Patient interface and respiratory support system

Abstract

The present invention provides a respiratory support system having a sensor on or near the patient interface. [Solution] A nasal cannula interface for supplying a gas flow to a patient is provided, comprising a body 32 defining at least a portion of a gas flow path and having a base portion and at least one prong extending from the base portion, the at least one prong being configured to direct the gas flow toward the patient's opening, and one or more sensors 29 configured to measure parameters. One or more sensors may include a pulse oximeter. One or more sensors may be mounted on the nasal cannula body or on a headgear to which the body is connected. One or more sensors may be configured to contact the patient's face and may be mounted on the cheek contact portion of the interface and / or be configured to be substantially coplanar therewith.

Description

Technical Field

[0001] The present disclosure generally relates to patient interfaces and respiratory assistance systems for providing a breathable gas flow to a patient, and more particularly to a respiratory assistance system having a sensor on or near the patient interface.

Background Art

[0002] When providing respiratory assistance to a patient, it may be beneficial to monitor one or more patient parameters during the course of treatment. To measure these patient parameters, one or more patient sensors, such as a pulse oximeter that can be used to determine blood oxygen saturation and heart rate, are used. These parameters can be used individually or in combination with additional parameters when assessing the patient's health status. Further, these parameters can be used to adjust one or more control parameters of a respiratory assistance system that is being used to provide respiratory assistance to the patient. This adjustment can be made manually by a clinician or automatically by a controller of the respiratory assistance system, such as by feedback control. The parameters to be adjusted can include any one or more of flow rate, pressure, temperature, humidity, dew point, oxygen concentration, and / or oxygen saturation.

Summary of the Invention

Means for Solving the Problems

[0003] The systems, methods, and devices described herein have innovative aspects, none of which are essential for their desirable attributes or serve a role alone. Without limiting the scope of the claims, some of the advantageous features are outlined here.

[0004] Throughout this specification, the term “respiratory support system” means a combination of a respiratory support device and any related components used to provide respiratory support to a patient, such as a patient interface and / or one or more gas conduits and / or other components used to provide respiratory support to a patient. Components that may constitute at least part of a respiratory support device include any one or more of a flow generator, a controller, a humidifier, a graphical user interface, and a flow control valve.

[0005] Throughout this specification, the term “circuit” means the entire inspiratory pathway of breathable gas from the gas supply unit to the patient, and may also include the expiratory gas pathway away from the patient to the gas supply unit. Thus, the circuit includes, at a minimum, the inspiratory gas pathway (including all components) from the gas supply unit to the patient interface. The interface itself, such as a mask or cannula, is separate from the gas pathway and is not part of the “circuit.”

[0006] Throughout this specification, “gas conduit” is any passage configured to transport a breathable gas flow.

[0007] Throughout this specification, the terms “clinician,” “patient,” and “user” may be used to refer to an individual who can interact with a respiratory support device. As used herein, “patient” means an individual receiving treatment (e.g., therapeutic gas flow) from a respiratory support system, and in particular an individual wearing a patient interface. As used herein, “clinician” means an individual, such as a nurse or physician, who is not receiving treatment from a respiratory support system but whose work, among other things, involves adjusting the settings of the respiratory support device, assisting in the setup of the respiratory support system, and / or assisting in attaching the patient interface to the patient, or prescribing therapy. As used herein, “user” means an individual whose work, among other things, involves adjusting the settings of the respiratory support device, assisting in the setup of the respiratory support system, and / or assisting in attaching the patient interface to the patient. Depending on the context, the user may be a clinician or the patient themselves. For example, in a hospital scenario, a clinician is more likely to set up the system for the patient, and therefore the term “user” is more likely to refer to a clinician. In scenarios where the "user" adjusts the operating parameters of a respiratory support device but does not necessarily interact with the patient, the user could be a biomedical engineer, maintenance engineer, or technician. Conversely, in scenarios where the patient uses the respiratory support system at home, the patient may configure the system themselves, and therefore the term "user" is more likely to refer to the patient.

[0008] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and Including one or more sensors, a) Patient interface, b) A headgear configured to attach the patient interface to the patient's head, c) Headgear connector configured to connect the headgear to the patient interface, d) Gas delivery conduit configured to deliver breathable gas to the patient A patient interface is provided which is mounted (i.e., positioned) on any one or more of the following.

[0009] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A body configured to engage with the patient's opening and direct the gas flow toward the opening, A frame to which the main body is permanently or detachably attached, configured to connect to a headgear for attaching a patient interface to the patient's head, One or more sensors configured to measure parameters and A patient interface is provided, which includes one or more sensors that are attached to the patient interface and / or frame and / or headgear.

[0010] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A body configured to engage with the patient's opening and direct the gas flow toward the opening, A lateral arm extending laterally outward from the main body and configured to connect to a headgear for attaching a patient interface to the patient's head, One or more sensors configured to measure parameters and A patient interface is provided, which includes one or more sensors that are attached to the patient interface and / or a lateral arm and / or headgear.

[0011] One or more sensors, a) Patient interface, b) A headgear configured to attach the patient interface to the patient's head, c) Headgear connector configured to connect the headgear to the patient interface, d) Gas delivery conduit configured to deliver breathable gas to the patient It can be detachably attached to any one or more of them (i.e., it can be removed from the patient interface and repositioned).

[0012] Having one or more sensors that are removable can be advantageous because they can be removed, cleaned, and attached to a different interface. This allows the sensors to be reused between different patients.

[0013] Instead, one or more sensors, a) Patient interface, b) A headgear configured to attach the patient interface to the patient's head, c) Headgear connector configured to connect the headgear to the patient interface, d) Gas delivery conduit configured to deliver breathable gas to the patient It can be integrated into one or more of these.

[0014] One or more sensors may be integrated in a way that prevents them from being removed. In this integrated configuration, one or more sensors may be disposable.

[0015] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and Includes, The main body further includes a top surface and a rear surface, the rear surface being adjacent to the patient when using the patient interface. A patient interface is provided in which the outer surfaces of one or more sensors are coplanar with the top or rear surface.

[0016] According to one aspect of the present disclosure, a patient interface for supplying a gas flow to a patient, comprising: a body configured to engage with an opening of the patient and direct a gas flow towards the opening; one or more sensors configured to measure a parameter; wherein the one or more sensors are embedded below an outer surface of the body of the patient interface.

[0017] At least one of the one or more sensors can be a patient sensor. The parameter can be a physiological parameter of the patient.

[0018] The parameter can be a measure of the patient's blood oxygenation.

[0019] The patient interface can be sealingly engaged with the opening of the patient.

[0020] The patient interface can include a mask.

[0021] The mask can be a nasal mask.

[0022] The mask can be an oral mask.

[0023] The mask can be a nasal mask.

[0024] The mask can be a full face mask.

[0025] The mask can include a cushion.

[0026] One or more sensors can be on the same plane as an outer surface of the cushion.

[0027] The patient interface can include a nasal pillow interface.

[0028] The patient interface can include a tracheostomy interface.

[0029] The patient interface may further include a head restraint assembly.

[0030] The head restraint assembly may include one or more straps.

[0031] The head restraint assembly may include one or more face pads.

[0032] Each facial pad may include an adhesive surface for attaching to the patient's skin.

[0033] Each facial pad may contain two separate patches.

[0034] The two separate patches can be joined together in a detachable manner.

[0035] One or more sensors may be pulse oximeters.

[0036] A pulse oximeter can be a reflective pulse oximeter.

[0037] One or more sensors may be positioned to make contact with the patient's nasal bridge while the patient interface is in use.

[0038] The patient interface is, A gas inlet conduit for receiving a gas flow from a gas source, comprising a gas inlet conduit that defines at least a portion of the gas flow path, An interface connector that receives the gas flow from the gas inlet conduit and directs the gas flow towards the patient. This may further include:

[0039] The patient interface may further include a set of wires, and the gas inlet conduit may further include a patient end and a distal end. The patient end is connected to the interface connector. The distal end includes an interface inlet, the interface inlet includes a set of electrical contacts, and The patient interface wire set provides electrical communication between one or more sensors and the set of electrical contacts at the interface inlet.

[0040] The set of electrical contacts at the interface inlet may include a flat surface, which may be substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

[0041] The set of electrical contacts at the interface inlet may include pins and / or sockets of a pin and socket electrical connector, and the longitudinal axis of the pins and / or sockets may be substantially parallel to the longitudinal axis of the lumen of the interface inlet.

[0042] The set of electrical contacts at the interface input can be in a fixed position relative to the rest of the interface input.

[0043] The patient interface may further include a mesh layer surrounding the outer surface of at least a portion of the body of the patient interface or the gas inlet conduit, the mesh may include a plurality of woven filaments, and at least a portion of the wire set of the patient interface may be woven with the filaments of the mesh layer.

[0044] At least a portion of the wire set of the patient interface may be embedded in at least a portion of the body of the patient interface, the interface connector of the patient interface, or the gas inlet conduit.

[0045] At least a portion of the wire set of the patient interface may be located on the outer surface of at least a portion of the body of the patient interface, the interface connector of the patient interface, or the gas inlet conduit.

[0046] At least a portion of the wire set of the patient interface may be located on the inner surface of at least a portion of the body of the patient interface, the interface connector of the patient interface, or the gas inlet conduit.

[0047] According to one aspect of this disclosure, a respiratory support system that generates a gas flow, A respiratory support device, Flow generator and The outlet of the respiratory support device, Controller and A respiratory support device including, Intake conduit, A patient end having an inspiratory conduit outlet, Device end having intake conduit inlet and An intake conduit including, The patient interface of any preceding or succeeding description and Includes, The respiratory support device outlet is configured to form pneumatic and electrical connections with the inspiratory conduit inlet. The respiratory support device outlet communicates electrically with the controller. A respiratory support system is provided, in which the controller is configured to power one or more sensors and to receive data from one or more sensors.

[0048] A flow generator can be a blower.

[0049] The respiratory support system may further include a humidifier that adds heat and / or moisture to the gas stream.

[0050] The respiratory support system may further include an ambient air inlet.

[0051] The respiratory support system may further include at least one auxiliary gas inlet that receives a flow of auxiliary gas.

[0052] The respiratory support system may further include a valve that regulates the flow of auxiliary gas through at least one auxiliary gas inlet.

[0053] The valve could be a proportional valve.

[0054] At least one auxiliary gas inlet may be an oxygen inlet.

[0055] The respiratory support device may include at least one gas composition sensor for measuring the composition of the gas flow.

[0056] At least one gas composition sensor may include an ultrasonic sensor system.

[0057] The controller is Receive a measure of the gas flow composition from at least one gas composition sensor, The composition of the gas flow is compared to the target gas composition. Adjust the valve position based at least partially on a comparison of two values. It can be configured in this way.

[0058] The target gas composition can be set by the user.

[0059] The controller is Receive parameter scales from one or more sensors, Compare the parameter scale with the parameter target value. Adjust the target gas composition based at least partially on a comparison between the scale and the target value. It can be configured in this way.

[0060] The target parameters can be set by the user.

[0061] The parameter scale can be used by the controller to determine when a patient is using the patient interface.

[0062] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, One or more sensors configured to be placed on the patient's skin and configured to measure at least one parameter, A body configured to engage with the patient's opening and direct the gas flow toward the opening, A patient interface is provided, which includes one or more sensors that are movable relative to the body of the patient interface.

[0063] The patient interface may further include a gas inlet conduit for receiving a gas flow from a gas source, the gas inlet conduit defining at least a portion of the gas flow path and including a patient end and a distal end.

[0064] The patient interface may further include a first set of wires.

[0065] The patient interface may further include an interface connector for receiving the gas flow from the gas inlet conduit and directing the gas flow toward the patient.

[0066] The patient end can be connected to an interface connector.

[0067] The distal end may include an interface inlet, which includes a set of electrical contacts.

[0068] A first set of wires in the patient interface can provide electrical communication between one or more sensors and a set of electrical contacts at the interface inlet.

[0069] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A gas inlet conduit for receiving a gas flow from a gas source, comprising a gas inlet conduit that defines at least a portion of the gas flow path and includes a patient end and a distal end, The first set of wires, One or more sensors configured to be placed on the patient's skin and configured to measure at least one parameter, The main unit and An interface connector that receives gas flow from the gas inlet conduit and Includes, The patient end is connected to the interface connector. The distal end includes an interface inlet, the interface inlet includes a set of electrical contacts, and A patient interface is provided, where a first set of wires for the patient interface provides electrical communication between one or more sensors and a set of electrical contacts at the interface inlet.

[0070] The patient interface can be sealed and engaged with the patient's orifice.

[0071] The patient interface may include a mask.

[0072] The mask could be a nasal mask.

[0073] The mask could be a mouth mask.

[0074] The mask could be a nasal mask.

[0075] The mask could be a full-face mask.

[0076] The mask may include a cushion.

[0077] One or more sensors may be coplanar with the outer surface of the cushion.

[0078] The patient interface may include a nasal pillow interface.

[0079] The patient interface may include a tracheostomy interface.

[0080] At least one of the one or more sensors may be a patient sensor. The parameters may be the patient's physiological parameters.

[0081] Physiological parameters can be measures of a patient's blood oxygenation.

[0082] At least one of the one or more sensors may be a pulse oximeter.

[0083] A pulse oximeter can be a reflective pulse oximeter.

[0084] A pulse oximeter can be a transmission-type pulse oximeter.

[0085] The patient interface may further include a head restraint assembly.

[0086] The head restraint assembly includes one or more straps.

[0087] The sensor may be movable relative to the main body of the patient interface.

[0088] The patient interface may further include a sensor arm, and one or more sensors may be located on the sensor arm.

[0089] The sensor arm can be rigid so that it cannot be easily bent by the user.

[0090] The sensor arm may be deformable so that it can be easily bent by the user. The sensor arm may be inelastically deformable so that it can remain bent after being deformed by the user. The sensor arm may be elastically deformable.

[0091] The surface of the sensor arm may contain an adhesive so that the surface can adhere to the patient's skin.

[0092] The length of the sensor arm may be adjustable.

[0093] The length of the sensor arm may be adjustable through extension and retraction.

[0094] The head restraint assembly may further include a sensor mount connected to one of the straps, with a sensor arm protruding from the sensor mount.

[0095] The sensor mount can be movably attached to one of the straps.

[0096] The sensor mount can be slidably attached to one of the straps.

[0097] The sensor mount can be detachably attached to one of the straps.

[0098] The patient interface may further include a sensor mount connected to a gas inlet conduit, with a sensor arm protruding from the sensor mount.

[0099] The sensor mount can be movably connected to the gas inlet conduit.

[0100] The sensor mount can be slidably connected to the gas inlet conduit.

[0101] The sensor mount can be removably connected to the gas inlet conduit.

[0102] The sensor arm may be movable relative to the sensor mount.

[0103] The sensor arm can be slidably mounted to the sensor mount.

[0104] The sensor arm may be slidably mounted to the sensor mount so that it can slide in a direction parallel to the length of the strap or gas inlet conduit to which the sensor mount is connected.

[0105] The sensor arm may be slidably mounted to the sensor mount so that it can slide in a direction transverse to the length of the strap or gas inlet conduit to which the sensor mount is connected.

[0106] The sensor arm may be configured to rotate around an axis to which it connects to the sensor mount.

[0107] The patient interface may further include a sensor clip configured to clip onto the patient, and one or more sensors may be located on the sensor clip.

[0108] The sensor clip may be configured to clip onto the patient's ear.

[0109] The gas inlet conduit can be substantially rigid.

[0110] The gas inlet conduit can be substantially flexible.

[0111] The gas inlet conduit can be integrated with the patient interface.

[0112] The gas inlet conduit can be connected to the patient interface in a releasable manner.

[0113] The set of electrical contacts at the interface input may include a flat surface, and The flat surface is substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

[0114] The set of electrical contacts at the interface inlet may include pins and / or sockets of a pin and socket electrical connector, and the longitudinal axis of the pins and / or sockets may be substantially parallel to the longitudinal axis of the lumen of the interface inlet.

[0115] The set of electrical contacts at the interface input can be in a fixed position relative to the rest of the interface input.

[0116] The patient interface may further include a mesh layer surrounding the outer surface of at least a portion of the patient interface or gas inlet conduit, the mesh may include a plurality of woven filaments, and at least a portion of the first set of wires of the patient interface may be woven with the filaments of the mesh layer.

[0117] At least a portion of the first set of wires of the patient interface may be embedded in at least a portion of the body of the patient interface, the interface connector of the patient interface, or the gas inlet conduit.

[0118] At least a portion of the first set of wires of the patient interface may be located on the outer surface of at least a portion of the body of the patient interface, the interface connector of the patient interface, or the gas inlet conduit.

[0119] At least a portion of the first set of wires of the patient interface may be located on the inner surface of at least a portion of the body of the patient interface, the interface connector of the patient interface, or the gas inlet conduit.

[0120] The patient interface is, Wire coil and, A second set of wires extending from the sensor to the wire coil and It further includes, The second set of wires can be retracted into the wire coil. The wire coil is connected to the first set of wires, and At least one of the one or more sensors, or one sensor, is located at the end of a second set of wires.

[0121] The second set of wires can automatically retract into the wire coil.

[0122] The second set of wires can be retracted into the wire coil when a button, switch, or lever is activated by the user.

[0123] The wire coil can be attached to one of the straps.

[0124] The wire coil can be detachably attached to one of the straps.

[0125] The wire coil can be attached to the gas inlet conduit.

[0126] The wire coil can be removably attached to the gas inlet conduit.

[0127] According to one aspect of this disclosure, a respiratory support system that generates a gas flow, A respiratory support device, Flow generator and The outlet of the respiratory support device, Controller and A respiratory support device including, Intake conduit, A patient end having an inspiratory conduit outlet, Device end having intake conduit inlet and An intake conduit including, The patient interface of any of the preceding descriptions and Includes, The respiratory support device outlet is configured to form pneumatic and electrical connections with the inspiratory conduit inlet. The respiratory support device outlet communicates electrically with the controller. A respiratory support system is provided, in which the controller is configured to power one or more sensors and to receive data from one or more sensors.

[0128] A flow generator can be a blower.

[0129] The respiratory support system may further include a humidifier that adds heat and / or moisture to the gas stream.

[0130] The respiratory support system may further include an ambient air inlet.

[0131] The respiratory support system may further include one or more auxiliary gas inlets that receive a flow of auxiliary gas.

[0132] At least one of the one or more auxiliary gas inlets may be an oxygen inlet.

[0133] The respiratory support system may further include a valve that regulates the flow of auxiliary gas through at least one of one or more auxiliary gas inlets.

[0134] The valve could be a proportional valve.

[0135] The respiratory support device may include at least one gas composition sensor for measuring the composition of the gas flow.

[0136] One or more gas composition sensors may include an ultrasonic sensor system.

[0137] The controller is Receive a measure of the gas flow composition from one or more gas composition sensors. The composition of the gas flow is compared to the target composition. Adjust the valve position based at least partially on the difference between the two values. It can be configured in this way.

[0138] The target gas composition can be set by the user.

[0139] The controller is Receive parameter scales from one or more sensors, Compare the parameter scale with the parameter target value. Adjust the target gas composition based at least partially on the difference between the scale and the target value. It can be configured in this way.

