Patient Interface Gas Sampling and Accessories for Patient Interfaces

Abstract

The present disclosure relates to a patient interface for providing respiratory assistance to a patient. The patient interface comprises a gas delivery interface configured to deliver a system gas flow to a patient. The gas delivery interface comprises a delivery outlet for delivering the system gas flow to the patient. The gas delivery interface also comprises a gas delivery side member extending from a first side of the delivery outlet and including a system gas flow path in fluid communication with the delivery outlet. The gas delivery side member includes a collapsible portion that is transitionable from a normally open configuration to a collapsed configuration in which the system gas flow path is reduced or closed when a collapsing force is applied to reduce or stop system gas flow through the system gas flow path. The patient interface further comprises a gas sampling interface comprising a sampling inlet configured to receive the patient gas flow at the patient and a sampling outlet configured to deliver 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.

Description

[Technical field]

[0001] cross reference This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 362,486, filed April 5, 2022, and Australian Patent Application No. 2021221742, filed August 25, 2021, the contents of each of which are hereby incorporated by reference.

[0002] The present disclosure relates to a patient interface for providing respiratory assistance to a patient. [Background technology]

[0003] Patients may lose respiratory function during anesthesia or sedation, or more generally during some medical procedures. Prior to a medical procedure, patients may be pre-oxygenated by a medical professional to ensure oxygen saturation, and this pre-oxygenation and CO2 flushing / washing out may be accomplished by high-flow respiratory support via a nasal cannula or other patient interface.

[0004] In various clinical situations, it may be desirable to monitor a patient's gases, such as exhaled gases, to monitor O2 content and whether the patient has become apneic. One example situation is when a patient is spontaneously breathing under general anesthesia or deep sedation, where the patient may experience repeated episodes of apnea. Another example is when a patient requires intubation. Intubation may be completed in 30-60 seconds, but intubation may take significantly longer, especially if the airway is difficult to secure (e.g., due to cancer, severe injury, obesity, or spasms of the neck muscles). Preoxygenation provides a buffer against oxygen desaturation, but in the case of prolonged intubation procedures, the intubation process must be interrupted and the patient's oxygen saturation must be increased to an adequate level. In the case of difficult intubation processes, several interruptions to intubation may be made, which is time-consuming and exposes the patient to significant health risks. After approximately three attempts to intubate, the medical procedure is abandoned.

[0005] When an apneic, non-intubated patient (e.g., due to a failed intubation of the patient or a sedated patient becoming apneic) needs to be manually ventilated urgently, a non-invasive ventilation mask, e.g., a face mask and bag, must be applied to the patient after rapid removal of the high-flow patient interface. The cannula may be difficult to quickly remove from the patient, and the connector between the headgear and the cannula may be difficult to quickly release or manipulate. Failure to remove the patient interface may result in the seal of the face mask falling over the patient interface or the gas delivery tube of the patient interface, destroying the seal between the face mask and the patient's face. This may result in gas leaking from the face mask during ventilation, making ventilation ineffective or inefficient. Summary of the Invention [Problem to be solved by the invention]

[0006] In procedures requiring multiple respiratory support systems, there may be concerns that the combination of support systems may result in excessive pressure delivery (e.g., when a cannula is in place on the patient and the anesthesiologist wants to provide support through a mask over the cannula.) Additionally, switching between different support systems may be time consuming or difficult.

[0007] The above discussion of the background of the disclosure is intended to facilitate an understanding of the disclosure. It should be understood, however, that this discussion is not an admission or acknowledgement that any aspect of this discussion was part of the common general knowledge at the priority date of this application. [Means for solving the problem]

[0008] Before proceeding with the description of this disclosure, it is useful to provide an explanation of some of the terms used to define the spatial relationships of its various portions. Spatial references throughout this specification are generally based on a patient interface that is configured to fit on the face of a patient and deliver breathing gas from a gas flow source through a gas delivery conduit to the patient's nostrils or mouth. With this as a basis, some terms, such as "patient-facing" and "non-patient-facing", shall be defined with reference to the patient. Terms, such as "inward-facing" and "outward-facing", shall be defined with reference to the patient's face. Some terms, such as "rear" and "front", shall be defined with reference to the gas delivery conduit.

[0009] Patient Interface Gas Sampling In view of the above-mentioned problems, the applicant has previously developed a patient interface with a collapsible conduit, as described in International Patent Application PCT / IB2019 / 051137 (WO2019159063). This patient interface provides a means for pre-oxygenating a patient and maintaining the patient's apneic period, such as during sedation or general anesthesia (whether or not intubation is required). The collapsible conduit includes a collapsible portion that is configured to collapse and temporarily interrupt the (high or low flow) respiratory gas flow, for example when the mask is placed on the patient's face and a part of the mask, for example a mask cuff, is overlaid (and pressed onto) the collapsible portion. This allows the clinician to easily apply a non-invasive ventilation mask to the patient over the patient interface when needed, while simultaneously interrupting the high flow patient interface gas flow while applying the ventilation mask.

[0010] During the use of a patient interface, such as the patented collapsible interface described in International Patent Application PCT / IB2019 / 051137 (WO 2019159063), it is beneficial to monitor gases in a patient receiving respiratory assistance. Gas monitoring provides useful feedback to the clinician, for example, during the preoxygenation phase, to determine if the patient has reached a desired end-tidal O2 level to indicate that preoxygenation is complete. Patented gas monitoring may also include monitoring of CO2 and / or volatile substances. Such gas monitoring is also useful to determine the patient's condition or changes in the patient's condition, for example, during a medical procedure in which an anaesthetic agent is used as described above, if the patient's respiratory function has deteriorated or is at risk of deterioration. Such changes in the patient's condition may include a spontaneously breathing patient becoming apneic or having a closed (not patent) airway, which may require interruption of high-flow respiratory assistance as discussed above.

[0011] The applicant has previously developed a gas sampling device as described in International Patent Application PCT / NZ2017 / 050134 (Publication No. WO2018070885). The device includes a movable inlet that can be positioned near the patient's nose or mouth to sample patient gas. A conduit can connect the sampling device to a respiratory gas monitor (e.g., a capnography device) that provides monitoring of the sampled gas. The sampling device is designed to be attachable to a standard nasal cannula, but is not configured to work with a collapsible patient interface of the type disclosed in International Patent Application PCT / IB2019 / 051137 (Publication No. WO2019159063).

[0012] It would therefore be desirable to provide a new or alternative patient interface that has a collapsible portion and that can also facilitate patient gas sampling.

[0013] According to one aspect of the present disclosure, 1. A gas delivery interface configured to deliver a system gas flow to a patient, comprising: a delivery outlet for delivering the system gas flow to the patient; a gas delivery side member including an apparatus gas flow path extending from a first side of the delivery outlet and in fluid communication with the delivery outlet, the gas delivery side member including a collapsible portion that is transitionable upon application of a collapsible force from a normally open configuration to a collapsed configuration in which the apparatus gas flow path is reduced or closed to reduce or stop apparatus gas flow through the apparatus gas flow path; A gas delivery interface comprising: There is provided a patient interface comprising: 1. A gas sampling interface, comprising: a sampling inlet configured to receive a patient gas flow at a patient; a sampling outlet configured to direct the patient gas flow away from the patient; 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 the sampling outlet when the collapsible portion transitions to the collapsed configuration; Gas sampling interface It further comprises:

[0014] The patient interface according to the first aspect of the present disclosure may advantageously facilitate sampling of patient gas while the collapsible gas delivery interface is simultaneously operating. In particular, the sampling conduit may continue sampling while the system gas of the gas delivery interface is reduced or stopped during transition of the collapsible portion to the collapsed configuration. The sampling conduit may be configured to deliver the patient gas to a gas sensor or gas monitoring device. The sampling conduit may be configured to deliver the patient gas to a sensor or monitoring device located in the patient gas stream. The sensor may be located within the sampling conduit. The sampling conduit may be configured to deliver the patient gas to a respiratory gas monitor in fluid communication with the sampling conduit via a sampling outlet.

[0015] The patient interface according to the first aspect of the present disclosure thereby facilitates continuous monitoring of patient gas to provide feedback to the clinician both during respiratory assistance provided via the gas delivery interface (e.g., high-flow respiratory assistance) and during interruption of device gas flow through the gas delivery interface (e.g., during application of a patient face mask to the patient's face).

[0016] It will be understood that when a "system gas flow" is referred to herein, it refers to a flow of gas from a system, such as a respiratory assistance system, which may include a flow generator or wall source, a compressed air source, or any other suitable source of breathing gas. Thus, the system gas flow may include a breathing gas flow. The system gas flow may also include anaesthetic or oxygen delivered to the patient.

[0017] The sampling inlet is configured to receive a patient gas flow at the patient, which may include exhaled gas from the patient and / or inhaled gas for the patient and / or system gas from the system gas flow and / or atmospheric gas, or a combination of two or more thereof. Atmospheric gas that may be sampled via the sampling inlet may include entrained atmospheric gas contained within the patient's exhaled gas and / or atmospheric gas present in front of the patient's face or within the patient's airway that has not been exhaled from the patient. Patient gas that is sampled may include system gas that has been delivered to the patient and not yet inhaled. Patient gas may also include other gases, such as anaesthetic agents, that are being delivered to the patient.

[0018] It will be appreciated that atmospheric gases, exhaled gases, system gases and anaesthetic gases may be mixed at the sampling inlet, and thus the patient gas received by the sampling inlet may typically include a mixture of two or more of these or other gases. Similarly, it will be appreciated that the patient gas stream received by the sampling inlet may in some cases include only one of these types of gases. The patient gas stream may vary over time (e.g., between patient exhalations), and thus the composition of the patient gas stream received by the sampling inlet may vary over time.

[0019] The patient gas flow received at the patient may be received from the patient's airway. The patient gas flow received at the patient may be received in front of the patient's mouth and / or nose. The patient gas flow received at the patient may be received inside the patient. For example, the patient gas flow may be received from inside the patient's mouth and / or nose.

[0020] The sampling outlet can be configured to be in fluid communication with a respiratory gas monitor. For example, the sampling outlet can be connected via a tube or other conduit to a gas monitoring device that can analyze patient gases received from the sampling inlet. The gas sampling interface can thus be configured for sidestream capnography. In this case, the sampling outlet thus facilitates delivery of a patient gas flow away from the patient and towards the respiratory gas monitor.

[0021] In one 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 wired or wireless data communication to a suitable receiver that can display the sensor data to the clinician. In this case, the sampling outlet may vent the patient gas flow to the environment once downstream of the sensor, and thus the sampling outlet is configured to direct the patient gas flow away from the patient to allow flow through the conduit and past the sensor.

[0022] In another alternative embodiment, the gas sampling interface may include a passive sampling arrangement, for example configured to sample patient gases via colorimetric analysis. In this example, the sampling conduit may be configured to deliver the patient gases to an assay of a colorimetric reagent or to another form of colorimeter configured to indicate the presence or concentration of one or more specific gases in the patient gas stream. In some configurations, the gas sampling interface may include a colorimetric analysis means in the sampling conduit or at the sampling outlet.

[0023] The collapsible portion of the gas delivery side member can transition from a normally open configuration to a collapsed configuration. The open configuration will be understood to mean a configuration in which the collapsible portion can deliver device gas to the patient at a desired flow rate. For example, the open configuration can include the lumen of the gas delivery member being sufficiently open and / or unobstructed to allow the required device gas flow rate to be delivered to the patient. The collapsible portion is configured to be in an "normally" open configuration, which will be understood to mean that the collapsible portion defaults to the open configuration or is in the open configuration "at rest". For example, the collapsible portion can remain in the open configuration (and return to the open configuration) in the absence of an external force biasing the collapsible portion out of the open configuration. In other embodiments, the collapsible portion may be naturally collapsible or in a "normally" closed configuration. That is, the collapsible portion can partially or completely collapse (collapsed configuration) when no device gas is flowing or a low flow rate of device gas is flowing, and expand (open configuration) when some level of device gas is flowing. However, an "always" open collapsible portion (which is in the open configuration in the absence of an external force urging the collapsible portion away from the open state) can be beneficial in that a substantial amount of flow and / or pressure is not required to initially open or maintain the collapsible portion in the open configuration in order to deliver device gases to the patient.

[0024] The normally open configuration of the collapsible portion can be achieved through the inherent material properties of the collapsible portion or through the geometric shape or other structural configuration of the collapsible portion. For example, the collapsible portion can be formed of a soft, resilient material that can be folded, flattened, or otherwise temporarily manipulated by an external force, but that biases toward its original state, position, or configuration when the external force is ceased or released.

[0025] A "collapsed configuration" of a collapsible portion will be understood to mean a configuration in which the collapsible portion is physically manipulated or influenced to reduce the path of device gases through the collapsible portion. Upon transitioning to the collapsed configuration, the collapsible portion may change cross-section, for example, reducing cross-section to create a more restricted or tortuous flow path. A collapsed configuration may include an internal passage, such as a lumen, decreasing in cross-section such that it occludes, blocks, or otherwise reduces flow.

[0026] The transition of the collapsible portion to the collapsed configuration can include the collapsible portion being folded, bent, twisted, flattened, compressed or twisted into the collapsed configuration. The collapsed configuration can include one or more side portions of the collapsible portion moving toward or towards each other to block or obstruct the system gas flow path. The collapsed configuration can reduce the flow of system gas to substantially zero, or alternatively, can reduce the flow of system gas compared to the open configuration, although some residual flow still occurs in the collapsed configuration.

[0027] In one embodiment of the present disclosure, the collapsible portion is elastically deformable from a normally open configuration to a collapsed configuration. For example, two or more side portions of the collapsible portion can be configured to elastically deform toward or towards each other under the influence of a crushing force and return to a normal position spaced apart from each other when the crushing force is removed. The movement toward or towards each other can be relative movement toward each other; that is, one of the side portions can remain stationary relative to the patient interface (and relative to the patient) and the other of the side portions can move toward or towards the stationary side portion. In an alternative embodiment of the present disclosure, the collapsible portion includes a side portion configured to elastically deform toward or towards another side portion of the collapsible portion.

[0028] The side portions may be adjacent to one another or connected to one another. For example, the side portions may be connected with fold lines and may be folded towards or toward one another. Alternatively, the side portions may be opposed to one another. For example, opposing sides of the collapsible portion may move towards one another.

[0029] The elastic deformation of the collapsible portion may include bending or folding one or more sides of the collapsible portion. The collapsible portion may include 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 include a relatively thin section of the wall that forms a hinge portion or a collapsed portion of the wall that causes the folding that occurs at the thin-walled portion upon application of a crushing force to the collapsible portion. The relatively thin section of the thin-walled portion may make that section of the wall particularly adapted to bend or fold at a crease to transition between the open and closed configurations. In this manner, the collapsible portion preferentially bends or folds at a crease to transition between the open and closed configurations.

[0030] According to one embodiment of the present disclosure, the collapsible portion includes a pair of thin-walled portions configured to provide a fold line about which the collapsible portion folds or bends when a collapsible force is applied. The pair of thin-walled portions may be located on opposite sides of the collapsible portion or may be otherwise positioned relative to one another, for example adjacent to one another.

[0031] The collapsible portion constitutes a part of the gas delivery side member, which may include a conduit. Thus, the collapsible portion may itself include a conduit, a tube, or other structure configured to deliver gas. The collapsible portion may have a circular cross section. The collapsible portion may have an elongated cross section, such as an elliptical or oval cross section or a stadium-like cross section. According to one embodiment of the present disclosure, the collapsible portion has an elongated cross section including a pair of longitudinal sides extending between a pair of ends, where the thin-walled portions are located at the ends. In certain embodiments, each of the ends includes a single thin-walled portion. Each of the ends may include two or more thin-walled portions.

[0032] Providing thin-walled portions at the ends of the elongated cross-section may advantageously facilitate folding or bending at the ends, resulting in one or both of the longitudinal sides moving toward the other longitudinal side. A collapsible force may be applied to a first longitudinal side of one of the longitudinal sides in the direction of the other longitudinal side, resulting in the first longitudinal side of the longitudinal sides moving toward or toward the second longitudinal side, thereby flattening the collapsible portion.

[0033] Various embodiments of possible collapsible portion configurations are discussed in the Applicant's previous international patent publications, WO 2018 / 029638 and WO 2019159063.

[0034] According to a first aspect of the disclosure, the gas sampling interface may be provided on the gas delivery side member or may be separate from the gas delivery side member. In one embodiment of the disclosure, the sampling conduit extends from a second side of the delivery outlet opposite the first side. For example, the gas delivery conduit may be separate from the gas delivery side member and may extend from an opposite side of the delivery outlet and / or towards an opposite side of the patient's face compared to the gas delivery side member.

[0035] The sampling conduit may have a dual function in that it may also be used as a structural component to support a portion of the patient interface. For example, the sampling conduit may be used in conjunction with or as part of a head strap that couples with a patient's head to secure the patient interface in place against the patient's face. In one embodiment, the sampling conduit includes an internal passage that provides fluid communication between a sampling inlet and a sampling outlet, including an end configured to connect to a head strap, and the sampling conduit also includes a patient-facing wall and a non-patient-facing wall.

[0036] Alternatively, the sampling conduit may not contribute to securing the patient interface and the delivery outlet may be supported by a component other than the sampling conduit. For example, in one embodiment, the patient interface further comprises a non-delivery side member extending from a second side of the delivery outlet opposite the first side, the non-delivery side member having a head strap end configured to connect to a head strap, the non-delivery side member also including a patient-facing wall and a non-patient-facing wall.

[0037] A "non-delivery" side member will be understood to mean a side member that is not configured to deliver system gases to a patient, i.e., the non-delivery side member does not form part of the system gas flow path provided by the gas delivery side member.

[0038] The non-delivery side member may be associated with the patient gas flow but not with the system gas flow. For example, a sampling conduit may be coupled to the non-delivery side member. In one embodiment, the sampling conduit is provided in the non-delivery side member.

[0039] The provision of a sampling conduit to the non-delivery side member can be provided by a variety of configurations.

[0040] In one embodiment, the sampling conduit extends through a portion of the non-delivery side member.

[0041] In one embodiment, the sampling conduit extends through an internal passage of the non-delivery side member.

[0042] In one embodiment, the sampling conduit extends between a pair of spaced apart openings in one or more walls of the non-delivery side member.

[0043] In one embodiment, the spaced apart openings include an inlet port proximate the delivery outlet and an outlet port proximate the head strap end.

[0044] In one embodiment, the inlet and / or outlet ports are located on the patient-facing wall of the non-delivery side member.

[0045] In one embodiment, the inlet and / or outlet ports are located on the non-patient facing wall of the non-delivery side member.

[0046] In one embodiment, the sampling inlet is located at or adjacent to the inlet port and the sampling outlet is located at or adjacent to the outlet port.

[0047] In one embodiment, the sampling conduit includes a tube that extends through both the inlet and outlet ports and through an internal passage that extends between the inlet and outlet ports.

[0048] In one embodiment, the sampling conduit comprises an internal passage of the non-delivery member, and the inlet port and / or outlet port are configured to be connected to respective sampling tubes configured to extend from the inlet port and outlet port to a sampling inlet and a sampling outlet, respectively.

[0049] In one embodiment, the inlet and / or outlet ports are configured to connect to a sampling tube via a luer lock or a threaded connection or a plug fit or a barb.

[0050] In one embodiment, the non-delivery member includes a sampling inlet tube molded to the sampling inlet and / or a sampling outlet tube molded to the sampling outlet.

[0051] In one embodiment, the sampling conduit is integrally formed with the non-delivery side member.

[0052] In one embodiment, the sampling conduit is attachable to the non-delivery side member, hi one embodiment, the non-delivery side member includes a channel configured to receive the sampling conduit and allowing for removable attachment between the sampling conduit and the non-delivery side member.

[0053] In one embodiment, the channel is located in a patient-facing wall of the non-delivery side member.In one embodiment, the channel is located in a non-patient-facing wall of the non-delivery side member.

[0054] In one embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the head strap end of the non-delivery side member.

[0055] In one embodiment, the sampling inlet and the sampling outlet are separated by a distance greater than the width of a section of the face mask seal configured to be placed on a patient's face and to rest over a portion of the non-delivery side member.

[0056] In one embodiment, the non-delivery side member is configured to resist deformation when a face mask seal rests on top of the non-delivery member.

[0057] In one embodiment, the non-delivery side member is configured to deform when the facemask seal rests on top of the non-delivery side member, where the sampling conduit remains open during deformation of the non-delivery side member.

[0058] In one embodiment, the patient-facing wall has a more pronounced curvature as compared to the non-patient-facing wall.

[0059] In one embodiment, the non-delivery side member has an elongated cross-section that is asymmetric in at least one axis.

[0060] In one embodiment, the cross-section is asymmetric about an axis substantially parallel to the patient-facing wall.

[0061] In one embodiment, the patient-facing wall has a different curvature configuration than the non-patient-facing wall.

[0062] In one embodiment, the non-delivery side member has an asymmetric lens cross-section.

[0063] In one embodiment, the non-delivery side member cross section includes a pair of opposed spaced apart edges, with the patient-facing wall and the non-patient-facing wall extending between the pair of edges.

[0064] In one embodiment, the patient-facing wall has a substantially convex structure extending between a pair of opposing edges.

[0065] In one embodiment, the non-patient facing wall has a substantially planar structure extending between a pair of opposing edges.

[0066] For example, in one 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 discussed above, the non-delivery side member may not be associated with the system gas flow, and therefore the internal passage of the non-delivery side member may not be configured to deliver system gas.

[0067] The sampling conduit can have any suitable diameter or profile. For example, any suitable diameter or profile of the interior or exterior of 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 may increase or decrease along the length of the sampling conduit.

[0068] In one embodiment, the sampling conduit can extend between a pair of spaced apart openings in one or more walls of the non-delivery side member. The spaced apart openings can include an inlet port proximate the delivery outlet and an outlet port proximate the head strap end of the non-delivery side member. The inlet and outlet ports can be located in a common wall, side or portion of the non-delivery side member, or alternatively, can be located in different walls, sides or portions of the non-delivery side member. The inlet and / or outlet ports can be located in a patient-facing wall of the non-delivery side member. The inlet and / or outlet ports may be located in a non-patient-facing wall of the non-delivery side member.

[0069] The sampling inlet can be positioned sufficiently close to the patient's airway to receive a patient airflow that can include exhaled gases, and the sampling outlet can be positioned to facilitate connection to a respiratory gas monitor.

[0070] In one embodiment, the sampling inlet is located at or adjacent to the inlet port and the sampling outlet is located at or adjacent to the outlet port. In one embodiment, the sampling inlet comprises the inlet port and / or the sampling outlet comprises the outlet port. In an alternative embodiment, the sampling conduit comprises a tube that extends through both the inlet and outlet ports and through an internal passage extending between the inlet and outlet ports.

[0071] In one embodiment, the sampling conduit comprises an internal passage of the non-delivery member, and the inlet port and / or outlet port are configured to be connected to respective sampling tubes configured to extend from the inlet port and outlet port to a sampling inlet and a sampling outlet, respectively.

[0072] In one embodiment, the sampling inlet may be located at (or consist of) the inlet port, in which case there may only be an outlet tube connecting the sampling outlet to the outlet port.

[0073] In an alternative embodiment, the sampling outlet may be located at (or consist of) the outlet port, in which case there may only be an inlet tube connecting the sampling outlet to the outlet port.

[0074] In one embodiment, the inlet and / or outlet ports are configured to connect to sampling tubing via a luer lock or threaded connection or plug fit or barb. The inlet port may utilize a different type of connection than the outlet port. This may advantageously increase usability by preventing components or tubing from being inaccurately connected to the wrong port.

[0075] In one embodiment, the non-delivery member comprises a sampling inlet tube molded to the sampling inlet and / or a sampling outlet tube molded to the sampling outlet. The sampling inlet tube may be integrally formed with the sampling inlet and / or inlet port. The sampling outlet tube may be integrally formed with the sampling outlet and / or sampling outlet.

[0076] In one embodiment, the sampling conduit is integrally formed with the non-delivery side member. In an alternative embodiment, the sampling conduit is attachable to the non-delivery side member. The sampling conduit may be removably attached or connected to the non-delivery side member. The non-delivery side member may be configured to be removably connected to the sampling conduit. For example, the non-delivery side member may include a channel configured to receive the sampling conduit and allow for removably attachment between the sampling conduit and the non-delivery side member. The channel may be located on an outer surface of the non-delivery side member. The channel may have a structure corresponding to the structure of the sampling conduit. For example, the channel may have a width or diameter approximately corresponding to the diameter of the sampling conduit to tightly receive and hold the sampling conduit within the channel. The channel may have a semicircular cross section. The sampling conduit may be frictionally held with the channel. The channel may be configured with a geometry to hold the sampling conduit within the channel. For example, the channel may have a width or diameter slightly smaller than the diameter of the sampling conduit such that the channel resiliently expands when the sampling conduit is fitted into the channel and held within the channel by resiliently "squeezing" the channel onto the sampling conduit. The sampling conduit may be formed of a material that is stiffer than the portion of the non-delivery member in which the channel is formed, to avoid deformation of the sampling conduit when fitted into a flow passage sized slightly smaller than the sampling conduit.

[0077] In one embodiment, the channel is located in the patient-facing wall of the non-delivery side member. In an alternative embodiment, the channel is located in the non-patient-facing wall of the non-delivery side member. The channel advantageously allows for convenient attachment and removal of the sampling conduit, such that the sampling conduit can be fitted into the non-delivery side member when needed and removed when not needed and / or to facilitate maintenance, cleaning or replacement of certain components.

[0078] In one embodiment, the sampling inlet is adjacent to the delivery outlet and the sampling outlet is adjacent to the head strap end of the non-delivery side member. The spacing between the sampling inlet and the sampling outlet may of course vary. In one embodiment, the sampling inlet and the sampling outlet are separated by a distance greater than the width of a section of the face mask seal configured to be placed on the patient's face and to rest on a portion of the non-delivery side member. This advantageously allows the patient's face mask to be positioned over the delivery outlet and the sampling inlet, allowing the sampling outlet to be located outside the patient's face mask. Thus, positioning the face mask over the non-delivery side member may not interfere with the sampling outlet and its fluid connection to the respiratory gas monitor.

[0079] As mentioned above, the sampling conduit of the first aspect of the present disclosure is configured to remain open when the collapsible portion transitions to the collapsed configuration. The face mask seal rests on the non-delivery member, exerting a force on the non-delivery side member, which may be transferred or applied directly to the sampling conduit. Thus, the sampling conduit may be configured to remain open under the application or influence of a face mask. Thus, the sampling conduit may enable continuous patient gas sampling.

[0080] In one embodiment, the non-delivery side member may itself be configured to resist deformation when the facemask seal rests on top of the non-delivery side member. Alternatively, the non-delivery side member may be configured to deform when the facemask seal rests on top of the non-delivery side member, where the sampling conduit remains open during deformation of the non-delivery side member. Deformation of the non-delivery side member may include flattening of the non-delivery side member. This may advantageously help to form a seal between the facemask and the patient's face and / or between the facemask and the non-delivery side member. For example, the non-delivery side member may be configured to transition to a flattened configuration, and the facemask may elastically 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 that may lead to undesired expansion of the patient gas flow being assisted and / or sampled when the facemask is placed on the patient interface.

[0081] The non-delivery side member may be hollow (e.g., tubular) or non-hollow. The non-delivery side member may comprise a conduit or tube. The non-delivery side member may have a circular cross-section or a non-circular cross-section. The non-delivery side member may have an elongated cross-section, such as an elliptical or oval cross-section or a stadium-like cross-section. According to one embodiment of the present disclosure, the non-delivery side member has an elongated cross-section including a pair of longitudinal sides extending between a pair of ends. The ends may be rounded, for example semicircular. Alternatively, the ends may include edges (e.g., angled edges) where the longitudinal sides meet each other.

[0082] The non-delivery side members may have a symmetrical cross-section, for example a circular, oval or stadium-shaped cross-section that is symmetrical about a length and / or width axis.

