Patent ID: 12194244

5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

The following description is provided in relation to various examples which may share one or more common characteristics and/or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.

5.1 THERAPY

In one form, the present technology comprises a method for treating a respiratory disorder comprising the step of applying positive pressure to the entrance of the airways of a patient1000.

In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

5.2 TREATMENT SYSTEMS

In one form, the present technology comprises an apparatus or device for treating a respiratory disorder. The apparatus or device may comprise an RPT device4000for supplying pressurised air to the patient1000via an air circuit4170to a patient interface3000, e.g., seeFIG.1.

5.3 PATIENT INTERFACE

As shown inFIG.2, a non-invasive patient interface3000in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure3100, a plenum chamber3200, a positioning and stabilising structure3300, a vent3400, one form of connection port3600for connection to air circuit4170, and a forehead support3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure3100is arranged to surround an entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways.

If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.

The patient interface3000in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 6 cmH2O with respect to ambient.

The patient interface3000in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 10 cmH2O with respect to ambient.

The patient interface3000in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure of at least 20 cmH2O with respect to ambient.

5.4 RPT DEVICE

An RPT device4000in accordance with one aspect of the present technology comprises mechanical, pneumatic, and/or electrical components, e.g., seeFIG.3, and is configured to execute one or more algorithms, such as any of the methods, in whole or in part, described herein. The RPT device4000may be configured to generate a flow of air for delivery to a patient's airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

In one form, the RPT device4000is constructed and arranged to be capable of delivering a flow of air in a range of −20 L/min to +150 L/min while maintaining a positive pressure of at least 6 cmH2O, or at least 10cmH2O, or at least 20 cmH2O.

A power supply may be located internal or external of the external housing of the RPT device4000.

In one form of the present technology, power supply provides electrical power to the RPT device4000only. In another form of the present technology, power supply provides electrical power to both RPT device4000and humidifier5000.

In one form of the present technology, the RPT device includes a central controller including one or a plurality of processors suitable to control an RPT device4000.

Suitable processors may include an x86 INTEL processor, a processor based on ARM® Cortex®-M processor from ARM Holdings such as an STM32 series microcontroller from ST MICROELECTRONIC. In certain alternative forms of the present technology, a 32-bit RISC CPU, such as an STR9 series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may also be suitable.

In one form of the present technology, the central controller is a dedicated electronic circuit.

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

The central controller may be configured to receive input signal(s) from one or more transducers, one or more input devices, and the humidifier5000.

The central controller may be configured to provide output signal(s) to one or more of an output device, a therapy device controller, a data communication interface, and the humidifier5000.

In some forms of the present technology, the central controller is configured to implement the one or more methodologies described herein, such as the one or more algorithms expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory. In some forms of the present technology, the central controller may be integrated with an RPT device4000. However, in some forms of the present technology, some methodologies may be performed by a remotely located device. For example, the remotely located device may determine control settings for a ventilator or detect respiratory related events by analysis of stored data such as from any of the sensors described herein.

5.5 AIR CIRCUIT

An air circuit4170in accordance with an aspect of the present technology is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components such as RPT device4000and the patient interface3000.

In particular, the air circuit4170may be in fluid connection with the outlet of the pneumatic block and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.

In some forms, the air circuit4170may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air. The heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors. In one form, the heated wire circuit may be helically wound around the axis of the air circuit4170. The heating element may be in communication with a controller such as a central controller. One example of an air circuit4170comprising a heated wire circuit is described in U.S. Pat. No. 8,733,349, which is incorporated herewithin in its entirety by reference.

5.6 HUMIDIFIER

5.6.1 Humidifier Overview

In one form of the present technology there is provided a humidifier to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient's airways.

FIGS.4A to4Cshow a RPT device4000and an integrated humidifier5000according to an example of the present technology. In the illustrated example, the humidifier5000includes a water reservoir dock5130structured to receive a water reservoir5110. Water reservoir5110may, throughout this specification, also be referred as a reservoir, a humidification reservoir or a humidification tub. As shown inFIGS.4A to4C, the water reservoir dock5130includes a cavity5160formed therein to receive the water reservoir5110, e.g., the water reservoir5110may be insertable/removable from the water reservoir dock5110in a lateral direction.

In the illustrated example, the RPT device4000is integrated with the humidifier5000. In this arrangement, the water reservoir dock5130is structured to connect the water reservoir5110to the pneumatic path. As best shown inFIGS.4A and4C, the reservoir dock5130comprises a dock air outlet5168to deliver a flow of air to the water reservoir5110, a dock air inlet5170to receive the flow of air that has been humidified in the water reservoir5110, and a humidifier outlet5172to transfer the flow of humidified air to the air circuit4170. The cavity5160may include a top portion configured to cover at least a portion of the lid of the water reservoir5110and a bottom portion including a heater plate5120.

However, it should be appreciated that the reservoir dock5130may be provided separately to RPT device4000in an alternative arrangement. In such an arrangement, additional interfaces may be used to connect the reservoir dock5130to the RPT device4000, e.g., directly coupled or coupled via an air circuit.

In another arrangement, the water reservoir dock5130may comprise an opening in a substantially horizontal plane, so that the water reservoir5110may be inserted from above or below the water reservoir dock5130.

