed substantially from flexible components, or in another form, the headgear can be semi-rigid in that it can include one or more rigid components such as, but not limited to, the various headgear embodiments described in International Patent Application No. WO 2012 / 140514, the contents of which are incorporated herein by reference.

[0022] The respiratory aid apparatus may preferably include one or more internal power modules mounted or integrated into the headgear arranged to power the apparatus. Alternatively, the power modules may be otherwise head-mounted along with the respiratory aid apparatus, such as mounted or integrated into the body or blower unit of the respiratory aid apparatus. The power modules are preferably connected to the respiratory aid apparatus by one or more power cables. In one form, the power module(s) may be detachable or releasable from the respiratory aid apparatus.

[0023] Alternatively or additionally, the power module(s) may be a separate non-head mounted portable module that is connected to the breathing apparatus by a power cable. Alternatively or additionally, the breathing aid apparatus may be configured to be connected to an AC power adapter to provide power.

[0024] In one form, one or more pockets are provided in the head strap(s) for holding one or more power modules. The pocket(s) are preferably openable to allow removal of the power module(s). In another form, the power module(s) may be releasably attached to a portion of the headgear such that the power module(s) may be removed from the headgear. In another form, the power module(s) may be provided in a flexible package secured to the headgear, the flexible package being configured to extend at least partially over the top of the user's head. The flexible package is preferably secureable to one or more of the head straps of the headgear by a base layer of flexible material.

[0025] The headgear may preferably further comprise one or more shields positioned between the one or more power modules and a surface of the user's head when the headgear is worn by a user.

[0026] The power module(s) preferably include one or more energy storage devices selected from a battery or battery pack (rechargeable or disposable), a fuel cell and / or a capacitor.

[0027] A lightweight impeller for the blower unit preferably allows it to be shrouded less or to reduce its material.

[0028] In one embodiment, the distal ends of the impeller blades are curved in the direction of blade rotation, while in another embodiment, the impeller blades are curved in the opposite direction to the blade rotation.

[0029] In some embodiments, the impeller is formed in one piece.

[0030] In some embodiments, the impeller comprises a radius of between 15 and 60 mm.

[0031] In some embodiments, the impeller has a mass of less than 2 grams, preferably between 0.8 and 1.8 grams.

[0032] In some embodiments, the impeller is configured to have a pressure to inertia to radius ratio of greater than 50:1 Pa per gram*mm, preferably greater than 80:1 Pa per gram*mm.

[0033] In some embodiments, the impeller is configured to have a moment of inertia to radius ratio of less than 15 g*mm, preferably between 8 and 12 g*mm.

[0034] In some embodiments, the impeller is configured to have a vane swept volume to vane volume ratio of 16:1 or greater.

[0035] The blower unit may further include a casing having upper and lower inner surfaces enclosing the impeller, the impeller preferably being unshrouded or otherwise reduced in material such that the impeller has a plurality of blades that are substantially open to the upper and lower inner surfaces of the casing, hi one form the casing forms part of or is integral with the respiratory assistance apparatus.

[0036] The blower unit may further include a partition for defining first and second internal regions within the casing, the first region being defined by the casing and the partition and including the gas inlet and the motor, and the second region being defined by the casing and the partition and including the impeller, and the first and second regions are preferably fluidly connected by an opening in or formed by the partition.

[0037] The impeller may have an axis of rotation and the partition preferably extends radially from the axis of rotation.

[0038] The casing of the blower unit may further include a volute structure fluidly connected to the second region by an air flow passage, and the gas outlet of the blower unit is preferably adjacent to a periphery of the volute structure.

[0039] In a first form, a blower unit may include a motor including a stator and at least one bearing arrangement for supporting a rotatable drive shaft within the stator, the bearing arrangement including one or more bearings supported by one or more bearing mounts about an axis of the rotatable drive shaft. The bearing mount(s) preferably compliantly support the rotatable shaft.

[0040] Preferably, the stator includes a stator frame, and an outer portion of the one or more bearing mounts engages the stator and / or an inner surface of the stator frame, hi one form, the outer portion of the one or more bearing mounts engages the stator and / or the stator frame and / or other structure.

[0041] Preferably, the blower unit may further comprise a motor mount which joins the stator and the casing and compliantly supports the motor.

[0042] The bearing mount and / or the motor mount are preferably flexible and / or resilient.

[0043] The bearing mounts are preferably made from a material that provides resilience and / or flexibility to provide the preload when in the engaged configuration.

[0044] The bearing mounts are preferably made from a material that provides damping.

[0045] The bearing mount may be flexible and / or resilient, and the bearing mount may have a curved annular body which, when engaged with the stator and / or stator frame, is preferably forced into an engagement configuration that preloads one or more bearings.

[0046] The motor is preferably operated with field oriented control.

[0047] In one form, the rotatable drive shaft can be plastic. The motor can further include a rotor within the stator, with the rotatable plastic drive shaft preferably being formed by injection molding and coupled to the rotor. In one form, the motor preferably includes a rotatable plastic shaft extending through and coupled to an opening in the magnet rotor.

[0048] A method of manufacturing a motor shaft and rotor assembly is also described that includes inserting a rotor having a central opening into a first mold section, supporting the shaft extending through the central opening, mating a second mold section to the first mold section to form a mold cavity around the central opening, and injection molding a plastic insert between the plastic shaft and the central opening to bond the plastic shaft to the rotor.

[0049] A method for manufacturing a motor shaft and rotor assembly is also described that includes inserting a rotor having a central opening into a first mold section, mating a second mold section to the first mold section to form a mold cavity around the central opening, and injection molding a plastic shaft that extends through and is mated to the central opening of the rotor.

[0050] In a second form, the blower unit includes a motor including a rotatable shaft located within a stator, and a bearing structure supporting the rotatable shaft within the stator, the bearing structure having one or more bearing mounts.

[0051] In a third form, the blower unit may include a centrifugal impeller driven by a motor within a casing having a gas inlet, a gas outlet and a partition (or divider) for defining first and second interior regions, the first and second regions being fluidly connected by an opening in the partition.

[0052] In a fourth form, the blower unit may include a motor having a rotatable shaft and at least one bearing structure for supporting the rotatable shaft within a stator, the bearing structure having one or more flexible and / or resilient bearing mounts for providing compliance and / or preload and / or damping to the rotatable shaft, and the blower unit may further include a lightweight impeller coupled to the rotatable shaft, a flexible and / or resilient motor mount connecting the stator and the housing to provide compliance and / or damping to the motor, and a partition for defining first and second internal regions within the housing, the first and second regions fluidly connected by openings formed in or by the partition.

[0053] In a fifth form, a blower unit includes a gas inlet, a gas outlet, a motor having a shaft, and a rotatable lightweight impeller connected to the motor for drawing in gas through the inlet and expelling gas through the outlet, the impeller being shrouded or otherwise reduced in material.

[0054] Each of the configurations of the blower unit may further include any one or more of the features mentioned with respect to the other configurations of the blower unit.

[0055] The respiratory assistance device preferably includes an operable control system having an on-board controller configured to control the blower unit to deliver a pressurized gas flow of a desired pressure and / or flow rate to the user during the user's breathing cycle. By way of example, the device may include an on-board electronic controller mounted on or within the respiratory assistance device that controls the pressure of breathing gas delivered to the user by controlling the speed of a motor in the blower unit.

[0056] Preferably, the apparatus may further comprise one or more sensors mounted at or within the respiratory assistance apparatus configured to sense operating parameters and generate and transmit representative sensor signals to the controller.

[0057] Preferably, the device may further comprise an internal wireless power transfer receiver configured to receive power from the wireless power transfer transmitter.

[0058] Preferably, the device may further comprise an internal power supply module.

[0059] In one form the blower unit may be releasably attached to the body, while in another form the blower unit may be integral with or fixed to the body.

[0060] In one form, the body may include a forehead support member configured to engage the forehead of a user, a mask body for receiving a mask seal assembly of a patient interface, a connecting member extending between the forehead support member and the mask body, and a gas inlet fluidly connected to a gas outlet of the blower unit. The forehead support member of the body is oriented horizontally, the connecting member extends vertically from a center of the forehead support member to form a T-shaped portion (or T-piece) with the forehead support member, and the blower unit is attached to the T-shaped portion. In one form, the blower unit may be provided on or attached to the forehead support member of the body so as to be located in the forehead region of the user in use.

[0061] In one form, the device is configured as a positive airway pressure (PAP) device. For example, the device can be configured to operate as a CPAP device, a Bi-PAP device, or any other PAP device.

[0062] In one form, the patient interface is releasably attached to the body, hi another form, the patient interface may be integral with or fixed to the body.

[0063] In one form, the patient interface can include a nasal mask configured to sealingly engage the user's face and cover the nose.

[0064] In another form, the patient interface may include any one of a full face mask configured to sealingly engage the user's face and cover the user's nose and mouth, a nasal pillows mask that sealingly engages the user's nares, a non-sealing nasal cannula configured to be placed within the user's nares, or an oral interface configured to sealingly engage at or within the user's mouth.

[0065] The body further includes a gas passage or conduit fluidly connecting the gas outlet of the blower unit to the gas inlet of the patient interface, the gas passage preferably forming part of the gas flow path.

[0066] In one form, the body can be configured to position the blower unit on the forehead region of the user's face and the patient interface on or in the nose and / or mouth region of the user's face when the device is worn in use. Alternatively, the blower unit can be fixedly or releasably attached to the front of the patient interface (e.g., a mask).

[0067] In a second form, the invention broadly resides in a base station operatively connectable to a head-mounted respiratory assistance device configured to supply a flow of respiratory gas to a user, the head-mounted respiratory assistance device comprising a body securable to the user's head, a blower unit provided on the body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurized gas flow at a gas outlet, and a patient interface provided on the body having a gas inlet fluidly connected via a gas flow path to the gas outlet of the blower unit and configured to deliver the pressurized gas to the user's nose and / or mouth via one or more gas outlets, the base station comprising a power supply system for providing power to the respiratory assistance device, a data transfer system for transmitting and receiving data to and from the respiratory assistance device, and a control system for controlling the respiratory assistance device via control signals.

[0068] In one form, the power supply system may be configured to transmit power to the respiratory assistance device via one or more power transmission cables.

[0069] In another form, the power system may include wireless power transfer circuitry configured to wirelessly transfer power to the respiratory assistance device.

[0070] The data transfer system may preferably comprise a first communication module for transferring data between the base station and the respiratory assistance device via a wired or wireless communication medium.

[0071] Preferably, the data transfer system may further comprise a second communication module for transferring data between the base station and an external server via a wired or wireless communication medium.

[0072] The control system is preferably capable of sending control signals to the respiratory assistance device to control any one or more of the following operational modes: on / off mode, charging mode, drying mode and / or data transfer mode.

[0073] In one form, the control system may be configured to automatically send control signals to the respiratory assistance device for controlling one or more operational modes based on whether an operable connection is detected between the base station and the respiratory assistance device.

[0074] In a third aspect, the invention broadly resides in a respiratory assistance system comprising a head-mounted respiratory assistance apparatus including a body securable to a user's head and configured to supply a respiratory gas flow to the user, a blower unit provided on the body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurized gas flow at a gas outlet, and a patient interface provided on the body having a gas inlet fluidly connected via a gas flow path to the gas outlet of the blower unit and configured to deliver the pressurized gas to the user's nose and / or mouth via one or more gas outlets, and a wireless power system configured to wirelessly supply power to the respiratory assistance apparatus.

[0075] The wireless power source may preferably be arranged to provide power to the respiratory assistance apparatus for operating the blower unit.

[0076] The respiratory assistance device may include one or more sensors configured to sense various operating parameters and generate representative sensor signals, and a wireless power source is preferably configured to provide power to the sensors.

[0077] In a fourth aspect, the invention broadly resides in a respiratory assistance system comprising a head-worn respiratory assistance apparatus including a body securable to a user's head and configured to supply a respiratory gas flow to the user, a blower unit provided on the body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurized gas flow at a gas outlet, and a patient interface provided on the body having a gas inlet fluidly connected via a gas flow path to the gas outlet of the blower unit and configured to deliver the pressurized gas to the user's nose and / or mouth via one or more gas outlets, and one or more wireless sensors mounted on or within the respiratory assistance apparatus configured to sense operating parameters and generate representative sensor signals.

[0078] The one or more wireless sensors may preferably be configured to wirelessly transmit the generated sensor signals directly or indirectly to a separate external device or system.

[0079] The one or more wireless sensors may preferably be wirelessly powered by a wireless power transfer system wirelessly connected to the respiratory assistance device.

[0080] In a fifth aspect, the invention broadly resides in a respiratory assistance system comprising a head-worn respiratory assistance apparatus including a main body securable to a user's head and configured to supply a respiratory gas flow to the user, a blower unit provided on the main body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurized gas flow at a gas outlet, and a patient interface provided on the main body having a gas inlet fluidly connected to the gas outlet of the blower unit via a gas flow path and configured to deliver the pressurized gas to the user's nose and / or mouth via one or more gas outlets, and a wireless communication module incorporated in the respiratory assistance apparatus for transmitting and receiving data to and from external devices and / or systems.