[0083] Alternatively, in one embodiment, the non-delivery side member has an elongated cross-section that is asymmetric in at least one axis. In one embodiment, the elongated cross-section can include a length axis and a width axis, and the cross-section is asymmetric about the length axis. The cross-section can include a pair of longitudinal sides extending between a pair of edges, and the longitudinal sides are asymmetric. For example, one of the side portions can include a channel configured to receive a sampling conduit. One of the sides can have a different curvature configuration than the other side. In one embodiment, the patient-facing wall has a different curvature configuration than the non-patient-facing wall. In one embodiment, the patient-facing wall of the non-delivery side member has a more pronounced curvature compared to the non-patient-facing wall. In one embodiment, the cross-section is asymmetric in an axis that is substantially parallel to the patient-facing wall.

[0084] The cross section of the non-delivery side member can have an asymmetric lens shape or an airfoil shape. For example, the cross section can include two longitudinal sides having different levels of curvature and meeting at opposing edges. Each of the longitudinal sides can have a convex configuration (i.e., an outwardly bulging configuration). The two longitudinally curved sides can include a patient-facing surface and a non-patient-facing surface. In one embodiment, the non-patient-facing side can have a low level of curvature and be substantially flat, and the patient-facing side has a higher level of curvature.

[0085] In one embodiment, a cross-section of the non-delivery side member includes a pair of opposed spaced apart edges, with the patient-facing wall and the non-patient-facing wall extending between the pair of edges. In one embodiment, the patient-facing wall has a substantially convex configuration extending between the pair of opposed edges. In one embodiment, the non-patient-facing wall has a substantially flat or planar configuration extending between the pair of opposed edges.

[0086] The non-delivery side member can be configured to partially recess or be recessed into the patient's face to facilitate the formation of an unbroken seal between the patient mask and the patient's face. The non-delivery side member can be slightly recessed into the patient's skin such that the non-patient-facing wall is generally flush or aligned with the patient's skin, such that the non-patient-facing wall forms a substantially continuous surface with the patient's skin over which the face mask can form a substantially unbroken seal.

[0087] The above discussion includes various embodiments and examples in which the gas sampling interface is provided on the non-delivery side member. However, as noted in the previous discussion, a patient interface according to the first aspect of the present disclosure may also be configured such that the gas sampling interface is provided on the gas delivery side member. Thus, the gas sampling interface may be located on, on, within, or otherwise physically associated with the gas sampling interface.

[0088] In one embodiment, the gas sampling interface is provided on a gas delivery side member including a delivery inlet at one end for receiving the system gas flow and including a patient-facing wall and a non-patient-facing wall, hi one embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the delivery inlet.

[0089] In one embodiment, the sampling conduit includes a sampling lumen for the patient gas flow and the gas delivery side member includes a gas delivery lumen for the system gas flow. In one embodiment, the patient interface includes a single sampling conduit. According to one embodiment, all of the patient gas flows channeled from the sampling inlet to the sampling outlet are channeled through the single sampling conduit. The physical association between the sampling lumen and the gas delivery lumen can be configured in a variety of ways.

[0090] In one embodiment, the sampling conduit is integral with the gas delivery side member.

[0091] In one embodiment, the sampling conduit extends through the gas delivery lumen.

[0092] In one embodiment, a portion of the sampling conduit is free to move within the gas delivery lumen.

[0093] In one embodiment, a sampling conduit extends through the collapsible portion, the sampling conduit having a cross-section configured to minimize blockage of device gas flow and to minimize interference with the transition of the collapsible portion to the collapsed configuration.

[0094] In one embodiment, the cross-section of the sampling conduit has a shape configured to facilitate occlusion of the gas delivery lumen when the collapsible portion is in the collapsed configuration.

[0095] In one embodiment, the sampling conduit has a cross-section that includes a curved outer surface, the curved outer surface configured such that the walls of the collapsible portion bend or fold around the curved outer surface.

[0096] In one embodiment, the sampling conduit has a cross-sectional area that is smaller than the cross-sectional area of ​​the gas delivery lumen.

[0097] In one embodiment, the gas delivery side member extends through the sampling lumen.

[0098] In one embodiment, the sampling conduit includes a sleeve that surrounds the gas delivery side member.

[0099] In one embodiment, the sampling inlet includes a funnel portion at an end of the sleeve proximate the delivery outlet, the funnel portion configured to receive the patient gas flow from the nose and / or mouth.

[0100] In one embodiment, the funnel portion is configured to receive a portion of the system gas flow.

[0101] In one embodiment, the gas delivery lumen and the sampling lumen are substantially concentric.

[0102] In one embodiment, the gas delivery lumen and the sampling lumen are substantially coaxial.

[0103] In one embodiment, the gas delivery lumen and the sampling lumen have parallel longitudinal axes.

[0104] In one embodiment, the gas delivery lumen and the sampling lumen are integrally formed within the gas delivery side member and are spaced apart from one another.

[0105] In one embodiment, the sampling lumen is formed in a wall of the gas delivery side member that surrounds the gas delivery lumen.

[0106] In one embodiment, the sampling conduit is integral with the gas delivery side member. The sampling conduit can be integrally formed with the gas delivery side member. Thus, the sampling lumen and the gas delivery lumen can also be integrally formed. For example, the sampling lumen and the gas delivery lumen can be molded simultaneously during the manufacture of the delivery side member.

[0107] In one embodiment, the sampling conduit includes a sampling lumen having an elongated cross-sectional shape. The cross-section of the sampling lumen may be circular.

[0108] In one embodiment, the sampling conduit extends through the gas delivery lumen. Thus, the sampling lumen (the interior of the sampling conduit) can also be located within the gas delivery lumen. In one embodiment, a portion of the sampling conduit can move freely within the gas delivery lumen. For example, the sampling conduit can be routed through the gas delivery lumen so that it is loosely contained by the gas delivery lumen and can move within it. Alternatively, the sampling conduit can extend through the gas delivery lumen but be fixed at a particular location therein. For example, by one or more ribs or webs connecting the outer surface of the sampling conduit to the outer surface of the gas delivery lumen. The sampling conduit can be fixed in some portions relative to the gas delivery lumen while allowing other portions to move within the gas delivery lumen.

[0109] In one embodiment, a sampling conduit extends through the collapsible portion, the sampling conduit having a cross-section configured to minimize occlusion of device gas flow and to minimize interference with the transition of the collapsible portion to the collapsed configuration. The sampling conduit can have a configuration that facilitates a reduction in device gas flow through the collapsible portion when the collapsible portion transitions to the collapsed configuration. The cross-section of the sampling conduit can have a shape configured to facilitate occlusion of the gas delivery lumen when the collapsible portion is in the collapsed configuration. For example, the sampling conduit can have a cross-section that includes a curved outer surface, the curved outer surface configured such that wall portions of the collapsible portion bend or fold around the curved outer surface.

[0110] The sampling conduit can be configured to facilitate forming a seal around the sampling conduit that limits the flow of system gas through the collapsible portion. For example, a seal between an outer surface of the sampling conduit and an inner 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. Thus, the sampling conduit can be configured to minimize or avoid interference with the collapsed configuration of the collapsible portion, i.e., to minimize or avoid interference with reduced cessation of system gas flow when the collapsible portion transitions to the collapsed configuration.

[0111] The sampling conduit can be configured so as not to obstruct gas flow through the collapsible portion when the collapsible portion is in the open configuration, for example, the outer surface of the sampling conduit can have a substantially smooth configuration (e.g., a curved configuration) so as not to create bottlenecks, blockages, or other obstructions to device gas flow.

[0112] The sampling conduit can be sized and configured to minimize interference with device gas flow through the gas delivery lumen. The sampling conduit can have a cross-sectional area smaller than the cross-sectional area of ​​the gas delivery lumen. In one embodiment, the sampling conduit has a width smaller than the width of the collapsible portion. The flow rate required for the gas delivery lumen can typically be higher than the flow rate required for the sampling lumen, and therefore the gas delivery lumen can have a cross-sectional area larger than the cross-sectional area of ​​the sampling lumen. For example, in some embodiments, a sampling flow rate of 40-500 mL / min of patient gas is provided through the sampling conduit. Thus, the sampling lumen can be configured with a cross-section to facilitate a flow of about 40-500 mL / min. The gas delivery lumen may be configured to accommodate significantly higher flow rates. In certain embodiments, in a normally open configuration, the gas delivery interface is configured to allow a device gas flow rate of about 20 L / min to 90 L / min through the device gas flow path. In another particular embodiment, in the normally open configuration, the gas delivery interface is configured to allow a system gas flow rate of 5-70 L / min through the system gas flow path.

[0113] In certain embodiments, in the collapsed configuration, the patient interface is configured to allow a system gas flow rate through the system gas flow path that is at least 20 times greater than the patient gas flow rate through the gas sampling interface. For example, the flow rate through the gas sampling interface may be less than about 500 ml / min, and the flow rate through the gas delivery interface when in the closed configuration may be less than about 10 L / min. In certain embodiments, in the collapsed configuration, the gas delivery interface is configured to allow a system gas flow rate of less than about 10 L / min through the system gas flow path, and the gas sampling interface is configured to allow a patient gas flow rate of less than about 500 mL / min, optionally between about 40 mL / min and about 500 mL / min.

[0114] In an alternative embodiment, the gas delivery side member extends through the sampling lumen. For example, the gas delivery lumen may be provided with a gas delivery lumen that extends through the sampling lumen. In this example, the sampling conduit may itself provide the gas delivery side member. Alternatively, the sampling conduit (through which the gas delivery conduit extends) may be attached to or extend through the gas delivery side member.

[0115] In one embodiment, the sampling conduit comprises a sleeve surrounding the gas delivery side member. In one embodiment, the sampling inlet is provided by a funnel portion at an end of the sleeve proximate the delivery outlet, the funnel portion configured to receive the patient gas flow from the nose and / or mouth. The funnel portion can include an opening that includes the sampling inlet. The funnel portion can include a flared or enlarged portion of the sleeve. The funnel can have a variety of configurations, for example, a truncated cone or an elongated truncated cone or an elliptical truncated cone. In one embodiment, the funnel portion is configured to receive a portion of the device gas flow.

[0116] In one embodiment, the gas delivery lumen and the sampling lumen are substantially concentric, e.g., one of the gas delivery lumen and the sampling lumen extends through the other of the gas delivery lumen and the sampling lumen such that each share a common central axis and each share a common center point (in cross section). The gas delivery lumen and the sampling lumen may be substantially coaxial.

[0117] In one embodiment, the gas delivery lumen and the sampling lumen have parallel longitudinal axes. This configuration can be provided in a number of ways. In a first example, one of the gas delivery lumen and the sampling lumen may extend through the other of the gas delivery or sampling lumen. In a second example, the gas delivery lumen and the sampling lumen may extend alongside each other (and outside each other). In a third example, the gas delivery lumen and the sampling lumen are both formed inside the gas delivery side member but also have parallel longitudinal axes.

[0118] In one embodiment, the gas delivery lumen and the sampling lumen are integrally formed within the gas delivery side member and are separated from one another, e.g., separated by an interior portion of the gas delivery side member. In one embodiment, the sampling lumen is formed within a wall of the gas delivery side member that surrounds the gas delivery lumen. In one embodiment, the gas delivery lumen is formed within a wall of the gas delivery side member that surrounds the sampling lumen. A wall-formed lumen (which may be either the sampling lumen or the gas delivery lumen) within the wall of the gas delivery side member may be localized to one side of the lumen surrounded by the wall. Alternatively, the wall-formed lumen may partially or completely surround the lumen surrounded by the wall.

[0119] Some of the above embodiments relate to the sampling lumen and the gas delivery lumen each being contained within the outer surface of the gas delivery member. In alternative embodiments, the sampling lumen extends along the outer surface of the gas delivery side member. For example, the gas delivery lumen may be provided within the gas delivery side member and the sampling conduit is located external to the gas delivery side member. In one embodiment, the sampling conduit is coupled to the outer surface of the gas delivery side member.

[0120] In one embodiment, the sampling conduit is integrally coupled to an outer surface of the gas delivery side member.

[0121] In one embodiment, the sampling conduit is integrally connected to the exterior surface via a connecting web, and the sampling conduit is spaced from the gas delivery side member by the width of the connecting web.

[0122] In one embodiment, the collapsible portion has an elongated cross-section including a pair of longitudinal sides extending between a pair of ends, and the connecting web extends between the sampling conduit and one of the ends of the collapsible portion.

[0123] In one embodiment, the patient interface further comprises an attachment located at or adjacent to the collapsible portion and configured to facilitate transition of the collapsible portion to the collapsed configuration.

[0124] In one embodiment, the attachment comprises a rigid member extending along a patient-facing wall of the gas delivery side member and configured to provide a reaction force to a load applied to the collapsible portion.

[0125] In one embodiment, the attachment comprises a portion extending along a non-patient facing wall of the gas delivery side member and configured to move towards the patient in response to a load applied to the attachment.

[0126] In one embodiment, the fitting comprises a conduit connector that connects a portion of the sampling conduit to the fitting.

[0127] In one embodiment, the sampling conduit extends through the fitting.

[0128] In one embodiment, the accessory includes a pair of spaced apart openings including a patient gas inlet port configured to be positioned proximate to the delivery outlet and a patient gas outlet port configured to be positioned proximate to the delivery inlet, and a sampling conduit extends internally through the accessory between the patient gas inlet and outlet.

[0129] In one embodiment, the patient interface comprises a rigid gas pathway connector connectable with the delivery inlet, the patient interface further comprising a conduit connector that removably connects a portion of the sampling conduit to the gas pathway connector.

[0130] In one embodiment, the conduit connector includes a first mounting arrangement including a pair of resilient arms configured to be removably attached to the gas path connector and a second mounting arrangement configured to be removably attached to the sampling conduit.

[0131] In one embodiment, the second mounting arrangement defines a pair of recesses corresponding to an outer diameter of the sampling conduit and includes a pair of hooks configured to receive and retain the sampling conduit.

[0132] In one embodiment, the sampling conduit is connected to both a conduit connector on the accessory and a conduit connector that is connected to the gas path connector.

[0133] In one embodiment, the gas delivery side member includes a channel configured to receive the sampling conduit and allow for removable attachment between the sampling conduit and the gas delivery side member.

[0134] In one embodiment, the channel is located in the patient-facing wall of the gas delivery side member.

[0135] In one embodiment, the channel is located in the non-patient facing wall of the gas delivery side member.

[0136] In one embodiment, the sampling conduit includes a sampling lumen, the sampling conduit configured to retain the shape of the sampling lumen in response to a collapsing force applied to the collapsible portion.

[0137] The sampling conduit can be integrally coupled to the outer surface of the gas delivery side member. For example, the sampling conduit can be integrally coupled to the outer surface via a connecting web, the sampling conduit being spaced from the gas delivery side member by the width of the connecting web. In one embodiment, the collapsible portion has an elongated cross-section including a pair of longitudinal sides extending between a pair of ends, the connecting web extending between the sampling conduit and one of the ends of the collapsible portion.

[0138] The above-mentioned spacing between the sampling conduit and the gas delivery side member can advantageously facilitate the transition of the collapsible portion to the collapsed configuration while not affecting the sampling conduit For example, the sampling conduit can be spaced from the gas delivery side member such that flattening or compression of the collapsible portion during application of the patient face mask does not affect the sampling conduit and cause it to deform, fold, or otherwise interfere with the flow of patient gas therethrough.

[0139] In some embodiments, the patient interface further comprises an attachment located at or adjacent to the collapsible portion and configured to facilitate the transition of the collapsible portion to the collapsed configuration. Various examples of suitable accessories are described in the applicant's U.S. Provisional Patent Application No. 63 / 362,486, filed on April 4, 2022. It will be understood that the accessories described in U.S. Provisional Patent Application No. 63 / 362,486 can be used with patient interfaces according to the present disclosure. For example, the accessories disclosed in U.S. Provisional Patent Application No. 63 / 362,486 can be used with a gas sampling interface including a gas sampling conduit. The sampling conduit can be integrated with the attachment according to U.S. Provisional Patent Application No. 63 / 362,486. In one embodiment, the attachment comprises a rigid member extending along the patient-facing wall of the gas delivery side member and configured to provide a counterforce to a load applied to the collapsible portion. In one embodiment, the appendage comprises a portion extending along a non-patient-facing wall of the gas delivery side member and configured to move toward the patient in response to a load applied to the appendage. The appendage may operate to enhance, focus, amplify, or supplement a crushing force applied to the collapsible portion.

[0140] The sampling conduit can be external to the attachment, but may also be coupled to the attachment. For example, in one embodiment, the attachment includes a conduit connector that connects a portion of the sampling conduit to the attachment. Alternatively, in one embodiment, the sampling conduit extends through the attachment. The sampling conduit may include a tube that extends through a passageway integrally formed in the attachment. Alternatively, the sampling conduit may be provided by a passageway integrally formed in the attachment.

[0141] In one embodiment, the accessory includes a pair of spaced apart openings including a patient gas inlet port configured to be positioned proximate to the delivery outlet and a patient gas outlet port configured to be positioned proximate to the delivery inlet, and a sampling conduit extends internally through the accessory between the patient gas inlet and outlet.

[0142] In one embodiment, the patient interface further includes a rigid gas pathway connector connectable with the delivery inlet, the patient interface further comprising a conduit connector for removably connecting a portion of the sampling conduit to the gas pathway connector. The gas pathway connector can be configured to connect the gas delivery side member to a flow supply conduit, e.g., a conduit connected to a device that supplies a device gas flow. The gas pathway connector can include a connection arrangement for connecting the gas pathway connector to a head strap.

[0143] In one embodiment, a conduit connector for mating with a gas pathway connector includes a first attachment arrangement including a pair of resilient arms configured to be removably attached to the gas pathway connector and a second attachment arrangement configured to be removably attached to a sampling conduit. In a particular embodiment, the second attachment arrangement includes a pair of hooks defining a pair of recesses corresponding to an outer diameter of the sampling conduit and configured to receive and hold the sampling conduit.

[0144] The above-mentioned conduit connector of the accessory can cooperate with the above-mentioned conduit connector that is connected to the gas path connector. For example, in one embodiment, the sampling conduit is connected to both the conduit connector of the accessory and to a conduit connector that is connected to the gas path connector.

[0145] As mentioned above, 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 the sampling outlet when the collapsible portion transitions to the collapsed configuration. This can be achieved in a variety of ways, some of which have been mentioned above. For example, the sampling conduit is connected to the gas delivery member, but is separated from the gas delivery member by a connecting web such that the sampling conduit is not in contact with or subject to the collapsing forces applied to the collapsible portion. Various other configurations for keeping the sampling conduit open are contemplated.

[0146] For example, in an alternative configuration, the sampling conduit can be positioned relative to the collapsible portion such that the sampling conduit is subjected to, exposed to, or affected by a collapsing force applied to the collapsible portion. This may occur directly (e.g., a facemask directly contacts and presses against the sampling conduit) or indirectly (e.g., the force of the facemask is applied to the collapsible portion and transmitted through the collapsible portion to the sampling conduit). In any of these or other scenarios, the sampling conduit can be configured to remain open in response to the direct or indirect application of a collapsing force to the sampling conduit.

[0147] For example, in one embodiment, the sampling conduit includes a sampling lumen, the sampling conduit configured to retain the shape of the sampling lumen in response to a collapsible force applied to the collapsible portion. In one embodiment, the sampling conduit is configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen when a collapsible force is applied. In certain embodiments, the sampling conduit is formed of a material having sufficient material stiffness to retain the shape of the sampling lumen. In one embodiment, the gas sampling interface is formed of a different material than the collapsible portion. In one embodiment, the sampling conduit is formed of a different material than the collapsible portion. In one embodiment, the sampling conduit is formed of a material having a higher material stiffness than the material of the collapsible portion. In one embodiment, the gas sampling interface includes silicone. In one embodiment, the collapsible portion includes a thermoplastic elastomer. In one embodiment, the gas sampling interface includes silicone and the collapsible portion includes a thermoplastic elastomer.

[0148] In one embodiment, the sampling conduit is configured to be stiffer than the collapsible portion via geometric features. For example, the sampling conduit can have thicker walls than the collapsible portion. The sampling conduit can include walls of uniform (i.e., consistent) thickness, while the collapsible portion can include thinner walled portions configured to facilitate bending or folding, thereby facilitating the transition of the collapsible portion to the collapsed configuration. The sampling conduit may include internal reinforcing structures, such as struts or cross members, that help resist closure of the sampling conduit.

[0149] According to a second aspect of the present disclosure, 1. A gas delivery interface configured to deliver a system gas flow to a patient, comprising: a delivery outlet for delivering the system gas flow to the patient; a gas delivery side member including an apparatus gas flow path extending from one side of the delivery outlet and in fluid communication with the delivery outlet, the gas delivery side member including a collapsible portion that is transitionable upon application of a collapsible force from a normally open configuration to a collapsed configuration in which the apparatus gas flow path is reduced or closed to reduce or stop apparatus gas flow through the apparatus gas flow path; A gas delivery interface comprising: There is provided a patient interface comprising: 1. A gas sampling interface, comprising: a sampling inlet configured to receive a patient gas flow at a patient; a sampling outlet configured to direct the patient gas flow away from the patient; a sampling conduit in fluid communication with the sampling inlet and the sampling outlet, the sampling conduit having a gas sampling interface disposed in the gas delivery side member; Gas sampling interface It further comprises:

[0150] Thus, according to the second aspect of the disclosure, the gas sampling interface is provided on the gas delivery side member. It will be appreciated that the various embodiments and features of the disclosure discussed above with respect to the first aspect of the disclosure are also applicable to the second aspect of the disclosure, except that the embodiments discussed above relate to a gas delivery interface provided on a non-delivery side member.

[0151] In contrast to the first aspect of the present disclosure, the sampling conduit of the second aspect of the present disclosure is not necessarily configured to remain open when the collapsible portion transitions to the collapsed configuration, however, it should be understood that the sampling conduit of the second aspect of the present disclosure can be configured to remain open, similar to the first aspect of the present disclosure.

[0152] Thus, various embodiments and features of the present disclosure discussed above with respect to the first aspect of the present disclosure relating to a sampling conduit that remains open when the collapsible portion transitions to a collapsed configuration may also be applicable and / or implemented in the second aspect of the present disclosure.

[0153] However, in one embodiment of the second aspect of the disclosure, the sampling conduit can be configured to selectively reduce or stop the flow of patient gas. This may be desirable in applications where a second respiratory assistance system (e.g., a face mask applied to the patient's face) also has gas sampling capability and the gas sampling interface on the collapsible cannula may introduce leakage during use of the second respiratory assistance. Thus, in some circumstances, it may be desirable to stop the patient gas flow through the gas sampling interface in order not to interfere with the secondary respiratory assistance system.

[0154] According to one embodiment of the second aspect of the present disclosure, the sampling conduit is transitionable from a normally open configuration to a collapsed configuration in which 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 discussed above that facilitates closure, obstruction or restriction of the sampling conduit in response to a collapsible force, such as that 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, when the sampling conduit transitions to the collapsed configuration, one or more residual openings, flow paths or passages of the sampling lumen in the sampling conduit may remain through which some residual patient gas flow still may flow.

[0155] In one embodiment, the sampling conduit includes one or more side portions configured to move toward or towards each other upon application of a crushing force to reduce or stop patient gas flow through the sampling conduit. The sampling conduit may include a material or shape configured to facilitate the side portions moving toward or towards each other. In one embodiment, the sampling conduit transitioning from an open configuration to a closed configuration includes bending or folding one or more sides of the sampling conduit. The sampling conduit may include one or more thin-walled portions configured to provide a fold line around which the sampling conduit folds or bends when a crushing force is applied. In one embodiment, the sampling conduit is elastically deformable from a normally open configuration to a collapsed configuration.

[0156] The preceding discussion relates to possible embodiments and features of the present disclosure that relate to one or both of the first and second aspects of the present disclosure. Various other possible embodiments and / or features of the present disclosure may be applicable to both aspects of the present disclosure, some of which are discussed below.

[0157] In one embodiment, the sampling inlet is located adjacent to or within the delivery outlet. The sampling inlet may include a mouth scoop configured to be located in front of the patient's mouth. The mouth scoop may include an opening configured to capture patient gases exhaled from the patient's mouth and / or nostrils. Thus, the mouth scoop may form part of the sampling interface. In one embodiment, the mouth scoop is configured to be removably attached to the sampling conduit. In one embodiment, the sampling inlet may be provided by the mouth scoop. For example, the mouth scoop may be configured to be removably attached to the sampling inlet, and when the mouth scoop is selectively attached to the sampling inlet, the sampling inlet is provided by or to the mouth scoop. In one embodiment, the mouth scoop may be non-removably attached to the sampling conduit, where the sampling inlet is provided by the mouth scoop.

[0158] The delivery outlet may include one or more nasal delivery prongs configured to be positioned in one or both of the patient's nostrils, hi one embodiment, the sampling inlet includes a nasal inlet and an oral inlet.

[0159] In one embodiment, the sampling inlet is provided by sampling nasal prongs configured for insertion into the patient's nares. The sampling inlet may be provided by a pair of nasal prongs. The sampling conduit may extend beyond the distal end of the nasal delivery prongs such that the sampling nasal prongs are configured to be positioned deeper within the patient's nares than the nasal delivery prongs.

[0160] The positioning of the sampling nasal prongs relative to the nasal delivery prongs can vary. In one embodiment, the sampling nasal prongs extend through the nasal delivery prongs. The sampling nasal prongs can be located substantially in the center of the nasal delivery prongs. For example, the sampling nasal prongs and the nasal delivery prongs can be concentric. Alternatively, the sampling nasal prongs can be located outside the nasal delivery prongs and extend alongside them.

[0161] In one embodiment, the sampling conduit has a flexibly resilient support structure that allows the sampling conduit to be manipulated into a desired shape and / or allows the sampling inlet to be positioned in a desired location. The support structure may include a wire located within the sampling conduit or coupled to a wall of the sampling conduit. The wire may be formed of steel and may be flexible to allow selective positioning of the wire into a desired shape or location.

[0162] In an alternative embodiment, the sampling conduit is provided without the flexibly resilient support structure described above. For example, the sampling conduit may be provided without wires located therein. In one embodiment, the sampling conduit is provided with a single lumen, the single lumen being the sampling lumen for the patient gas flow. According to this embodiment, the sampling conduit does not include a support wire and therefore does not include any additional lumen for a support wire. In one embodiment, the sampling conduit has a homogenous material composition. For example, the sampling conduit may be formed only of silicone or silicone type material, and not of silicone material with embedded support wires formed of metal or non-silicone material, according to the alternative embodiment described above. Providing a sampling interface with a single lumen that is the sampling lumen (i.e., no flexibly resilient support wire is housed in the wire lumen) can advantageously conserve material and reduce manufacturing complexity.

[0163] In one 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 that may 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 elastically deforms around the non-patient facing surface to form a seal between the mask cuff and the sampling conduit.

[0164] In one embodiment, the sampling inlet is located proximate to the delivery outlet such that it is located within a cavity formed between the patient face mask and the patient's face during application of the patient face mask to the patient, and the sampling outlet is spaced from the delivery outlet such that it is outside the cavity during application of the mask to the patient. In this manner, the patient face mask applied to the patient's face covers the sampling inlet but not the sampling outlet that is in fluid communication (or available for fluid communication) with the respiratory gas monitor.

[0165] From the above discussion, it will be appreciated that the present disclosure provides a patient interface configured to allow sampling and monitoring of patient gas when the collapsible portion transitions to a collapsed configuration, e.g., when a patient face mask is placed over the patient interface. Thus, the patient interface allows the breathing system to be switched (e.g., from a high flow nasal cannula to a face mask). It will also be appreciated from the above discussion that the patient interface can be configured to not disrupt (or minimize disruption of) the seal of a mask placed against the patient's face.

[0166] Patient Interfaces and Their Accessories The present disclosure also relates to patient interfaces and accessories thereto.

[0167] As discussed above, the collapsible conduit includes a collapsible portion that is configured to collapse and restrict respiratory gas flow, for example, when the mask is placed on the patient's face and a portion of the mask, for example a mask cuff, is folded over (and pressed onto) the collapsible portion, thereby allowing a clinician to easily apply a non-invasive ventilation mask to a patient over the patient interface, restricting gas flow through the collapsed conduit when desired.

[0168] When a clinician wishes to manually ventilate a patient using a bag and mask, they may need to apply a significant amount of pressure to the collapsible portion to cause sufficient collapse that insufficient collapse can allow residual gas to flow through the collapsible portion.

