AU2021221742A1

AU2021221742A1 - Patent interface gas sampling

Info

Publication number: AU2021221742A1
Application number: AU2021221742A
Authority: AU
Inventors: Taylor James EDWARDS; Max William Anstiss Hayman; Samantha Dale OLDFIELD; Hamish Adrian Osborne; Matthew Jon Payton; Graeme Matthew SMITH; Craig Karl White
Original assignee: Fisher and Paykel Healthcare Ltd
Current assignee: Fisher and Paykel Healthcare Ltd
Priority date: 2021-08-25
Filing date: 2021-08-25
Publication date: 2023-03-16

Abstract

The disclosure relates to a patient interface for delivering respiratory support to a patient. The patient interface includes a gases delivery interface configured to deliver 5 an apparatus gas flow to a patient. The gases delivery interface comprises a delivery outlet to deliver the apparatus gas flow to the patient. The gases delivery interface also comprises a gases delivery side member extending from a first side of the delivery outlet and which includes an apparatus gases flow path in fluid communication with the delivery outlet. The gases delivery side member comprises a collapsible portion 10 movable upon application of a collapsing force from a normally open configuration to a collapsed configuration in which the apparatus gases flow path is reduced or closed and in order to reduce or stop the apparatus gas flow through the apparatus gases flow path. The patient interface further includes a gas sampling interface which comprises a sampling inlet configured to receive a patient gas flow at the patient and a sampling 15 outlet configured for delivery of the patient gas flow away from the patient. The gas sampling interface also comprises a sampling conduit in fluid communication with the sampling inlet and the sampling outlet. Figure 11 8/25 509 500 515 518 508 517 503 520 516 FIGURE 11 517 518 L*--A IA FIGURE 12 503 522 516 514 Aw 520 521 FIGURE 13 Section A-A

Description

8/25 509 500 515 518 508 517

503 520 516

FIGURE 11

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IA

FIGURE 12 503 522 516 514

Aw

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FIGURE 13 Section A-A

PATIENT INTERFACE GAS SAMPLING

Technical Field

[0001] This disclosure relates to a patient interface for delivering respiratory support to a patient.

Background of Invention

[0002] Patients may lose respiratory function during anaesthesia, or sedation, or more generally during certain medical procedures. Prior to a medical procedure a patient may be pre-oxygenated by a medical professional to provide a reservoir of oxygen saturation, and this pre-oxygenation and C02 flushing/washout may be carried out with high flow respiratory support via a nasal cannula or other patient interface.

[0003] In various clinical situations it can be desirable to monitor patient gases such as exhalation gases to monitor 02 content and to monitor whether a patient has become apnoeic. One example situation is where a patient is spontaneously breathing under general anaesthesia or under deep sedation where a patient may drift into and out of apnoea. Another example is where a patient is required to be intubated. In some cases, intubation is completed in 30 to 60 seconds, but in other cases, particularly if the patient's airway is difficult to traverse (for example, due to cancer, severe injury, obesity or spasm of the neck muscles), intubation will take significantly longer. While pre-oxygenation provides a buffer against declines in oxygen saturation, for long intubation procedures, it is necessary to interrupt the intubation process and increase the patient's oxygen saturation to adequate levels. The interruption of the intubation process may happen several times for difficult intubation processes, which is time consuming and puts the patient at serious health risk. After approximately three attempts at intubation the medical procedure, such as an intubation method will be abandoned.

[0004] In the event that manual ventilation of the apnoeic, non-intubated, patient is urgently required (such as due to unsuccessful intubation of the patient or a sedated patient that has drifted into apnoea) it is necessary to quickly remove the high flow patient interface and then apply a non-invasive ventilation mask, e.g. a face mask and bag, to the patient. A cannula may be difficult to remove quickly from the patient, for example connectors between headgear and a cannula may be difficult to release quickly or manipulate. Failure to remove the patient interface may result in the seal of the face mask overlying the patient interface or patient interface gases supply tube, disrupting the seal between the face mask and the patient's face. Gases may consequently leak from the face mask during ventilation, rendering ventilation ineffective or inefficient.

[0005] In procedures where multiple respiratory support systems are required, there may be a concern that the combination(s) of support systems could cause excessive pressure delivery (for example when a cannula is in place on a patient and an anaesthetist wishes to deliver support through a mask over the top of the cannula). Furthermore, switching between different support systems may be time consuming or difficult.

[0006] The above discussion of the background to the disclosure is intended to facilitate an understanding of the disclosure. However, it should be appreciated that the discussion is not an acknowledgement or admission that any aspect of the discussion was part of the common general knowledge as at the priority date of the application.

Summary of Invention

[0007] Before turning to a description of the present disclosure, it is useful to provide an explanation of some of the terms that will be used to define the spatial relationship of various parts thereof. Spatial references throughout this specification will generally be based upon a patient interface fitted to a patient's face and configured to deliver respiratory gases from a flow source and through a gases delivery conduit to the patient's nares or mouth. With this environment as the basis, some terms may be defined with reference to the patient such as 'patient-facing' and 'non-patient-facing'. Terms such as 'inwards' and 'outwards' may be defined with reference to the patient's face. Some terms may be defined with reference to the gases delivery conduit such as 'behind'and 'in front'.

[0008] In view of the issues noted above, the Applicant has previously developed a patient interface having a collapsible conduit, as described in International Patent application PCT/IB2019/051137 (International Patent Publication W02019159063). The patient interface provides a means for pre-oxygenating the patient and maintaining the apnoeic window of the patient such as during sedation or under use of general anaesthesia (whether or not intubation is required). The collapsible conduit includes a collapsible portion configured to collapse and temporarily interrupt the (high flow or low flow) respiratory gas flow when, for example, a mask is placed onto a patient's face and a portion of the mask, e.g. the mask cuff, is overlaid across (and pressed onto) the collapsible portion. This allows a clinician to easily apply a non-invasive ventilation mask to the patient over the patient interface when needed and which simultaneously interrupts the high flow patient interface gas flow during application of the ventilation mask.

[0009] During use of a patient interface such as the collapsible patent interface described in International Patent application PCT/IB2019/051137 (International Patent Publication W02019159063), it is beneficial to monitor gases at the patient where the patient is receiving respiratory support. Gas monitoring provides useful feedback to clinicians and, for example, during the pre-oxygenation phase to determine whether the patient has reached a desired end expiratory 02 level to indicate that pre-oxygenation is complete. Patent gas monitoring may also include monitoring of C02 and/or volatiles. Such gas monitoring may also be useful to determine the patient condition or a change in the patient condition when the patient has diminished respiratory function or a risk of diminished respiratory function, for example during a medical procedure when anaesthetic agents are used as described above. Such change in patient condition can include a spontaneously breathing patient becoming apnoeic or experiencing a blocked (non-patent) airway, such that an interruption of the high flow respiratory support is required as discussed above.

[0010] The Applicant has previously developed a gas sampling device, as described in International Patent application PCT/NZ2017/050134 (International Patent Publication W02018070885). This device includes a moveable inlet which can be positioned near a patient's nose or mouth to sample patient gases. A conduit may connect the sampling device to a respiratory gases monitor (for example, a capnography device) which provides a monitor of the sampled gases. The sampling device has been designed to be attachable to a standard nasal cannula but is not configured to operate with a collapsible patient interface of the type disclosed in International patent application PCT/IB2019/051137 (International Patent Publication W02019159063).

[0011] Accordingly, it is desirable to provide a new or alternative patient interface with a collapsible portion and which can also facilitate patient gas sampling.

[0012] According to an aspect of the disclosure, there is provided a patient interface including: a gases delivery interface configured to deliver an apparatus gas flow to a patient, the gases delivery interface comprising: a delivery outlet to deliver the apparatus gas flow to the patient; and a gases delivery side member extending from a first side of the delivery outlet and including an apparatus gases flow path in fluid communication with the delivery outlet, the gases delivery side member comprising a collapsible portion movable upon application of a collapsing force from a normally open configuration to a collapsed configuration in which the apparatus gases flow path is reduced or closed and in order to reduce or stop the apparatus gas flow through the apparatus gases flow path, and the patient interface further including: a gas sampling interface comprising: a sampling inlet configured to receive a patient gas flow at the patient; a sampling outlet configured for delivery of the patient gas flow away from the patient; and a sampling conduit in fluid communication with the sampling inlet and the sampling outlet, the sampling conduit configured to remain open to maintain fluid communication between the sampling inlet and sampling outlet when the collapsible portion is moved to the collapsed configuration.

[0013] The patient interface according to the first aspect of the disclosure may advantageously facilitate sampling of patient gases whilst the collapsible gases delivery interface is concurrently operated. In particular, the sampling conduit is able to continue sampling whilst the apparatus gases of the gases delivery interface are reduced or stopped during movement of the collapsible portion to the collapsed configuration. The sampling conduit may be configured for delivering patient gases to a gas sensor or gas monitoring device. The sampling conduit may be configured for delivering patient gases to a sensor or monitoring device located within the patient gas flow. The sensor may be located within the sampling conduit. The sampling conduit could be configured to deliver patient gases to a respiratory gas monitor in fluid communication with the sampling conduit via the sampling outlet.

[0014] A patient interface according to the first aspect of the disclosure thereby facilitates continuous monitoring of the patient gases to provide feedback for clinicians both during respiratory support (for example high-flow respiratory support) provided via the gases delivery interface and also during interruption of the apparatus gas flow through the gases delivery interface (for example, during application of a patient face mask onto the patient's face).

[0015] It will be appreciated that references herein to "apparatus gas flow" refers to a gas flow from an apparatus such as a respiratory support system which could comprise a flow generator or a wall source, a compressed air source or any other suitable respiratory gas source. Apparatus gas flow may therefore include a respiratory gas flow. Apparatus gas flow could also include anaesthetic agents or oxygen delivered to the patient.

[0016] The sampling inlet is configured to receive a patient gas flow at the patient which may include expiratory gases from the patient and/or inhalation gases for the patient and/or apparatus gases from the apparatus gas flow and/or atmospheric gases or a combination of two or more thereof. The atmospheric gases which may be sampled via the sampling inlet could include entrained atmospheric gases contained within the patient's expiratory gases and/or atmospheric gases present in front of the patient's face or within the patient's airway that have not been exhaled from the patient. The patient gases sampled may include apparatus gases which have been delivered to the patient and which are yet to be inhaled. The patient gases could also include other gases such as anaesthetic agents being delivered to the patient.

[0017] It will be appreciated that atmospheric gases, expiratory gases, apparatus gases and anaesthetic gases may become mixed at the sampling inlet and therefore the patient gases received by the sampling inlet may typically comprise a mixture of two or more of these or other gases. Similarly, it will be appreciated that the patient gas flow received by the sampling inlet could in some instances comprise only one of these types of gases. The patient gas flow can vary with time (for example, between patient exhalations) and therefore the composition of the patient gas flow received by the sampling inlet can vary with time.

[0018] The patient gas flow received at the patient may be received from a patient's airway. The patient gas flow received at the patient may be received in front of a patient's mouth and/or nose. The patient gas flow received at the patient may be received internally of the patient. For example, the patient gas flow may be received from inside the patient's mouth and/or nose.

[0019] The sampling outlet may be configured for fluid communication with a respiratory gas monitor. For example, the sampling outlet may be connected via a tube or other conduit to a gas monitoring device capable of analysing the patient gases received through the sampling inlet. The gas sampling interface may therefore be configured for sidestream capnography. In this instance, the sampling outlet may therefore facilitate delivery of the patient gas flow away from the patient and towards the respiratory gas monitor.

[0020] In an embodiment, the gas sampling interface may include a gas sensor in or at the sampling conduit and/or in or at the sampling outlet. For example, the gas sampling interface may be configured for mainstream capnography. The gas sensor may be connected via a wired or wireless data communication to an appropriate receiver capable of displaying the sensor data to a clinician. In this instance, the sampling outlet may vent patient gas flow to ambient once downstream of the sensor and in this manner the sampling outlet is configured to deliver the patient gas flow away from the patient in order to enable flow through the conduit and past the sensor.

[0021] In another alternative embodiment, the gas sampling interface could include a passive sampling configuration and, for example, could be configured to sample the patient gases via colourimetry. In this instance, the sampling conduit could be configured to deliver patient gases to an assay of colorimetric reagents or to another form of colourimeter configured to indicate the presence or concentration of one or more particular gases in the patient gas flow. In some configurations, the gas sampling interface may include the colourimetry means in the sampling conduit or at the sampling outlet.

[0022] The collapsible portion of the gases delivery side member may be moved from a normally open configuration to a collapsed configuration. An open configuration will be understood as meaning a configuration in which the collapsible portion is capable of delivering apparatus gases to the patient at the desired flow rate. For example, the open configuration may involve a lumen of the gases delivery member being sufficiently open and/or unobstructed to allow for the required apparatus gas flow rate to be delivered to the patient. The collapsible portion is configured to be in a 'normally' open configuration which will be understood as meaning the collapsible portion will default to the open configuration or is in the open configuration 'at rest'. For example, the collapsible portion can remain in (and will return to) the open configuration in the absence of an external force urging the collapsible portion away from the open configuration. In other embodiments, the collapsible portion may be self-collapsing or be in a 'normally' closed configuration. That is, it may be partially or fully collapsed (collapsed configuration) when there is no apparatus gas or a low flow of apparatus gas flowing through it, and expands (open configuration) when there is some level of apparatus gas flowing through it. However, a 'normally' open collapsible portion (in an open configuration in the absence of an external force urging the collapsible portion away from the open configuration) can be beneficial in that a substantial amount of flow and/or pressure is not needed to first open or maintain the collapsible portion in an open configuration for delivery of the apparatus gas to the patient.

[0023] The normally open configuration of the collapsible portion may be achieved via inherent material properties of the collapsible portion or via geometry or other structural configuration of the collapsible portion. For example, the collapsible portion may be formed of a flexibly resilient material which can be folded, flattened or otherwise temporarily manipulated by an external force but urges toward its original state, position or configuration upon cessation or release of the external force.

[0024] The'collapsed configuration' of the collapsible portion will be understood as meaning a configuration in which the collapsible portion is physically manipulated or affected so as to reduce the path of apparatus gases through the collapsible portion. Upon movement to the collapsed configuration, the collapsible portion may undergo a change in cross-section. For example, a reduction in cross-section to as to produce a more restricted or convoluted flow path. The collapsed configuration may involve an internal passageway such a lumen becoming reduced in cross-section so as to occlude, obstruct or otherwise reduce flow.

[0025] Movement of the collapsible portion to the collapsed configuration may involve the collapsible portion being folded, bent, kinked, flattened, compressed or twisted into the collapsed configuration. The collapsed configuration may involve one or more side portions of the collapsible portion moving toward or against each other so as to occlude or obstruct the apparatus gas flow path. The collapsed configuration could reduce the flow of apparatus gases to substantially zero or, alternatively, could reduce the flow of apparatus gases as compared to the open configuration but with some residual flow still occurring in the collapsed configuration.

[0026] In an embodiment of the disclosure, the collapsible portion is resiliently deformable from the normally open configuration to the collapsed configuration. For example, two or more side portions of the collapsible portion may be configured for resilient deformation towards or against each other under influence of the collapsing force and to return to a normal position spaced from one another upon removal of the collapsing force. The movement towards or against each other may be relative movement towards one another. That is, one of the side portions may remain static relative to the patient interface (and to the patient) and the other of the side portions may move toward or against the static side portion. In an alternative embodiment of the invention, the collapsible portion includes a side portion configured for resilient deformation towards or against another side portion of the collapsible portion.

[0027] The side portions may be located adjacent to or may be connected to one another. For example, side portions may be connected at a fold line and may be folded toward or against one another. Alternatively, the side portions may be opposite to one another. For example, opposite sides of the collapsible portion could be moved toward one another.

[0028] The resilient deformation of the collapsible portion may comprise bending or folding or one or more sides of the collapsible portion. The collapsible portion may comprise a wall of non-uniform thickness. For example, the collapsible portion may include a thin-walled portion which facilitates folding or bending of the collapsible portion at the thin-walled portion. The collapsible portion may include a single thin walled portion. The thin-walled portion may comprise a relative thin section of the wall which forms a hinge portion or collapsing portion of the wall which induces folding to occur at the thin-walled portion upon application of the collapsing force to the collapsible portion. The relatively thin section of the thin-walled portion allows the section of wall to be particular adapted to fold or bend at the fold points so as to transition between the open and closed configurations. In this way, the collapsible portion preferentially bends or folds at the fold points to move between the open and closed configurations.

[0029] According to an embodiment of the invention, the collapsible portion includes a pair of thin-walled portions configured to provide fold lines at which the collapsible portion folds or bends upon application of the collapsing force. The pair of thin-walled portions may be located on opposite sides of the collapsible portion or could be otherwise relatively located, for example adjacent to one another.

[0030] The collapsible portion comprises a portion of the gases delivery side member which may comprise a conduit. The collapsible portion may therefore itself comprise a conduit, tube or other structure configured to deliver gases. The collapsible portion could have a circular cross-section. The collapsible portion could have an elongate cross section such as an oval or ovoid cross-section or a stadium cross section. According to an embodiment of the invention, the collapsible portion has an elongate cross-section which includes a pair of longitudinal sides extending between a pair of ends and wherein the thin-walled portions are located at the ends. In a particular embodiment, each of the ends includes a single thin-walled portion. Each of the ends may include more than one thin-walled portion.

[0031] The provision of a thin-walled portion at the ends of the elongate cross section may advantageously promote folding or bending at the ends resulting in one or both of the longitudinal sides moving toward the other longitudinal side. The collapsible force may be applied to a first of one of the longitudinal sides and in the direction of the other longitudinal side which results in a flattening of the collapsible portion as the first of longitudinal sides is moved toward or against the second longitudinal side.

[0032] Various embodiments of possible collapsible portion configurations are discussed in Applicant's previous international patent publications W02018/029638 and W02019159063.

[0033] According to the first aspect of the disclosure, the gas sampling interface could be provided to the gases delivery side member or could be separate to the gases delivery side member. In an embodiment of the invention, the sampling conduit extends from a second side of the delivery outlet that is opposite to the first side. For example, the gases delivery conduit may be separate from the gases delivery side member and may extend from the opposite side of the delivery outlet and/or toward an opposite side of the patient's face as compared to the gases delivery side member.

[0034] The sampling conduit may have a dual function in that it may also be used as a structural component to support part of the patient interface. For example, the sampling conduit may be used with or as part of a head strap which connects with the patient's head to secure the patient interface in position relative to the patient's face. In an embodiment, the sampling conduit has an end configured for coupling to a headstrap and includes an internal passageway providing the fluid communication between the sampling inlet and sampling outlet, the sampling conduit also comprising a patient facing wall and a non-patient-facing wall.