Further examples and details of such RPT device4000and integrated humidifier5000are described in PCT Publication No. WO 2014/138804, published Sep. 18, 2014, which is incorporated herein by reference in its entirety.

5.6.2 Humidifier Components

5.6.2.1 Water Reservoir

FIGS.5A and5Bshow a water reservoir or tub5110according to an example of the present technology. The water reservoir5110includes a cavity (e.g., provided by a body or base of the water reservoir) configured to hold, or retain, a volume of liquid (e.g., water) to be evaporated for humidification of the flow of air. The water reservoir5110may be configured to hold a predetermined maximum volume of water in order to provide adequate humidification for at least the duration of a respiratory therapy session, such as one evening of sleep. Typically, the reservoir5110is configured to hold several hundred millilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400 ml, although it is to be understood that other volumes of liquid may be utilized, e.g., at least 100 ml. In other forms, the humidifier5000may be configured to receive a supply of water from an external water source such as a building's water supply system.

In the illustrated example, the water reservoir5110includes a reservoir body or base5112and a reservoir lid5114removably coupled to the reservoir base. A compliant portion or deformable seal5116may be provided to the reservoir lid5114and/or to the reservoir base5112. When the reservoir lid5114is coupled to the reservoir base5112, the seal5116is structured and arranged to engage between the reservoir lid5114and the reservoir base5112to seal the reservoir lid5114and the reservoir base5112and prevent egress of water from the water reservoir5110. The reservoir lid5114may be structured to be fully removable from the reservoir base5112, e.g., for patient usability to clean the interior of the reservoir base5112and/or the reservoir lid5114. In an alternative example, the reservoir lid5114may be permanently attached to the reservoir base5112.

According to one aspect, the water reservoir5110is configured to add humidity to a flow of air from the RPT device4000as the flow of air travels therethrough. In one form, the water reservoir5110may be configured to encourage the flow of air to travel in a tortuous path through the reservoir5110while in contact with the volume of water therein.

According to one form, the water reservoir5110may be removable from the humidifier5000, for example in a lateral direction as shown inFIG.4BandFIG.4C.

The reservoir5110may also be configured to discourage egress of liquid therefrom, such as when the reservoir5110is displaced and/or rotated from its normal, working orientation, such as through any apertures and/or in between its sub-components. As the flow of air to be humidified by the humidifier5000is typically pressurised, the reservoir5110may also be configured to prevent losses in pneumatic pressure through leak and/or flow impedance.

In the illustrated example, the reservoir lid5114comprises an inlet5118for receiving the flow of air into the reservoir5110and an outlet5122for delivering a flow of air from the reservoir5110. The reservoir lid5114is pivotably connected to the base5112by hinges5158to allow the reservoir5110to be converted between a closed configuration, as shown inFIGS.5A and5B, and an open configuration. When the water reservoir5110is in its closed configuration, the compliant portion5116is put into sealing engagement between the base5112and the lid5114to seal the base5112and the lid5114and prevent egress of water from the reservoir5110. The compliant portion5116may also perform other functions, such as to improve thermal contact between the reservoir5110and the heater plate5120.

The reservoir base5112may be configured as a receptacle to retain the given, maximum volume of liquid that the reservoir5110is configured to hold. In one form, the base5112may comprise further features such as an overfill prevention feature, e.g., at least one orifice5138in the water reservoir5110to indicate over-filling as shown inFIG.7A.

In one form, the reservoir base5112may further comprise an inner lip5224and/or an outer lip5226, for example as shown inFIG.7A. According to one aspect, the inner lip5224and/or outer lip5226may prevent egress of liquid from the reservoir5110through the interface between an intermediate portion (e.g., the compliant portion5116) and the base5112, for example when the intermediate portion is compressed, or when the intermediate portion is under vibration.

In one form, the reservoir base5112includes a main body5140and a conducive portion5150which together form a receptacle. However, it should be appreciated that the reservoir base5112may be constructed in other number of parts.

In an example, the main body5140and/or the lid5114may be constructed from a bio-compatible material suitable for retaining the volume of liquid, such as a plastic or thermoplastic polymer material, for example, acrylonitrile butadiene styrene (ABS) or polycarbonate or copolyester materials. However, it should be appreciated that the main body5140and/or lid5114may comprise other suitable materials.

Further examples of the water reservoir are described in PCT Publication No. WO 2014/138804, published Sep. 18, 2014, which is incorporated herein by reference in its entirety.

5.6.2.2 Conductive Portion

According to one arrangement, the reservoir5110comprises a conductive portion5150configured to allow efficient transfer of heat from the heater plate5120to the volume of liquid in the reservoir5110. The conductive portion5150comprises a heat conducting material structured and arranged for thermal engagement or contact with the heater plate5120so as to allow thermal transfer of heat from the heater plate5120to the volume of liquid. In one form, the conductive portion may be arranged as a circular plate, although other shapes may also be suitable. All or a part of the conductive portion may be made of a thermally conductive metal sheet such as aluminium, stainless steel sheet, (e.g. approximately 2 mm thick, such as 0.2 mm, 0.3 mm, 0.4 mm, 1 mm, 1.5 mm, 2.5 mm or 3 mm), or any other heat conducting material, including heat conductive plastics. In some cases, suitable heat conductivity may be achieved with less conductive materials of suitable geometry.