[0169] Appendages according to this aspect of the disclosure may be provided to reduce residual flow and / or otherwise improve the consistency or ease with which sufficient collapse is achieved.

[0170] The attachments can be configured to help facilitate or promote improved collapse of the collapsible portion in a variety of different ways. For example, the attachments can be configured to be located at specific locations relative to the collapsible portion to promote sufficient collapse. Alternatively or additionally, the attachments may include geometric features that provide a localized concentration of force on the collapsible portion to amplify the pressure applied to the collapsible portion. In another example, the attachments may be configured to amplify the force applied to the collapsible portion. Various embodiments of these and other concepts are discussed below.

[0171] According to one aspect of the disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising: an attachment arrangement configured to attach the accessory to the patient interface; and a contact portion configured to facilitate collapse of the collapsible portion in a collapsed position in fixed relationship relative to the attachment arrangement when a collapsible force is applied to the contact portion and / or the collapsible portion.

[0172] The attachment may advantageously enhance the consistency of collapse by promoting or otherwise facilitating the collapse of the collapsible portion at a predetermined collapse location in a fixed relationship to the attachment arrangement, which may allow a user to control the collapse location by varying the position of the attachment and the attachment arrangement.

[0173] The attachment can include a base, bar, or plate positionable behind the collapsible portion (i.e., between the patient's face and the patient-facing side of the collapsible portion) to provide a rigid surface against which the collapsible portion compresses when a crushing force is applied to the collapsible portion. For example, the attachment can provide a backing plate configured to support the collapsible portion and provide a rigid surface against which the collapsible portion squeezes or compresses when the bag mask is applied to the patient's face.

[0174] The contact portion of the attachment can provide a surface against which the collapsible portion is pressed such that the collapsible portion is sandwiched or interleaved between the mask cuff and the attachment. The contact portion can be configured to engage the collapsible portion to facilitate collapse of the collapsible portion. For example, the contact portion can be configured to contact the collapsible portion. The contact portion can be configured to apply a force to the collapsible portion to cause or aid in the collapse of the collapsible portion.

[0175] The contact portion can contact the patient interface at the collapsible portion. Alternatively, the contact portion may contact the patient interface at a location other than the collapsible portion, for example at a location on the gas delivery conduit that is upstream or downstream of the collapsible portion. In this case, the contact portion can still facilitate collapse of the collapsible portion. For example, the contact portion can contact a portion of the gas delivery conduit adjacent the collapsible portion and provide a hinge or pivot point about which the gas delivery conduit can bend or twist to facilitate or cause collapse of the collapsible portion. The contact portion can contact and support one or more portions of the gas delivery conduit adjacent the collapsible portion, such that at least a section of the collapsible portion is not supported by the attachment. The unsupported section of the collapsible portion can span between supported sections of the collapsible portion or of the gas delivery conduit. The attachment can be configured to facilitate collapse at the unsupported section that spans between one or more supported sections.

[0176] According to certain embodiments, the accessory includes a backing plate positionable, in use, between the patient-facing surface of the collapsible portion and the patient's face, the backing plate having a patient-facing surface and an opposing conduit-facing surface that faces the patient-facing surface of the collapsible portion.

[0177] The contact portion of the attachment can be configured in a variety of ways. According to one embodiment, the contact portion includes a conduit-facing surface of a backing plate. The conduit-facing surface of the backing plate can be configured to facilitate collapse of the collapsible portion in the collapsed position. For example, the conduit-facing surface of the backing plate may include focusing structures configured to concentrate forces on the patient-facing surface of the collapsible portion.

[0178] According to one embodiment, the focusing structure includes at least one rib on the conduit-facing surface of the backing plate. The focusing structure may include a plurality of ribs. The focusing structure may include a serrated surface. The focusing structure may include other configurations, such as protrusions or tapered protrusions. The focusing structure may be configured to contact the collapsible portion at a single location corresponding to the collapse location.

[0179] In certain embodiments, the backing plate is shaped with a preformed curvature configured to match the contours of the gas delivery conduit and / or the contours of the patient's face. The preformed curvature can advantageously conform or fit to the patient's face to guide or position the gas delivery conduit in a desired location relative to the patient's face and / or to enhance patient comfort.

[0180] The accessories can be provided in different sizes to accommodate different patient facial sizes or shapes. For example, an accessory can be provided with a backing plate sized and / or shaped to accommodate a child's face and also with a backing plate sized and / or shaped to accommodate an adult's face. In this manner, a healthcare provider, such as a nurse, can select an appropriately sized accessory based on the patient's facial features.

[0181] In some embodiments of the present disclosure, the attachment is not provided with a backing plate, but alternative members may be provided, For example, the attachment may include a support member extending between the mounting arrangement and the contact portion, the support member configured to support the contact portion in a fixed relationship relative to the mounting arrangement.

[0182] In one embodiment, the support member may include a pre-formed curvature to conform to the contours of the gas delivery conduit and / or the patient's face.

[0183] In one embodiment, the contact portion includes a tapered configuration configured to concentrate forces on the patient-facing surface of the collapsible portion.

[0184] In one embodiment, the tapered configuration includes a tapered rib located at a distal end of the support member.

[0185] In one embodiment, the tapered rib includes an edge configured to concentrate a force on the patient-facing surface of the collapsible portion. The edge may include a linear or planar or straight edge. The edge may include a rounded or non-linear or non-planar edge.

[0186] In one embodiment, the edge is substantially transverse to the length of the collapsible portion.

[0187] In one embodiment, the contact portion includes a first member positionable, in use, between the patient-facing surface of the collapsible portion and the patient's face, and a second member moveably coupled to the first member and configured to move toward the first member and facilitate collapse of the collapsible portion in response to application of a crushing force. In use, the attachment may be fitted to or otherwise positioned on the collapsible portion such that the collapsible portion is positioned between the first and second members. The moveable coupling between the first and second members may be configured to squeeze, compress, pinch, sandwich or clamp the collapsible portion between the first and second members to facilitate collapse of the collapsible portion.

[0188] In one embodiment, the attachment arrangement includes an opening configured to receive the collapsible portion and to position a collapsed location of the collapsible portion between the first and second members, the first and second members being configured to apply a clamping load to the collapsed location of the collapsible portion when a crushing force is applied.

[0189] In one embodiment, the second member includes an action surface configured to receive a crushing force, whereby application of the crushing force to the action surface causes movement of the second member toward the first member. The action surface can include a portion of the second member located on a non-patient facing (i.e., outer) side of the collapsible portion. For example, the portion of the second member that is first contacted by a bag mask that is applied to a patient's face. The action surface can be located at or adjacent to the collapsed position, or can be spaced apart from the collapsed position, depending on the particular configuration and length of the second member.

[0190] In one embodiment, each of the first and second members includes a proximal end, a distal end, and a clamping portion located between the proximal and distal ends, the proximal and distal ends being hinged together, and in use, the collapsible portion is positionable between the respective clamping portions.

[0191] The movable connection between the first and second members can include a variety of different configurations. In certain embodiments, the first and second members are hingedly connected, and in use, the collapsible portion is positionable between the first and second members. The hinged connection can include a pin extending between corresponding openings in the ends of the first and second members. Alternatively, the hinged connection can include any other suitable configuration. For example, the hinged connection can include a flexible hinge portion connecting the first and second members.

[0192] In one embodiment, the first member comprises a backing plate and the second member comprises a cantilever member hingedly or pivotally coupled to the backing plate. In use, the backing plate is positioned behind the collapsible portion, i.e. between the patient's face and the patient-facing side of the collapsible portion. At least a portion of the second member may be positioned in front of the collapsible portion, i.e. on the non-patient-facing side of the collapsible portion, so as to contact the second member when the bag mask is applied to the patient's face. The backing plate and / or the cantilever member may include one or more ribs for concentrating forces on the collapsible portion. In use, the collapsible portion may be compressed or pinched between the ribs of the backing plate and the ribs of the cantilever member. This configuration may advantageously provide a reliable collapse location and may reduce the force required to achieve sufficient collapse of the collapsible portion due to the localized force concentration provided by the ribs.

[0193] The attachment configuration of the accessory can be provided in various configurations and can be advantageously configured to allow selective positioning or adjustment of the position of the accessory to achieve a desired collapse position. According to one embodiment, adjustment of the position of the attachment configuration allows adjustment of the position of the collapse position. The accessory configuration can be attachable to an attachment location on the patient interface, where the collapse position is predetermined by selection of the attachment location. In use, a user can select (e.g. visually) a desired collapse position of the collapsible portion and position the attachment configuration accordingly to achieve the desired collapse position. This configuration can also advantageously provide a consistent collapse position relative to the attachment configuration. That is, the accessory can allow a user to accurately predict where collapse of the collapsible portion will occur when a crushing force is applied.

[0194] According to certain embodiments, the attachment arrangement is attachable to the collapsible portion. The attachment arrangement may be attachable to a portion of the patient interface other than the collapsible portion. For example, the attachment arrangement may be attachable to a portion of the gas delivery conduit upstream and / or downstream of the collapsible portion.

[0195] In one embodiment, the attachment arrangement is attachable to a rigid portion of the patient interface, which in a particular embodiment is a rigid portion of the gas delivery conduit that is upstream of the collapsible portion relative to a flow direction of breathing gas in the gas delivery conduit.

[0196] In one embodiment, the contact portion is co-located with the crush location, and the contact portion can cause the crushing of the crushable portion at an interaction surface between the contact portion and the crushable portion, thus allowing a user to advantageously predict a consistent crush location based on the location of the contact portion.

[0197] In one embodiment, the collapsed location is spaced apart from the attachment feature. For example, the contact portion and the attachment feature can be located at generally opposite ends of the accessory such that the contact portion and the collapsed location are spaced apart from the attachment feature by approximately the length of the accessory.

[0198] In one embodiment, the contact portion and the collapse location are located in the same location as the attachment structure. For example, the attachment structure can be positioned generally in the same location or adjacent to the contact portion in the collapsible portion. Thus, the collapse location can be in approximately the same location as the attachment structure. Thus, a user can expect the collapse to occur in the same location as the attachment structure.

[0199] In one embodiment, the attachment configuration includes at least one of a mount, a clamp, a fitting, a connector, a fastener, a clip, a snap-fit ​​fitting, or a recess.

[0200] In one embodiment, the attachment arrangement is configured to be attached to or detached from the patent interface without interrupting the flow of respiratory gas to the patient through the gas delivery conduit. This embodiment may advantageously allow a user to fit or install an accessory or remove an accessory while the patient is still receiving respiratory assistance through the patient interface.

[0201] In one embodiment, the attachment arrangement comprises an opening configured to receive the collapsible portion, such that in use, the collapsible portion extends through the opening. The opening may include an aperture or passageway through a portion of the attachment. The opening may include a recess, trough, groove, or cutout. For example, if the opening includes an aperture, it may surround the collapsible portion in use. Alternatively, for example, if the opening includes a cutout, trough, or recess, it may only partially surround the collapsible portion in use.

[0202] In one embodiment, the attachment arrangement is configured to maintain the position of the contact portion relative to the collapsible portion.

[0203] In one embodiment, the collapse location is in a fixed relationship to the attachment arrangement, regardless of where the collapse force is applied to the collapsible portion and / or the contact portion.

[0204] In one embodiment, the contact portion is configured to cooperate with the crushing force to provide a compressive force to the collapsible portion at the collapsed position.

[0205] In one embodiment, the contact portion is configured to apply a force to at least one discrete location of the collapsed portion, which may include a discrete point or edge or side of the collapsible portion.

[0206] In one embodiment, the contact portion is configured to apply force at multiple discrete locations in the collapsed position.

[0207] In one embodiment, the contact portion is configured to provide a reaction force to the collapsible portion in response to application of a crushing force. The reaction force can act on the collapsible portion in a direction opposite to the direction of the crushing force. In one embodiment, the contact portion applies a reaction force to the collapsible portion in a direction away from the patient's face.

[0208] In one embodiment, the collapsing force is an external force applied to the contact portion and / or the collapsible portion, hi one embodiment, the collapsing force is an external force applied by a cuff of a patient mask.

[0209] In one embodiment, the attachment includes a plurality of contact portions. For example, the attachment may include a pair of spaced apart contact portions configured to position the collapsible portion between the pair of contact portions. Alternatively, the attachment may include a series of contact portions including a plurality of tapered projections configured to create a plurality of collapse locations in the collapsible portion.

[0210] In one embodiment, the contact portion is configured to apply a force to the collapsible portion when the mask is applied to a patient such that the mask cuff covers the collapsible portion.

[0211] In one embodiment, the contact portion has a contact surface configured to contact the crushable portion and to concentrate the crushing force at the contact surface and an interaction surface with the crushable portion. In one embodiment, the contact surface has a relatively small area configured to concentrate the crushing force at the interaction surface. According to a particular embodiment, the contact surface is located at a tip of a tapered protrusion. The crushing force applied to the crushable portion and / or the contact portion can be concentrated at the crushing location by the tip of the tapered protrusion. According to a particular embodiment, the tapered protrusion includes a tapered rib.

[0212] According to certain embodiments, collapse of the collapsible portion reduces the flow of breathing gas through the patient interface.

[0213] According to another aspect of the present disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising: an attachment arrangement configured to attach the accessory to the patient interface; a contact portion configured to contact and facilitate collapsing of the collapsible portion when a collapsible force is applied to the contact portion and / or the collapsible portion; and an indicator configured to identify a location where the collapsible force is applied.

[0214] This aspect of the disclosure can advantageously facilitate effective positioning of the collapsing force. For example, the indicator can allow for more accurate and effective positioning of a bag mask on the collapsible portion and / or more accurate and effective positioning of an attachment relative to the collapsible portion. The indicator can indicate to a user the optimal location to apply the collapsing force to achieve optimal collapse of the collapsible portion.

[0215] According to one embodiment, the indicator comprises a visual indicator. According to a particular embodiment, the visual indicator comprises a colored indicator.

[0216] In one embodiment, the visual indicator comprises a symbol or marking indicia.

[0217] In one embodiment, the visual indicator is configured to be visualized through a transparent or translucent portion of the collapsible portion.

[0218] In one embodiment, the indicator includes a tactile indicator.

[0219] In one embodiment, the tactile indicator comprises a tactile structure on a surface of the accessory, hi one embodiment, the tactile indicator comprises at least one of a rib, a bar, a knurl, a depression, a rebate, a notch, a cavity channel, a slit, a groove, an opening, a protrusion, a bulge, or a raised portion.

[0220] In one embodiment, the attachment includes a patient facing surface and an opposing non-patient facing surface, and the indicator is located on the non-patient facing surface. According to certain embodiments, the indicator is located on the contact portion.

[0221] In one embodiment, the indicator is configured to provide a positioning guide for a user to apply a crushing force to the crushable portion or contact portion.

[0222] According to another aspect of the present disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising: an attachment arrangement configured to attach the accessory to the patient interface; and a contact portion, the contact portion configured to impart a collapsible load to the collapsible portion upon application of an external load to the contact portion and / or to the collapsible portion, the accessory configured to amplify the external load such that a force and / or pressure of the collapsible load imparted to the collapsible portion is higher than a force and / or pressure of the applied external load.

[0223] In one embodiment, the attachment is configured to exert a pressure on the collapsible portion that is greater than the pressure of an applied external load.

[0224] In one embodiment, the contact portion has a contact area configured to apply a crushing load at an interface between the contact portion and the collapsible portion. According to a particular embodiment, the contact area of ​​the contact portion is relatively small. For example, the contact area may be smaller than the working area of ​​the contact portion or the collapsible portion to which the external load is applied. It will be appreciated that when an equivalent force is applied to a smaller area, the pressure applied to that area will increase. Thus, when a crushing load of a particular force and pressure is applied to the working area, such that an equivalent force is applied to the collapsible portion at the contact area, the pressure at the contact area will increase due to the contact area being smaller than the working area.

[0225] In one embodiment, the attachment is configured to apply a force to the crushable portion that is greater than a force of an applied external load. In one embodiment, the attachment is configured to amplify the force of the applied external load by a predetermined factor. According to one embodiment, the predetermined factor is greater than 1. According to one embodiment, the predetermined factor is between 1 and 20. According to one embodiment, the predetermined factor is between 5 and 20. According to one embodiment, the predetermined factor is between 5 and 15.

[0226] In one embodiment, the applied external load is a force or pressure of the bag mask being applied to the collapsible portion, and the attachment is configured to apply a force and / or pressure to the collapsible portion that is greater than the force and / or pressure applied by the bag mask.

[0227] In one embodiment, the lever mechanism includes a pivot, the lever mechanism configured to generate a rotational moment about the pivot in response to an applied external load. In one embodiment, the lever mechanism can be configured to receive the force of the applied external load at a first portion of the lever mechanism and provide an amplified force to a collapsible portion at a second portion of the lever mechanism spaced apart from the first portion of the lever mechanism. In one embodiment, the second portion of the lever mechanism is positioned closer to the pivot than the first portion of the lever mechanism.

[0228] In one embodiment, the attachment comprises a lever mechanism configured to amplify the force of an applied external load. The lever mechanism can include a second type of lever configuration, i.e., a configuration in which the load applied to the collapsible portion is positioned between a fulcrum and a force applied to the lever mechanism.

[0229] In one embodiment, the second type lever configuration includes a pair of clamping arms pivoted at a fulcrum, the pair of clamping arms including a pair of opposing clamping surfaces positioned between the fulcrum and a distal end of each clamping arm, and a clamping region disposed between the pair of opposing clamping surfaces configured to receive the collapsible portion.

[0230] In one embodiment, the attachment is configured such that an external load is applied to at least one of the clamping arms at a location at or adjacent to a distal end of the clamping arm.

[0231] In one embodiment, the distance between the applied crushing load and the fulcrum is less than the distance between the applied external load and the fulcrum. It will be appreciated that the force of the applied external load creates a torque or moment on the clamping arm about the fulcrum. This moment causes a greater force at a location along the clamping arm closer to the fulcrum. Thus, a force applied to the crushable portion closer to the fulcrum than the applied external force is an amplification of the applied external force. The amplification factor can be predetermined by the distance from the fulcrum to the applied load and the distance from the fulcrum to the applied load. As an example, a clamping surface positioned 1 cm from the fulcrum and an applied load positioned 3 cm from the fulcrum results in a force amplification factor of 3.

[0232] The attachment may be configured to amplify both the force and pressure of an applied external load, or may be configured to amplify only one of the force or pressure. For example, the attachment may be configured to apply approximately the same force to the collapsible portion as applied by the external load, but over a smaller area, resulting in an increase in pressure. In other words, the attachment may concentrate the same force over a smaller area to increase the pressure of the crushing load applied to the collapsible portion.

[0233] According to another aspect of the present disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising: an attachment portion configured to attach the accessory to the patient interface; and a support, in use, positionable between the gas delivery conduit and the patient's face and configured to facilitate collapse of the collapsible portion when a collapsible force is applied to the collapsible portion.

[0234] In one embodiment, the support includes a rigid support. The support can include a rigid surface configured to provide a resistive force to the patient-facing side of the collapsible portion in response to a crushing force being applied to the non-patient-facing side of the collapsible portion. In certain embodiments, the support is rigid but has some resiliently flexibility.

[0235] In one embodiment, the support is shaped to conform to the contours of the collapsible portion and / or the patient's face. The support may be shaped to have a curvature. In one embodiment, the support includes a preformed curvature configured to conform to the contours of the collapsible portion and / or the patient's face.

[0236] According to one embodiment, the mounting portion is in fixed relationship with the support. For example, the support may be fixedly coupled to the mounting portion or may be integrally formed with the mounting portion. In this manner, the position of the support may be adjusted or determined based on the position of the mounting portion.

[0237] In one embodiment, the attachment portion comprises at least one of a mount, a clamp, a coupling, a connector, a fastener, a clip, a snap-fit ​​attachment, or a recess. The attachment portion may comprise any suitable attachment means, it being understood that other forms of attachments may be suitable for use as the attachment portion. According to certain embodiments, the attachment portion comprises a clip in fixed relationship to the support. The clip may be formed of a rigid material. The clip may be formed of a resilient material. The clip may be formed of a deformable material.

[0238] In one embodiment, the clip is configured to provide a removable snap-fit ​​connection to a rigid portion of a patient interface, hi one embodiment, the clip is configured to provide a connection to a rigid portion of a gas delivery conduit that is located upstream of the collapsible portion relative to a flow direction of gas in the gas delivery conduit.

[0239] In one embodiment, the clip comprises a C-clip or a U-clip. For example, the clip can comprise a resiliently flexible C-clip configured to be secured to the rigid portion of the gas delivery conduit with a snap fit. In one embodiment, a support extends from the clip. In one embodiment, the clip is configured to couple to the rigid portion of the gas delivery conduit at a location upstream of the collapsible portion, and a support extends from the clip in a downstream direction between the patient's face and the collapsible portion.

[0240] In one embodiment, the support comprises a backing plate. The backing plate may be configured to be positioned such that, in use, a longitudinal axis of the backing plate is substantially parallel to a longitudinal axis of the collapsible portion. The backing plate may have a width direction perpendicular to the longitudinal axis of the backing plate, the backing plate having a width along the width direction at least equal to a width of the collapsible portion. In one embodiment, the backing plate has a width greater than a width of the collapsible portion. According to one embodiment, the backing plate has a substantially planar configuration.

[0241] In one embodiment, the support includes a proximal end, a distal end, and a curved portion intermediate the proximal and distal ends, hi one embodiment, the attachment arrangement is located at or adjacent the proximal end of the support.

[0242] In one embodiment, the patient interface includes a nasal cannula including one or more prongs configured to be inserted into the patient's nasal passages, and the support is sized such that the distal end of the backing plate is spaced from the one or more prongs in use.

[0243] In one embodiment, the support includes a contact portion configured to contact a patient-facing surface of the gas delivery conduit. The contact portion can be configured to contact the patient-facing surface of the collapsible portion. In one embodiment, the contact portion is configured to contact the patient-facing surface of the gas delivery conduit upstream or downstream of the collapsible portion relative to a flow direction within the gas delivery conduit.

[0244] In one embodiment, the contact portion is configured to provide a space or cavity between the support and the patient-facing surface of the gas outlet line in a region upstream of the contact portion relative to the flow direction of breathing gas in the gas outlet line.

[0245] In one embodiment, the attachment is configured to allow the collapsible portion to collapse and enter into a space or cavity when a collapsible force is applied. In one embodiment, the attachment is configured to allow the collapsible portion to twist and enter into a space or cavity when a collapsible force is applied. For example, the attachment may be configured to engage the collapsible portion to induce a kink in the collapsible portion. The attachment may be configured to induce two or more kinks in the collapsible portion. The attachment may be configured to collapse and / or twist the collapsible portion to create a tortuous path for breathing gas and reduce flow rate by increasing flow resistance through the tortuous path.

[0246] In one embodiment, the support includes an outward facing surface configured to face the patient-facing surface of the collapsible portion in use, and the contact portion extends from the outward facing surface of the support in an outward direction away from the patient's face.

[0247] In one embodiment, the support includes a patient-facing side that faces the patient's face, an outward-facing side that faces the patient-facing side of the collapsible portion, and a concentrating structure located on the outward-facing side of the support that concentrates a resistive force on the collapsible portion. In one embodiment, the resistive force is generated in response to application of a crushing force. That is, the support resists movement of the collapsible portion toward the patient's face by applying a resistive force to the patient-facing side of the collapsible portion that is concentrated by the concentrating structure. In one embodiment, the concentrating structure is configured to increase the pressure of the resistive force.

[0248] In one embodiment, the contact portion comprises at least one of a rib, a ledge, a bar, a knurl, a projection, or a raised portion, hi one embodiment, the contact portion is located at or adjacent to a distal end of the support.

[0249] In one embodiment, the contact portion includes one or more ribs. In one embodiment, the one or more ribs extend at least partially between a pair of opposing longitudinal edges of the support. In one embodiment, the one or more ribs are oriented parallel to a longitudinal axis of the support.

[0250] In one embodiment, the support includes a first rib and a second rib spaced apart from the first rib by a seat configured to receive the collapsible portion. In one embodiment, the first rib and the second rib extend along opposing raised edges of the support. In one embodiment, the opposing raised edges include a pair of opposing first and second longitudinal edges, the first rib located adjacent the first longitudinal edge and the second rib located adjacent the second longitudinal edge.

[0251] According to certain embodiments, the first rib is configured to contact an upper portion of the collapsible portion and the second rib is configured to contact a lower portion of the collapsible portion. For example, in use, the support can be oriented such that the first rib is at a higher position than the second rib. Thus, the first rib can contact the collapsible portion at a higher position on the collapsible portion than the second rib, which contacts the collapsible portion at a lower position on the collapsible portion.

[0252] According to one embodiment, the first rib and the second rib are pivotally connected to position the collapsible portion within the seat.

[0253] According to one embodiment, the first and second ribs are movable toward or away from each other between an open configuration configured to receive the collapsible portion and a closed configuration configured to engage the collapsible portion between the first and second ribs.

[0254] In one embodiment, the first and second ribs are biased to the open configuration and are movable toward the closed configuration when a crushing force is applied.

[0255] In one embodiment, the accessory is attachable to the patient interface with the attachment arrangement positioned upstream of the support relative to a flow direction of breathing gas in the gas delivery conduit.

[0256] In one embodiment, the support comprises a backing plate including a conduit-facing surface including an elongated protrusion, and the attachment comprises a pair of mounting portions including a pair of flanges extending from opposite sides of the backing plate, each flange including an opening configured for the collapsible portion to extend therethrough.

[0257] In one embodiment, the backing plate is configured to protect or shield the patient's face from the applied crushing forces, for example, the backing plate can be fixedly coupled to the patient interface via an attachment arrangement such that the applied crushing forces are not transferred to the patient's face.

[0258] In one embodiment, the attachment arrangement includes a clip with the backing plate extending from the clip. The clip can be attached to a head strap-pneumatic connector of the patient interface that acts as a support for the accessory. The back plate can be shaped with a curvature along its length. This curvature allows a substantial portion of the back plate to seat between the patient's face and the collapsible portion. In one embodiment, the back plate is stiffer than the collapsible portion. The stiffness of the back plate can be achieved through the material of the back plate and / or through the geometric configuration of the back plate.

[0259] In one embodiment, the clip comprises a C-clip. In one embodiment, the clip comprises a U-clip. In one embodiment, the attachment arrangement may include alternative attachment means such as adhesive, overmolding, or integral molding.

[0260] In one embodiment of the present disclosure, the back plate provides a rigid surface behind the collapse location of the collapsible portion such that the rigid surface of the back plate provides resistance to an applied collapse load, such as the crushing force applied by a bag mask, and in this manner, the back plate helps to facilitate optimal collapse of the collapsible portion.

[0261] The backing plate may be elongated or generally rectangular and may have a width greater than the collapsible portion. According to certain embodiments, the backing plate may be provided in a variety of sizes to accommodate different patient facial sizes or shapes. The backing plate may be customized to fit a particular patient's face.

[0262] According to one embodiment, the backing plate includes a visual or tactile indicator to assist the user in applying force to collapse the crushable portion. The backing plate may be configured to indicate an optimized collapse location. For example, the backing plate may include a visual or tactile indicator of the location of the contact portion. In particular, the indicator may indicate to the user where the contact portion is positioned under the crushable portion, so that the user can apply a load at the location of the crushable portion overlying the contact portion.

[0263] According to another aspect of the present disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising a clamping arrangement including a first clamping member and a second clamping member configured to receive the collapsible portion between the first clamping member and the second clamping member, the first clamping member being positionable in use between a patient-facing surface of the collapsible portion and a face of the patient, the second clamping member being coupled to the first clamping member by a movable coupling and configured to move towards the first clamping member in response to application of a collapsible force to facilitate collapsing of the collapsible portion.

[0264] In one embodiment, at least one of the first clamping member and the second clamping member includes a concentrating structure configured to concentrate a force at the collapsible portion.

[0265] In one embodiment, the converging structure includes one or more ribs.

[0266] In one embodiment, the first clamping member includes a first rib extending toward the second clamping member, and the second clamping member includes a second rib extending toward the first clamping member.

[0267] In one embodiment, one of the first or second clamping members includes a rib extending toward the other of the first or second clamping members.