[0035] Alternatively, the sampling conduit may not contribute to securing of the patient interface and the delivery outlet may be supported by a component other than the sampling conduit. For example, in an embodiment, the patient interface further includes a non-delivery side member extending from a second side of the delivery outlet that is opposite to the first side and the non-delivery side member having a headstrap end that is configured for coupling to a headstrap, the non-delivery side member also comprising a patient-facing wall and a non-patient-facing wall.

[0036] The "non-delivery" side member will be understood as meaning a side member which is not configured for delivering the apparatus gases to the patient. That is, the non-delivery side member does not form part of the apparatus gases flow path which is provided by the gases delivery side member.

[0037] Whilst the non-delivery side member is unassociated with the apparatus gas flow, the non-delivery side member may be associated with the patient gas flow. For example, the sampling conduit may be associated with the non-delivery side member. In an embodiment, the sampling conduit is provided on the non-delivery side member.

[0038] The provision of the sampling conduit to the non-delivery side member can be provided by various configuration. For example, in an embodiment, the sampling conduit extends through a portion of the non-delivery side member. The sampling conduit may extend through an internal passage of the non-delivery side member. As noted above, the non-delivery side member may be unassociated with the apparatus gas flow and therefore the internal passage of the non-delivery side member may be unconfigured for delivering apparatus gases.

[0039] The sampling conduit may have any suitable diameter or profile. For example, any suitable diameter or profile internal or external to the non-delivery side member. The sampling conduit may have a uniform cross-section. The sampling conduit may have a varying cross-section. The varying cross-section could increase or decrease along the length of the sampling conduit.

[0040] In an embodiment. the sampling conduit may extend between a pair of spaced apart openings in one or more walls of the non-delivery side member. The spaced apart openings may comprise an inlet port proximate to the delivery outlet and an outlet port proximate to the headstrap end of the non-delivery side member. The inlet and outlet ports could be provided in a common wall, side or side portion of the non-delivery side member or could alternatively be on different walls, sides or side portions of the non-delivery side member. The inlet and/or the outlet port may be located in the patient-facing wall of the non-delivery side member. The inlet and/or the outlet port may be located in the non-patient-facing wall of the non-delivery side member.

[0041] The sampling inlet may be located sufficiently close to the patient's airway so as to receive the patient airflow which can include expiratory gases. The sampling outlet may be located to facilitate connection with a respiratory gas monitor.

[0042] In an embodiment, the sampling inlet is located at or adjacent the inlet port and the sampling outlet is located at or adjacent the outlet port. In an embodiment, the sampling inlet consists of the inlet port and/or the sampling outlet consists of the outlet port. In an alternative embodiment, the sampling conduit comprises a tube extending through both the inlet port and the outlet port and through the internal passage which extends between the inlet and outlet ports.

[0043] In an embodiment, the sampling conduit comprises the internal passage of the non-delivery member and wherein the inlet and/or outlet ports are configured for connection to respective sampling tubes configured to extend from the inlet and outlet ports to the sampling inlet and sampling outlet respectively.

[0044] In an embodiment, the sampling inlet could be located at (or consist of) the inlet port in which case there may only an outlet tube connecting the sampling outlet to the outlet port.

[0045] In an alternative embodiment, the sampling outlet could be located at (or consist of) the outlet port in which case there may only an inlet tube connecting the sampling outlet to the outlet port.

[0046] In an embodiment, the inlet and/or outlet ports are configured for connection to sampling tubes via a luer lock or threaded connection or plug-fit or a barb. The inlet port could utilise a different type of connection from the outlet port. This may advantageously improve usability by preventing components or tubes from being incorrectly connected to the wrong port.

[0047] In an embodiment, the non-delivery member includes a sampling inlet tube moulded to the sampling inlet and/or a sampling outlet tube moulded to the sampling outlet. The sampling inlet tube may be integrally formed with the sampling inlet and or the inlet port. The sampling outlet tube may be integrally formed with the sampling outlet and/or the sampling outlet.

[0048] In an embodiment, the sampling conduit is integrally formed with the non delivery side member. In an alternative embodiment, the sampling conduit is attachable with the non-delivery side member. The sampling conduit may be removably attached or connected with the non-delivery side member. The non-delivery side member may be configured for removable connection with the sampling conduit. For example, the non-delivery side member may comprise a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the non-delivery side member. The channel may be located in an external surface of the non-delivery side member. The channel may have a formation which corresponds to the formation of the sampling conduit. For example, the channel may have a width or diameter approximately commensurate with a diameter of the sampling conduit so as to snugly receive and retain the sampling conduit in the channel. The channel may have a semi-circular cross-section. The sampling conduit may be frictionally retained with the channel. The channel may be configured in geometry to retain the sampling conduit in the channel. For example, the channel may be have a width or diameter slightly less than a diameter of the sampling conduit such that the channel is resiliently expanded when the sampling conduit is fitted in the channel and retained therein by resilient 'squeezing' of the channel onto the sampling conduit. The sampling conduit may be formed of a more rigid material than the portion of the non-delivery member in which the channel is formed so as to avoid deformation of the sampling conduit when fitted into a channel of slightly smaller size than the sampling conduit.

[0049] In an embodiment, the channel is located in the patient-facing wall of the non-delivery side member. In an alternative embodiment, the channel is located the non-patient-facing wall of the non-delivery side member. The channel advantageously allows for convenient attachment and detachment of the sampling conduit and whereby the sampling conduit can be fitted to the non-delivery side member when required and removed when not required and/or to facilitate maintenance, cleaning or replacement of certain components.

[0050] In an embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the headstrap end of the non-delivery side member. The spacing between the sampling inlet and sampling outlet may of course vary. In an embodiment, the sampling inlet and sampling outlet are separate by a distance that is greater than a width of a section of a face mask seal that is configured for placement on the patient's face and to bear over a portion of the non-delivery side member. This may advantageously allow for a patient face mask to be positioned over the delivery outlet and the sampling inlet and for the sampling outlet to be located outside of the patient face mask. The positioning of the face mask onto the non-delivery side member may therefore not interfere with the sampling outlet and its fluid connection with the respiratory gas monitor.

[0051] As noted, the sampling conduit of the first aspect of the disclosure is configured to remain open when the collapsible portion is moved to the collapsed configuration. The bearing of the face mask seal over the non-delivery member applies a force to the non-delivery side member which may be transmitted or directly applied to the sampling conduit. Accordingly, the sampling conduit may be configured to remain open under application or influence of the face mask force. The sampling conduit may therefore allow for continuous patient gas sampling.

[0052] In an embodiment, the non-delivery side member may itself be configured to resist deformation upon bearing of the face mask seal over the non-delivery side member. Alternatively, the non-delivery side member may be configured to deform upon bearing of the face mask seal over the non-delivery side member and wherein the sampling conduit remains open during deformation of the non-delivery side member. The deformation of the non-delivery side member may involve a flattening of the non-delivery side member. This may advantageously help to form a seal between the face mask and the patient's face and/or between the face mask and the non delivery side member. For example, the non-delivery side member may be configured to move to a flattened configuration and the face mask can resiliently deform around the flattened configuration to form a seal with the patient's face. The patient interface may be configured to reduce or avoid leaks when a face mask is placed over the patient interface, which could lead to undesirable dilatation of the respiratory support and/or the patient gas flow which is being sampled.

[0053] The non-delivery side member may be hollow (e.g. tubular) or may be non hollow. The non-delivery side member could comprise a conduit or tube. The non delivery side member could have a circular cross-section or could have a non-circular cross section. The non-delivery side member could have an elongate cross section such as an oval or ovoid cross-section or a stadium cross-section. According to an embodiment of the invention, the non-delivery side member has an elongate cross section which includes a pair of longitudinal sides extending between a pair of ends. The ends may be rounded for example semi-circular. Alternatively, the ends may comprise edges (for example, angular edges) and at which the longitudinal sides meet one another.

[0054] The non-delivery side member may have a symmetrical cross-section. For example, a circular, oval or stadium cross-section which is symmetrical about a length axis and/or a width axis.

[0055] Alternatively, in an embodiment the non-delivery side member has an elongate cross-section which is asymmetric in at least one axis. In an embodiment, the elongate cross-section may comprise a length axis and a width axis and the cross section is asymmetric about the length axis. The cross-section may include a pair of longitudinal sides extending between a pair of end edges and wherein the longitudinal sides are asymmetric. For example, one of the side portions may include a channel configured to receive the sampling conduit. One of the sides may have a different curve configuration from the other side. In an embodiment, the patient-facing wall has a different curvature configuration to the non-patient-facing wall. In an embodiment, the patient-facing wall of the non-delivery side member has a more pronounced curve as compared to the non-patient-facing wall. In an embodiment, the cross-section is asymmetric in an axis substantially parallel with the patient-facing wall.

[0056] The non-delivery side member cross-section may have an asymmetric lens shaped or an air foil shape. For example, the cross-section may comprise two longitudinal sides having different levels of curvature and which meet at opposite end edges. Each of the longitudinal sides may have a convex configuration (i.e. bulging outward). The two longitudinal curved sides may comprise the patient-facing side and the non-patient-facing side. In an embodiment, the non-patient-facing side has a low level of curvature and may be substantially flat and the patient-facing side has a higher level of curvature.

[0057] In an embodiment, the non-delivery side member cross-section including a pair of opposite and spaced apart edges and wherein the patient-facing wall and the non-patient-facing wall extend between the pair of edges. In an embodiment, the patient-facing wall has a substantially convex formation extending between the pair of opposite edges. In an embodiment, the non-patient-facing wall has a substantially flat or planar formation extending between the pair of opposite edges.

[0058] The non-delivery side member may be configured to be partially sunken or recessed into a patient's face so as to facilitate formation of an undisrupted seal between a patient mask and the patient's face. The non-delivery side member may be slightly recessed into the patient's skin such the non-patient-facing wall is approximately flush or aligned with the patient's skin. The non-patient-facing wall may thereby form a substantially continuous surface with the patient's skin and onto which the face mask may form a substantially undisrupted seal.

[0059] The above discussion contains various embodiments and examples of the gas sampling interface being provided to a non-delivery side member. However, as noted in earlier discussion, a patient interface according to the first aspect of the disclosure may also be configured with the gases sampling interface provided to the gases delivery side member. The gases sampling interface may therefore be located at, on, within or be otherwise physically associated with the gases sampling interface.

[0060] In an embodiment, the gas sampling interface is provided to the gases delivery side member the gases delivery side member comprising a delivery inlet at one end to receive the apparatus gas flow and the gases delivery side member comprising a patient-facing wall and a non-patient-facing wall. In an embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the delivery inlet.

[0061] In an embodiment, the sampling conduit comprises a sampling lumen for the patient gas flow and the gases delivery side member comprising a gases delivery lumen for the apparatus gas flow. The physical association between the sampling lumen and the gases delivery lumen can be configured in a variety of ways.

[0062] In an embodiment, the sampling conduit is integrated with the gases delivery side member. The sampling conduit may be integrally formed with the gases delivery side member. The sampling lumen and gases delivery lumen may therefore also be integrally formed. For example, the sampling lumen and gases delivery lumen may be simultaneously moulded during manufacture of the delivery side member.

[0063] In an embodiment, the sampling conduit comprises a sampling lumen with an elongate cross-sectional shape. The cross-section of the sampling lumen could be circular.

[0064] In an embodiment, the sampling conduit extends through the gases delivery lumen. The sampling lumen (inside of the sampling conduit) may therefore also be located within the gases delivery lumen. In an embodiment, a portion of the sampling conduit is free to move within the gases delivery lumen. For example, the sampling conduit may be fed through the gases delivery lumen so as to be loosely contained by the gases delivery lumen and capable of movement therein. Alternatively, the sampling conduit may extend through the gases delivery lumen but be fixed in a particular position therein. For example, by one or more ribs or webs which connect an outer surface of the sampling conduit to an peripheral surface of the gases delivery lumen. The sampling conduit may be fixed at certain portions relative to the gases delivery lumen but has other portions permitted to move within the gases delivery lumen.

[0065] In an embodiment, the sampling conduit extends through the collapsible portion and the sampling conduit has a cross-section configured to minimise obstruction of apparatus gas flow and to minimise interference with moving of the collapsible portion to the collapsed configuration. The sampling conduit may have a configuration which facilitates a reduction in apparatus gas flow through the collapsible portion when the collapsible portion is moved to the collapsed configuration. The cross-section of the sampling conduit can have a geometry configured to facilitate occlusion of the gases delivery lumen when the collapsible portion is in the collapsed configuration. For example, the sampling conduit can have a cross-section with a curved exterior surface configured for a wall portion of the collapsible portion to bend or fold around the curved exterior surface.

[0066] The sampling conduit may be configured so to facilitate formation of a seal around the sampling conduit which restricts the flow of apparatus gases through the collapsible portion. For example, a seal between an exterior surface of the sampling conduit and an interior surface of the collapsible portion. The sampling conduit may have a substantially curved cross-section such as a circular cross-section. The sampling conduit may have a cross-section without angular edges. The sampling conduit may therefore be configured to minimise or avoid interference with the collapsed configuration of the collapsible portion. That is, minimise or avoid interference with the reduction of stopping of apparatus gas flow when the collapsible portion is moved to the collapsed configuration.

[0067] The sampling conduit may be configured so as not to obstruct gas flow through the collapsible portion when the collapsible portion is in the open configuration. For example, an exterior surface of the sampling conduit may have a substantially smooth configuration (for example, a curved configuration) so as not to cause a choke point, blockage or other obstruction in the apparatus gas flow.

[0068] The sampling conduit may be configured in its size to minimise interference with the apparatus gas flow through the gases delivery lumen. The sampling conduit may have a cross-sectional area that is less than a cross-sectional area of the gases delivery lumen. A flow volume required of the gases delivery lumen may typically be higher than a flow volume required of the sampling lumen and therefore the gases delivery lumen may have a cross-sectional area that is larger than the cross-sectional area of the sampling lumen. For example, in some embodiments, a sampling flow rate of 40 - 500mL/min of patient gases are provided through the sampling conduit. The sampling lumen may therefore be configured in its cross-section to facilitate a flow of approximately 40 - 500mL/min. The gases delivery lumen may be configured for a significantly greater flow rate and, in particular, an apparatus gas flow rate of between 5 - 70 L/min.

[0069] In an alternative embodiment, the gases delivery side member extends through the sampling lumen. For example, the gases delivery lumen may be provided in a gases delivery conduit which extends through the sampling conduit. In this instance, the sampling conduit may itself provide the gases delivery side member. Alternatively, the sampling conduit (with the gases delivery conduit extended therethrough) may be attached to or extend through the gases delivery side member.

[0070] In an embodiment, the sampling conduit comprises a sleeve that surrounds the gases delivery side member. In an embodiment, the sampling inlet is provided by a funnel portion at an end of the sleeve proximate to the delivery outlet, the funnel portion configured to receive patient gas flow from the nose and/or mouth. The funnel portion may include an opening which comprises the sampling inlet. The funnel portion could comprise a flared or enlarged portion of the sleeve. The funnel could have various configurations, for example a frustoconical or elongated-frustoconical or oval frustoconical in configuration. In an embodiment, the funnel portion is configured to receive a portion of the apparatus gas flow.

[0071] In an embodiment, the gases delivery lumen and the sampling lumen are substantially concentric. For example, one of the gases delivery lumen and the sampling lumen extends through the other of the gases delivery lumen and the sampling lumen such that each shares a common central axis and (in cross-section) each shares a common central point. The gases delivery lumen and the sampling lumen may be substantially co-axial.

[0072] In an embodiment, the gases delivery lumen and the sampling lumen have parallel longitudinal axes. This configuration could be provided in a number of ways. In a first example, one of the gases delivery lumen and the sampling lumen may extend through the other of the gases delivery lumen or the sampling lumen. In a second example, the gases delivery lumen and the sampling lumen may extend alongside (and externally of) one another. In a third example, the gases delivery lumen and the sampling lumen are both formed internally within the gases delivery side member but also have parallel longitudinal axes.

[0073] In an embodiment, the gases delivery lumen and sampling lumen are integrally formed within the gases delivery side member and are spaced apart from one another. For example, spaced apart by an internal portion of the gases delivery side member. In an embodiment, the sampling lumen is formed within a wall of the gases delivery side member which surrounds the gases delivery lumen. In an embodiment, the gases delivery lumen is formed within a wall of the gases delivery side member which surrounds the sampling lumen. The wall-formed lumen (which could be either the sampling lumen or the gases delivery lumen) within the wall of the gases delivery side member could be localised to one side of wall-surrounded lumen. Alternatively, the wall-formed lumen could partially or completely surround the wall-surrounded lumen.

[0074] Some of the above embodiments relate to the sampling lumen and gases delivery lumen being each contained within an external surface of the gases delivery member. In an alternative embodiment, the sampling conduit extends alongside an external surface of the gases delivery side member. For example, the gases delivery lumen may be provided inside the gases delivery side member and the sampling conduit is located outside of the gases delivery side member. In an embodiment, the sampling conduit is connected with an external surface of the gases delivery side member.

[0075] The sampling conduit may be integrally connected with the external surface of the gases delivery side member. For example, the sampling conduit may be integrally connected with the external surface via a connection web and the sampling conduit is spaced apart from the gases delivery side member by a width of the connection web. In an embodiment, the collapsible portion has an elongate cross-section which includes a pair of longitudinal sides extending between a pair of ends and wherein the connection web extends between the sampling conduit and one of the ends of the collapsible portion.

[0076] The above-noted spacing between the sampling conduit and the gases delivery side member may advantageously facilitate movement of the collapsible portion to the collapsed configuration whilst not affecting the sampling conduit. For example, the sampling conduit may be spaced from the gases delivery side member so that flattening or compression of the collapsible portion during application of a patient face mask does not impact, deform, collapse or otherwise interfere with the patient gas flow through the sampling conduit.

[0077] In some embodiments, the patient interface further includes an accessory located at or proximate the collapsible portion and configured to facilitate the collapsible portion moving to the collapsed configuration. Various examples of a suitable accessory are described in Applicant's US Provisional application 63/201,428 filed 29 April 2021. It will be appreciated that an accessory described in US provisional application 63/201,428 may be used with a patient interface according to the present disclosure. For example, an accessory disclosed in US 63/201,428 may be used in conjunction with a gas sampling interface including a gas sampling conduit. A sampling conduit could be integrated with an accessory according to US 63/201,428. In an embodiment, the accessory comprises a rigid member extending along the patient-facing wall of the gases delivery side member and configured to provide a reaction force to a load applied to the collapsible portion. In an embodiment, the accessory comprises a portion extending along the non-patient-facing wall of the gases delivery side member and configured to move towards the patient in response to a load applied to the accessory. The accessory may operate to enhance, focus, amplify or supplement a collapsing force applied to the collapsible portion.