[0140] The target values ​​for parameters can be set by the user.

[0141] The parameter scale can be used by the controller to determine when a patient is using the patient interface.

[0142] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A patient interface that defines at least a portion of a gas flow path, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and The sensor is configured to come into contact with the patient's nose when the patient interface is being used. A patient interface including the following is provided.

[0143] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A patient interface that defines at least a portion of a gas flow path, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and The sensor is configured to contact the patient's upper lip when the patient interface is in use. A patient interface including the following is provided.

[0144] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A patient interface that defines at least a portion of a gas flow path, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and The sensor is configured to contact the patient's lower lip when the patient interface is in use. A patient interface including the following is provided.

[0145] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A patient interface that defines at least a portion of a gas flow path, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and The sensor is configured to come into contact with the patient's mouth when the patient interface is being used. A patient interface including the following is provided.

[0146] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A patient interface that defines at least a portion of a gas flow path, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and The sensor is configured to make contact with the patient's cheek when the patient interface is being used. A patient interface including the following is provided.

[0147] According to one aspect of this disclosure, a patient interface for supplying a gas flow to a patient, A patient interface that defines at least a portion of a gas flow path, A body configured to engage with the patient's opening and direct the gas flow toward the opening, One or more sensors configured to measure parameters and The sensor is configured to make contact with the patient's neck when the patient interface is in use. A patient interface including the following is provided.

[0148] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and Includes, The main body further includes a top surface and a rear surface, the rear surface being adjacent to the patient when using the nasal cannula interface. The outer surface of one or more sensors is coplanar with the top or rear surface of the nasal cannula. A nasal cannula interface including this is provided.

[0149] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The nasal cannula includes one or more sensors, which are embedded below the outer surface of the nasal cannula body. A nasal cannula interface including this is provided.

[0150] At least one of the one or more sensors may be a patient sensor. The parameters may be the patient's physiological parameters.

[0151] The parameter may be a measure of the patient's blood oxygenation.

[0152] At least one prong may be configured to be received by one or more nostrils of the patient.

[0153] At least one or more of the prongs may be configured to form a seal with one of the patient's nostrils.

[0154] At least one or more of the prongs may be configured to be received in an open manner into one of the patient's nostrils.

[0155] The nasal cannula may further include a head restraint assembly.

[0156] The head restraint assembly may include one or more straps.

[0157] The head restraint assembly may include one or more face pads.

[0158] Each facial pad may include an adhesive surface that adheres to the patient's skin.

[0159] Each facial pad may contain two separate patches.

[0160] The two separate patches can be joined together in a detachable manner.

[0161] Nasal cannulas may further include a pair of side arms.

[0162] The pair of side arms may be integrated with the main body of the nasal cannula.

[0163] The head restraint assembly can be connected to the side arm.

[0164] The face pad may be positioned on the side arm.

[0165] The outer surface of the patient sensor may be coplanar with the top surface, and the top surface may be the patient contact surface, or the outer surface of the patient sensor may be coplanar with the rear surface, and the rear surface may be the patient contact surface.

[0166] One or more sensors may be pulse oximeters.

[0167] A pulse oximeter can be a reflective pulse oximeter.

[0168] The nasal cannula may further include a second prong extending from the base portion.

[0169] One or more sensors may be located between the two prongs.

[0170] At least one prong may extend from the upper surface of the body of the nasal cannula, and one or more sensors may be located on the upper surface.

[0171] One or more sensors may be positioned to contact the patient's nasal columella while the nasal cannula interface is in use.

[0172] At least one prong may extend from the upper surface of the nasal cannula body, and one or more sensors may be located on the surface of the body adjacent to the upper surface.

[0173] One or more sensors may be positioned on the body of the nasal cannula to contact the patient's upper lip while the nasal cannula interface is in use.

[0174] The nasal cannula interface is A gas inlet conduit for receiving a gas flow from a gas source, comprising a gas inlet conduit that defines at least a portion of the gas flow path, An interface connector for receiving the gas flow from the gas inlet conduit and directing the gas flow toward at least one prong, This may further include:

[0175] The nasal cannula interface may further include a set of wires, and the gas inlet conduit may further include a patient end and a distal end. The patient end is connected to the interface connector. The distal end includes an interface inlet, the interface inlet includes a set of electrical contacts, and The wire set of the nasal cannula interface provides electrical communication between one or more sensors and a set of electrical contacts at the interface inlet.

[0176] The set of electrical contacts at the interface inlet may include a flat surface, which may be substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

[0177] The set of electrical contacts at the interface inlet may include pins and / or sockets of a pin and socket electrical connector, and the longitudinal axis of the pins and / or sockets may be substantially parallel to the longitudinal axis of the lumen of the interface inlet.

[0178] The set of electrical contacts at the interface input can be in a fixed position relative to the rest of the interface input.

[0179] The nasal cannula interface may further include a mesh layer surrounding the outer surface of at least a portion of the nasal cannula or gas inlet conduit, the mesh may include a plurality of woven filaments, and at least a portion of the wire set of the nasal cannula interface may be woven with the filaments of the mesh layer.

[0180] At least a portion of the wire set of the nasal cannula interface may be embedded in at least a portion of the nasal cannula body, the nasal cannula interface connector, or the gas inlet conduit.

[0181] At least a portion of the wire set of the nasal cannula interface may be located on the outer surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

[0182] At least a portion of the wire set of the nasal cannula interface may be located on the inner surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

[0183] According to one aspect of this disclosure, a respiratory support system that generates a gas flow, A respiratory support device, Flow generator and The outlet of the respiratory support device, Controller and A respiratory support device including, Intake conduit, A patient end having an inspiratory conduit outlet, Device end having intake conduit inlet and An intake conduit including, The patient interface of any of the preceding descriptions and Includes, The respiratory support device outlet is configured to form pneumatic and electrical connections with the inspiratory conduit inlet. The respiratory support device outlet communicates electrically with the controller. A respiratory support system is provided, in which the controller is configured to power one or more sensors and to receive data from one or more sensors.

[0184] A flow generator can be a blower.

[0185] The respiratory support system may further include a humidifier that adds heat and / or moisture to the gas stream.

[0186] The respiratory support system may further include an ambient air inlet.

[0187] The respiratory support system may further include at least one auxiliary gas inlet that receives a flow of auxiliary gas.

[0188] The respiratory support system may further include a valve that regulates the flow of auxiliary gas through at least one auxiliary gas inlet.

[0189] The valve could be a proportional valve.

[0190] At least one auxiliary gas inlet may be an oxygen inlet.

[0191] The respiratory support device may include at least one gas composition sensor for measuring the composition of the gas flow.

[0192] At least one gas composition sensor may include an ultrasonic sensor system.

[0193] The controller is Receive a measure of the gas flow composition from at least one gas composition sensor, The composition of the gas flow is compared to the target gas composition. Adjust the valve position based at least partially on a comparison of two values. It can be configured in this way.

[0194] The target gas composition can be set by the user.

[0195] The controller is Receive parameter scales from one or more sensors, Compare the parameter scale with the parameter target value. Adjust the target gas composition based at least partially on a comparison between the scale and the target value. It can be configured in this way.

[0196] The target parameters can be set by the user.

[0197] The parameter scale can be used by the controller to determine when a patient is using the patient interface.

[0198] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, One or more sensors configured to be placed on the patient's skin and configured to measure at least one parameter, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, Nasal cannula including A nasal cannula interface is provided, which includes one or more sensors that are movable relative to the body of the nasal cannula.

[0199] The nasal cannula interface may further include a gas inlet conduit for receiving a gas flow from a gas source, the gas inlet conduit defining at least a portion of the gas flow path and including a patient end and a distal end.

[0200] The nasal cannula interface may further include a first set of wires.

[0201] The nasal cannula may further include an interface connector for receiving the gas flow from the gas inlet conduit and directing the gas flow towards the patient.

[0202] The patient end can be connected to an interface connector.

[0203] The distal end may include an interface inlet, which includes a set of electrical contacts.

[0204] A first set of wires in the nasal cannula interface can provide electrical communication between one or more sensors and a set of electrical contacts at the interface inlet.

[0205] A nasal cannula interface for supplying gas flow to a patient, A gas inlet conduit for receiving a gas flow from a gas source, comprising a gas inlet conduit that defines at least a portion of the gas flow path and includes a patient end and a distal end, The first set of wires, One or more sensors configured to be placed on the patient's skin and configured to measure at least one parameter, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, An interface connector for receiving the gas flow from the gas inlet conduit and directing the gas flow toward at least one prong, Nasal cannula including Includes, The patient end is connected to the interface connector. The distal end includes an interface inlet, the interface inlet includes a set of electrical contacts, and A nasal cannula interface is provided, in which a first set of wires of the nasal cannula interface provides electrical communication between one or more sensors and a set of electrical contacts at the interface inlet.

[0206] At least one prong may be configured to be received by one or more nostrils of the patient.

[0207] At least one prong may be configured to form a seal with one of the patient's nostrils.

[0208] At least one prong may be configured to be accepted in an open manner into one of the patient's nostrils.

[0209] The nasal cannula interface may further include a second prong extending from the base portion.

[0210] At least one of the one or more sensors may be a patient sensor. The parameters may be the patient's physiological parameters.

[0211] Physiological parameters can be measures of a patient's blood oxygenation.

[0212] At least one of the one or more sensors may be a pulse oximeter.

[0213] A pulse oximeter can be a reflective pulse oximeter.

[0214] A pulse oximeter can be a transmission-type pulse oximeter.

[0215] The main body of the nasal cannula further includes a pair of side arms.

[0216] The nasal cannula interface may further include a head fixation assembly.

[0217] The head restraint assembly can be connected to the side arm.

[0218] The head restraint assembly may include one or more straps.

[0219] The sensor may be movable relative to the body of the nasal cannula interface.

[0220] The nasal cannula interface may further include a sensor arm, and one or more sensors may be located on the sensor arm.

[0221] The sensor arm can be rigid so that it cannot be easily bent by the user.

[0222] The sensor arm may be elastically deformable so that it can be easily bent by the user.

[0223] The surface of the sensor arm may contain an adhesive so that the surface can adhere to the patient's skin.

[0224] The length of the sensor arm may be adjustable.

[0225] The length of the sensor arm may be adjustable through extension and retraction.

[0226] The head restraint assembly may further include a sensor mount connected to one of the straps, with a sensor arm protruding from the sensor mount.

[0227] The sensor mount can be movably attached to one of the straps.

[0228] The sensor mount can be slidably attached to one of the straps.

[0229] The sensor mount can be detachably attached to one of the straps.

[0230] The nasal cannula interface may further include a sensor mount connected to one gas inlet conduit, and the sensor arm projects from the sensor mount.

[0231] The sensor mount may be movably connected to the gas inlet conduit.

[0232] The sensor mount may be slidably connected to the gas inlet conduit.

[0233] The sensor mount may be removably connected to the gas inlet conduit.

[0234] The sensor arm may be movable relative to the sensor mount.

[0235] The sensor arm may be slidably attached to the sensor mount.

[0236] The sensor arm may be slidably attached to the sensor mount such that it can slide in a direction parallel to the length of the strap to which the sensor mount is connected or the gas inlet conduit.

[0237] The sensor arm may be slidably attached to the sensor mount such that it can slide in a direction transverse to the length of the strap to which the sensor mount is connected or the gas inlet conduit.

[0238] The sensor arm may be configured to rotate about an axis by which it is connected to the sensor mount.

[0239] The nasal cannula interface may further include a sensor clip configured to clip onto the patient, and one or more sensors may be located on the sensor clip.

[0240] The sensor clip may be configured to clip onto the patient's ear.

[0241] The gas inlet conduit may be substantially rigid.

[0242] The gas inlet conduit can be substantially flexible.

[0243] The gas inlet conduit can be formed integrally with the nasal cannula.

[0244] The gas inlet conduit can be releasably connected to the nasal cannula.

[0245] The set of electrical contacts at the interface input may include a flat surface, and The flat surface is substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

[0246] The set of electrical contacts at the interface input may include pins and / or sockets of an electrical connector, and The longitudinal axis of the pin and / or socket may be substantially parallel to the longitudinal axis of the lumen of the interface inlet.

[0247] The set of electrical contacts at the interface input can be in a fixed position relative to the rest of the interface input.

[0248] The nasal cannula interface may further include a mesh layer that surrounds the outer surface of at least a portion of the nasal cannula or gas inlet conduit. The mesh may contain multiple interwoven filaments. At least a portion of the wire set of the nasal cannula interface can be woven with the filaments of the mesh layer.

[0249] At least a portion of the wire set of the nasal cannula interface may be embedded in at least a portion of the nasal cannula body, the nasal cannula interface connector, or the gas inlet conduit.

[0250] At least a portion of the wire set of the nasal cannula interface may be located on the outer surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

[0251] At least a portion of the set of wires of the nasal cannula interface can be positioned on the inner surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

[0252] The nasal cannula interface may further include a wire coil and a second set of wires extending from the sensor to the wire coil, and the second set of wires can be retracted into the wire coil, the wire coil is connected to the first set of wires, and at least one of the one or more sensors or the sensor is located at the end of the second set of wires.

[0253] The second set of wires can be automatically retracted into the wire coil.

[0254] The second set of wires can be retracted into the wire coil when a user operates a button, switch, or lever.

[0255] The wire coil can be attached to one of the straps.

[0256] The wire coil can be removably attached to one of the straps.

[0257] The wire coil can be attached to the gas inlet conduit.

[0258] The wire coil can be removably attached to the gas inlet conduit.

[0259] ​The nasal cannula interface may be configured such that one or more sensors are connected to one or more sensor wires via inductive coupling. For example, one or more sensors may be configured to be connected to one or more sensor wires in a gas delivery conduit via inductive coupling. Such coupling can avoid the need for physical electrical connectors and exposed electrical contacts.

[0260] According to another aspect of this disclosure, a headgear for a patient interface, A strap forming part of a headgear to assist in holding or stabilizing the patient interface on the user, A first connector at the first end of the strap for connecting the strap to the patient interface, A first cheek engagement member having a surface area adapted to be positioned between the user's cheek and the connector, which is adapted to enclose the first connector and to minimize direct contact of the connector with the user's skin during use. A headgear is provided, which includes one or more sensors configured to be positioned on or adjacent to the patient's skin and configured to measure at least one parameter, and the one or more sensors are mounted on a first cheek engagement member.

[0261] The headgear may further include a second connector at the second opposite end of the strap for connecting the strap to the patient interface, and a second cheek engagement member configured to enclose the second connector and having a surface area adapted to be positioned between the user's other cheek and the connector to minimize direct contact of the connector with the user's skin during use.

[0262] Each cheek engagement member may be configured to be removably coupled around its respective connector.

[0263] The surface area of ​​each cheek engagement member includes a material that is substantially softer than the material of the respective connector.

[0264] The surface area of ​​each cheek engagement member may include a surface material with relatively higher friction than the respective connector in order to assist in holding or stabilizing the patient interface on the user's face.

[0265] The material may be a thermoplastic elastomer.

[0266] The surface area of ​​each cheek engagement member may have a larger surface area at the ends of adjacent cheek engagement members separated by the patient interface than at the opposite end of the cheek member that is further from the patient interface.

[0267] The surface area of ​​each cheek engagement member may be tapered from a relatively wider end to a relatively smaller end.

[0268] Each cheek engagement member may be a sleeve configured to receptively hold the respective connector therein.

[0269] The sleeves may be configured to be removably attached around each connector.

[0270] The connector can be fitted to extend through a passage within the sleeve.

[0271] The sensor may be connected to one or more sensor wires, one or more of which extend through a passage within the sleeve.

[0272] Each connector can be substantially housed by its respective sleeve in an area adapted to be positioned adjacent to the user's cheek during use.

[0273] Each sleeve may curve along at least a portion of its length to complement the contour of each cheek.

[0274] Each connector may be curved along at least a portion of the length of the connector that is adapted to be positioned adjacent to each cheek.

[0275] The connector may be pre-formed to have a curved contour.

[0276] Each sleeve can be pre-formed to have a curved contour.

[0277] Each sleeve may bend when enclosing its respective connector.

[0278] Each connector includes a clip for detachable connection to the patient interface.

[0279] Each connector, once in a predetermined position, can be frictionally engaged with its respective cheek engagement member or mechanically engaged.

[0280] One or more sensors can be mounted on the sleeve.

[0281] One or more sensors may be removably attached to the cheek member.

[0282] The outer surfaces of one or more sensors may lie coplanar with the surface area of ​​the cheek member.

[0283] According to one aspect of this disclosure, a respiratory support system that generates a gas flow, A respiratory support device, Flow generator and The outlet of the respiratory support device, Controller and A respiratory support device including, Intake conduit, A patient end having an inspiratory conduit outlet, Device end having intake conduit inlet and An intake conduit including, A nasal cannula interface or headgear of any of the preceding descriptions Includes, The respiratory support device outlet is configured to form pneumatic and electrical connections with the inspiratory conduit inlet. The respiratory support device outlet communicates electrically with the controller. A respiratory support system is provided, in which the controller is configured to power one or more sensors and to receive data from one or more sensors.

[0284] A flow generator can be a blower.

[0285] The respiratory support system may further include a humidifier that adds heat and / or moisture to the gas stream.

[0286] The respiratory support system may further include an ambient air inlet.

[0287] The respiratory support system may further include at least one auxiliary gas inlet that receives a flow of auxiliary gas.

[0288] One or more auxiliary gas inlets may include at least one oxygen inlet.

[0289] The respiratory support system may further include a valve that regulates the flow of auxiliary gas through at least one of one or more auxiliary gas inlets.

[0290] The valve could be a proportional valve.

[0291] The respiratory support device may include one or more gas composition sensors for measuring the composition of the gas flow.

[0292] One or more gas composition sensors may include an ultrasonic sensor system.

[0293] The controller is Receive a measure of the gas flow composition from one or more gas composition sensors. The composition of the gas flow is compared to the target gas composition. Adjust the valve position based at least partially on the difference between the two values. It can be configured in this way.

[0294] The target gas composition can be set by the user.

[0295] The controller is Receive parameter scales from one or more sensors, Compare the parameter scale with the parameter target value. Adjust the target gas composition based at least partially on the difference between the scale and the target value. It can be configured in this way.

[0296] The target values ​​for parameters can be set by the user.

[0297] The parameter scale can be used by the controller to determine when the patient is using a nasal cannula interface.

[0298] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula comprising a body that defines at least a portion of the gas flow path and has a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, and the body comprises a nasal cannula with a lateral mount, A headgear according to any one of the above descriptions, wherein the first connector of the headgear is connected to the lateral mount of the main unit, and A nasal cannula interface including this is provided.

[0299] The main body may include recesses positioned between pairs of prongs, and the prongs extend from the main body. The sensor may be located within the recesses between the prongs.

[0300] The nasal cannula interface may include a manifold portion (i.e., a facial attachment portion) that is received within the opening of the main body, the manifold portion having a recess, and when the manifold is inserted into the main body, the recess of the manifold portion aligns with a recess in the main body.