FIGS.6A to6Care sequential schematic views of an exemplary blanking process known in the art, e.g., for cutting sheet metal M into a desired shape, a process that can optionally be used for forming the metal conductive portion5150. As illustrated, sheet metal M may be sheared by a punch P to form a blank or desired shape. As shown inFIG.6D, the blanking process for sheet metal may create a sharp edge or burr B on a side of the blank. Any sharp edge or burr, once integrated into plastic molding, is a source of stress concentration and during the life of a product it can propagate a crack in the plastic molding. In the context of a water reservoir, any crack is a risk of water leak.

For example,FIG.6Eis a cross-sectional view showing a possibility of crack propagation C within a plastic material portion PP due to the sharp edge or burr of a metal plate MP. The burr in this case is formed on the edge of the upper side of the metal conductive portion5150. The risk of stress concentration still exists if the blanking process was modified to change the burr side, e.g., seeFIG.6Fshowing another possibility of crack propagation C within a plastic material portion PP due to the sharp edge or burr of a metal plate MP, the burr this time being created on the edge of the lower side of metal conductive portion5150, facing the heater plate5120.

To remove this sharp edge or burr from a metal plate, a secondary process may be used, e.g., such as Electro polishing (chemical process) or linishing (mechanical process), etc. However, such secondary process may increase manufacturing cost and time, and may not sufficiently remove the source of stress concentration.

An aspect of the present technology relates to a metal conductive portion5150that is structured and arranged to reduce or eliminate stress concentration at the interface between the metal conductive portion5150and the plastic material main body5140, thereby reducing or eliminating the possibility of crack propagation within the plastic material main body5140during the life of the reservoir base5112.

FIGS.7A to7Dshow the reservoir base5112according to an example of the present technology. In the illustrated example, the reservoir base5112comprises two-part construction, i.e., only a main body5140and a conductive portion5150. It should be noted that the described technology refers mostly to the conductive portion5150which is applicable to a variety of water reservoir structures. For example, in the illustrated examples, the water reservoir5110includes a reservoir body or base5112and a reservoir lid5114removable coupled to the reservoir base5112. However, the described technology is equally applicable to reservoir structures where the reservoir lid is not openable/removable and is permanently attached to the reservoir base, to form an integral reservoir body.

In the illustrated example, the main body5140comprises a plurality of walls and the conductive portion5150is provided to a bottom one of the walls to form a chamber or cavity to hold the volume of water. For example, the main body5140includes side walls5142extending around the perimeter of the main body5140and a bottom wall5144that joins the side walls5142. The conductive portion5150is provided or otherwise incorporated into the bottom wall5144, forming part of the chamber for holding water. For example, the bottom wall5144includes a hole structured to receive the conductive portion5150. The conductive portion5150is sealingly secured within the hole in an operative position so as to form at least a portion of a bottom of the reservoir base5112.

In an example, the conductive portion5150is provided as a separate and distinct structure from the main body5140and then secured or otherwise provided to the bottom wall5144in an operative position, e.g., the conductive portion5150comprises a pre-formed structure that is secured to the bottom wall5144.

In an example, the conductive portion5150comprises a metallic material, e.g., metal plate, and the main body5140comprises a plastic or thermoplastic polymer material.

In an example, the metal conductive portion5150may be pre-formed, and then insert molded to the plastic material main body5140. For example, the metal conductive portion5150is first formed into its working configuration by one or more metal-forming processes. The metal conductive portion5150or insert is then inserted into an injection mold for the main body5140prior to melt injection. During the injection process, the melt flows around the edges of the metal conductive portion5150and locks or connects the metal conductive portion5150to the main body5140as the melt solidifies. The surfaces of metal conductive portion5150or insert may be chemically treated or Plasma treated before being inserted into the injection mold to enhance the bonding between metal and plastic.

As shown inFIGS.7C and7D, the metal conductive portion5150includes an interfacing portion5156according to an example of the present technology that is structured and arranged to secure the metal conductive portion5150to the plastic material main body5140while reducing or eliminating stress concentration between the metal conductive portion5150and the plastic material main body5140.

As illustrated, the metal conductive portion5150includes a generally planar bottom wall or plate5152, a side wall5154extending around the perimeter of the plate5152, and an interfacing portion5156to secure the metal conductive portion5150to the plastic material main body5140. The length/width of side wall5154may be approximately between 2 mm and 2 cm, e.g., or more specifically between 5 and 10 mm.

In the illustrated example, the plate5152includes a circular shape (e.g., seeFIG.7B), however other suitable shapes are possible, e.g., rectangular, square, oval. The shape of the plate5152may or may not correspond to a shape of the heater plate5120. As illustrated, the plate5152includes a first side5152.1adapted to form a bottom interior surface of the reservoir5110exposed to the water. The plate5152includes a second side5152.2, opposite to the first side5152.1, adapted to form a bottom exterior surface of the reservoir5110exposed to the heater plate5120, e.g., second side5152.2of the plate5152provides a contact surface structured and arranged to directly engage with the heater plate5120. In an alternative example, the plate5152may comprise a non-planar shape.