[0081] The respiratory assistance device preferably includes one or more sensors that can be configured to sense operating parameters and generate representative sensor signals, and the communications module is configured to transmit the generated sensor signals to a separate external device or system.

[0082] The respiratory assistance device may include an on-board electronic controller configured to store usage data indicative of a user's use of the respiratory assistance device, and the communications module is preferably configured to wirelessly transfer the usage data to a separate external device or system.

[0083] In a sixth aspect, the invention broadly resides in a head-mounted respiratory assistance apparatus configured to supply a flow of respiratory gas to a user, the apparatus comprising a body securable to a user's head, a blower unit provided on the body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurized gas flow at a gas outlet, a patient interface provided on the body having a gas inlet fluidly connected to the gas outlet of the blower unit via a gas flow path and configured to deliver the pressurized gas to the user's nose and / or mouth via one or more gas outlets, and a head-mounted power source configured to provide power to the breathing apparatus.

[0084] In another aspect, a head-mounted respiratory aid device configured to supply a respiratory gas flow to a user is also described, the head-mounted respiratory aid device comprising a main body securable to the user's head, a blower unit provided on the main body having a gas inlet for receiving a supply of gas from the ambient atmosphere and generating a pressurized gas flow at a gas outlet, and a patient interface provided on the main body having a gas inlet fluidly connected to the gas outlet of the blower unit via a gas flow path and configured to deliver the pressurized gas to the user's nose and / or mouth.

[0085] In some embodiments, the respiratory aid apparatus can be configured to provide a bias flow and can include one or more gas vents near the patient interface that can allow a portion of the exhaled gas to exit the respiratory aid apparatus, hi other embodiments, the respiratory aid apparatus can be configured to have a zero bias flow.

[0086] In another aspect, a respiratory assistance system is also described that includes a head-mounted respiratory assistance device according to any of the above aspects and a base station configured to receive and hold the respiratory assistance device when not in use.

[0087] Each aspect of the invention described above may further comprise any one or more of the features described in relation to the other aspects.

[0088] The term "bias flow" as used in this specification and claims, unless the context indicates otherwise, is intended to mean an intentional or controlled leak or flow of gas from the respiratory aid apparatus to the surrounding atmosphere through one or more gas outlets or outlets located on the respiratory aid apparatus and fluidly connected to or along a portion of an air or gas flow path within the apparatus.

[0089] The phrases "zero bias flow" or "zero bias" as used herein and in the claims, unless the context indicates otherwise, are intended to mean no bias flow, or in some embodiments, a minimal bias flow of 5 liters per minute or less.

[0090] The term "comprising" as used in this specification and the claims means "consisting at least in part of." In interpreting each description containing the term "comprising" in this specification and the claims, there may be features other than the feature or features following the term. Related terms such as "comprise" and "comprises" should be interpreted in the same manner.

[0091] Reference to a numerical range disclosed herein (e.g., 1-10) also includes reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), and every range of rational numbers within that range (e.g., 2-8, 1.5-5.5, and 3.1-4.7), and thus is intended to be expressly disclosed herein, and all subranges of every range explicitly disclosed herein. These are only examples of what is specifically intended, and similarly, the application should be considered to expressly represent all possible combinations of numerical values ​​between the lowest and highest values ​​recited.

[0092] As used herein, the term "and / or" means "and" or "or," or both.

[0093] As used herein, "(s)" after a noun refers to the plural and / or singular form of the noun.

[0094] The invention has been described above and also contemplates the following configurations, which are merely illustrative.

[0095] Preferred embodiments of the invention will now be described, by way of example only, with reference to the following drawings: [Brief description of the drawings]

[0096] [Figure 1] 1 is a schematic diagram of a known form of respiratory assistance device in which a modular blower unit is connected to a humidifier unit; [Diagram 2] 1 is a schematic diagram of another known form of respiratory assistance device in which the blower unit and the humidifier unit are integrated into a single main housing; [Diagram 3] FIG. 1 is a plan view of an example of a known blower unit. [Figure 4] FIG. 4 is a side view of the blower unit of FIG. 3. [Diagram 5] FIG. 1 is a profile diagram of a known impeller. [Figure 6] FIG. 6 is another profile view of the impeller of FIG. [Figure 7] FIG. 1 is a perspective view of a wearable respiratory assistance device according to an embodiment of the present invention, showing a head-mounted blower unit attached to a user's head, without showing headgear. [Figure 8] FIG. 8 is a front and upper perspective view of the respiratory assistance device of FIG. 7, omitting the user. [Figure 9] FIG. 8 is a rear underside perspective view of the respiratory assistance apparatus of FIG. 7. [Figure 10] FIG. 8 is a side view of the respiratory assistance device of FIG. [Figure 11] FIG. 8 is a front view of the respiratory assistance device of FIG. [Figure 12] FIG. 8 is a rear view of the respiratory assistance device of FIG. [Figure 13] FIG. 8 is a rear underside perspective view of the respiratory assistance apparatus of FIG. 7, without the frame, showing in detail the mask seal, blower unit and forehead bumper elements; [Figure 14] FIG. 8 is a rear perspective view of the frame of the respiratory assistance device of FIG. 7. [Figure 15] FIG. 8 is a front perspective view of the frame of the respiratory assistance device of FIG. 7. [Figure 16] FIG. 8 is a side view of the frame of the respiratory assistance device of FIG. 7. [Figure 17] FIG. 8 is a front perspective view of the blower unit of the respiratory assistance device of FIG. 7. [Figure 18] FIG. 8 is a rear perspective view of the blower unit of the respiratory assistance device of FIG. 7. [Figure 19] FIG. 18 is a front perspective view of the blower unit of FIG. 17 with the gas inlet filter removed to expose the motor assembly. [Figure 20] FIG. 20 is a front perspective view of the blower unit of FIG. 19 with the motor assembly removed from the blower unit casing. [Figure 21] 18 is a rear perspective view of the blower unit of FIG. 17 with a portion of the rear side of the casing cut away to expose the impeller. [Figure 22] 18 is a cross-sectional view of a casing of the blower unit of FIG. 17. [Figure 23] FIG. 18 is a perspective view of an impeller of the blower unit of FIG. 17 in accordance with an embodiment of the present invention. [Figure 24] FIG. 18 is a plan view of an impeller of the blower unit of FIG. 17 in accordance with an embodiment of the present invention. [Figure 25A] FIG. 18 is a perspective view of an impeller of the blower unit of FIG. 17 according to another embodiment of the present invention. [Figure 25B] FIG. 18 is a plan view of an impeller of the blower unit of FIG. 17 according to another embodiment of the present invention. [Figure 26A] FIG. 18 is a plan view of an impeller with reduced shroud material of the blower unit of FIG. 17 according to another embodiment of the present invention. [Figure 26B] FIG. 18 is a perspective view of an impeller with reduced shroud material of the blower unit of FIG. 17 according to another embodiment of the present invention. [Figure 26C] FIG. 18 is a plan view of an impeller having a web structure of the blower unit of FIG. 17 according to another embodiment of the present invention. [Figure 26D] FIG. 18 is a perspective view of an impeller having a web structure of the blower unit of FIG. 17 according to another embodiment of the present invention. [Figure 27] FIG. 18 is a top perspective view of a motor and impeller assembly of the blower unit of FIG. 17 according to the first embodiment of the present invention. [Figure 28]FIG. 28 is a top perspective view of a stator isolation arrangement of the motor assembly of FIG. 27 in accordance with an embodiment of the present invention. [Figure 29] FIG. 28 is a top perspective view of the motor and impeller assembly of the blower unit of FIG. 27 omitting stator isolator elements. [Diagram 30] FIG. 30 is a top perspective view of the motor and impeller assembly of FIG. 29 without the upper stator mounting. [Figure 31A] FIG. 28 is a center cross-sectional view of the motor and impeller assembly of FIG. 27. [Figure 31B] FIG. 28 is a side view of the upper and lower bearing mounts, magnets and impeller of the motor and impeller assembly of FIG. [Figure 32A] FIG. 18 is a perspective view of a motor and impeller assembly of the blower unit of FIG. 17 according to a second embodiment of the present invention. [Figure 32B] 6A and 6B are diagrams illustrating a stator lamination of a motor according to a second embodiment. [Figure 32C] 6A and 6B are diagrams illustrating a magnetic pole face of a motor according to a second embodiment. [Fig. 32D] 11A and 11B are diagrams illustrating a bearing mount of a motor according to a second embodiment. [Figure 32E] FIG. 11 is a cross-sectional view of a motor and an impeller according to a second embodiment. [Fig. 32F] 6A to 6C are diagrams illustrating a motor mounting structure of a motor according to a second embodiment. [Figure 33A] FIG. 2 shows a metal shaft and magnet rotor assembly forming part of the motor. [Figure 33B] FIG. 2 shows a metal shaft and magnet rotor assembly forming part of the motor. [Figure 33C] FIG. 33C shows the metal shaft of the assembly of FIGS. 33A and 33B. [Figure 33D] FIG. 13 illustrates a plastic shaft and magnet rotor assembly forming part of another embodiment of the motor. [Figure 33E] FIG. 33E shows an injection molding tool for manufacturing the plastic shaft and rotor assembly of FIG. 33D. [Figure 33F] FIG. 33E shows an injection molding tool for manufacturing the plastic shaft and rotor assembly of FIG. 33D. [Figure 33G] FIG. 1 is a flow diagram of an injection molding process for a metal shaft / insert rotor assembly. [Fig. 33H] FIG. 1 is a flow diagram of an injection molding process for a plastic shaft rotor assembly. [Diagram 34] 8 is a perspective view of the respiratory assistance apparatus of FIG. 7 worn by a user and attached to the user's head by headgear, in accordance with an embodiment of the present invention. [Figure 35A] FIG. 8 is a perspective view of the respiratory assistance device of FIG. 7 worn by a user and attached to the user's head by headgear with batteries integrated into the upper and / or lower head straps of the headgear in accordance with another embodiment of the present invention. [Figure 35B] FIG. 8 is a perspective view of the respiratory assistance device of FIG. 7 worn by a user and attached to the user's head by headgear, with upper and lower head straps and a battery module attached to the top of the user's head, in accordance with another embodiment of the present invention. [Diagram 36] FIG. 1 is a perspective view of a wearable respiratory assistance device attached to a user's head, according to an alternative embodiment of the present invention. [Figure 37] FIG. 1 is a perspective view of a wearable respiratory assistance device attached to a user's head, according to another alternative embodiment of the present invention. [Figure 38] FIG. 13 is a front view of a wearable respiratory assistance device attached to a user's head, according to another alternative embodiment of the present invention. [Figure 39] FIG. 1 is a perspective view of a wearable respiratory assistance device attached to a user's head, according to another alternative embodiment of the present invention. [Diagram 40] 1 is a pressure response graph of a conventional blower unit. [Diagram 41] 4 is a pressure response graph of a blower unit according to an embodiment of the present invention. [Diagram 42] 1 is a graph showing average sound pressure levels of a conventional blower unit. [Diagram 43]4 is a graph of average sound pressure levels of a blower unit according to an embodiment of the present invention. [Diagram 44] FIG. 1 is a schematic diagram of a first embodiment of a base station communicating with a wearable respiratory assistance device and powering an independently powered mat for loosely coupled wireless power transfer to the respiratory assistance device. [Diagram 45] FIG. 11 is a schematic diagram showing, as examples, two different embodiments of a base station of the second embodiment for direct data communication and wireless power transmission to a wearable respiratory assistance device, one with an internal battery and one without. [Diagram 46] FIG. 11 is a schematic diagram detailing a third embodiment of a base station in the form of a data hub in data communication with the wearable respiratory aid device, as well as an independent power cable for powering and / or charging, and various different powering and / or charging configurations for wearable respiratory aid devices with built-in batteries and battery-free wearable respiratory aid devices, or charging of batteries removable from such devices; [Figure 47] A schematic diagram showing in detail the powering and / or charging configuration for wearable respiratory assistance devices with built-in batteries and battery-free wearable respiratory assistance devices of a fourth embodiment of a base station that is in data communication with the wearable respiratory assistance device and includes a battery pack charging dock and a power cable for powering and / or charging. [Figure 48] This is a schematic diagram showing in detail the powering and / or charging configuration of a wearable respiratory assistance device with an internal battery and a battery-less wearable respiratory assistance device of a fifth embodiment of a base station that performs data communication with the wearable respiratory assistance device and includes an integrated charging mat for wireless charging of the respiratory assistance device and a power cable for powering and / or charging. [Figure 49] FIG. 11 is a schematic diagram of a sixth embodiment of a base station in data communication with a wearable respiratory support device and including a power cable for powering and / or charging, detailing various different powering and / or charging configurations for wearable respiratory support devices with built-in batteries and battery-free wearable respiratory support devices, or charging of batteries removable from such devices. [Figure 50]FIG. 13 is a schematic diagram of a seventh embodiment of a base station communicating directly with a wearable respiratory support device via an independently powered mat for loosely coupled wireless power transfer to the respiratory device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097] overview The present invention relates to a respiratory assistance device (respiratory device) capable of supplying a user or patient with a flow of respiratory gas for respiratory therapy. By way of example, an embodiment of the respiratory device configured as a CPAP respiratory device is described, but it will be understood that the respiratory device may also be adapted or configured for other PAP therapies, including but not limited to Bi-PAP therapy, or any other suitable respiratory therapy that delivers a flow of gas to a user.