[0268] In one embodiment, the second fastening member is configured to overlie a non-patient facing surface of the collapsible portion, i.e., the second fastening member is configured to overlie an outer or outward facing side of the collapsible portion that faces away from the patient's face, said non-patient facing surface of the collapsible portion may be the surface that is contacted in use by an applied collapsing force, for example the surface that is contacted by the cuff of a bag mask that is applied to the patient's face.

[0269] In one embodiment, the second clamping member includes a non-patient-facing surface defining an active surface configured to receive an applied crushing force such that application of the crushing force to the active surface causes the second clamping member to move toward the first clamping member.

[0270] In one embodiment, the working surface is located at or adjacent to a distal end of the second clamping member.

[0271] In one embodiment, the first and second clamping members are pivotally connected. The first and second clamping members may be hingedly connected at a hinged connection. The hinged connection may include a multi-piece hinge mechanism, such as a pin that engages an opening in the clamping members. Alternatively, the hinged connection may include an integrally formed hinge, such as a flexible portion of material connecting the first and second clamping members. It will be appreciated that other pivot or hinge configurations may be suitable.

[0272] In one embodiment, the first and second ribs are located between the hinged connection and the distal end of the fastening member.

[0273] In one embodiment, the first and second clamping members have a second type of lever arrangement configured to amplify the applied crushing force applied to the collapsible portion. By a second type of lever arrangement, it is understood that a lever arrangement in which the load applied by the lever is positioned between a fulcrum and the force applied to the lever mechanism. According to this embodiment, the load applied to the collapsible portion is positioned between the fulcrum (pivot or hinged connection) and the force applied to the lever mechanism.

[0274] In one embodiment, the second fastening member includes an opening configured for the collapsible portion to extend therethrough.

[0275] In one embodiment, at least one of the fastening members is formed from a flexibly resilient or soft material.

[0276] In one embodiment, the accessory further comprises an attachment arrangement configured to attach the accessory to a patient interface. The attachment arrangement may be coupled to the first fastening member. In one embodiment, the attachment arrangement comprises a C-clip or a U-clip configured to provide a snap-fit ​​connection to a portion of the patient interface.

[0277] In one embodiment, the clamping arrangement is transitional between an open position configured to allow unrestricted flow through the collapsible portion and a clamping position configured to impose a restriction on flow through the collapsible portion, hi one embodiment, the clamping arrangement is biased toward the open position and transitional toward the clamping position when a collapsing force is applied.

[0278] According to one embodiment, the first and second clamping members include respective clamping surfaces biased apart by a biasing arrangement, which may include, for example, a spring or a flexibly resilient linkage or brace.

[0279] In one embodiment, the first and second clamping members are configured to form a series of pinch points in the collapsible portion when in the clamped configuration. The first and second clamping members may be configured to form a series of kinks in the collapsible portion. In one embodiment, the first and second clamping members are coupled via at least one linkage that is movable relative to at least one of the clamping members. In certain embodiments, the clamping members are coupled via a plurality of linkages. In one embodiment, each linkage of the plurality of linkages is flexibly resilient.

[0280] In one embodiment, the attachment includes four flexibly resilient linkages extending between the clamping members and configured to maintain the clamping members in a normally spaced apart configuration, i.e., the linkages are configured to bias the clamping members into the normally spaced apart configuration. The resilient flexibility of the linkages allows the clamping members to move together under a load, e.g., a compressive load, such as the force exerted by applying a bag mask to one of the clamping members. The linkages are configured to return the clamping members to their normally spaced apart configuration when the force is removed.

[0281] In one embodiment, the linkages are configured to flexibly deform when a crushing force is applied, allowing the clamping members to collapse towards each other. In one embodiment, the clamping members have a square or rectangular profile, with four linkages extending from each of the four corners of the clamping members. In one embodiment, each of the four corners of the clamping members is connected by one of the linkages. In one embodiment, the linkages are oriented approximately parallel to each other when the clamping members are in the normally separated configuration. In an alternative embodiment, the linkages may have a crossover configuration, with one or more linkages crossing over at least one of the other linkages.

[0282] In one embodiment, the linkage has a constantly linear configuration. In one embodiment, the linkage has a constantly non-linear configuration. In one embodiment, the linkage has a diamond configuration.

[0283] In one embodiment, the clamping members have a plate or planar configuration. In one embodiment, each clamping member comprises a bar. In one embodiment, each clamping member has a cylindrical configuration.

[0284] According to another aspect of the present disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising a first portion configured to apply a collapsing force to a first region of the collapsible portion, and a second portion spaced apart from the first portion, the second portion having a fulcrum between the first and second portions, wherein application of the collapsing force in a first direction to the first portion causes the second portion to move in a second direction to collapse the second region of the collapsible portion.

[0285] In one embodiment, the first and second portions are angled relative to one another. The first and second portions may be angled at an obtuse angle relative to one another. In certain embodiments, the first portion is located on a first lever arm and the second portion is located on a second lever arm, each of the lever arms extending from a fulcrum.

[0286] According to one embodiment, the attachment is rigid such that the first lever arm, the second lever arm and the fulcrum are in a fixed relationship to each other.

[0287] In one embodiment, the fulcrum comprises a rigid corner at the intersection or joining of the first and second lever arms.

[0288] In one embodiment, the first portion includes an opening configured to receive the collapsible portion therethrough.

[0289] In one embodiment, the accessory further comprises a support positionable between the patient's face and the fulcrum.

[0290] In one embodiment, the support includes a backing plate. The backing plate may include a rigid surface configured to act as a pivot surface for the fulcrum.

[0291] In one embodiment, the fulcrum includes a pivot connected to the backing plate.

[0292] In one embodiment, the first direction is toward the patient's face and the second direction is away from the patient's face.

[0293] In one embodiment, the first and second parts are unequally spaced from the fulcrum. According to a particular embodiment, the second part is spaced further from the fulcrum than the first part. As mentioned above, the first part may be located on the first lever arm and the second part may be located on the second lever arm. According to this embodiment, the second lever arm may be longer than the first lever arm relative to the fulcrum. That is, the second lever arm may extend further from the fulcrum than the first lever arm extends from the fulcrum.

[0294] According to one embodiment, the attachment can include a see-saw configuration, where a first lever arm and a second lever arm each extend from opposite sides of a fulcrum. In one embodiment, the attachment can have a generally "V" shaped configuration.

[0295] According to another aspect of the present disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the accessory comprising a gripping portion configured to apply a force in a direction away from the patient's face to facilitate collapsing or bending of the collapsible portion.

[0296] This aspect of the disclosure may advantageously provide a relatively simple and reliable means of facilitating collapse of the collapsible portion by providing a gripping portion that allows a user to pull the collapsible portion away from the patient's face. This pulling action may occur simultaneously as the mask is applied to the patient's face and over the collapsible portion, whereby the collapsible portion is pulled outwardly away from the patient's face by the gripping portion while simultaneously being pushed inwardly toward the patient's face by the mask. This simultaneous, opposing force may thereby facilitate collapse of the collapsible portion.

[0297] In one embodiment, the fitting includes a connector configured to connect a tube of the gas delivery conduit to the collapsible portion, For example, the fitting may be integrally formed with the connector of the patient interface.

[0298] According to an alternative embodiment, the accessory further includes an attachment arrangement for attaching the accessory to the patient interface. For example, the accessory may be removably connectable to the patient interface.

[0299] It will be appreciated from the foregoing that the gripping portion may be integrally formed with the connector or may be separately and selectively attachable to the connector.

[0300] In one embodiment, the attachment arrangement comprises an opening, clip or recess, hi one embodiment, the attachment arrangement comprises a C-shaped or U-shaped clip.

[0301] According to one embodiment, the mounting arrangement is configured to be attached to a rigid portion of the gas delivery conduit.

[0302] In one embodiment, the attachment arrangement is configured to attach to a rigid connector located between the gas delivery tube and the collapsible portion.

[0303] In one embodiment, a gripping portion extends from the connector and is configured to allow a pulling force to be applied with the fingers away from the patient's face.

[0304] In one embodiment, the gripping portion comprises a hook, loop, ring or strap.

[0305] In one embodiment, the gripping portion comprises a rigid hook or ring.

[0306] In one embodiment, the grip portion includes a flexible finger loop or finger strap.

[0307] The fitting of any one of the foregoing aspects of the embodiments of the present disclosure may be formed of at least one of a thermoplastic elastomer, a thermoset or thermoplastic elastomer, or a metal. The fitting may be formed of titanium, steel, copper, or Nitinol. The fitting may be formed of other metallic materials, polymers, or ceramics. The fitting may be formed of polyethylene.

[0308] It will be appreciated that the force required to achieve a sufficient or desired level of collapse of the collapsible portion may vary depending on a variety of factors, such as the resiliency of the collapsible portion and the breathing gas pressure passing through the collapsible portion. However, according to certain embodiments, the collapsible portion is collapsible when subjected to a collapsible force of greater than 5 N, and more particularly, greater than 7 N. In other embodiments, the collapsible portion is collapsible when subjected to a minimum collapsible force of between 5 N and 30 N.

[0309] The attachment in the preceding discussion may be configured for use with a patient mask, such as a bag mask. The attachment may be configured to cooperate with the patient mask when overlaid over a collapsible portion or portion of the attachment. The attachment may be configured to cooperate with the mask, such that the mask seals over the attachment and the patient interface to form a seal with the patient's face.

[0310] According to one embodiment, the attachment is configured to amplify, concentrate or increase the crushing load applied by the cuff of the patient mask.

[0311] In one embodiment, the attachment is operable to form a tortuous flow path in the collapsible portion.

[0312] In one embodiment, the attachment is operable to increase flow resistance in the collapsible portion.

[0313] According to one aspect of the present disclosure, there is provided a breathing system including an accessory as discussed in any of the above aspects or embodiments.

[0314] According to another aspect of the present disclosure, there is provided a patient interface including an accessory as discussed in any of the preceding aspects or embodiments.

[0315] In one embodiment, the patient interface includes a gas delivery conduit for delivering respiratory gas to a patient, the gas delivery conduit including a collapsible portion configured to restrict or prevent flow through the collapsible portion when a collapsible force is applied to the collapsible portion.

[0316] In one embodiment of the patient interface, the collapsible portion includes a portion of a conduit formed of a resilient material and is configured to collapse under a collapsible force applied from an overlying mask across the collapsible portion. The patient interface may include an attachment according to any one of the aspects or embodiments described above.

[0317] In one embodiment, the patient interface includes a nasal cannula. The nasal cannula may include a non-sealing nasal cannula. The nasal cannula may include a cannula body and prongs extending from the cannula body and configured to deliver respiratory gas to the patient's nares.

[0318] According to another aspect of the present disclosure, there is provided a breathing system configured to deliver breathing gas to a patient via a gas delivery conduit including a collapsible portion, the system comprising a breathing gas flow source, a patient interface including a gas delivery conduit having a collapsible portion, and an accessory configured to reduce a flow rate of breathing gas through the collapsible portion below a threshold flow rate.

[0319] In one embodiment, the breathing system further comprises a humidifier.

[0320] In one embodiment, the breathing system includes a heated inhalation tube.

[0321] In one embodiment, the accessory of the breathing system is configured to reduce the flow of breathing gas in response to a collapsing force being applied to the accessory and / or to the collapsible portion.

[0322] In one embodiment, the breathing system is configured to provide a flow of breathing gas at a rate of at least 20 L / min. In one embodiment, the breathing system is configured to provide a flow of breathing gas at a rate of between 20 and 90 L / min. In one embodiment, the breathing system is configured to provide a flow of breathing gas at a rate of between 40 and 70 L / min.

[0323] In one embodiment of the breathing system, the accessory is configured to reduce the flow rate from an initial flow rate of 40-70 L / min to below a threshold flow rate. In one embodiment of the breathing system, the accessory is configured to reduce the flow rate from an initial flow rate of about 70 L / min to below a threshold flow rate. In one embodiment, the threshold flow rate is less than 10 L / min.

[0324] According to one embodiment of the breathing system, the collapsible portion is collapsible from an open configuration to a collapsed configuration, the open configuration allowing unrestricted flow of breathing gas through the collapsible portion and the collapsed configuration providing restricted flow of breathing gas through the collapsed portion.

[0325] In one embodiment of the breathing system, the unrestricted flow rate of breathing gas is in the range of 40-70 L / min and the restricted flow rate is below the threshold flow rate.

[0326] In one embodiment of the respiratory system, the accessory is provided according to any one of the aspects discussed above for the accessory embodiment for use with the patient interface.

[0327] According to another aspect of the present disclosure, there is provided a breathing system configured to deliver breathing gas to a patient via a gas delivery conduit including a collapsible portion, the system comprising a breathing gas flow source, a patient interface including a gas delivery conduit having a collapsible portion, and an accessory configured to reduce a cross-sectional area of ​​the collapsible portion by a minimum factor.

[0328] In one embodiment of the respiratory system, the accessory is configured to reduce a cross-sectional area of ​​the collapsible portion in response to a collapsing force being applied to the accessory and / or the collapsible portion.

[0329] In one embodiment of the breathing system, the attachment is configured to facilitate collapse of the collapsible portion to reduce the cross-sectional area.

[0330] In one embodiment of the breathing system, the minimum magnification is at least 90%. In an embodiment, the minimum magnification is at least 95%.

[0331] In one embodiment of the respiratory system, the respiratory system includes an accessory according to any one of the aspects or embodiments discussed above for the accessory used with the patient interface.

[0332] According to another aspect of the present disclosure, there is provided a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit including a collapsible portion, the patient interface comprising an attachment configured to facilitate collapsing of the collapsible portion when a collapsible force is applied to the attachment and / or to the collapsible portion.

[0333] In one embodiment of the patient interface, the accessory is permanently coupled to or integrally formed with the patient interface.

[0334] In one embodiment of the patient interface, the fitting is integrally formed with a portion of the gas delivery conduit.

[0335] In one embodiment of the patient interface, the accessory is removably coupled to the patient interface.In one embodiment of the patient interface, the accessory includes an attachment arrangement configured to attach the accessory to the patient interface.

[0336] In one embodiment of the patient interface, the accessories are provided according to any of the above discussed aspects or embodiments of accessories for use with the patient interface.

[0337] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein and from the figures that follow. [Brief description of the drawings]

[0338] [Figure 1] 1 shows a respiratory support system. [Diagram 2] 1 shows a patient wearing a patient interface. [Diagram 3] A patient is shown wearing a patient interface (first patient interface) and a face mask (second patient interface). [Figure 4] 1 shows a cross section of a portion of a patient interface or conduit. [Diagram 5] 1 shows the airway of a typical patient. [Figure 6] 1 shows a patient wearing a patient interface and a gas sampling interface. [Figure 7] 1 illustrates a patient interface configured to deliver device gases to a patient via a gas delivery side member that includes a collapsible portion. [Figure 8] 8 shows a cross section of a non-collapsible portion of the gas delivery side member of FIG. 7. [Figure 9] 8 shows a cross section of the collapsible portion of the gas delivery side member of FIG. 7. [Figure 10] 8 shows a cross section of the collapsible portion of the gas delivery side member of FIG. 7. [Figure 11] FIG. 1 illustrates a front perspective view of a patient interface according to one embodiment. [Figure 12] FIG. 12 is a front view of the embodiment of FIG. [Figure 13] 13 is a cross-sectional view taken along the section AA shown in FIG. 12. [Figure 14] FIG. 12 is a front view of the first embodiment patient interface of FIG. 11 shown with a seal for a patient face mask. [Figure 15] FIG. 2 is a cross-sectional view of the mask seal, patient interface and patient's face. [Figure 16] 13 is a rear perspective view of a patient interface according to an alternative embodiment. [Figure 17] 13 is a rear perspective view of a patient interface according to an alternative embodiment. [Figure 18] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 19] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 20] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 21] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 22] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 23] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 24] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Diagram 25] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 26]13 is a rear perspective view of a patient interface according to an alternative embodiment. [Figure 27] 8 is a side perspective view of the patient interface of FIG. 7, showing a cross section of the non-delivery side member. [Figure 28] 13 illustrates an alternative configuration of a conduit receiving channel provided in the non-delivery side member of the patient interface. [Figure 29] 13 illustrates an alternative configuration of a conduit receiving channel provided in the non-delivery side member of the patient interface. [Diagram 30] 13 is a rear perspective view of a patient interface according to an alternative embodiment. [Diagram 31] 13 is a rear perspective view of a patient interface according to an alternative embodiment. [Diagram 32] 13 is a cross-sectional view of a gas delivery side member of a patient interface according to an alternative embodiment. [Diagram 33] 33 shows the cross section of FIG. 32 in a collapsed configuration, with the sampling lumen remaining open. [Diagram 34] 33 shows the cross section of FIG. 32 in a collapsed configuration with the sampling lumen also in a collapsed configuration. [Diagram 35] 13 is a cross-sectional view of a gas delivery side member of a patient interface according to an alternative embodiment. [Diagram 36] 36 shows the cross section of FIG. 35 in a collapsed configuration, with the sampling lumen remaining open. [Figure 37] 35 shows the cross section of FIG. 35 in a collapsed configuration with the sampling lumen also in a collapsed configuration. [Figure 38] 13 is a cross-sectional view of a gas delivery side member of a patient interface according to an alternative embodiment. [Figure 39] A cross section of FIG. 38 is shown in a collapsed configuration, with the sampling lumen remaining open. [Diagram 40] 39 shows the cross section of FIG. 38 in a collapsed configuration with the sampling lumen also in a collapsed configuration. [Diagram 41] 13 is a cross-sectional view of a gas delivery side member of a patient interface according to an alternative embodiment. [Diagram 42]A cross section of FIG. 41 is shown in a collapsed configuration, with the sampling lumen remaining open. [Diagram 43] 42 shows the cross section of FIG. 41 in a collapsed configuration with the sampling lumen also in a collapsed configuration. [Diagram 44] 13 is a cross-sectional view of a gas delivery side member of a patient interface according to an alternative embodiment. [Diagram 45] 45 shows the cross section of FIG. 44 in a collapsed configuration, with the sampling lumen remaining open. [Diagram 46] 45 shows the cross section of FIG. 44 in a collapsed configuration with the sampling lumen also in a collapsed configuration. [Figure 47] 13 is a cross-sectional view of a gas delivery side member of a patient interface according to an alternative embodiment. [Figure 48] A cross section of FIG. 47 is shown in a collapsed configuration, with the sampling lumen remaining open. [Figure 49] 48 shows the cross section of FIG. 47 in a collapsed configuration with the sampling lumen also in a collapsed configuration. [Figure 50] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 51] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 52] FIG. 13 is a rear view of a patient interface according to an alternative embodiment. [Figure 53] FIG. 13 is a rear view of a patient interface according to an alternative embodiment. [Figure 54] FIG. 54 is a more detailed view of a portion of FIG. 53. [Figure 55] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 56] 13 is a front perspective view of a patient interface according to an alternative embodiment; FIG. [Figure 57] 57 shows the gas path connector of FIG. 56. [Figure 58] FIG. 57 is a cross-sectional view of the sampling line of FIG. 56. [Figure 59] 58 illustrates a mounting clip coupled to the gas path connector of FIG. 57. [Figure 60] FIG. 13 is a front perspective view of a patient interface according to an alternative embodiment fitted with accessories. [Figure 61] FIG. 13 is a diagram of alternative accessories for use with the patient interface. [Figure 62] 62 shows the accessory of FIG. 61 coupled to the gas path connector of FIG. 57. [Figure 63] FIG. 63 is a front perspective view of a patient interface according to an alternative embodiment, the patient interface being fitted with the accessory of FIGS. 61 and 62; [Figure 64] 13A is a rear view of an alternative accessory for use with a patient interface in one embodiment of the present disclosure; [Figure 65] FIG. 13 is a front perspective view of an alternative accessory for use with a patient interface in one embodiment of the present disclosure. [Figure 66] 1 illustrates an accessory according to one aspect of the present disclosure for use with a patient interface that includes a collapsible portion. [Figure 67] 67 shows the accessory of FIG. 66 fitted to a patient interface. [Figure 68] FIG. 8 is a side cross-sectional view of the attachment of FIGS. 6 and 7 in an uncollapsed configuration when used with a patient interface. [Figure 69] FIG. 8 is a side cross-sectional view of the accessory of FIGS. 6 and 7 in a collapsed configuration when used with a patient interface. [Figure 70] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 70A] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 71] FIG. 71 is a side cross-sectional view of the embodiment shown in FIG. 70 in an uncollapsed configuration when used with a patient interface. [Figure 72] FIG. 71 is a side cross-sectional view of the embodiment shown in FIG. 70 in a collapsed configuration when used with a patient interface. [Figure 73] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 74] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Fig. 74A] 1 shows a cross section of a collapsible conduit on a flat backing plate in an uncollapsed configuration. [Fig. 74B] 74B shows a cross-section of the collapsible conduit of FIG. 74A in a collapsed configuration. [Fig. 74C] 75 shows a cross section of a collapsible conduit when used with the attachment shown in FIG. 74 in an uncollapsed configuration. [Fig. 74D] 14D shows a cross-section of the collapsible conduit of FIG. 14C in a collapsed configuration. [Figure 75] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Fig. 75a] FIG. 76 is a perspective view of the embodiment of FIG. 75 when used with a patient interface. [Figure 76] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 77] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure, the attachment being in an open position. [Figure 78] 1 is a perspective view of an attachment according to another embodiment of the present disclosure, the attachment being in a closed position; FIG. [Figure 79] 13 is a side cross-sectional view of another embodiment attachment according to the present disclosure in an uncollapsed configuration when used with a patient interface; FIG. [Figure 80] 13 is a side cross-sectional view of another embodiment accessory according to the present disclosure in a collapsed configuration when used with a patient interface; FIG. [Figure 81] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure comprising a backing plate and a pivot member; [Figure 82] FIG. 82 is a perspective view of an alternative pivot member for use with the backing plate shown in FIG. 81; [Figure 83] FIG. 22 is a side cross-sectional view of the embodiment of FIG. 21 in an uncollapsed configuration when used with a patient interface. [Figure 84] FIG. 22 is a side cross-sectional view of the embodiment of FIG. 21 in a collapsed configuration when used with a patient interface. [Fig. 84A] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Fig. 84B] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Fig. 84C] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Fig. 84D] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 85] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 86] FIG. 86 is a perspective view of the embodiment of FIG. 85 when fitted to a patient interface. [Figure 86a] FIG. 87 is a side view of the arrangement shown in FIG. [Figure 87] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 88] FIG. 88 is a side cross-sectional view of the embodiment of FIG. 87 in an uncollapsed configuration when used with a patient interface. [Figure 89] FIG. 88 is a side cross-sectional view of the embodiment of FIG. 87 in a collapsed configuration when used with a patient interface. [Figure 90] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 91] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 92] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 93] FIG. 93 is a side cross-sectional view of the embodiment of FIG. 92 in use with a patient interface in an uncollapsed configuration. [Figure 94] FIG. 93 is a side cross-sectional view of the embodiment of FIG. 92 in use with a patient interface, in a collapsed configuration. [Figure 95] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 96] FIG. 97 is a perspective view of an embodiment of the accessory of FIG. 95 used in cooperation with the embodiment shown in FIG. 66 and in use with a patient interface. [Figure 97] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 98] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 99] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 100] FIG. 100 is a perspective view of the embodiment of FIG. 99 when fitted to a patient interface. [Figure 101] 100 is a side view of the embodiment of FIG. 99 when in use with a patient interface during application of a patient mask to the patient interface. [Figure 101a] FIG. 102 is a more detailed view of the cross section of FIG. 101 showing the cuff of the patient mask and the collapsible portion of the patient interface just before contact between the collapsible portion and the mask cuff. [Figure 101b] 101a when a pulling force is applied to the attachment and a pushing force is applied to the collapsible portion through the mask cuff. [Figure 102] FIG. 13 is a side view of an accessory including a gas path connector according to another embodiment of the present disclosure. [Figure 103] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 104] FIG. 104 is a perspective view of the embodiment of FIG. 103 when engaged in a patient interface. [Figure 105] FIG. 104 is a side view of the embodiment of FIG. 103 when used with a patient interface. [Figure 106] FIG. 13 is a perspective view of an attachment according to another embodiment of the present disclosure. [Figure 107] FIG. 107 is a perspective view of the embodiment of FIG. 106 when fitted to a patient interface. [Figure 108] FIG. 107 is a perspective view of the embodiment of FIG. 106 when fitted to a patient interface. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0339] Various embodiments are described with reference to the figures.

[0340] Throughout the figures and the specification, the same reference numbers will be used to indicate the same or similar components, and redundant descriptions thereof may be omitted.

[0341] As used herein, "high flow" or other equivalent terms refer to any gas flow at a higher than usual / normal rate, such as, without limitation, higher than the normal inspiratory flow rate of a healthy patient. Alternatively or additionally, it may be higher than some other threshold flow rate relevant to the context, for example, if a gas flow is provided to a patient at a rate that meets or exceeds the inspiratory demand, the flow rate may be considered "high flow" since it is higher than the nominal flow rate that could have been provided otherwise. Thus, "high flow" is context dependent, and what constitutes "high flow" depends on many factors, such as the health of the patient, the type of treatment / therapy / assistance being provided, the nature of the patient (large, small, adult, child), etc. A person skilled in the art will know from the context what constitutes "high flow", which is a magnitude of flow rate that exceeds the rate that could have been provided otherwise.

[0342] However, without limitation, some implied values ​​of high flow can be as follows:

[0343] In some configurations, gas delivery to the patient at a flow rate of about five or ten liters per minute (5 or 10 LPM or L / min) or greater.

[0344] In some configurations, gas is delivered to the 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 various embodiments and configurations thereof described herein, the flow rate of gas supplied or provided through the system or from a gas flow source or flow regulator to an interface may be, without limitation, at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM, or more, and a useful range may be selected from any of these values ​​(e.g., 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).

[0345] In "high flow", the gas delivered is selected depending on the intended use, for example, therapy and / or respiratory support. The gas delivered may include a percentage of oxygen. In some configurations, the percentage of oxygen in the gas 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%.

[0346] In some embodiments, the delivered gas may include a percentage of carbon dioxide. In some configurations, the percentage of carbon dioxide in the delivered gas may be greater than 0%, between about 0.3% and about 100%, between about 1% and about 100%, between about 5% and about 100%, between about 10% and about 100%, between about 20% and about 100%, between about 30% and about 100%, between about 40% and about 100%, between about 50% and about 100%, between about 60% and about 100%, between about 70% and about 100%, between about 80% and about 100%, between about 90% and about 100%, or about 100%.

[0347] The "High Flow" flow rate for premature babies / infants / children (weight range: 1 to 30 kg) may be different. The flow rate can be set to 0.4 to 8 L / min / kg, with a minimum of about 0.5 L / min and a maximum of about 70 L / min. For patients weighing less than 2 kg, the maximum flow rate can be set to 8 L / min.

[0348] High flow has been found to be effective in meeting or exceeding a patient's normal actual inspiratory flow, increasing the patient's oxygenation and / or decreasing the work of breathing. Additionally, high flow therapy and / or respiratory assistance can create a flushing effect in the nasopharynx such that the anatomical dead space in the upper airway is flushed by the incoming high flow gas stream. This can provide a reservoir of fresh gas available for every breath while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0349] By way of example, a high flow breathing system 100 is described below with reference to Figure 1. High flow can be used as a means of enhancing gas exchange and / or respiratory support through the delivery of oxygen and / or other gases and through the removal of CO2 from the patient's airways. High flow can be particularly useful before, during or after medical and / or anesthesia procedures.

[0350] When used prior to a medical procedure, a high flow rate of gas can pre-load the patient with oxygen (i.e., increase the oxygen stores in the blood) to cause the patient's blood oxygen saturation and amount of oxygen in the lungs to be higher than normal in order to provide an oxygen buffer during the patient's apneic phase during the medical procedure.

[0351] During medical procedures (such as during anesthesia), where respiratory function may be compromised (e.g., respiratory function slows down or stops), a continuous supply of oxygen is important to maintain healthy respiratory function. When this supply is compromised, conditions such as hypoxia and / or hypercarbia may result. During medical procedures such as anesthesia and / or sedation, the patient's breathing is monitored to detect a decrease or cessation of spontaneous breathing. If oxygen delivery and / or CO2 removal is compromised, the clinician stops the medical procedure and promotes oxygen delivery and / or CO2 removal. This can be accomplished, for example, by manually ventilating the patient, for example through bag mask ventilation, or by using a high-flow breathing system to provide a high flow of gas to the patient's airway. It will further be appreciated that the mask (not necessarily limited to a bag mask) used for sedation / ventilation can be used for both pre-oxygenation and monitoring patient parameters such as end-tidal CO2.

