Patient interface and respiratory support system

Abstract

The present application relates to patient interfaces and respiratory support systems. A nasal cannula interface for supplying a flow of gas to a patient is provided, the nasal cannula interface comprising: a nasal cannula defining at least a portion of a gas flow path and comprising: a body having a base portion and at least one prong extending from the base portion, the at least one prong being configured to direct the flow of gas to an orifice of the patient, and one or more sensors configured to measure a parameter. The one or more sensors can comprise a pulse oximeter. The one or more sensors can be mounted on the nasal cannula body, or a headgear to which the body is connected. The one or more sensors can be configured to be in contact with the patient's face, and can be configured to be mounted to be flush and / or substantially flush with a cheek-contacting portion of the interface.

Description

[0001] This application is a divisional application of the invention patent application 202180061796.X, filed on August 6, 2021, entitled "Patient Interface and Respiratory Support System". Technical Field

[0002] This disclosure generally relates to patient interfaces and respiratory support systems for providing a breathable gas flow to a patient, and more specifically to respiratory support systems having sensors on or near the patient interface. Background Technology

[0003] When providing respiratory support to a patient, monitoring one or more patient parameters during the treatment process may be beneficial. To measure these patient parameters, one or more patient sensors, such as a pulse oximeter, are used to determine blood oxygen saturation and heart rate. These parameters can be used alone or in combination with other parameters to assess the patient's health status. Additionally, these parameters can be used to adjust one or more control parameters of the respiratory support system used to provide respiratory support to the patient. These adjustments can be made manually by the clinician or automatically by the respiratory support system's controller, such as through feedback control. The adjusted parameters may include any or more of the following: flow rate, pressure, temperature, humidity, dew point, oxygen concentration, and / or oxygen saturation. Summary of the Invention

[0004] The systems, methods, and apparatuses described herein have novel aspects, in which no single aspect is essential or independently responsible for their desirable properties. Without limiting the scope of the claims, some advantageous features will now be outlined.

[0005] Throughout this document, the term "respiratory support system" refers to a combination of a respiratory support device and any associated components used to provide respiratory support to a patient (such as a patient interface and / or one or more gas tubing and / or other components used to provide respiratory support to a patient). Components that may constitute at least a part of a respiratory support device may include any or more of the following: a flow generator, a controller, a humidifier, a graphical user interface, and a flow control valve.

[0006] Throughout this text, the term "circuit" refers to the entire inspiratory gas pathway from the gas supply source to the patient, and may also include the exhaled gas pathway from the patient back to the gas supply source. Therefore, a circuit includes at a minimum the inspiratory gas pathway (including all components) from the gas supply source to the patient interface. The interface itself (e.g., a mask or cannula) is separate from the gas pathway and is not part of the "circuit".

[0007] Throughout this article, "gas conduit" is any channel configured to deliver a flow of breathable gas.

[0008] 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" refers to an individual receiving therapy (e.g., a therapeutic gas flow) from a respiratory support system, particularly an individual wearing a patient interface. As used herein, "clinician" refers to an individual (e.g., a nurse or physician) who does not receive therapy from a respiratory support system but performs other tasks such as adjusting the settings of the respiratory support device, assisting in setting up the respiratory support system and / or helping to attach the patient interface to a patient, or prescribing therapy. As used herein, "user" refers to an individual who can adjust the settings of the respiratory support device, assist in setting up the respiratory support system, and / or help to attach the patient interface to a patient, and perform other tasks. Depending on the situation, the user may be a clinician or the patient themselves. For example, in a hospital setting, a clinician may set up the system for a patient; in this case, the term "user" may refer to the clinician. In scenarios where the "user" adjusts the operating parameters of the respiratory support device but does not necessarily interact with the patient, the user may be a biomedical engineer, maintenance engineer, or technician. Conversely, in scenarios where patients use respiratory support systems at home, patients can set up the system themselves, so the term "user" can refer to the patient.

[0009] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0010] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0011] One or more sensors configured to measure parameters.

[0012] The one or more sensors are mounted (i.e., positioned) on one or more of the following:

[0013] a) Patient interface;

[0014] b) A headgear configured to mount the patient interface onto the patient's head;

[0015] c) A head cap connector configured to connect the head cap to the patient interface;

[0016] d) A gas delivery catheter configured to deliver breathable gas to a patient.

[0017] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0018] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0019] A frame on which the body is permanently or removably mounted, the frame being configured to connect to a headgear to mount a patient interface on the patient's head;

[0020] One or more sensors configured to measure parameters.

[0021] The sensor is mounted on the patient interface and / or frame and / or headgear.

[0022] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0023] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0024] Lateral arms, which extend laterally outward from the body and are configured to connect to the head cap to mount the patient interface on the patient's head;

[0025] One or more sensors configured to measure parameters.

[0026] The sensor is mounted on the patient interface and / or the lateral arm and / or the head cap.

[0027] The one or more sensors can be removably mounted (i.e., can be removed from the patient interface and repositioned) to any one or more of the following:

[0028] a) Patient interface;

[0029] b) A headgear configured to mount the patient interface onto the patient's head;

[0030] c) A head cap connector configured to connect the head cap to the patient interface;

[0031] d) A gas delivery catheter configured to deliver breathable gas to a patient.

[0032] It may be advantageous if one or more sensors are removable, as they can be removed, cleaned, and installed into another interface. This allows the sensors to be reused between different patients.