[0098] Wearables As can be seen with reference to Figures 7-12, in this embodiment, the respiratory apparatus 20 is portable and fully wearable. Specifically, the respiratory apparatus 20 takes the form of a head-mounted CPAP respiratory apparatus. The respiratory apparatus 20 delivers or supplies a flow of respiratory gas (e.g., air) at a controllable, continuous pressure as is well known to those skilled in the art of CPAP devices and therapies. The respiratory apparatus can be configured to deliver gas at any desired flow rate and / or pressure required by the patient, whether specialized for a single flow rate and / or pressure, or specialized for a number of different flow rates and / or pressures, or configured to operate at various ranges of flow rates and / or pressures. By way of example only, the respiratory apparatus can deliver gas at one or more flow rates in the range of 0-120 liters per minute, and can produce one or more pressures in the range of 0-25 cmH2O, or can be customized to operate within subranges of these ranges depending on the patient's requirements. The respiratory apparatus 20 is portable in that all of the major components are provided within a head-mountable or otherwise wearable unit or assembly. As will be described in further detail below, the power source for the respiratory apparatus may also be head mounted or may be hard wired to a body that may be carried by the user, for example in a pocket or on a belt. The respiratory apparatus 20 includes a base or body 20 to which is integral, fixedly or releasably attached a blower unit 24 and a patient interface or mask 26. The respiratory apparatus 20 has a side facing the user (i.e., rear side), as indicated by arrow A in Figure 10, and an outward facing side (i.e., front side), as indicated by arrow B.

[0099] Blower unit 24 includes a rotatable impeller configured to draw or draw in ambient atmospheric gases or air via blower gas inlet 28 and then pressurize the gases to produce a supply or flow of pressurized gas. As will be appreciated by those skilled in the art of CPAP devices and therapies, blower unit 24 includes a controllable variable speed fan unit that can be controlled by one or more control signals to generate a desired level of gas flow and / or gas pressure at mask 26.

[0100] The blower unit 24 is fluidly connected or in communication with the mask 26 via air or gas passageways such that pressurized gas generated by the blower unit 24 flows into an interior cavity 30 of the mask 26 (see FIG. 9 ) and can be inhaled or breathed into by the user through the nose and / or mouth, depending on the type of mask used. In this embodiment, a nasal mask 26 is provided that is configured to sealingly engage about the nose on the user's face, although other patient interfaces or masks could alternatively be used, including, but not limited to, a full face mask that covers the user's nose and mouth, an oral mask for the user's mouth, nasal cannulas or prongs, or any other suitable mask or patient interface for respiratory gases.

[0101] Headgear (not shown in Figures 7-12) is provided on the breathing apparatus 20 for securing the apparatus to the user's head. There are a variety of headgear assembly configurations that can be used to secure the breathing apparatus to the user's head, and some example headgear configurations are described below by way of example. Some example headgear configurations include an upper head strap that is connected or coupled to an upper portion of the breathing apparatus near the blower unit 24 and extends around the user's head above the ears, and a lower head strap that is connected or coupled to a lower portion of the breathing apparatus near the mask 26 and extends around the user's head below, typically at or below ear level.

[0102] controller The breathing apparatus 20 has an on-board electronic controller (such as a microcontroller, microprocessor or the like) or a control system mounted on or within the blower unit 24, the body 22 or another part of the breathing apparatus. As will be appreciated by those skilled in the art of CPAP breathing apparatus, this electronic controller is configured to control, among other functions, the pressure of breathing gas delivered to the user primarily by controlling the motor speed within the blower unit 24. For example, in use, the blower unit is set to a pressure level specified by the user and / or this pressure level may also be controlled automatically. The flow rate of the preferred embodiment varies during use in response to the user's breathing. Varying the power to the blower unit can vary the speed at which the impeller is rotating and therefore the pressure.

[0103] The electronic controller may be controlled by an on-board user interface or control panel, including one or more switches, buttons, dials, touch screen control panel, provided on the respiratory apparatus. Additionally or alternatively, the on-board controller may be operated or controlled remotely by an external control device (such as a remote control device, a personal computer, a portable communication device such as a smart phone running a smart phone application, or any other programmable portable or separate device) that communicates with the on-board controller via a wireless communication medium, such as RF communication, Bluetooth, Wi-Fi, infrared, or any other wireless communication standard or technology.

[0104] In some embodiments, the controller can be configured to employ sensorless vector control (also known as field-oriented control) of the motor in the blower unit.

[0105] The control system may include one or more sensors within the respiratory device configured to sense various operating parameters and generate representative sensor signals for the controller. For example, in some embodiments, the respiratory system may include a flow sensor and / or a pressure sensor within the airflow path. As is known to those skilled in the art of CPAP respiratory devices, the sensed signals are processed by the controller and used to control a motor within the blower unit to deliver a desired pressure and / or flow rate to the user.

[0106] The control system may also include further sensors such as an EEG sensor, humidity sensor, temperature sensor or accelerometer to provide further functionality or benefits as desired.

[0107] The sensors can be wired or wireless, or a combination thereof. In some embodiments, the sensors can be hardwired to an on-board power module, or can be powered wirelessly by a wireless power transfer system within range of the connection. In some embodiments, the sensors are hardwired to the on-board controller such that the controller receives the generated sensor signal and / or sensor data. Additionally or alternatively, the sensors can be configured to transmit the sensor signal or sensor data wirelessly to the on-board controller, or directly to an external system or device within range of the connection.

[0108] power supply The respiratory apparatus 20 is preferably powered by a head-mounted, self-contained power package or module. The power module may take the form of an energy storage device or device such as, but not limited to, a battery package including one or more batteries, typically but not necessarily rechargeable, a fuel cell, a capacitor, or any other suitable energy storage device. The power source and associated power circuitry may be mounted, such as on or within the blower unit 24 or body 22 of the respiratory apparatus, or may be mounted on or integrated into the headgear or any other part of the respiratory apparatus. Additionally or alternatively, the power module may be non-head mounted but otherwise portable and wearable and connected to the respiratory apparatus by a power cable or other hardwired connection. In such an embodiment, the power module may be carried or worn, for example, in a pocket of the user's clothing or attached to a belt if the user is mobile. Otherwise, the power module may be dropped off at a convenient location near the user as needed. Typically, the power module is a DC power source. Additionally or alternatively, the respiratory apparatus may be configured to be optionally connected to an AC power adapter that connects to an AC outlet and converts it to DC power for the respiratory apparatus. The power provided by the AC power adapter can also be configured to recharge any battery power modules contained within the respiratory apparatus.

[0109] If the power module is a rechargeable energy storage device, such as a rechargeable battery pack, or includes a rechargeable battery, the power module can be recharged by a wired charging system or a wireless charging system including inductive power transfer, some examples of which are described below with reference to Figures 44-50.

[0110] It will be appreciated that in some embodiments the respiratory apparatus may be battery-free (i.e. have no built-in power module) and may be powered directly by an AC power adapter or via a wireless power transfer system, as described below.

[0111] Passive humidification In this embodiment, the respiratory apparatus 20 is configured to passively humidify and warm or heat the respiratory gases using accumulated moisture or humidity in the mask cavity and the remaining volume of the airflow passage or airflow path in the respiratory apparatus created by the user's exhaled breath. This passive humidification can also heat the respiratory gases. This passive humidification method eliminates the requirement for active humidification, which is typically achieved by conventional humidification units that include a humidification chamber behind the blower unit, as known in conventional CPAP therapy respiratory apparatus. In some embodiments, one or more heat and moisture exchangers (HMEs) can be provided in the airflow path to further enhance the recirculation effect of passive humidification.

[0112] In some embodiments, mask condensation control / reduction methods may also be used, including but not limited to transparent mask materials, droplet collection systems, and mask surface heating.

[0113] Zero Bias Current In this embodiment, the respiratory apparatus 20 does not use a bias flow to assist in exhalation from the user, as is known in conventional CPAP therapy breathing apparatus, such as a nasal mask in which breathing gases are delivered to the patient along a flexible gas conduit 3 to a patient interface 5, as described with reference to Figures 1 and 2. In this embodiment, the respiratory apparatus has a zero bias flow configuration. The respiratory apparatus 20 is configured to include a substantially sealed internal airflow passage or airflow path defined between the blower inlet 28 and the outlet region of the mask 26, of a volume small enough to control or reduce CO2 re-inhalation to an acceptable or desirable level without requiring a bias flow to assist in cleaning the exhaled air, as in conventional CPAP breathing apparatus. The total volume of the internal air flow path or gas pathway within the breathing apparatus 20 is generally defined by the total cumulative volume of the air flow path or gas pathway within the breathing apparatus between the atmosphere and the mouth of the user, i.e., from the gas inlet of the blower unit 24 to the gas outlet or outlet area of ​​the patient interface or mask 26 at the user's nose and / or mouth (depending on the type of patient interface), including the internal volume of the blower unit 24, any air flow paths or connection ports between the outlet of the blower unit 24 and the inlet of the mask 26 within the body 22, and the internal volume or cavity 30 of the mask 26. The volume of this air flow path is configured to be within a predetermined range to control the re-inhalation of CO2 to a desired level by controlling a portion of the exhaled air to pass backward through the breathing apparatus and be exhausted to the atmosphere through the gas inlet 28 of the blower unit of the breathing apparatus. In this embodiment, the total volume of the internal air flow path is preferably less than 200 mL.

[0114] In other embodiments, the breathing apparatus may optionally be configured to provide a "low" or reduced amount of bias flow, typically through one or more gas bleed holes in the patient interface or mask or elsewhere in the airflow path, typically at a lower level than that provided by the conventional CPAP therapy breathing apparatus of Figures 1 and 2. In some embodiments, the level of the bias flow may be controllable.

[0115] heating In some embodiments, further heating of the respiratory gases can be provided in the blower unit 24, where heat dissipated from the motor and control circuitry can act to heat the incoming respiratory gases above ambient temperature by forced convective heat transfer.

[0116] base station In this embodiment, the respiratory apparatus also optionally comprises a separate base station configured to provide power to the respiratory apparatus for operation and / or charging of any built-in energy storage device, such as a battery pack or the like. This base station may be further configured for data communication for transferring compliance data and / or may be configured as a docking station or mounting stand to which the respiratory apparatus can be docked or attached or otherwise stored when not in use. The base station may be a unit or assembly configured to rest on a flat surface, such as a table, or may be wall mounted or fixed to any other structure at a convenient location. The base station may comprise or control an integrated or separate power module or system configured to connect to and power the respiratory apparatus during operation and / or recharging of any built-in power source when the respiratory apparatus is docked or otherwise within connection range. The power system may be connected via a hardwired cable connection to the respiratory apparatus or to a wireless energy transfer system (such as, but not limited to, electromagnetic induction power transfer, electromagnetic radiation power transfer, etc.). Additionally or alternatively, the base station may provide other optional features and functionality such as communication modules for compliance data transfer, memory stick interface, calibration, drying, cleaning, clock radio, music player, etc. Various embodiments of the base station are described below, by way of example only, with reference to Figures 44-50.

[0117] Model Variations In some embodiments, some or all of the elements or components of the respiratory assistance device may be disposable or replaceable, including but not limited to the mask or mask assembly, the blower unit and the main body itself or components thereof.

[0118] In some embodiments, one or both of the blower unit and the patient interface may be modular components that are releasably or removably attached or mounted to the main body so that different patient interfaces or blower units of different types, specifications, sizes or any other characteristics can be connected to the main body to modify or customize the operation, capabilities, specifications, characteristics and / or functionality of the respiratory apparatus to suit a particular application or end user requirements.

[0119] In some embodiments, the respiratory support device may be provided or configured as a snoring treatment device by operating over a limited pressure range, such as 1-4 cmH2O. In such embodiments, the size of the respiratory support device may be smaller than devices configured for PAP therapy.

[0120] In some embodiments, the respiratory support device may be configured to operate in a diagnostic mode for use in the home or in a sleep clinic, in which case the respiratory support device may include one or more additional sensors (EEG, accelerometer, SpO2, etc.).

[0121] In some embodiments, the respiratory assistance device may be switchable to a "zero pressure" or "low pressure" mode upon detection of the patient waking up, or by manual intervention by the patient, for example by pressing a button on the device, or by detection of head or body movement indicative of an awake state.

[0122] In some embodiments, multiple different models of respiratory assistance devices may be provided, each configured to operate over a specific limited pressure range to minimize the weight and size of the device for each pressure range, and having a blower unit and power source optimized for the target pressure range of that model. For example, in one embodiment, three separate models may be provided, each covering pressure ranges of 4-10, 18-14, and 12-20 cmH2O, respectively.