[0078] The sampling conduit may be located external of the accessory but may be associated with the accessory. For example, in an embodiment the accessory includes a conduit connector for connecting a portion of the sampling conduit to the accessory. Alternatively, in an embodiment the sampling conduit extends through the accessory. The sampling conduit may comprise a tube extending through a passageway integrally formed in the accessory. Alternatively, the sampling conduit may be provided by a passageway integrally formed in the accessory.

[0079] In an embodiment, the accessory includes pair of spaced apart openings comprising a patient gas inlet port configured for location proximate the delivery outlet and a patient gas outlet port configured for location proximate the delivery inlet, the sampling conduit extending internally through the accessory between the patient gas inlet and outlet.

[0080] In an embodiment, the patient interface further includes a rigid gas path connector connectable with the delivery inlet and the patient interface further including a conduit connector for removably connecting a portion of the sampling conduit to the gas path connector. The gas path connector may be configured for connecting the gases delivery side member to a flow supply conduit, for example a conduit connected to the apparatus supplying the apparatus gas flow. The gas path connector may include a connection configuration for connecting the gas path connector to a headstrap.

[0081] In an embodiment, the conduit connector in connection with the gas path connector includes a first attachment configuration comprising a pair of resilient arms configured for removable attachment to the gas path connector and a second attachment configuration configured for removable attachment to the sampling conduit. In a particular embodiment, the second attachment configuration comprises a pair of hooks defining a pair of recesses corresponding to an external diameter of the sampling conduit and configured to receive and retain the sampling conduit.

[0082] The above-noted conduit connector of the accessory may cooperate with the above-noted conduit connector in connection with the gas path connector. For example, in an embodiment, the sampling conduit is connected to both the conduit connector of the accessory and the conduit connector that is connected to the gas path connector.

[0083] As noted, the sampling conduit according to the first aspect of the disclosure is configured to remain open to maintain fluid communication between the sampling inlet and sampling outlet when the collapsible portion is moved to the collapsed configuration. This can be achieved in a variety of ways some of which were noted in the foregoing. For example, the sampling conduit being connected to the gases delivery member but spaced therefrom by a connection web such that the sampling conduit is not contacted or affected by a collapsing force applied to the collapsible portion. Various other configurations which maintain the sampling conduit in an open state are envisaged.

[0084] For example, in an alternative configuration, the sampling conduit can be located with respect to the collapsible portion such that the sampling conduit receives or is exposed to or influenced by the collapsing force applied to the collapsible portion. This could occur directly (for example a face mask directly contacting and pressing onto the sampling conduit) or could occur indirectly (for example a face mask force being applied to the collapsible portion and transmitted through the collapsible portion onto the sampling conduit). In either of these or other scenarios, the sampling conduit can be configured to remain open in response to direct or indirect application of the collapsing force to the sampling conduit.

[0085] For example, in an embodiment, the sampling conduit comprises a sampling lumen and the sampling conduit is configured to retain the shape of the sampling lumen in response to the collapsing force applied to the collapsible portion. In an embodiment, the sampling conduit is configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen upon application of the collapsing force. In a particular embodiment, the sampling conduit is formed of a material having sufficient material stiffness to retain the shape of the sampling lumen. In an embodiment, the sampling conduit is formed of a material that has greater material stiffness than a material of the collapsible portion.

[0086] In an embodiment, the sampling conduit is configured via geometric features to be stiffer than the collapsible portion. For example, the sampling conduit may have a thicker wall than the collapsible portion. The sampling conduit may comprise a wall of uniform (i.e. consistent) thickness whereas the collapsible portion may include thin walled portions configured to facilitate bending or folding and thereby facilitate movement of the collapsible portion to the collapsed configuration. The sampling conduit may include an internal reinforcement structure such as struts or cross members which help to resist closure of the sampling conduit.

[0087] According to a second aspect of the disclosure, there is provided a patient interface including: a gases delivery interface configured to deliver an apparatus gas flow to a patient, the gases delivery interface comprising: a delivery outlet to deliver the apparatus gas flow to the patient; and a gases delivery side member extending from a side of the delivery outlet and including an apparatus gases flow path in fluid communication with the delivery outlet, the gases delivery side member comprising a collapsible portion movable upon application of a collapsing force from a normally open configuration to a collapsed configuration in which the apparatus gases flow path is reduced or closed and in order to reduce or stop the apparatus gas flow through the apparatus gases flow path, and the patient interface further including: a gas sampling interface comprising: a sampling inlet configured to receive a patient gas flow at the patient; a sampling outlet configured for delivery of the patient gas flow away from the patient; and a sampling conduit in fluid communication with the sampling inlet and the sampling outlet, the gas sampling interface being provided to the gases delivery side member.

[0088] According to the second aspect of the disclosure, the gas sampling interface is therefore provided to the gases delivery side member. The various embodiments and features of the disclosure discussed above with respect to the first aspect of the disclosure will be understood as being applicable to the second aspect of the disclosure also, with the exception of the above-discussed embodiments which relate to the gases delivery interface being provided to the non-delivery side member.

[0089] In contrast to the first aspect of the disclosure, the sampling conduit of the second aspect of the disclosure is not necessarily configured to remain open when the collapsible portion is moved to the collapsed configuration. However, it is to be appreciated that the sampling conduit of the second aspect of the disclosure could be configured to remain open in the same manner as the first aspect of the disclosure.

[0090] The various embodiments and features of the disclosure discussed above with respect to the first aspect of the disclosure which relate to the sampling conduit remaining open when the collapsible portion is moved to the collapsed configuration may therefore also be applicable and/or implemented to the second aspect of the disclosure.

[0091] However, in an embodiment of the second aspect of the disclosure, the sampling conduit may be configured such that the patient gases flow can be selectively reduced or stopped. This may be desired in applications where a second respiratory support system (for example a face mask applied to a patient's face) also has gas sampling functionality and wherein a gas sampling interface on the collapsible cannula could introduce a leak to during use of the second respiratory support. Accordingly, in some situations, it may be desirable to stop patient gas flow through the gas sampling interface in order to not disrupt the secondary respiratory support system.

[0092] According to an embodiment of the second aspect of the disclosure, the sampling conduit is movable from a normally open configuration to a collapsed configuration in which the patient gas flow through the sampling conduit is reduced or stopped. The sampling conduit may have a configuration similar to that of the collapsible portion which is discussed in the foregoing and which facilitates closure, occlusion or restriction of the sampling conduit in response to a collapsing force. For example, a collapsing force applied to the collapsible portion by a patient face mask. The sampling conduit may be configured such that no patient gas flow occurs when in the collapsed configuration. Alternatively, the sampling conduit may be configured such that some residual patient gas flow still occurs through the sampling conduit when in the collapsed configuration. For example, one or more residual openings, channels or passageways may remain of a sampling lumen inside the sampling conduit when the sampling conduit is moved to the collapsed configuration and some residual patient gas flow may still flow through these residual openings, channels or passageways.

[0093] In an embodiment, the sampling conduit includes one or more side portions configured to move toward or against each other upon application of the collapsing force to reduce or stop the patient gas flow through the sampling conduit. The sampling conduit may comprise a material or geometry that is configured to facilitate movement of the side portions toward or against each other. In an embodiment, the sampling conduit moving from the open configuration to the closed configuration comprises bending or folding of one or more sides of the sampling conduit. The sampling conduit may include one or more thin-walled portions configured to provide folding lines at which the sampling conduit folds or bends upon application of the collapsing force. In an embodiment, the sampling conduit is resiliently deformable from the normally open configuration to the collapsed configuration.

[0094] The foregoing discussion relates to possible embodiments and features of the disclosure which relate to one or both of the first and second aspects of the disclosure. Various other possible embodiments and/or features of the disclosure may be applicable to both aspects of the disclosure and some of which are discussed below.

[0095] In an embodiment, the sampling inlet is located adjacent to the delivery outlet or within the delivery outlet. The delivery outlet may comprise a mouth scoop configured for location in front of the patient's mouth. The delivery out may comprise one or more nasal delivery prongs configured for location in one or both of the patient's nares.

[0096] In an embodiment, the sampling inlet is provided by a sampling nasal prong configured for insertion into a patient's nares. The sampling inlet could be provided by a pair of nasal prongs. The sampling conduit may extend beyond a distal end of the nasal delivery prongs such that the sampling nasal prong is configured to locate deeper in the patient's nares than the nasal delivery prongs.

[0097] The positioning of the sampling nasal prong relative to the nasal delivery prong could vary. In an embodiment, the sampling nasal prong extends through the nasal delivery prong. The sampling nasal prong may be located substantially centrally in the nasal delivery prong. For example, the sampling nasal prong and the nasal delivery prong may be concentric. Alternatively, the sampling nasal prong may be located externally of the nasal delivery prong and extending alongside the nasal delivery prong.

[0098] In an embodiment, the sampling conduit has a flexibly resilient support structure allowing the sampling conduit to be manipulated into a desired shape and/or allowing the sampling inlet to be located at a desired position. The support structure could comprise a wire located within the sampling conduit or associated with a wall of the sampling conduit. The wire may be formed of steel and may be flexible so as to allow selectively positioning of the wire into a desired shape or position.

[0099] In an embodiment, the sampling conduit has an outer surface configured to seal against a mask cuff of a patient face mask. The sampling conduit may include a non-patient-facing surface which could be configured to seal against the mask cuff. The non-patient-facing surface may be provided with a stiffer configuration than the mask cuff such that the mask cuff is resiliently deformed around the non-patient-facing surface so as to form a seal between the mask cuff and the sampling conduit.

[0100] In an embodiment, the sampling inlet is located proximate the delivery outlet so as to be located within a cavity formed between a patient face mask and the patient's face during application of the face mask to the patient and wherein the sampling outlet is spaced from the delivery outlet so as to be outside of the cavity during the application of the mask to the patient. In this manner, a patient face mask applied to a patient's face will cover the sampling inlet but not the sampling outlet which is in (or available for) fluid communication with a respiratory gas monitor.

[0101] It will be appreciated from the above discussion that the present disclosure provides a patient interface configured to allowing sampling and monitoring of patient gases when the collapsible portion is moved to the collapsed configuration. For example, when a patient face mask is placed over the patient interface. The patient interface therefore allows for respiratory systems to be switched (for example, from a high-flow nasal canula to a face mask). It will also be appreciated from the above discussion that the patient interface can be configured so as not to disrupt (or to minimise disruption) of a mask seal placed against the patient's face.

Brief Description of Drawings

[0102] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:

[0103] Figure 1 shows a respiratory support system;

[0104] Figure 2 shows a patient wearing a patient interface;

[0105] Figure 3 shows a patient wearing a patient interface (a first patient interface) and a face mask (a second patient interface);

[0106] Figure 4 shows a cross-section of a portion of a patient interface or conduit;

[0107] Figure 5 shows a typical airway of a patient;

[0108] Figure 6 shows a patient wearing a patient interface and a gas sampling interface;

[0109] Figure 7 shows a patient interface configured to deliver apparatus gases to a patient via a gases delivery side member which includes a collapsible portion;

[0110] Figure 8 shows a cross-section of a non-collapsible portion of the gases delivery side member in Figure 7;

[0111] Figures 9 and 10 show a cross-section of the collapsible portion of the gases delivery side member in Figure 7;

[0112] Figure 11 is a front perspective view of a patient interface according to an embodiment;

[0113] Figure 12 is a front view of the Figure 11 embodiment;

[0114] Figure 13 is a cross-sectional view taken along the section A-A illustrated in Figure 12;

[0115] Figure 14 is a front view of the first embodiment patient interface of Figure 11 shown with a seal of a patient face mask;

[0116] Figure 15 is a cross-sectional view of a mask seal, the patient interface and a patient's face;

[0117] Figure 16 is a rear perspective view of a patient interface according to an alternative embodiment;

[0118] Figure 17 is a rear perspective view of a patient interface according to an alternative embodiment;

[0119] Figure 18 is a front perspective view of a patient interface according to an alternative embodiment;

[0120] Figure 19 is a front perspective view of a patient interface according to an alternative embodiment;

[0121] Figure 20 is a front perspective view of a patient interface according to an alternative embodiment;

[0122] Figure 21 is a front perspective view of a patient interface according to an alternative embodiment;

[0123] Figure 22 is a front perspective view of a patient interface according to an alternative embodiment;

[0124] Figure 23 is a front perspective view of a patient interface according to an alternative embodiment;

[0125] Figure 24 is a front perspective view of a patient interface according to an alternative embodiment;

[0126] Figure 25 is a front perspective view of a patient interface according to an alternative embodiment;

[0127] Figure 26 is a rear perspective view of a patient interface according to an alternative embodiment;

[0128] Figure 27 is a side perspective view of the patient interface of Figure 7 and showing a cross-section of the non-delivery side member;

[0129] Figures 28 and 29 show alternative configurations of a conduit-receiving channel provided to a non-delivery side member of a patient interface;

[0130] Figure 30 is a rear perspective view of a patient interface according to an alternative embodiment;

[0131] Figure 31 is a rear perspective view of a patient interface according to an alternative embodiment;

[0132] Figure 32 is a cross-sectional view of a gases delivery side member of a patient interface according to an alternative embodiment;

[0133] Figure 33 shows the Figure 32 cross-section in a collapsed configuration and with the sampling lumen remaining open;

[0134] Figure 34 shows the Figure 32 cross-section in a collapsed configuration and with the sampling lumen also in a collapsed configuration;

[0135] Figure 35 is a cross-sectional view of a gases delivery side member of a patient interface according to an alternative embodiment;

[0136] Figure 36 shows the Figure 35 cross-section in a collapsed configuration and with the sampling lumen remaining open;

[0137] Figure 37 shows the Figure 35 cross-section in a collapsed configuration and with the sampling lumen also in a collapsed configuration;

[0138] Figure 38 is a cross-sectional view of a gases delivery side member of a patient interface according to an alternative embodiment;

[0139] Figure 39 shows the Figure 38 cross-section in a collapsed configuration and with the sampling lumen remaining open;

[0140] Figure 40 shows the Figure 38 cross-section in a collapsed configuration and with the sampling lumen also in a collapsed configuration;

[0141] Figure 41 is a cross-sectional view of a gases delivery side member of a patient interface according to an alternative embodiment;

[0142] Figure 42 shows the Figure 41 cross-section in a collapsed configuration and with the sampling lumen remaining open;

[0143] Figure 43 shows the Figure 41 cross-section in a collapsed configuration and with the sampling lumen also in a collapsed configuration;

[0144] Figure 44 is a cross-sectional view of a gases delivery side member of a patient interface according to an alternative embodiment;

[0145] Figure 45 shows the Figure 44 cross-section in a collapsed configuration and with the sampling lumen remaining open;

[0146] Figure 46 shows the Figure 44 cross-section in a collapsed configuration and with the sampling lumen also in a collapsed configuration;

[0147] Figure 47 is a cross-sectional view of a gases delivery side member of a patient interface according to an alternative embodiment;

[0148] Figure 48 shows the Figure 47 cross-section in a collapsed configuration and with the sampling lumen remaining open;

[0149] Figure 49 shows the Figure 47 cross-section in a collapsed configuration and with the sampling lumen also in a collapsed configuration;

[0150] Figure 50 is a front perspective view of a patient interface according to an alternative embodiment;

[0151] Figure 51 is a front perspective view of a patient interface according to an alternative embodiment;

[0152] Figure 52 is a rear view of a patient interface according to an alternative embodiment;

[0153] Figure 53 is a rear view of a patient interface according to an alternative embodiment;

[0154] Figure 54 is a view of a closer detail of a portion of Figure 53;

[0155] Figure 55 is a front perspective view of a patient interface according to an alternative embodiment;

[0156] Figure 56 is a front perspective view of a patient interface according to an alternative embodiment;

[0157] Figure 57 shows the gas path connector of Figure 56;

[0158] Figure 58 is a cross-sectional view of the sampling line of Figure 56;

[0159] Figure 59 shows an attachment clip for connection to the gas path connector of Figure 57;

[0160] Figure 60 is a front perspective view of a patient interface fitted with an accessory and according to an alternative embodiment;

[0161] Figure 61 is a view of an alternative accessory for use with a patient interface;

[0162] Figure 62 shows the accessory of Figure 61 connected with the gas path connector of Figure 57;

[0163] Figure 63 is a front perspective view of a patient interface according to an alternative embodiment and in which the patient interface is fitted with the accessory of Figures 61 and 62; and

[0164] Figures 64 and 65 are rear and front perspective views of an alternative accessory for use with a patient interface in an embodiment of the disclosure.

Detailed Description

[0165] Various embodiments are described with reference to the Figures.

[0166] Throughout the Figures and specification, the same reference numerals may be used to designate the same or similar components, and redundant descriptions thereof may be omitted.

[0167] In this specification, "high flow", "high flows", "high-flow" or other equivalent terminology means, without limitation, any gas flow with a flow rate that is higher than usual/normal, such as higher than the normal inspiration flow rate of a healthy patient. Alternatively, or additionally, it can be higher than some other threshold flow rate that is relevant to the context - for example, where providing a gas flow to a patient at a flow rate to meet or exceed inspiratory demand, that flow rate might be deemed "high flow" as it is higher than a nominal flow rate that might have otherwise been provided. "High flow" is therefore context dependent, and what constitutes "high flow" depends on many factors such as the health state of the patient, type of procedure/therapy/support being provided, the nature of the patient (big, small, adult, child) and the like. Those skilled in the art know from context what constitutes "high flow". It is a magnitude of flow rate that is over and above a flow rate that might otherwise be provided.

[0168] But, without limitation, some indicative values of high flow can be as follows.

[0169] In some configurations, delivery of gases to a patient at a flow rate of greater than or equal to about 5 or 10 litres per minute (5 or 10 LPM or L/min).

[0170] In some configurations, delivery of gases to a patient at a flow rate of about 5 or 10 LPM to about 150 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. For example, according to those various embodiments and configurations described herein, a flow rate of gases supplied or provided to an interface via a system or from a flow source or flow modulator, may comprise, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM, or more, and useful ranges may be selected to be any of these values (for example, about 20 LPM to about 90 LPM, about 40 LPM to about 70 LPM, about 40 LPM to about 80 LPM, about 50 LPM to about 80 LPM, about 60 LPM to about 80 LPM, about 70 LPM to about 100 LPM, about 70 LPM to about 80 LPM).