[0301] A nasal cannula interface for supplying a gas flow to a patient, comprising a nasal cannula defining at least a portion of the gas flow path, A body having a base portion and a pair of prongs extending from the base portion, wherein the prongs are configured to direct the gas flow toward the patient's orifice, A gas flow manifold section including a gas inlet for receiving the gas flow from the gas source and a gas outlet for sending the gas flow to the prongs of the main body. The nasal cannula interface includes a patient sensor configured to measure parameters, the patient sensor is positioned between the prongs, and the body includes a recess adjacent to the patient's face.

[0302] The patient sensor may include a pulse oximeter.

[0303] The nasal cannula interface may include multiple patient sensors.

[0304] The gas flow manifold portion may include a recessed portion between the prongs and the sensor positioned within the recess, and The nasal cannula further includes a manifold portion (i.e., a facial attachment portion) that is received within the opening of the main body, the manifold portion having a recess, and when the manifold is inserted into the main body, the recess of the manifold portion aligns with a recess in the main body.

[0305] According to one aspect of the present disclosure, a nasal cannula interface comprising a facial attachment portion having a base portion and at least one nasal prong extending from the base portion and capable of fitting into at least one of the user's nostrils, A gas flow manifold portion having a gas inlet for receiving a gas flow from a gas source and a gas outlet for delivering the gas flow to at least one nasal prong of a facial attachment portion, further including a recess adapted to be received by a base portion of the facial attachment portion for fluid connection of the outlet of the manifold to at least one nasal prong of the facial attachment portion, wherein a patient sensor is positioned within the recess, and A nasal cannula interface including this is provided.

[0306] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The sensor is configured to come into contact with the patient's nose when the nasal cannula interface is in use. A nasal cannula interface including this is provided.

[0307] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The sensor is configured to contact the patient's upper lip when the nasal cannula interface is in use. A nasal cannula interface including this is provided.

[0308] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The sensor is configured to contact the patient's lower lip when the nasal cannula interface is in use. A nasal cannula interface including this is provided.

[0309] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body having a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The sensor is configured to come into contact with the patient's mouth when the nasal cannula interface is in use. A nasal cannula interface including this is provided.

[0310] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body having a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The sensor is configured to come into contact with the patient's cheek when the nasal cannula interface is in use. A nasal cannula interface including this is provided.

[0311] According to one aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body having a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, One or more sensors configured to measure parameters and The sensor is configured to come into contact with the patient's neck when the nasal cannula interface is in use. A nasal cannula interface including this is provided.

[0312] Reference numerals may be reused throughout the drawings to indicate the overall correspondence between reference elements. The drawings are provided to illustrate the embodiments described herein and are not intended to limit the scope of this disclosure. [Brief explanation of the drawing]

[0313] [Figure 1] A respiratory support device is shown in diagram form. [Figure 2] Figure 1 shows a schematic diagram of the closed-loop control system used in the respiratory support device. [Figure 3] An aspect of this disclosure shows a nasal cannula in use by a patient. [Figure 4] A partial front view of a nasal cannula according to one aspect of this disclosure is shown. [Figure 5] Figure 4 shows a disassembled view of the nasal cannula. [Figure 6] This shows a front view of the main body of a nasal cannula according to one aspect of the present disclosure. [Figure 7]Figure 6 shows a rear view of the nasal cannula body, including the patient sensor. [Figure 8] Figure 6 shows a rear view of the nasal cannula body, including an alternative placement of the patient sensor. [Figure 9] Figure 6 shows a rear view of the nasal cannula body, including further alternative placements of the patient sensor. [Figure 10] Figure 6 shows a view of the nasal cannula body directly from the back, including further alternative placements of the patient sensor. [Figure 11] A front perspective view of an alternative configuration for the body of a nasal cannula, including a facial pad, according to one aspect of this disclosure, is shown. [Figure 12] Figure 11 shows a view of the nasal cannula body directly from the back. [Figure 13] This shows a front perspective view of an alternative configuration for the body of a nasal cannula, including a two-component facial pad, according to one aspect of the present disclosure. [Figure 14] Figure 13 shows a lateral view of a nasal cannula. [Figure 15] Figure 13 shows a disassembled view of a nasal cannula. [Figure 16] A nasal cannula in use by a patient is shown, including an alternative configuration for a patient sensor according to one aspect of this disclosure. [Figure 17] Figure 16 shows an enlarged view of Section B. [Figure 18] This invention shows a patient-coupled nasal cannula, including an alternative configuration for a patient sensor according to one aspect of this disclosure. [Figure 19] Figure 15 shows an enlarged view of section B. [Figure 20] A nasal cannula in use by a patient is shown, including an alternative configuration for a patient sensor according to one aspect of this disclosure. [Figure 21] Figure 19 shows an enlarged view of section B. [Figure 22] Figures 20 and 21 show the range of motion of the patient sensor. [Figure 23] Figures 20 and 21 show the further range of motion of the patient sensor. [Figure 24] Figures 20 and 21 show the further range of motion of the patient sensor. [Figure 25] Figures 20 and 21 show the further range of motion of the patient sensor. [Figure 26] Figures 26–28 show a nasal cannula in use in a patient, including an alternative arrangement of wire coils according to one aspect of the present disclosure. [Figure 27] Figures 26–28 show a nasal cannula in use in a patient, including an alternative arrangement of wire coils according to one aspect of the present disclosure. [Figure 28] Figures 26–28 show a nasal cannula in use in a patient, including an alternative arrangement of wire coils according to one aspect of the present disclosure. [Figure 29] Figure 27 shows an enlarged view of section D. [Figure 30] Figures 30 to 32 show a nasal cannula in use in a patient, including a wire coil, according to one aspect of the present disclosure. [Figure 31] Figures 30 to 32 show a nasal cannula in use in a patient, including a wire coil, according to one aspect of the present disclosure. [Figure 32] Figures 30 to 32 show a nasal cannula in use in a patient, including a wire coil, according to one aspect of the present disclosure. [Figure 33] An aspect of this disclosure shows a nasal cannula in use by a patient, including a patient sensor on a frontal strap. [Figure 34] An aspect of this disclosure shows a mask assembly in use by a patient, including a patient sensor on a frontal strap. [Figure 35] An aspect of this disclosure shows a tracheostomy interface in use by a patient, including a patient sensor on a neck strap. [Figure 36] An aspect of this disclosure shows a tracheostomy interface in use by a patient, including a patient sensor on a neckband. [Figure 37A] Figures 37A and 36B show perspective views and exploded perspective views, respectively, of another nasal cannula according to this disclosure, and Figure 37B shows a perspective view of the headgear of the nasal cannula. [Figure 37B]Figures 37A and 36B show perspective views and exploded perspective views, respectively, of another nasal cannula according to this disclosure, and Figure 37B shows a perspective view of the headgear of the nasal cannula. [Figure 37C] Figures 37A and 36B show perspective views and exploded perspective views, respectively, of another nasal cannula according to this disclosure, and Figure 37B shows a perspective view of the headgear of the nasal cannula. [Figure 38A] Figures 38A and 38B show enlarged perspective views of the connection between the nasal cannula and the headgear, illustrating a preferred form of the headgear sleeve. [Figure 38B] Figures 38A and 38B show enlarged perspective views of the connection between the nasal cannula and the headgear, illustrating a preferred form of the headgear sleeve. [Figure 39A] Figures 39A and 39B show enlarged perspective views of the nasal cannula retaining clip according to this disclosure. [Figure 39B] Figures 39A and 39B show enlarged perspective views of the nasal cannula retaining clip according to this disclosure. [Figure 39C] Figures 39A and 39B show enlarged perspective views of the nasal cannula retaining clip according to this disclosure. [Figure 40A] Figures 40A to 40C show enlarged perspective views of the headgear connector that connects to the nasal cannula according to this disclosure. [Figure 40B] Figures 40A to 40C show enlarged perspective views of the headgear connector that connects to the nasal cannula according to this disclosure. [Figure 40C] Figures 40A to 40C show enlarged perspective views of the headgear connector that connects to the nasal cannula according to this disclosure. [Figure 41A] Figures 41A and 41B show cross-sectional views corresponding to Figures 40A and 40B, respectively. [Figure 41B] Figures 41A and 41B show cross-sectional views corresponding to Figures 40A and 40B, respectively. [Figure 42] This is a perspective view of another embodiment of the nasal cannula according to the present disclosure. [Figure 43] Figure 42 is a perspective view of the manifold portion of a nasal cannula. [Modes for carrying out the invention]

[0314] This specification describes several embodiments and examples of respiratory support systems and patient interfaces for such systems. Those skilled in the art will understand that this disclosure extends beyond the embodiments and / or uses specifically disclosed and their apparent modifications and equivalents. Accordingly, the scope of the disclosure disclosed herein is not intended to be limited by any particular embodiment described herein.

[0315] Patients with various health conditions and diseases can benefit from respiratory support. For example, patients with chronic obstructive pulmonary disease (COPD), pneumonia, asthma, bronchopulmonary dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, respiratory trauma, acute dyspnea, pre- and post-operative oxygen delivery, and other conditions or diseases can benefit from respiratory support. As part of providing respiratory support to patients, one or more physiological parameters of the patient can be measured by a patient sensor for the purpose of monitoring the patient's health. The patient sensor may be a pulse oximeter that provides information on heart rate and blood oxygen saturation (SpO2).

[0316] When providing respiratory support, particularly oxygen supplementation therapy, to a patient, a common way to monitor the patient's health is to ensure that the patient's SpO2 does not drop excessively (e.g., usually below about 90%). However, supplying the patient with too much oxygen can over-oxygenate the patient's blood and is considered equally dangerous. Generally, a patient's SpO2 is maintained in the range of about 80% to about 99%, preferably about 92% to about 96%, although these ranges may vary depending on the patient's condition and / or from patient to patient.

[0317] Due to various patient factors such as respiratory rate, tidal volume, heart rate, activity level, height, weight, age, sex, and other factors, there is no single prescribed level of supplemental oxygen that can consistently achieve a target SpO2 response for each patient. Individual patients need regular monitoring and adjustment of the oxygen fraction (FdO2) delivered to them to ensure they receive the correct FdO2 to achieve their target SpO2. Achieving accurate and consistent SpO2 is a critical factor in treating patients with various health conditions or diseases. Furthermore, patients with these health problems can benefit from systems that automatically control oxygen saturation. This disclosure is applicable to a wide range of patients requiring rapid and accurate oxygen saturation control.

[0318] The fraction of oxygen (FdO2) delivered to the patient can be manually controlled. For example, the user can manually adjust the oxygen supply valve to change the flow rate or concentration of oxygen delivered to the patient. The user can determine the patient's SpO2 level using a patient monitor such as a pulse oximeter. The SpO2 measurement can be displayed on the respiratory support device 10 or on the pulse oximeter itself. The user can continue to manually adjust the amount of oxygen delivered to the patient until the patient's SpO2 level reaches the determined level.

[0319] When patient sensors are used as part of a respiratory support system, the user is required to attach the patient sensor to the patient. This adds another task to the already potentially large set of tasks required to set up the respiratory support system. Furthermore, the separate patient sensor can lead to problems such as incorrect sensor installation and / or the sensor falling out during use, resulting in inaccurate measurements.

[0320] Therefore, a patient interface incorporating patient sensors enables the use of patient sensors without increasing the user's workload. This could be beneficial in hospital settings where one clinician may need to attend to many patients. Furthermore, it could also be beneficial in home settings, as it simplifies the setup process for patients who may need to perform these tasks themselves. In addition, integrating patient sensors into the patient interface helps ensure the correct orientation of the patient sensors and prevents them from falling during use.

[0321] This disclosure refers to a conduit heater, which is a broad term and should be given its ordinary and customary meaning to those skilled in the art (i.e., not limited to any special or customized meaning), and without limitation includes one or more heater strips, one or more heater wires, and / or one or more conductive elements that generate heat when power is supplied. Examples of such conduit heaters include wires made of a conductive metal (e.g., copper), conductive polymers, conductive inks printed on the surface of a conduit, conductive materials used to create tracks on a conduit, and the like.

[0322] Furthermore, this disclosure refers to conduits, rims, and medical conduits in relation to gas delivery. For example, conduit is a broad term and its common and customary meaning should be given to those skilled in the art, and without limitation includes passages having various cross-sections, such as cylindrical and non-cylindrical passages.

[0323] The disclosed systems, devices, and medical conduits can also be used in breathing circuits configured to provide other forms of respiratory support, such as continuous, variable, or bi-level positive airway pressure (PAP) therapy or high-flow or low-flow oxygen therapy. The breathing circuit may include, for example, an inspiratory circuit that includes at least an inspiratory gas pathway (including all components) from the gas supply unit to the patient interface.

[0324] The respiratory support system may include a respiratory support device 10 and a patient interface incorporating sensors, as shown in Figure 1. The respiratory support device 10 may be configured to provide, for example, high-flow therapy. The respiratory support device 10 may include a main housing 100 that houses a flow generator 11, such as in the form of a motor / impeller arrangement (e.g., a blower), an optional humidifier 12, a controller 13, and a user interface 14 (including, for example, a display and input devices such as buttons and a touchscreen). The humidifier may include a heater bay configured to receive a humidification chamber and include a heating element such as a heater plate. When in use, the humidification chamber receives heat from the heating element, raising the temperature of the water body contained within the humidification chamber. A gas flow passes over the water body, and heat and moisture are added to the gas flow.

[0325] The controller 13 can be configured or programmed to control the operation of the device. For example, the controller can control components of the device, such as, but not limited to, operating the flow generator 11 to generate a flow of gas to be delivered to the patient (gas flow), operating the humidifier 12 (if present) to humidify and / or heat the generated gas flow, controlling the flow of oxygen to the flow generator, receiving user input from the user interface 14 for reconfiguration and / or user-defined operation of the device 10, and outputting information to the user (e.g., on the display). The user may be a patient, a medical professional, or any other person interested in using the device. As used herein, “gas flow” may refer to any flow of gas that can be used in breathing assistance or the breathing assistance device 10, such as a flow of ambient air, a flow containing substantially 100% oxygen, or a flow containing any combination of ambient air and oxygen.

[0326] An inspiratory conduit 16 is connected at one end to a gas outlet 21 within the housing 100 of the respiratory support device 10. In an alternative configuration, the inspiratory conduit 16 is connected at one end to the gas outlet of a humidifier 12. The inspiratory conduit 16 is connected at the other end to a patient interface 17, such as an unsealed nasal cannula having a body 19 including one or more nasal prongs 18. Alternatively, the inspiratory conduit 16 can be connected to a face mask, nasal mask, nasal pillow mask, endotracheal tube, tracheostomy interface, etc. The gas flow generated by the respiratory support device 10 can be humidified and delivered to the patient through the cannula 17 via the inspiratory conduit 16. The inspiratory conduit 16 may have a conduit heater, such as one or more heater wires 16a, which heat the gas flow as it passes to the patient. The conduit heater may be under the control of a controller 13. The respiratory support device 10, the inspiratory conduit 16, and the patient interface 17 can together form a respiratory support system.

[0327] The controller 13 can control the flow generator 11 to generate a gas flow of a desired flow rate. The controller 13 can also control the supplemental oxygen inlet to enable the delivery of supplemental oxygen, and the humidifier 12 (if present) can humidify the gas flow and / or heat the gas flow to an appropriate level. The gas flow is directed to the patient through the inspiratory conduit 16 and cannula 17. The controller 13 can also control the heating element in the humidifier 12 and / or the heating element 16a in the inspiratory conduit 16 to heat the gas to a desired temperature for a desired level of therapy and / or a desired level of comfort for the patient. The controller 13 can be programmed with a preferred target temperature for the gas flow, or the controller 13 can determine such a temperature.

[0328] The oxygen inlet port 28 may include a valve through which pressurized gas can enter the respiratory support device 10. The valve can control the flow of oxygen to the respiratory support device 10. The valve may be any type of valve, including a proportional valve or a binary valve. The oxygen source may be an oxygen tank or a hospital oxygen supply facility. Medical oxygen is typically 95% to 100% pure. Lower purity oxygen sources may also be used. Examples of valve modules and filters are disclosed in U.S. Provisional Patent Application No. 62 / 409,543, entitled “Valve Module and Filter,” filed on 18 October 2016, and in U.S. Provisional Patent Application No. 62 / 488,841, entitled “Valve Module and Filter,” filed on 23 April 2017, which are incorporated herein by reference in their entirety.

[0329] The respiratory support device 10 can measure and control the oxygen content of the gas delivered to the patient, and therefore the oxygen content of the gas inhaled by the patient. During high-flow therapy, the delivered high-flow gas meets or exceeds the patient's peak inspiratory requirement. This means that the volume of gas delivered to the patient by the respiratory support device 10 during inspiration meets or exceeds the volume of gas inhaled by the patient during inspiration. Thus, high-flow therapy helps prevent the inhalation of ambient air when the patient inhales and flushes the patient's airways with exhaled gas. As long as the flow rate of the delivered gas meets or exceeds the patient's peak inspiratory requirement, the inhalation of ambient air is prevented, and the gas delivered by the respiratory support device 10 is substantially the same as the gas inhaled by the patient. Therefore, the oxygen concentration measured by the respiratory support device 10, i.e., the delivered oxygen fraction (FdO2), is substantially the same as the oxygen concentration inhaled by the user, i.e., the inspiratory oxygen fraction (FiO2), and thus these terms can be considered equivalent.

[0330] Operating sensors 3a, 3b, 3c, such as flow rate, temperature, humidity, and / or pressure sensors, can be placed at various locations within the respiratory support device 10. Additional sensors (e.g., sensors 20, 25) can be placed at various locations on the inspiratory conduit 16 and / or cannula 17 (e.g., a temperature sensor may be located at or near the end of the inspiratory conduit 16). Sensors 20, 25 may be CO2 sensors or pressure sensors or flow rate sensors or oxygen sensors. Outputs from the sensors are received by the controller 13, which can help the controller operate the respiratory support device 10 to provide a suitable therapy. In some configurations, providing a suitable therapy includes meeting the patient's peak inspiratory demands. The device 10 may have transmitters and / or receivers 15 that enable the controller 13 to receive signals 8 from the operating sensors and any additional sensors and / or control various components of the respiratory support device 10 or accessories or peripheral devices associated with the respiratory support device 10, including, but not limited to, a flow generator 11, a humidifier 12, and a heater wire 16a. Furthermore, or alternatively, the transmitter and / or receiver 15 may send data to a remote server or enable remote control of the device 10.

[0331] The respiratory support device 10 can receive measurements from one or more gas composition sensors. The gas composition sensors may be located in the respiratory support device 10, the inspiratory conduit 16, the patient interface, or any other suitable location. The gas composition sensors may be located where the ambient air and any auxiliary gas flow, such as oxygen, ends up mixing, or downstream thereof. The gas composition sensors may be configured to measure oxygen concentration. The gas composition sensors may be ultrasonic transducer systems, also referred to herein as ultrasonic sensor systems.