[0123] Main Body and Mask Assembly The body 22 and mask 26 of the breathing apparatus 20 are described in further detail with reference to Figures 7-16. Figures 14-16 show the body 22 in isolation. In this embodiment, the upper or top portion of the body 22 includes a forehead support member 32 that is configured to extend generally horizontally or laterally relative to the remainder of the body. The forehead support 32 is configured to be positioned adjacent the user's forehead when worn by a user. The lower or bottom portion of the body 22 includes a mask body 34 that forms part of the mask 26 or mask assembly of the breathing apparatus 20. The forehead support 32 and mask body 34 are connected to each other by a vertical support or connecting member 36 that extends vertically through their centers. In this embodiment, the forehead support 32, vertical support 36 and mask body 34 are preferably formed from a rigid plastic material such as, but not limited to, polycarbonate, nylon, acetyl or other similar rigid plastics. It will be appreciated that components 32, 34, 36 are preferably integrally molded as a single piece, although in alternative embodiments, these components may be formed separately and connected, secured or otherwise releasably coupled to one another to form body 22. Horizontal forehead support member 32 and vertical support member 36 combine to form a T-shape and therefore may be collectively referred to as a "T-piece."

[0124] In this embodiment, the forehead support 32 is substantially horizontally elongated and extends between a first end 38a and a second end 38b. At or towards each end, a connection opening 40 is provided to allow a respective end of the head strap to be releasably or fixedly connected or coupled. The forehead support 32 is also provided with one or more attachment openings 42 to allow one or more pads or cushions 44 to be releasably or fixedly attached to the side of the body 22 facing the user. In this embodiment, a pair of attachment openings 42 are provided for receiving and holding a respective cushion member 44 (see FIG. 13), each located towards a respective side relative to the center of the forehead support 32. In this embodiment, the attachment openings 42 are configured to releasably receive and hold a complementary attachment structure 44a located on the rear side of the cushion member 44. In use, the forehead support 32 rests against the forehead of the user, providing stability to the mask 26 when secured.

[0125] In this embodiment, the mask body 34 of the body 22 defines an internal cavity 30 (see FIG. 14 ) that is supplied with breathing gas from a connected blower unit 24 that is in fluid communication with the mask body 34 via one or more air flow passages in the body 22. As can be seen with reference to FIGS. 15 and 16 , the mask body 34 is provided with a gas inlet 50 at or towards the top of the front of the mask body, in this embodiment centrally located or aligned with the vertical support 36 of the body 22. A gas flow passage or passage extends from the inlet 50 in the mask body and terminates or opens into the internal cavity 30 of the mask body 34.

[0126] In this embodiment, the mask 26 or mask seal assembly is configured to be releasably attached to the mask body 34. As can be seen with reference to FIG. 13, the mask 26 in this embodiment is a nasal mask configured to sealingly engage about the nose of a user's face and has a front user engagement side 26a and a rear side 26b that engages with the mask body 34. The mask seal assembly 26 may include a flexible seal or cushion on its front side 26a that is shaped to substantially conform or match the contours of the user's face for sealing engagement, and its rear side 26b may include a plastic clip for releasably attaching or engaging a complementary receiving and retaining structure on the mask body 34. For example, the plastic or rigid clip of the mask seal assembly 26 may be structured to extend around the periphery of the rear side 26b of the mask seal assembly 26 to engage or releasably couple with a complementary shaped recess or structure extending around the periphery 34a (see FIG. 14) of the mask body 34. The flexible seal on the front side 26a of the mask seal assembly 26 may be formed of a soft plastic material such as silicone. Those skilled in the art of patient interfaces will appreciate that the structure and construction of the mask assembly formed by the mask body 34 and the mask seal assembly 26 may be of the type described in, for example, U.S. Patent Application Publication No. 2010 / 0006101, the contents of which are incorporated herein by reference. It will be appreciated that while the mask 26 is preferably releasably attached to the mask body 34 so that it can be removed, replaced or cleaned as required, in alternative embodiments the mask may be integrally formed with or secured to the mask body 34.

[0127] In this embodiment, the front side of the mask body 34 is provided with one or more clips 52 (see FIGS. 15 and 16) or retention structures configured to slidably receive and retain a portion of the headgear assembly. For example, the headgear assembly may have a lower strap that extends below or at ear level on the user's head and is connected to a lower portion of the breathing apparatus by clips 52. In one embodiment, as will be described in further detail below, this lower head strap may include an elongated sliding member that may slide or glide within the one or more clips 52 to allow for lateral movement of the mask assembly relative to the headgear.

[0128] In this embodiment, the blower unit 24 is attached to the body 22 such that it is located in the forehead area of ​​the user during use. For example, the blower unit 24 is provided on or attached to the top of the body, such as on a T-piece. In this embodiment, the blower unit 24 is attached to the forehead support 32 or within the forehead support area of ​​the T-piece, and is typically centrally located relative to the sides of the body.

[0129] In this embodiment, the blower unit 24 is releasably attached to the body 22. The forehead support 32 is provided with a central mounting opening 54 (see FIG. 15) configured to receive and retain a complementary mounting protrusion or structure 56 provided on the rear side of the blower unit 24 (see FIG. 13). In this embodiment, the mounting opening 54 has a keyhole type shape formed by an upper circular opening extending into or overlapping a lower smaller opening. The retaining structure 56 of the blower unit takes the form of a cylindrical protrusion terminating in a larger diameter circular stop member so that in use the structure 56 can be inserted through the larger opening of the keyhole type mounting opening 54 and then slid into secure retaining engagement with the smaller opening of the keyhole type mounting opening 54. It will be appreciated that this configuration is just one type of releasable attachment configuration for mounting the blower unit 24 of the breathing apparatus 20 to the body 22. Alternatively, various other releasable attachment configurations or structures can be used, such as, but not limited to, electromagnetic coupling, clip or clipping systems, hook and loop fastening configurations, etc. Additionally, in alternative embodiments, the casing or housing of the blower unit may be integrally formed with the body 22 .

[0130] The bottom or underside of the blower unit 24 is provided with a gas outlet (see FIG. 13) for discharging the pressurized gas flow generated by the rotating fan or impeller of the blower unit from the blower unit. In this embodiment, the gas outlet includes a tubular connector 57 terminating in an outlet opening 58 or aperture. The connector 57 is configured to sealingly engage within or with the gas inlet 50 of the mask body 34 when the blower unit is securely attached to the body. This allows breathing gas to flow from the blower unit 24 into the airflow passage of the body 22 and thereafter into the interior cavity 30 of the mask body 34.

[0131] Blower unit casing An embodiment of the blower unit 24 of the breathing apparatus 20 will now be described in further detail with reference to Figures 17-33H. In this embodiment, the blower unit 24 includes a casing or housing 60 which is substantially circular when viewed in plan. The casing 60 has a front or front side, generally indicated by arrow C, and a rear or back side, generally indicated by arrow D, with a peripheral wall 72 extending therebetween. The casing 60 defines a substantially hollow interior which includes one or more areas for receiving and retaining blower components such as a motor and impeller.

[0132] The front or front side of the casing includes one or more openings or apertures 64 forming a gas inlet. In this embodiment, the gas inlet 64 is a circular hole or aperture located approximately in the center of the front or front side of the casing 60 and running from the outside to the inside of the casing. In use, the front side of the blower unit 24 faces away from the user and ambient air is drawn into the blower unit casing via the gas inlet 64, which is then pressurized by the rotating impeller to generate a pressurized gas flow at the blower unit gas outlet. The primary direction of respiratory gas flow is from the blower unit gas inlet 64 to the blower unit gas outlet 58, then into the mask body 22 and received by the user through the mask 26, although there is also a counterflow in the opposite direction during the user's exhalation cycle, where exhaled air flows backward through the mask 26 and is expelled backwards into the atmosphere from the blower unit gas inlet 64 of the breathing device. The gas inlets / outlets referred to are therefore bi-directional in that they do not restrict flow in any particular direction. In this embodiment, the gas inlet 64 includes a filter 66, which may be a foam material that has the dual purpose of filtering incoming air and acting as a heat and moisture exchanger (HME). In alternative embodiments, the gas inlet does not necessarily include a filter. The rear side or face of the casing, which faces the user in use, includes a mounting projection or structure 56 (see FIG. 18) as described above for mounting the blower unit to the body 22.

[0133] The blower unit casing 60 houses a motor configured to rotate or drive an impeller also mounted within the casing. In this embodiment, the blower unit includes a lightweight / low inertia impeller. The light weight of the impeller results in low inertia. In use, the blower unit 24 can be controlled or set to deliver a flow rate and / or pressure level of breathing gas specified by a user. The flow rate during use can be varied in response to the user's breathing. The speed at which the impeller is rotating, and therefore the flow rate and / or pressure of breathing gas in the mask 26, can be varied by varying the power supplied to the blower unit motor via a control signal from a controller.

[0134] With reference to FIG. 22, with the motor and impeller omitted, the overall interior structure of the casing 60 can be seen more clearly. As shown, the interior of the casing is divided or segmented into one or more fluidly connected regions. In this embodiment, the interior of the casing 60 is divided or separated into a first or upper interior region 82 adjacent the front side and a second or lower interior region 92 adjacent the rear side. In this embodiment, the upper region 82 and the lower region 92 are formed or created by a dividing layer or divider 84. In this embodiment, the divider 84 is a horizontally oriented circular plate or member that is parallel to the front and rear sides of the casing and extends across the interior regions at a location midway or between the front and rear sides of the casing, between the inner surfaces of the peripheral wall 72.

[0135] As shown in FIG. 19, the motor assembly 80 is mounted in an upper region 82 of the casing 60 defined between the front side of the casing, which includes the gas inlet 64 and the filter 66, and a divider plate 84. FIG. 20 shows the casing 60 with the motor 80 removed to expose the receiving cavity in the upper region in which the motor is mounted. As shown, the divider plate 84 includes a central opening 86 through which the rotatable drive shaft of the motor extends to couple to an impeller 90 in the lower region 92 below. This opening 86 is also large enough to allow gas to flow or be drawn through the opening between the upper region 82 and the lower region 92. For example, during operation, ambient air is drawn through the gas inlet 64 and the filter 66 into the upper region 82, where the motor is located, and then through the opening 86 in the divider plate into the lower region 92, where the impeller 90 is located. It will be appreciated that the divider 84 may include one or more additional openings to increase air flow from the upper region 82 to the lower region 92 .

[0136] In alternative embodiments, the opening in the divider 84 that allows gas to flow between the upper and lower regions can be an open hole located at or near the outer edge of the divider. For example, the open hole can be a cutout in the dividing layer 84 or some other configuration / shape of the casing such that the combination / arrangement of the dividing layer 84 and the casing forms an opening / opening between them. For example, the cutout can form a circumferential opening between the casing and the dividing layer 84. The radius curvature / center of the circumferential opening is preferably offset from the center of the radius of the dividing layer 84 or otherwise has a different curvature than the curvature of the periphery of the dividing layer 84 to provide a circumferential opening that is eccentric or otherwise offset around the periphery of the dividing layer. This forms an opening with a crescent ("smile") shaped open hole that extends from the leading edge to the trailing edge. However, the opening can be any shape that gradually opens and closes relative to the plane of rotation of the impeller. The opening allows for a gradual supply of pressure and flow from a high static pressure source at the top of the blower. The opening angle of the opening is adjusted to allow a steady flow of reverse flow back through the system. The opening also contributes to reducing blade pass noise due to the lack of significant discontinuities in its geometry.

[0137] Impeller 90 is mounted within a lower region 92 of casing 60 defined between the rear side of the casing and divider plate 84, as shown in FIG. 21, where the rear side of the casing has been cut away to expose impeller 90.

[0138] In this embodiment, the gas outlet of the blower unit 24 extends outwardly from the peripheral wall 72 of the casing. As can be seen with reference to Figures 17, 18 and 22, this gas outlet includes a gas outlet passage 70 connected to an interior region of the casing 60 and extending outwardly from the peripheral side wall 72 of the casing at or towards the bottom of the blower unit. The gas outlet passage 70 is provided at its outer end with a tubular connector 57 which terminates in an outlet opening 58 through which the pressurized gas flow can flow. The connector 57 in this embodiment is circular in cross section and is configured to connect or couple to the gas inlet 50 of the body 22 so as to fluidly connect the blower unit to the body 22 and the mask 26 for gas flow. In this embodiment, the gas outlet passage 70 has a generally circular cross section and extends radially outwardly from the center of the casing. However, the outlet passages 70 may be configured to extend outwardly at any other suitable angle relative to the circular casing, such as aligned approximately tangentially with the sidewall of the casing, or at any suitable angle between a tangential angle and a radial angle. It will be understood that the cross-sectional shape of the outlet passages 70 and connector 57 need not necessarily be circular, but may be any other desired or suitable shape. The outlet passages 70 merge the gas forced outwardly by the impeller 90 into a gas flow and determine the direction in which this gas flow flows from the blower unit.

[0139] Referring again to FIG. 22, the casing 60 is also provided with an internal structure 93 that forms or provides an air flow passage 94 or pathway from the lower region 92 to the volute 96 or transition region. The volute 96 collects the gas forced outward from the rotating impeller 90 before discharging it from the blower unit through the outlet passage 70 that is fluidly connected to the volute. In operation, the gas circulating within the volute 96 disperses to the outlet passage 70 to form a pressurized gas flow. In this embodiment, the volute 96 is a channel or passage that extends circumferentially within the casing around the outside of the upper region 82. In this embodiment, the air flow passage 94 extends from the lower region to the volute 96 and is circumferentially within the casing 60 around the outer periphery.