The interfacing portion5156extends laterally outwardly from the side wall5154and into a thickness of the bottom wall5144of the main body5140. The interfacing portion5156provides the connection or attachment between the metal conductive portion5150and the plastic material main body5140.

In the illustrated example ofFIG.7D, the interfacing portion5156includes inner portion5156.1extending from the side wall5154, a sloped portion5156.2extending from the inner portion5156.1to an intermediate portion5156.3, and an end portion5156.4extending from the intermediate portion5156.3. In an example, the width W1(in radial direction) of the inner portion5156.1is about 1-5 mm, the width W2of the sloped portion5156.2is about 0.5-2 mm, the width W3of intermediate portion5156.3is about 1-5 mm, and the width W4of the end portion5156.4is less than about 5 mm (e.g., 1-3 mm).

As illustrated, the sloped portion5156.2creates an offset between the inner portion5156.1and the intermediate portion5156.3so that the inner portion5156.1is out of plane, e.g., parallel, with the intermediate portion5156.3. Such arrangement creates a mechanical interlock, e.g., an undercut, to prevent stripping or pull-out of the interfacing portion5156from the bottom wall5144of the main body5140.

As illustrated, the end portion5156.4is rolled or curled underneath the intermediate portion5156.3so that the end portion5156.4and the intermediate portion5156.3are adjacent to one another, e.g., the end portion5156.4and the intermediate portion5156.3are generally parallel and flush to one another. Such arrangement moves any sharp edge or burr at the edge5156.5of the end portion5156.4into a non-critical area underneath the intermediate portion5156.3, which at least reduces or eliminates stress concentration due to any sharp edge or burr. It should be noted that the area below the intermediate portion5156.3is considered less critical because it is located further away from the water facing surface of the bottom wall5144. For that reason, even a small downwardly directed angle of bending of the end portion5156.4with respect to the intermediate portion5156.3, is expected to move the burr further into the less risky zone in the lower part of the bottom wall5144, and therefore reduce the risk of leakage, even if stress caused by the burr leads to a crack in the bottom wall5144. With this regard, the larger the downward angle of the bending, the smaller the risk of leakage is. The configuration shown inFIG.7D, where the end portion5156.4and the intermediate portion5156.3are generally parallel and flush to one another, is expected to carry the lowest risk of stress concentration and crack propagation and therefore the lowest risk of water leak. This is especially the case when the burr is formed on the inner edge of the end portion5156.4, which in this full-hem configuration is in contact with the intermediate portion5156.3. Since, during the hemming process, this inner surface of the end portion5156.4is depressed against the lower surface of the intermediate portion5156.3, the burr is squashed, thus no longer posing any danger to the integrity of the bottom wall5144.

Apart from the burr formed during the cutting process of edge5156.5, there is another mechanical feature that may increase the risk of cracks in the bottom wall5144. As can be seen inFIGS.8A to8Cshowing an exemplary processing method, the hemming process can include three stages, e.g., a first stage including bending of (also referred to as reclining) the end portion5156.4at 90 degrees with respect to the intermediate portion5156.3(FIG.8A), a second stage including bending the end portion5156.4a further 30-60 degrees with respect to the intermediate portion5156.3(FIG.8B), and a third stage including full bending (full hem) of the end portion5156.4to 180 degrees with respect to the intermediate portion5156.3(FIG.8C). The first stage may also include bending of the inner portion5156.1relative to the side wall5154, bending of the sloped portion5156.2relative to the inner portion5156.1, and bending of the intermediate portion5156.3relative to the sloped portion5156.2. The first stage is often performed within a punching die PD (seeFIG.8A), which leaves tool marks on the external surface, which can be a potential cause of stress, cracks and leaks. Whilst these marks are being referred to as “tool marks”, they may be caused not only by the tool (by the dragging/friction forces of the die wall during bending), but also by the fact that large peripheral surface of the base metal plate is squeezed into a smaller circumference or perimeter during the bending process. These marks are always on the external surface. For example, inFIG.7D, the hemming process may leave such marks on the lower (outer) surface of the end portion5156.4. This is not accidental as the hemming and molding processes are preferably performed so that the marks are left on the metal plate surface which, when molded within the bottom wall5144, points downwardly and away from the critical zone close to the water facing surface of the bottom wall5144.

As described above, the bending of the end portion5156.4downwardly with respect to the intermediate portion5156.3at a progressively increasing angle is expected to bring a progressively smaller risk of leak-causing cracks caused by the burr. It should be noted that in the configuration ofFIG.7D, it is the lower surface of the end portion5156.4that may carry any tool marks. Thus, bending the end portion5156.4at a progressively increasing angle downwardly will also move any such tool marks away from the critical zone close to the water facing surface of the bottom wall5144.

In another example, as shown inFIG.7G, the end portion5156.4may not be curled underneath the intermediate portion5156.3, but be curled above or over the intermediate portion5156.3so that the end portion5156.4is located closer to the water facing surface of the bottom wall5144than the intermediate portion5156.3.