[0332] The respiratory support device 10 may be configured to connect to a patient sensor 29, such as a pulse oximeter or patient monitoring system, which will be described later, to measure one or more physiological parameters of the patient, such as the patient's blood oxygen saturation (SpO2) (i.e., peripheral arterial oxyhemoglobin), heart rate, respiratory rate, and perfusion index, and to provide a measure of signal quality. The patient sensor 29 may be part of additional sensors 20, 25, or may be a separate additional sensor located on or within the patient interface or delivery conduit. The sensor may communicate with the controller 13 via a wired connection or via a wireless transmitter on the sensor. Sensors designed for different age groups and to connect to different locations on the patient are available and can be used in the respiratory support device.

[0333] The pulse oximeter is connected to the processor of the respiratory support device 10 and continuously provides a signal indicating the patient's blood oxygen saturation. The patient sensor 29 may be a hot-swappable device. As used herein, the term “hot-swappable device” refers to a device that can be attached to or replaced while the respiratory support device 10 is in operation. For example, the patient sensor 29 may be connected to the respiratory support device 10 using a USB interface with lead wires or wires, or using a wireless communication protocol (e.g., near-field communication, WiFi, or Bluetooth®). The output of the pulse oximeter can be displayed on the graphical user interface 14. Measurements from the pulse oximeter 29 may be transmitted to a remote patient management system (e.g., a remote server system) via a suitable wireless protocol, such as GSM.

[0334] If the patient sensor 29 is disconnected (from the patient or the respiratory support device) during operation, the respiratory support device 10 may continue operating in its previous operating state for a predetermined period of time. After the predetermined period, the respiratory support device 10 may trigger an alarm, switch from automatic mode to manual mode, and / or completely exit control mode (e.g., automatic mode or manual mode).

[0335] The respiratory support device 10 may be configured to recognize whether the patient sensor 29 is a standalone patient sensor, or a patient sensor located on or included in the patient interface 17. The respiratory support device 10 can recognize the type of sensor by receiving identification information when the patient sensor 29 is initially connected. The respiratory support device 10 may recognize the sensor type through the method of receiving signals from the patient sensor 29. For example, an integrated patient sensor 29 may be configured to communicate with the respiratory support device 10 via an electrical connection located at the gas outlet of the respiratory support device 10 (as described herein), while a standalone patient sensor may be configured to connect with the respiratory support device via a separate connection port.

[0336] The respiratory support device 10 may be configured to use the output of a patient sensor 29 located on or included in the patient interface 17 to determine whether the patient is wearing the patient interface 17. In this context, “wearing” means that the patient interface 17 is fitted in place on the patient’s face so that a gas flow can be delivered to the patient and the patient sensor 29 can measure one or more patient parameters. The patient sensor 29 may generate a signal indicating that it cannot reliably measure one or more patient parameters. Furthermore, or alternatively, the patient sensor 29 may communicate separate parameters such as signal quality. When determining whether the patient sensor 29 can reliably measure one or more patient parameters, the respiratory support device 10 may check these parameters against a threshold. The respiratory support device 10 may use the determination that the patient sensor 29 cannot reliably measure one or more patient parameters to further determine that the patient is not wearing the patient interface 17.

[0337] The respiratory support device 10 can be used to determine whether or not the patient is wearing the patient interface 17 in order to activate or deactivate several control algorithms, such as a closed-loop SpO2 controller, which will be described in detail later in this specification. The respiratory support device 10 can use its indicators when increasing or decreasing the flow rate. For example, the respiratory support device 10 can reduce the flow rate when the patient is not wearing the patient interface 17 in order to reduce noise and power consumption. The respiratory support device 10 can use its indicators to generate an alarm, such as an alarm sounding if the patient removes the patient interface 17. This alarm may occur instantaneously after the output of the patient sensor 29 is lost, or within a set period of time.

[0338] In a further configuration, the respiratory support device 10 is configured to switch to standby mode if the output of the patient sensor 29 indicates that the patient is not wearing the patient interface 17. In standby mode, the respiratory support device 10 may be configured to control the blower to operate at a reduced motor speed. The reduced motor speed may be the minimum operating speed of the blower. The reduced motor speed may be approximately 1000 RPM to 2000 RPM. In standby mode, the respiratory support device 10 may be configured to control the blower to deliver a reduced flow rate. The reduced motor speed may be approximately 1 LPM to 2 LPM.

[0339] The respiratory support device 10 may include a high-flow respiratory support device. High-flow therapy as considered herein is intended to be given its typical and common meaning as understood by those skilled in the art, and it generally refers to a respiratory support system that delivers a target flow rate of humidified respiratory gas through a deliberately open patient interface at a flow rate generally intended to meet or exceed the patient's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults are, but are not limited to, often in the range of about 15 liters / minute (LPM) to about 70 liters / minute or more. Typical flow rates for pediatric patients (neonatal, infant and child, etc.) are, but are not limited to, often in the range of about 1 liter / minute per kilogram of patient weight to about 3 liters / minute per kilogram of patient weight or more. High-flow therapy may optionally also include the administration of gas mixture compositions containing supplemental oxygen and / or therapeutic agents. High-flow therapy is commonly referred to by various names, including nasal high-flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen (HFNO), high-flow therapy (HFT), or tracheostomy high-flow (THF). The flow rate used to achieve "high flow" may be any of the flow rates listed below. For example, in some configurations, for adult patients, "high-flow therapy" may refer to the delivery of gas to the patient at a flow rate of approximately 10 liters / minute (10 LPM) or higher, such as approximately 10 LPM to 100 LPM, or approximately 15 LPM to 95 LPM, or approximately 20 LPM to 90 LPM, or approximately 25 LPM to 75 LPM, or approximately 25 LPM to 85 LPM, or approximately 30 LPM to 80 LPM, or approximately 35 LPM to 75 LPM, or approximately 40 LPM to 70 LPM, or approximately 45 LPM to 65 LPM, or approximately 50 LPM to 60 LPM.In some configurations, for neonatal, infant, or pediatric patients, “high-flow therapy” may refer to the delivery of gas to the patient at a flow rate exceeding 1 LPM, such as approximately 1 LPM to approximately 25 LPM, approximately 2 LPM to approximately 25 LPM, or approximately 2 LPM to approximately 5 LPM, or approximately 5 LPM to approximately 25 LPM, or approximately 5 LPM to approximately 10 LPM, or approximately 10 LPM to approximately 25 LPM, or approximately 10 LPM to approximately 20 LPM, or approximately 10 LPM to approximately 15 LPM, or approximately 20 LPM to approximately 25 LPM. High-flow respiratory support devices for adult patients, neonatal, infant, or pediatric patients can deliver gas to the patient at a flow rate of approximately 1 LPM to approximately 100 LPM or any flow rate within the subrange outlined above. Respiratory support device 10 can deliver oxygen (e.g., FdO2) at any concentration up to 100% at any flow rate of approximately 1 LPM to approximately 100 LPM. In some configurations, any flow rate can be combined with oxygen concentrations (FdO2) of approximately 20%-30%, 21%-30%, 21%-40%, 30%-40%, 40%-50%, 50%-60%, 60%-70%, 70%-80%, 80%-90%, and 90%-100%. In some combinations, the flow rate can be approximately 25 LPM-75 LPM when combined with oxygen concentrations (FdO2) of approximately 20%-30%, 21%-30%, 21%-40%, 30%-40%, 40%-50%, 50%-60%, 60%-70%, 70%-80%, 80%-90%, and 90%-100%. In some configurations, the respiratory support device 10 may include a safety threshold to prevent the user from delivering excessive oxygen to the patient when operating in manual mode.

[0340] High-flow therapy can be administered to the user through the nostrils and / or orally or via a tracheostomy interface. High-flow therapy can deliver gas to the user at or above the intended user peak inspiratory flow rate requirement. High-flow therapy can generate a flushing effect in the nasopharynx so that it is flushed by a high-flow gas stream entering the anatomical dead space of the upper airway. This can provide a reservoir of fresh gas available with each breath while minimizing nitrogen and carbon dioxide rebreathing. Meeting inspiratory demands and flushing the airways is even more important when trying to control the patient's FdO2. High-flow therapy can be delivered using an unsealed patient interface, such as a nasal cannula. The nasal cannula may be configured to deliver respiratory gas to the user's nostrils at a flow rate exceeding the intended user peak inspiratory flow rate requirement.

[0341] As used herein, the term “unsealed patient interface” may refer to an interface that provides a pneumatic link between the patient’s airway and a gas flow source (such as from the flow generator 11) without completely occluding the patient’s airway. An unsealed pneumatic link may involve occlusion of less than approximately 95% of the patient’s airway. An unsealed pneumatic link may involve occlusion of less than approximately 90% of the patient’s airway. An unsealed pneumatic link may involve occlusion of approximately 40% to approximately 80% of the patient’s airway. The airway may include one or more of the patient’s nostrils or mouth. In the case of a nasal cannula, the airway passes through the nostrils.

[0342] The respiratory support device 10 may include an ambient air inlet port 27 for drawing in ambient room air. The respiratory support device 10 may also include an oxygen inlet port 28 leading to a valve through which pressurized gas can enter the respiratory support device 10. The valve can control the flow of oxygen to the respiratory support device 10. The valve may be any type of valve, including a proportional valve or a binary valve.

[0343] In a further configuration, the respiratory support device 10 includes two or more oxygen inlet ports. A first oxygen inlet port, also called a high-pressure oxygen inlet, receives oxygen from an oxygen source at a set pressure. The flow rate of oxygen from the first oxygen inlet port is regulated by a valve as described above. A second oxygen inlet port, also called a low-pressure oxygen inlet, receives oxygen from an oxygen source at a set flow rate. The flow rate of oxygen passing through the second oxygen inlet port can be adjusted by adjusting the external flow regulator of the oxygen source.

[0344] The blower can operate at motor speeds between approximately 1,000 RPM and less than approximately 30,000 RPM, approximately 2,000 RPM and less than approximately 21,000 RPM, approximately 4,000 RPM and less than approximately 19,000 RPM, or any of the values ​​mentioned above. The blower's operation can mix the gas flow entering the blower through the inlet port. By using the blower as a mixer, the pressure drop that would otherwise occur in a system with a separate mixer, such as a static mixer containing a baffle, due to the energy required for mixing can be reduced. The presence of a static mixer may also increase the volume of the gas flow path between the valve and the gas composition sensor, which may further increase the delay between when the valve current changes and when the corresponding change in oxygen concentration is measured.

[0345] Based on user input and the therapy supplied from the respiratory support device 10, the controller 13 can determine the target output parameter of the blower. The controller receives the measured value of the target output parameter and can adjust the blower speed based on the difference between the determined flow rate and the measured flow rate.

[0346] Referring again to Figure 1, the controller 13 may be programmed with or configured to run a closed-loop control system for controlling the operation of the respiratory support device. The closed-loop control system may be configured to ensure that the patient's SpO2 reaches and consistently remains at or near a target level.

[0347] The controller 13 can receive user input that can be used for the controller 13 to perform a closed-loop control system. The target SpO2 value may be a single value or a range of values. The value may be preset, selected by a clinician, or determined based on the patient type, where the patient type may refer to information about the patient, such as the current pain and / or age, weight, height, sex, and other patient characteristics. The target SpO2 value can be entered by a clinician or user via a user interface on the device and received by the controller 13. Similarly, the target SpO2 may be two values, each selected in any of the ways described above. These two values ​​represent an acceptable range of values ​​for the patient's SpO2. The controller may target a value within the range. The target value may be an intermediate value within the range or any other value within the range, and may be preset or selected by the user. Alternatively, the range may be automatically set based on the target SpO2 value. The controller may be configured to show one or more set responses when the patient's SpO2 value falls outside the range. Possible responses include issuing an alarm, switching to manual control of FdO2, changing FdO2 to a predetermined value, and / or other responses. The controller may have one or more ranges, and one or more different responses may occur when the value falls outside each range.

[0348] Generally, SpO2 is controlled between approximately 80% and 100%, or approximately 80% and 90%, or approximately 88% and 92%, or approximately 90% and 99%, or approximately 92% and 96%. SpO2 can be controlled between any two preferred values ​​from any two of the above ranges. The target SpO2 may be approximately 80% and 100%, or approximately 80% and 90%, or approximately 88% and 92%, or approximately 90% and 99%, or approximately 92% and 96%, or approximately 94%, or 94%, or approximately 90%, or 90%, or approximately 85%, or 85%. The target SpO2 can be any value between any two preferred values ​​from any two of the above ranges. The target SpO2 can correspond to the middle of the specified SpO2 range.

[0349] FdO2 can be configured to be controlled within a certain range. As previously mentioned, the oxygen concentration (FdO2) measured within the device is substantially the same as the oxygen concentration (FiO2) inhaled by the patient, as long as the flow rate meets or exceeds the patient's peak inspiratory demand; therefore, these terms can be considered equivalent. Each of the range limits can be preset, selected by the user, or determined based on the patient type, where the patient type may refer to information about the patient, such as current distress and / or age, weight, height, sex, and / or other patient characteristics. Alternatively, a single value for FdO2 can be selected, and the range can be determined at least partially based on this value. For example, the range may be a set amount above and below the selected FdO2. The selected FdO2 can be used as the controller's starting point. If the controller attempts to move FdO2 outside the range, the system may exhibit one or more responses. These responses may include issuing an alarm, preventing FdO2 from falling outside a range, switching to manual control of FdO2, and / or switching to a predetermined FdO2. The respiratory support device 10 may have one or more ranges, and one or more different responses may occur when the limit of each range is reached.

[0350] Referring to Figure 2, a schematic diagram of the closed-loop control system 1000 is shown. The closed-loop control system can utilize two control loops. The first control loop can be implemented by the SpO2 controller. The SpO2 controller can determine the target FdO2 based in part on the target SpO2 and / or the measured SpO2. As mentioned above, the target SpO2 value can be a single value or a range of acceptable values. This value can be pre-set, selected by the clinician, or automatically determined based on the user's characteristics. Generally, the target SpO2 value can be received at any point during the treatment session, but is received or determined before or at the start of the treatment session. During the treatment session, the SpO2 controller can also receive measured FdO2 readings from the gas composition sensor, measured SpO2 readings from the patient sensor 29, and signal quality readings as input. In some configurations, the SpO2 controller can accept target FdO2 as input, in which case the output of the SpO2 controller can be directly returned to the SpO2 controller as input. Based on the input in at least some cases, the SpO2 controller can output target FdO2 to a second control loop.

[0351] During a treatment session, the SpO2 controller and FdO2 controller can continue to automatically control the operation of the respiratory support device until the treatment session ends or an event triggers a change from automatic to manual mode.

[0352] For example, a respiratory support system that uses blood oxygen saturation measurements from a pulse oximeter to automatically adjust the oxygen fractionation of a gas stream delivered to a patient via a patient interface is described in the applicant’s earlier PCT application, International Publication No. 2019 / 070136 (hereinafter referred to herein as WO’136), filed on 5 October 2018 and incorporated herein by reference in its entirety.

[0353] The respiratory support system described in WO'136 uses a separate pulse oximeter and patient interface. Therefore, the clinician must attach both the pulse oximeter and patient interface to the patient individually, and both of these components are also connected individually to the respiratory support device.

[0354] Referring again to Figure 1, the controller 13 may be programmed with or configured to run an FdO2 control system for controlling the operation of the respiratory support device.

[0355] An FdO2 control system can be configured to ensure that instantaneous FdO2 is maintained at a target level at all points during a treatment session. The controller can measure FdO2, compare it to the target FdO2, and then adjust the oxygen inlet valve accordingly. However, if the FdO2 sensor is located at a considerable distance from the valve, there is a time delay between when the valve is modified and when the corresponding change in FdO2 is measured. The controller can adjust the valve after that time delay. However, if the flow rate fluctuates, the controller may be able to achieve the target FdO2 on average, but not continuously and substantially instantaneously. As shown in Figure 2, in order to maintain FdO2 at the target level continuously and substantially instantaneously without moving the FdO2 sensor closer to the valve, the FdO2 controller can take the total flow rate measurements into account when controlling the valve.

[0356] A patient interface 17 is connected to one end of the inspiratory conduit 16 and is used to provide the patient with a breathable gas flow. During the setup of the respiratory support device 10, the clinician or patient is required to attach the patient interface 17 to the patient. Furthermore, if a separate patient sensor 29 is also used, the clinician or patient is also required to attach it to the patient. Both the patient interface 17 and the patient sensor 29 also need to be attached to the respiratory support device 10 itself. Forming these various connections may be undesirable.

[0357] The patient interface 17 has one or more patient sensors 29. One or more integrated patient sensors 29 may be configured to measure the patient's blood oxygen saturation. One or more integrated patient sensors 29 are positioned on the patient interface 17 to facilitate the measurement of the patient's blood oxygen saturation.

[0358] The patient interface 17 can be used with the respiratory support device 10 described above. Alternatively, the patient interface 17 can be used with any other respiratory support device that can utilize the patient interface 17 having a patient sensor 29, such as a ventilator, CPAP device, standalone humidifier and / or oxygen blender.

[0359] The patient interface 17 may include a nasal cannula interface, as shown in Figures 3 to 33. In this configuration, the nasal cannula interface generally includes a head fixation assembly and a nasal cannula 30, as well as a gas inlet conduit 62. The head fixation assembly allows the user to position and maintain the nasal cannula 30 in a precise working position. The gas inlet conduit 62 forms a fluid or gas connection between the outlet end of the inspiratory conduit 16 and the nasal cannula 30, allowing fluid or gas to flow between the inspiratory conduit and the nasal cannula. Details of the gas inlet conduit 62 and the main parts of the nasal cannula 30 will be described in detail later.

[0360] The head fixation assembly of the nasal cannula 30 may include one or more straps. The one or more straps may include two anterior straps 50, a posterior strap 53a, and a apical strap 53b, as shown in Figure 3. In some configurations, the proximal end of the anterior strap 50 is removably connected to the nasal cannula 30. In other configurations, the proximal end of the anterior strap 50 is non-removably connected to the nasal cannula 30. The posterior strap 53a and apical strap 53b extend between the distal ends of the anterior strap 50. When in use, the posterior strap 53a wraps around the back of the patient's head. When in use, the apical strap 53b wraps around the top of the patient's head. In some configurations, the head fixation assembly is adjustable so that patients with different head shapes and sizes can use the nasal cannula 30. For example, it may include an adjuster such as an adjustment buckle 54 that allows the patient to loosen or tighten the apical strap 53b.

[0361] In some configurations, one or more of the straps are substantially elastic (i.e., made from an elastic material that can stretch to accommodate the patient's head, such as Lycra®). In some configurations, one or more of the straps are substantially rigid. In some configurations, one or more of the straps are made from a substantially rigid material. In some configurations, one or more of the straps are substantially non-stretchable. In some configurations, one or more of the straps are made from a substantially non-stretchable material. In some configurations, one or more of the straps are self-supporting. In some configurations, one or more of the straps maintain their shape when not in use.

[0362] Alternatively, the patient interface 17 is secured to the patient's head and face by a front strap 50 and a single rear strap 53a attached to the front strap 50. The rear strap is attached to the front strap 50 via a buckle 54. Alternatively, the rear strap 53a is integrated with the front strap 50. The buckle 54 allows the patient to loosen or tighten the front strap 50 according to their personal preference. Alternatively, the integrated front strap 50 and rear strap 53a are elastic and can be stretched over the patient's head. The elasticity of the straps applies force to the head to hold the nasal cannula 30 in the optimal position when in use. The elastic straps 50, 53a can be used with the adjustable buckle 54, or the elastic straps 50, 53a can be used alone without the buckle 54.