[0140] It will be appreciated that the gas path from gas inlet 64 of casing 60 to lower region 92 where impeller 90 is located may be provided in other ways and need not necessarily flow through upper region 82 where the motor is located. For example, in an alternative embodiment, the gas inlet may be provided on the rear side of the casing adjacent the impeller in lower region 92.

[0141] operation During operation of the blower unit 24, gas is drawn into the upper region 82 of the casing through the gas inlet 64 by the rotation of the impeller 90 by the motor 80, through the motor assembly 80, and into the central opening 86 of the partition plate 84. The air drawn through the motor assembly 80 can also serve to cool the motor. The shrouded impeller thus draws air through the motor, thus providing cooling. Gas enters the lower region 92 through the opening 86 and flows through the impeller blades toward the peripheral side wall 72 of the casing in the lower region. The impeller blades create high circulating gas velocity by exerting a strong rotational force on the gas circulating in the lower region 92 of the blower casing. Naturally, the gas in the lower region 92 flows into the volute 96 through the air passage 94 due to the pressure difference between the regions. When the high velocity and low pressure gas in the lower region 92 enters the volute 96, the gas velocity decreases and the pressure increases. Typically, the spiral structure 96 has a larger volume than the lower region 92 to facilitate this increase in gas pressure.

[0142] Dividing the interior space of the blower into separate regions can provide several advantages. In a conventional blower, high velocity gas leaving the impeller flows into an edge or tongue that defines a physical boundary where the gas separates from the volute and enters the outlet passage. The high velocity gas flow entering the tongue is turbulent and inefficient for the performance of the blower. The turbulence caused by the tongue also forms a noise source. In contrast, dividing the casing of the blower unit into separate but connected gas regions reduces the effects caused by the tongue. In the lower region 92, the gas can circulate at high velocity. The gas path or flow passage 94 provides aerodynamic edge-free fluid paths in the volute 96. As the circulating gas enters the volute region 96, the large volume of the volute encourages the gas velocity to weaken and pressure to increase. As the gas velocity decreases, the effects of turbulence normally caused by the tongue also decrease to low or negligible levels. Thus, the blower unit can operate over a wide pressure and flow range with substantially reduced noise output when compared to other blowers. The wider the passage 94, the greater the flow rate of the volute relative to the lower region. Thus, the size of the passage 94 is selected according to the desired flow rate and pressure range of the blower unit.

[0143] Impeller 23 and 24 show a first embodiment of an impeller 90. The impeller 90 has a number of vanes 98 extending outward from a central hub 100. The impeller is a centrifugal impeller. The hub 100 defines the axis of rotation of the impeller. The hub 100 preferably has an opening 102 or recess that allows engagement with a rotatable drive shaft of a motor 80 that facilitates rotation of the impeller. However, other engagement mechanisms, such as an overmolding of the hub on the shaft, can be used. As the impeller rotates, air enters the region of the impeller vanes close to the hub 100 and moves radially outward and is expelled near the vane tips. The impeller is preferably made in one piece ("monolithic") rather than molded and joined in multiple pieces. This method of construction is possible when there is no shroud, or at most one. This reduces misalignment of the parts, which can lead to imbalance or other inconveniences. In a preferred embodiment, there is no shroud (as opposed to, for example, the shroud 12 shown in Figures 5 and 6).

[0144] The blades 98 preferably present a substantially flat surface from the hub 100 to their tips and have a direction of rotation as indicated by arrow R to impart a centrifugal force to the gas. In this embodiment, the blades 98 are arcuate or curved from the hub 100 to their tips, and the curve preferably slopes rearwardly in the opposite direction to the rotation of the impeller as indicated by arrow R. This impeller is a rearward facing impeller in that each blade 98 extends from the hub 100 in a rearward direction of an associated radius extending from the hub relative to the direction of rotation R of the impeller. For example, FIG. 24 shows a blade 99 extending rearwardly relative to its associated radius X.

[0145] 25A and 25B show a second embodiment of the impeller 90a. The structure of the impeller 90a is similar to that of the impeller 90, except for the blade profile 98a. In this second embodiment, the blade 98a has a profile that includes a blade tip 104 that is partially curved in the impeller rotation direction R. That is, the blade tip 104 is inclined forward. The forward inclined blade tip helps to impart a stronger rotational force to the gas passing through the impeller than a straight or backward inclined blade. The forward inclined blade tip helps to generate a high pressure annulus beyond the tip of each blade. For example, this impeller creates a high pressure annulus between the blade tip and the inner surface of the peripheral side wall of the casing. The inner portion 106 of the impeller blade 98a between the hub 100 and the blade tip 104 can be inclined slightly backward. The backward-sloped blades allow for some recirculation of gas at the blade surface itself. The backward-sloped inner blade portion 106 can help to enhance pressure generation and allow for a steady low reverse gas flow. The impeller of this embodiment is a backward-facing impeller in that each blade 98a extends from the hub 100 in a backward direction with an associated radius extending from the hub relative to the impeller's direction of rotation R. For example, FIG. 25B shows blade 99a extending backward with respect to its associated radius Y.

[0146] It will be appreciated that the impeller of the blower unit may be implemented with any suitable blade profile, whether forward blades, rearward blades, radial blades, or any other suitable profile.

[0147] In either embodiment, the impeller 90, 90a is constructed to be lightweight. This weight reduction is preferably achieved by making the impeller shrouded or at least partially shrouded. A lightweight impeller can be achieved by defining a shrouded centrifugal impeller by having each of the impeller's blades open between the blades (i.e., having the upper and lower "faces" or "planes" of the impeller open to the interior surface of the casing 60 of the blower unit 24), as shown in Figures 23-25B. The weight of the impeller can be substantially reduced by eliminating the shroud on the upper and lower surfaces of the impeller blades. In addition to or instead of eliminating the shroud, the weight of the impeller can be reduced in other ways. For example, lighter materials can be used. Weight can also be reduced by implementing thinner blades with a minimal amount of material and larger gaps between the blades.

[0148] Alternatively, a shroud 101 with some material removed can be used as shown in the third embodiment impeller 90b in Figures 26A and 26B. By providing a shroud with corrugations 103, some material between the vanes 98a is removed. Any suitable amount of material can be removed. The shroud directs air from the impeller. If significant material is removed, the resulting structure can no longer actually perform the function of a shroud, but rather only provide support for the impeller vanes 98a. In this case, the impeller 90b can be considered shroudless, even though it has some structure between the impeller vanes 98a. In a further fourth embodiment impeller 90C shown in Figures 26C and 26D, the structure between the impeller vanes 98a is a web structure 105 centrally located between the upper and lower surfaces of the impeller. Such a structure does not function as a shroud. The material reducing or webbed structures 105 can be of any shape or degree (not just corrugated), two examples of which are shown in Figures 26A-26D.

[0149] A lightweight impeller provides advantages such as manufacturing cost, low rotational inertia, and is well balanced or requires little effort to maintain rotational balance once manufactured. Impellers with low rotational inertia can accelerate and decelerate quickly. Thus, a lightweight shrouded impeller is well suited for rapid response to changing pressure requirements, such as the normal inhalation and exhalation cycles of a patient connected to the respiratory assistance device in which the impeller is operating. In other embodiments, the impeller need not necessarily be lightweight.

[0150] For example, a 17g weight and 6kg.mm inertia are commonly used in respiratory assist devices. 2 A conventional shrouded impeller can respond to a 10cmH2O pressure change in about 2 seconds. On the other hand, it weighs about 1.7 grams and has an inertia of 0.5 kg.mm 2 Impellers according to both embodiments 90, 90a respond to a pressure fluctuation of 10 cmH2O in approximately 100 ms. Figure 40 shows a pressure versus time graph for a conventional shrouded impeller weighing 17 grams. This impeller operates to maintain a constant pressure of 4 cmH2O during a patient's normal inhalation and exhalation cycles. Meanwhile, Figure 41 shows a pressure versus time graph for the preferred impeller 90, 90a. It can be seen that the pressure fluctuations are much less than the conventional impeller of Figure 40 due to the reduced mass and rotational inertia over previous impellers. The reduced pressure fluctuations have the advantage of reducing turbulence to the patient's exhalation process and therefore increasing patient comfort.

[0151] As mentioned above, this light weight can be achieved by eliminating the shroud. However, it is not necessary to eliminate the entire shroud, but rather only enough of it to bring the weight of the impeller to a suitable level, as shown in Figures 26A-26D. Thus, light weight can be achieved by having as much open space (area or volume) between the blades as possible. This open space can be defined as the ratio / proportion of the volume of the blade to the swept volume of the blade. That is, the blades sweep out a volume X as they rotate, and the blades themselves have a combined volume Y (which is the combined volume of each blade). Alternatively, from a perspective view, the open space can be defined as the area of ​​the blade to the swept area of ​​the blade. This ratio should be kept as low as possible. In one embodiment, for example, the swept volume of the impeller is about 19,000 mm 3 The blade is about 1,200 mm 3 Therefore, the ratio of swept volume to blade volume is approximately 16:1, which defines a lightweight impeller compared to the heavier impellers of smaller, higher density designs used in conventional blower units.

[0152] A lightweight impeller may have a weight of, for example, less than 2 grams, preferably 0.8 to 1.8 grams, more preferably 1.2 to 1.7 grams, and even more preferably 1.7 grams. These are just a few examples of preferred embodiments, and the impeller does not have to be this weight, but any other weight that would be considered lightweight.

[0153] Alternatively, the lightweight impeller may be designed to remove as much shroud as necessary to achieve a moment of inertia to radius ratio of preferably less than 15 gram*mm, more preferably 8-12 gram*mm, and in one contemplated embodiment, about 11 gram*mm. For example, in one contemplated embodiment, such an impeller may have a radius of 35 mm, a circumference of 219 mm, and a moment of inertia of 344.22 at 15,000 rpm, a tip speed of 54.98 m / s, a pressure of 1,800 Pa, and a tip speed to inertia to radius ratio of 3.5 or more, such as 5.59. More generally, the lightweight impeller may have dimensions / parameters in the following ranges: radius: 15 mm to 60 mm, weight: less than 2 grams, and a pressure ratio to inertia to radius ratio of greater than 50:1 Pascal per gram*mm, preferably 80:1 Pa or more per gram*mm at 1,000 Pa (note that these ranges are indicative and not limiting).

[0154] Lightweight impellers can be achieved by reducing mass through any suitable means, such as removing shrouds and / or material from the impeller and / or using lighter materials. One possible way to reduce the mass of an impeller is to reduce the number of blades.

[0155] Motor 27-31B, a first embodiment of the motor 80 will now be described by way of example only with reference to a first impeller 90 embodiment, it being understood that this motor could also drive the second embodiment impeller 90a or any other suitable impeller design. In FIG. 31A, the motor used to drive the impeller 90 is shown in cross section, and in FIGS. 27-30 and 31B, various views of the motor components described can also be seen. The motor is preferably a brushless DC motor or a permanent magnet synchronous motor. The controller preferably includes a microcontroller, microprocessor or the like utilising a sensorless vector control method (also referred to as a "field oriented control method"). The central hub 100 of the impeller 90 engages with a drive shaft 110 extending from the motor 80. Attached to the shaft are a number of preferably small magnetic segments forming a rotor 112. In one embodiment, the magnet 112 has a diameter of 20 mm, but more typically this diameter can be less than 20 mm, preferably between 10 mm and 15 mm. Typically, the volume of a magnet is 1600 mm 3 Less than 500mm 3 ~1600mm 3 The rotor 112 is surrounded by a laminated stator 114 (see also FIG. 30) having a plurality of poles and windings that are selectively energized by a controller via connectors coupled to the windings to facilitate rotation of the rotor 112, and thus the drive shaft 110 and impeller 90, about a central axis defined by the centerline of the shaft.

[0156] The drive shaft 110 is held within the motor by a bearing structure, preferably including one or more bearings 116 and one or more bearing mounts 118. The bearing mounts 118 as shown engage the bearings 116 on an inner surface and the stator assembly on an outer surface. The preferred engagement of the bearing mounts to the bearings and stator assembly is frictional engagement. The bearing mounts 118 are made of a soft yet resilient and / or flexible material, such as silicone rubber or other elastomeric material, to facilitate the frictional engagement. The material can be low creep, temperature stable, low compression set (high viscosity) with a high loss factor, and high damping. Examples are shown below. Premixed moulded rubbers such as NBR, nitrile and fluorosilicone, Thermoplastic elastomers (TPEs), such as Exxon's Santoprene; Thermoplastic urethanes such as Dynaplast manufactured by GL, Thermoset casting urethanes such as 10T90 from National Urethanes; and · Several other cold cast rubber-like compounds such as RTV (Room Temperature Vulcanized Hard Rubber) from Dow Corning and Whacker.

[0157] Such materials allow the bearing mount 118 to compress upon introduction and then expand into a selected location to be held in place by the limited dimensions expanded by engagement. The mount 118 is optionally restrained by respective protrusions 119 provided on the upper stator mount 120a and the lower stator mount 120b (bobbin) of the stator assembly or frame that sandwich the stator 114. The stator frame can be configured as an electrical insulator / insulator. Similarly, the bearing 116 can be restrained by a protrusion 118a formed as part of the bearing mount 118. One or both of the protrusions can be located individually around the inner and outer annular portions of the bearing mount, or can extend around the outer periphery of the mount to define a recess in which the mount is located.