[0352] Further benefits of high flow gas streams include that the high flow gas streams increase pressure within the patient's airways, thereby providing pressure support that opens the airways, trachea, lungs / alveoli and bronchioles. Opening these structures can aid in oxygenation, aid in some degree in the removal of CO2, and / or help support patients with collapsed areas of the lung.

[0353] A high flow gas stream, when humidified, can also prevent airway drying, mitigate mucociliary damage, reduce the risk of infection, and reduce the risk of laryngospasm and the risks associated with a dry airway, such as nosebleeds, aspiration (as a result of nosebleeds), and airway obstruction, swelling, and bleeding. Another advantage of a high flow gas stream is that the stream can remove smoke generated in the airway during surgery. For example, smoke can be generated by lasers and / or cauterizing devices.

[0354] FIG. 1 illustrates a respiratory assistance system 100. The system 100 may be configured to provide high-flow respiratory assistance and / or high-flow therapy. The respiratory assistance system 100 includes a flow generator 102. The flow generator 102 is configured to generate a gas flow that passes through the respiratory assistance system 100. The flow generator 102 passes air to a humidifier 104. The humidifier 104 is configured to heat and humidify the gas flow generated by the flow generator 102. In some configurations, the flow generator 102 includes a blower that is adapted to receive gas from an environment external to the respiratory assistance system 100 and to propel the gas through the respiratory assistance system 100. In some configurations, the flow generator 102 may include some other gas generation means. For example, in some configurations, the flow generator 102 may include a source (e.g., oxygen or air) available from a gas outlet of the hospital, 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 gas exits the one or more containers. As another example, in some configurations, the flow generator 102 may include an oxygen concentrator. In some configurations, the flow generator 102 may be adapted to provide high-flow respiratory assistance and / or high-flow therapy. In some embodiments, the gas flow source may include a compressed gas source, a device that varies the flow rate from the compressed gas source, and / or a flow generator that generates the gas flow.

[0355] FIG. 5 illustrates a typical human airway and includes arrows illustrating how a relatively high flow rate of gas delivered to a user can be utilized to effectively push or drive the delivered gas further or deeper into the user's airway than when the person is in a normal or typical spontaneous breathing state or when the patient's respiratory urge is reduced.

[0356] The respiratory assistance system 100 comprises a housing 106 that at least partially houses both the flow generator 102 and the humidifier 104 (e.g., the respiratory assistance system 100 may comprise an integrated flow generator / humidifier device). In other configurations, the flow generator 102 and the humidifier 104 may have separate housings. Although a hardware controller 108 is shown in electronic communication with the flow generator 102 and the humidifier 104, in some configurations the hardware controller 108 may only be in communication with the flow generator 102 or the humidifier 104. The hardware controller 108 may include a microcontroller or other architecture configured to direct the operation of controllable components of the respiratory assistance system 100, including but not limited to the flow generator 102 and / or the humidifier 104.

[0357] An input / output module 110 is shown 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 control of controllable components of the respiratory assistance system 100, including but not limited to the flow generator 102 and / or the humidifier 104, and / or to view data regarding the operation of the respiratory assistance system 100 and / or its components. The input / output module 110 may include, for example, one or more buttons, knobs, dials, switches, levers, touch screens, speakers, displays, and / or other input or output peripherals that a user may use to view data and / or input commands to control components of the respiratory assistance system 100.

[0358] As further shown in FIG. 1, an auxiliary gas source 124 can be used to add one or more auxiliary gases to the gas flowing through the respiratory assistance system 100. The one or more auxiliary gases join the gas flow generated by the flow generator 102. The auxiliary gas source 124 can be configured to deliver one or more auxiliary gases, including, but not limited to, air, oxygen (O2), carbon dioxide (CO2), nitrogen (N2), nitrous oxide (NO), anaesthetics, and / or heliox (a mixture of helium and oxygen). The auxiliary gas source 124 can deliver one or more auxiliary gases to or towards the flow generator 102 via a first auxiliary gas conduit 128 and / or can deliver one or more auxiliary gases to a location in the flow path between the flow generator 102 and the humidifier 104 via a second auxiliary gas conduit 132. One or more auxiliary flow valves 126, 130 may be used to control the rate at which the one or more auxiliary gases may flow from the auxiliary gas source 124 through the first and / or second auxiliary gas conduits 128, 132. One or more of the auxiliary flow valves 126, 130 may be in electronic communication with the controller 108, which may control the operation and / or state of the one or more auxiliary flow valves 126, 130. In other configurations, the auxiliary gas source 124 may be configured to add one or more auxiliary gases downstream of the humidifier 104.

[0359] As shown in FIG. 1, a conduit 112 extending from the humidifier 104 connects the humidifier 104 to a patient interface 200. The conduit 112 may include a conduit heater 114 adapted to heat gas 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 disposed between the conduit 112 and the patient interface 200. Although the patient interface 200 is shown to be a nasal cannula, it should be understood that in some configurations, other patient interfaces may be suitable. For example, in some configurations, the patient interface 200 may include a sealing or non-sealing interface and may include a nasal mask, an oral mask, an oral-nasal mask, a full face mask, a nasal pillow mask, a nasal cannula, an endotracheal tube, a tracheotomy tube, a combination of the above, or some other gas delivery system. In one embodiment, the patient interface 200 is a non-sealing interface, such as a nasal cannula, which allows gas to be exchanged with the environment. For example, a non-sealing cannula allows carbon dioxide to be removed and / or purged from the patient's airway while the patient receives a flow of gas from the system 100. Additionally, in some embodiments, the patient interface 200 is in the form of a nasal interface, preventing the system from interfering with other oral airway equipment and / or devices, such as a tracheal tube in an intubation procedure.

[0360] Thus, the patient can 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 the user's mouth. An oral interface may be preferred in situations involving medical procedures through the nose so as not to interfere with nasal airway instruments and / or devices, for example, tracheal tubes used in nasal intubation procedures. In other embodiments, the interface may be suitable for both nasal and oral placement, or may be adapted between nasal and oral configurations.

[0361] As shown, in some configurations, the patient interface 200 may also include a gas sensing module 120 adapted to measure the properties of the gas passing through the patient interface 200. The gas sensing module 120 may be located elsewhere in the gas delivery system, for example, in a respiratory conduit or a humidifier. In some embodiments, there may be one or more gas sensing modules 120. In other configurations, the gas sensing module 120 may be positioned and adapted to measure the properties of the gas at or near other parts of the respiratory assistance system 100. The gas sensing module 120 may include one or more sensors adapted to measure various properties of the gas, including, but not limited to, pressure, flow, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration (e.g., to determine end tidal CO2), and / or nitrogen concentration. The gas properties determined by the gas sensing module 120 may be utilized in many ways, including, but not limited to, closed loop control of the parameters of the gas. For example, in some configurations, flow data acquired by the gas detection module 120 can be used to determine an instantaneous flow rate, which can be further used to determine the patient's breathing cycle to facilitate delivery of a flow rate synchronized with portions of the breathing cycle. The gas detection module 120 can communicate with the controller 108 via a first transmission line 122. In some configurations, the first transmission line 122 can include a data communication connection adapted to transmit a data signal. The data communication connection can include 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 can be communicated over the same first transmission line 122. For example, the gas detection module 120 can include a modulator that can allow a data signal to be "superimposed" on the power signal. The data signal can be superimposed on the power signal, and the combined signal can be demodulated before being used by the controller 108.In other configurations, the first transmission line 122 may include an air communication connection adapted to deliver a flow of gas for analysis in a portion of the respiratory assistance system 100 .

[0362] 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 the patient's health, including, but not limited to, heart rate, EEG signals, EKG / ECG signals, inertial sensors attached to the patient (e.g., on the chest) to detect movement, blood oxygen level (e.g., via a pulse oximeter), blood CO2 level, transcutaneous CO2 (TcCO2), and / or blood glucose. Similarly, the physiological sensor module 121 may communicate with the controller 108 via a second transmission line 123. The second transmission line 123, like the first transmission line 122, may include a wired or wireless data communication connection and may communicate power and data in a similar manner. The physiological sensor module 121 may be used, for example, to determine the patient's blood oxygen saturation.

[0363] FIG. 2 shows a user or patient P wearing a patient interface 200, for example the patient interface 200 of the respiratory system of FIG. 1. The patient shown is an adult, but the patient may be an infant or child. In the non-limiting configuration shown, 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 gas from the respiratory assistance system 100 (e.g., via the conduit 112 shown in FIG. 1) and convey the gas to the patient P. The first gas conduit 202 may comprise a reinforcing 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 caused by the application of forces thereto. The reinforcing element 203 may include a number of structures, including, but not limited to, plastic or metallic reinforcing beads located in or on the wall of the first conduit lumen 202.

[0364] The first gas conduit 202 is in pneumatic communication with a flow manifold 206. The flow manifold 206 receives gas from the first gas conduit 202 and passes the gas 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 nostrils. Each nasal prong 208 can be shaped or angled to extend inwardly toward the nasal septum of the patient's nose. Alternatively, the first patient interface 200 can be a sealing nasal interface.

[0365] In the embodiment shown in FIG. 2, the flow manifold 206 receives flow from one lateral side of the flow manifold 206 (e.g., relative to an imaginary vertical plane that bisects the face of the patient P) and conveys the flow to each of the manifold and nasal prongs 208. In one example, the flow manifold 206 receives flow from one side of the flow manifold 206 and conveys the flow to each of the manifold and nasal prongs 208. In some embodiments, a conduit can extend from the left or right side of the manifold. In some circumstances, providing a conduit on the left side of the patient interface may be preferred for clinician access, for example, for intubation. Alternatively, a conduit extending from the right side may be preferred in procedures such as endoscopy, where the patient is typically in a left lateral position. In other configurations, the patient interface 200 may include more (e.g., three or four) or fewer (e.g., one) nasal delivery elements 208. In other configurations, each nasal delivery element 208 may have different characteristics. For example, one of the pair of nasal delivery elements 208 can be relatively long, and the other nasal delivery element 208 can be relatively short.

[0366] In some configurations, the flow manifold 206 may be configured to receive flow from two sides of the flow manifold 206 (e.g., from the "left" and "right" of the flow manifold 206, as well as the patient's right side of the flow manifold 206 as seen in FIG. 2). In some such configurations, multiple gas conduits may be used to provide air communication between the flow manifold 206 and the respiratory assistance system 100. For example, the patient interface may comprise a dual conduit, i.e., a first gas conduit 203 extending from a first side of the interface (the patient's right side in the illustrated example) and a second gas conduit extending from an opposite, second 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 the "bottom" or "top" of the flow manifold 206).

[0367] The patient interface may further comprise a mount and / or support for attaching and / or supporting the gas conduit 202 or multiple conduits to and / or on the patient's face, such as a cheek support 210. Alternatively or additionally, the patient interface may be held in place via one or more head straps or headgear.

[0368] The first gas conduit 202 of the patient interface 200 includes a first portion 204 that is configured to transition from a first configuration that allows a first level of gas to pass through the first portion 204 to a second configuration that allows a second level of gas to pass through the first portion 204.

[0369] FIG. 3 illustrates a non-limiting exemplary embodiment of a patient P wearing a patient interface 200 (first patient interface) as shown in FIG. 2 under a face mask 300 assembly (second patient interface). FIG. 3 illustrates the face mask diagrammatically as a transparent structure to illustrate the patient interface 200 under the face mask. The first patient interface 200 can be used with a first respiratory support subsystem and the second patient interface 300 can be used with a second respiratory support subsystem. In some embodiments, the first patient interface 200 and the second patient interface 300 can be used with the same respiratory support system.

[0370] The system may find advantages in selectively providing separate respiratory assistance and / or therapy to the patient using different patient interfaces, and / or in being able to stop or discontinue the provision of respiratory assistance and / or therapy from an interface, and / or to sample gases provided by the interface.

[0371] Systems and devices as described have particular application in high-flow respiratory support and / or therapy, emergency resuscitation for intubation of patients undergoing ear, nose and throat (ENT) surgery, assisting in conditioning patients in a pre-operative state prior to administration of anesthetic agents, and following extubation and during recovery.

[0372] The face mask assembly 300 may be used as or in conjunction with the second respiratory support subsystem and / or to deliver one or more substances to the patient other than the substance delivered by the cannula 200, such as anaesthetic or oxygen, or the same substance but at a different flow rate and / or pressure level. Alternatively, the face mask assembly 300 may be used to stop the provision of respiratory support and / or therapy from the first respiratory support subsystem. The face mask assembly 300 may also be adapted to measure respiratory gases, such as exhaled carbon dioxide from the patient, which measurements may be inherently affected by flow from the patient interface 200 of the first respiratory support subsystem.

[0373] 3 allows for the alternating use of two different respiratory support subsystems. Furthermore, this configuration allows the patient interface 200 to remain on the patient throughout the surgical procedure and / or until recovery (whether or not the patient continues to receive gas flow via the patient interface 200 throughout the procedure) without interfering with other clinical activities.

[0374] In the illustrated embodiment, the face mask assembly 300 includes 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 that is placed over the patient interface 200 to cover only the patient's nasal region.

[0375] As shown, the face mask 302 includes a seal area 304 adapted to seal against the patient's face. The face mask assembly 300 is connected to a second gas source, e.g., via a filter element 350 or a humidity / moisture exchanger (not shown), which supplies one or more other gases to the patient via the face mask. That is, the second gas source is preferably different from the source (e.g., auxiliary gas source 124 / flow generator 102) that supplies gas 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.

[0376] In one embodiment, the face mask assembly 300 is connected to a separate gas source or a separate breathing assistance device. For example, the breathing assistance device can be a ventilator or a CPAP or high flow breathing assistance and / or therapy device or a manual resuscitator (e.g., a handheld face mask with a bag). Alternatively or additionally, the face mask assembly 300 may be connected to a device that measures the characteristics of the breathing gas.

[0377] Alternatively, the mask assembly 300 can be connected to an anesthesia machine and anesthesia gas, or air, or oxygen, or a combination of gases can be delivered through the mask 302.

[0378] The embodiment shown in FIG. 3 allows for the delivery of gas from multiple sources via at least two different respiratory assistance modes, and further allows a physician, clinician or medical professional to quickly and easily change the type of respiratory assistance mode.

[0379] In one particular application, a patient preparing for anesthesia may be pre-oxygenated by delivering a high flow of oxygen or humidified gas or a mixture of both via a nasal cannula. In some situations, an anesthesiologist administering a patient's sedation and / or anesthesia may wish to switch between delivering gas flow from one patient interface (e.g., nasal cannula 200) and another patient interface, such as via a face mask 300.

[0380] Anesthesiologists also oxygenate patients using a mask with a bag, and in some cases, determine that using a bag mask is more beneficial when the patient's vital signs begin to decline, for example to deliver a higher pressure or to control the variation in the delivered pressure more. In some situations, medical professionals may wish to switch between different breathing systems or support modes. In a first mode, breathing assistance can be provided by a first breathing assistance system (e.g., via the patient interface 200), and in a second mode, breathing assistance can be provided by a second breathing assistance system (e.g., via the patient interface 300), with assistance from the first system being reduced or stopped. For example, the additional flow from the high flow provided by the nasal interface 200 may also change the expected behavior of the anesthesia 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 breathing system.

[0381] In some configurations, switching between two respiratory assistance modes or subsystems can be facilitated by the structure of a first gas conduit 202 having a first portion 204 configured to transition from a first configuration that allows a first level of gas to pass through the first portion 204 to a second configuration that allows a second level of gas to pass through the first portion 204.

[0382] In some configurations, the first portion 204 is more collapsible or otherwise adapted to alter the flow of gas through the first portion 204 (and thus reduce the flow of gas through the conduit to the patient) than other portions of the conduit 202, and / or is configured to allow the mask seal to seal against 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 gas from the conduit to atmosphere.

[0383] In some embodiments, the first configuration or state is a substantially open configuration and the second configuration or state is a substantially closed configuration, i.e., the conduit 202 is configured to be more collapsible, deformable, or otherwise adapted to completely block flow in the first portion 204 than in other portions of the conduit 202. In the second state, gas to the nasal delivery element 208 can be reduced or stopped.

[0384] FIG. 4 shows an example of this configuration, where the conduit in the first portion 204 (e.g., conduit 204 of nasal cannula 200 of FIG. 3) is substantially closed by seal 304 of face mask 302. In such an embodiment, the first portion of the first gas conduit (i.e., the more collapsible or deformable section) should have a length equal to or greater than the width of the section of the seal of the face mask that rests on the first portion of the first gas conduit. This allows the seal of the face mask not to rest on the non-collapsible section of the first gas conduit. For example, the first portion may extend from a distance of 35 mm or less from the center of the user's nose to at least 50 mm from the center of the user's nose. The first portion 204 may have a length of at least about 5 mm, a length of about 1 mm to about 30 mm, or a length of about 5 mm to about 15 mm, or a length of about 10 mm. In some embodiments, the length of the first portion may be at least 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm or more.

[0385] The first portion 204 can transition 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 can be applied by a seal 304 of a face mask 302. In this example, the first portion 204 is configured to be positioned below the seal 304 of the face mask 302.

[0386] Alternatively, force may be applied to first portion 204 by other means, such as a clamp (not shown), or alternatively, the physician may compress the conduit by pressing against the conduit wall with their fingers.

[0387] In some embodiments, the face mask seal acts on the first portion of the gas conduit such that the first portion forms a seal or at least a partial seal between the nasal outlet of the first patient interface 200 and the flow generator 102. Additionally, the face mask seal forms a seal or at least a partial seal over the first portion of the gas conduit.

[0388] Thus, switching of respiratory support therapy is accomplished by simply applying the mask to the patient's face, such that the mask seal collapses (partially or fully) 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 provided by the first interface 200, and also provides a seal between the face mask 300 and the outer surface of the first portion 204 of the conduit 202, allowing respiratory support and / or therapy to be provided by the mask 300 with the respiratory support and / or therapy provided by the first interface stopped or reduced. As mentioned above, the first portion 204 of the patient interface 200 is configured to be collapsible, and is hereinafter referred to as the collapsible portion 204.

[0389] A cannula with a collapsible conduit portion allows a user, e.g., an anesthesiologist or nurse or clinician, to use a mask and prevent delivery of gas from multiple sources (e.g., mask and cannula). The first interface 200 is constructed and operative to reduce or terminate the provision of high flow and other respiratory assistance and / or respiratory therapy or delivery of anesthetic gas through the mask when the interface 200 transitions to the collapsed configuration. In some embodiments, removal of the mask from the patient's face causes the conduit to return from the collapsed configuration to the open configuration, allowing the respiratory assistance and / or therapy provided by the first interface to resume.

[0390] Patient Interface Gas Sampling 6 is a schematic diagram of a patient wearing a gas delivery system with a respiratory apparatus 1000A including a nasal cannula 8040 configured to deliver gas to the patient via a gas delivery tube 8060. The gas sampling interface 100A includes a gas sampling conduit 101A, the tip 7050 of which is positioned proximate to the patient's mouth and / or nose for sampling gas exhaled and / or exhaled from the mouth.

[0391] The gas sensing module 120 shown in FIG. 1 is shown located in the manifold portion of the patient interface and in some embodiments may form part of the gas sampling interface of the present disclosure. For example, the gas sensing module 120 may be utilized to supplement data provided by a respiratory gas monitor in fluid communication with a sampling outlet of the gas sampling interface. The gas sensing module 120 may form part of the gas sampling interface and may include, for example, a flow meter in the sampling conduit. The gas sensing module 120 may include a capnography sensor in the sampling conduit or at the sampling outlet. Thus, the gas sampling interface may be configured to be used for mainstream capnography applications. In this example, the sampling outlet may vent the patient gas flow to the environment once downstream of the sensing module 120, and thus, the sampling outlet is configured to direct the patient gas flow away from the patient to allow flow through the conduit and past the sensor. The gas sensing module 120 may be connected via wired or wireless data communication to a suitable receiver that may display data collected by the sensing module 120 to a clinician.

[0392] The gas sensing module 120 may be a separate component from the gas sampling interface and may be located elsewhere in the patient interface. The gas sensing module 120 may include a gas composition sensor and may be located in or at the sampling conduit and / or in or at the sampling outlet.

[0393] Alternatively, the gas sampling interface may not include a sensor in the manifold portion and may not include any sensor at the patient. For example, the gas sampling interface may be configured such that only the sampling inlet is located at the patient and patient gas analysis occurs away from the patient, for example, at a respiratory gas monitor. Thus, the gas sampling interface may be used for side stream capnography applications. In this case, the sampling outlet may facilitate delivery of a patient gas flow from the patient toward the respiratory gas monitor. Omission of a sensor at the patient may improve ease of access to medical equipment.

[0394] In an alternative embodiment (not shown), the gas sampling interface may include a passive sampling arrangement, for example configured to sample patient gases via colorimetric analysis. In this example, the sampling conduit may be configured to deliver the patient gases to an assay of a colorimetric reagent or to another form of colorimeter configured to indicate the presence or concentration of one or more specific gases in the patient gas stream. In some configurations, the gas sampling interface may include a colorimetric analysis means in the sampling conduit or at the sampling outlet.

[0395] 7-65 illustrate various embodiments of collapsible patient interfaces and / or accessories for use with the collapsible patient interfaces configured to provide a gas sampling interface for receiving a flow of gas at a patient.

[0396] 7-10 illustrate a patient interface 400 with a nasal cannula, the patient interface 400 including a gas delivery side member 401 having a hollow interior providing a system gas flow path and configured to deliver system gases to a patient via a manifold 406 to a delivery outlet including a pair of nasal prongs 408 extending from the manifold 406. The gas 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 opposite the first side. The non-delivery side member 403 includes an end 409 configured to connect to a head strap 411.

[0397] The gas delivery side member 401 includes a collapsible portion 404 that is configured to transition from a normally open configuration, as shown in Figures 7, 9, and 10, to a collapsed configuration in which device gas flow through the collapsible portion 404 is reduced or stopped. The collapsible portion 404 is configured to transition to the collapsed configuration upon application of a collapsible force, such as from a patient's mask placed on the patient's face, where a seal of the mask is forced against the collapsed portion 404. The gas delivery side member 401 also includes a non-collapsible portion 407 that is configured to remain open during application of a collapsible force to the collapsible portion 404. The collapsible portion 404 can include or be formed from a thermoplastic elastomer. The gas delivery side member 401 can include or be formed from a thermoplastic elastomer.

[0398] One end of the non-collapsible portion 407 includes a delivery inlet 407a that receives system gas flow. The patient interface 400 further includes a gas pathway connector 413 having a rigid structure and including a delivery inlet 413a and a delivery outlet 413b. The gas pathway connector delivery inlet 413a is connectable to a system gas supply via a conduit (not shown). The gas pathway connector delivery outlet 413b is connected to the delivery outlet 407a of the non-collapsible portion 407. The gas pathway connector 413 is also connected to the head strap 411 at an end opposite that connected to the head strap end 409 of the non-delivery side member 403.

[0399] FIG. 8 shows a cross-section of the non-collapsible portion 407, which includes walls 412 of uniform thickness. FIGs. 9 and 10 show a cross-section of the collapsible portion 404, which includes walls 404a of non-uniform thickness. The collapsible portion 404 has an elongated cross-section, specifically a stadium-shaped cross-section, which includes a pair of longitudinal sides 404b extending between a pair of ends 404c. As shown in FIG. 10, each of the ends 404c is provided with a thin-walled portion 404d. The thin-walled portions 404d are configured to provide fold lines about which the collapsible portion 404 will bend or fold when a crushing force is applied.

[0400] Patient interface 400 shown in Figures 7-10 provides a reference and context for the background of Figures 11-68 which show various embodiments of patient interfaces (or portions thereof) similar to interface 400, but which also include a gas sampling interface with a sampling inlet for receiving a patient gas flow at a 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 the respiratory gas monitor used to provide patient feedback to a clinician.

[0401] In particular, Figures 11-31 show embodiments in which the gas sampling interface is provided on (or instead of) the non-delivery side member. Figures 32-60 show embodiments in which the gas sampling interface is provided on the gas delivery side member. The various embodiments of the patient interface each comprise a gas delivery side member generally equivalent to gas delivery side member 401, each including a collapsible portion configured to transition between a normally open configuration and a collapsed configuration through which system gas flow therethrough is reduced or stopped.

[0402] FIG. 11 shows a perspective view of a patient interface 500 generally similar to patient interface 400, but where the non-delivery side member 503 includes a gas sampling interface 515. The patient interface 500 includes a gas delivery interface comprising a gas delivery side member 501 including a collapsible portion. The gas delivery side member 501 is configured to deliver a system gas flow to a patient. The gas delivery interface includes a delivery outlet including nasal prongs 508 for delivering the system gas flow to a patient. The gas delivery interface further includes a gas delivery side member 501 extending from a first side of the delivery outlet and including a system gas flow path in fluid communication with the nasal prongs 508. The collapsible portion 504 is configured to transition from a normally open configuration shown in FIG. 11 to a collapsed configuration in which system gas flow through the collapsible portion 504 is reduced or terminated in order to reduce or stop system gas flow through the system gas flow path.

[0403] The gas sampling interface 515 includes a pair of spaced apart openings formed in a non-patient facing wall 516 of the non-delivery side member 503. The pair of spaced apart openings include an inlet port 517 and an outlet port 518 in fluid communication with the inlet port 517 via a sampling conduit 520 that extends inwardly through the non-delivery side member 503.

[0404] The outlet port is located towards a head strap end 509 of the non-delivery side member 503 that is configured to couple to a head strap. The inlet port 517 is positioned at or near the delivery outlet including the nasal delivery prongs 508. A sampling conduit 520 extends along the length 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 configured to fluidly connect to a respiratory gas monitor.

[0405] In one embodiment, the sampling outlet can be connected in fluid communication with a respiratory gas monitor. The respiratory gas monitor (not shown) can apply suction or pressure or vacuum through the sampling conduit 520 to draw and receive the patient gas flow for analysis. In another embodiment, the respiratory gas monitor can passively receive the patient gas flow through the sampling conduit 520, i.e., the respiratory gas monitor can receive the patient gas flow without drawing in a patient gas flow via suction or pressure or vacuum, etc.

[0406] Figure 12 provides a front view of the patient interface 500 to better illustrate 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 along section AA of Figure 12. The sampling conduit 520 has a substantially circular cross-section and is formed in the otherwise 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 contacts the patient's face in use. The patient facing wall 514 and the non-patient facing wall 516 extend between a pair of edges including an upper edge 522 and a lower edge 523.

[0407] 13, the cross-section of the non-delivery side member 503 is elongate and also asymmetric in at least one axis. The cross-section is defined by a width axis A extending through the patient-facing wall 516 and the non-patient-facing wall 514. W The cross section also includes a width axis A W A length axis A extending perpendicular toL Includes length axis A L is substantially parallel to the patient-facing wall and is also substantially parallel to the non-patient-facing wall.

[0408] The cross section of the non-delivery side member 503 is along a width axis A. W 13. In other embodiments, the cross section may be asymmetric, for example the sampling conduit 520 may be located closer to one of the upper edge 522 or the lower edge 523. As seen in FIG. 13, the sampling conduit 520 is substantially centered in the cross section such that the sampling conduit 520 is equidistant between the upper edge 522 and the lower edge 533, and also between the patient-facing wall 514 and the non-patient-facing wall 516.

[0409] The cross section of the non-delivery side member 503 is along a length axis A. L Asymmetric about the length axis A L 14 and 15. The asymmetry about the length axis A results from the patient-facing wall 514 having a greater curvature compared to the non-patient-facing wall 516 which is substantially planar. The substantially planar configuration of the non-patient-facing wall 516 can aid in providing a seal between the non-patient-facing wall 516 and a seal of a patient face mask, as will be discussed in more detail below with reference to Figures 14 and 15. In other alternative embodiments, the cross section of the non-delivery side member 503 is L The cross section of the non-delivery side member 503 may be substantially symmetrical about a length axis A. L and width axis A W The distance between the center of gravity and the center of gravity may be substantially symmetrical about both the center of gravity and the center of gravity.