[0363] The head restraint assembly may also include a loop 55 that holds and supports the gas inlet conduit 62 at or near its inlet end, as shown in Figure 3. The loop 55 includes a first end connected to one of the front straps 50. The first end may be slidably connected to the front strap 50. The loop 55 includes a second end connected to the gas inlet conduit 62. The second end may be detachably connected to the gas inlet conduit 62. Alternatively, the interface may include a tube clip that connects to the tube and can be detachably coupled to the cannula. The tube clip supports the weight of the inlet conduit 62 and reduces the moment caused by the conduit 62, thereby improving the stability of the patient interface 17. The clip helps reduce the likelihood of the patient interface 17 coming loose. The clip may be formed of a rigid material.

[0364] A lanyard 63 can also be provided on the patient interface 17. Figure 3 shows an example of a lanyard 63. In the illustrated configuration, the lanyard 63 is connected to the gas inlet conduit 62. Alternatively, the lanyard 63 is connected at or near the connection point between the inspiratory conduit 16 and the gas inlet conduit 62. When in use, the lanyard 63 supports the weight of the inspiratory conduit 16 and the gas inlet conduit 62. A toggle 64 is provided on the lanyard 63 to allow adjustment of the lanyard's length. The toggle 64 makes the lanyard 63 suitable for patients of any size using the patient interface 17. When in use, the lanyard 63 supports at least a portion of the weight of the inspiratory conduit 16, so that the weight does not act on the user or the nasal cannula 30. The use of the lanyard 63 reduces the combined weight portion of the inspiratory conduit 16 and gas inlet conduit 62 that pulls the nasal cannula 30, and helps prevent the nasal prongs 33, 34 from interfering with the sensitive inner surface of the nasal cavity or shifting or becoming misaligned during use. In the illustrated configuration, the lanyard 63 fits loosely around the neck to reduce the possibility of strangulation of the user. The lanyard 63 also provides a convenient way to support the inspiratory conduit 16 and gas inlet conduit 62. This helps allow the patient to turn over in bed without strongly pulling or pulling the inspiratory conduit 16 and to avoid the gas inlet conduit 62 overheating under the blanket. In one configuration, the lanyard 63 has a clip that allows the user to open and close the lanyard in order to position and secure the lanyard 63 around the user's neck. The clip includes male and female connectors that snap together. The clip is separated by pulling one end of the lanyard 63. The clip is easily detachable, and the user can release the connection by pulling one end of the lanyard. This allows for the rapid removal of the lanyard 63 in emergency situations, such as when intubation is required in a patient.

[0365] Next, the gas inlet conduit 62 will be described in detail. The gas inlet conduit 62 is a conduit or tube that is shorter in length than the inspiratory conduit 16, extending between the outlet of the inspiratory conduit 16 and the nasal cannula 30. When in use, the gas inlet conduit 62 forms a lumen, which defines a gas pathway between the inspiratory conduit 16 and the patient interface 17, so that the gas flow exits the inspiratory conduit 16, enters the gas inlet conduit 62, travels along the gas inlet conduit 62 to the patient interface 17, and is delivered to the patient. One reason why secondary conduits such as the gas inlet conduit 62 can be used is as follows: The inspiratory conduit 16 is relatively heavy and difficult to handle because it is used to transport the gas flow over a moderately long distance (from the humidifier unit 2 to a point close to the patient). Therefore, the inspiratory conduit 16 is required to have walls that are strong enough to support its own weight without collapsing. Because the inspiratory conduit 16 is typically relatively long (e.g., 8-10 feet), this additional length and thicker wall structure increase the weight of the inspiratory conduit 16. If the outlet of the inspiratory conduit 16 is connected directly to the patient interface in a manner that requires the patient to support this weight, the weight of the inspiratory conduit 16 acts on the patient, which can cause discomfort. Furthermore, the weight of the inspiratory conduit 16 can pull on the patient interface 17, potentially causing it to detach or become displaced. A lighter and shorter secondary conduit (e.g., a gas inlet conduit 62) can be used extending between the outlet of the inspiratory conduit 16 and the patient interface 17.

[0366] The gas inlet conduit 62 is lighter and shorter than the inspiratory conduit 16 and, as outlined above, is generally used with, for example, a lanyard 63 connected to the gas inlet conduit 62 or to the connection between the inspiratory conduit 16 and the gas inlet conduit 62. When in use, the lanyard 63 (as outlined above) supports at least a portion of the weight of the inspiratory conduit 16, so that the patient interface 17 only needs to support the relatively lighter gas inlet conduit 62. Furthermore, in a configuration where the lanyard 63 is connected to the end of the gas inlet conduit 62, the patient does not need to remove the lanyard 63 when separating the inlet conduit 62 from the inspiratory conduit.

[0367] Here, various embodiments of the nasal cannula 30 will be described in more detail with reference to Figures 4 to 33. Unless otherwise noted, the nasal cannula 30 shown in Figures 4 to 33 includes all the generalized features of the nasal cannula described with reference to Figure 3.

[0368] The nasal cannula 30 includes two main components: an interface connector 35 and a main body 32. Here, an example of the configuration of these two components will be described with particular reference to Figures 4 and 5.

[0369] When in use, the interface connector 35 is connected to the gas inlet conduit 62 and is in fluid communication with the gas inlet conduit 62, as described above. However, in an alternative embodiment, it may be directly connected to the intake conduit 16.

[0370] The configuration in Figure 5 shows the interface connector 35 as detachable from the rest of the nasal cannula 30. Alternatively, the interface connector 35 may be an integral part of the nasal cannula 30. Alternatively, the interface connector 35 and the nasal cannula 30 form a one-time mating configuration that prevents the user from disassembling the two components after initial assembly. In the integral or one-time mating configuration, a continuous gas flow path is formed through the inspiratory conduit 16, the gas inlet conduit 62, the interface connector 35, and up to the prongs of the nasal cannula 30.

[0371] In some configurations, the interface connector 35 is generally tubular in shape, having a substantially circular inlet 59 on one side that curves to an oval or elliptical outlet 37, with the outlet 37 formed on one side of the interface connector 35 so as to be perpendicular to the inlet 59. In the illustrated configuration, the circular inlet 59 receives the patient end of the gas inlet conduit 62, allowing the gas flow from the gas inlet conduit 62 to pass through the interface connector 35.

[0372] In some configurations, the interface connector 35 is integrated with or permanently coupled to the gas inlet conduit 62. Alternatively, the interface connector 35 is detachably attached to the gas inlet conduit 62. The interface connector 35 engages with the body 32 so that the gas flow can pass through the outlet 37 and travel from the gas inlet conduit 62 to the patient through the nasal prongs 33, 34 (described in detail later).

[0373] In some configurations, the interface connector 35 is manufactured from a rigid plastic material that deforms only under relatively high load conditions (i.e., is not easily crushed in the user's hand). The interface connector 35 can be molded, injection molded, machined, or cast.

[0374] The interface connector 35 is connected to the main unit 32 when in use, so that the gas flow from the interface connector 35 enters the main unit 32. The main unit 32 will now be described in detail.

[0375] The main body 32 includes nasal prongs 33 and 34 extending from the base portion 39 of the main body 32. The gas flow enters the nasal prongs 33 and 34 through the main body 32 and is delivered to the patient. In some configurations, the nasal prongs 33 and 34 extend parallel to each other. In some configurations, the nasal prongs 33 and 34 curve backward from the facial attachment portion 32. In some configurations, the nasal prongs 33 and 34 curve toward each other. The structure of the prongs 33 and 34 will be described in detail later.

[0376] The body 32 of the illustrated embodiment includes a side arm 31 and a tubular member 38 with a recess, which are integrally molded together as shown in Figures 4 and 5. The tubular member 38 extends downward from the body 32 and is adapted to receive the interface connector 35 (in configurations where the body 32 and the interface connector 35 are separable or are separate articles). The body 32 has a lip 39 that extends around the upper edge of the tubular member 38. The interface connector 35 is connected to the body 32 by friction fitting, and the lip 39 of the body 32 helps to grip the interface connector 35 and form a sealed connection between the interface connector 35 and the body 32. The tubular member 38 includes a rib 40 that extends downward from the body 32. The rib 40 helps to rock the interface connector 35 to hold it in the correct position when the interface connector 35 engages with the body 32, and the rib 40 extends around the outside of the interface connector 35. The outlet 37 on the interface connector 35 aligns with the underside of the facial attachment portion 32 when the interface connector 35 is connected to the main body 32 during use. This alignment reduces the amount of gas leaking from the nasal cannula 30, enabling effective treatment for the user by delivering the maximum amount of humidified gas.

[0377] The side arms 31 are used to attach the front strap 50 to the main body 32. The side arms 31 extend from both sides of the main body 32. In some configurations, the side arms 31 are formed as an integral part of the main body 32. The front strap 50 is attached to the side arms 31 so that the user can put on the patient interface when in use. In some configurations, the ends of the front strap 50 are looped through a pair of slits on the side arms 31, and these ends include hook-and-loop fasteners or similar to hold the ends in place when looped back to themselves. Alternatively, the front strap 50 or loop 66 may be clipped to the side arms 31 by, for example, cooperating male-female clips, or may be attached to the side arms 31 with adhesive.

[0378] In some configurations, the main body 32, nasal prongs 33, 34, side arms 31, and tubular members 38 are all manufactured as a single continuous article. The main body 32, nasal prongs 33, 34, side arms 31, and tubular members 38 are all manufactured from flexible polymer materials such as soft thermoplastic elastomer (TPE) or silicone.

[0379] The following is a description of the nasal prongs. In the following description, the terms “posterior” or “rear” or any such synonyms refer to the part of the structure that faces the patient’s face when the nasal cannula is in use and is closest to the patient’s face. The terms “anterior” or “front” or any such synonyms refer to the side, face, or part that faces away from the user’s or patient’s face when in use and is furthest from the user’s face. The terms “top” or “upper” refer to the side, face, or part that faces away from the floor when the user or patient wearing the interface is standing upright or sitting and looking forward. The terms “bottom” or “lower” also refer to the side, face, or part that faces towards the ground when the user or patient wearing the interface is standing upright or sitting and looking forward. For example, Figure 3 shows the patient interface 17 being worn by a patient, where the directions described above can be evaluated by referring to this figure. These directional definitions are consistent throughout, including in the diagram showing patient interface 17 without a patient.

[0380] In some configurations, the main body 32 includes two nasal prongs 33, 34 that extend upward from the upper surface of the main body 32 and curve inward, as shown in Figures 4 to 10. Referring to Figures 4 to 10, the nasal prongs 33, 34 extend from the upper surface of the main body 32, and each prong is positioned within each nostril of the patient when the nasal cannula is in use. The prongs 33, 34 are configured to deliver a gas flow to the patient. The prongs 33, 34 receive a humidified gas flow from the gas inlet conduit 62 via the gas inlet conduit 62, interface connector 35, and main body 32. Thus, the nasal prongs 33, 34 are in fluid communication with the interface connector 35 and receive a gas flow from the gas inlet conduit 62.

[0381] Referring to Figures 7, 8, and 12, the patient sensor 29 is positioned on the body 32 of the nasal cannula 30. In some configurations, the patient sensor 29 is positioned on the nasal cannula 30 so as to come into contact with the patient's skin during use. The patient sensor 29 may have an adhesive surface so as to be able to come into contact with and be fixed to the patient's skin.

[0382] The outer surface of the main body 32 of the nasal cannula 30 can generally be divided into an outward-facing surface and an inward-facing surface. As used herein, the term “outward-facing surface” may refer to the outer surface of the main body 32 that faces away from the patient while the nasal cannula 30 is in use. As used herein, the term “inward-facing surface” may refer to the outer surface of the main body 32 that faces towards the patient while the nasal cannula 30 is in use. The front and bottom surfaces of the main body 32 can be considered outward-facing surfaces, and the rear surface can be considered inward-facing surfaces. The central portion of the upper surface of the main body 32, which is located below the patient’s nose during use, can be considered an inward-facing surface, and the remaining portion of the upper surface can be considered an outward-facing surface.

[0383] Referring to Figure 7, the first position of the patient sensor 29 is shown. In this configuration, the patient sensor 29 is located on the rear surface 103 of the main body 32. In the illustrated configuration, the patient sensor 29 is located in the center of the rear surface 103. Alternatively, the patient sensor 29 may be located anywhere on the rear surface 103, such as along one of the two side arms 31 (for example, the rear surface is the surface closest to or in contact with the patient when the interface 17 is in use). By positioning the patient sensor 29 on the rear surface 103, the patient sensor 29 will be in contact with the patient's upper lip while the cannula is in place.

[0384] Referring to Figures 8 and 9, the second position of the patient sensor 29 is shown. In this configuration, the patient sensor 29 is located on the upper surface 104 of the main body 32 between the nasal prongs 33 and 34. By placing the patient sensor 29 on this surface, the patient sensor 29 will be in contact with the patient's columella while the cannula is in place.

[0385] In some configurations, the patient sensor 29 is a pulse oximeter.

[0386] In the configurations shown in Figures 7 to 9, the patient sensor 29 is a reflective pulse oximeter. The reflective pulse oximeter includes a light emitter 29a and a photodetector 29b. During use, the light emitter 29a emits light, which is reflected from the patient's skin and then received by the photodetector 29b. Based on the wavelength of the received light, physiological parameters such as the patient's SpO2 and heart rate can be calculated. The positions of the light emitter 29a and the photodetector 29b shown can be equally reversed. Furthermore, in the first position, the light emitter 29a and the photodetector 29b are shown spaced horizontally apart. In the alternative configuration, the light emitter 29a and the photodetector 29b are arranged spaced vertically apart. In the alternative configuration shown in Figure 8, the light emitter 29a and the photodetector 29b are arranged spaced horizontally apart in the second position. In the alternative configuration shown in Figure 9, the light-emitting element 29a and the photodetector 29b are positioned at the second position with a gap between them in front of and behind each other. Further orientations are equally applicable.

[0387] In some configurations of the nasal cannula 30, the patient sensor 29 may be located in a recess in the body 32 of the nasal cannula 30. The shape of the recess corresponds to the shape of the patient sensor 29 such that the outward-facing surface of the patient sensor 29 is coplanar with the surface of the body 32. In a configuration where the patient sensor is a pulse oximeter, the outward-facing surface of the patient sensor 29 is the working surface of the patient sensor 29, i.e., the light-emitting element 29a and the light-receiving element 29b.

[0388] The patient sensor 29 can be considered to be "coplanar" with the surface of the main body 32 when the adjacent portion of the surface of the patient sensor 29 facing outward and the surface of the main body 32 form a smooth bonding surface. The bonding surface is considered smooth if there are no prominent indentations or protrusions at the boundary between the patient sensor 29 and the main body 32. Indentations or protrusions are considered prominent only if they are perceptible to the user visually and / or tactilely.

[0389] In some configurations, the bonding surface is flat. In other configurations, the bonding surface is curved. In other configurations, the bonding surface has a mixture of curved and flat portions. In some configurations, the outer surface of the patient sensor 29 is tangential to the adjacent portion of the surface of the main body 32.

[0390] Referring here to Figure 10, further configurations of the patient sensor 29 are shown. In this configuration, the patient sensor 29 is located on one or more outer surfaces of the nasal prongs 33, 34. In configurations where the patient sensor 29 is a pulse oximeter, a through-beam pulse oximeter is used. A through-beam pulse oximeter includes a light emitter 29a and a photodetector 29b. During use, the light emitter 29a emits light, which passes through a part of the patient's body and is then received by the photodetector 29b. Based on the wavelength of the received light, physiological parameters such as the patient's SpO2 and heart rate can be calculated. In some configurations, the light emitter 29a is located on the outer surface facing the center of one of the nasal prongs 33, 34, and the photodetector 29b is located on the outer surface facing the opposite center of the other nasal prong 33, 34 so that the light passes through the patient's nasal septum.

[0391] Each of the nasal prongs 33, 34 may have a conceptual central axis extending from the base to the tip through the center of the lumen of each nasal prong 33, 34. During use, the central axis is parallel to the direction of gas flow. The nasal prongs 33, 34 may have a cross-section with at least one flat edge, with the cross-section taken perpendicular to the central axis defined above. For example, the cross-section may be a shape with an entirely flat edge, such as a rectangle or a triangle. Alternatively, the cross-section may be a shape with a mixture of one or more curved edges and at least one flat edge, such as a semicircle. This flat edge results in a flat surface along one face of each nasal prong 33, 34. In some configurations, the cross-section is consistent throughout the length of each nasal prong 33, 34. In other configurations, the size and / or dimensions of the cross-section vary throughout the length of each nasal prong 33, 34. For example, each nasal prong 33, 34 may be tapered inward along its length but maintain a semicircular cross-section throughout. In a further configuration, the nasal prongs 33, 34 do not have a consistent cross-sectional shape throughout their length but have at least one flat outer surface.

[0392] The patient sensor 29 is located on the flat outer surface of the nasal prongs 33, 34. The flat surfaces of the nasal prongs 33, 34 may be located on the inner surface of the nasal prongs 33, 34 such that their two surfaces face each other. Using a flat surface as the position of the patient sensor 29 allows for a more consistent orientation, as slight misalignments during manufacturing do not cause changes in orientation. This is particularly useful in the case of a transmissive pulse oximeter, as it relies on the proper alignment of the light emitter 29a and the light receiver 29b. In some configurations, positioning the patient sensor 29 on a flat surface helps to facilitate contact between the patient sensor and the patient's nasal septum.

[0393] The nasal prongs 33 and 34 can be tilted toward each other when not in use. When the nasal cannula 30 is attached to the patient, the nasal prongs 33 and 34 can elastically deform to fit the patient's nasal cavity. This deformation provides a tightening force against the patient's nasal septum. This tightening force helps to provide consistent contact between the patient's nasal septum and the patient sensor 29.

[0394] Alternatively, a transmissive pulse oximeter may be set up to penetrate the outer wall of the patient's nose. In this configuration, either the light emitter 29a or the light receiver 29b is located on the outer surface facing one of the nasal prongs 33, 34, while the other component of the light emitter 29a and light receiver 29b is located on an additional projection that constricts the outer surface of the patient's nasal cavity during use. In some configurations, the additional projection extends from the body 32 of the nasal cannula 30. In some configurations, the additional projection has a flat outer surface parallel to the flat outer surface on one of the nasal prongs 33, 34. The flat outer surfaces of the nasal prongs 33, 34 face the additional projection. One of each of the light emitter 29a and light receiver 29b is located on one of each of the flat surfaces.

[0395] In a further alternative configuration, a reflective pulse oximeter may be used instead of a transmissive pulse oximeter. In this configuration, both the light emitter 29a and the light receiver 29b are located on the same nasal prongs 33, 34. Alternatively, a reflective pulse oximeter may be used by including both the light emitter 29a and the light receiver 29b on an auxiliary projection that contacts the outer surface of the patient's nasal cavity wall. In some configurations, the auxiliary projection extends from the body 32 of the nasal cannula 30.