[0158] The bearing mounts 118 provide compliance with the rotatable drive shaft 110. Since rotatable objects such as the rotor 112, shaft 110, and impeller 90 typically have some degree of rotational imbalance, the bearing mounts are able to isolate the inherent rotationally induced vibrations from the rotor of the motor. It has been found that the light weight, low rotational inertia shrouded impeller as described above, combined with the given compliance of the bearing mounts, allows for the complete elimination of any balancing process of the rotor 112, shaft 110, and impeller 90 after their manufacture. These advantages are advantageous for manufacturing costs and time. The light weight of the impeller allows any imbalance to be compensated for by the bearing mounts. A light weight impeller also allows for a fast response of the impeller to changing conditions. Any undesirable pressure fluctuations resulting from the absence of a shroud can be compensated for by quickly changing the impeller speed to restore pressure to a desired level.

[0159] It should be noted that although Figure 31A shows the bearing mount 118 mounted within the stator assembly, the mount could equally well be housed external to the motor. Alternatively, the mount 118 could be mounted within a journal formed within the blower casing, for example. Figure 31B shows the bearing mount 118 in a compression configuration rather than a static configuration.

[0160] Optionally, the motor and impeller may be mounted on a corresponding mounting device to provide additional vibration damping of the rotating components of the blower. FIG. 28 illustrates one embodiment of such a mounting device 120. According to an embodiment of the present invention, the mount 120 is most preferably made of a soft, flexible, and resilient material, such as silicone rubber, and may act as a stator insulator. The mounting device 120 has an internal recess or seat 122 that receives and holds the stator. The internal recess is preferably smaller than the outer surface of the motor to facilitate an interference fit between these components. FIG. 27 illustrates the motor 80 positioned within the mounting device 120. In this embodiment, a first set of multiple protrusions 124 extend from the outer periphery wall of the mounting device 120. Also, a second set of multiple protrusions 126 extend below the lower surface of the mounting device 120. The protrusions 124, 126 provide support to the mount and motor assembly. By allowing the body of the mount 120 to move relative to the surface on which the protrusions 124, 126 support or engage during operation of the motor, vibrations caused by imbalance of any of the rotating components are absorbed by each of the protrusions 124, 126. The first set of protrusions 124 are configured to abut or engage the inner surface of the peripheral side wall of the upper region 82 of the casing 60. The second set of protrusions 124 are configured to ride on or engage the upper surface of the casing divider plate 84.

[0161] FIG 42 is a graph of the sound pressure levels of a conventional blower unit tested in an anechoic chamber. FIG 43 is a graph of the sound pressure lever of the blower unit according to the embodiment described above. It can be seen that the lightweight shrouded impeller 90, 90a, flexible bearing mount 118 and flexible motor mount 120 contribute to a significant reduction in noise output over the tested spectral range of 50Hz to 10kHz.

[0162] A second embodiment of the motor and impeller assembly is shown in Figures 32A-32F. Many aspects of this embodiment are the same as those of the previous embodiment. Features not described in this embodiment that are described in connection with the previous embodiment may be assumed to be present in this embodiment, if necessary. Similar features are designated with the same reference numerals as in the previous embodiment. Figure 32E shows in cross section the motor used to drive the impeller 90a. While this embodiment of the motor is shown driving the impeller 90a, it will be understood that any of the other impeller embodiments described may be used. The motor is preferably a brushless DC motor operated using a sensorless vector control ("field oriented control") method, controlled by a microcontroller, microprocessor or similar controller, for example via a connector 255 mounted on a PCB / substrate 256 (such as shown in Figure 32A). This control can be adjusted to suit low inertia impellers. As can be seen with reference to Figures 32A, 32B and 32E, the central hub 100 of the impeller 90a engages with a shaft 160 extending from the motor 161. A plurality of preferably small magnetic segments are attached to the shaft to form the rotor 162. The rotor 162 is surrounded by a laminated stator 241 having an annular outer portion 242, a plurality of poles 243, and windings 168. The stator is attached to a PCB or other substrate 256, and the windings 168 are coupled to a connector 255. The stator 241 has electrical insulators / insulators 270a, 270b (forming a stator frame) that cover the top and bottom of the annular portion 242 and the poles 243. Each winding 168 is preferably mounted on the insulators 270a, 270b that cover each pole 243. The periphery of the upwardly extending circumferential portion 271 and the ends of the upwardly extending poles 272a and downwardly extending poles 272b are provided with projections for engagement and retention.

[0163] Referring to the plan view of one of the laminations 240 in FIG. 32B, each lamination includes an annular outer portion 242 and a pole portion 243 extending radially inward. The edge 244 of each pole portion 243 includes a corrugation. The corrugation includes two recesses 244a, 244b that meet at a central apex 244c. As can be seen with reference to FIG. 32C, when multiple laminations 240 are stacked to form a stator 241, each pole 243 has a corrugated inner radial surface 250 as shown in FIG. 32C. The surface 250 includes two recesses 250a, 250b that meet at a central apex 250c. This configuration reduces cogging. The stator and / or rotor can have asymmetric magnetization. The windings are selectively energized through connectors 255 using a controller to facilitate rotation of the rotor about a central axis defined by the centerline of the shaft 160, and thus the shaft 160 and impeller 90a.

[0164] The shaft 160 is held within the motor by a bearing structure that includes one or more bearings 164 and one or more bearing mounts 260 (see FIG. 32D). As shown in FIG. 32E, the bearing mount 260 as shown engages the bearing 164 on an inner surface 261 and engages the stator 241 / insulators 270a / 270b on an outer surface. The bearing mount 260 includes a main annular body 265 that curves from a lowest point at a central opening 263 to a highest point at an outer periphery 262. The outer periphery includes an engagement lip 264 that preferably has a chamfer 264a at the intersection of the outer periphery 262 and the main annular body 265. The intersection of the inner opening 263 with the inner periphery 261 of this annular body 265 also preferably has a chamfer 261a. Extending upwardly from the main annular body 265 at the inner opening 263 is an annular wall / boss 266. The top 267 of the annular wall 266 has a protruding engagement lip 268. The intersection of the lip 268 with the annular wall 266 and the protruding lip sidewall 268a is preferably chamfered 268b, 268c. The preferred engagement of the bearing mount 260 with the bearing 164 and the stator 241 is frictional engagement. The bearing mount 260 is made of a soft yet elastic and / or flexible material such as silicone rubber or other elastomeric material to facilitate frictional engagement. The material can be low creep, temperature stable, low compression set (high viscosity) with high loss factor, high damping. Possible materials have been described in connection with the previous embodiment. Such materials allow the mount 260 to compress upon introduction and then stretch into a selected location to be held in place by the limited dimensions expanded by the engagement. The mount 260 also provides compliance.

[0165] FIG. 32E shows the bearing mount in a pre-installation / pre-assembly state, with the bearing mount curved upwards in solid lines. The dotted lines show the bearing mount 260 in an installed / assembled state, attached to the stator / insulators 279a, 270b. In the installed state (also referred to as an engaged state or engaged configuration), the annular body engages the stator 241 and / or stator frame 270a, 270b, and the annular body 265 is forced from the curved state (shown in solid lines) to an engaged (flat) configuration (shown in dotted lines) that preloads one or more bearings by the action of the bearing mount providing a biasing force on the stator and / or stator frame and bearings provided by the elastic / flexible body. The mount 260 is optionally restrained by protrusions 272c, 272d formed on the insulators 270a, 270b. Similarly, the bearing 164 can be restrained by a protrusion 268 formed as part of the boss 266 on the bearing mount 260. One or both of the projections may be located around the inner and outer annular portions of the bearing mount, respectively, or may extend around the outer periphery of the mount to define a recess in which the mount sits. The impeller / shaft / rotor is assembled into the stator 241 by assembling the bearing 164 on the shaft 160, assembling the bearing mount 260 on the bearing 164, and manipulating the bearing mount 260 (by hand, jig, or other means) so that they engage the stator insulators 270a, 270b at each pole 243. In an alternative embodiment, the bearing mount 260 does not directly couple to the stator or insulators 270a / 241, but rather to another structure, such as a housing. Any suitable coupling arrangement may be provided with any suitable structure that provides the required functionality as described below.

[0166] The bearing mount 260 provides compliance with the rotatable shaft 160. Since rotatable objects such as the rotor 162, shaft 160, and impeller 90a typically have some degree of rotational imbalance, the bearing mount can isolate the inherent rotationally induced vibrations from the motor rotor. It has been found that the light weight, low rotational inertia shrouded impeller as described above, combined with the given compliance of the bearing mount, allows for the complete elimination of any balancing process of the rotor 162, shaft 160, and impeller 90a after their manufacture. These advantages are beneficial for manufacturing costs and time. The light weight of the impeller allows any imbalance / misalignment to be corrected by the bearing mount 260, which is self-aligning due to the bearing mount compliance (e.g., due to elasticity and / or flexibility). The mount structure, including the bearing geometry and material, provides an axial preload of up to 7 Newtons to the bearing. The annular nature of the bearing provides a consistent / uniform preload around the bearing 164. The bearing can be driven into place and preloaded by a resilient / flexible curved annulus. The annular nature of the bearing mount 260 provides a uniform preload around the circumference of the bearing, and the low creep structural material maintains the preload. The material of the bearing mount 260 is preferably a viscoelastic damping material that also provides damping, thereby reducing the possibility of resonance during operation of the motor. Such a viscoelastic material can also provide the required resilience / flexibility to provide the preload. An example of such a material is a thermoplastic urethane such as Dynaplast by GL. Other materials, such as the above-mentioned resilient and / or flexible materials of the bearing mount 260, can be adapted to provide the required damping by adding mica. The lightweight impeller also allows for a fast reaction of the impeller to changing conditions. Any undesirable pressure fluctuations due to the absence of a shroud can be compensated for by quickly changing the impeller speed to bring the pressure back to the desired level. This bearing mount also provides vibration isolation.

[0167] To provide additional vibration damping of the rotating components of the blower, the motor and impeller may optionally be mounted on a corresponding mounting device (motor mount) 180. One embodiment of such a mounting device 280 is shown in Figures 32A, 32E and 32F. In accordance with an embodiment of the invention, the mount is most preferably made from a soft, flexible and resilient material such as silicone rubber. The mounting device 280 has an annular body 282 including upper and lower engagement lips 282a, 282b that define an internal recess 281 in which the stator 241 is located. The internal recess 281 is preferably smaller than the outer surface of the motor to facilitate an interference fit between these components. Figure 32E shows the motor positioned within the mounting recess 281.

[0168] The upper and lower surfaces of mount 280 are surrounded by a number of protrusions 283. The ends of the protrusions protrude beyond the upper and lower surfaces of the mount to provide support for the mount and motor assembly. During operation of the motor, vibrations caused by imbalance of any of the rotating components are absorbed by each of the protrusions by allowing the body of mount 280 to move relative to the surface on which the protrusions 283 are supported.

[0169] In the above description, an embodiment of a blower unit including a lightweight impeller assembly has been described. Figures 31A and 32E show an embodiment with a metal shaft (such as steel) 110, 160 mounted on a magnet rotor 112, 162. The metal shaft is press fit into an opening in the magnet rotor. This requires close tolerance control to ensure a good interference fit with minimal slippage. However, the fit should not be so tight that there is a risk of the magnet rotor cracking.

[0170] An alternative shaft and magnet rotor assembly that can be used in the stator instead of the assemblies shown in Figures 31A or 32E is shown in Figures 33A-33F.

[0171] 33A, 33B and 33C show another possible rotor assembly of the above-described embodiment. The assembly includes a metal shaft 400 (see FIG. 33C) and a magnet rotor 401. The magnet rotor 401 has a central opening 402. The central opening 402 has a central portion including indentations 403a-403d. The central opening also includes a contoured edge that forms a stepped shelf 408 (see FIG. 33B) in the central cross section. The metal shaft 400 has a knurled portion 409b on its exterior and extends through the central opening 402. A plastic insert 403 is injection molded between the shaft 400 and the magnet rotor 401 in the central opening 402. The plastic insert 403 is overmolded onto the stepped shelf 408 of the magnet rotor. This gives the insert 403 a similar profile to the central opening 402. An interlocking portion (cog-dog) is formed between the shaft 400 and the overmolded (insert) material 403 such that the knurled portion 409b of the metal shaft engages the overmolded insert 403 to couple the shaft 400 to the magnet rotor 401. The assembly 404 can also be used in the embodiments described above such as in Figures 31A and 32E, where the shafts 110, 160 and magnet rotors 112, 162 of those embodiments are replaced with the metal shaft 400 / plastic insert 403 / magnet rotor 401 assembly 404 as described in Figures 33A, 33B and 32C. The assembly can be formed as shown in Figure 33G. The rotor is placed in the mold (step 440), the shaft is introduced (step 441), the other mold half is introduced (step 442), the insert is injection molded between the shaft and rotor (step 443), and then the mold is removed (step 444).

[0172] 33D illustrates plan, elevation, and isometric views of a magnet rotor and shaft assembly 420 according to another alternative embodiment. The assembly 420 includes a rotor 401 formed of a magnetic material. The magnet rotor 401 has a central opening 402. The central opening 402 has a central portion that includes indentations 403a-403d. The central opening also includes a contoured edge that forms a stepped shelf 408 in the central cross section.