[0410] 14, the inlet port 517 and the outlet port 518 are spaced apart from each other by a distance greater than or equal to a width W of the seal 304 of the face mask 302, and the face mask 302 is configured to be placed on the patient's face with the seal 304 resting on a portion of the non-delivery side member 503. In particular, the seal 304 overlies the non-patient-facing wall 516. A portion of the seal 304 of the face mask 302 rests on a portion of the gas delivery side member 501, in particular overlies the collapsible portion 504. When the face mask 302 is applied (i.e., the face mask 302 is pressed towards the patient's face), the collapsible portion transitions to a collapsed configuration in which system gas flow through the system gas flow path is reduced or stopped.

[0411] The inlet port 517 and the outlet port 518 are positioned such that the mask 302 covers only the inlet port 517. In other words, when the mask 302 is applied to the patient's face over the patient interface 500, the inlet port 517 is located within the cavity formed by the patient's face and the mask 302. A sampling device (e.g., a sampling tube with a sampling inlet) can connect to the inlet port 517 and fit within the area under the mask 302. Alternatively, the inlet port 517 may not connect to a sampling device and may itself provide a sampling inlet. The sampling lumen 520 acts as a tunnel under the mask seal 304 to provide fluid communication between the inlet port 517 and the outlet port 518, allowing a sample of the patient gas stream taken at the inlet port 517, which is also located on the patient and inside the mask 302, to be available at the outlet port 518.

[0412] 15 shows a cross section of the non-delivery side member 503 sandwiched between the mask seal 304 and the face of a patient P. The mask seal 304 is pressed against the non-patient-facing wall 516 with a force F (e.g., applied manually by the clinician or held by headgear), causing the non-delivery side member 503 to retract partially into the patient's facial surface 524 where the patient-facing wall 514 retracts below the facial surface 524. The substantially planar configuration of the non-patient-facing wall 516 is approximately aligned with the facial 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 facial surface 524 on either side of the non-delivery side member 503, which facilitates the 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 facial surface 524 and the mask seal 304 deforms around the non-delivery side members 503 so that the non-delivery side members 503 do not retract into the patient's face to the extent illustrated in FIG. 15.

[0413] As can be seen from FIG. 15, the sampling conduit 520 fits within the cross section of the non-delivery side member 503 and therefore does not contribute to any disruption of 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. Thus, the sampling conduit 520 remains open while the mask seal 304 rests on the non-delivery side member 503. In this manner, the sampling conduit 520 is configured to remain open to maintain fluid communication between the inlet port 517 and the outlet port 518 when the collapsible portion 504 transitions to a collapsed configuration. That is, the sampling conduit 520 is configured to remain open when the system gas flow through the collapsible portion 504 is reduced or stopped.

[0414] This has usability advantages. For example, it may allow a user to continue monitoring gases in a patient while the mask 302 is applied over the patient interface 500 without having to disconnect the gas sampling interface 515 from a respiratory gas monitor (e.g., a capnography device) and without reconnecting the respiratory gas monitor to another sampling interface (e.g., to a sampling port (not shown) of the mask 302). Additionally or alternatively, it may allow a user to monitor the output from a single respiratory gas monitor rather than multiple monitors connected to different sampling interfaces (e.g., the gas sampling interface 515 and the sampling port of the mask 302), which may be confusing and thereby increase the risk of erroneous or inaccurate measurements.

[0415] 16 shows an alternative embodiment of the patient interface 500, where the patient interface 600 comprises a gas delivery side member 601 including a collapsible portion 604. The patient interface 600 further comprises an inlet port 617 and an outlet port 618 located on the patient-facing wall 614 of the non-delivery side member 603. In one embodiment, the respective sampling tubes can be connected to the inlet port 617 and the outlet port 618 via, for example, a luer lock or threaded connection or a plug fit or barbed connection. In this embodiment, the sampling conduit is thus comprised of a passageway 620 extending internally through the non-delivery side member between the inlet port 617 and the outlet port 618.

[0416] 17 illustrates another alternative embodiment patient interface 700 in which the sampling conduit comprises a sampling line, specifically a sampling tube 725. In one example, the sampling conduit is part of or forms part of the sampling line. The tube 725 extends through an interior passageway 720 of the non-delivery side member 703 and extends from each of the spaced apart openings in the patient-facing wall 714, including a sampling tube inlet 717 and a sampling tube outlet 718. The portion of the tube 725 that extends from the sampling tube inlet 717 includes a sampling nasal prong 726 formed at an end of the tube 725, which provides a 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 in fluid communication with the gas delivery side member 701, including the collapsible portion 704. The portion of the tube 725 extending from the sampling tube outlet 718 may include a sampling outlet and may be configured to be in fluid communication with the respiratory gas monitor to provide fluid communication. Thus, the tube 725 can provide fluid communication between the sampling nasal prongs 726 and the respiratory gas monitor.

[0417] 18 illustrates a further alternative embodiment in which a patient interface 800 includes a gas delivery side member 801 that includes a collapsible portion 804. The patient interface 800 includes a non-delivery side member 803 of a similar configuration to the interface 500 illustrated in FIG. 11, where the non-delivery side member 803 includes a pair of spaced apart openings formed in a non-patient facing wall 816 and connected by an internal passageway 820, including a sampling line inlet 817 and a sampling line outlet 818. An inlet sampling line 825 includes a sampling device 827 and is connected to the sampling line inlet 817, for example, via a luer lock, threaded connection, plug fit, or barbed connection. An outlet sampling line 828 is connected to the sampling line outlet 818, for example, via a luer lock, threaded connection, plug fit, or barbed connection. The outlet sampling line 828 can be connected to a respiratory gas monitor (not shown).

[0418] The sampling device 827 includes a sampling inlet for the gas sampling interface. The sampling device 827 is located at the end of the inlet sampling line 825 and is configured to be positioned in front of and / or around the patient's face and / or inside the patient's mouth. The sampling device 827 may include a gas sampling tip equivalent or similar to that previously described in WO 2018 / 070885 by the applicant. In an alternative embodiment, the inlet sampling line 825 and the outlet sampling line 828 may be permanently connected to the non-delivery side member 803 and molded, for example, into the inlet 817 and the outlet 818, respectively.

[0419] Figure 19 shows a patient interface 900 that is a variation of the patient interface 800 shown in Figure 18. The patient interface 900 includes a gas delivery side member 901 that includes a collapsible portion 904. The patient interface 900 includes an inlet sampling line 925, which is a Y-piece sampler line and includes an oral line 925a and a nasal line 925b. An oral sampling device 927a is located at the end of the oral line 925a and a nasal sampling device 927b is located at the end of the nasal line 925b. Sampling at both the nose and mouth can allow for more reliable capture of patient gases in some cases, especially when it is unknown whether the patient is breathing through the nose or mouth.

[0420] 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 such that a minimal level of force is required to manipulate and reposition the sampling lines. This may prevent undesired movement of the sampling devices that may affect the intake of patient gases. The malleability of the sampling line 825 of Figure 18 may allow the sampling device 827 to be repositioned between the mouth and nose as needed and / or moved out of the way to allow access for other medical equipment. One or more of the sampling lines may be made from a variety of suitable materials, such as silicone, PVC (polyvinyl chloride), thermoplastics, etc.

[0421] FIG. 20 illustrates another alternative embodiment in which the patient interface 1000 includes a mouth sampling scoop 1032 including a scoop opening 1034 configured to be positioned in front of the patient's mouth. Patient gases exhaled from the mouth are captured by the scoop opening 1034, through the scoop 1032, through the non-delivery side member 1003, and through an internal sampling conduit 1020 that extends to a sampling outlet port 1018 configured to be in fluid communication with a respiratory gas monitor, for example, via a sampling outlet line. In this regard, the gas sampling interface includes a mouth scoop 1032 configured to capture patient gases exhaled from the patient. In an alternative embodiment (not shown), the mouth scoop 1032 is configured to be removably attached to the patient interface, and optionally to the gas delivery interface. The patient interface 1000 further comprises a gas delivery side member 1001 including a collapsible portion 1004.

[0422] The scoop 1032 has a substantially flat profile so that it can fit under a patient mask applied on top of the interface 1000. The scoop 1032 can be sized to cover a relatively small portion of the mouth to allow for exhaled gas collection but also allow space for other medical equipment. The sampling conduit 1020 extends under an interior wall 1029 that separates the scoop 1032 from the gas delivery passageway 1036 so that the sampling conduit 1020 does not interfere with the gas delivery passageway 1036 that provides gas to the nasal delivery prongs 1008. In other embodiments, the sampling conduit can extend into the gas delivery passageway 1036. The mouth scoop 1032 can be made of or formed of a soft material so that it can bend around equipment as needed. The mouth scoop 1032 can be any suitable shape to limit interference with equipment requiring access to the mouth.

[0423] FIG. 21 illustrates a patient interface 1100 that is a variation of the interface 1000 illustrated in FIG. 20. In addition to the features / structures of the interface 1000, the patient interface 1100 further includes a nasal septum sampling port 1138 for sampling the nasal patient gas flow delivered through a nasal septum sampling line 1139 extending from the junction 1140 of the sampling conduit 1120. This configuration allows for simultaneous sampling of the nose and mouth, thereby improving the reliability of sampling when it is unknown from which location the patient is breathing. In certain embodiments, the nasal septum port 1138 receives the nasal gas flow directly from the patient. In another embodiment, the nasal septum port 1138 can be connected to another sampling device, such as nasal sampling prongs or the malleable sampling line described above with respect to FIGS. 18 and 19. The patient interface 1100 further includes a gas delivery side member 1101 that includes a collapsible portion 1104.

[0424] 20 and 21 may also be advantageous in that the inlets 1034, 1138 are centrally positioned and substantially aligned with the patient's nose and mouth. For example, the inlets 1034, 1138 lie substantially in a common plane with the patient's nose and mouth, as well as the nasal delivery prongs 1008. Centrally locating the mouth and nose inlets 1034, 1138 may advantageously further reduce the possibility of interfering with the seal of a patient mask applied to the patient's face.

[0425] 22 shows another embodiment patient interface 1200 similar to the previous embodiment, but in which the sampling conduit 1220 connects via a Y-piece 1240 to a pair of nasal sampling prongs 1226 positioned substantially parallel alongside (and also below) the nasal delivery prongs 1208. The nasal sampling prongs may be malleable to allow for better positioning or engagement with the patient's nares. The patient interface 1200 further comprises a gas delivery side member 1201 including a collapsible portion 1204.

[0426] The patient interface 1200 may also be provided with an oral sampling scoop 1332, as shown in FIG. 23 which illustrates a patient interface 1300. The scoop 1332 may have a configuration equivalent to that described above with respect to the scoop 1032 of FIG. The patient interface 1300 thus includes a sampling conduit 1320 which may sample the patient gas stream from each of the patient's nares via a pair of nasal prongs 1326, and from the patient's mouth via the oral scoop 1332 and its opening 1334. The patient interface 1200 thus provides sampling inlets including both a nasal inlet via the nasal prongs 1326 and an oral inlet via the oral scoop 1032. The patient interface 1300 further includes a gas delivery side member 1301 which includes a collapsible portion 1304.

[0427] FIG. 24 shows a further embodiment of the patient interface 1400 in which the nasal sampling prongs 1426 extend through the nasal delivery prongs 1408. The nasal sampling prongs 1426 are generally concentric with the nasal delivery prongs 1408. Although the nasal sampling prongs 1426 are shown terminating at approximately the same point as the nasal delivery prongs 1408, they can extend beyond the end of the nasal delivery prongs, as illustrated in an alternative embodiment later in FIG. 51. In other embodiments, the nasal sampling prongs can extend through the nasal delivery prongs, but not centrally or concentrically. For example, the nasal sampling prongs can be attached to the inner surface of the nasal delivery prongs, and thus offset from the center of the nasal delivery prongs. The patient interface 1400 further comprises a gas delivery side member 1401 including a collapsible portion 1404.

[0428] FIG. 25 shows an alternative patient interface 1500 in which the non-delivery side member and sampling conduit are provided by a sampling tube 1503 having a nasal prong 1526 at one end providing a sampling inlet 1517 and an opening at the opposite end providing a 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 can be connected to a head strap (not shown). The sampling tube 1503 can be removably or non-removably connected to the manifold 1506 and / or to the nasal delivery prong 1508. In the illustrated embodiment provided by FIG. 25, the nasal sampling prong 1526 is molded to the manifold 1506 as well as to the nasal delivery prong 1508. The patient interface 1500 further comprises a gas delivery side member 1501 including a collapsible portion 1504.

[0429] 26 shows a variation of the patient interface 1500, where the patient interface 1600 includes a pair of nasal sampling prongs 1626 attached (e.g., via molding, adhesive, etc.) to nasal delivery prongs 1608. The nasal sampling prongs include a sampling inlet 1617 in fluid communication with a sampling outlet port 1618 positioned on the patient-facing surface 1614 of the non-delivery side member 1603 and configured to be connected to a respiratory gas monitor via an outlet tube or the like. The patient interface 1600 further includes a gas delivery side member 1601 including a collapsible portion 1604.

[0430] Figure 27 provides a side perspective view of the patient interface 400 previously shown in Figure 7 with the non-delivery side member 403 cut away to reveal cross section 421. Cross section 421 is similar to that described above with reference to Figure 15, and in particular is asymmetric, having a curved patient-facing wall 414 and a non-patient-facing wall 416 that is less curved and substantially planar.

[0431] FIG. 27 provides a background reference for FIGS. 28-31, which show various embodiments of non-delivery side members that are provided with channels configured to receive sampling conduits.

[0432] FIG. 28 shows a cross section 1721 of the non-delivery side member 1703 with a channel 1742 in the non-patient facing wall 1716. The channel 1742 is substantially circular and configured with a diameter to receive and retain a tubular sampling conduit 1720. The conduit 1720 is retained within the channel 1742 (e.g., via a snap-fit ​​arrangement), such that the sampling conduit and / or channel 1742 are flexibly resilient such that slight elastic deformation of the conduit 1720 and / or channel 1742 retains the conduit 1720 within the channel 1742. In configurations where the sampling conduit 1720 has a non-circular cross section, the channel 1742, or a portion thereof, can have a cross-sectional shape that matches the cross-sectional shape of the sampling conduit 1720 for receiving and optionally retaining the sampling conduit 1720. In other configurations, the channel may be shallower than those illustrated in FIGS. 28 and 29 and may include a circular or curved cross section less than 180° in circumference. In some configurations, the conduit 1720 is retained within the channel 1742 by a retention mechanism, such as an adhesive, a hook-and-loop arrangement, or the like.

[0433] The channel 1742 may be deep enough to receive most or all of the diameter of the conduit 1720 and such that the circumference of the non-delivery side member cross section 1721 does not substantially increase or change when the sampling conduit is fitted within the channel 1742. This may advantageously minimize disruption of the mask seal when placed on top of the patient interface.

[0434] FIG. 29 provides an alternative configuration in which the channel 1842 is located in the patient-facing wall 1814 such that the conduit 1820 is located in the patient-facing wall 1814 instead of the non-patient-facing wall 1716 as in FIG.

[0435] Figure 30 provides a rear perspective view of a patient interface 1800 having a non-delivery side member 1803 having the cross-section shown in Figure 29. Figure 30 shows a channel 1842 formed in the patient-facing wall 1814 and extending along the length of the non-delivery side member between a sampling inlet end 1817 adjacent the delivery outlet 1808 and a sampling outlet end 1818 adjacent the head strap end 1809 of the non-delivery side member 1803.

[0436] A variation of the patient interface 1800 is shown in Figure 31 where the patient interface 1900 includes a non-delivery side member 1903 having a sampling conduit exit aperture 1918 and a sampling conduit entrance aperture 1917. The entrance aperture 1917 and the exit aperture 1918 are provided at opposite ends of a channel 1942 into which the sampling conduit is inserted to securely hold the sampling conduit in place. The entrance aperture 1917 and the exit aperture 1918 extend through a portion of the non-delivery side arm 1903 to effectively provide a connecting loop into which the sampling conduit is inserted to allow further fixation of the conduit within the channel 1942. The patient interface 1800 further comprises a gas delivery side member 1801 including a collapsible portion 1804.

[0437] The embodiment illustrated in Figures 11-31 shows a configuration in which the sampling conduit is configured to remain open during application of a collapsing force to the patient interface that causes the collapsible portion to transition to the collapsed configuration. This has usability advantages. For example, this may allow a user to continue monitoring gases in a patient while the mask 302 is applied over the patient interface 500 without having to disconnect the gas sampling interface 515 from a respiratory gas monitor (e.g., a capnography device) and without reconnecting the respiratory gas monitor to another sampling interface (e.g., to a sampling port (not shown) of the mask 302). Additionally or alternatively, this may allow a user to monitor the output from a single respiratory gas monitor rather than multiple monitors connected to different sampling interfaces (e.g., the gas sampling interface 515 and the sampling port of the mask 302), which may be confusing and thereby increase the risk of erroneous or inaccurate measurements. For example, the sampling conduits shown in Figures 11-24 and 26 can be configured to remain open by being located inside a non-delivery side member that may be sufficiently resistant to deformation so as not to allow for collapse of the internal sampling conduit during application of a crushing force. These sampling conduits may be less collapsible than the collapsible portion of the patient interface. The sampling conduits may include internal reinforcement or support portions configured to prevent deformation, restriction or closure of the sampling conduit upon application of a crushing force. The sampling conduits may have thicker walls along a common plane or cross section than the collapsible portion of the patient interface. The sampling conduits may have walls of uniform thickness along a common plane or cross section, and the collapsible portion may have walls of non-uniform thickness. The sampling conduit illustrated in Figure 25 is itself a non-delivery side member, where the sampling tube 1503 may have a sufficiently rigid configuration (e.g., provided by the material or shape of the tube 1503) to remain open upon application of a crushing force.Similarly, the sampling conduits illustrated in Figures 28-31 may be only partially surrounded and protected by the non-delivery side members, and therefore may have a configuration (e.g., in material or shape or via an internal support structure) that allows the sampling line to remain open when a crushing force is applied.

[0438] The previous description of Figures 11-31 relates to embodiments of the present disclosure in which the gas sampling interface is provided on (or instead of) the non-delivery side member 403. The following description of Figures 32-65 relates to embodiments in which the gas sampling interface is provided on the gas delivery side member 401 (shown in Figure 7).

[0439] Figures 32-49 show cross-sectional views of various configurations in which a sampling conduit is provided in a gas delivery side member. The sampling conduit includes a sampling lumen designated "S" and the gas delivery side member includes a gas delivery lumen designated "G". The cross-sections shown in Figures 32-49 are of the collapsible portion 404 of the gas delivery side member 401.

[0440] 32, 35, 38, 41, 44, and 47 show a normally open configuration of the collapsible portion, in which both the gas delivery lumen G and the sampling lumen S are open. Each of these figures also shows an embodiment in which the gas delivery lumen G and the sampling lumen S have parallel longitudinal axes. FIGS. 33, 36, 39, 42, 45, and 48 show the collapsible portion in a collapsed configuration, in which the sampling lumen is configured to remain open. Thus, in these configurations, continuous sampling of patient gases through the sampling lumen is possible even during the reduction or cessation of gas flow through the gas delivery lumen by the collapsible portion transitioning to the collapsed configuration. This has the advantage of usability. For example, this may allow a user to continue monitoring gas in a patient without having to disconnect the gas sampling interface from the respiratory gas monitor (e.g., a capnography device) when the collapsible portion is in the collapsed configuration (e.g., when the mask is placed over the patient interface) and without reconnecting the respiratory gas monitor to another sampling interface (e.g., to a sampling port (not shown) of the mask 302). Additionally or alternatively, this may allow a user to monitor the output from a single respiratory gas monitor rather than multiple monitors connected to different sampling interfaces (e.g., the gas sampling interface and the sampling port of the mask), which may be confusing and thereby increase the risk of erroneous or inaccurate measurements.

[0441] 34, 37, 40, 43, 46, 49 show alternative embodiments in which the collapsible portion is in a collapsed configuration and the sampling lumen is also configured to be closed. It is envisioned that these configurations may be used when sampling is not required when the collapsible portion transitions to the collapsed configuration. For example, when a patient mask including its own patient gas sampling system is applied to the patient's face, it may be desirable for the sampling lumen S to be closed to prevent gas leakage from inside the patient mask. For example, in certain circumstances, some system flow delivery devices may interpret sampled patient gas removed from the system through the sampling conduit as a "leak," thereby triggering an alarm. This scenario is more likely to occur when a relatively low flow rate is delivered through the patient mask and the sampled flow rate removed through the sampling conduit constitutes a substantial portion (e.g., 20%) of the system gas flow rate delivered.

[0442] Alternative configurations in which the sampling lumen remains open or closes (i.e., alternative configurations shown in Figures 33 and 34, 36 and 37, 39 and 40, 42 and 43, 45 and 46, 48 and 49) can be achieved according to the level of crush resistance of the sampling lumen. This can be due to the stiffness of the sampling lumen. For example, in some embodiments, the sampling lumen can be surrounded by a material with higher stiffness compared to the material surrounding the gas delivery lumen. As a result, a crushing force applied to the collapsible portion (transmitted directly or indirectly to the sampling lumen) can cause the gas delivery lumen to occlude or close while the sampling lumen remains open. Alternatively, the sampling lumen can be surrounded by a material with similar or lower stiffness than the gas delivery lumen, in which case a crushing force applied to the collapsible portion can cause both lumens to close.

[0443] 32 shows a first configuration in which the sampling lumen S is incorporated within a wall 2021 of the collapsible portion 2004 of the gas delivery member. The wall 2021 surrounds the gas delivery lumen G. The wall 2021 is formed of a non-rigid material and is configured with a material and / or shape such that opposing wall portions 2021a, 2021b can move toward and towards each other when the collapsible portion 2004 transitions 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 gas delivery lumen G. The wall 2021 is enlarged at one end to accommodate the sampling lumen S therein.

[0444] Figures 33 and 34 show the collapsible portion 2004 in a collapsed configuration, where the sampling lumen G is closed by movement of the wall portions 2021a, 2021b towards and toward each other. Figure 33 shows an embodiment in which the sampling lumen S is configured to remain open while the collapsible portion 2004 is in the collapsed configuration. Figure 34 shows an alternative embodiment in which the sampling lumen S is also configured to close when the collapsible portion 2004 is in the collapsed configuration.

[0445] FIG 35 shows an embodiment in which the collapsible portion 2104 extends through a sampling lumen S and the sampling conduit includes 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. FIG 36 shows the collapsible portion 2104 in a collapsed configuration in which the gas delivery lumen G is closed but portions of the sampling lumen remain open between the outer ends of the collapsible portion 2104 and the inner ends of the sleeve 2144.

[0446] FIG. 37 illustrates an alternative embodiment to FIG. 36 in which the open configuration shown in FIG. 36 has been transitioned to a collapsed configuration in which both the sampling lumen S and the gas delivery lumen G are closed.

[0447] Figure 38 illustrates an embodiment in which the sampling lumen S and gas delivery lumen S are integrally formed within the gas delivery side member, with the sampling lumen S formed within a wall 2221 surrounding the gas delivery lumen G. The embodiment of Figure 38 is thus a variation on Figure 32, except that the sampling lumen S of Figure 38 has an elongated curved cross-section that runs alongside the longitudinal sides of the gas delivery lumen cross-section. The wall 2221 is enlarged on one side to accommodate the sampling lumen S therein.

[0448] Figure 39 shows an embodiment in which the configuration of Figure 38 transitions to a collapsed configuration to close gas delivery lumen G, but the sampling lumen remains open. Figure 40 shows an alternative embodiment in which the open configuration of Figure 38 transitions to a collapsed configuration, with both the sampling lumen S and the gas delivery lumen G being closed.

[0449] 41 illustrates an embodiment in which the sampling conduit 2320 is integrally formed with the collapsible portion 2304 such that the sampling conduit extends alongside an outer surface 2346 of the collapsible portion 2304. The collapsible portion 2304 has an elongated cross-section including a pair of longitudinal sides 2348 extending between a pair of opposing ends 2350, with the sampling conduit 2320 integrally connected to the outer surface 2346 at one of the ends 2350.

[0450] Figure 42 shows an embodiment in which the configuration of Figure 41 has transitioned to a collapsed configuration with the longitudinal sides 2348 moving towards and toward each other to close the gas delivery lumen. The sampling conduit 2320 is unaffected and the sampling lumen S remains open. Figure 43 shows an alternative embodiment in which, while the collapsible portion 2304 transitions to the collapsed configuration, the sampling conduit 2320 has also elastically deformed to the collapsed configuration and the sampling lumen is also closed.

[0451] FIG. 44 illustrates a variation of the embodiment shown in FIG. 41 in which a sampling conduit 2420 is connected to the outer surface 2446 (specifically, one of the ends 2450) via a connecting web 2452, and the sampling conduit 2420 is spaced apart from the width W CW 24. The collapsible portion 2404 is spaced apart from the collapsible portion 2404 only by a distance of 0.5 mm.

[0452] Figure 45 shows an embodiment in which the open configuration of Figure 44 transitions to a collapsed configuration, leaving the sampling conduit 2420 open. Figure 46 shows an alternative embodiment in which the sampling conduit 2420 elastically deforms to a collapsed configuration while the collapsible portion 2404 transitions to the collapsed configuration, and the sampling lumen is also closed.

[0453] 47 illustrates an embodiment in which a sampling conduit 2520 extends through the gas delivery lumen G. The sampling conduit 2520 may be free to move within the gas delivery lumen G, or alternatively may be held in place via an internal web or retaining member (not shown). The sampling conduit 2520 has a small cross-section relative to the gas delivery lumen G so as to minimize obstruction of device gas flow through the gas delivery lumen G and minimize interference with the transition of the collapsible portion 2504 to the collapsed configuration.

[0454] Figure 48 shows an embodiment in which the open configuration of Figure 47 transitions to a collapsed configuration and the sampling conduit 2520 remains open. The sampling conduit 2520 has a curved outer surface without sharp edges that facilitate wall portions 2521a and 2521b bending or folding around the sampling conduit 2520. Figure 49 shows an alternative embodiment in which the open configuration of Figure 47 transitions to a collapsed configuration and the sampling conduit 2520 elastically deforms into the collapsed configuration such that the sampling lumen is closed.

[0455] It will be appreciated that Figures 32, 38, 41 and 44 illustrate the sampling conduit (and sampling lumen) being integral with the gas delivery side member. Figures 35 and 47 illustrate the gas delivery and sampling lumen being substantially concentric and coaxial. Figures 32 and 38 illustrate an embodiment in which the gas delivery lumen G and the sampling lumen S are integrally formed within the gas delivery side member and spaced apart from one another. Figures 41 and 44 illustrate an embodiment in which the sampling conduit extends alongside the outer surface of the gas delivery side member.

[0456] FIG. 50 illustrates a patient interface 2600 in which the gas delivery side member 2601 has the cross-sectional configuration shown in FIG. 47, where a sampling conduit 2620 extends through a gas delivery lumen contained within the gas delivery side member 2601. The gas delivery side member 2601 includes a collapsible portion 2604. The sampling conduit 2620 extends between a sampling outlet including an exit port 2618 and a sampling inlet 2617 including an opening at the end of a nasal sampling prong 2626 located within the nasal delivery prong 2608. The sampling conduit 2620 is free to move within the gas delivery side member 2601 and is fixed to the gas delivery side member 2601 only at the exit port 2618. In other embodiments, the gas delivery side member 2601 includes an internal structure that supports the sampling conduit 2620 at a desired position within the gas delivery side member 2601. The nasal sampling prongs 2626 terminate in the same place as the nasal delivery prongs 2608 .

[0457] FIG. 51 illustrates a variation of a patient interface 2600, where the patient interface 2700 includes a nasal sampling prong 2726 that extends through and beyond the opening of the nasal delivery prong 2708. The patient interface 2700 includes a gas delivery side member 2701 that includes a collapsible portion 2704. The nasal sampling prong 2726 is thus configured to position the sampling inlet 2617 further into the patient's nares than the outlet of the nasal delivery prong 2708. Positioning the sampling inlet 2617 further inside the nares than the delivery outlet (i.e., the nasal delivery prong 2708) can provide a number of advantages, including minimizing dilution of the sampled patient gas. Additionally, this configuration can minimize the formation of turbulence that may in some cases limit or reduce the patient gas from entering the sampling prong 2726. Additionally, the sampling prongs 2726 may extend beyond the nasal delivery prongs 2708 to shield patient gases entering the sampling prongs 2726 from delivered system gases exiting the outlet of the nasal delivery prongs 2708 .