[0396] Alternative configurations of the nasal cannula 30 are described here with reference to Figures 11 and 12. In this configuration, the head restraint assembly includes one or more facial pads 44 positioned on the side arms 31. During use, the facial pads 44 can be attached to the patient's cheeks. In some configurations, the facial pads 44 have adhesive surfaces that allow the facial pads 44 to be attached to the patient's cheeks. In some scenarios, this may be more comfortable for the patient and may reduce the possibility of the nasal cannula 30 shifting from its precise position during use. One or more notches may be present in the facial pads 44 corresponding to the position of the patient sensor 29 in order to allow the patient sensor 29 to make contact with the patient's skin.

[0397] In the configuration shown in Figure 12, the patient sensor 29 is located in the same area as the facial pad 44 on the side arm 31 of the main body 32 of the nasal cannula 30. Since the facial pad 44 is in contact with the patient's skin, a reflective pulse oximeter (as described above) can be mounted on it. The light emitter 29a and the light receiver 29b are located side by side on either of the facial pads 44. The light emitter 29a and the light receiver 29b are located on the same plane as the surface of the facial pad 44.

[0398] In the alternative configurations shown in Figures 13 to 15, the facial pad may include a two-component releasable mounting or connection arrangement 551. The releasable connection arrangement 551 acts between pairs of patches attached to the patient and the patient interface 17, respectively, and releasably connects them.

[0399] The first patch is a skin patch 550 that is adhered to or otherwise attached to the patient's skin. The skin patch has a patient side that faces the patient's skin and an interface side that faces the patient interface 17. The patient side of the skin patch 550 can be attached to the patient's skin with a dermatologically harmless adhesive such as a hydrophilic colloid. The patient interface side of the skin patch is provided with a first member 553 of a two-member releaseable mounting or connection system 551.

[0400] The second patch is a patient interface patch 552. The patient interface patch 552 also has a patient side and an interface side. The patient side of the patient interface patch 552 is positioned adjacent to the skin patch when the patient interface 17 is engaged. The complementary second member of the two-member releaseable mounting or connection system 553 is attached to the patient side of the patient interface patch 552 so that the respective members of the two-member releaseable mounting or connection system 551 can be easily engaged when the patches 550 and 552 are put together. The interface side of the patient interface patch 552 is attached to the patient interface 17. The patient interface patch can be integrated with the patient interface 17 or preferably adhered to the patient interface 17.

[0401] A portion or corner of the patient interface patch 552 may include an area that does not adhere to the skin patch 550. The schematic purpose of this is to allow for an area (or tab) that the patient can more easily grasp in order to remove or pull the patient interface 17 away from the skin patch. For example, the backing 2004 may also include such a corner area.

[0402] The two-member detachable mounting or connection arrangement 551 is a hook and loop material (Velcro TMThis may include magnets or arrays of magnets arranged on each patch with poles suitably positioned, an adhesive arrangement that is activated when the patches are joined, or any other suitable releaseable bond. The interface side of the skin patch 550 may have one of the hook or loop material, and the patient side of the patient interface patch 552 may have the other of the hook or loop material, so that the skin patch and the patient interface patch can be releasedly attached to each other.

[0403] In this configuration, the patient sensor 29 described above is still located in the same area as the facial pad on the side arm 31 of the main body 32 of the nasal cannula 30.

[0404] One or more wires 46 connect the patient sensor 29 to the controller 13 in order to supply power to the patient sensor 29 and receive data from the patient sensor 29. The wires 46 can be attached to or mounted on or inside the body 32, interface connector 35 and / or gas inlet conduit 62 of the nasal cannula 30. See, for example, Figures 16 to 20.

[0405] In accordance with this disclosure, there are many ways in which the wire 46 can be attached to, or mounted on or within, the body 32, interface connector 35 and / or gas inlet conduit 62. For example, in some configurations, the wire 46 is embedded in the material of the body 32 and gas inlet conduit 62 of the nasal cannula 30. In some configurations, the wire 46 is attached to the inner surface of the body 32, interface connector 35 and gas inlet conduit 62. In some configurations, the wire 46 is attached to the outer surface of the body 32, interface connector 35 and gas inlet conduit 62. In some configurations, a mesh wrap containing woven filaments surrounds the body 32, interface connector 35 and / or gas inlet conduit 62. In some configurations, at least a portion of the filaments is at least partially metallic. In some configurations, at least a portion of the filaments is at least partially plastic. In some configurations, at least a portion of the filaments is at least partially made from natural fibers. In some configurations, the wire 46 is woven with the filaments of the mesh wrap. Alternatively, any two or more of these configurations can be combined. For example, the wiring 46 may be embedded in the material of the main body 32 and then attached to the outer surface of the interface connector 35 and the gas inlet conduit 62.

[0406] In a configuration in which the interface connector 35 is detachably attached to the main body 32, the interface connector 35 and the main body 32 each include one or more electrical contacts to enable the formation of an electrical connection between the wire 46 on the interface connector 35 and the main body 32 when the nasal cannula 30 is assembled. The wire 46 in the interface connector 35 enters the gas inlet conduit 65, and the opposite end of the gas inlet conduit 62 further includes a connector that includes additional electrical contacts corresponding to the electrical contacts on the connector of the inspiratory conduit 16. The electrical contacts of the gas inlet conduit 62 and the inspiratory conduit 16 may be configured such that an electrical connection is automatically formed when the two components are pneumatically connected. For example, the electrical contacts of the gas inlet conduit 62 and the inspiratory conduit 16 may be configured such that a pneumatic connection cannot be formed unless an electrical connection is also formed. Furthermore, the electrical contacts of the gas inlet conduit 62 and the inspiratory conduit 16 may be configured such that an electrical connection cannot be formed unless a pneumatic connection is also formed. The corresponding electrical contacts may be configured to contact each other when a pneumatic connection is formed. The corresponding electrical contacts may include a flat surface. Alternatively, the electrical contacts may include a pin and socket arrangement. This configuration offers the advantage of further reducing the setup time of the respiratory support system by not requiring the formation of a separate electrical connection between the respiratory support device 10 and the patient sensor 29.

[0407] The electrical contacts between the gas inlet conduit 62 and the intake conduit 16 can be immovable relative to the rest of the connector, as the two components can automatically form an electrical connection when the two components are pneumatically connected.

[0408] In a further configuration, the patient interface 17 includes one or more patient sensors 29 located on a sensor arm 47, which will be described with reference to Figures 16-25. The sensor arm 47 may be relatively rigid in that it cannot be easily deformed by the user. Alternatively, the sensor arm 47 may be elastically deformable in that it can be easily deformed by the user. The sensor arm 47 may have a patient contact surface configured to contact the patient's skin. The patient contact surface may be coated with an adhesive to ensure contact between the sensor arm 47 and the patient's skin.

[0409] The sensor arm 47 includes a patient sensor 29, such as a pulse oximeter. The pulse oximeter may be a reflective pulse oximeter including a light emitter 29a and a light receiver 29b as described above. Unless otherwise specified, the wiring 46 for the configuration of the sensor arm 47 is substantially the same as that described above for the configuration without the sensor arm 47.

[0410] In the configurations shown in Figures 16 and 17, the sensor arm 47 is located below the nasal cannula 30. The sensor arm 47 may be located near the center of the nasal cannula 30. The position and dimensions of the sensor arm 47 are designed so that the patient sensor 29 contacts the patient's upper lip while the nasal cannula 30 is in use. Alternatively, in the configurations shown in Figures 18 and 19, the position and dimensions of the sensor arm 47 are designed so that the patient sensor 29 contacts the patient's skin above its upper lip while the nasal cannula 30 is in use.

[0411] In a further configuration, a sensor arm 47 extends from a sensor mount 48, which will be described in detail here with reference to Figures 20-25. In the configuration shown in Figures 20 and 21, the nasal cannula 30 further includes a sensor mount 48 located on one or more parts of the anterior straps 50, such as one of the anterior straps 50. The sensor mount 48 may be fixedly attached to one of the anterior straps 50. Alternatively, the sensor mount 48 may be detachably attached to one of the anterior straps 50. Furthermore or alternatively, the sensor mount 48 may be slidably attached to one of the anterior straps 50. Alternatively, the sensor mount 48 may be detachably attached to the gas inlet conduit 62. Furthermore or alternatively, the sensor mount 48 may be slidably attached to the gas inlet conduit 62. A slidable pulse oximeter can be slid along the face to position the sensor in the appropriate location on the face to obtain pulse oximeter (i.e., SpO2) readings. For example, the sensor could be located in the cheek area.

[0412] The sensor arm 47 extends from the sensor mount 48 and is configured to contact the patient's skin while the nasal cannula 30 is in use. The sensor arm 47 can be positioned to extend perpendicularly from the sensor mount 48 to the anterior strap 50. In a configuration in which the sensor mount 48 is slidably attached to one of the anterior straps 50, this direction is perpendicular to the direction of movement of the sensor mount 48.

[0413] The sensor arm 47 can be fixedly attached to the sensor mount 48.

[0414] Alternatively, as shown in Figures 22 and 23, the sensor arm 47 may be slidably mounted on the sensor mount 48. As shown in Figure 22, the sensor arm 47 may be slidable in the same direction as the front strap 50 extends. Alternatively, the sensor arm 47 may be slidable in a direction perpendicular to the direction in which the sensor arm 47 extends from the sensor mount 48. Alternatively, as shown in Figure 23, the sensor arm 47 may be slidable in a direction perpendicular to the direction in which the front strap 50 extends. Alternatively, the sensor arm 47 may be slidable in the same direction as the direction in which the sensor arm 47 extends from the sensor mount 48.

[0415] Alternatively, as shown in Figure 24, the sensor arm 47 may be rotatably mounted on the sensor mount 48. Alternatively, as shown in Figure 25, the sensor arm 47 may be retractable and extendable relative to the sensor mount 48.

[0416] By enabling the sensor mount 48 to be detachably and / or slidably attached to one of the front straps 50, and / or the sensor arm 47 to be movably attached to the sensor mount using one or more of the techniques described above, the user can still set up the system relatively quickly while adjusting the position of the patient sensor as needed. Furthermore, the system still benefits from the integrated electrical and pneumatic connectors of the nasal cannula 30, while allowing the user to adjust the patient sensor as needed. The sensor and sensor mount are adjustable so that the sensor can be positioned on the patient's face to obtain accurate SpO2 measurements.

[0417] In a further configuration, the sensor arm 47 is replaced with a sensor clip, which allows the patient sensor 29 to be clipped to a part of the patient, such as the earlobe. In this configuration, a transmissive pulse oximeter is used instead of a reflective pulse oximeter.

[0418] Here, further possible configurations, including a wire coil, will be described in relation to Figures 26 to 28. In this configuration, the sensor mount 48 is replaced by a wire coil 49. The wiring 46 leading to the wire coil 49 is substantially the same as in the previously described configuration.

[0419] As shown in Figures 26-29, the sensor arm 47 may be connected to the wire coil 49 by a secondary wire 46a. The sensor arm 47 may have any of the features described for the sensor arm 47 in the previous configuration. In this particular configuration, the sensor arm 47 may have an adhesive surface that allows the sensor arm 47 to adhere to the patient's skin. This arrangement of the sensor allows the sensor 29 to be located in the temporal region of the face, or the forehead region of the frontal region, or the jaw region near the lower lip, where there are blood vessels that can be used to obtain blood oxygen (i.e., SpO2) readings. The structure of the wire coil provides adjustability for the position of the sensor 29 to areas on the face where there are larger blood vessels useful for obtaining SpO2 readings.

[0420] As shown in Figure 26, the sensor arm 47 starts in an initial position, where it is positioned above or next to the wire coil 49, and the secondary wire 46a is substantially completely retracted into the wire coil 49. As shown in Figures 27 and 28, the sensor arm 47 can then be moved to a location on the patient's skin so that the patient sensor 29 can begin measuring one or more patient parameters. As the sensor arm 47 moves onto the patient's skin, the secondary wire 46a is unwound from the wire coil 49 as needed. This arrangement provides the user with further flexibility in the placement of the patient sensor 29. For example, Figures 27 and 20C show examples of how the patient sensor 29 can be positioned on the patient's cheek or temple, depending on the user and / or patient preference.

[0421] The secondary wire 46a can be retracted into the wire coil 49. The wire coil 49 may have a coil spring mechanism. The coil spring mechanism allows the secondary wire 46a to be compactly stored with minimal user intervention when winding is required. The coil spring mechanism may be configured to automatically retract the secondary wire 46a. This is advantageous in that it reduces the likelihood of the user forgetting to wind the secondary wire 46a. Furthermore, automatic retraction means that only the minimum necessary length of the secondary wire 46a is unwound, thereby reducing the possibility of the secondary wire 46a becoming entangled with other components. Alternatively, the coil spring mechanism may be configured to retract the secondary wire 46a only when the user activates a component such as a switch, button, or lever. This is advantageous in that there is no tension on the secondary wire 46a during use, which may improve patient comfort and reduce the possibility of the sensor arm 47 becoming detached.

[0422] The wire coil 49 may be fixedly attached to one of the front straps 50. Alternatively, the wire coil 49 may be detachably attached to one of the front straps 50 so that it can be removed and replaced in one separate section of the front strap 50 and / or a separate part of the nasal cannula 30 by using a clip or any other suitable connector. To facilitate this, the wire coil 49 may have a second coil spring mechanism corresponding to a second wire that connects the wire coil 49 to the wire 46 of the nasal cannula 30. The second coil spring mechanism may have any of the same features as the first coil spring mechanism.

[0423] In a further configuration, as shown in Figures 30-32, the wire coil 49 may be fixedly or detachably attached to the gas inlet conduit 62. In this configuration, the wire coil 49 may be connected to the wire 46 as the wire 46 passes through the gas inlet conduit 62. This configuration may be more suitable if the user wishes to attach the patient sensor 29 to the patient's neck or chest. The coil 49 allows for adjustability, which helps to obtain more accurate SpO2 measurements by moving the sensor 29 to various locations.

[0424] The maximum length of the secondary wire 46a is set based on the expected required maximum length. The expected required maximum length is determined by the expected locations where the user may want to place the patient sensor 29. For example, a longer maximum length may be provided so that the user can attach the patient sensor 29 to the patient's chest, upper back, or shoulder. In one configuration, the secondary wire 46a has a maximum length of approximately 300 mm.

[0425] In a further configuration, the sensor arm 47 is replaced with a sensor clip, which allows the patient sensor 29 to be clipped to a part of the patient, such as the earlobe. In this configuration, a transmissive pulse oximeter is used instead of a reflective pulse oximeter. This variant can also be applied to any of the wire coil configurations described above.

[0426] Here, a further configuration in which the patient sensor 29 is integrated into the head fixation assembly will be described with reference to Figures 33 to 36.

[0427] Referring to Figure 33, a configuration is shown in which the patient sensor 29 is incorporated into the forehead strap 53c. The patient sensor 29 may be a reflective pulse oximeter as described earlier. The forehead strap 53c can be made of an elastic material, which helps to stabilize the head restraint assembly and maintain contact between the patient sensor 29 and the patient's forehead. In this configuration, the wire 46 enters the head restraint assembly from the side arm 31 and continues to the location of the patient sensor 29. In a configuration in which the side arm 31 is detachably attached to the head restraint assembly, the head restraint assembly and the side arm 31 include corresponding electrical contacts.

[0428] In the configurations listed above, the patient interface 17 is a nasal cannula 30. Referring to Figure 34, a configuration is shown where the patient interface 17 is a sealed nasal mask 80. Alternatively, the patient interface may be another type of sealed interface, such as a mouth mask, a full-face mask, or a nasal pillow interface. The sealed interface typically utilizes a forehead support 81 where a patient sensor 29 may be located. The patient sensor 29 may be a reflective pulse oximeter as described earlier. In this configuration, the wire 46 enters the head restraint assembly from the patient interface 17 and continues to the location of the patient sensor 29. In a configuration where the patient interface 17 is detachably attached to the head restraint assembly, the head restraint assembly and the patient interface 17 include corresponding electrical contacts.

[0429] Referring here to Figures 35 and 36, a configuration is shown in which the patient interface is a tracheostomy interface 90. As shown in Figure 35, the patient sensor 29 can be placed on the neck strap 91. Alternatively, the patient sensor 29 may be placed on the sensing neckband 92. The sensing neckband 92 may be made of an elastic material to facilitate contact between the patient sensor 29 and the patient's skin. Wiring 46 for the patient sensor 29 can be incorporated into the neck strap 91 and / or neckband 92, as described for the above configuration. The patient sensor 29 may be a reflective pulse oximeter, as previously described.

[0430] The above-described features of the patient sensor 29 can be used in combination with a nasal cannula, as substantially described in the earlier international patent application, International Publication No. 2014 / 182179, filed on May 7, 2014, which is incorporated herein by reference in its entirety.

[0431] For example, a nasal cannula can be provided, such as the one described in International Publication No. 2014 / 182179, which includes a body configured to engage with the patient's orifice and direct the gas flow toward the orifice. Such a nasal cannula may constitute part of a respiratory therapy system, as described with reference to Figures 1 to 3. The nasal cannula may be equipped with one or more sensors configured to measure parameters, as described with reference to Figures 3 to 36. One or more sensors are attached (i.e., positioned) to the nasal cannula. Such embodiments are described in more detail below.

[0432] Refer to Figures 37 to 43 here. These embodiments show a patient interface 101 configured to deliver respiratory gas to a patient from a gas supply unit and a humidifier (not shown), and a headgear 200 configured to support and hold the patient interface against the patient's face when in use. The patient interface 101 is in the form of a nasal cannula 1000 including at least one, preferably two, nasal prongs 111 and 112 adapted to connect an inspiratory conduit 300 and configured to fit into the patient's nasal cavity to deliver a flow of gas to the patient. The headgear 200 is in the form of a head strap 200 which is preferably adjustable in length to customize the strap size for the patient.

[0433] The nasal cannula 1000 includes at least one, preferably a pair, tubular nasal prongs 111 and 112 that are integrally molded with or detachably attached to the facial attachment portion 110 (i.e., the main body), and a gas flow manifold portion 120 that is detachably attached to or integrally molded with the conduit 300. The gas flow manifold portion 120 can be inserted into the facial attachment portion from either one of two opposite horizontal directions, i.e., either the left or the right side. Thus, the position or location of the gas flow manifold portion 120 is reversible with respect to the facial attachment portion 110 (i.e., the main body). In other words, the user can choose to have the manifold portion 120 (and the conduit 300, which essentially extends from it) extend from either the left or right side of the cannula 1000, depending on which is most convenient, for example, depending on which side of the user the gas source or ventilator is located.

[0434] The facial attachment portion 110 is formed from a soft and flexible material such as silicone or other cannula materials known in the art. The nasal prongs 111 and 112 are preferably flexible and can be formed from a sufficiently thin layer of silicone to achieve this property.