[0173] The assembly 420 also includes a plastic shaft 421 that extends through the center of the insertion opening 410 and is overmolded onto the magnet rotor 401 as described below. When overmolded, the shaft includes an integral overmolded magnet insert 423. The shaft 421 may be formed with a hexagon 422 or other position profile for press fit mating with the impeller. The plastic shaft 421 includes any suitable plastic, such as acetyl or polypropylene, or a combination thereof, although any suitable injection molded or other plastic may be used.

[0174] The assembly 420 may also be used in the embodiments described above, such as in Figures 31A and 32E, in which case the shafts 110, 160 and magnet rotors 112, 162 of those embodiments are replaced with a plastic shaft 421 / magnet rotor 401 assembly 420 as described in Figure 33D.

[0175] 33E and 33F show an injection mold that can be used to manufacture the shaft / rotor assembly 420, and FIG. 33H is a flow diagram of a manufacturing method. The mold 420 is an openable two-part mold that includes a first mold part 431a and a second mold part 431b that come together to form a mold / cavity 432 that includes the magnet jig 433. The mold includes a cavity for forming the shaft 421, the hexagonal interlocking shape 422, and the overmolded portion 423. During the manufacture of the assembly 420, the magnet rotor 401 with the opening 402 as described above is introduced into the mold and placed in place on the mold half that forms the jig 433 (step 450). The top part 421a of the mold is placed in place to form the mold cavity 432 with the bottom part 421b (step 451). The injection molding process is started to injection mold plastic to form the shaft 421 overmolded onto the magnet rotor 401 (step 452). The injection molding process overmolds plastic onto the stepped ledges 408 of the rotor magnet 401 to form the inserts 423. Once the injection molding process is complete, the mold sections 421a, 421b are removed (step 453) leaving the assembly 420. The assembly 420 can then be used in the motor of, for example, FIG. 31A or FIG. 32E.

[0176] Heretofore, it has not been possible to use a plastic shaft / rotor assembly in a blower motor for a CPAP machine or similar machine. Plastic shafts are not strong enough to withstand the forces generated by such motors. However, the lightweight impeller embodiments described above only generate forces that make a plastic shaft rotor possible. The light weight and low inertia of the rotor, as well as flexible bearing mounts and other features that reduce unbalanced and other forces, make the use of a plastic shaft possible. Both the plastic rotor assembly and its manufacturing method provide advantages over existing metal shaft rotors.

[0177] The combination of various motor and impeller features provides advantages that can be achieved with a single impeller. The use of a lighter / lower inertia impeller (e.g., by removing some or all of the shroud and / or reducing blade material) reduces impeller imbalance due to manufacturing tolerances. Previously, material had to be removed / added to the impeller after manufacturing and during assembly of the blower to improve balance. The light weight of the impeller means that any slight imbalance can be tolerated without the need for adjustment. In addition, the resilient / flexible bearing structure mount 118 and / or stator mount 120 can compensate for any imbalance of the impeller, even if the imbalance is not that small. The impeller is light enough that any imbalance is small enough that it can be compensated for by the bearing structure mount 118, without the need to change the weight of the impeller during assembly. In addition, the small magnets in the motor (combined with the bearing structure) eliminate the need for balancing during assembly, improving dynamic performance.

[0178] The resilient / flexible bearing structure allows for self-alignment, compliance, damping and preloading of the impeller and shaft assembly. This eases assembly and, combined with the light weight / low inertia impeller, reduces or eliminates the need for balance corrections during assembly as described above. The bearing structure compensates for larger tolerances, thus relaxing tolerances during manufacturing. The bearing structure also provides vibration isolation and / or damping, and allows for high RPM speeds of the impeller if desired. The stator frame / motor mount also provides vibration isolation.

[0179] A casing configuration that separates the blower into different internal regions separates high velocity regions to reduce noise, allows and maintains a constant high flow velocity, and spreads this velocity out into pressure.

[0180] The use of plastic shafts also offers several advantages over metal shafts (such as steel), including (but not limited to):

[0181] Reliability risks associated with dissimilar materials are reduced.

[0182] The knurled interface between the cog / dog insert and the shaft does not need to be monitored for cracks, slippage, leakage, shrinkage, fluid ingress / corrosion.

[0183] Improved impeller to shaft interface, similarly reducing reliability risks. Less susceptible to cracking due to similar thermal expansion (from pressing plastic into plastic). Opportunity to add some fixed features such as hexagons or grooves, reducing the chance of slippage.

[0184] The plastic shaft assembly is press-fit rather than slip-fit, which increases stability and reduces rattle noise.

[0185] The cost is reduced compared to metal shafts for the following reasons:

[0186] The plastic nature of the plastic shaft allows for a much larger tolerance or imprecision to be tolerated for pressing in the bearings, so there is no need to manufacture the shaft to snug fit tolerances.

[0187] There is no need to grind the shaft to restore straightness after knurling.

[0188] There is no need to manipulate the shaft to insert it into the mold.

[0189] Materials with better vibration absorbing properties than steel can be used.

[0190] Ease of assembly can be improved by reducing the shaft diameter with a hexagon and by reducing the length of the bearing press fit engagement by undercutting the impeller side of the shaft.

[0191] In general, the following advantages of the motor and impeller of this embodiment are provided by a combination of one or more of the following features:

[0192] [Table 1]

[0193] headgear 34-39, various headgear configurations for securing the breathing apparatus 20 to the head of a user are described in further detail. These embodiments are provided by way of example only, and those skilled in the art of respiratory apparatus patient interfaces will appreciate that various other headgear configurations could alternatively be used. Typically, the headgear includes one or more head straps that connect to the breathing apparatus and extend around the user's head to secure or attach the breathing apparatus to the user's head.

[0194] Referring to FIG. 34, a first embodiment of a headgear 201 for fastening the breathing apparatus 20 to the user's head 1 is shown. In this embodiment, the headgear includes upper headgear straps 203 coupled at each end to either side of the forehead support 32 and extending around the back of the user's head at a height above the ears in the forehead region of the user's head. Specifically, each end of the headgear straps 203 is coupled or connected to a respective connection opening 40 provided in the forehead support 32 of the body 22. The headgear 201 also includes lower headgear straps 205 configured to fasten or hold a lower portion of the breathing apparatus 20 against the user's face in the region of the mask 26, and configured primarily to hold the mask 26 in sealing engagement around the nose of the user's face. The headgear straps 203, 205 in this embodiment are formed of a laminate of open cell foam sandwiched between two textile sheets, although any other suitable material could be used.

[0195] In this embodiment, the lower headgear straps 205 are connected to the mask body 34 of the respiratory apparatus body 22 by an elongated slide member 207. Specifically, the elongated slide member extends across the front of the mask body 34 and is attached to the mask body via at least one clip 52. In this embodiment, the elongated slide member 207 can slide or glide within the clip 52 to allow the mask assembly to move laterally relative to the headgear straps 205. The lower headgear straps 205 are coupled at both ends to respective ends of the elongated slide member 207. In this embodiment, each end of the lower straps 205 is coupled to or looped around a hook structure 207a formed at each end of the elongated slide member 207. It will be appreciated that alternative embodiments may employ fixed or stationary configurations for connecting the lower straps to the mask body.

[0196] Integrated battery-powered headgear Referring to Fig. 35A, a second embodiment 211 of headgear for mounting the breathing apparatus 20 on the head 1 of a user is shown. In this embodiment, the headgear 201 includes upper and lower headgear straps 213 and 215 that are coupled to the breathing apparatus in a similar manner to the upper and lower headgear straps described with respect to the embodiment of the headgear 201 of Fig. 34. However, in this embodiment, one or more power modules of the breathing apparatus, which may be in the form of one or more battery packs, are integrated, fixed or attached to the headgear. In this embodiment, one or both of the upper and lower headgear straps 213 and 215 include integrated battery packs or modules connected to each other and configured to provide power to the breathing apparatus 20 via a power loom or cable 217 connected to a battery.

[0197] These batteries can be integrated into the straps 213, 215 in a variety of ways. In one embodiment, the straps can be formed of a material that includes an internal pouch, pocket, or chamber that holds the batteries. The recess or cavity in the head strap can be sealed or can be openable so that the batteries can be removed and replaced as needed. It is not necessary for the battery packs to be attached within or inside the headgear. For example, one or more battery packs or packages can be releasably attached to any portion of the headgear such that they can be removed from the headgear.

[0198] Typically, the battery type and configuration is selected based on parameters such as energy density per volume and mass, i.e., watt-hours per kilogram and watt-hours per cubic centimeter. In some embodiments, high density batteries such as lithium polymer and lithium ion batteries can be used. Alternatively, it will be understood that non-rechargeable or disposable batteries can be used instead, if desired.

[0199] Referring to FIG. 35B, a third embodiment of headgear 221 for mounting the respiratory apparatus 20 on the head of a user is shown. Again, the headgear 221 has an upper head strap 203 and a lower head strap 205 of the type described with respect to the first embodiment of the headgear 201 of FIG. 34. Also provided on the top of the user's head is a flexible battery package module 223 configured to extend at least partially over the top of the user's head and secured to the top straps 203 of the headgear via a web or mesh material. Specifically, whether the material is a web, mesh or other flexible material, its base is configured to extend over at least a portion of the top of the user's head and secured to the top straps 203 on either side of the user's head. This battery package module 223 may include one or more batteries as described with reference to FIG. 35A for powering the respiratory apparatus via a power cable 217. The battery package module 223 may include a flexible material having an internal pouch, pocket or recess for securely receiving and holding one or more batteries.

[0200] In those embodiments in which the battery pack is provided within or otherwise attached to the headgear, the headgear may also include one or more shielding plates that are positioned between the battery and the user's head when the headgear is worn. The one or more shielding plates provide physical and electromagnetic shielding to the user. In some embodiments, the shielding plates may be formed of a metallic material. In some embodiments, the shielding plates may be embedded within or integrated into the headgear material so as not to cause discomfort to the user. Alternatively, the shielding plates may be fixedly or releasably attached to the headgear in any other suitable manner.

[0201] Yet another headgear configuration 36-39 show various other breathing apparatus configurations and alternative headgear configurations, the operation and functionality of which are similar to those described above with respect to breathing apparatus 20.

[0202] The breathing apparatus 230 shown in FIG. 36 includes a main housing 231 having a blower unit 232 located at the top of the breathing apparatus, configured to be worn on the forehead region of a user 1, a mask assembly 233, and a body 231. The headgear of the breathing apparatus includes upper headgear straps 234 and lower headgear straps 235 configured to secure the breathing apparatus to a user in the manner described with reference to FIGS. 34-35B. In this embodiment, the blower unit 232 has one or more user interface control buttons 236 operable by a user that may be configured to switch the blower unit on and off and / or control one or more operational modes. FIGS. 37-39 show a breathing apparatus 203 having a variety of different control button 236 configurations. The user interface may include one button, two buttons, or multiple buttons that may serve alone or interactively to control one or more operational modes and / or functions of the apparatus. It will be appreciated that the control button or buttons may be any form of tactile switch, dial or knob, or touch-sensitive button, or any other operable user interface mechanism. In some embodiments, the control button or buttons are located on the front side of the blower unit in the forehead area of ​​the respiratory apparatus, but may also be located on the body of the respiratory apparatus, or on the patient interface, or other area, if desired.

[0203] Base station configuration Various base station configurations for one or more of the types of wearable respiratory devices described above are further detailed, by way of example only, with reference to Figures 44-50. Various wireless power transfer configurations are described, and it will be understood that in some embodiments a typical connection range between a transmitter and receiver of such a system may be up to 2m, although greater ranges may be achieved depending on the hardware used. It will be understood that features of the various base station embodiments may be combined and interchanged as desired to form further configurations.

[0204] Generally speaking, in various embodiments, the base station may include any one or more of the following modules or systems: a power system that provides power to the respiratory assistance device, a data transfer system that transmits and receives data to and from the respiratory assistance device, and a control system that controls the respiratory assistance device via control signals. The control system may operate automatically and / or may include a user interface that allows a user to control the head mounted breathing device. Each of these systems may be operatively connected to the head mounted breathing device via a hardwired connection, such as a connecting cable, and / or wirelessly via a wireless medium.

[0205] In some embodiments, the base station is further configured as a physical docking station in which the head mounted respiratory apparatus can be stored and / or attached when not in use, however in other embodiments the base station performs power supply, data transfer and / or control aspects when connected via a hardwired connection or within wireless range.

[0206] Base station of the first embodiment using an independent wireless power transmission mat As can be seen with reference to Fig. 44, in this first embodiment the base station 300 takes the form of a clinical module adapted to be placed near the bed of the user, although it will be understood that the base station is portable so that it can be placed in any suitable location within range of the respiratory apparatus when in use. The base station includes a data transfer system having one or more communication modules for communicating with the respiratory apparatus 301 and other external devices or systems via any type of wireless communication medium, protocol or network, including but not limited to Wi-Fi, Bluetooth, Cellular 3G or the like, or using a wired communication link. In this embodiment, the base station includes a first communication module 302 adapted to communicate with an external system 307 or network to transmit compliance data regarding the use of the respiratory apparatus by the user to a healthcare provider or other relevant entity. In this embodiment, the first communication module 302 of the base station communicates with the external system 307 via a wireless medium, although a wired communication link or connection can also be used. For example, the base station can be connected to an external system such as a personal computer, a server, a network such as a LAN, via a communication cable link using USB or Ethernet or the like. It will be appreciated that the base station may also be connected wirelessly or via a wired connection to a stand-alone communication or transmission device for transmitting data to another device or system.