[0458] Figure 52 illustrates a patient interface 2800 in which the gas delivery side member 2801 has the cross-sectional configuration shown in Figure 41 and the sampling conduit 2820 is integrally formed with the gas delivery side member 2801. In particular, the sampling conduit 2820 is molded into the lower end 2850 of the gas delivery side member 2801. The sampling conduit 2820 includes a sampling inlet that includes a nasal sampling prong 2826 molded into (extending alongside) one of the nasal delivery prongs 2808. The gas delivery side member 2801 includes a collapsible portion 2804.

[0459] 53 and 54 show a variation of the patient interface 2800, where the patient interface 2900 includes a sampling conduit 2920 that is removably attached to a lower end 2950 of the gas delivery side member 2901 via an attachment clip 2954. The gas delivery side member 2901 includes a collapsible portion 2904. In another configuration (not shown), the sampling conduit can be similarly attached but located at the top of the gas delivery side member. In one example (not shown), the sampling conduit is removably attached to the patient interface at or near the manifold, with the remaining portion of the conduit being separate from but running along the same side as the gas delivery side member. This avoids wrapping multiple conduits around the patient's head, which may get in the way of other medical equipment.

[0460] The gas sampling interface may be formed of a different material than the collapsible portion. For example (with reference to FIG. 53), the sampling conduit 2920 may be formed of a different material than the collapsible portion 2904. The sampling conduit 2920 may be formed of a material having a higher material stiffness than the material of the collapsible portion 2904. In certain embodiments, the sampling conduit 2920 comprises silicone. In one embodiment, the collapsible portion 2904 comprises a thermoplastic elastomer. In one embodiment, the sampling conduit 2920 comprises silicone and the collapsible portion 2904 comprises a thermoplastic elastomer.

[0461] As illustrated in various embodiments, including FIG. 53, the sampling conduit 2920 has a width that is less than the width of the collapsible portion 2904 .

[0462] FIG. 55 illustrates a patient interface 3000 in which the gas delivery side member 3001 has the cross-sectional configuration shown in FIG. 35, where the gas delivery side member 3001 is surrounded by a sleeve 3144. The gas delivery side member 3001 includes a collapsible portion 3104 that is hidden by the sleeve 3144 in FIG. 55. The sleeve 3144 includes an outlet port 3018 configured to be connected with a respiratory gas monitor. The sleeve 3144 includes an outlet end 3058 that is sealed with the gas delivery side member 3001. The sleeve 3144 further includes a funnel portion 3056 at an inlet end 3059 of the sleeve proximate the delivery outlet 3008. The funnel portion 3056 is configured to receive a patient gas flow from the nose and / or mouth via an opening 3017 that provides a sampling inlet.

[0463] 56 shows a patient interface 3100 fitted with a ring connector 3158 including a loop 3160 that receives and secures a portion of the sampling line 3120 to the gas pathway connector 3113. The ring connector 3158 thereby secures a portion of the sampling line 3120 to the gas pathway connector 3113. The sampling line 3120 includes a sampling inlet comprised of a sampling device 3127 at a distal end of the sampling line 3120. The sampling line 3120 has a free-standing malleable configuration such that the sampling device 3127 can be repositioned as needed. For example, the sampling device 3127 can be positioned in front of the delivery outlet 3108 (i.e., non-patient side) to receive a patient gas flow from the patient's mouth and / or nose.

[0464] 57 shows a gas pathway connector 3113 that includes a threaded portion 3162 that connects to a gas supply tube that provides the device gas supply. The gas pathway connector 3113 also includes a flange 3164 that connects to a head strap. A ring connector 3158 is configured to fit over the threaded portion 3162 (and preferably over the gas supply tube connected to the threaded portion 3162) to removably attach the sampling line 3120 to the gas pathway connector 3113. The ring connector 3158 can include locating features (e.g., ribs) that resist axial movement relative to the gas pathway connector 3113 and the gas supply tube when connected.

[0465] 58 shows a cross-sectional view of a sampling line 3120 that includes a flexible resilient wire 3166 incorporated therein to provide the sampling line 3120 with a self-supporting malleable function. The sampling line 3120 includes a sampling lumen S. The flexible resilient wire 3166 is provided in a lumen separate from the sampling lumen S. Both the sampling line 3120 and the sampling lumen S have an elongated cross-section, and in particular an elliptical cross-section. The sampling line 3120 is relatively thin in width to allow a patient's face mask to be placed over the sampling line 3120 and to minimize disruption to the face mask seal.

[0466] 59 illustrates an attachment ring 6140, which was shown prior to Applicant's previous patent publication, WO2018070885, and which is also suitable for use with a patient interface according to aspects of the present disclosure. The attachment ring 6140 includes a pair of resilient arms 6150 configured to connect with the gas pathway connector 3113 shown in FIG. 57. An interior region 6142 of the arms 6150 can have a contour (e.g., a protrusion) that correspondingly engages a threaded portion 3162 of the gas pathway connector 3113.

[0467] The attachment ring 6140 further comprises a pair of clips 6167 forming a hook including arms 6168 extending from the clip body 6141. The clips 6167 provide a recessed receiving area 6170 into which a portion of the gas sampling conduit 6120 is received and retained. The gas sampling conduit 6120 is threaded through the receiving area 6170 as shown in FIG. 59 and secured in place via a snap fit connection.

[0468] FIG. 60 illustrates a patient interface 3200 in which the gas delivery side member 3201 is fitted with an attachment including a ring 3258 configured to facilitate the transition of the collapsible portion 3204 to a collapsed configuration upon application of a collapsing force. As shown, the ring 3258 is fitted around the collapsible portion 3204. A previous embodiment of a similar attachment intended to facilitate the collapse of the collapsible portion is disclosed in applicant's International Patent Application PCT / IB2019 / 051137 (WO2019159063). FIGS. 25A-25F of that disclosure show a ring 215 configured to extend around the conduit and configured to tilt or rotate when a force is applied to the ring 215 to pinch or twist the conduit.

[0469] The ring 3258 shown in FIG. 60 of the present disclosure may have a generally equivalent configuration (and function similarly to) the ring 215 disclosed in International Patent Application PCT / IB2019 / 051137 (WO2019159063). However, the ring 3258 further includes an attachment loop 3260 for attachment to the sampling conduit 3220. Thus, the ring 3258 may perform a dual function of facilitating the transition of the collapsible portion to the collapsed configuration and also acting as a conduit connector. Application of a face mask over the patient interface may force the ring 3258 to roll and seal the collapsible portion 3204. The ring 3258 may be small enough to minimize any disruption to the seal of the patient's face mask.

[0470] FIG. 61 illustrates an attachment 3358 configured to attach to a patient interface, such as the patient interface 400 illustrated in FIG. 7. The attachment 3358 includes a rigid member 3368 configured to extend along the patient-facing wall of the gas delivery side member 401. A contact element 3370 is provided at a distal end of the rigid member 3368, which is configured to provide a concentrated reaction force to a load applied to the collapsible portion 404 illustrated in FIG. 7. The contact element 3370 is configured to provide a reaction force to the patient-facing wall of the collapsible portion 404 in response to a crushing force (e.g., 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 localize / concentrate the reaction force to a smaller area of ​​the collapsible portion, thereby further facilitating bending or folding of the patient-facing wall and thus transitioning to the collapsed configuration.

[0471] The accessory 3358 further includes an attachment arrangement 3372 for attaching the accessory 3358 to the patient interface 400. The attachment arrangement 3372 includes an opening 3374 configured to receive and engage the head strap flange 3164 on the gas pathway connector 3113 shown in FIG. 57 (also shown in FIG. 7). An embodiment of the attachment is shown in FIG. 62, which shows the attachment arrangement 3372 attached to the gas pathway connector 3113 of FIG. 57 with the head strap flange 3164 protruding through the opening 3374. In other embodiments, attachment to the gas pathway connector can be via a C-shaped or U-shaped clip. Other forms of attachment are possible, such as adhesive, overmolding, or integrally molding the accessory with the gas pathway connector.

[0472] The contact element 3370 includes a connecting ring 3360 configured to connect with a sampling line, such as the sampling line 3220 of FIG. 60 or the sampling line 3120 of FIG.

[0473] FIG 63 shows the patient interface 400 of FIG 7 fitted with the attachment 3358. The contact element 3370 is located rearward of the collapsible portion 404 such that the ribs 3371 contact the patient-facing wall of the collapsible portion 404. The attachment arrangement 3372 is connected to the gas path connector 3113 through which system gas flow is provided to the gas delivery side member 401. The attachment ring 3360 is located above (and spaced from) the collapsible portion 404 such that a sampling line can be connected to and extend generally along and above the gas delivery side member 401 towards the delivery outlet 408.

[0474] 64 and 65 are rear and front views of an alternative attachment 3458 which is similar to the attachment 3358 shown in FIGS. 61-63 except that the attachment 3458 does not include a mounting ring 3360, but instead includes an integral sampling conduit 3420 extending internally through the attachment 3458. The sampling conduit 3420 extends between a pair of openings located at opposite ends of the attachment 3458 which include a sampling inlet 3417 in a contact element 3470 and a sampling outlet 3418 in a mounting arrangement 3472.

[0475] The sampling inlet 3417 may be configured to connect 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 molded, to the sampling device or sampling line. The sampling outlet 3418 may be configured to connect to an outlet line in fluid communication with the respiratory gas monitor, or may be integrally connected to the outlet line. The sampling conduit 3420 is formed within the rigid material of the fitting 3458 and is thus prevented from collapsing during collapse of the collapsible portion, and thus allows sampling to continue when device gas flow through the collapsible portion is reduced or stopped.

[0476] Various embodiments of the patient interface have been described above with reference to the accompanying figures. It will be appreciated that the patient interface comprises a gas delivery interface including a system gas flow path configured to provide system gas to the patient. According to certain embodiments, in a normally open configuration, the gas delivery interface is configured to allow a system gas flow rate of between about 20 L / min and about 90 L / min through the system gas flow path. By way of example, referring to the patient interface 500 shown in FIG. 11, the gas delivery side member 501 is configured to allow a system gas flow rate of between about 20 L / min and about 90 L / min through the system gas flow path in the gas delivery side member 501.

[0477] In certain embodiments, when the collapsible portion 504 is transitioned to the collapsed configuration, the patient interface 500 is configured to allow a system gas flow rate through the system gas flow path of the gas delivery member 501 that is at least 20 times greater than the patient gas flow rate through the gas sampling interface 515. For example, the flow rate through the gas sampling interface 515 (and through the sampling conduit 520) may be less than about 500 ml / min, and the flow rate through the gas delivery member 501 when the collapsible portion 504 is in the closed configuration may be less than about 10 L / min.

[0478] In certain embodiments, when the collapsible portion 504 is in the collapsed configuration, the gas delivery member 501 is configured to allow a system gas flow rate of less than about 10 L / min through the system gas flow path and the gas sampling interface 515 is configured to allow a patient gas flow rate of less than about 500 mL / min, optionally between about 40 mL / min and about 500 mL / min through the gas sampling interface 515.

[0479] It will be appreciated from the various embodiments shown that the patient interface may include a single sampling conduit. Providing only a single conduit may advantageously minimize the number of conduits associated with the patient interface.

[0480] The sampling conduit 520 of FIG. 11 (as well as the sampling conduits of various alternative embodiments shown in other figures) includes a single lumen, which is the sampling lumen for the patient gas flow. The sampling conduit 520 does not include any additional lumens other than the sampling lumen. In contrast to the embodiments shown in FIGS. 56 and 58, the sampling conduit 520 of FIG. 11 does not include a support member or support wire, and thus the sampling conduit 520 does not need or include a lumen for a support wire. Providing a single lumen (i.e., the sampling lumen) can advantageously simplify manufacturing and reduce costs.

[0481] Patient Interfaces and Their Accessories Figures 66-108 show non-limiting exemplary embodiments of an accessory for a patient interface configured to deliver respiratory gas to a patient via a gas delivery conduit that includes a collapsible portion. For example, an accessory according to one of the embodiments shown in Figures 66-108 can be used with the collapsible first portion 204 of a patient interface 200 as described above and shown in Figures 2-4.

[0482] As mentioned above, the first portion 204 of the patient interface 200 is configured to be collapsible, hereafter referred to as the collapsible portion 204. The attachment according to various embodiments is configured to facilitate or otherwise enhance or promote collapsing of the collapsible portion 204 to reduce or stop the flow of respiratory gas through the patient interface 200. In one example, the attachment according to various embodiments is configured to facilitate or otherwise enhance or promote collapsing of the collapsible portion 204 to reduce or stop the flow of respiratory gas to an outlet of the patient interface 200, such as the prongs 208. Various attachment embodiments shown in Figures 66-108 will now be considered in more detail.

[0483] Referring to FIG. 66, there is shown an accessory 3500 that includes a mounting arrangement comprising a clip 3502 and a backing plate 3504 extending from the clip 3502 .

[0484] The clip 3502 includes a flexibly resilient C-clip configured to be attached over a portion of the patient interface 200. For example, the clip 3502 can be attached to the gas conduit 202 or to a gas connector of the patient interface 200. In one embodiment, the clip interfaces with a rigid support for added stability. For example, the clip can be coupled to a rigid support of the gas connector. The clip 3502 includes a pair of flexibly resilient clip arms 3506 that are preformed with a curvature that matches the opposing curved sides 212 of the gas conduit 202, as best shown in FIG. 67.

[0485] Returning to FIG. 66, the backing plate 3504 includes a preformed curvature that conforms to the contours of the patient P's face and / or the contours of the patient interface 200. The backing plate 3504 includes an elongated straight portion 3508 and a curved portion 3510 between the clip 3502 and the straight portion 3508. In some embodiments, the straight portion 3508 is substantially planar. The straight portion 3508 includes a rigid contact surface 3512 configured to face the gas conduit 202 in use. The straight portion 3508 includes a patient-facing surface 3514 opposite the contact surface 3512 of the backing plate 3504, which is best seen in FIG.

[0486] Referring to Fig. 67, a cross section of the patient interface 200 is shown showing the gas conduit 202, the collapsible portion 204 and the nasal prongs 208. The gas conduit 202 and the collapsible portion 204 have a patient-facing side 224, which may also be referred to as the "inner" side, and a non-patient-facing side 226, which may also be referred to as the "outer" side, the terms inner and outer being understood in spatial relationship to the patient's face. Fig. 67 is a perspective view looking towards the patient-facing side 224. The accessory 3500 is located on the patient-facing side 224 and thus, in use, is positioned between the patient's face and the collapsible portion 202.

[0487] In use, the patient-facing surface 3514 of the straight portion 3508 faces toward (and typically contacts) the patient's face. As shown in FIG. 67, the contact surface 3512 (shown in FIG. 66 and hidden in FIG. 67) faces toward and contacts the patient-facing surface of the collapsible portion 204, which is hidden in FIG. 67 behind the straight portion 3514.

[0488] The contact surface 3512 defines a contact portion of the attachment which, in use, contacts the collapsible portion 204 and provides a rigid support surface between the collapsible portion 204 and the patient's face. The contact surface 3512 facilitates collapse of the collapsible portion 204 when a collapsible force is applied to the collapsible portion 204, such as a collapsing force applied by a face mask layered over the collapsible portion 204 as shown in FIG. 3. This functionality is further described with reference to FIGS. 68 and 9, which provide side cross-sectional perspective views of the arrangement shown in FIG. 67 in both an uncollapsed (FIG. 68) and collapsed (FIG. 69) configuration.

[0489] 68 shows the collapsible portion 204 overlying the straight portion 3508 of the backing plate. The collapsible portion 204 includes a patient side 224 and a non-patient side 226 opposite the patient side 226. The patient side 224 includes a patient-facing surface 214 that generally faces toward the patient's face in use. The non-patient side 226 includes a non-patient-facing surface 216 that generally faces away from the patient's face in use.

[0490] As shown in Fig. 68, the patient-facing surface 214 overlaps and contacts the contact surface 3512 of the straight portion 3508 of the backing plate. The interior of the collapsible portion 204 defines a lumen 205 that provides a passageway for breathing gas G to flow through the gas conduit 202. Fig. 68 shows the uncollapsed configuration in which the collapsible portion is open and unobstructed, allowing a high flow rate of breathing gas G to pass through the lumen 205 in a downstream direction towards the patient.

[0491] 69, the collapsed configuration is shown whereby the seal 304 (e.g., an inflatable cuff) of the patient mask is forced down over the non-patient-facing surface 216 of the collapsible portion 204. The force F applied to the non-patient-facing surface 216 is M 3508, causing the non-patient side 226 to collapse inwardly against the backing plate 3508 and contact the patient side 224, forming an occlusion 3518 that occludes or blocks the lumen 205, thereby reducing or preventing the flow of respiratory gas G towards the patient. M 3508 of the backing plate 214. R is generated.

[0492] In some configurations, this may completely block the flow of breathing gas G towards the patient. In other configurations, a residual flow of breathing gas may remain from the upstream side 220 of the obstruction 3518 to the downstream side 222 of the obstruction 3518. If the residual flow passes through the obstruction 3518, the total flow rate through the collapsible portion 204 is still significantly reduced as compared to the uncollapsed configuration shown in FIG.

[0493] 69, the patient-facing surface of the collapsible portion 204 is supported by the contact surface 3512 and preferably does not move while the collapsible portion is collapsed. In this manner, the contact surface 3512 provides a rigid support surface against which the non-patient-facing surface 216 presses when the force of the mask seal 304 is applied to the collapsible portion 204. The backing plate 3508 thereby facilitates the collapse of the collapsible portion 204 insofar as it provides an abutment against which the collapsible portion 204, or a portion thereof, is compressed, thereby causing the collapsible portion 204 to deform into the collapsed configuration shown in FIG.

[0494] Thus, the attachment 3500 shown in Figures 66 and 67, and operatively in Figures 68 and 69, provides a rigid support surface at an appropriate location along the patient interface, rearward of the collapsible portion 204, to facilitate collapse of the collapsible portion. Mwhich cooperates with the reaction force F to cause the collapse of the crushable portion 204. R The collapsible portion can be positioned in a desired collapsed position to provide

[0495] 70, an alternative embodiment of an attachment 3600 configured to be positioned between a patient's face and the collapsible portion 204 of the patient interface 200 is illustrated. The attachment 3600 includes a patient-facing surface 3614 that faces toward and / or contacts the patient's face in use. The attachment 3600 includes a non-patient-facing surface 3616 that faces away from or outwardly from the patient's face in use.

[0496] The attachment 3600 includes a C-shaped clip 3602 equivalent to the clip 3502 of the previous embodiment. The clip 3602 includes a pair of resilient clip arms 3606 that extend away from the patient's face in use. The clip 3602 allows for releasable attachment of the attachment 3600 to the patient interface 200. The attachment 3600 includes a support member 3604 that extends between the clip 3602 and a contact element 3616. The contact element 3620 has an elongated profile that is oriented generally perpendicular to the support member 3604. The contact element includes a flat base 3622 that defines a portion of the patient-facing surface 3614. Located on the contact portion 3620 opposite the flat base 3622 is a tapered rib 3618. The tapered rib 3618 extends in a non-patient-facing direction and extends outward from the patient's face in use. In certain embodiments, the ribs need not necessarily be tapered, but may have a non-tapered configuration, such as a generally flat contact surface.

[0497] The support member 3604 comprises an elongated rod having a preformed curvature to conform the support member 3604 to the contours of the patient's face and / or the gas delivery conduit 202 shown in FIGS.

[0498] FIG. 70A shows an accessory 3600A that includes a modification of the accessory 3600 shown in FIG. 70. The accessory 3600A includes a contact element 3620A that has a wider, flatter configuration compared to the contact element 3620. The wider contact element 3620A includes a rib 3618A and a base 3622A that are larger in width compared to the base 3622 of FIG. 70. The rib 3618A is less tapered compared to the rib 3618, and thus the surface 3619A that intersects at the top of the rib 3618A defines a larger angle with the base 3622A compared to the surface 3619 with the base 3622 of FIG. 70. The increased width of the contact element 3620A provides a larger contact surface 3619A (compared to the contact surface 3619 of FIG. 70) on either side of the rib 3618A that contacts the patient-facing surface of the collapsible portion in use. The wider contact element 3620A of FIG. 70A contacts and applies a reaction load over a larger area of ​​the collapsible portion compared to the narrower contact element 3620 of FIG. 70. Thus, the wider contact element 3620A can apply a reaction load at a lower pressure compared to the reaction load applied to the collapsible portion by the narrower contact element 3620.

[0499] 71 shows the collapsible portion 204 overlying the contact elements 3620 such that the patient-facing surface 214 of the collapsible portion overlies and rests on the tapered edges of the ribs 3618. The edges of the ribs 3618 provide a relatively small area of ​​contact with the patient-facing surface 214 such that the interaction surface between the collapsible portion 204 and the contact elements 3620 is relatively small. This configuration concentrates the force over a small area of ​​the patient-facing surface 3614, thereby increasing the pressure applied by the attachment 3600 to the collapsible portion 204.

[0500] Fig. 71 shows the uncollapsed configuration in which the lumen 205 of the collapsible portion 204 is open, providing an unobstructed passage for breathing gas G. Referring to Fig. 72, the collapsed configuration is shown in which the inflatable mask cuff 304 is pressed against the non-patient-facing surface 216 of the collapsible portion 204 in a location generally overlapping the contact portion 3620. The applied force F of the mask cuff 304M is the reaction force F applied to the patient-facing surface 214 by the contact element 3620. R 72, which together cause the non-patient side 226 and the patient side 224 to collapse towards each other, creating an occlusion 3618 in the lumen 205 that restricts or obstructs the flow of breathing gas G. It will also be appreciated that the cross-sectional area of ​​the lumen 205 is significantly reduced in the collapsed configuration shown in FIG. 72 as compared to the uncollapsed configuration shown in FIG.

[0501] 72, the patient-facing side 224 of the collapsible portion 204 is partially collapsed or folded around the tapered rib 3618. A portion of the patient-facing side 224 is folded into a cavity 3628 between the contact element 3620 and the support arm 3604. A force F is applied from the mask cuff 304 to the non-patient side 226. M When applied, the tapered edge of the rib 3618 exerts an equal and opposite reaction force F on the patient side 224. R As shown in FIG. 72, the contact area between the mask cuff 304 and the non-patient facing surface 216 is significantly greater than the contact area between the ribs 3618 and the patient facing surface 214. As a result, the reaction force F exerted by the tapered ribs 3618 R is applied to the patient-facing surface 214 as a mask force F M The contact portion 3600 applies a pressure greater than that applied to the non-patient facing surface 216 by the clip. This configuration of the attachment 3600 thereby amplifies the external pressure applied to the collapsible portion 204 to facilitate collapse of the collapsible portion. In some embodiments, the contact portion may be adjustable relative to the clip, for example, to allow adjustment of the position of the clip relative to the collapse position along the collapsible portion 204.

[0502] As can be seen from the collapsed configurations shown in Figs. 69 and 72, the contact portions of the accessories (illustrated by contact surface 3512 of accessory 3500 in Fig. 69 and contact element 3620 of accessory 3600 in Fig. 72) are in a fixed relationship to clip 3502, 3602, respectively. The contact portions of the accessories facilitate collapse of the collapsible portion at the collapsed position when a collapsible force of mask cuff 304 is applied to collapsible portion 204. The resulting collapse of the collapsible portion occurs at the position of the contact portions such that the collapsed position can be said to be at the same position as the collapsed position. It will further be seen that since the contact portions are in a fixed relationship to the clips, the collapsed position is therefore also in a fixed relationship to the clips. As a result, the collapsed position can be adjusted by adjusting the position of the clip.

[0503] 73, an attachment 3700 according to another embodiment of the present disclosure is shown. The attachment 3700 is similar in configuration to the previously described attachment 3500 shown in FIGS. 66 and 67 in that the attachment 3700 includes a C-shaped clip 3702 and a curved backing plate 3704 extending from the clip 3702. The attachment 3700 differs from the attachment 3500 in that the backing plate 3704 of the attachment 3700 includes a plurality of ribs 3718 on its contact surface 3712. The plurality of ribs 3718 collectively define a serrated surface configured to promote and facilitate collapse of the collapsible portion 204.

[0504] The plurality of ribs 3618 are configured to concentrate forces on a plurality of separate interacting surfaces at the tips of each rib 3618. The valleys between adjacent ribs 3618 may also provide a series of cavities 3728 into which the patient side 224 of the collapsible portion 204 may collapse. This may serve to deform the lumen 205 into a tortuous or kinked path having flow resistance, thereby reducing or preventing residual flow through the collapsible portion 204 when in the collapsed configuration. The backing plate 3708 thus provides a rigid support surface that exerts a reaction force on the collapsible portion, as described above with respect to the attachment 3500. Additionally, the ribs 3718 may act to concentrate the reaction force, thereby amplifying the pressure applied to the patient-facing surface of the collapsible portion. These combined effects may then facilitate the collapse of the collapsible portion.

[0505] 74, an attachment 3800 according to another embodiment of the present disclosure is shown. Similar to the attachment 3500 and the attachment 3700 of the previous embodiment, the attachment 3800 includes a C-shaped clip 3802 with a backing plate 3804 extending from the clip 3802 and including a curved portion 3810 and a straight portion 3808 having a longitudinal axis L. The straight portion 3808 includes a contact surface 3812 configured to contact the patient-facing surface of the collapsible portion. The contact surface 3812 includes a pair of longitudinal ribs 3818 oriented parallel to the longitudinal axis L and located adjacent a pair of opposing longitudinal sides 3830 of the straight portion 3808. A saddle-shaped seat 3832 is positioned between the ribs 3818. The seat 3832 is saddle-shaped when viewed in cross section transverse to the longitudinal axis L and generally includes a central base and opposing sides extending at an angle away from the central base. The angle may be obtuse. Each of the central base and opposing sides may be planar or curved. The seat 3832 may have a concave profile when viewed in cross section transverse to the longitudinal axis L (i.e., when viewed in the direction of the longitudinal axis L). One embodiment of a saddle-shaped seat 3832 is shown in FIG. 74C.

[0506] In use, the ribs 3818 serve to position the collapsible portion 204 on the saddle 3832 such that the collapsible portion is restricted from moving in a direction perpendicular to the axis L while pressure is being applied to the non-patient side of the collapsible portion. The configuration of the ribs 3818 and the saddle 3832 thus serves to maintain the collapsible portion in a desired position on the contact surface 3812. Additionally, the ribs 3818 facilitate higher pressure being applied to the edges of the collapsible portion along the longitudinal direction. This may serve to facilitate more complete collapse of the collapsible portion (and achieve greater occlusion of the collapsible portion). In particular, this configuration may reduce or prevent the formation of residual longitudinally extending flow paths that form in one or more edge regions of the collapsible portion when in the collapsed configuration. The longitudinal orientation of the ribs 3818, and their positioning to engage opposing edge regions of the collapsible portion, may increase the pressure applied to areas of the collapsible portion where such flow paths may be most likely to form. Positioning the ribs 3818 in these locations and longitudinal orientations can facilitate higher pressure being applied to the flow passages, thereby facilitating sealing or narrowing of the flow passages, or can prevent or reduce the formation of the flow passages.

[0507] The above-mentioned advantages of the attachment 3800 are further explained with reference to FIGS. 74A-74D.

[0508] 74A provides a cross-sectional view of the collapsible portion 204 overlying a flat (planar) backing plate 3870. The applied force F A is applied to the non-patient-facing surface 216 of the collapsible portion 204 and a reaction force F applied to the patient-facing surface 214 by the backing plate 3870. R From the force arrows shown in Figure 74A, the reaction force F R It will be noted (and would otherwise be generally understood by one of ordinary skill in the art) that the reaction force F is applied to the patient facing surface 214 only where contact occurs between the patient facing surface 214 and the backing plate 3870. In some embodiments, such as that shown in FIG. RGenerally, no additional heat may be applied to the side portions 207.