[0171] In "high flow" the gas delivered will be chosen depending on for example the intended use of a therapy and/or respiratory support. Gases delivered may comprise a percentage of oxygen. In some configurations, the percentage of oxygen in the gases delivered may be about 15% to about 100%, about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.

[0172] In some embodiments, gases delivered may comprise a percentage of carbon dioxide. In some configurations, the percentage of carbon dioxide in the gases delivered may be more than 0%, about 0.3% to about 100%, about 1% to about 100%, about 5% to about 100%, about 10% to about 100%, about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.

[0173] Flow rates for "high flow" for premature/infants/paediatrics (with body mass in the range of about 1 to about 30 kg) can be different. The flow rate can be set to 0.4 8 L/min/kg with a minimum of about 0.5 L/min and a maximum of about 70 L/min. For patients under 2 kg maximum flow may be set to 8 L/min.

[0174] High flow has been found effective in meeting or exceeding the patient's normal real inspiratory flow, to increase oxygenation of the patient and/or reduce the work of breathing. Additionally, high flow therapy and/or respiratory support may generate a flushing effect in the nasopharynx such that the anatomical dead space of the upper airways is flushed by the high incoming gas flows. This creates a reservoir of fresh gas available of each and every breath, while minimising re-breathing of carbon dioxide, nitrogen, etc.

[0175] By example, a high flow respiratory system 100 is described below with reference to Figure 1. High flow may be used as a means to promote gas exchange and/or respiratory support through the delivery of oxygen and/or other gases, and through the removal of C02 from the patient's airways. High flow may be particularly useful prior to, during or after a medical and/or anaesthetic procedure.

[0176] When used prior to a medical procedure, high gas flow can pre-load the patient with oxygen (i.e. increase the reservoir of oxygen in the blood) so that their blood oxygen saturation level and volume of oxygen in the lungs is higher than normal in order to provide an oxygen buffer while the patient is in an apnoeic phase during the medical procedure.

[0177] A continuous supply of oxygen is important to sustain healthy respiratory function during medical procedures (such as during anaesthesia) where respiratory function might be compromised (e.g. diminishes or stops). When this supply is compromised, conditions such as hypoxia and/or hypercapnia can occur. During medical procedures such as anaesthesia and/or sedation, patient breathing is monitored to detect if spontaneous breathing is diminished or ceases. If oxygen supply and/or C02 removal is compromised, the clinician stops the medical procedure and facilitates oxygen supply and/or C02 removal. This can be achieved for example by manually ventilating the patient for example through bag mask ventilation, or by providing a high flow of gases to the patient's airway using a high flow respiratory system. Further, it will be appreciated that a mask that is used for sedation/ventilation (not necessarily limited to a bag mask) may also be used for pre-oxygenation and also for monitoring patient parameters such as end tidal C02, etc.

[0178] Further advantages of high gas flow can include that the high gas flow increases pressure in the airways of the patient, thereby providing pressure support that opens airways, the trachea, lungs/alveolar and bronchioles. The opening of these structures enhances oxygenation, and to some extent assists in removal of C02 and/or can help support patients with collapsed areas of the lung.

[0179] When humidified, the high gas flow can also prevent airways from drying out, mitigating mucociliary damage, reducing risk of infection and reducing risk of laryngospasms and risks associated with airway drying such as nose bleeding, aspiration (as a result of nose bleeding), and airway obstruction, swelling and bleeding. Another advantage of high gas flow is that the flow can clear smoke created during surgery in the air passages. For example, smoke can be created by lasers and/or cauterizing devices.

[0180] Figure 1 shows a respiratory support system 100. The system 100 may be configured to provide high flow respiratory support and/or high flow therapy. The respiratory support system 100 comprises a flow generator 102. The flow generator 102 is configured to generate gas flows that are passed through the respiratory support system 100. The flow generator 102 passes the air to a humidifier 104. The humidifier 104 is configured to heat and humidify gas flows generated by the flow generator 102. In some configurations, the flow generator 102 comprises a blower adapted to receive gases from the environment outside of the respiratory support system 100 and propel them through the respiratory therapy system 100. In some configurations, the flow generator 102 may comprise some other gas generation means. For example, in some configurations, the flow generator 102 may comprise a source available from a hospital gas outlet (e.g. oxygen or air), or one or more containers of compressed air and/or another gas and one or more valve arrangements adapted to control the rate at which gases leave the one or more containers. As another example, in some configurations, the flow generator 102 may comprise an oxygen concentrator. In some configurations, the flow generator 102 may be adapted to deliver a high flow respiratory support and/or high flow therapy. In some embodiments, the flow source may include a compressed gas source, a device that modifies the flow from a compressed gas source and/or a flow generator which generates a gas flow.

[0181] Figure 5 shows a typical airway of a person, and includes arrows to indicate how a relatively high flow rate of gases supplied to a user may be utilised to effectively push or drive the supplied gases further or deeper into a user's airway than when the person is under normal or typical self-driven respiratory conditions, or when a patient has a diminished respiratory drive.

[0182] The respiratory support system 100 comprises a housing 106 that at least partially houses both the flow generator 102 and the humidifier 104 (e.g. the respiratory support system 100 may comprise an integrated flow generator/humidifier apparatus). In other configurations the flow generator 102 and humidifier 104 may have separate housings. A hardware controller 108 is shown to be in electronic communication with the flow generator 102 and the humidifier 104, although in some configurations the hardware controller 108 might only communicate with the flow generator 102 or the humidifier 104. The hardware controller 108 may comprise a microcontroller or some other architecture configured to direct the operation of controllable components of the respiratory support system 100, including but not limited to the flow generator 102 and/or the humidifier 104.

[0183] An input/output module 110 is shown to be in electronic communication with the controller 108. The input/output module 110 may be configured to allow a user to interface with the controller 108 to facilitate the control of controllable components of the respiratory support system 100, including but not limited to the flow generator 102 and/or the humidifier 104, and/or view data regarding the operation of the respiratory support system 100 and/or its components. The input/output module 110 might comprise, for example, one or more buttons, knobs, dials, switches, levers, touch screens, speakers, displays and/or other input or output peripherals that a user might use to view data and/or input commands to control components of the respiratory support system 100.

[0184] As further shown in Figure 1, a supplementary gas source 124 may be used to add one or more supplementary gases to the gases flowing through the respiratory support system 100. The one or more supplementary gases join the gas flow generated by the flow generator 102. The supplementary gas source 124 may be configured to deliver one or more supplementary gases including but not limited to air, oxygen (02), carbon dioxide (C02), nitrogen (N2), nitrous oxide (NO), anaesthetic agents and/or heliox (a mixture of helium and oxygen). The supplementary gas source 124 may deliver the one or more supplementary gases via a first supplementary gas conduit 128 to or towards the flow generator 102, and/or may deliver the one or more supplementary gases via a second supplementary gas conduit 132 to a location in the flow passage between the flow generator 102 and the humidifier 104. One or more supplementary flow valves 126, 130 may be used to control the rates at which the one or more supplementary gases can flow from the supplementary gas source 124 and through the first and/or second supplementary gas conduits 128, 132. One or more of the supplementary flow valves 126, 130 may be in electronic communication with the controller 108, which may in turn control the operation and/or state of the one or more supplementary flow valves 126, 130. In other configurations, the supplementary gas source 124 may be configured to add one or more supplementary gases downstream of the humidifier 104.

[0185] As shown in Figure 1, a conduit 112 extending from the humidifier 104 links the humidifier 104 to a patient interface 200. The conduit 112 may comprise a conduit heater 114 adapted to heat gases passing through the conduit 112. In other configurations the conduit heater 114 may not be present. In some embodiments, an optional filter (not shown) is arranged between conduit 112 and patient interface 200. The patient interface 200 is shown to be a nasal cannula, although it should be understood that in some configurations, other patient interfaces may be suitable. For example, in some configurations, the patient interface 200 may comprise a sealing or non-sealing interface, and may comprise a nasal mask, an oral mask, an oro-nasal mask, a full face mask, a nasal pillows mask, a nasal cannula, an endotracheal tube, tracheostomy tube, a combination of the above or some other gas conveying system. In an embodiment, the patient interface 200 is a non-sealing interface such as a nasal cannula, which allows gases to be exchanged with the environment. For example, the non-sealing cannula allows carbon dioxide to be removed and/or cleared from the patient's airways while the patient receives a gas flow from the system 100. Further, in some embodiments, the patient interface 200 is in the form of a nasal interface, such that the system does not interfere with other oral airway equipment and/or devices, for example, a tracheal tube in an intubation procedure.

[0186] Accordingly, the patient may continue to receive gas flow throughout the intubation procedure. In other embodiments, the patient interface 200 is an oral interface, for example an oral interface that is received in a user's mouth. An oral interface may be preferred in situations involving medical procedures via the nose, such that the interface does not interfere with nasal airway equipment and/or devices, for example a tracheal tube used in a nasal intubation procedure. In other embodiments the interface may be suitable for both nasal and oral placement or may be adapted between a nasal and an oral configuration.

[0187] As shown, in some configurations the patient interface 200 may also comprise a gas sensing module 120 adapted to measure a characteristic of gases passing through the patient interface 200. The gas sensing module 120 could be located elsewhere within the gas delivery system and, for example, at the breathing conduit or humidifier. In some embodiments, there may be one or more gas sensing modules 120. In other configurations the gas sensing module 120 could be positioned and adapted to measure the characteristics of gases at or near other parts of the respiratory support system 100. The gas sensing module 120 may comprise one or more sensors adapted to measure various characteristics of gases, including but not limited to pressure, flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration (e.g. for determining end tidal C02), and/or nitrogen concentration. Gas properties determined by the gas sensing module 120 may be utilized in a number of ways, including but not limited to closed loop control of parameters of the gases. For example, in some configurations flow rate data taken by a gas sensing module 120 may be used to determine the instantaneous flow, which in turn may be used to determine the respiratory cycle of the patient to facilitate the delivery of flow in synchronicity with portions of the respiratory cycle. The gas sensing module 120 may communicate with the controller 108 over a first transmission line 122. In some configurations, the first transmission line 122 may comprise a data communication connection adapted to transmit a data signal. The data communication connection could comprise a wired data communication connection such as but not limited to a data cable, or a wireless data communication connection such as but not limited to Wi-Fi or Bluetooth. In some configurations, both power and data may be communicated over the same first transmission line 122. For example, the gas sensing module 120 may comprise a modulator that may allow a data signal to be 'overlaid' on top of a power signal. The data signal may be superimposed over the power signal and the combined signal may be demodulated before use by the controller 108. In other configurations the first transmission line 122 may comprise a pneumatic communication connection adapted to transmit a gas flow for analysis at a portion of the respiratory support system 100.

[0188] Additionally as shown a physiological sensor module 121 may be present. The physiological sensor module 121 may be configured to detect various characteristics of the patient or of the health of the patient, including but not limited to heart rate, EEG signal, EKG/ECG signal, inertial sensors attached to the patient (e.g. to the chest) to detect movement, blood oxygen concentration (via, for example, a pulse oximeter), blood C02 concentration, transcutaneous C02 (TcC02) and/or blood glucose. Similarly, the physiological sensor module 121 may communicate with the controller 108 over a second transmission line 123. The second transmission line 123 may comprise wired or wireless data communication connections similarly to the first transmission line 122, and power and data may be communicated similarly. The physiological sensor module 121 may be used, for example, to determine the blood oxygen saturation of the patient.

[0189] Figure 2 shows a user or patient P wearing a patient interface 200, for example the patient interface 200 of the respiratory system of Figure 1. The patient depicted is an adult, however, the patient may be an infant or juvenile. In the illustrated non-limiting configuration, the patient interface 200 is a nasal cannula. The patient interface 200 comprises a first gas conduit 202. The first gas conduit 202 is adapted to receive gases from the respiratory support system 100 (for example, via the conduit 112 shown in Figure 1) and channel the gases to the patient P. The first gas conduit

202 may comprise a reinforcement element 203 adapted to strengthen and/or add rigidity to the first gas conduit to prevent deformation or collapse of the first gas conduit 202 arising due to the application of forces against the first gas conduit 202. The reinforcement element 203 may include a number of structures, including but not limited to plastic or metallic reinforcing beads that lie in or on the wall of the first conduit lumen 202.

[0190] The first gas conduit 202 is in pneumatic communication with a flow manifold 206. The flow manifold 206 receives gases from the first gas conduit 202 and passes them to one or more nasal delivery elements 208 (e.g. nasal prongs). The one or more nasal delivery elements 208 extend outwardly from the flow manifold 206. The one or more nasal delivery elements 208 are adapted to be non-sealing when positioned in one or more nares of the patient P. As shown, the patient interface 200 comprises two nasal prongs 208 adapted to be positioned one in each of the patient's nares. Each nasal prong 208 may be shaped or angled such that it extends inwardly towards a septum of the patient's nose. Alternatively the first patient interface 200 may be a sealing nasal interface.

[0191] In the embodiment shown in Figure 2, the flow manifold 206 receives flow from one lateral side of the flow manifold 206 (e.g. with respect to an imaginary vertical plane bisecting the face of the patient P) and channels flow to the manifold and each of the nasal prongs 208. In some embodiments a conduit may extend from the left hand side or from the right hand side of the manifold. In some situations providing the conduit on the left hand side of the patient interface may be preferred for access for a clinician, for example for intubation. Alternatively, a conduit extending from the right hand side may be preferred, for example in procedures such as endoscopies where the patient is typically lying on his or her left hand side. In other configurations, the patient interface 200 may comprise greater (for example, three or four) or fewer (for example, one) nasal delivery elements 208. In other configurations, each nasal delivery elements 208 can have different properties. For example, one of a pair of nasal delivery elements 208 can be relatively long and the other nasal delivery elements 208 can be relatively short.

[0192] In some configurations, the flow manifold 206 may be configured to receive flow from two lateral sides of the flow manifold 206 (e.g. from a 'left' and 'right' of the flow manifold 206 instead of just the patient's right hand side of the flow manifold 206 as seen in Figure 2). In some such configurations, multiple gas conduits may be used to provide for pneumatic communication between the flow manifold 206 and the respiratory support system 100. For example, the patient interface may comprise dual conduits, the first gas conduit 203 extending from a first side of the interface (in the illustrated example the right hand side of the patient) and a second gas conduit extending from a second opposite side of the interface. In some configurations, the flow manifold 206 may be configured to receive flow from a non-lateral side of the flow manifold 206 (e.g. from a 'bottom' or'top' of the flow manifold 206).

[0193] The patient interface may further comprise mounts and/or supports, e.g., cheek supports 210, for attaching and/or supporting the gas conduit 202 or conduits on the patient's face. Alternatively or additionally, the patient interface may be held in place via one or more headstraps or headgear.

[0194] The first gas conduit 202 of the patient interface 200 comprises a first portion 204 configured to transition from a first configuration in which a first level of gases is able to pass through the first portion 204 to a second configuration in which a second level of gases is able to pass through the first portion 204.

[0195] Figure 3 shows a non-limiting exemplary embodiment of a patient P wearing the patient interface 200 as shown in Figure 2 (a first patient interface) underneath a face mask 300 assembly (a second patient interface). Figure 3 schematically shows the face mask as a transparent structure in order to illustrate the patient interface 200 under it. The first patient interface 200 may be used with a first respiratory support subsystem and the second patient interface 300 may be used together with a second respiratory support subsystem. In some embodiments, the first patient interface 200 and second patient interface 300 may be used with the same respiratory support system.

[0196] A system may find benefit in the selective delivery of separate respiratory supports and/or therapies to a patient using different patient interfaces, and/or in stopping or ceasing the delivery of a respiratory support and/or therapy from an interface and/or allowing gases provided by an interface to be sampled.

[0197] The system and devices as described find particular application in emergency resuscitation, around intubation of a patient receiving high flow respiratory support and/or therapy, ear, nose, and throat (ENT) surgery, in assisting with conditioning of a patient in a pre-operative state prior to administration of anaesthetics, and during post-extubation and recovery.

[0198] Face mask assembly 300 may be used as or with a second respiratory support subsystem and/or to deliver one or more substances other than a substance delivered by the cannula 200, for example anaesthetic agents or oxygen, to the patient, or the same substance but at different flow and/or pressure levels. Alternatively, the face mask assembly 300 may be used to stop the delivery of respiratory support and/or therapy from a first respiratory support subsystem. The face mask assembly 300 may also be adapted to measure respiratory gases, for example exhaled carbon dioxide from the patient, the measurements of which may otherwise be affected by flow from the patient interface 200 of the first respiratory support subsystem.

[0199] Accordingly, the embodiment shown in Figure 3 allows for the alternation between the two different respiratory support subsystems. Additionally, this configuration may allow the patient interface 200 to be left on the patient throughout the surgical procedure and/or into recovery (whether or not the patient continues to receive a gas flow through the patient interface 200 throughout the procedure) without interfering with other clinical practices.

[0200] In the embodiment shown, face mask assembly 300 comprises a full face mask 302 configured to cover both the patient's nose and mouth. In other configurations, the face mask 300 may be a nasal mask which is placed over the patient interface 200 to cover only the patient's nasal region.

[0201] As shown, the face mask 302 comprises a seal region 304 adapted to seal against the patient's face. The face mask assembly 300 is connected to a second gas source, for example via a filter element 350 or a humidity moisture exchanger (not shown), which supplies the one or more other gases to the patient via the face mask. That is, the second gas source is preferably different from the source supplying gas (for example, supplementary gas source 124/flow generator 102) to the patient interface

200. In other embodiments, the patient interface 200 and the face mask assembly 300 are connected to a common gas source.

[0202] In an embodiment, the face mask assembly 300 is connected to a separate gas source or a separate respiratory support device. For example, the respiratory support can be a ventilator or a CPAP or a high flow respiratory support and/or therapy device or a manual resuscitator (for example a hand-held face mask with bag). Alternatively or in addition, the face mask assembly 300 may be connected to a device for measuring a characteristic of respiratory gases.

[0203] Alternatively, the mask assembly 300 could be connected to an anaesthetic device and anaesthetic gas, or air, or oxygen, or a combination of gases, can be delivered via the mask 302.

[0204] The embodiment shown in Figure 3 allows for the delivery of gas from multiple sources via at least two different respiratory support modes, and further allows a doctor, clinician or medical professional to quickly and easily change the type of respiratory support mode.

[0205] In one particular application, a patient preparing for anaesthesia can be pre oxygenated by delivering a high flow of oxygen or humidified gases or mixture of both via a nasal cannula. In some circumstances, anaesthesiologists managing the sedation and/or anaesthesia of a patient may want to switch between delivery of gas flow from one patient interface (for example a nasal cannula 200) and delivery of gas flow from another patient interface, such as via a face mask 300.