[0435] The gas flow manifold portion 120 is formed from a relatively rigid material such as polycarbonate, high-density polyethylene (HDPE), or any other suitable plastic material known in the art. The facial attachment portion 110 provides a flexible interface component to the patient to comfortably deliver the gas flow through the nasal prongs 111 and 112, while the gas flow manifold portion 120 fluidly connects the conduit 300 to the nasal prongs 111 and 112 of the facial attachment portion 110.

[0436] A patient sensor 29, such as one pulse oximeter or multiple pulse oximeter sensors, may be located on or within the manifold portion 120.

[0437] The sensor 29 can be integrated into the manifold portion 120 and therefore may be disposable. Alternatively, the sensor 29 may be detachably mounted to the manifold portion 120. The manifold portion 120 may have suitable recesses or receiving ports / openings for receiving one or more sensors 29. One or more sensors 29 may be detachable and reusable.

[0438] One or more sensors 29 may be wireless or wired. The wires of the sensor 29, or one or more wires, may be routed through the manifold section 120, through the inlet 122, and back to the system controller via the intake conduit 300.

[0439] One or more sensors are positioned on the manifold portion 120 so as to be in contact with or adjacent to the upper lip region, for example, in the mouth region of the face. The upper lip has numerous blood vessels, and the sensor 29 can be used to determine blood oxygen levels by contact with or proximity to the upper lip region via the manifold portion 120.

[0440] The manifold portion 120 may be formed from a rigid plastic material so as to be received within the soft silicone body of the cannula. The rigidity of the manifold portion 120 makes it easier to insert the manifold portion into the facial mounting portion and to hold the manifold portion in its operating position (i.e., in the position inserted within the facial mounting portion). The manifold portion is inserted into the facial mounting portion and fluidly communicates with the prongs to direct the gas from the inlet conduit to the prongs. By positioning the sensor 29 located above or within the manifold portion within the facial mounting portion, the sensor 29 is positioned in a detection position, i.e., the sensor is positioned adjacent to or in contact with the upper lip.

[0441] The patient's nasal septum and / or columella are generally very sensitive areas and can cause discomfort if subjected to excessive contact pressure over a long period of time. The nasal cannula of this disclosure can alleviate or reduce this pressure by providing a cushioning area of ​​the cannula 1000 adjacent to the patient's nasal septum / columella. Referring to Figures 42 and 43, in one embodiment, the outlet 123 includes a pair of opposing recesses or grooves 124 / 125 on its outer circumference to form a recess or indentation 127 in the area located adjacent to the nasal septum / columella during use. When coupled to the facial attachment portion 110, this recess 127 forms a gap between the base portion 118 and the outlet 123 of the manifold 120. During use, this gap cushions / softens the area of ​​the cannula 100 directly adjacent to the nasal septum / columella. This relieves the pressure from the more rigid manifold portion 120 from the nasal septum / columella, allowing the nasal septum / columella to rest solely on the soft base of the facial attachment portion 110.

[0442] The base portion 118 is also preferably formed to have a hollowed outer portion and / or a recessed outer contour portion 118b between the prongs 111 and 112 to relieve pressure in the nasal septum / columella. The hollowing should be as large as possible without (significantly) impairing the flow delivered to the patient. The recessed portion 118b is preferably also complementary to the outer circumference of the outlet 123 to maintain an effective seal between the two portions of the cannula.

[0443] The pulse oximeter 29 can be positioned between the prongs 111, 112 on the upper surface of the cannula so as to contact the nasal septum / columella. For example, the pulse oximeter 29 is positioned in the recess 118b between the prongs. A concave manifold is advantageous when the sensor 29 is positioned between the prongs 111, 112 to reduce pressure ulcers or other pressure injuries caused by the sensor 29 contacting the nasal septum / columella. The concave portion, i.e., the recess 127, of the facial mounting portion 110 allows the cannula to deform into a concave cross-section, thereby ensuring sensor contact while reducing pressure injuries. Therefore, the recess 127 may be beneficial when the pulse oximeter 29 is positioned on the upper surface of the base portion 118 (for example, between the two prongs 111, 112, as shown in Figure 9).

[0444] In the embodiments shown in Figures 37 to 41, the headgear used to hold the patient interface 100 against the patient's face includes a single continuous length head strap 200, which is fitted to extend along the patient's cheeks, above the ears and around the back of the head when in use.

[0445] The primary end portions 201 and 202 of the strap 200 are adapted to be releasably connected to the respective structures 101 and 102 on either side of the nasal cannula 100 (see, for example, Figure 38A) to hold the cannula 100 in place during use.

[0446] A strap connector 230 is provided at each of the secondary end portions 203 / 204 of the main strap 210 and at each of the end portions 203 / 204 of the strap segment 220.

[0447] Each connector 230 is provided with a strap connection mechanism at one end for connecting to a strap material, and a coupling mechanism at the opposite end for detachably connecting each end of a similar connector 230.

[0448] Cannula connectors 240 are provided at the primary end portions 201 and 202 of the main strap 210. These connectors 240 have a strap connection mechanism similar to the strap connectors 230 at the secondary end portions 203 and 204, but the ends of the connectors 240 facing the strap ends include a clip member such as a push-fit clip 241. The clip 241 is configured to releasably connect the respective structures 101 / 102 at the side of the cannula 110. The clip member 241 is preferably a bendable part such as a plastic part that forms a hinge portion with respect to the strap. Preferably, the clip 241 is pre-formed to have a curved shape along its length, for example, having a flat to 20-degree angle. This curvature allows the clip 241 to fit the contour of the patient's face in the area of ​​the clip 241.

[0449] Here, with reference to Figures 40 and 41, a method for engaging and disengaging each connector 240 of the head strap 200 from the patient interface 110 will be described. Each connector 240 includes a clip member 241 having an elongated connector body 242 and a lateral projection 243 at the end of the body 242. The lateral projection 243 includes an inward-facing engagement surface 243a. The surface 244 of the connector 240 opposite to the surface 245 from which the projection 243 extends is preferably substantially smooth or planar. The corresponding structure 101 / 102 of the cannula 110 includes a channel 101a / 102a, the channel 101a / 102a having inlet apertures 101b / 102b and outlet apertures 101c / 102c at both ends of the channel 101a / 102a. The peripheral walls of the exit apertures 101c / 102c define contact portions 101ci / 102ci configured to engage with the surface 243a of the projection 243 of the clip member 241. The peripheral portions 101bi / 102bi of the inlet apertures 101b / 102b define contact portions for engaging with a flange 246 at the end of the body 242 opposite to the projection 243. This acts to limit the range of insertion of the connector 240 into the corresponding channels 101a / 102a. The flange 246 can be provided by a strap connection mechanism and / or the end portion of the sleeve 270.

[0450] Each section of the head strap 200 adjacent to the respective primary end portions 201 / 202 includes a cheek support portion 270, or a cheek support portion 270 is applied to each section, and the cheek support portion 270 includes at least a surface area 271, which frictionally engages with the user's face to stabilize the headgear 200 on the cheek, such as on or below the cheekbone, both during and after the headgear is attached to the patient interface 100. The surface area 270 is preferably made of a surface material with relatively higher friction than the rest of the strap 200.

[0451] The high-friction surface material 271 helps to hold or stabilize the patient interface 100 on the patient's face by extending over a portion of the side of the patient's face during use, preferably on the patient's cheek, or at least substantially toward the cheek. The fact that the high-friction surface material can be positioned on the user's cheek further helps to keep the rest of the head strap 200 away from the user's eye or orbit, preferably extending below the eye or orbit, to prevent obstruction of vision and / or discomfort resulting from the head strap 200 bridging over or near the eye or orbit.

[0452] It will be understood that the high-friction surface material 271 can be adapted to extend over a portion of the side of the patient's face during use, for example, on or near the left and right outer upper lips, or extending backward from above there, and upward across the left and right cheeks.

[0453] The friction surface material can be provided in the form of an elongated sleeve 270 configured to receive each primary end portion 201 / 202 of the strap 200. The sleeve 270 is configured to be removably coupled (or instead permanently coupled) around the strap 200, the sections of the strap 200 and / or the cannula connectors 240 / 260 at the primary end portions of the strap.

[0454] The sleeve 270 is coupled around the strap 210 at its primary end portions 201 / 202 and also around a portion of the connector 240. The strap 210 extends through a passage 272 within the sleeve 270, as can be seen in Figure 37B. The strap 210 is adapted to pass through this passage and, preferably in the sleeved configuration, is still freely stretchable, elastic, or elongated. The connector 240 is substantially housed by the sleeve 270 or concealed by its surface area to minimize direct contact with the user's skin, thereby improving the stability and comfort of the headgear 200. The clip 241 extends from the end 273 of the sleeve 270. In another embodiment, the sleeve 270 can be overmolded onto the connector 240 and / or the strap 210.

[0455] Referring to Figure 38A, the sleeve 270 can be coupled around a connector 260 extending from the strap 210 at its primary end portions 201 / 202. In this embodiment, the connector 260 is substantially housed by the sleeve 270 or concealed by its surface area to minimize direct contact with the user's skin, thereby improving the stability and comfort of the headgear 200. In other words, the connector 260 extends entirely through the passage 272 of the sleeve 270. The buckles 251 / 252 extend from the end 274 of the sleeve 270, and the clip 261 extends from the opposite end 273.

[0456] The sleeve 270 may be pre-formed to have a curved shape along its length, for example, having a flat to 20-degree angle. This curvature allows the sleeve 270 to fit the contour of the patient's face or cheek in the area of ​​the sleeve when in use. Alternatively, the sleeve 270 may elastically or inelastically deform to become a curved sleeve shape when engaged with the primary end portions 201 / 202 of the head strap 200 or the connector 260.

[0457] The sleeve 270 provides a surface area 271 of a relatively high-friction surface material for frictional engagement with the user's face or facial skin. This surface area 271 will be positioned to frictionally engage with the skin of the user's cheek. The surface area 271 will be localized at least to the strap or a section of the strap that will be positioned over the user's cheek. The surface area 271 provided with the relatively high-friction surface material is preferably smooth and a material that is comfortable on the patient's skin. Therefore, the sleeve 270 or at least the surface area 271 is formed from a material that is relatively softer than the connectors 240 and 260.

[0458] In one preferred embodiment, the surface region 271 or sleeve 270 is formed from a soft thermoplastic elastomer (TPE), but it may instead be formed from another plastic material such as silicone or any other biocompatible material.

[0459] Headgear for other forms of interfaces in addition to nasal cannulas may include cheek support portions 270, as described or similar, that frictionally engage with the user's face to stabilize the mask on the cheeks, connecting to or adjacent to either side end of the strap of the interface headgear, and connecting to a mask, particularly a direct nasal mask including, for example, a nozzle or pillow that enters into or engages with the wearer's nostrils. Such headgear, in this case as well, includes a single head strap adapted to extend along the patient's cheeks above the ears and around the back of the head when in use, and the ends include any preferred form of clips that connect to (or are permanently attached to) the mask on both sides.

[0460] A patient sensor 29, for example in the form of a pulse oximeter, can be attached to the nasal cannula 1000 shown in Figures 37 to 41.

[0461] The patient sensor 29 can be attached to the nasal cannula 1000 according to any of the configurations described for the nasal cannula 100 in Figures 1 to 36.

[0462] The patient sensor 29 can be mounted on the headgear 200, on another removable part of the nasal cannula 1000 connected to the facial mounting part 110, or on the gas flow manifold part 120 of the nasal cannula 1000. In this way, if the facial mounting part 110 and / or the gas flow manifold part 120 is replaced or disposed of, the patient sensor 29 can be retained with the headgear 200 or other removable part, and therefore the patient sensor 29 is not discarded and can be reused. For example, the patient sensor 29 can be mounted on the headgear 200 configured to connect to multiple facial mounting parts 110 and / or gas flow manifold parts 120 of different sizes. This allows the user to replace or swap parts of the cannula without having to discard the patient sensor 29.

[0463] Referring to Figures 37 to 41, the patient sensor 29 can be mounted on the sleeve 270. Any wiring associated with the patient sensor 29 can extend through the passage 272 of the sleeve 270 and from the end 274.

[0464] The patient sensor 29 can be fitted onto the face contact surface 271 of the sleeve 270 and may be coplanar with the face contact surface 271. The patient sensor 29 may be located at any suitable position along the length of the sleeve 270, for example, adjacent to the structures 101, 102 or adjacent to the headgear strap 210.

[0465] The patient sensor 29 can be permanently attached to the sleeve; for example, the patient sensor 29 can be overmolded onto the sleeve 270.

[0466] The patient sensor 29 can be detachably attached to the sleeve 270, thereby allowing the patient sensor 29 to be replaced or reused when the sleeve 270 is discarded. The patient sensor 29 can be removed, wiped clean, and incorporated into different cannulas having similar recesses in the sleeve 270 to receive the sensor 29. This allows the sensor to be reused for patients, thereby reducing costs for healthcare facilities.

[0467] Alternatively, the patient sensor 29 may be provided on a complementary sensor body that can be permanently or removablely mounted on the sleeve 270, for example, in a corresponding recess on the sleeve 270. The recess and the complementary body may be provided with one or more retaining structures configured to hold the body within the recess. By incorporating the sensor 29 into the sleeve 270, the sensor 29 comes into contact with the cheek region, for example, the buccal or temporal region of the face. This region of the face contains blood vessels, and the sensor can be positioned adjacent to the blood vessels to detect blood oxygen.

[0468] A patient interface such as a nasal cannula, as shown in Figures 37 to 43, may include multiple patient sensors 29.

[0469] For example, a patient interface may include multiple sensors 29 (i.e., multiple pulse oximeters) incorporated into the patient interface. For example, each or at least one sleeve 270 may have one or more pulse oximeters 29 positioned on or within the side arm (i.e., sleeve 270). The controller can average the measurements from these multiple sensors 29 to provide a blood oxygen (SpO2) reading.

[0470] Therefore, each sleeve 270 may include one sensor 29.

[0471] In a further alternative configuration, each sleeve 270 of the cannula (i.e., each side arm) may include multiple sensors. One, some, or all of the sensors may be removable. Each sleeve 270 may include multiple recesses or openings for receiving sensors 29.

[0472] Multiple sensors 29 can be advantageous because averaging the measurements provides more accurate SpO2 readings and reduces noise in the sensor readings received by the controller.

[0473] Referring to Figure 39, a retaining clip 280 can be provided, which includes a tubular body 281 that receives and accommodates a portion of the conduit 300. A hook 282 protrudes from the body 281 to connect to the strap or other components of the headgear 200. In this way, the conduit 300 can be connected to or tethered to the head strap 210 or the headgear 200 when in use. If the conduit 300 is pulled, the force will be exerted on the head strap 210 rather than directly on the cannula 100. This redistribution of force reduces the likelihood that the prongs 111 and 112 of the cannula 100 will protrude from the patient's nostril.

[0474] On the headgear 200, one or more anchoring points may be available for attaching the clip 280, preferably at least two symmetrical anchoring points on each side of the headgear to improve ease of use.

[0475] It will also be understood that the retaining clip 280 may be removable from the gas supply tube 300, or it may be a permanent fitting on the gas supply tube 300.

[0476] The retaining clip 280 may be connected to or held to a part of a patient interface, such as a part of the patient interface that provides a relatively more rigid area (for example, to facilitate support of a gas supply tube article 300).

[0477] The retaining clip 280 can be positioned or attached to a specific location on the gas supply tube article 300, for example, to provide a predetermined place for holding the retaining clip 280 in place.

[0478] The retaining clip 280 may be configured to hold the wiring of the patient sensor 29 in order to secure the wiring to the conduit 300. Thus, the wiring of the patient sensor may extend parallel to the longitudinal axis of the conduit 300.

[0479] The conduit 300 may be provided with one or more sensor wires extending, for example, within the wall of the conduit or through the bore of the conduit. One or more sensor wires may be configured to be electrically coupled to the patient sensor 29.

[0480] Such electrical coupling can be provided by a physical electrical coupling, such as through an electrical connector, between the wiring of the patient sensor 29 and one or more sensor wires in the conduit 300.

[0481] Such electrical coupling can be provided via inductive coupling. For example, patient sensor wiring may extend along the sleeve 270 and / or be provided on the facial attachment portion 110 and / or gas flow manifold portion 120 of the cannula 1000. Conduit wiring may extend to the end of the conduit 300 or an adjacent position where the conduit 300 is connected to the entrance of the nasal cannula. The conduit 300 and cannula 1000 may be provided with inductive couplers configured to electrically couple the conduit 300 to the patient sensor wiring.

[0482] This configuration eliminates or reduces the need for physical electrical connectors and one or more exposed electrical contacts. This configuration eliminates or reduces the number of connections that the user needs to make when using the nasal cannula 1000. For example, when the patient sensor 29 and headgear 200 are reused, the user does not need to physically disconnect the patient sensor wiring from the conduit 300.

[0483] The conduit 300 may be a heated conduit or an unheated conduit. The conduit may be an extension of any desired length.

[0484] Unless otherwise explicitly required by the context, throughout this specification and the claims, words such as “includes,” “contains,” and “contains” should be interpreted in a comprehensive sense, i.e., “includes, but not limited,” as opposed to an exclusive or exhaustive sense.

[0485] Where references to directional terms such as “upward,” “downward,” “forward,” “backward,” “horizontal,” and “vertical” are made herein, these terms refer to the position in which the device is typically in use and are used to indicate and / or describe a relative direction or orientation.

[0486] As used herein, the terms “approximately,” “about,” and “substantially” refer to quantities close to the stated quantity that still perform the desired function or achieve the desired result. For example, in some embodiments, where the context allows, the terms “approximately,” “about,” and “substantially” may refer to quantities that are within 10%, 5%, and 1% or less of the stated quantity.

[0487] No reference to prior art in this specification constitutes, and should not be construed as, an endorsement or any form of suggestion, that such prior art forms part of the common general knowledge in any country in the field of focus worldwide.

[0488] The disclosed devices and systems may also be broadly said to include any or all combinations of two or more of the parts, elements and features that are referred to or shown individually or collectively in the specification of this application.

[0489] In the above description, we refer to complete bodies or components having known equivalents, and these complete bodies are incorporated herein as individually shown.

[0490] Depending on the embodiment, some actions, events, or functions of any of the algorithms, methods, or processes described herein may be performed in a different order, added, merged, or omitted entirely (for example, not all of the described actions or events are necessarily required for the implementation of the algorithm). Furthermore, in some embodiments, the actions or events may be performed not sequentially, but simultaneously, for example, through multithreading, interrupt handling, or across multiple processors or processor cores or on other parallel architectures.

[0491] It should be noted that various modifications and alterations to the currently preferred embodiments described herein will be apparent to those skilled in the art. Such modifications and alterations may be made without departing from the spirit and scope of the disclosed apparatus and system and without diminishing its incidental benefits. For example, various components may be rearranged as needed. Thus, such modifications and alterations are intended to fall within the scope of the disclosed apparatus and system. Furthermore, not all features, embodiments, and advantages are necessarily required to implement the disclosed apparatus and system. Accordingly, the scope of the disclosed apparatus and system is intended to be defined solely by the following claims.