FIGS.9A to9Cshow an exemplary hemming process for the interfacing portion5156ofFIG.7G, e.g., a first stage including bending (reclining) of the end portion5156.4upwards at 90 degrees with respect to the intermediate portion5156.3(FIG.9A), a second stage including bending the end portion5156.4a further 30-60 degrees with respect to the intermediate portion5156.3(FIG.9B), and a third stage including full bending (full hem) of the end portion5156.4to 180 degrees with respect to the intermediate portion5156.3(FIG.9C). The first stage may also include bending of the inner portion5156.1relative to the side wall5154, bending of the sloped portion5156.2relative to the inner portion5156.1, and bending of the intermediate portion5156.3relative to the sloped portion5156.2. The first stage is often performed within a punching die PD (seeFIG.9A).

The interfacing portion5156ofFIG.7G(and associated hemming process ofFIGS.9A to9C) is different than that ofFIG.7Das it includes bending in an upward direction and towards the more critical water facing surface of the bottom wall5144. In this case, any tool marks associated with an outer bending surface, and any burrs associated with the cutting edge5156.5, get closer to the water facing surface of the bottom wall5144. In this case, regardless of which end of the edge5156.5the burr is on, the larger the upward bending angle, the larger the risk that any cracks caused by the burr or by the marks, may cause leakage. Only when the burr is on the upper side and the angle is sufficiently large that the configuration is close to a full hem, can the risk of leak be mitigated significantly. Especially advantageous again is the case of full-hem, when the surface of end portion5156.4with the burr is depressed against the upper surface of the intermediate portion5156.3, the burr is squashed and its stress inducing effect mitigated. At the same time, the tool marks will also be mitigated, as the surface with these marks is the one that, in this full-hem configuration, is in contact with the upper surface of the intermediate portion5156.3.

One process that provides an alternative way of removing the burr and reducing stress concentration is electro polishing of the edge5156.5of the conductive metal plate. However, during the process, the metal plate usually needs to be held in several places and some burrs may remain at point of contact. Another alternative process includes linishing, but this process may lack consistency over a large number of samples.

In an example, such rolled end portion5156.4may be a hem formed by a hemming metal-forming process as described above, e.g., seeFIGS.8A to8C and9A to9C. Also, in some cases, the rolled end5156.6provided by the hem may be provided with a relatively large outer radius or curvature to avoid stress concentration. It is assumed that any radius that is equal or large than the thickness of the metal sheet will be sufficient to avoid creating stress in the bottom wall of the main body in the vicinity of the hem.

In an alternative example, as shown inFIG.7E, the end portion5156.4and the intermediate portion5156.3of the hem may not be completely flush, e.g., a space or pocket may be provided between the end portion5156.4and the intermediate portion5156.3. Also, even though the end portion5156.4includes a similar length to the intermediate portion5156.3inFIG.7D, this does not have to be the case. For example, the end portion5156.4and the intermediate portion5156.3may have different lengths with respect to one another, as shown inFIG.7Ewhere the end portion5156.4includes a shorter length than the intermediate portion5156.3. In an example, the rolled end portion5156.4inFIG.7Emay be a curl formed by a curling metal-forming process. Again, the rolled end5156.6provided by the curl may include a relatively large outer radius or curvature to avoid stress concentration.

In another example, as shown inFIG.7F, the end portion5156.4may not be “curled”, but be bent relative to the intermediate portion5156.3so that the end portion5156.4extends at an angle to the intermediate portion5156.3. In the illustrated example, the end portion5156.4extends about 90° to the intermediate portion5156.3, however it should be appreciated that other suitable angles are possible. Whilst acute angles are also believed acceptable, it is believed that any downward pointing angles close to, and especially larger than, 90 degrees are more beneficial. In an example, the bent end portion5156.4inFIG.7Fmay be formed by a bending metal-forming process. Also, the bent end5156.6provided by the bend includes a relatively large outer radius or curvature to avoid stress concentration.

Further configurations of the metal conductive portion5150are also possible. For example, as shown inFIG.7Gdescribed above, the end portion5156.4may be curled/bent backwards so it can be directed above the intermediate portion5156.3, and not under as shown inFIGS.7D to7F. It should be appreciated that “above” and “under” here refer to relative directions defined in relation to the operative configuration of the tub of which metal conductive portion5150forms part of. As discussed above, the “above” configuration ofFIG.7Gmay be less advantageous than the “under” configuration ofFIGS.7D to7Fbecause the burr is moved from the less-critical area at the lower part of the bottom wall5144(which is further away from the water inside the tub) into the more critical area of the upper portion of the bottom wall5144, which area is closer to the water in the operative configuration of the tub. One exception is the configuration where the upward angle is close to 180 degrees, which may completely crush the burr, if the burr is on the upper surface of the end portion5156.4. As this “upper” surface is in this case the inner surface for the bend, the burr is crushed between the two folded surfaces. Such a configuration, where the angle is close to 180 degrees, is referred here as a full-hem configuration, and may also be advantageous for mitigating the risk of leak.

Another aspect of the present technology relates to improving the seal between a metal conductive portion5150and the hard plastic material of the main body5140, with which the peripheral interfacing portion5156is mechanically engaged. The improved sealing limits the ingress of water to the peripheral interfacing portion5156. The limited access of water to the peripheral interfacing portion5156of the metal conductive portion5150reduces the likelihood of leak, as well as reduces the likelihood of oxidation of the peripheral interfacing portion5156of the metal conductive portion5150, thereby enhancing the lifetime of the reservoir base5112.