[0206] Anaesthesiologists also use a mask with a bag to oxygenate a patient, and in some instances find it more beneficial to use a bag mask if a patient's vital signs begin to drop for example to deliver more pressure or have greater control over the variation in delivered pressure. In some situations a medical professional may wish to switch between different respiratory systems or support modes. In a first mode respiratory support may be provided by a first respiratory support system (for example via the patient interface 200) and in a second mode respiratory support may be provided by a second respiratory support system (for example via the patient interface 300), with the support from the first system reduced or stopped. For example, the additional flow from a high flow provided by nasal interface 200 may also modify the expected behaviour of the anaesthetic circuit provided by the face mask 300, and therefore it may be advantageous to be able to reduce or stop the additional flow from the first respiratory system.

[0207] In some configurations, the switching between two respiratory support modes or subsystems may be facilitated by a structure of the first gas conduit 202, which has first portion 204 configured to transition from a first configuration in which a first level of gases is able to pass through the first portion 204 to a second configuration in which a second level of gases is able to pass through the first portion 204.

[0208] In some configurations, the first portion 204 is configured to be more collapsible or otherwise better adapted at changing the flow of gas through the first portion 204 (therefore reducing the flow of gas through the conduit and to the patient) than other portions of the conduit 202, and/or allowing a seal of a mask to seal over the top of the conduit. In other configurations the entire conduit may be configured to be collapsible. In some configurations a vent arrangement may be provided to vent gases from the conduit to atmosphere.

[0209] In some embodiments, the first configuration or first condition is a substantially open configuration and the second configuration or second condition is a substantially closed configuration. That is, the conduit 202 is configured to be more collapsible, deformable or otherwise adapted to fully close off the flow at the first portion 204 than at other portions of the conduit 202.

[0210] Figure 4 shows one example of this configuration, in which the conduit (for example the conduit 204 of the nasal cannula 200 of figure 3) at a first portion 204 is substantially closed by the seal 304 of face mask 302. In such an embodiment, the first portion (i.e. the more collapsible or deformable section) of the first gas conduit should be of a length that is greater or equal to a width of a section of a seal of the face mask that bears over the first portion of the first gas conduit. This may provide that the seal of the face mask does not bear over a non-collapsible section of the first gas conduit. For example, the first portion may extend from a distance of 35mm or less from the centre of a user's nose to at least 50mm from the centre of a user's nose, The first portion 204 may have a length of at least about 5mm, about 1mm to about 30mm in length, or about 5mm to about 15mm in length, or about 10mm in length. In some embodiments the length of the first portion may be at least 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm or greater.

[0211] The first portion 204 may progress between the first and second configurations based on a relative level of force applied to a wall of the first portion 204. For example, as shown in Figure 3, the force may be applied by the seal 304 of face mask 302. In this example, first portion 204 is configured to be positioned under the seal 304 of the face mask 302.

[0212] Alternatively, the force may be applied to first portion 204 by other means, e.g., clamps (not shown), or alternatively a medical practitioner may compress the conduit by pressing on the conduit wall with a finger or thumb.

[0213] In some embodiments, the seal of the face mask acting on the first portion of the gas conduit causes the first portion to form a seal or at least a partial seal between the nasal outlets of the first patient interface 200 and the flow generator 102. Additionally, the seal of the face mask forms a seal or at least a partial seal over the first portion of the gas conduit.

[0214] Switching between respiratory support therapies is therefore achieved simply by applying a mask to the patient's face so that the seal of the mask collapses (partially or completely) the first portion of the gas conduit of the first interface 200 to '

'stop' or'turn off' or reduce the respiratory support and/or therapy supplied by the first interface 200 and also provides a seal between the face mask 300 and the external surface of the first portion 204 of the conduit 202 such that respiratory support and/or therapy can be provided by the mask 300 with the respiratory support and/or therapy provided by the first interface is stopped or reduced. As noted, the first portion 204 of the patient interface 200 is configured to be collapsible and will hereinafter be referred to as collapsible portion 204.

[0215] The cannula with a collapsible conduit portion allows a user, e.g. an anaesthetist or a nurse or a clinician to use a mask and prevent delivery of gases from multiple sources (e.g. the mask and cannula). The first interface 200 is structured and functions in a manner to reduce or close the delivery of high flow and other respiratory support and/or respiratory therapy or anaesthesia gases through a mask when the interface 200 is moved to a collapsed configuration. In some embodiments the removal of the mask from the patient's face allows the respiratory support and/or therapy supplied by the first interface to recommence, as the conduit returns from the collapsed configuration to the open configuration.

[0216] Figure 6 is a schematic view of a patient wearing a gas delivery system comprising a breathing apparatus 1000 comprising a nasal cannula 8040 configured to deliver gases to a patient that are supplied via a gas delivery tube 8060. A gas sampling interface 100 includes a gas sampling conduit 101 in which the tip 7050 of the gas sampling conduit 101 is positioned proximate to the patient's mouth and/or nose to sample exhaled and/or expired gases from the mouth.

[0217] The gas sensing module 120 shown in Figure 1 is shown to be located on a manifold portion of a patient interface and, in some embodiments, could form part of the gas sampling interface of the present disclosure. For example, the gas sensing module 120 could be utilised to supplement data provided by a respiratory gas monitor in fluid communication with the sampling outlet of the gas sampling interface. The gas sensing module 120 could form part of the gas sampling interface and could, for example, comprise a flow meter in the sampling conduit. The gas sensing module 120 could comprise a capnography sensor in the sampling conduit or at the sampling outlet. The gas sampling interface may therefore be configured for use in the application of mainstream capnography. In this instance, the sampling outlet may vent patient gas flow to ambient once downstream of the sensing module 120 and in this manner the sampling outlet is configured to deliver the patient gas flow away from the patient in order to enable flow through the conduit and past the sensor. The gas sensing module 120 may be connected via a wired or wireless data communication to an appropriate receiver capable of displaying data collected by the sensing module 120 to a clinician.

[0218] The gas sensing module 120 could be a separate component to the gas sampling interface and could be located elsewhere on the patient interface. The gas sensing module 120 could comprise a gas composition sensor and could be located in or at the sampling conduit and/or in or at the sampling outlet.

[0219] Alternatively, the gas sampling interface may include no sensors at the manifold portion nor any sensors at the patient. For example, the gas sampling interface may be configured for only the sampling inlet to be located at the patient and for the patient gas analysis to occur away from the patient, for example at a respiratory gas monitor. The gas sampling interface may therefore be used in the application of sidestream capnography. In this instance, the sampling outlet may facilitate delivery of the patient gas flow away from the patient and towards a respiratory gas monitor. The omission of sensors at the patient may in some instances improve accessibility for medical instruments.

[0220] In alternative embodiment (not illustrated), the gas sampling interface could include a passive sampling configuration and, for example, could be configured to sample the patient gases via colourimetry. In this instance, the sampling conduit could be configured to deliver patient gases to an assay of colorimetric reagents or to another form of colourimeter configured to indicate the presence or concentration of one or more particular gases in the patient gas flow. In some configurations, the gas sampling interface may include the colourimetry means in the sampling conduit or at the sampling outlet.

[0221] Figures 7 to 10 exemplify a patient interface 400 comprising a nasal cannula and including a gases delivery side member 401 configured to deliver apparatus gases to a patient via a manifold 406 to a delivery outlet comprising a pair of nasal prongs 408. The pair of nasal prongs 408 extend from the manifold 406. The gases delivery side member 401 extends from a first side of the manifold 406 and the interface 400 further includes a non-delivery side member 403 extending from a second side of the manifold 406 which is opposite to the first side. The non-delivery side member 403 includes an end 409 configured for connection to a headstrap 411.

[0222] The gases delivery side member 401 includes a collapsible portion 404 configured to move from the normally open configuration shown in Figures 7 9 and 10 to a collapsed configuration in which apparatus gas flow through the collapsible portion 404 is reduced or stopped. The collapsible portion 404 is configured to move to the collapsed configuration upon application of a collapsing force such as from a patient mask placed over the patient's face and wherein a seal of the mask is pressed down upon the collapsed portion 404. The gases delivery side member 401 also includes a non-collapsible portion 407 configured to remain open during application of the collapsing force onto the collapsible portion 404.

[0223] One end of the non-collapsible portion 407 comprises a delivery inlet 407a for receiving apparatus gas flow. The patient interface 400 further includes a gas path connector 413 which has a rigid structure and includes a delivery inlet 413a and a delivery outlet 413b. The gas path connector delivery inlet 413a is connectable to an apparatus gas supply via a conduit (not shown). The gas path connector delivery outlet 413b is connected to the delivery inlet 407a of the non-collapsible portion 407. The gas path connector 413 is also connected to the headstrap 411 at an opposite end of the headstrap to that which is connected to the headstrap end 409 of the non-delivery side member 403.

[0224] Figure 8 illustrates a cross-section of the non-collapsible portion 407 which includes wall 412 of uniform thickness. Figures 9 and 10 illustrate a cross-section of the collapsible portion 404 which includes a wall 404a of non-uniform thickness. The collapsible portion 404 has an elongate cross-section and in particular a stadium shaped cross section which includes a pair of longitudinal sides 404b extending between a pair of ends 404c. As shown in Figure 10, a thin-walled portion 404 is provided at each of the ends 404c. The thin wall portions 404d are configured to provide fold lines at which the collapsible portion 404 bends or folds upon application of the collapsing force.

[0225] The patient interface 400 illustrate in Figures 7 - 10 provides background reference and context for Figures 11 to 68 which illustrate various embodiments of patient interfaces (or parts thereof) similar to interface 400 but which also include a gas sampling interface including a sampling inlet for receiving a patient gas flow at the patient, a sampling outlet configured for fluid communication with a respiratory gas monitor and a sampling conduit in fluid communication between the sampling inlet and the sampling outlet. The gas sampling interface facilitates fluid communication between the patient gas flow and a respiratory gas monitor for use in providing patient feedback to a clinician.

[0226] In particular, Figures 11 to 31 illustrate embodiments in which the gas sampling interface is provided to (or in lieu of) the non-delivery side member 403. Figures 32 to 68 illustrate embodiments in which the gas sampling interface is provided to the gases delivery side member 401.

[0227] Figure 11 illustrates a perspective view of a patient interface 500 generally equivalent to patient interface 400 but in which the non-delivery side member 503 includes a gas sampling interface 515. The gas sampling interface 515 includes a pair of spaced apart openings formed in a non-patient-facing wall 516 of the non-delivery member 503. The pair of spaced apart openings comprise an inlet port 517 and an outlet port 518 which is in fluid communication with the inlet port 517 via a sampling conduit 520 extending internally through the non-delivery side member 503.

[0228] The outlet port is located toward the headstrap end 509 of the non-delivery side member 503. The inlet port 517 is positioned at or near the delivery outlet comprising nasal delivery prongs 508. The sampling conduit 520 extends along a length direction of the non-delivery side member 503. The inlet port 517 provides a sampling inlet through which patient gases can be received at the patient. The outlet port 518 provides a sampling outlet which is configured for fluid connection to a respiratory gas monitor.

[0229] In an embodiment, the sampling outlet may be connected in fluid communication with a respiratory gas monitor. The respiratory gas monitor (not shown) may apply suction or pressure or a vacuum through the sampling conduit 520 in order to draw and receive patient gas flow for analysis. In another embodiment, the respiratory gas monitor may passively receive the patient gas flow through the sampling conduit 520 i.e. the respiratory gas monitor may receive patient gas flow without drawing the patient gas flow via suction or pressure or a vacuum etc.

[0230] Figure 12 provides a front view of the patient interface 500 and which better illustrates the spacing between the inlet port 517 and the outlet port 518. Figure 13 provides a cross-section of the non-delivery side member 503 taken along the section A-A in Figure 12. The sampling conduit 520 has a substantially circular cross-section and is formed in an otherwise non-hollow solid body 521 of the non-delivery side member 503. The non-delivery side member includes a non-patient-facing wall 516 and a patient-facing wall 514 which, in use, is placed into contact with the patient's face. The patient-facing wall 514 and the non-patient-facing wall 516 extend between a pair of edges comprising an upper edge 522 and a lower edge 523.

[0231] As shown in Figure 13, the cross-section of the non-delivery side member 503 is elongate and is also asymmetric in at least one axis. The cross-section includes a width axis Aw extending through the patient-facing wall 516 and the non-patient facing wall 514. The cross-section also includes a length axis AL extending perpendicularly to the width axis Aw.. The length axis AL is substantially parallel with the patient-facing wall and also with the non-patient-facing wall.

[0232] The cross-section of the non-delivery side member 503 is substantially symmetrical about the width axis Aw. In other embodiments, the cross-section may be asymmetrical and, for example, the sampling conduit 520 could be located closer to one of the upper or lower edges 522, 523. As seen in Figure 13, the sampling conduit 520 is located substantially centrally in the cross-section such that the sampling conduit 520 is equidistant between the upper and lower edges 522 and 533 and also between the patient-facing wall 514 and the non-patient-facing wall 516.

[0233] The cross-section of the non-delivery side member 503 is asymmetric about the length axis AL. The asymmetry about the length axis AL is due to the patient-facing wall 514 having greater curvature as compared to the non-patient-facing wall 516 which is substantially planar. The substantially planar configuration of the non-patient-facing wall 516 may help provide a seal between the non-patient-facing wall 516 and a seal of a patient face mask, which will be discussed in further detail below with reference to Figures 14 and 15. In other alternative embodiments, the cross-section of the non delivery side member 503 could be substantially symmetrical about the length axis AL. The cross-section of the non-delivery side member 503 could be substantially symmetrical about both the length axis AL and the width axis Aw.

[0234] Turning to Figure 14, the inlet port 517 and outlet port 518 are spaced from one another by a distance that is greater than or equal to a width W of a seal 304 of a face mask 302 that is configured for placement on the patient's face and with the seal 304 bearing over a portion of the non-delivery side member 503. In particular, the seal 304 is overlaid onto the non-patient-facing wall 516.

[0235] The inlet port 517 and outlet port 518 are positioned such that the mask 302 covers only the inlet port 517. In other words, the inlet port 517 lies within the cavity formed by the patient's face and the mask 302 when the mask 302 is applied over the patient interface 500 onto the patient's face. A sampling device (for example a sampling tube comprising the sampling inlet) may connect to the inlet port 517 and fit within the area under the mask 302. Alternatively, the inlet port 517 may not be connected to a sampling device and may itself provide the sampling inlet. The sampling lumen 520 acts as a tunnel under the mask seal 304 so as to provide fluid communication between the inlet port 517 and outlet port 518 and making available at the outlet port 518 a sample of the patient gas flow taken at the inlet port 517 which is located at the patient and also inside of the mask 302.

[0236] Figure 15 illustrates a cross-section of the non-delivery side member 503 sandwiched between the mask seal 304 and the face of the patient P. The mask seal 304 is pressed onto the non-patient-facing wall 516 with a force F (for example applied manually by a clinician or retained by headgear) and causing the non-delivery side member 503 to become partially recessed into the surface 524 of the patient's face and in which the patient-facing wall 514 is recessed below the face surface 524. The substantially planar configuration of the non-patient-facing wall 516 is approximately aligned with the face surface 524 on either side of the non-delivery side member 503. A substantially continuous surface is formed by the non-patient-facing wall 516 and the face surface 524 on either side of the non-delivery side member 503 and thereby facilitating formation of a seal between the mask seal 304, the non-patient-facing wall 516 and the patient's face. In an alternative configuration (not shown) the patient facing-wall 514 may remain substantially flush with the face surface 524 and the mask seal 304 deforms around the non-delivery side member 503 such that the non-delivery side member 503 does not become recessed into the patient's face to the extent that is illustrated in Figure 15.

[0237] As will be appreciated from Figure 15, the sampling conduit 520 fits within the cross-section of the non-delivery side member 503 and therefore does not contribute any disruption to the mask seal 304. The sampling conduit 520 is contained within the solid body 521 of the non-delivery side member 503 and is protected from substantial deformation during application of the face mask. The sampling conduit 520 therefore remains open during bearing of the mask seal 304 onto the non-delivery side member 503.

[0238] Figure 16 illustrates an alternative embodiment to patient interface 500 and in which a patient interface 600 includes an inlet port 617 and an outlet port 618 located in the patient-facing wall 614 of the non-delivery side member 603. In an embodiment, respective sampling tubes could connect to the inlet and outlet ports 617, 618 and for example via a luer lock or threaded connection or plug fit or barb connection. In this embodiment, the sampling conduit is therefore comprised of the passage 620 extending internally through the non-delivery side member between the inlet and outlet ports 617, 618.

[0239] Figure 17 illustrates another alternative embodiment in which the sampling conduit comprises a sampling line and in particular a sampling tube 725. The tube 725 extends through the internal passage 720 of the non-delivery side member 703 and extends out of each of spaced apart openings in the patient-facing wall 714 which comprise a sampling tube inlet 717 and a sampling tube outlet 718. The portion of the tube 725 which extends from the sampling tube inlet 717 includes a sampling nasal prong 726 formed at the end of the tube 725 and which provides the sampling inlet configured to receive a patient gas flow at the patient. The sampling nasal prong 726 is located adjacent to and extends alongside one of the nasal delivery prongs 708 which is in fluid communication with the gases delivery side member 701. The portion of the tube 725 extending from the sampling tube outlet 718 may comprise the sampling outlet and may be configured for fluid communication with a respiratory gas monitor so as to provide fluid communication. The tube 725 may therefore provide fluid communication between the sampling nasal prong 726 and a respiratory gas monitor.

[0240] Figure 18 illustrates a further alternative embodiment in which a patient interface 800 includes a non-delivery side member 803 similar in configuration to interface 500 shown in Figure 11 and in which the non-delivery side member 803 includes pair of spaced apart openings comprising a sampling line inlet 817 and a sampling line outlet 818 formed in the non-patient facing wall 816 and connected by an internal passage 820. An inlet sampling line 825 includes a sampling device 827 and is connected to the sampling line inlet 817 via for example a luer lock, threaded connection, plug fit or barb connection. An outlet sampling line 828 is connected to the sampling line outlet 818 via for example a luer lock, threaded connection, plug fit or barb connection. The outlet sampling line 828 may connect to a respiratory gases monitor (not shown).

[0241] The sampling device 827 comprises the sampling inlet for the gas sampling interface. The sampling device 827 is located at an end of the inlet sampling line 825 and is configured for positioning in front of the patient's face and/or around the face and/or inside the patient's mouth. The sampling device 827 could comprise a gas sampling tip equivalent or similar to that which has been previously described by the Applicant in International Patent Publication WO/2018/070885. In an alternative embodiment, the inlet sampling line 825 and outlet sampling line 828 are non removably connected to the non-delivery side member 803 and could, for example, be moulded to the inlet 817 and outlet 818 respectively.