Claims

1. A nasal cannula interface for supplying gas flow to a patient, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's opening, One or more sensors configured to measure parameters, Includes, The main body further includes an upper surface and a rear surface, the rear surface being adjacent to the patient when the nasal cannula interface is in use, The outer surface of one or more of the sensors is on the same plane as the top surface or the rear surface. Nasal cannula, A nasal cannula interface, including one.

2. The nasal cannula interface according to claim 1, wherein at least one of the one or more sensors is a patient sensor, and the parameter is a physiological parameter of the patient.

3. The nasal cannula interface according to claim 1 or 2, wherein the parameter is a measure of the patient's blood oxygenation.

4. The nasal cannula interface according to any one of claims 1 to 3, wherein the at least one prong is configured to be received in one or more nostrils of the patient.

5. The nasal cannula interface according to any one of claims 1 to 4, wherein one or more of the at least one prongs are configured to form a seal with one of the patient's nostrils.

6. The nasal cannula interface according to any one of claims 1 to 4, wherein one or more of the at least one prongs are configured to be received in an open manner into one of the patient's nostrils.

7. The nasal cannula interface according to any one of claims 1 to 6, further comprising a head fixation assembly.

8. The nasal cannula interface according to claim 7, wherein the head fixation assembly includes one or more straps.

9. The nasal cannula interface according to claim 7, wherein the head fixation assembly includes one or more facial pads.

10. The nasal cannula interface according to claim 9, wherein the aforementioned or each facial pad includes an adhesive surface that adheres to the patient's skin.

11. The nasal cannula interface according to claim 9 or 10, wherein the aforementioned or each facial pad comprises two separate patches.

12. The nasal cannula interface according to claim 11, wherein the two separate patches are removably coupled together.

13. A nasal cannula interface according to any one of claims 1 to 12, further comprising a pair of side arms.

14. The nasal cannula interface according to claim 13, wherein the pair of side arms is integrated with the main body of the nasal cannula.

15. The head restraint assembly is connected to the side arm, the nasal cannula interface according to claim 13 or 14, as dependent on any one of claims 7 to 9.

16. The facial pad is located on the side arm, and the nasal cannula interface is according to claim 13 or 14, as dependent on any one of claims 9 to 12.

17. The nasal cannula interface according to any one of claims 1 to 16, wherein the outer surface of the patient sensor is coplanar with the upper surface and the upper surface is a patient contact surface, or the outer surface of the patient sensor is coplanar with the rear surface and the rear surface is a patient contact surface.

18. The nasal cannula interface according to any one of claims 1 to 17, wherein at least one of the one or more sensors is a pulse oximeter.

19. The nasal cannula interface according to claim 18, wherein the pulse oximeter is a reflective pulse oximeter.

20. The nasal cannula interface according to any one of claims 1 to 19, further comprising a second prong extending from the base portion.

21. The nasal cannula interface according to claim 20, wherein the one or more sensors are located between the two prongs.

22. The nasal cannula interface according to any one of claims 1 to 21, wherein the at least one prong extends from the upper surface of the body of the nasal cannula, and the one or more sensors are located on the upper surface.

23. The nasal cannula interface according to any one of claims 1 to 22, wherein the one or more sensors are positioned to contact the patient's columella while the nasal cannula interface is in use.

24. The nasal cannula interface according to any one of claims 1 to 20, wherein the at least one prong extends from the upper surface of the body of the nasal cannula, and the one or more sensors are located on the surface of the body adjacent to the upper surface.

25. The nasal cannula interface according to any one of claims 1 to 20 or 24, wherein the one or more sensors are positioned on the body of the nasal cannula so as to contact the patient's upper lip while the nasal cannula interface is in use.

26. A gas inlet conduit for receiving the gas flow from a gas source, comprising a gas inlet conduit that defines at least a portion of the gas flow path, An interface connector for receiving the gas flow from the gas inlet conduit and directing the gas flow toward the at least one prong, The nasal cannula interface according to any one of claims 1 to 25, further comprising:

27. The gas inlet conduit further includes a set of wires, and the gas inlet conduit further includes a patient end and a distal end. The patient end is connected to the interface connector, The distal end includes an interface inlet, the interface inlet includes a set of electrical contacts, and The nasal cannula interface according to claim 26, wherein the set of wires of the nasal cannula interface provides electrical communication between the one or more sensors and the set of electrical contacts at the interface inlet.

28. The set of electrical contacts at the interface inlet includes a flat surface, The nasal cannula interface according to claim 27, wherein the flat surface is substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

29. The set of electrical contacts at the interface input includes pins and / or sockets of an electrical connector. The nasal cannula interface according to claim 27, wherein the longitudinal axis of the pin and / or socket is substantially parallel to the longitudinal axis of the lumen of the interface inlet.

30. The nasal cannula interface according to any one of claims 27 to 29, wherein the set of electrical contacts at the interface inlet is fixed relative to the rest of the interface inlet.

31. The invention further includes a mesh layer that surrounds the outer surface of at least a portion of the nasal cannula or the gas inlet conduit, The mesh comprises a plurality of interwoven filaments, and The nasal cannula interface according to any one of claims 27 to 30, wherein at least a portion of the set of wires of the nasal cannula interface is woven with the filaments of the mesh layer.

32. The nasal cannula interface according to any one of claims 27 to 31, wherein at least a portion of the set of wires of the nasal cannula interface is embedded in at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

33. The nasal cannula interface according to any one of claims 27 to 32, wherein at least a portion of the set of wires of the nasal cannula interface is located on the outer surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

34. The nasal cannula interface according to any one of claims 27 to 33, wherein at least a portion of the set of wires of the nasal cannula interface is located on the inner surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

35. A nasal cannula interface for supplying gas flow to a patient, A gas inlet conduit for receiving the gas flow from a gas source, comprising a gas inlet conduit that defines at least a portion of the gas flow path and includes a patient end and a distal end, The first set of wires, One or more sensors configured to be placed on the patient's skin and configured to measure at least one parameter, A nasal cannula that defines at least a portion of the gas flow path, A body comprising a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's opening, An interface connector for receiving the gas flow from the gas inlet conduit and directing the gas flow toward the at least one prong, A nasal cannula including, Includes, The patient end is connected to the interface connector, The distal end includes an interface inlet, the interface inlet includes a set of electrical contacts, and The first set of wires of the nasal cannula interface provides electrical communication between the one or more sensors and the set of electrical contacts at the interface inlet. Nasal cannula interface.

36. The nasal cannula interface according to claim 35, wherein the at least one prong is configured to be received in one or more nostrils of the patient.

37. The nasal cannula interface according to claim 35 or 36, wherein the at least one prong is configured to form a seal with one of the patient's nostrils.

38. The nasal cannula interface according to claim 35 or 36, wherein the at least one prong is configured to be received in an unsealed manner into one of the patient's nostrils.

39. The nasal cannula interface according to any one of claims 35 to 38, further comprising a second prong extending from the base portion.

40. The nasal cannula interface according to any one of claims 35 to 39, wherein at least one of the one or more sensors is a patient sensor, and the parameter is a physiological parameter of the patient.

41. The nasal cannula interface according to claim 40, wherein the physiological parameter is a measure of the patient's blood oxygenation.

42. The nasal cannula interface according to any one of claims 35 to 41, wherein at least one of the one or more sensors is a pulse oximeter.

43. The nasal cannula interface according to claim 42, wherein the pulse oximeter is a reflective pulse oximeter.

44. The nasal cannula interface according to claim 42, wherein the pulse oximeter is a transmissive pulse oximeter.

45. The nasal cannula interface according to any one of claims 35 to 44, wherein the body of the nasal cannula further includes a pair of side arms.

46. The nasal cannula interface according to any one of claims 35 to 45, further comprising a head fixation assembly.

47. The head restraint assembly is connected to the side arm, as per claim 46, in accordance with claim 45.

48. The head fixation assembly comprises one or more straps, according to claim 46 or 47, for the nasal cannula interface.

49. The nasal cannula interface according to any one of claims 35 to 48, wherein the sensor is movable relative to the main body of the nasal cannula interface.

50. The nasal cannula interface according to any one of claims 35 to 49, further comprising a sensor arm, wherein one or more sensors are located on the sensor arm.

51. The nasal cannula interface according to claim 50, wherein the sensor arm is rigid so that it cannot be easily bent by the user.

52. The nasal cannula interface according to claim 50, wherein the sensor arm is elastically deformable so that it can be easily bent by a user.

53. The nasal cannula interface according to any one of claims 50 to 52, wherein the surface of the sensor arm includes an adhesive so that the surface can adhere to the patient's skin.

54. The length of the sensor arm is adjustable, according to any one of claims 50 to 53, nasal cannula interface.

55. The nasal cannula interface according to claim 54, wherein the length of the sensor arm is adjustable through extension and retraction.

56. The head restraint assembly further includes a sensor mount connected to one of the straps, and the sensor arm protrudes from the sensor mount, according to any one of claims 50 to 55 as dependent on claim 63.

57. The nasal cannula interface according to claim 56, wherein the sensor mount is movably connected to one of the straps.

58. The nasal cannula interface according to claim 57, wherein the sensor mount is slidably connected to one of the straps.

59. The nasal cannula interface according to any one of claims 56 to 58, wherein the sensor mount is detachably connected to one of the straps.

60. The nasal cannula interface according to any one of claims 50 to 55, further comprising a sensor mount connected to one of the gas inlet conduits, wherein the sensor arm protrudes from the sensor mount.

61. The nasal cannula interface according to claim 60, wherein the sensor mount is movably connected to the gas inlet conduit.

62. The nasal cannula interface according to claim 61, wherein the sensor mount is slidably connected to the gas inlet conduit.

63. The nasal cannula interface according to any one of claims 60 to 62, wherein the sensor mount is removably connected to the gas inlet conduit.

64. The nasal cannula interface according to any one of claims 56 to 63, wherein the sensor arm is movable relative to the sensor mount.

65. The nasal cannula interface according to claim 64, wherein the sensor arm is slidably attached to the sensor mount.

66. The nasal cannula interface according to claim 65, wherein the sensor arm is slidably attached to the sensor mount so as to be able to slide in a direction parallel to the length of the strap or gas inlet conduit to which the sensor mount is connected.

67. The nasal cannula interface according to claim 66, wherein the sensor arm is slidably attached to the sensor mount so as to be able to slide in a direction transverse to the length of the strap or gas inlet conduit to which the sensor mount is connected.

68. The nasal cannula interface according to any one of claims 64 to 67, wherein the sensor arm is configured to rotate around an axis to which the sensor arm is connected to the sensor mount.

69. The nasal cannula interface according to any one of claims 35 to 49, further comprising a sensor clip configured to be attached to the patient by clip, wherein one or more sensors are located on the sensor clip.

70. The nasal cannula interface according to any one of claims 69, wherein the sensor clip is configured to be clipped onto the patient's ear.

71. The nasal cannula interface according to any one of claims 35 to 70, wherein the gas inlet conduit is substantially rigid.

72. The nasal cannula interface according to any one of claims 35 to 70, wherein the gas inlet conduit is substantially flexible.

73. The gas inlet conduit is formed integrally with the nasal cannula, as described in any one of claims 35 to 72.

74. The nasal cannula interface according to any one of claims 35 to 72, wherein the gas inlet conduit is releasably connected to the nasal cannula.

75. The set of electrical contacts at the interface inlet includes a flat surface, and The nasal cannula interface according to any one of claims 35 to 74, wherein the flat surface is substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

76. The set of electrical contacts at the interface input includes pins and / or sockets of an electrical connector, and The nasal cannula interface according to any one of claims 35 to 74, wherein the longitudinal axis of the pin and / or socket is substantially parallel to the longitudinal axis of the lumen of the interface inlet.

77. The nasal cannula interface according to any one of claims 35 to 76, wherein the set of electrical contacts at the interface inlet is fixed relative to the rest of the interface inlet.

78. The invention further includes a mesh layer that surrounds the outer surface of at least a portion of the nasal cannula or the gas inlet conduit, The mesh comprises a plurality of interwoven filaments, and The nasal cannula interface according to any one of claims 35 to 76, wherein at least a portion of the first set of wires of the nasal cannula interface is woven with the filaments of the mesh layer.

79. The nasal cannula interface according to any one of claims 35 to 78, wherein at least a portion of the first set of wires of the nasal cannula interface is embedded in at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

80. The nasal cannula interface according to any one of claims 35 to 79, wherein at least a portion of the first set of wires of the nasal cannula interface is located on the outer surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

81. The nasal cannula interface according to any one of claims 35 to 80, wherein at least a portion of the first set of wires of the nasal cannula interface is located on the inner surface of at least a portion of the body of the nasal cannula, the interface connector of the nasal cannula, or the gas inlet conduit.

82. Wire coil and, A second set of wires extending from the sensor to the wire coil, It further includes, The second set of wires may be retracted into the wire coil. The wire coil is connected to the first set of wires, and The nasal cannula interface according to any one of claims 35 to 81, wherein at least one of the one or more sensors or the sensor is located at the end of the second set of wires.

83. The nasal cannula interface according to claim 82, wherein the second set of wires automatically retracts into the wire coil.

84. The nasal cannula interface according to claim 82, wherein the second set of wires retracts into the wire coil when a button, switch, or lever is activated by the user.

85. The nasal cannula interface according to any one of claims 82 to 84, wherein the wire coil is attached to one of the straps.

86. The nasal cannula interface according to any one of claims 82 to 85, wherein the wire coil is detachably attached to one of the straps.

87. The nasal cannula interface according to any one of claims 82 to 85, wherein the wire coil is attached to the gas inlet conduit.

88. The nasal cannula interface according to claim 87, wherein the wire coil is removably attached to the gas inlet conduit.

89. A headgear for a patient interface, A strap forming part of the headgear to assist in holding or stabilizing the patient interface on the user, A first connector at the first end portion of the strap for connecting the strap to the patient interface, A first cheek engagement member having a surface area adapted to enclose the first connector and to minimize direct contact of the connector with the user's skin during use, and positioned between the user's cheek and the connector, Includes, A headgear comprising one or more sensors configured to be positioned on or adjacent to the patient's skin and configured to measure at least one parameter, wherein the one or more sensors are mounted on the first cheek engagement member.

90. The headgear according to claim 89, further comprising: a second connector at a second opposite end of the strap for connecting the strap to the patient interface; and a second cheek engagement member configured to enclose the second connector and having a surface area adapted to be positioned between the user's other cheek and the connector in order to minimize direct contact of the connector with the user's skin during use.

91. The headgear according to claim 89 or 90, wherein each cheek engagement member is configured to be removably coupled around the respective connector.

92. The headgear according to any one of claims 89 to 91, wherein the surface region of each cheek engagement member comprises a material that is substantially softer than the material of the respective connector.

93. The headgear according to any one of claims 89 to 92, wherein the surface region of each cheek engagement member includes a surface material that is relatively more frictional than the respective connector in order to assist in holding or stabilizing the patient interface on the user's face.

94. The headgear according to claim 92 or 93, wherein the material is a thermoplastic elastomer.

95. The headgear according to any one of claims 89 to 94, wherein the surface area of ​​each cheek engagement member is a surface with a larger surface area at the end of each cheek engagement member adjacent to the patient interface than the surface area of ​​the opposite end of the cheek member that is further from the patient interface.

96. The headgear according to claim 95, wherein the surface region of each cheek engagement member is tapered from a relatively wider end to a relatively smaller end.

97. The headgear according to any one of claims 89 to 96, wherein each cheek engagement member is a sleeve configured to receptively hold the respective connector therein.

98. The headgear according to claim 97, wherein the sleeve is configured to be removably coupled around each of the connectors.

99. The headgear according to claim 97 or 98, wherein the connector is adapted to extend through a passage within the sleeve.

100. The headgear according to claim 99, wherein the sensor is connected to one or more sensor wires, and the one or more sensor wires extend through the passage within the sleeve.

101. The headgear according to any one of claims 97 to 100, wherein each connector is substantially housed by the respective sleeve in an area adapted to be positioned adjacent to the user's cheek when in use.

102. The headgear according to any one of claims 97 to 101, wherein each sleeve is curved along at least a portion of the length of the sleeve to complement the contour of the respective cheek.

103. The headgear according to any one of claims 97 to 102, wherein each connector is curved along at least a portion of the length of the connector which is adapted to be positioned adjacent to the respective cheek.

104. The headgear according to claim 103, wherein the connector is pre-formed to have a curved contour.

105. The headgear according to any one of claims 102 to 104, wherein each sleeve is pre-formed to have a curved contour.

106. The headgear according to any one of claims 102 to 105, wherein each sleeve is curved when enclosing the respective connector.

107. The headgear according to any one of claims 89 to 106, wherein the connector includes a clip for releasably connecting to the patient interface.

108. The headgear according to any one of claims 89 to 107, wherein each connector, when in a predetermined position, is frictionally engaged with or mechanically engaged with the respective cheek engaging member.

109. The headgear according to any one of claims 97 to 108, wherein one or more sensors are mounted on the sleeve.

110. The headgear according to any one of claims 97 to 109, wherein one or more sensors are detachably mounted on the cheek member.

111. The headgear according to any one of claims 89 to 110, wherein the outer surface of one or more of the sensors lies on the same plane as the surface area of ​​the cheek member.

112. A nasal cannula interface for supplying gas flow to a patient, A nasal cannula comprising a body that defines at least a portion of a gas flow path and has a base portion and at least one prong extending from the base portion, wherein the at least one prong is configured to direct the gas flow toward the patient's orifice, and the body comprises a nasal cannula with a lateral mount, A headgear according to any one of claims 89 to 111, wherein the first connector of the headgear is connected to the lateral mount of the main body, A nasal cannula interface including a nasal cannula interface.

113. The nasal cannula interface according to claim 112, wherein the body includes a recess positioned between a pair of prongs, and the prongs extend from the body.

114. The nasal cannula interface according to claim 113, wherein the sensor is located in the recess between the prongs.

115. A nasal cannula interface according to any one of claims 112 to 114, comprising a manifold portion (i.e., a facial attachment portion) that is received within an opening of the main body, wherein the manifold portion includes a recess, and when the manifold is inserted into the main body, the recess of the manifold portion aligns with the recess of the main body.

116. A nasal cannula interface for supplying a gas flow to a patient, comprising a nasal cannula defining at least a portion of the gas flow path, A body comprising a base portion and a pair of prongs extending from the base portion, wherein the prongs are configured to direct the gas flow toward the patient's opening, A gas flow manifold section including a gas inlet for receiving the gas flow from a gas source and a gas outlet for sending the gas flow to the prongs of the main body, Includes, The nasal cannula interface includes a patient sensor configured to measure parameters, the patient sensor being positioned between the prongs, and the body of the nasal cannula interface includes a recess adjacent to the patient's face.

117. The nasal cannula interface according to claim 116, wherein the patient sensor includes a pulse oximeter.

118. A nasal cannula interface according to claim 116 or 117, comprising a plurality of patient sensors.

119. The gas flow manifold portion includes a recessed portion between the prong and the sensor positioned within the recess, and The nasal cannula interface according to any one of claims 116 to 118, further comprising a manifold portion (i.e., a facial attachment portion) received within an opening of the main body, the manifold portion comprising a recess, and when the manifold is inserted into the main body, the recess of the manifold portion aligns with the recess of the main body.

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