FIGS.10A to10Bshow a metal conductive portion5150with a silicone overmold5300according to an example of the present technology, andFIGS.11A to11Bshow such metal conductive portion5150with a silicone overmold5300provided to a reservoir base5112according to an example of the present technology.

As shown inFIGS.10A and10B, the metal conductive portion5150includes a generally planar bottom wall or plate5152, a side wall5154extending around the perimeter of the plate5152, and an interfacing portion5156to secure the metal conductive portion5150to the plastic material main body5140.

The interfacing portion5156extends laterally outwardly from the side wall5154and into a thickness of the bottom wall5144of the main body5140. The interfacing portion5156provides the connection or attachment between the metal conductive portion5150and the plastic material main body5140.

In the illustrated example ofFIGS.10A and10B, the interfacing portion5156includes inner portion5156iextending from the side wall5154, an end portion5156e, and a sloped portion5156sextending from the inner portion5156ito the end portion5156e. The sloped portion5156screates an offset between the inner portion5156iand the end portion5156eso that the inner portion5156iis out of plane with the end portion5156e, thus improving the retention of the interfacing portion5156of the metal conductive portion5150within the hard plastic material of the main body5140. According to an example of the present technology, a silicone overmold5300is provided to the interfacing portion5156and configured to wrap around and cover exterior surfaces of at least a portion of the end portion5156e(including the end face5156fat the free end of the end portion5156e). This does not have to be the case and the silicone overmold5300may be located only on limited area of the upper surface (as viewed inFIGS.10B and11B) of the interfacing portion5156and cover only a limited portion of this upper surface. In the illustrated configuration, the silicone overmold5300covers both exterior upper and lower surfaces of the entire end portion5156e, the entire sloped portion5156s, and even a portion of the inner portion5156i. The additional silicone overmold5300preferably covers as much of the length of the interfacing portion5156as possible to provide further protection from oxidation and improved sealing at the interface between the metal conductive portion5150and the plastic material main body5140. The silicone overmold5300however should preferably not protrude outside the plastic material main body5140(e.g., seeFIG.11Bwhich shows how the silicone overmold5300is contained within the plastic material main body5140), as such a protrusion outside the plastic material main body5140will interfere with the manufacturing process of the reservoir base.

In an example, the metal conductive portion5150may be pre-formed, the silicone overmold5300may be overmolded over at least a portion of the interfacing portion5156of the metal conductive portion5150, and then the plastic material main body5140may be overmolded over the interfacing portion5156of the metal conductive portion5150and the silicone overmold5300thereof.

For example, the metal conductive portion5150is first formed into its working configuration by one or more metal-forming processes, e.g., press metal forming. One or more secondary processes may follow the one or more metal forming processes, e.g., electro-polishing (chemical process) to remove burrs from the metal conductive portion5150and passivation to improve resistance to oxidation. Following the one or more metal-forming processes and the one or more secondary processes, silicone is then overmolded over a portion of the interfacing portion5156of the metal conductive portion5150to form the silicone overmold5300(e.g., seeFIGS.10A and10B). Referring toFIGS.10B and11B, the portion of the interfacing portion5156mentioned here is with reference to the radial direction. The silicone material for the silicone overmold5300comprises a silicone grade with a suitable bond strength for connection with the metal conductive portion5150.

Then, the plastic material main body5140is overmolded over the interfacing portion5156of the metal conductive portion5150and the silicone overmold5300thereof (e.g., seeFIGS.11A and11B). In an example, the metal conductive portion5150and silicone overmold5300thereof (i.e., the insert) is inserted into an injection mold for the main body5140prior to injection of molten plastic material into the injection mold. During the injection process, the molten plastic material flows around the interfacing portion5156and the silicone overmold5300, and locks or connects the metal conductive portion5150to the main body5140as the molten plastic material solidifies. The additional silicone overmold5300preferably covers as much of the length of the interfacing portion5156as possible, without protruding outside the plastic material main body5140, to facilitate blanking off the metal plate during the overmolding process of the plastic material main body5140. From this point of view, one way of deciding on how much inwardly (in radial direction, in the case of a circular metal plate, as illustrated inFIG.7B) should the silicone overmold5300extend may be by first considering how much of the interfacing portion5156should be engaged with the plastic material main body5140.

The silicone overmold5300, provided to surfaces of the interfacing portion5156before the metal conductive portion5150is inserted into the injection mold, provides further protection from oxidation and enhanced sealing. Because the silicone overmold5300is already cured before the second overmolding process, there is no strong chemical bond between the silicone overmold5300and the overmolded plastic material of the main body5140. However, when the hard plastic of the main body5140shrinks during the curing process at the end of the second overmolding, it compresses the underlying flexible silicone overmold5300. This compression and the flexible nature of the silicone overmold5300seals any gaps between the two interfaces (i.e., (1) the one between the metal conductive portion5150and the silicone overmold5300and (2) the one between the silicone overmold5300and the plastic of main body5140) thereby making the two interfaces substantially watertight. Other fastening processes, such as ultrasonic welding, may also be used to attach the main body5140to the interfacing portion5156. However, such techniques need at least two plastic parts to sandwich the interfacing portion5156and may have less uniform control and/or distribution of the compression force, which may cause displacement of the silicone overmold during welding in some areas of the periphery of the metal plate. This may result in less than sufficient compression in some peripheral areas and may negatively affect the overall sealing performance.