[0242] Figure 19 illustrates a patient interface 900 which is a variation on the patient interface 800 shown in Figure 18. The patient interface 900 includes an inlet sampling line 925 which is a wye-piece sampler line and includes a mouth line 925a and a nasal line 925b. A mouth sampling device 927a is located at the end of the mouth line 925a and a nasal sampling device 927b is located at the end of the nasal line 925b. Sampling at both nose and mouth may in some instances provide more reliable capture of patient gases and particularly in instances where it is uncertain where of the nose or mouth the patient is breathing from.

[0243] The inlet sampling lines 825, 925 shown in Figures 18 and 19 may be malleable to allow for selective positioning of the sampling devices 827, 927a, 927b. The malleability may be configured to require a minimum level of force to manipulate and reposition the sampling lines. This may prevent the sampling devices from undesirable movement which could affect intake of patient gases. The malleability of sampling line 825 in Figure 18 may allow for the sampling device 827 to be repositioned between the mouth and nose according to need and/or moved out of the way to provide access for other medical instruments. The sampling lines may be made from a variety of suitable materials such as silicone, pvc, thermoplastics etc.

[0244] Figure 20 illustrates another alternative embodiment in which a patient interface 1000 includes a mouth sampling scoop 1032 which includes a scoop opening 1034 configured for location in front of the patient's mouth. Patient gases exhaled through the mouth are captured by the scoop opening 1034 and taken through an internal sampling conduit 1020 which extends through the scoop 1032 and through non-delivery side member 1003 to a sampling outlet port 1018 which is configured for fluid communication with a respiratory gas monitor e.g. via a sampling outlet line.

[0245] The scoop 1032 has a substantially flat profile allowing it to fit under a patient mask applied over the top of the interface 1000. The scoop 1032 may be sized to cover a relatively small portion of the mouth in order to enable expiratory gas catchment but also allowing room for other medical equipment. The sampling conduit 1020 extends beneath an internal wall 1029 which separates the scoop 1032 from the gases delivery passage 1036 such that the sampling conduit 1020 does not interfere with the gas delivery passage 1036 providing gases to the nasal delivery prongs 1008. In other embodiments, the sampling conduit could extend within the gases delivery passage 1036. The mouth scoop 1032 may be made from or formed of a soft material allowing it to bend around instruments if necessary. The mouth scoop 1032 could be any suitable shape so as to limit interference with instruments which require mouth access.

[0246] Figure 21 illustrates a patient interface 1100 which is a variation on the interface 1000 shown in Figure 20. In addition to the features/structure of interface 1000, the patient interface 1100 further includes a septum sampling port 1138 for sampling nasal patient gas flow which is transported through a septum sampling line 1139 extending from a junction 1140 in the sampling conduit 1120. This configuration allows for simultaneous nasal and mouth sampling and thereby improving sampling reliability when it is uncertain where the patient is breathing from. In a particular embodiment, the septum port 1138 receives nasal gas flow directly from the patient. In another embodiment, the septum port 1138 could be connected to a nasal sampling prong or another sampling device such as a malleable sampling line described above with respect to Figures 18 and 19.

[0247] The configurations shown in Figures 20 and 21 may also be advantageous in that the inlets 1034, 1138 are positioned centrally and are substantially aligned with the patient's nose and mouth. For example, the inlets 1034, 1138 lie substantially on a common plane with the patient's nose and mouth and also with the nasal delivery prongs 1008. The central positioning of the mouth and nasal inlets 1034, 1138 may advantageously further reduce the chance of interference with the seal of a patient mask which is applied to the patient's face.

[0248] Figure 22 illustrates another embodiment patient interface 1200 similar to the preceding embodiments but in which the sampling conduit 1220 connects via a wye-piece 1240 to a pair of nasal sampling prongs 1226 positioned alongside and substantially parallel to (and also beneath) the nasal delivery prongs 1208. The nasal sampling prongs could be malleable to allow better positioning or engagement with a patient's nares.

[0249] The patient interface 1200 could also be provided with a mouth sampling scoop 1332 as is shown in Figure 23 which illustrates a patient interface 1300. The scoop 1332 may have an equivalent configuration to that which is described above with respect to scoop 1032 in Figure 20. The patient interface 1300 includes a sampling conduit 1320 which is therefore capable of sampling patient gas flow from each of the patient's nares via the pair of nasal prongs 1326 as well as from the patient's mouth via the mouth scoop 1332 and its opening 1334.

[0250] Figure 24 illustrates a further embodiment patient interface 1400 in which the nasal sampling prongs 1426 extend through the nasal delivery prongs 1408. The nasal sampling prongs 1426 are approximately concentric with the nasal delivery prongs 1408. The nasal sampling prongs 1426 are illustrated terminating at approximately the same point as the nasal delivery prongs 1408 but could also extend beyond the end of the nasal delivery prongs as is exemplified in an alternative embodiment below in Figure 51. In other embodiments, the nasal sampling prongs could extend through the nasal delivery prongs but not centrally or concentrically. For example, the nasal sampling prongs could be attached to an internal surface of the nasal delivery prongs and therefore offset from the centre of the nasal delivery prongs.

[0251] Figure 25 illustrates an alternative patient interface 1500 in which the non delivery side member and the sampling conduit is provided by a sampling tube 1503 having at one end a nasal prong 1526 which provides the sampling inlet 1517 and, at the opposite end, an opening which provides the sampling outlet 1518. The nasal sampling prong 1526 is positioned alongside and extends parallel to one of the nasal delivery prongs 1508. The sampling tube 1503 could be connected to a headstrap (not shown). The sampling tube 1503 could be removable or non-removably connected to the manifold 1506 and/or to the nasal delivery prong 1508. In the illustrated embodiment provided by Figure 25, the nasal sampling prong 1526 is moulded with the manifold 1506 and also to the nasal delivery prong 1508.

[0252] A variation to patient interface 1500 is shown in Figure 26 in which a patient interface 1600 includes a pair of nasal sampling prongs 1626 attached (e.g. via moulding, adhesive, etc) to the nasal delivery prongs 1608. The nasal sampling prongs comprise a sampling inlet 1617 in fluid communication with a sampling outlet port 1618 which is positioned on a patient-facing surface 1614 of the non-delivery side member 1603 and which is configured for connection to a respiratory gas monitor via an outlet tube or the like.

[0253] Figure 27 provides a side perspective of the patient interface 400 previously shown in Figure 7 and with the non-delivery side member 403 cut-away to show the cross section 421. The cross-section 421 is equivalent to that which is described above with reference to Figure 15 and, in particular, is asymmetric and having a patient-facing wall 414 which is curved and a non-patient-facing wall 416 which is less curved and substantially planar.

[0254] Figure 27 provides contextual reference for Figures 28 to 31 which illustrate various embodiments of the non-delivery side member being provided with a channel configured to receive the sampling conduit.

[0255] Figure 28 illustrates a cross-section 1721 of the non-delivery side member 1703 in which a channel 1742 is provided in the non-patient-facing wall 1716. The channel 1742 is substantially circular and is configured in diameter to receive and retain a tubular sampling conduit 1720. The conduit 1720 is retained in the channel 1742 (e.g. via a snap-fit arrangement) whereby the sampling conduit and/or the channel 1742 is flexibly resilient such that the conduit 1720 is retained within the channel 1742 by slight resilient deformation of the conduit 1720 and/or the channel 1742. In configurations where the sampling conduit 1720 has a non-circular cross-section, the channel 1742 or a part thereof may comprise a cross-sectional shape that matches the cross sectional shape of the sampling conduit 1720 in order to receive and optionally retain it. In other configurations, the channel may be shallower than what is illustrated in Figures 28 and 29 and could comprise a circular or curved cross-section that is less than 1800 around. In some configurations, the conduit 1720 is retained within the channel 1742 by a retention mechanism, e.g. adhesive, hook-and-loop configuration, etc.

[0256] The channel 1742 may be sufficiently deep so as to receive most or all of the diameter of the conduit 1720 and in order that the periphery of the non-delivery side member cross-section 1721 is not substantially increased or altered when the sampling conduit is fitted within the channel 1742. This may advantageously minimise disruption to the mask seal when placed over the top of the patient interface.

[0257] Figure 29 provides an alternative configuration in which the channel 1842 is located in the patient-facing-wall 1814 and therefore the conduit 1820 is located at the patient-facing wall 1814 instead of the non-patient-facing wall 1716 as in Figure 28.

[0258] Figure 30 provides a rear perspective of a patient interface 1800 having a non-delivery side member 1803 with the cross-section that was illustrated in Figure 29. Figure 30 illustrates the channel 1842 formed in the patient-facing wall 1814 and extending along a length of the non-delivery side member between a sampling inlet end 1817 adjacent to the delivery outlet 1808 and a sampling outlet end 1818 adjacent to a headstrap end 1809 of the non-delivery side member 1803.

[0259] A variation to patient interface 1800 is shown in Figure 31 in which a patient interface 1900 includes a non-delivery side member 1903 having a sampling conduit outlet aperture 1918 and a sampling conduit inlet aperture 1917. The inlet and outlet apertures 1917, 1918 are provided at opposite ends of the channel 1942 for the sampling conduit to be inserted through in order to hold the sampling conduit securely in place. The inlet and outlet apertures 1917, 1918 extend through a portion of the non delivery side arm 1903 so as to effectively provide connection loops through which the sampling conduit in inserted to provide additional securing of the conduit within the channel1942.

[0260] The embodiments exemplified in Figures 11 to 31 illustrate configurations in which the sampling conduit is configured to remain open during application of the collapsing force to the patient interface which induces movement of the collapsible portion to the collapsed configuration. For example, the sampling conduits illustrated in Figures 11 to 24 and 26 may be configured to remain open by virtue of being located internally of the non-delivery side member which may be sufficiently resistant to deformation so as not to allow collapse of the internal sampling conduit during application of the collapsing force. The sampling conduits could include internal stiffening or support portions configured to prevent deformation, restriction or closure of the sampling conduit upon application of the collapsing force. The sampling conduit exemplified in Figure 25 is itself the non-delivery side member and in which the sampling tube 1503 could have a sufficiently rigid configuration (for example, provided by the material or geometry of the tube 1503) so as to remain open upon application of the collapsing force. Similarly, the sampling conduits illustrated in Figures 28 - 31 may be only partially surrounded and protected by the non-delivery side member and so may also have a configuration (e.g. in material or geometry or via internal support formations) which allows the sampling conduit to remain open during application of the collapsing force.

[0261] The preceding description of Figures 11 to 31 related to embodiments of the present disclosure in which the gas sampling interface is provided to (or in lieu of) the non-delivery side member 403. The following description of Figures 32 to 65 relate to embodiments in which the gas sampling interface is provided to the gases delivery side member 401 (illustrated in Figure 7).

[0262] Figures 32 - 49 illustrate cross-sections of various configurations in which the sampling conduit is provided to the gases delivery side member. The sampling conduit includes a sampling lumen denoted by'S'and the gases delivery side member includes a gases delivery lumen denoted by 'G'. The cross-sections illustrated in Figures 32 - 49 are taken through the collapsible portion 404 of the gases delivery side member 401.

[0263] Figures 32, 35, 38, 41, 44 and 47 illustrate the normally open configuration of the collapsible portion in which both the gases delivery lumen G and the sampling lumen S are open. Each of these figures also illustrate embodiments in which the gases delivery lumen G and the sampling lumen S have parallel longitudinal axes. Figures 33, 36, 39, 42, 45 and 48 illustrate the collapsible portion in the collapsed configuration and wherein the sampling lumen is configured to remain open. These configurations therefore allow for continuous sampling of patient gases through the sampling lumen even during reduction or cessation of gas flow through the gases delivery lumen due to the collapsible portion being moved to the collapsed configuration.

[0264] Figures 34, 37, 40, 43, 46, 49 illustrate alternative embodiments in which the collapsible portion is in the collapsed configuration and wherein the sampling lumen is also configured to be closed. It is envisaged that these configurations may be used where sampling is not required when the collapsible portion is moved to the collapsed configuration. For example, where a patient mask is applied to a patient's face which contains its own patient gas sampling system, it may be desirable for the sampling lumen S to be closed in order to prevent gas leakage from inside the patient mask. For example, in particular situations, certain apparatus flow supply devices could interpret the sampled patient gas removed from the system through the sampling conduit as a 'leak' which could trigger an alarm. This scenario could be more likely to occur where a relatively low flow rate is being delivered through a patient mask and wherein the sampled flow rate removed through the sampling conduit constitutes a substantial portion (e.g. 20%) of the apparatus gas flow that is delivered.

[0265] The alternative configurations of the sampling conduit remaining open or becoming closed (i.e. the alternative configurations shown in figures 33 and 34, figures 36 and 37, figures 39 and 40, figures 42 and 43, figures 45 and 46, figures 48 and 49) may be achieved according to the level of sampling lumen collapse-resistance. This may be due to the stiffness of the sampling lumen. For example, in some embodiments the sampling lumen may be surrounded by material having higher stiffness as compared to the material surrounding the gases delivery lumen. Consequentially, a collapsing force applied to the collapsible portion (and which is transmitted either directly or indirectly to the sampling lumen) can cause the gases delivery lumen to become occluded or closed whilst the sampling lumen remains open. Alternatively, the sampling lumen could be surrounded by material having similar or lower stiffness to that of the gases delivery lumen and in which case the collapsing force applied to the collapsible portion can cause both lumens to become closed.

[0266] Figure 32 illustrates a first configuration in which the sampling lumen S is integrated within a wall 2021 of the gases delivery member collapsible portion 2004. The wall 2021 surrounds the gases delivery lumen G. The wall 2021 is formed of a non rigid material and is configured in material and/or in geometry to allow movement of opposite wall portions 2021a, 2021b towards and against each other upon movement of the collapsible portion 2004 to the collapsed configuration. The sampling lumen S has a circular cross section and is located adjacent an end of the elongated cross section of the gases delivery lumen G. The wall 2021 is enlarged at one end so as to accommodate the sampling lumen S therein.

[0267] Figures 33 and 34 illustrate the collapsible portion 2004 in the collapsed configuration and in which the sampling lumen G has been closed by movement of the wall portions 2021a, 2021b towards and against each other. Figure 33 illustrates an embodiment in which the sampling lumen S is configured to remain open whilst the collapsible portion 2004 is in the collapsed configuration. Figure 34 illustrates an alternative embodiment in which the sampling lumen S is configured to also become closed when the collapsible portion 2004 is in the collapsed configuration.

[0268] Figure 35 illustrates an embodiment in which the collapsible portion 2104 extends through the sampling lumen S and the sampling conduit comprises a sleeve

2144 that surrounds the collapsible portion 2104. The sampling lumen S is formed in the volume between the sleeve and the collapsible portion 2104. Figure 36 illustrates the collapsible portion 2104 in the collapsed configuration such that the gases delivery lumen G is closed but in which a portion of the sampling lumen remains open between opposite external ends of the collapsible portion 2104 and opposite internal ends of the sleeve 2144.

[0269] Figure 37 illustrates an alternative embodiment to Figure 36 in which the open configuration shown in Figure 36 is moved to a collapsed configuration and wherein both the sampling lumen S and the gases delivery lumen G are closed.

[0270] Figure 38 illustrates an embodiment in which the sampling lumen S and gases delivery lumen S are integrally formed in the gases delivery side member and wherein the sampling lumen S is formed in a wall 2221 which surrounds the gases delivery lumen G. The embodiment of Figure 38 is therefore a variation to Figure 32 but differs in that the sampling lumen S of Figure 38 has an elongated and curved cross section which extends alongside a longitudinal side of the gases delivery lumen cross section. The wall 2221 is enlarged at one side so as to accommodate the sampling lumen S therein.

[0271] Figure 39 illustrates an embodiment in which the configuration of Figure 38 is moved to the collapsed configuration so as to close the gases delivery lumen G but wherein the sampling lumen remains open. Figure 40 illustrates an alternative embodiment in which the open configuration of Figure 38 is moved to the collapsed configuration and wherein both the sampling lumen S and the gases delivery lumen G are closed.

[0272] Figure 41 illustrates an embodiment in which a sampling conduit 2320 is integrally formed with the collapsible portion 2304 and whereby the sampling conduit extends alongside an external surface 2346 of the collapsible portion 2304. The collapsible portion 2304 has an elongate cross-section which includes a pair of longitudinal sides 2348 extending between a pair of opposite ends 2350 and the sampling conduit 2320 being integrally connected with the external surface 2346 at one ofthe ends 2350.

[0273] Figure 42 illustrates an embodiment in which the configuration of Figure 41 is moved to the collapsed configuration and wherein the longitudinal sides 2348 have moved towards and against one another to close the gases delivery lumen. The sampling conduit 2320 is unaffected and with the sampling lumen S remaining open. Figure 43 illustrates an alternative embodiment in which the sampling conduit 2320 has also become resiliently deformed to a collapsed configuration during movement of the collapsible portion 2304 to its collapsed configuration and wherein the sampling lumen has also become closed.

[0274] Figure 44 is a variation on the embodiment shown in Figure 41 and in which the sampling conduit 2420 is connected with the external surface 2446 (in particular one of the ends 2450) via a connection web 2452 and the sampling conduit 2420 is spaced apart from the collapsible portion 2404 by a width Wcw of the connection web 2452.

[0275] Figure 45 illustrates an embodiment in which the open configuration of Figure 44 is moved to the collapsed configuration and wherein the sampling conduit 2420 remains open. Figure 46 illustrates an alternative embodiment in which the sampling conduit 2420 is resiliently deformed to a collapsed configuration during movement of the collapsible portion 2404 to the collapsed configuration and wherein the sampling lumen has also become closed.

[0276] Figure 47 illustrates an embodiment in which the sampling conduit 2520 extends through the gases delivery lumen G. The sampling conduit 2520 may be free to move within the gases delivery lumen or could, alternatively, be retained in position via an internal web or retention member (not shown). The sampling conduit 2520 has a small cross-section relative to the gases delivery lumen G so as to minimise obstruction of apparatus gas flow through the gases delivery lumen G and to minimise interference with the moving of the collapsible portion 2504 to the collapsed configuration.

[0277] Figure 48 illustrates an embodiment in which the open configuration of Figure 47 is moved to the collapsed configuration and in which the sampling conduit 2520 remains open. The sampling conduit 2520 has a curved exterior surface without angular edges which facilitate the wall portions 2521a and 2521b to bend or fold around the sampling conduit 2520. Figure 49 illustrates an alternative embodiment in which the open configuration of Figure 47 is moved to the collapsed configuration and in which the sampling conduit 2520 is resiliently deformed to a collapsed configuration such that the sampling lumen is closed.