[0207] The base station also includes a second communication module 303a that communicates wirelessly or via a wired connection with a complementary communication module 303b built into the respiratory device. This second communication module can be used to retrieve usage compliance data from the respiratory device and store it in an integrated data storage medium of the base station and / or further transmit it to an external system as described above. The second communication module 303a can also transmit control signals for configuring operating parameters or settings of the respiratory device. The base station includes a control system for generating the control signals automatically or in response to signals generated by a user interface that a user can operate to control such operating parameters or settings via the second communication module 303a. By way of example, the control signals can be used to initiate various operating modes of the respiratory device, including but not limited to an on / off mode that can switch the device on and off, a charging mode that charges an internal power source, a drying mode that operates the blowing unit for a predetermined time to dry the gas flow path after use, and a data transfer mode that transfers user usage data and / or sensor data to the base station.

[0208] In some embodiments, the control system may be configured to automatically send control signals to the respiratory apparatus for controlling one or more of the operational modes, including starting, stopping or otherwise controlling these operational modes, based on whether an operable connection (wired or wireless) is detected between the base station and the respiratory apparatus.

[0209] The second communication module 303a may optionally be configured to receive sensor signals and / or sensor data directly from any wireless sensors embedded in the respiratory apparatus.

[0210] Either or both of the respiratory device 301 and the base station 300 may be provided with removable data storage media to allow transfer of compliance data.

[0211] The base station may be powered by a power source such as a stand-alone AC power adapter 304 coupled to a mains AC voltage source 306. It will be appreciated that in alternative embodiments, the AC power adapter circuitry may be integrated into the base station.

[0212] In this embodiment, the base station provides a power system in the form of a connected power mat 305 configured to transfer power via wireless power transfer to the unconnected respiratory apparatus 301. In use, the power mat 305 is located under the user's pillow for loosely coupled power transfer when the user is wearing the respiratory apparatus while sleeping. Power received from the power mat can be used to power the respiratory apparatus and / or to charge any energy storage device such as a battery pack, supercapacitor, etc. built into the respiratory apparatus. In this embodiment, power is transferred from the power mat 305 to the respiratory apparatus 301 using magnetic resonance power transfer or a similar method.

[0213] The power system may also optionally be configured to directly power any wireless sensors contained within the respiratory apparatus.

[0214] Second embodiment base station with integrated wireless power transfer As can be seen with reference to Fig. 45, the base station 310 of the second embodiment is similar to the base station of the first embodiment, with like reference numbers indicating like features and functions. The main difference of the second embodiment is that wireless power transfer hardware is integrated into the base station so that data communication and power transfer can occur simultaneously over the same connection, i.e. wireless connection medium, between the base station and the wearable respiratory device. As shown, the base station can wirelessly power 311 a wearable respiratory device 312 that does not have a built-in energy storage device (such as a battery pack or supercapacitor), or power and / or charge a wearable respiratory device 313 that does have a built-in energy storage device. As shown, the base station and the respiratory device also include a communication module as described in the first embodiment.

[0215] Base station of the third embodiment using a data hub As can be seen with reference to Fig. 46, the base station of the third embodiment takes the form of a data hub 320. The data hub 320 communicates with the respiratory device 322 via communication modules 303a, 303b as described above. The data hub 320 also wirelessly communicates 302 with an external system 321, such as a computer or a portable communication device such as a laptop, tablet, smartphone or the like. A user can operate a computer or application program running on the external system to wirelessly control settings or operating parameters of the respiratory device. It will be appreciated that in alternative embodiments, the external system 321 and the respiratory device 322 can also communicate directly without the use of the data hub 320. As described above, compliance data and device settings are wirelessly relayed from the respiratory device to the standalone data hub 320 for storage and / or further wirelessly transmitted to the external system. Removable media can also be used for the transfer of data in these two steps.

[0216] In this third embodiment configuration, a power source 304, such as an AC adapter connectable to a mains AC voltage 306, can be connected to the components of the respiratory apparatus via a power cable 327 to power or charge, i.e. the respiratory apparatus is physically connected to this power source to operate and / or charge any on-board energy storage devices. The intention is to allow the battery to be charged while the apparatus is not in use, however, in a connected mode of operation, the apparatus can be used and charged at the same time, as shown at 325. Similarly, the battery can be removed from the headgear / blower for charging, as shown at 324, or the respiratory apparatus can be used without a battery by connecting the power source directly to the respiratory apparatus, as shown at 326. The battery or power connection to the respiratory apparatus can include a breakaway electrical connection, such that the cable can be pulled out of the battery or apparatus if a significant pulling force is applied.

[0217] Base station of the fourth embodiment using a battery dock As can be seen with reference to FIG. 47, the base station 330 of the fourth embodiment also includes communication modules 302, 303 allowing the transmission and storage of compliance data as well as allowing the user to change the operational settings of the respiratory apparatus via a user interface on the base station.

[0218] The base station is powered by an AC adapter 304 connected to the AC voltage of the mains 306, although it will be understood that the AC adapter circuitry can also be integrated into the base station. The base station includes a battery dock for receiving and charging a removable energy storage device such as a battery or battery pack 331 of the breathing apparatus, i.e. the battery is physically removed from the headgear of the breathing apparatus and docked in the base station for charging. A power cable 332 extends from the base station and can optionally be connected to the breathing apparatus for powering and / or charging. For example, the power cable 332 can be connected to a breathing apparatus 333 having an internal battery 334 to allow the breathing apparatus to be connected and used while simultaneously charging the battery. Alternatively or additionally, the power cable can be connected to a non-battery powered breathing apparatus as shown at 335 to allow such an apparatus to be connected and used. Again, the power connection to the battery or breathing apparatus can include a breakaway electrical connection such that the cable is pulled out of the apparatus if a significant pulling force is applied.

[0219] Fifth embodiment of base station using integrated wireless power transmission mat As can be seen with reference to figure 48, the base station 350 of the fifth embodiment has a similar configuration to the base station of the fourth embodiment, with like reference numbers indicating like features and functions. The main difference is that the base station 340 of the fifth embodiment does not have a battery dock, but an integrated charging mat 341 of the type described for the base station of the first embodiment, arranged to transfer power to the respiratory device 342 via wireless power transfer. For example, the battery of the respiratory device is physically placed on this charging mat 341 for charging. Charging can be done either with the battery still attached to the respiratory device (as shown) or with the battery removed and placed on the mat by itself. The charging mat 341 can be open-sided (as shown) or integrated into a housing so that the device is hidden during charging.

[0220] Base station of the sixth embodiment using plug-in charging As can be seen with reference to Figure 49, the base station 340 of the sixth embodiment has a similar configuration to the base station of the fifth embodiment, with like reference numerals indicating like features and functions, the main difference being that the base station 350 of the sixth embodiment does not have a battery dock, but rather can optionally connect a power cable 332 to a battery pack 336 that is removable from the breathing apparatus.

[0221] Seventh embodiment base station using stand-alone wireless power and data transfer mat As can be seen with reference to Fig. 50, the base station 360 of the seventh embodiment is similar to the base station of the first embodiment, with like reference numbers indicating like features and functions. The main difference of the seventh embodiment is that a communication module for communicating with the respiratory apparatus 301 is integrated in the power mat 305. In particular, the power mat 305 includes both a wireless power transfer transmitter or transmitter circuit 305a and a communication module communication circuit 305b. The wireless power transfer transmitter 305a is configured for loosely coupled power transfer to a complementary wireless power transfer receiver or receiver circuit 362a provided in a control board 362 of the respiratory apparatus 301. Similarly, this control board also includes a communication module communication circuit 362b for communicating with the communication module 305b of the power mat 305. In this configuration, both power and data can be transferred from the power mat 305 to the respiratory apparatus 301 via the same or a single wireless connection medium or link 365.

[0222] As shown, the power transfer at 305 is connected to a base station 360 via cable 367. This connection 367 enables the base station 360 to power the wireless power transfer circuitry of the power mat 305 as well as to transmit and receive data to and from the respiratory apparatus. In particular, the base station can transmit control signals to configure the operating parameters or settings of the respiratory apparatus as well as retrieve usage compliance data from the respiratory apparatus as described with reference to the first embodiment of the base station in Fig. 44.

[0223] As described in the first embodiment with reference to FIG. 44, the power received from the power supply mat can be used to power the breathing apparatus and / or to charge any energy storage device such as a battery pack, supercapacitor, etc. built into the breathing apparatus.

[0224] In this seventh embodiment, a control board 362 built into the breathing apparatus is shown attached to headgear 363, specifically to a top head strap at the top of the user's head. The control board 362 is then connected via cable 364 to the blower unit of the breathing apparatus 301 and / or to any further control circuitry within the blower unit housing. However, it will be appreciated that in alternative embodiments the control board 362 could be integrated into the main housing of the breathing apparatus rather than being attached to the headgear as shown.

[0225] The above description of the invention includes preferred forms thereof, to which modifications may be made without departing from the spirit and scope of the invention as defined by the appended claims. [Explanation of symbols]

[0226] 20 Breathing apparatus 22 Main unit 24 Blower unit 26 Mask

Claims

1. 1. A respiratory assistance system comprising: a portable respiratory assistance device configured to be operatively connected to an independent base station; The base station, a power supply system for supplying power to the respiratory assistance apparatus; a data transfer system for transmitting and receiving data to and from the respiratory assistance device; a control system for controlling said respiratory assistance apparatus via a control signal; Equipped with the portable respiratory assistance device is configured to provide a flow of respiratory gas to a user; The portable respiratory aid device comprises a body and a blower unit mounted on the body having a gas inlet for receiving a supply of gas from the ambient atmosphere and for generating a pressurized gas flow at a gas outlet; the portable respiratory assistance device is connectable to a patient interface having a gas inlet fluidly connectable to the gas outlet of the blower unit via a gas flow path and configured to deliver pressurized gas to the user's nose and / or mouth via one or more gas outlets; The portable respiratory assistance device is a wearable device, and the main components of the portable respiratory assistance device are provided in a wearable unit. A respiratory support system comprising:

2. the power supply system of the base station is configured to transmit power to the respiratory assistance device via one or more power transmission cables; 2. The respiratory assistance system according to claim 1 .

3. the power supply system of the base station includes wireless power transfer circuitry configured to wirelessly transfer power to the respiratory assistance device; 2. The respiratory assistance system according to claim 1 .

4. the data transfer system of the base station includes a first communication module for transferring data between the base station and the respiratory assistance device via a wired or wireless communication medium; A respiratory assistance system according to any one of claims 1 to 3.

5. The data transfer system of the base station further comprises a second communication module for transferring data between the base station and an external server via a wired or wireless communication medium; 5. A respiratory assistance system as claimed in claim 4.

6. the control system of the base station sends control signals to the respiratory assistance device to control any one or more of the following operational modes: an on / off mode, a charging mode, a drying mode, and / or a data transfer mode; A respiratory assistance system according to any one of claims 1 to 5.

7. the control system of the base station is configured to automatically send control signals to the respiratory assistance device for controlling one or more modes of operation based on whether an operable connection between the base station and the respiratory assistance device is detected.

7. A respiratory assistance system as claimed in claim 6.

8. the respiratory assistance device includes one or more sensors configured to sense various operating parameters and generate representative sensor signals, the wireless power source being configured to provide power to the sensors; A respiratory assistance system according to any one of claims 1 to 7.

9. the one or more wireless sensors are configured to wirelessly transmit the generated sensor signals directly or indirectly to a separate external device or system; 9. A respiratory assistance system as claimed in claim 8.

10. the respiratory assistance device includes an on-board electronic controller configured to store usage data indicative of use of the respiratory assistance device by the user, and the communications module configured to wirelessly transfer the usage data to a separate external device or system. A respiratory assistance system according to any one of claims 1 to 9.

11. The respiratory assistance system further comprises a power supply module(s), the power supply module(s) including one or more energy storage devices selected from a battery or battery pack (rechargeable or disposable), a fuel cell and / or a capacitor. A respiratory assistance system according to any one of claims 1 to 10.

12. the base station is configured to receive and hold the respiratory assistance apparatus when not in use; A respiratory assistance system according to any one of claims 1 to 11.

13. the portable respiratory aid device includes an integrated electronic controller mounted on or within the respiratory aid device, which controls the blower unit and thereby controls the pressure of breathing gas delivered to the user; A respiratory assistance system according to any one of claims 1 to 11.

14. The patient interface is provided on the body. A respiratory assistance system according to any one of claims 1 to 13.

15. The portable respiratory assistance device is configured as a positive airway pressure (PAP) device.

15. A respiratory assistance system according to any one of claims 1 to 14.

16. The wearable device is a head-worn device.

16. A respiratory assistance system according to any one of claims 1 to 15.

17. the main components of the device are provided in a unit that can be fixed to a user's head; 17. A respiratory assistance system as claimed in claim 16.

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