The two staged overmolding process (i.e., (1) overmolding the silicone overmold5300over the interfacing portion5156of the metal conductive portion5150and (2) overmolding the main body5140over the silicone overmold5300) offers a more robust water seal, with improved manufacturing convenience, efficiency and cost savings.

While the example illustrated inFIGS.10A to11Bis described with reference to a large portion of the interfacing portion5156being enclosed by the silicone overmold5300(FIGS.10A to11B), it should be appreciated that a silicone, or other sealing material (overmolded or otherwise) may be provided in other configurations to the interfacing portion5156of a metal conductive portion5150(e.g., seeFIG.7C) to improve sealing and increase the resistance to oxidation. For example,FIG.12shows a cross-sectional view of an arrangement where a continuous bead5400of a silicone material (in this case with a semi-circular cross-section) has been dispensed only on a portion of the upper exterior surface of the end portion5156ealong the periphery of the interfacing portion5156. The plastic material of the main body5140is then overmolded over the interfacing portion5156and the silicone bead5400. Whilst water (which in the figure is located in the space above the metal plate) can reach a portion of the interfacing portion5156that is upstream (i.e., to the left as viewed inFIG.12) of the silicone bead5400, the silicone bead5400creates a barrier to the further penetration of water and protects the downstream portions of the interfacing portion5156(which covers the end face5156fat the free end of the end portion5156eand the underside or lower exterior surface of the peripheral interfacing portion5156) from corrosion and water leak. In an example, the higher upstream the silicone bead5400is disposed (i.e., towards the sloped portion5156sand the inner portion5156i), the larger portion of the interfacing portion5156is protected from water ingress.

Thus, one or more sealing materials, such as silicone or other materials, can be overmolded, or otherwise dispensed, over at least a portion of the interfacing portion5156, over which the main body5140is then overmolded. For example, similar sealing effect may be achieved if the interfacing portion5156of the metal conductive portion5150is dipped into a melted plastic or rubber material.

Alternatively, instead of using the above described sealing effect of a compressed flexible material that has been overmolded or otherwise dispensed, adhesion promoters, powder coatings, enamel coatings, epoxy materials, foam gasket materials, etc. can be dispensed over the interfacing portion5156to enhance the bond and seal between the interfacing portion5156and the main body5140.

In addition, the illustrated examples are provided with reference toFIGS.7D to7G and11Bwhere the interfacing portion5156of the conductive portion5150is engaged with a bottom wall5144of the main body5140. However, it should be appreciated that other configurations are possible. For example, in another configuration, the conductive portion5150may comprise the entire bottom of the water reservoir. In this case, it may be considered that the peripheral edge of the conductive portion5150is engaged not with a bottom wall, but with one or more side walls of the main body of the water reservoir.

5.6.2.3 Humidifier Reservoir Dock

In one form, the humidifier5000may comprise a humidifier reservoir dock5130(as shown inFIGS.4A to4C) configured to receive the humidifier reservoir5110. In some arrangements, the humidifier reservoir dock5130may comprise a locking feature configured to retain the reservoir5110in the humidifier reservoir dock5130.

5.6.2.4 Water Level Indicator

The humidifier reservoir5110may comprise a water level indicator. In some forms, the water level indicator may provide one or more indications to a user such as the patient1000or a care giver regarding a quantity of the volume of water in the humidifier reservoir5110. The one or more indications provided by the water level indicator may include an indication of a maximum, predetermined volume of water, any portions thereof, such as 25%, 50% or 75% or volumes such as 200 ml, 300 ml or 400 ml.

5.6.2.5 Humidifier Transducer(s)

As shown inFIG.13, the humidifier5000may comprise one or more humidifier transducers (sensors)5210instead of, or in addition to, transducers provided in the RPT device4000. Humidifier transducers (sensors)5210may include one or more of an air pressure transducer/sensor5212, an air flow rate transducer/sensor5214, a temperature transducer/sensor5216, or a humidity transducer/sensor5218as shown inFIG.13. A humidifier transducer (sensor)5210may produce one or more output signals which may be communicated to a controller such as the central controller of the RPT device4000and/or a central humidifier controller5250. In some forms, a humidifier transducer may be located externally to the humidifier5000(such as in the air circuit4170) while communicating the output signal to the controller. Each of the reference numbers5210-5218is used to refer to both the respective transducer, as well as the overall sensor, which usually includes further electronic circuitry to facilitate the management and processing of the data generated by the respective transducer.

5.6.2.5.1 Pressure Transducer

One or more pressure transducers5212may be provided to the humidifier5000in addition to, or instead of, a pressure sensor provided in the RPT device4000.

5.6.2.5.2 Flow Rate Transducer

One or more flow rate transducers5214may be provided to the humidifier5000in addition to, or instead of, a flow rate sensor provided in the RPT device4000.

5.6.2.5.3 Temperature Transducer

The humidifier5000may comprise one or more temperature transducers5216. The one or more temperature transducers5216may be configured to measure one or more temperatures such as of the heating element5240and/or of the flow of air downstream of the humidifier outlet. In some forms, the humidifier5000may further comprise a temperature sensor5216to detect the temperature of the ambient air.