[0509] 74B, this may result in the formation of residual flow paths 209 within the side portions 207 when the collapsible portion 204 is in the collapsed configuration. As shown in FIG. 74B, the flow paths 209 are located at both edge regions of the collapsible portion 204 and extend longitudinally. The flow paths 209 provide a residual path for breathing gas to pass through the collapsible portion 204 and contribute to the residual gas flow present in the collapsed configuration. The design, dimensions and / or materials of the collapsible portion may affect the formation and / or characteristics of such residual flow paths 209, for example, a collapsible portion having a constant wall thickness may form a larger residual flow path 209 compared to a collapsible portion having a wall thickness that tapers towards the edges at each of the side portions 207. A larger force F may be applied to attempt to substantially reduce the residual flow paths 209. A Although forces may be applied to the non-patient facing surface 216, such forces may result in injury and / or discomfort to the patient and / or damage to the crushable portions.

[0510] 74C, the collapsible portion 204 is shown for use with the attachment 3800 of FIG. 74. The patient-facing surface 214 is seated within a saddle-shaped seat 3832 of the attachment 3800. Compared to the arrangement of FIG. 74A, the applied force F A The reaction force F R In particular, the reaction force F R is provided to the side portion 207 at the interface 211 between the rib 3818 and the side portion 207 .

[0511] Referring to Fig. 74D, the collapsible portion 204 from Fig. 74C is shown when in a collapsed configuration. In comparison to Fig. 74B, it can be seen that the collapsible portion 204 of Fig. 74D has less or no evidence of channel formation in the side portions 207. The longitudinal ribs 3818 act to apply a reaction force F to the side portions 207.R 74D , thereby allowing for more complete collapse at the side portions 207 as compared to the collapsed configuration shown in FIG 74B . Thus, the collapsed configuration achieved by the attachment 3800 as shown in FIG 74D can, in some cases, achieve a lower level of residual flow through the collapsible portion 204 as compared to the collapsed configuration achieved by the flat backing plate 3870 as shown in FIG 74B .

[0512] The residual flow paths 209 do not necessarily occur at edge regions of the collapsible portion 204 in the collapsed configuration, but may occur anywhere along the width of the collapsed collapsible portion 204. Thus, the attachment 3800 may be configured such that the ribs 3818 may be located anywhere along the width of the seat 3832 to facilitate the collapse of such residual flow paths 209. In such cases, the seat 3832 may not be saddle-shaped, but may have a contour of other shapes.

[0513] 75, an attachment 3900 according to another embodiment of the present disclosure is shown. The attachment 3900 is similar in configuration to the attachment 3600 shown in FIG. 70 insofar as the attachment 3900 includes an attachment arrangement including a C-shaped clip 3902, a contact portion including a contact element 3920, and a curved support member 3904 extending between the clip 3902 and the contact element 3920. In contrast to the attachment 3600, the contact element 3920 includes a rectangular, flat abutment surface 3918 configured to contact the patient-facing surface of the collapsible portion. The abutment surface 3918 and the contact element 3920 each have a generally rectangular profile with a longitudinal axis generally perpendicular to the longitudinal axis of the support member 3904.

[0514] The abutment surface 3918 provides a rigid surface against which the non-patient side of the collapsible portion is compressed by an external force applied (e.g., by a patient mask cuff or by a user's hand), thereby facilitating collapse of the collapsible portion. The contact element 3920 extends in a non-patient facing direction from the support element such that a corner cavity 3928 is formed between the support member 3904 and the contact element 3920. In use, the corner cavity provides a volume for the patient side of the collapsible portion to collapse to form a tortuous or kinked flow path within the collapsible portion, thereby further reducing residual gas flow in the collapsed configuration.

[0515] 75a shows the accessory 3900 in use with the patient interface 200, where a space 3929 is formed between the patient-facing surface 214 of the collapsible portion 204 and the support member 3904. The space 3929 includes an additional volume formed between the support member 3904 and the collapsible portion 204, along with a corner cavity 3928. The space 3929 is formed in an area upstream of the contact element 3920, with respect to the flow direction of breathing gas in the gas delivery conduit. A section of the collapsible portion 204 extends between the contact element 3920 and the clip 3902 (without being supported by the accessory 3900), whereby the collapsible portion 204 is lifted or spaced away from the patient's face.

[0516] Applied force F A is applied to the non-patient-facing surface 216 of the collapsible portion 204. The contact element 3920 is A provides a pivot point about which the collapsible portion 204 may collapse when an applied force F Acan induce a double bending moment on the collapsible portion. As shown by arrows B1 and B2, the double bending includes a first bending moment B1 occurring around the contact element 3920 and a second bending moment B2 occurring around the inner edge 3911 of the curved portion 3910 of the clip 3902 and / or support member 3904. The collapsible portion can be caused to collapse, bend, or kink in at least one location (and possibly more than one location) such that the collapsible portion collapses into the space 3929. As illustrated in FIG. 75a, the contact portion 3920 can withstand the applied F. A may be offset from

[0517] 75a, it is noted that although this particular embodiment shows the contact element 3920 in contact with the patient-facing surface 214, the attachment 3900 can also be positioned such that the contact element does not contact the collapsible portion. For example, the contact element 3920 can contact a portion of the gas delivery conduit downstream of the collapsible portion. In some embodiments, the contact element 3920 can contact a portion of the gas delivery conduit upstream of the collapsible portion. In these cases, the collapsible portion may not be fully supported (at least directly) by the attachment 3900. The unsupported collapsible portion 204 may extend between supported sections of the gas delivery conduit. This arrangement may facilitate collapse of the collapsible portion, which may bend or collapse into the space 3929 due to being unsupported.

[0518] Referring to Fig. 76, an attachment 4000 according to another embodiment of the present disclosure is shown. The attachment 4000 has a similar configuration to the attachment 3500 of Fig. 66, the attachment 3700 of Fig. 73, and the attachment 700 of Fig. 74 insofar as the attachment 4000 includes a C-clip 4002 and a backing plate 4004 extending from the clip 4002. The backing plate 4004 has a preformed curved portion and a straight portion 4008. The non-patient-facing surface 4012 of the straight portion 4008 includes a contact portion including an elongated rib 4018 configured to contact the patient-facing surface of the collapsible portion. The rib 4018 has a longitudinal axis that extends parallel to the longitudinal axis of the straight portion 4008. The rib 4018 is not tapered and may have a generally hump-shaped (having a convex cross-sectional shape) with curved or undulating edges. In use, the patient side of the collapsible portion collapses over the ribs 4018. The tops of the ribs 4018 provide a rigid surface against which the non-patient side of the collapsible portion can be compressed by the applied mask cuff force.

[0519] Referring to Fig. 77, an attachment 4100 according to another embodiment of the present disclosure is shown. The attachment 4100 includes a base plate including a first lever arm 4102 positionable, in use, between the patient's face and a patient-facing surface of the collapsible portion. A second lever arm 4104 is hingedly connected to the first lever arm 4102 by a pair of identical hinge arrangements 4106 (only one of which is visible in Fig. 77). Each hinge arrangement 4106 includes a hinge pin 4108 extending from the second lever arm 4104 and received in a corresponding opening 4110 formed in a hinge portion 4112 on the first lever arm 4102.

[0520] The first lever arm 4102 and the second lever arm 4104 each include a contact portion including a rib 4118 for concentrating force on the collapsible portion. The second lever arm 4104 includes an opening 4114 configured to receive the collapsible portion such that, in use, the collapsible portion extends through the opening and is located between the first lever arm 4102 and the second lever arm 4104. In an alternative embodiment, the first lever arm 4102 includes an opening 4114 configured to receive the collapsible portion such that, in use, the collapsible portion extends through the opening and is located between the first lever arm 4102 and the second lever arm 4104.

[0521] A distal end of the second lever arm 4104 provides a force application portion 4120 for receiving a force applied from a bag mask applied to the patient's face. The force application portion includes an application surface 4122 where the second lever arm 4104 rotates about the hinge arrangement 4106 towards the first lever arm 4102 such that the collapsible portion is clamped and squeezed between the ribs 4118 of the first lever arm 4102 and the second lever arm 4104.

[0522] The rib 4118 of the second lever arm 4104 is positioned between the action surface 4122 and the hinge arrangement 4106 such that the attachment 4100 comprises a second class of lever configuration, i.e., a "nutcracker" lever configuration. Thus, the force provided to the collapsible portion at the rib 4118 is a amplification of the force applied to the action surface 4122. The degree of force amplification depends on the particular configuration of the lever arm, and in particular the distance between the action surface 4122 and the rib 4118 on the second lever arm 4104. It will be appreciated that the greater the distance between the rib 4118 on the second lever arm 4104 and the action surface 4122, the greater the degree of force amplification. For example, the degree of force amplification can be increased by positioning the rib 4118 closer to the hinge arrangement 4106 and / or increasing the length of the second lever arm 4104 such that the distance between the action surface 4122 and the rib 4118 is greater.

[0523] Referring to Fig. 78, a variation of the embodiment shown in Fig. 77 is shown. Fig. 78 shows an attachment 4200 having a similar configuration to the attachment 4100 of Fig. 77, except that the opening 4214 of the attachment 4200 is a side open opening as opposed to the enclosed opening 1014 of the attachment 4100. The side open opening 4214 is open ended at the proximal end of the second lever arm 4204 and therefore may allow the collapsible portion to extend through the opening 4214 with less obstruction when in the uncollapsed configuration. Additionally, the end open opening 4214 of the attachment 4200 allows the second lever arm to be attached to the collapsible portion without having to disconnect the patient interface to feed the collapsible portion through the opening.

[0524] The attachment 4200 also differs from the attachment 4100 in that the hinge arrangement 4206 of the attachment 4200 has an open configuration in which the hinge pin 4208 is secured by a snap fit into a pin recess 4210 formed in the hinge portion 4212. This configuration allows the second lever arm 4204 to be disconnected from the first lever arm 4202 and then reconnected by securing the hinge pin 4208 by a snap fit into the recess 4200. In use, the attachment 4200 can be attached to a gas delivery conduit by temporarily disconnecting the first lever arm 4202 and the second lever arm 4204 from each other such that the first lever arm 4202 is located between the patient's face and the patient-facing surface of the collapsible portion during operation of the patient interface. The second lever arm 4204 may then be fitted over the gas delivery conduit received in the open ended opening 4214 and then snap fit together with the first lever arm 4202 at the hinge arrangement 4206. The accessory 4200 may be coupled onto the operable patient interface and then slid along the gas delivery conduit until the collapsible portion is located between the ribs 4218. This configuration also allows the accessory to be conveniently removed from the patient interface if required.

[0525] It will be appreciated that the attachment 4100 of FIG. 77 and the attachment 4200 of FIG. 78 provide a lever configuration that can amplify the force of an applied load when the load is applied further from the hinge than the rib 4218. There may be alternative uses (or alternative configurations of the attachment) where the force is applied to the second lever arm at the same distance from the hinge as the rib. In such cases, there may be no amplification of the applied force. However, the attachment still functions as a tightening mechanism that applies force to both sides of the collapsible portion (further concentrating it on the rib). The attachment also still provides the applied force via the rib 4118 that concentrates the applied force (thereby increasing the pressure). With this configuration, the attachment still facilitates the collapse of the collapsible portion.

[0526] 79 and 80, another embodiment of the present disclosure is shown. The attachment 4300 includes a base plate 4302 and a pivot arm 4304 pivotally connected to the base plate 4302 at a pivot 4306. A collapsible portion is located between the base plate 4302 and the pivot arm 4304, and the collapsible portion 204 extends through an opening in the pivot arm 4304 that is not visible in FIGS. 79 and 80, but which may be similar or equivalent to the openings 4114 and 4214 shown in FIGS. 77 and 78.

[0527] 79, the patient-facing surface 214 of the collapsible portion 204 overlies and is in contact with the base plate 4302. The ribs 4318 rest on the non-patient-facing surface 216 of the collapsible portion 204. The resiliency of the collapsible portion is sufficient to support and maintain the pivot arms 4304 in the open configuration shown in FIG.

[0528] Referring to FIG. 80, the force F applied from the bag mask cuff 304 to the pivot arm 4304 A The action of the rib 4318 is sufficient to overcome the resilience of the collapsible portion 204 and rotate the pivot arm toward the base plate 4302 in a clockwise direction as indicated by arrow A. The rib 4318 acts to counter the applied force F of the mask cuff 304. A4304。 Concentrating the force of the applied pressure on the pivot arm 4304 to a relatively small area on the non-patient facing surface 216, thereby applying a higher pressure to the collapsible portion than would be applied to the pivot arm 4304 by the mask cuff 304. A is concentrated at rib 4318 and the crushing force F applied to crushable portion 204 C The crushing force F C is the equivalent reaction force F applied to the patient-facing surface 214 by the base plate 4302. R 80, the collapsible portion is clamped between the ribs 4318 and the base plate 4302, creating an occlusion within the collapsible portion and occluding the breathing gas path within the lumen 205.

[0529] As shown in Figure 80, the applied force F A is applied along the distal end of the pivot arm 4304. A may be a UDL load (uniformly distributed load) or an UVL load (uniformly distributed load), or may be a point load. The applied force F A is applied, on average, farther from the pivot 4306 than from the rib 4318 to the pivot 4306. Thus, the crushing force F applied by the rib C is the applied force F A It is an amplification of.

[0530] In some embodiments, the bottom plate 4302 can be provided by a backing plate of one of the above-discussed embodiments of this disclosure. Returning briefly to FIG. 73, a pair of hinge pins 3708 extend from side edges of the backing plate 3704. The hinge pins 3708 allow a pivot arm, such as the pivot arm 4304 described with reference to FIG. 79, to be coupled to the backing plate 3704 shown in FIG.

[0531] A previous embodiment of an attachment intended to facilitate collapse of a collapsible portion was disclosed in the applicant's International Patent Application PCT / IB2019 / 051137. Figures 25A-25F of that disclosure illustrate a ring 215 that extends around the conduit and is configured to tilt or rotate when a force is applied to the ring 215 to pinch or twist the conduit. This concept has been improved upon and an advantageous improvement has been developed, which is shown in Figures 81-84. Referring to Figures 81-84, an attachment 4400 according to a further embodiment of the present disclosure is shown. The attachment 4400 comprises a backing plate and a pivot member assembly. In particular, the attachment 4400 includes a backing plate 4404 similar to the attachment 3500 shown in Figure 66, but also includes a pivot member recess 4406 located on the patient-facing side 4414 of the backing plate 4404. The pivot member recess 4406 is configured to receive and engage the pivot member to allow pivoting of the pivot member relative to the backing plate 4404. The pivot member may be engageable with the pivot member recess 4406 via a snap-fit ​​connection. The pivot member may also be engageable with the pivot member recess 4406 via a one-time or removable connection.

[0532] 81 , the pivot member includes a pivot ring 4430 configured to seat within the ring recess 4406. The pivot ring 4430 includes a central opening 4415 configured with the collapsible portion extending therethrough. The pivot ring 4430 includes a pair of semi-circular sections 4432 connected by a pair of straight sections 4434.

[0533] FIG. 82 includes an alternative pivot member including a pivot arm 4480 in place of the pivot ring 4430, which may also be used with the backing plate 4404 of the attachment 4400. The pivot arm 4480 includes a pair of side members 4482 extending between a pair of cylindrical bars 4484. The bars 4484 are spaced apart by the length of the side members 4482. The pivot arm 4480 includes a central opening 4486.

[0534] Figures 83 and 84 illustrate the operation of the assembly shown in Figure 81 with the backing plate 4404 and pivot ring 4430. As shown in Figure 83, the collapsible portion 204 extends through the opening 4415 with the patient side 224 of the collapsible portion 204 overlying the backing plate 4404. The patient side 4432 of the pivot ring 4430 is received in and pivotally engaged with the recess 4406 to allow pivoting of the pivot ring 4430 relative to the backing plate 4404. Figure 83 illustrates the uncollapsed configuration with the non-patient side 4434 of the pivot ring 4430 resting on the non-patient side 226 of the collapsible portion.

[0535] 84 shows the collapsed configuration in which the mask cuff 304 is pressed down onto the non-patient side 4434 of the pivot ring 4430 causing a counter-clockwise rotation (from the perspective of FIGS. 82 and 84 ) of the pivot ring 4430 towards the backing plate 4404, causing a collapse of the non-patient side 226 of the collapsible portion 204. The collapsible portion 204 is clamped and sandwiched between the pivot ring 4430 and the backing plate 4404, forming an occlusion in the lumen 205 of the collapsible portion 204.

[0536] 83 and 84 show operation of the attachment 4400 using a backing plate 4404 and pivot ring 4430 assembly, it will be appreciated that the attachment 4400 may also include an assembly of a backing plate 4404 and a pivot arm 4480. In this configuration, a first one of the bars 4484 is received and engaged in the recess 4406 to allow pivoting of the pivot arm 4480 relative to the backing plate 4404. The collapsible portion 204 extends through a central opening 4486 in the pivot arm 4480 and a second one of the bars 4484 rests on the non-patient facing side 226 of the collapsible portion 204.

[0537] In an alternative embodiment (not shown), a variation of the pivot arm 4480 includes only a single side member 4482 such that a pair of cylindrical bars 4484 and the single side member 4482 form a U-shape.

[0538] The combination of the backing plate 4404 and pivot ring 4430 provides a significant improvement over the ring 215 disclosed in the applicant's earlier patent application PCT / IB2019 / 051137. In particular, the backing plate 4403 enables the ring 4430 to be properly positioned in a desired location. Furthermore, the recess 4406 provides improved rotational movement of the pivot ring 4430, which further enhances the collapse achieved during use.

[0539] 84A-84D, there are shown four alternative embodiments of an attachment according to the present disclosure that are variations on the concept of operation provided by attachment 4400 and shown in FIGS.

[0540] Figure 84A shows an accessory 4400A in which the backing plate 4404A is equivalent to the backing plate 4404 of the accessory 4400, but where the pivot ring comprises a D-shaped ring 4430A as opposed to the oval shaped pivot ring 4430 shown in Figure 81. The D-shaped ring 4430A comprises a straight portion 4403A and a U-shaped portion 4407A extending from the straight portion, which together form a D-shape. The straight portion 4403A is received within a pivot member recess 4406A and, in use, rotates within the recess 4406A to allow pivoting of the D-shaped ring 4430A relative to the backing plate 4404A.

[0541] 84B shows an accessory 4400B comprising a backing plate 4404B and a pivot member 4430B. The pivot member 4430B has a square configuration formed of four cylindrical members including a pair of side members 4482B extending between a top member 4483B and a bottom member 4484B that sits in a pivot member recess 4406B on the underside of the backing plate 4404B. The pivot member 4430B includes a central opening 4415B. In use, a collapsible portion of a gas delivery conduit extends through the opening 4415B.

[0542] The backing plate 4404B is similar in construction to the backing plate 4404 shown in Figures 81 and 84, but differs in that it includes side protrusions 4401B which provide an enlarged contact surface 4412B compared to the contact surface 4412 of the backing plate 4404 shown in Figure 81. The side protrusions 4401B may further facilitate collapse of the collapsible portion by ensuring that the longitudinal side portions of the collapsible portion are properly supported and do not fold over the side edges of the backing plate 4404B.

[0543] Further, the distance D1 between the outer edges of the side projections 4401B is greater than the distance D2 between the inner edges of the side members 4482B. Thus, when the attachment 4400B is not attached to the patient interface, pivoting of the pivot arm 4430B towards the contact surface 4412B brings the side members 4482B and the side projections 4401B into contact. In use, when the attachment 4400B is attached to the patient interface and the collapsible portion of the gas delivery conduit extends through the opening 4415B, pivoting of the pivot arm 4430B towards the contact surface 4412B causes the collapsible portion to be pinched between the pivot member 4430B and the contact surface 4412B. In particular, a longitudinal side portion of the collapsible portion (e.g., side portion 207 shown in Figures 84A-D) may be pinched between the side projections 4401B and the side members 4482B. The attachment 4400B thereby minimizes the formation of longitudinal flow paths in the longitudinal side portions of the collapsible portion, further reducing residual flow through the collapsible portion when in the collapsed configuration.

[0544] Referring to FIG. 84C, an attachment 4400C according to another embodiment of the present disclosure is shown. The attachment 4400C is similar in configuration to the attachment 4400A, except that the attachment 4400C includes a modified backing plate 4404C that includes a contact portion 4420C. The contact portion 4420C includes a pair of elongated ribs 4418C oriented perpendicular to the longitudinal axis of the backing plate 4404C. The ribs 4418C are longer in their length direction than the width of the backing plate 4404C. Thus, the ribs 4418C extend beyond the longitudinal edge 4405C of the backing plate 4404C. The pair of ribs 4418C are positioned relative to the pivot arm 4430C such that when the pivot member 4430C pivots towards the backing plate 4404C, the top member 4483C of the pivot member 4430C can seat in the recess 4421C between the ribs 4418C. The recess 4421C is therefore positioned within the arcuate path of the top member 4483C. In use, a portion of the collapsible portion is sandwiched between the recess 4421C and the top member 4483C.

[0545] This configuration can bias a portion of the collapsible portion to kink or fold into the recess 4421C. This configuration can also provide two pinch points in that the collapsible portion is first sandwiched between the top member 4483C and a first one of the ribs 4418C, and second sandwiched between the top member 4483C and a second one of the ribs 4418C. The contact portion 4420C is configured to contact a patient-facing surface of the collapsible portion at a collapsed position when the collapsible portion is sandwiched between the rib 4418C and the top member 4483C of the pivot member 4430C, thereby facilitating collapse of the collapsible portion.

[0546] Referring to Fig. 84D, an attachment 4400D according to another embodiment of the present disclosure is shown. The attachment 4400D is similar in configuration to the attachment 4400C of Fig. 84C, except that the contact portion 4420D includes a single rib 4418D instead of the double rib configuration of the contact portion 4420C of Fig. 84C. The single rib 4418D is positioned within the arcuate path of the top member 4483D of the pivot arm 4430D. Movement of the pivot arm towards the contact portion 4420D brings the top member 4483D into contact with the top of the rib 4418D. As a result, in use, the collapsible portion is pinched between the top member 4483D and the rib 4418D. This pinch point thereby defines a collapse position where, in use, the attachment 4400D can cause the collapsible portion to collapse.

[0547] It will be appreciated that, similar to the attachment 4400 shown in Figures 81, 83 and 84, for each attachment shown in Figures 84A-D, the gas delivery conduit of the proprietary interface extends through a central opening in the pivot member 4430A-D and overlies the backing plate 4403A-D. An external force, for example from a bag mask being applied to the patient's face, contacting the top member 4483A-D, will cause the pivot member 4430A-D to rotate within the pivot arm recess and pinch the collapsible portion between the top member 4483A-D and the backing plate 4404A-D, thereby facilitating collapse of the collapsible portion.

[0548] 85 and 86, an attachment 4500 according to another embodiment of the present disclosure is shown. The attachment 4500 includes a rigid one-piece component having a "see-saw" configuration, with a first lever arm 4502 and a second lever arm 4504 extending on either side of a fulcrum 4506. The first lever arm 4502 and the second lever arm 4504 are angled relative to one another to form a generally V-shape.

[0549] The first lever arm 4502 includes a C-shaped member extending outwardly from a fulcrum 4506. The first lever arm 4502 defines an opening 4514 that provides an attachment arrangement to allow attachment of an accessory to the collapsible portion. In particular, the opening 4514 is configured so that the collapsible portion 204 extends therethrough in use.

[0550] The second lever arm 4504 includes an elongated bar 4508 extending from the fulcrum 4506 and a cylindrical bar 4510 at a distal end of the elongated bar 4508. The cylindrical bar 4510 has a longitudinal axis perpendicular to the longitudinal axis of the elongated bar 4508. The angle α between the longitudinal axes of the first lever arm 4502 and the second lever arm 4504 may depend on the length or other configuration of the first and second lever arms. According to certain embodiments, the angle α is an obtuse angle, i.e., between 90 and 180°.

[0551] The first lever arm 4502 has a longitudinal axis A1. The second lever arm 4504 has a longitudinal axis A1. The fulcrum includes a rigid corner 4506 that extends perpendicular to the longitudinal axes A1, A2 along the interface of the first lever arm 4502 and the second lever arm 4504. The corner 4506 provides a beveled edge and is aligned with the axis of rotation A1. R When the corner 4506 is located on the surface, the first lever arm 4502 and the second lever arm 4504 define a rotation ...

Claims

1. a gas delivery interface configured to deliver a flow of device gas to a patient, the gas delivery interface comprising: a delivery outlet for delivering the device gas flow to the patient; a gas delivery side member including an apparatus gas flow path extending from a first side of the delivery outlet and in fluid communication with the delivery outlet, the gas delivery side member including a collapsible portion that is transitionable from a normally open configuration to a collapsed configuration in which the apparatus gas flow path is reduced or closed when a collapsing force is applied to reduce or stop the apparatus gas flow through the apparatus gas flow path; a gas delivery interface comprising: Equipped with 1. A gas sampling interface, comprising: a sampling inlet configured to receive a patient gas flow at the patient; a sampling outlet configured to direct the patient gas flow away from the patient; 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 the sampling outlet when the collapsible portion transitions to the collapsed configuration; Equipped with a gas sampling interface The patient interface further comprises:

2. 10. The patient interface of claim 1, further comprising a non-delivery side member extending from a second side of the delivery outlet opposite the first side, the non-delivery side member comprising a head strap end configured to connect to a head strap, the non-delivery side member also including a patient-facing wall and a non-patient-facing wall.

3. 10. The patient interface of claim 1, wherein the gas sampling interface is provided on the gas delivery side member, the gas delivery side member having a delivery inlet at one end for receiving the device gas flow, the gas delivery side member including a patient-facing wall and a non-patient-facing wall.

4. The patient interface of claim 3 , wherein the sampling inlet is located proximate to the delivery outlet, and the sampling outlet is located proximate to the delivery inlet.

5. The patient interface of claim 3 , wherein the sampling conduit includes a sampling lumen for the patient gas flow and the gas delivery side member includes a gas delivery lumen for the device gas flow.

6. The patient interface of claim 3 , wherein the sampling conduit extends along an outer surface of the gas delivery side member.

7. The sampling conduit is configured to be stiffer than the collapsible portion so as to maintain the shape of the sampling lumen when the crushing force is applied; the sampling conduit: formed of a material having sufficient material stiffness to maintain the shape of the sampling lumen; or or formed from a material having a higher material stiffness than the material of the collapsible portion; configured to be stiffer than the collapsible portion via geometric features; Either one of the following:

6. A patient interface according to claim 5.

8. 10. The patient interface of claim 1, wherein in the normally open configuration, the gas delivery interface is configured to allow a system gas flow rate of between about 20 L / min and about 90 L / min through the system gas flow path.

9. 10. The patient interface of claim 1, wherein in the collapsed configuration, the patient interface is configured to allow a system gas flow rate through the system gas flow path that is at least 20 times greater than the patient gas flow rate through the gas sampling interface.

10. 10. The patient interface of claim 1, wherein in the collapsed configuration, the gas delivery interface is configured to allow a system gas flow rate of less than about 10 L / min through the system gas flow path, and the gas sampling interface is configured to allow a patient gas flow rate of less than about 500 mL / min, optionally between about 40 mL / min and about 500 mL / min through the gas sampling interface.

11. The patient interface of claim 1 , wherein the patient interface comprises a single sampling conduit.

12. The patient interface of claim 1 , wherein the sampling conduit includes a single lumen, the single lumen being a sampling lumen for the patient gas flow.

13. The patient interface of claim 1 , wherein the sampling inlets include a nasal inlet and an oral inlet.

14. The patient interface of claim 1 , wherein the sampling conduit includes a wall that is thicker than a wall of the collapsible portion.

15. The patient interface of claim 1 , wherein the sampling conduit includes a wall of uniform thickness and the collapsible portion includes a wall of non-uniform thickness.

16. 10. A patient interface according to claim 1, wherein the collapsible portion includes one or more thin-walled portions configured to facilitate folding or collapsing, thereby facilitating transition of the collapsible portion to the collapsed configuration.

17. The patient interface of claim 1 , wherein the gas sampling interface is formed from a different material than the collapsible portion.

18. 18. A patient interface according to claim 17, wherein the gas sampling interface comprises silicone and / or the collapsible portion comprises a thermoplastic elastomer.

19. The patient interface of claim 1 , wherein the sampling conduit has a width that is less than a width of the collapsible portion.

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