[0278] It will be appreciated that Figures 32, 38, 41 and 44 exemplify the sampling conduit (and sampling lumen) being integrated with the gases delivery side member. Figures 35 and 47 exemplify the gases delivery lumen and the sampling lumen being substantially concentric and coaxial. Figures 32 and 38 illustrate embodiments in which the gases delivery lumen G and the sampling lumen S are integrally formed within the gases delivery side member and spaced apart from one another. Figures 41 and 44 illustrate embodiments in which the sampling conduit extends alongside an external surface of the gases delivery side member.

[0279] Figure 50 illustrates a patient interface 2600 in which the gases delivery side member 2601 has the cross-sectional configuration shown in Figure 47 wherein the sampling conduit 2620 extends through the gases delivery lumen contained within the gases delivery side member 2601. The sampling conduit 2620 extends between a sampling outlet comprising an outlet port 2618 and sampling inlets 2617 comprising openings in the ends of nasal sampling prongs 2626 located inside nasal delivery prongs 2608. The sampling conduit 2620 is free to move within the gas delivery side member 2601 and is only fixed to the gases delivery side member 2601 at the outlet port 2618. In other embodiments, the gases delivery side member 2601 comprises internal structures that support the sampling conduit 2620 within the gases delivery side member 2601 at a desired position. The nasal sampling prongs 2626 terminate at the same point as the nasal delivery prongs 2608.

[0280] A variation to patient interface 2600 is shown in Figure 51 in which a patient interface 2700 includes nasal sampling prongs 2726 which extend through and beyond the openings of the nasal delivery prongs 2708. The nasal sampling prongs 2726 are therefore configured to position the sampling inlets 2617 further into the patient's nares than the outlets of the nasal delivery prongs 2708. Positioning of the sampling inlets 2617 further inside the nares than the delivery outlet (i.e. the nasal delivery prongs

2708) may provide a number of benefits including minimising dilution of the sampled patient gases. Moreover, this configuration may in some instances minimise the formation of turbulent flow which could restrict or reduce patient gases from entering the sampling prongs 2726. Furthermore, having the sampling prongs 2726 extend beyond the nasal delivery prongs 2708 may shield the patient gases entering the sampling prongs 2726 from the delivered apparatus gases exiting the outlet of the nasal delivery prongs 2708.

[0281] Figure 52 illustrates a patient interface 2800 in which the gases delivery side member 2801 has the cross-sectional configuration shown in Figure 41 and wherein the sampling conduit 2820 is integrally formed with the gases delivery side member 2801. In particular, the sampling conduit 2820 is moulded to an underside end 2850 of the gases delivery side member 2801. The sampling conduit 2820 includes a sampling inlet comprising a nasal sampling prong 2826 moulded to (and extending alongside) one of the nasal delivery prongs 2808.

[0282] A variation to patient interface 2800 is shown in Figures 53 and 54 in which a patient interface 2900 includes a sampling conduit 2920 which is removably attached to the underside end 2950 of the gases delivery side member 2901 via an attachment clip 2954. In another configuration (not illustrated) the sampling conduit could be similarly attached but located at a top of the gases delivery side member.

[0283] Figure 55 illustrates a patient interface 3000 in which the gases delivery side member 3001 has the cross-sectional configuration shown in Figure 35 and wherein the gases delivery side member 3001 is surrounded by a sleeve 3144. The sleeve 3144 includes an outlet port 3018 configured for connection with a respiratory gas monitor. The sleeve 3144 includes an outlet end 3058 that is sealed with the gases delivery side member 3001. The sleeve 3144 further includes a funnel portion 3056 at an inlet end 3059 of the sleeve proximate to the delivery outlet 3008. The funnel portion 3056 is configured to receive patient gas flow from the nose and/or mouth via an opening 3017 which provides the sampling inlet.

[0284] Figure 56 illustrates a patient interface 3100 in which the gas path connector 3113 is fitted with a ring connector 3158 which includes a loop 3160 to receive and secure part of the sampling line 3120. The ring connector 3158 thereby secures part of the sampling line 3120 to the gas path connector 3113. The sampling line 3120 includes a sampling inlet which is comprised of a sampling device 3127 at a distal end of the sampling line 3120. The sampling line 3120 has a self-supporting and malleable configuration and whereby the sampling device 3127 can be repositioned as required. For example, the sampling device 3127 can be positioned in front of (i.e. on the non patient side of) the delivery outlet 3108 so as to receive patient gas flow from the patients mouth and/or nose.

[0285] Figure 57 shows the gas path connector 3113 which includes a threaded portion 3162 for connection to a gas supply tube that provides an apparatus gas supply. The gas path connector 3113 also includes a flange 3164 for connection to a head strap. The ring connector 3158 is configured to fit over the threaded portion 3162 (preferably also over the gas supply tube connected to the threaded portion 3162) in order to removably attach the sampling line 3120 to the gas path connector 3113. The ring connector 3158 can comprise a locating feature (e.g. a rib) to resist axial movement with respect to the gas path connector 3113 and gas supply tube when connected.

[0286] Figure 58 shows a cross-sectional view of the sampling line 3120 which includes a flexibly resilient wire 3166 integrated within the sampling line 3120 to provide the sampling line 3120 with its self-supporting and malleable functionality. The sampling line 3120 includes a sampling lumen S. Both the sampling line 3120 and the sampling lumen S have an elongate cross-section and, in particular, an oval cross-section. The sampling line 3120 is relatively thin in a width direction so as to allow a patient face mask to be placed over the sampling line 3120 and to introduce minimal disruption to the face mask seal.

[0287] Figure 59 illustrates an attachment ring 6140 which was previously illustrated in Applicant's earlier patent publication W02018070885 and which is also suitable for use with a patient interface according to an aspect of the present disclosure. The attachment ring 6140 includes a pair of resilient arms 6150 configured for connection with the gas path connector 3113 shown in Figure 57. The interior region 6142 of the arms 6150 may have a profile (e.g. a protrusion) to correspond and engage with the threaded portion 3162 of the gas path connector 3113.

[0288] The attachment ring 6140 further comprises a pair of clips 6167 forming hooks which comprise arms 6168 extending from the clip body 6141. The clips 6167 provide a concave receiving region 6170 within which a portion of the gas sampling conduit 6120 is received and held. The gas sampling conduit 6120 is threaded through the receiving regions 6170 as shown in Figure 59 to secure the conduit 6120 in place via a snap-fit connection.

[0289] Figure 60 illustrates a patient interface 3200 in which the gases delivery side member 3201 is fitted with an accessory comprising a ring 3258 that is configured to facilitate moving of the collapsible portion 3204 to the collapsed configuration upon application of the collapsing force. As shown, the ring 3258 is fitted around the collapsible portion 3204. An earlier embodiment of a similar accessory intended to facilitate collapse of a collapsible portion was disclosed in Applicant's International Patent Application PCT/IB2019/051137 (International Patent Publication W02019159063). Figures 25A-F of this disclosure illustrated a ring 215 configured to extend around the conduit and to tilt or rotate when a force is applied to the ring 215 in order to pinch or kink the conduit.

[0290] The ring 3258 shown in Figure 60 of the present disclosure may have a generally equivalent configuration to (and function the same as) the ring 215 disclosed in International Patent Application PCT/IB2019/051137 (International Patent Publication W02019159063). However, the ring 3258 further includes an attachment loop 3260 for attachment to the sampling conduit 3220. The ring 3258 may therefore serve a dual function to facilitate movement of the collapsible portion to the collapsed configuration and also act as a conduit connector. The application of a face mask over the patient interface can force the ring 3258 to roll over and seal the collapsible potion 3204. The ring 3258 may be sufficiently small so as to minimise any disruption to the seal of the patient face mask.

[0291] Figure 61 illustrates an accessory 3358 configured for attachment to a patient interface such as the patient interface 400 illustrated in Figure 7. The accessory 3358 comprises a rigid member 3368 configured for extending along the patient-facing wall of the gases delivery side member 401. A contact element 3370 is provided at a distal end of the rigid member 3368 and which is configured to provide a concentrated reaction force to a load applied to the collapsible portion 404 shown in Figure 7. The contact element 3370 is configured to provide the reaction load to a patient-facing wall of the collapsible portion 404 in response to the application of a collapsing force (for example from a patient mask) applied to the non-patient-facing wall of the collapsible portion 404. The contact element 3370 includes a saddle-shaped tapered rib 3371 configured to localise/concentrate the reaction force onto a smaller area of the collapsible portion and thereby further promote bending or folding of the patient-facing wall and thus facilitate movement to the collapsed configuration.

[0292] The accessory 3358 further includes an attachment configuration 3372 for attaching the accessory 3358 to the patient interface 400. The attachment configuration 3372 includes an opening 3374 configured to receive and engage with the headstrap flange 3164 on the gas path connector 3113 shown in Figure 57 (and also shown in Figure 7). The mode of attachment is shown in Figure 62 which shows the attachment configuration 3372 attached to the gas path connector 3113 of Figure 57 and with the headstrap flange 3164 protruding through the opening 3374. In other embodiments, the attachment to the gas path connector could be via a C or U-shaped clip. Other forms of attachment are possible such as adhesive, overmoulding or integrally forming of the accessory with the gas path connector.

[0293] The contact element 3370 includes a connection ring 3360 configured for connection with a sampling line such as the sampling line 3220 of Figure 60 or 3120 of Figure 56.

[0294] Figure 63 illustrates the patient interface 400 of Figure 7 fitted with the accessory 3358. The contact element 3370 is located behind the collapsible portion 404 such that the rib 3371 contacts the patient-facing wall of the collapsible portion 404. The attachment configuration 3372 is connected to the gas path connector 3113 through which apparatus gas flow is provided to the gas delivery side member 401. The attachment ring 3360 is located above (and is spaced from) the collapsible portion 404 to allow for a sampling line to be connected and to run generally along and above the gases delivery side member 401 toward the delivery outlet 408.

[0295] Figures 64 and 65 are rear and front views of an alternative accessory 3458 which is equivalent in condition to accessory 3358 shown in Figures 61 - 63 except accessory 3458 does not include the attachment ring 3360 and instead includes an integrated sampling conduit 3420 extending internally through the accessory 3458. The sampling conduit 3420 extends between a pair of openings located at opposite ends of the accessory 3458 and comprising a sampling inlet 3417 provided in the contact element 3470 and a sampling outlet 3418 provided at the attachment configuration 3472.

[0296] The sampling inlet 3417 may be configured for connection to a sampling device or sampling line. For example, via a luer lock, threaded connection, plug fit, barb fit. The sampling inlet 3417 may be integrally connected, for example moulded, to a sampling device or sampling line. The sampling outlet 3418 may be configured for connection with or may be integrally connected with an outlet line in fluid communication with a respiratory gas monitor. The sampling conduit 3420 is formed within the rigid material of the accessory 3458 and is therefore prevented from collapse during collapse of the collapsible portion thus enabling sampling to continue when apparatus gas flow through the collapsible portion is reduced or stopped.

[0297] The inventions may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features. Where, in the foregoing description reference has been made to integers or components having known equivalents thereof, those integers are herein incorporated as if individually set forth.

[0298] Where any or all of the terms "comprise", "comprises", "comprised" or "comprising" are used in this specification (including the provisional claims) they are to be interpreted as specifying the presence of the stated features, integers, steps or components, but not precluding the presence of one or more other features, integers, steps or components or group thereof.

[0299] Although the present disclosure has been described in terms of certain embodiments, other embodiments apparent to those of ordinary skill in the art also are within the scope of this disclosure. Thus, various changes and modifications may be made without departing from the spirit and scope of the disclosure. For instance, various components may be repositioned as desired. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present disclosure. Accordingly, the scope of the present disclosure is intended to be defined only by the claims that follow.

Claims

The claims defining the invention are as follows:

1. A patient interface including:

a gases delivery interface configured to deliver an apparatus gas flow to a patient, the gases delivery interface comprising: a delivery outlet to deliver the apparatus gas flow to the patient; and a gases delivery side member extending from a first side of the delivery outlet and including an apparatus gases flow path in fluid communication with the delivery outlet, the gases delivery side member comprising a collapsible portion movable upon application of a collapsing force from a normally open configuration to a collapsed configuration in which the apparatus gases flow path is reduced or closed and in order to reduce or stop the apparatus gas flow through the apparatus gases flow path, and the patient interface further including: a gas sampling interface comprising: a sampling inlet configured to receive a patient gas flow at the patient; a sampling outlet configured for delivery of the patient gas flow away from the patient; and a sampling conduit in fluid communication with the sampling inlet and the sampling outlet, the sampling conduit configured to remain open to maintain fluid communication between the sampling inlet and sampling outlet when the collapsible portion is moved to the collapsed configuration.

2. A patient interface according to claim 1, the sampling conduit extending from a second side of the delivery outlet that is opposite to the first side.

3. A patient interface according to claims 1 or 2, the sampling conduit having an end configured for coupling to a headstrap, and including an internal passageway providing the fluid communication between the sampling inlet and sampling outlet, the sampling conduit also comprising a patient-facing wall and a non-patient-facing wall.

4. A patient interface according to claim 1, the patient interface further including a non delivery side member extending from a second side of the delivery outlet that is opposite to the first side and the non-delivery side member having a headstrap end that is configured for coupling to a headstrap, the non-delivery side member also comprising a patient-facing wall and a non-patient-facing wall.

5. A patient interface according to claim 4, the sampling conduit provided on the non delivery side member.

6. A patient interface according to claim 5, the sampling conduit extending through a portion of the non-delivery side member.

7. A patient interface according to claim 6, the sampling conduit extending through an internal passage of the non-delivery side member.

8. A patient interface according to claim 7, the sampling conduit extending between a pair of spaced apart openings in one or more walls of the non-delivery side member.

9. A patient interface according to claim 8, the spaced apart openings comprising an inlet port proximate to the delivery outlet and an outlet port proximate to the headstrap end.

10.A patient interface according to claim 9, the inlet port and/or the outlet port located in the patient-facing wall of the non-delivery side member.

11.A patient interface according to claim 10, the inlet port and/or the outlet port located in the non-patient-facing wall of the non-delivery side member.

12. A patient interface according to any one of claims 9 to 11, the sampling inlet located at or adjacent the inlet port and the sampling outlet located at or adjacent the outlet port.

13.A patient interface according to any one of claims 9 to 12, the sampling conduit comprising a tube extending through both the inlet port and the outlet port and through the internal passage which extends between the inlet and outlet ports.

14.A patient interface according to any one of claims 9 to 12, the sampling conduit comprising the internal passage of the non-delivery member and wherein the inlet and/or outlet ports are configured for connection to respective sampling tubes configured to extend from the inlet and outlet ports to the sampling inlet and sampling outlet respectively.

15.A patient interface according to claim 14, the inlet and/or outlet ports being configured for connection to sampling tubes via a luer lock or threaded connection or plug-fit or barb.

16.A patient interface according to any one of claims 9 to 12 wherein the non-delivery member includes a sampling inlet tube moulded to the sampling inlet and/or a sampling outlet tube moulded to the sampling outlet.

17. A patient interface according to claim 4, the sampling conduit being integrally formed with the non-delivery side member.

18.A patient interface according to claim 4, the sampling conduit being attachable with the non-delivery side member.

19.A patient interface according to claim 18, the non-delivery side member comprising a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the non-delivery side member.

20.A patient interface according to claim 19, the channel being located in the patient facing wall of the non-delivery side member.

21.A patient interface according to claim 19, the channel being located in the non patient-facing wall of the non-delivery side member.

22.A patient interface according to any one of claims 4 to 21, the sampling inlet being proximate to the delivery outlet and the sampling outlet being proximate to the headstrap end of the non-delivery side member.

23.A patient interface according to any one of claims 4 to 22, the sampling inlet and sampling outlet being separate by a distance that is greater than a width of a section of a face mask seal that is configured for placement on the patient's face and to bear over a portion of the non-delivery side member.

24.A patient interface according to claim 23, the non-delivery side member configured to resist deformation upon bearing of the face mask seal over the non-delivery member.

25.A patient interface according to claim 23, the non-delivery side member configured to deform upon bearing of the face mask seal over the non-delivery side member and wherein the sampling conduit remains open during deformation of the non delivery side member.

26.A patient interface according to any one of claims 4 to 25, the patient-facing wall having a more pronounced curve as compared to the non-patient-facing wall.

27.A patient interface according to any one of claims 3 to 26, the non-delivery side member having an elongate cross-section which is asymmetric in at least one axis.

28.A patient interface according to claim 27, the cross-section being asymmetric in a axis substantially parallel with the patient-facing wall.

29.A patient interface according to claim 27 or 28, the patient-facing wall having a different curvature configuration to the non-patient-facing wall.

30.A patient interface according to any one of claims 27 to 29, the non-delivery side member having an asymmetric lens cross section.

31.A patient interface according to any one of claims 27 to 30, the non-delivery side member cross-section including a pair of opposite and spaced apart edges and wherein the patient-facing wall and the non-patient-facing wall extend between the pair of edges.

32.A patient interface according to claim 31, wherein the patient-facing wall has a substantially convex formation extending between the pair of opposite edges.

33.A patient interface according to claim 31 or 32, wherein the non-patient-facing wall has a substantially planar formation extending between the pair of opposite edges.

34.A patient interface according to claim 1, the gas sampling interface provided to the gases delivery side member, the gases delivery side member comprising a delivery inlet at one end to receive the apparatus gas flow and the gases delivery side member comprising a patient-facing wall and a non-patient-facing wall.

35.A patient interface according to claim 34, the sampling inlet being proximate to the delivery outlet and the sampling outlet being proximate to the delivery inlet.

36.A patient interface according to any one of claims 34 or 35, the sampling conduit comprising a sampling lumen for the patient gas flow and the gases delivery side member comprising a gases delivery lumen for the apparatus gas flow.

37. A patient interface according to claim 36, the sampling conduit being integrated with the gases delivery side member.

38.A patient interface according to claim 36 or 37, the sampling conduit extending through the gases delivery lumen.

39.A patient interface according to claim 38, wherein a portion of the sampling conduit is free to move within the gases delivery lumen.

40.A patient interface according to claims 38 or 39, the sampling conduit extending through the collapsible portion and the sampling conduit having a cross-section configured to minimise obstruction of apparatus gas flow and to minimise interference with moving of the collapsible portion to the collapsed configuration.

41.A patient interface according to claim 40, the cross-section of the sampling conduit having a geometry configured to facilitate occlusion of the gases delivery lumen when the collapsible portion is in the collapsed configuration.