5.6.2.5.4 Humidity Transducer

In one form, the humidifier5000may comprise one or more humidity sensors5218to detect a humidity of a gas, such as the ambient air. The humidity sensor5218may be placed towards the humidifier outlet in some forms to measure a humidity of the gas delivered from the humidifier5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

5.6.2.6 Heating Element

A heating element5240may be provided to the humidifier5000in some cases to provide a heat input to one or more of the volume of water in the humidifier reservoir5110and/or to the flow of air. The heating element5240may comprise a heat generating component such as an electrically resistive heating track. One suitable example of a heating element5240is a layered heating element such as one described in the PCT Patent Application Publication No. WO 2012/171072, which is incorporated herewith by reference in its entirety.

In some forms, the heating element5240may be provided in the humidifier base where heat may be provided to the humidifier reservoir5110primarily by conduction.

5.6.2.7 Humidifier Controller

According to one arrangement of the present technology, a humidifier5000may comprise a humidifier controller5250as shown inFIG.13. In one form, the humidifier controller5250may be a part of a central controller of the RPT device4000. In another form, the humidifier controller5250may be a separate controller, which may be in communication with a central controller of the RPT device4000.

In one form, the humidifier controller5250may receive as inputs measures of properties (such as temperature, humidity, pressure and/or flow rate), for example of the flow of air, the water in the reservoir5110and/or the humidifier5000. The humidifier controller5250may also be configured to execute or implement humidifier algorithms and/or deliver one or more output signals.

As shown inFIG.13, the humidifier controller5250may comprise one or more controllers, such as a central humidifier controller5251, a heated air circuit controller5254configured to control the temperature of a heated air circuit4171and/or a heating element controller5252configured to control the temperature of a heating element5240.

5.7 GLOSSARY

For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.

5.7.1 General

Air: In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. atmospheric air enriched with oxygen.

Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.

In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. Total flow rate, Qt, is the flow rate of air leaving the RPT device. Vent flow rate, Qv, is the flow rate of air leaving a vent to allow washout of exhaled gases. Leak flow rate, Ql, is the flow rate of leak from a patient interface system or elsewhere. Respiratory flow rate, Qr, is the flow rate of air that is received into the patient's respiratory system.

Humidifier: The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.

Leak: The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient's face. In another example leak may occur in a swivel elbow to the ambient.

Noise, conducted (acoustic): Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.

Noise, radiated (acoustic): Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power/pressure levels of the object in question according to ISO 3744.

Noise, vent (acoustic): Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.

Patient: A person, whether or not they are suffering from a respiratory condition.

Pressure: Force per unit area. Pressure may be expressed in a range of units, including cmH2O, g-f/cm2and hectopascal. 1 cmH2O is equal to 1 g-f/cm2and is approximately 0.98 hectopascal. In this specification, unless otherwise stated, pressure is given in units of cmH2O.

The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the mask pressure Pm at the current instant of time, is given the symbol Pt.

Respiratory Pressure Therapy (RPT): The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.

Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

5.7.1.1 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: a thermoplastic polymer of Bisphenol-A Carbonate.

5.7.1.2 Mechanical Properties

Resilience: Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

Resilient: Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

Hardness: The ability of a material per se to resist deformation (e.g. described by a Young's Modulus, or an indentation hardness scale measured on a standardised sample size).‘Soft’ materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure.‘Hard’ materials may include polycarbonate, polypropylene, steel or aluminium, and may not e.g. readily deform under finger pressure.

Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load may be a force or a moment, e.g. compression, tension, bending or torsion. The structure or component may offer different resistances in different directions.

Floppy structure or component: A structure or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.

Rigid structure or component: A structure or component that will not substantially change shape when subject to the loads typically encountered in use. An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient's airways, e.g. at a load of approximately 20 to 30 cmH2O pressure.

As an example, an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

5.8 OTHER REMARKS

Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include their plural equivalents, unless the context clearly dictates otherwise.

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

The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

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

It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.

5.9 REFERENCE SIGNS LIST

Feature ItemNumberpatient1000bed partner1100patient interface3000seal - forming structure3100plenum chamber3200positioning and stabilising structure3300vent3400connection port3600forehead support3700RPT device4000air circuit4170humidifier5000water reservoir5110reservoir base5112reservoir lid5114compliant portion5116inlet5118heater plate5120outlet5122reservoir dock5130orifice5138main body5140side walls5142bottom wall5144conductive portion5150bottom wall5152first side5152.1second side5152.2side wall5154interfacing portion5156inner portion5156.1sloped portion5156.2intermediate portion5156.3end portion5156.4edge5156.5end5156.6end portion5156eend face5156finner portion5156isloped portion5156shinges5158cavity5160dock air outlet5168dock air inlet5170humidifier outlet5172humidifier transducer (sensor)5210pressure transducer (sensor)5212flow rate transducer (sensor)5214temperature transducer (sensor)5216humidity sensor5218inner lip5224outer lip5226heating element5240humidifier controller5250central humidifier controller5251heating element controller5252air circuit controller5254silicone overnnold5300silicone bead5400metalMpunchPburrBcrackCplastic material portionPPmetal plateMP