42.A patient interface according to claim 41, the sampling conduit having a cross section with a curved exterior surface configured for a wall the collapsible portion to bend or fold around the curved exterior surface.

43.A patient interface according to any one of claims 38 to 42, the sampling conduit having a cross-sectional area that is less than a cross-sectional area of the gases delivery lumen.

44.A patient interface according to claim 36 or 37, the gases delivery side member extending through the sampling lumen.

45.A patient interface according to claim 44, the sampling conduit comprising a sleeve that surrounds the gases delivery side member.

46.A patient interface according to claim 45, the sampling inlet comprising a funnel portion at an end of the sleeve proximate to the delivery outlet, the funnel portion configured to receive patient gas flow from the nose and/or mouth.

47.A patient interface according to claim 46, the funnel portion configured to receive a portion of the apparatus gas flow.

48. A patient interface according to any one of claims 36 to 47, the gases delivery lumen and the sampling lumen being substantially concentric.

49. A patient interface according to any one of claims 36 to 47, the gases delivery lumen and the sampling lumen being substantially co-axial.

50. A patient interface according to any one of claims 36 to 47, the gases delivery lumen and the sampling lumen having parallel longitudinal axes.

51.A patient interface according to claim 36 or 37, the gases delivery lumen and sampling lumen being integrally formed within the gases delivery side member and spaced apart from one another.

52.A patient interface according to claim 51, the sampling lumen being formed within a wall of the gases delivery side member which surrounds the gases delivery lumen.

53.A patient interface according to any one of claims 34 to 37, the sampling conduit extending alongside an external surface of the gases delivery side member.

54. A patient interface according to claim 53, the sampling conduit integrally connected with an external surface of the gases delivery side member.

55. A patient interface according to claim 54, the sampling conduit integrally connected with the external surface via a connection web and the sampling conduit being spaced apart from the gases delivery side member by a width of the connection web.

56. A patient interface according to claim 55, the collapsible portion having an elongate cross-section which includes a pair of longitudinal sides extending between a pair of ends and wherein the connection web extends between the sampling conduit and one of the ends of the collapsible portion.

57.A patient interface according to any one of claims 34 to 53, further including an accessory located at or proximate the collapsible portion and configured to facilitate the collapsible portion moving to the collapsed configuration.

58.A patient interface according to claim 57, the accessory comprising a rigid member extending along the patient-facing wall of the gases delivery side member and configured to provide a reaction force to a load applied to the collapsible portion.

59.A patient interface according to claim 57 or 58, the accessory comprising a portion extending along the non-patient-facing wall of the gases delivery side member and configured to move towards the patient in response to a load applied to the accessory.

60. A patient interface according to any one of claims 57 to 59, the accessory including a conduit connector for connecting a portion of the sampling conduit to the accessory.

61.A patient interface according to any one of claims 57 to 60, the sampling conduit extending through the accessory.

62.A patient interface according to claim 61, the accessory including pair of spaced apart openings comprising a patient gas inlet port configured for location proximate the delivery outlet and a patient gas outlet port configured for location proximate the delivery inlet, the sampling conduit extending internally through the accessory between the patient gas inlet and outlet.

63.A patient interface according to any one of claims 34 to 62, including a rigid gas path connector connectable with the delivery inlet and the patient interface further including a conduit connector for removably connecting a portion of the sampling conduit to the gas path connector.

64.A patient interface according to claim 63, the conduit connector including a first attachment configuration comprising a pair of resilient arms configured for removable attachment to the gas path connector and a second attachment configuration configured for removable attachment to the sampling conduit.

65.A patient interface according to claim 64, the second attachment configuration comprising a pair of hooks defining a pair of recesses corresponding to an external diameter of the sampling conduit and configured to receive and retain the sampling conduit.

66. A patient interface according to any one of claims 63 to 65 when dependent through claim 60, wherein the sampling conduit is connected to both the conduit connector of the accessory and the conduit connector in connection with gas path connector.

67.A patient interface according to any one of claims 34 to 36, the gases delivery side member comprising a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the gases delivery side member.

68.A patient interface according to claim 67, the channel being located in the patient facing wall of the gases delivery side member.

69.A patient interface according to claim 67, the channel being located in the non patient-facing wall of the gases delivery side member.

70.A patient interface according any one of claims 34 to 69, the sampling conduit comprising a sampling lumen and the sampling conduit configured to retain the shape of the sampling lumen in response to the collapsing force applied to the collapsible portion.

71.A patient interface according to claim 70, the sampling conduit configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen upon application of the collapsing force.

72.A patient interface according to claim 71, the sampling conduit being formed of a material having sufficient material stiffness to retain the shape of the sampling lumen.

73.A patient interface according to claim 72, the sampling conduit being formed of a material that has greater material stiffness than a material of the collapsible portion.

74.A patient interface according to claim 71, the sampling conduit configured via geometric features to be stiffer than the collapsible portion.

75.A patient interface including: a gases delivery interface configured to deliver an apparatus gas flow to a patient, the gases delivery interface comprising: a delivery outlet to deliver the apparatus gas flow to the patient; and a gases delivery side member extending from a side of the delivery outlet and including an apparatus gases flow path in fluid communication with the delivery outlet, the gases delivery side member comprising a collapsible portion movable upon application of a collapsing force from a normally open configuration to a collapsed configuration in which the apparatus gases flow path is reduced or closed and in order to reduce or stop the apparatus gas flow through the apparatus gases flow path, and the patient interface further including: a gas sampling interface comprising: a sampling inlet configured to receive a patient gas flow at the patient; a sampling outlet configured for delivery of the patient gas flow away from the patient; and a sampling conduit in fluid communication with the sampling inlet and the sampling outlet, the gas sampling interface being provided to the gases delivery side member.

76.A patient interface according to claim 75, the gases delivery side member comprising a delivery inlet at one end to receive the apparatus gas flow and the gases delivery side member comprising a patient-facing wall and a non-patient facing wall.

77.A patient interface according to claim 76, the sampling inlet being proximate to the delivery outlet and the sampling outlet being proximate to the delivery inlet.

78.A patient interface according to any one of claims 76 or 77, the sampling conduit comprising a sampling lumen for the patient gas flow and the gases delivery side member comprising a gases delivery lumen for the apparatus gas flow.

79. A patient interface according to claim 78, the sampling conduit being integrated with the gases delivery side member.

80.A patient interface according to claim 78 or 79, the sampling conduit extending through the gases delivery lumen.

81.A patient interface according to claim 80, wherein a portion of the sampling conduit is free to move within the gases delivery lumen.

82.A patient interface according to claims 80 or 81, the sampling conduit extending through the collapsible portion and the sampling conduit having a cross-section configured to minimise obstruction of apparatus gas flow and to minimise interference with moving of the collapsible portion to the collapsed configuration.

83.A patient interface according to claim 82, the cross-section of the sampling conduit having a geometry configured to facilitate occlusion of the gases delivery lumen when the collapsible portion is in the collapsed configuration.

84.A patient interface according to claim 83, the sampling conduit having a cross section with a curved exterior surface configured for a wall the collapsible portion to bend or fold around the curved exterior surface.

85.A patient interface according to any one of claims 80 to 84, the sampling conduit having a cross-sectional area that is less than a cross-sectional area of the gases delivery lumen.

86.A patient interface according to claim 78 or 79, the gases delivery side member extending through the sampling lumen.

87.A patient interface according to claim 76, the sampling conduit comprising a sleeve that surrounds the gases delivery side member.

88. A patient interface according to claim 87, the sleeve including a funnel portion at an end of the sleeve proximate to the delivery outlet, the funnel portion configured to receive patient gas flow from the nose and/or mouth.

89.A patient interface according to claim 88, the funnel portion configured to receive a portion of the apparatus gas flow.

90. A patient interface according to any one of claims 78 to 89, the gases delivery lumen and the sampling lumen being substantially concentric.

91. A patient interface according to any one of claims 78 to 89, the gases delivery lumen and the sampling lumen being substantially co-axial.

92. A patient interface according to any one of claims 78 to 89, the gases delivery lumen and the sampling lumen having parallel longitudinal axes.

93.A patient interface according to claim 78 or 79, the gases delivery lumen and sampling lumen being integrally formed within the gases delivery side member and spaced apart from one another.

94.A patient interface according to claim 93, the sampling lumen being formed within a wall of the gases delivery side member which surrounds the gases delivery lumen.

95.A patient interface according to any one of claims 76 to 79, the sampling conduit extending alongside an external surface of the gases delivery side member.

96. A patient interface according to claim 95, the sampling conduit integrally connected with an external surface of the gases delivery side member.

97.A patient interface according to claim 96, the sampling conduit integrally connected with the external surface via a connection web and the sampling conduit being spaced apart from the gases delivery side member by a width of the connection web.

98. A patient interface according to claim 97, the collapsible portion having an elongate cross-section which includes a pair of longitudinal sides extending between a pair of ends and wherein the connection web extends between the sampling conduit and one of the ends of the collapsible portion.

99.A patient interface according to any one of claims 76 to 95, further including an accessory located at or proximate the collapsible portion and configured to facilitate moving of the collapsible portion to the collapsed configuration.

100. A patient interface according to claim 99, the accessory comprising a rigid member extending along the patient-facing wall of the gases delivery side member and configured to provide a reaction force to a load applied to the collapsible portion.

101. A patient interface according to claim 99 or 100, the accessory comprising a portion extending along the non-patient-facing wall of the gases delivery side member and configured to move towards the patient in response to a load applied to the accessory.

102. A patient interface according to any one of claims 99 to 101, the accessory including a conduit connector for connecting a portion of the sampling conduit to the accessory.

103. A patient interface according to any one of claims 99 to 102, the sampling conduit extending through the accessory.

104. A patient interface according to claim 103, the accessory including pair of spaced apart openings comprising a patient gas inlet port configured for location proximate the delivery outlet and a patient gas outlet port configured for location proximate the delivery inlet, the sampling conduit extending internally through the accessory between the patient gas inlet and outlet.

105. A patient interface according to any one of claims 76 to 104, including a rigid gas path connector connectable with the delivery inlet and the patient interface further including a conduit connector for removably connecting a portion of the sampling conduit to the gas path connector.

106. A patient interface according to claim 105, the conduit connector of the gas path connector including a first attachment configuration comprising a pair of resilient arms configured for removable attachment to the gas path connector and a second attachment configuration configured for removable attachment to the sampling conduit.

107. A patient interface according to claim 106, the second attachment configuration comprising a pair of hooks defining a pair of recesses corresponding to an external diameter of the sampling conduit and configured to receive and retain the sampling conduit.

108. A patient interface according to any one of claims 105 to 107 when dependent through claim 102, wherein the sampling conduit is connected to both the conduit connector of the accessory and the conduit connector of the gas path connector.

109. A patient interface according to any one of claims 76 to 78, the gases delivery side member comprising a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the gases delivery side member.

110. A patient interface according to claim 109, the channel being located in the patient-facing wall of the gases delivery side member.

111. A patient interface according to claim 109, the channel being located in the non patient-facing wall of the gases delivery side member.

112. A patient interface according to any one of claims 75 to 111, the sampling conduit configured to remain open to maintain fluid communication between the sampling inlet and sampling outlet when the collapsible portion is in the collapsed configuration.

113. A patient interface according any claim 112, the sampling conduit comprising a sampling lumen and the sampling conduit configured to retain the shape of the sampling lumen in response to the collapsing force applied to the collapsible portion.

114. A patient interface according to claim 113, the sampling conduit configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen upon application of the collapsing force.

115. A patient interface according to claim 114, the sampling conduit being formed of a material having sufficient material stiffness to retain the shape of the sampling lumen.

116. A patient interface according to claim 115, the sampling conduit being formed of a material that has greater material stiffness than a material of the collapsible portion.

117. A patient interface according to claim 114, the sampling conduit configured via geometric features to be stiffer than the collapsible portion.

118. A patient interface according to nay one of claims 75 to 111 wherein the sampling conduit is movable from a normally open configuration to a collapsed configuration in which the patient gas flow through the sampling conduit is reduced or stopped.

119. A patient interface according to claim 118, the sampling conduit including one or more side portions configured to move toward or against each other upon application of the collapsing force to reduce or stop the patient gas flow through the sampling conduit.

120. A patient interface according to claim 119, the sampling conduit comprising a material or geometry that is configured to facilitate movement of the side portions toward or against each other.

121. A patient interface according to any one of claims 118 to 120, wherein the sampling conduit moving from the open configuration to the closed configuration comprises bending or folding of one or more sides of the sampling conduit.

122. A patient interface according to claim 121, the sampling conduit including one or more thin-walled portions configured to provide folding lines at which the sampling conduit folds or bends upon application of the collapsing force.

123. A patient interface according to any one of claims 118 to 122, wherein the sampling conduit is resiliently deformable from the normally open configuration to the collapsed configuration.

124. A patient interface according to any one of the preceding claims, the sampling inlet located adjacent to the delivery outlet or within the delivery outlet.

125. A patient interface according to any one of the preceding claims, the delivery outlet comprising a mouth scoop configured for location in front of the patient's mouth.

126. A patient interface according to any one of the preceding claims, the delivery outlet comprising one or more nasal delivery prongs configured for location in one or both of the patient's nares.

127. A patient interface according to claim 126, the sampling inlet provided by a sampling nasal prong configured for insertion into a patient's nares.

128. A patient interface according to claim 127, the sampling conduit extending beyond a distal end of the nasal delivery prongs such that the sampling nasal prong is configured to locate deeper in the patient's nares than the nasal delivery prongs.

129. A patient interface according to claim 127 or 128, the sampling nasal prong extending through the nasal delivery prong.

130. A patient interface according to claim 129, the sampling nasal prong located substantially centrally in the nasal delivery prong.

131. A patient interface according to claim 127 or 128, the sampling nasal prong located externally of the nasal delivery prong and extending alongside the nasal delivery prong.

132. A patient interface according to any one of the preceding claims, the sampling conduit having a flexibly resilient support structure allowing the sampling conduit to be manipulated into a desired shape and/or allowing the sampling inlet to be located at a desired position.

133. A patient interface according to claim 132, the support structure comprising a wire located within the sampling conduit or associated with a wall of the sampling conduit.

134. A patient interface according to any one of the preceding claims, the sampling conduit having an outer surface configured to seal against a mask cuff of a patient face mask.

135. A patient interface according to any one of the preceding claims, the sampling inlet located proximate the delivery outlet so as to be located within a cavity formed between a patient face mask and the patient's face during application of the face mask to the patient and wherein the sampling outlet is spaced from the delivery outlet so as to be outside of the cavity during the application of the mask to the patient.

136. A patient interface according to any one of the preceding claims, the sampling conduit comprising a sampling lumen with an elongate cross-sectional shape.

137. A patient interface according to any one of the preceding claims, the sampling inlet and sampling outlet being separated by a distance greater than a width of a section of a face mask seal that is configured to bear over a portion of the collapsible portion.

138. A patient interface according to any one of the preceding claims, wherein the collapsible portion is resiliently deformable from the normally open configuration to the collapsed configuration.

139. A patient interface according to claim 138, wherein two or more side portions of the collapsible portion are configured for resilient deformation towards or against each other under influence of the collapsing force and to return to a normal position spaced from one another upon removal of the collapsing force.

140. A patient interface according to claims 138 or 139, wherein resilient deformation of the collapsible portion comprises bending or folding of one or more sides of the collapsible portion.

141. A patient interface according to any one of the preceding claims, the collapsible portion comprising a wall of non-uniform thickness.

142. A patient interface according to claim 141, the collapsible portion comprising a pair of thin-walled portions configured to provide fold lines at which the collapsible portion folds or bends upon application of the collapsing force.

143. A patient interface according to claim 142, the pair of thin-walled portions located on opposite sides of the collapsible portion.

144. A patient interface according to claim 142 or 143, the collapsible portion having an elongate cross-section which includes a pair of longitudinal sides extending between a pair of ends and wherein the thin-walled portions are located at the ends.

145. A patient interface according to any one of the preceding claims, the patient gas flow including expiratory gases from the patient and/or apparatus gases from the apparatus gas flow and/or atmospheric gases or a combination of two or more thereof.

146. A patient interface according to any one of the preceding claims, wherein the patient gas flow received at the patient is received from a patient's airway.

147. A patient interface according to any one of the preceding claims, wherein the patient gas flow received at the patient is received in front of a patient's mouth and/or nose.

148. A patient interface according to any one of the preceding claims, wherein the patient gas flow received at the patient is received internally of the patient.

149. A patient interface according to claim 148, wherein the patient gas flow is received from inside the patient's mouth and/or nose.

150. A patient interface according to any one of the preceding claims wherein the sampling outlet is configured for fluid communication with a respiratory gas monitor.

151. A patient interface according to any one of the preceding claims wherein the sampling conduit is configured for delivering patient gases to a gas sensor located within the patient gas flow.

152. A patient interface according to claim 151, wherein the gas sensor is located within the sampling conduit.

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FIGURE 6

7 / 25 Aug 2021

400 409 FIGURE 7 411 403 413 2021221742

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8 / 25 509 500 Aug 2021

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9 / 25 Aug 2021

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10 / 25 600 Aug 2021

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11 / 25 Aug 2021

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13 / 25 Aug 2021

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14 / 25 1400 Aug 2021

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FIGURE 24

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FIGURE 25

15 / 25 1600 Aug 2021

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400

414 FIGURE 27

421 403 416

16 / 25 Aug 2021

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17 / 25 2021 2004 Aug 2021

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19 / 25 Aug 2021

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20 / 25 2600 Aug 2021

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2708

FIGURE 51

21 / 25 2800 Aug 2021

2801 2808 2826 2021221742

2850 2820

FIGURE 52 2900

2901

2920 2950

FIGURE 53

2954

FIGURE 54

22 / 25 Aug 2021

3000

3008 3058 3059 3144 2021221742

FIGURE 55

3018 3056 3017 3001

3100 3158 3113 3108

3160 3127

3164 3120 FIGURE 56 3113 3120 3166

3162 S

FIGURE 58 FIGURE 57

23 / 25 Aug 2021

6120 2021221742

FIGURE 59

3200

3204 3258

3220 FIGURE 60 3260

24 / 25 Aug 2021

3358

3360 2021221742

3370 3374

3372 3371 FIGURE 61 3368

3164

3374 3358 3360

3113

FIGURE 62

25 / 25 3372 400 Aug 2021

3360 408

FIGURE 63 2021221742

3113 404 3371 3370 401 3458 3417

3418

3420

3472 3470 FIGURE 64 3472 3458

3470

3417 3420

FIGURE 65