[0033] Alternatively, the one or more sensors can be integrated into one or more of the following:

[0034] a) Patient interface;

[0035] b) A headgear configured to mount the patient interface onto the patient's head;

[0036] c) A head cap connector configured to connect the head cap to the patient interface;

[0037] d) A gas delivery catheter configured to deliver breathable gas to a patient.

[0038] The one or more sensors can be integrated in a way that prevents them from being removed. In such an integrated arrangement, the one or more sensors can be disposable.

[0039] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0040] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0041] One or more sensors configured to measure parameters.

[0042] The body further includes a top surface and a rear surface, wherein the rear surface is adjacent to the patient when using the patient interface; wherein,

[0043] The outer surface of one or more sensors is flush with the top surface or the rear surface.

[0044] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0045] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0046] One or more sensors configured to measure parameters.

[0047] The one or more sensors are embedded below the outer surface of the body of the patient interface.

[0048] At least one of the sensors may be a patient sensor, and the parameter may be a physiological parameter of the patient.

[0049] This parameter can be a measure of the patient's blood oxygenation.

[0050] The patient interface can be sealed to the patient's orifice.

[0051] The patient interface may include a cover.

[0052] The mask can be a nose mask.

[0053] This cover can be a face mask.

[0054] The mask can be a nose mask.

[0055] The mask can be a full-face mask.

[0056] The cover may include a cushioning pad.

[0057] The one or more sensors can be flush with the outer surface of the cushioning pad.

[0058] The patient interface may include a nasal pillow interface.

[0059] The patient interface may include a tracheostomy interface.

[0060] The patient interface may further include a head fixation component.

[0061] The head fixation component may include one or more straps.

[0062] The head fixation component may include one or more facial pads.

[0063] Each or every facial pad may include an adhesive surface that attaches to the patient's skin.

[0064] Each face pad may include two different patches.

[0065] The two different patches can be removably connected.

[0066] The one or more sensors may be a pulse oximeter.

[0067] This pulse oximeter can be a reflective pulse oximeter.

[0068] The one or more sensors can be arranged to contact the patient's columella when the patient interface is in use.

[0069] The patient interface may further include:

[0070] A gas inlet conduit for receiving a gas flow from a flow source, the gas inlet conduit defining at least a portion of a gas flow path; and

[0071] An interface connector for receiving a gas flow from the gas inlet catheter and directing that gas flow toward the patient.

[0072] The patient interface may further include a set of wires, wherein the gas inlet conduit further includes a patient end and a distal end, and

[0073] The patient end is connected to the interface connector.

[0074] The remote end includes an interface entry point, which includes a set of electrical contacts, and

[0075] This set of wires at the patient interface provides electrical communication between the one or more sensors and this set of electrical contacts at the interface inlet.

[0076] The set of electrical contacts at the interface inlet may include a planar surface, and the planar surface may be substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

[0077] The electrical contacts at the interface inlet may include pins and / or sockets of a pin-to-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.

[0078] This set of electrical contacts at the interface inlet can be in a fixed position relative to the rest of the interface inlet.

[0079] The patient interface may further include a mesh layer surrounding at least a portion of the outer surface of the body of the patient interface or the gas inlet conduit.

[0080] The net may include multiple interwoven filaments, and

[0081] At least a portion of the wires in the patient interface can be interwoven with the filaments of the mesh layer.

[0082] At least a portion of the wires of the patient interface can be embedded in the body of the patient interface, the interface connector of the patient interface, or at least a portion of the gas inlet conduit.

[0083] At least a portion of the wires of the patient interface may be located on the outer surface of the body of the patient interface, the interface connector of the patient interface, or at least a portion of the gas inlet conduit.

[0084] At least a portion of the wires of the patient interface may be located on the inner surface of the body of the patient interface, the patient interface connector, or at least a portion of the gas inlet conduit.

[0085] According to this disclosure, a respiratory support system for generating a gas flow is provided, the respiratory support system comprising:

[0086] Respiratory support device, the respiratory support device comprising:

[0087] Flow generator

[0088] Export of respiratory support equipment, and

[0089] Controller;

[0090] Inhalation tubing, the inhalation tubing comprising:

[0091] The patient end with the inspiratory duct outlet, and

[0092] The end of the device has an intake duct inlet;

[0093] The patient interface as described in the foregoing or any subsequent statement;

[0094] The outlet of the respiratory support device is configured to form a pneumatic and electrical connection with the inhalation duct inlet.

[0095] The respiratory support device's outlet is in electrical communication with the controller, and

[0096] The controller is configured to power one or more sensors and receive data from them.

[0097] The flow generator can be a blower.

[0098] The respiratory support system may further include a humidifier for adding heat and / or humidity to the gas flow.

[0099] The respiratory support system may further include an ambient air inlet.

[0100] The respiratory support system may further include at least one supplemental gas inlet for receiving a supplemental gas flow.

[0101] The respiratory support system may further include a valve to adjust the flow of supplemental gas through the at least one supplemental gas inlet.

[0102] This valve can be a proportional valve.

[0103] The at least one supplemental gas inlet may be an oxygen inlet.

[0104] The respiratory support device may include at least one gas composition sensor to measure the composition of the gas flow.

[0105] The at least one gas composition sensor may include an ultrasonic sensor system.

[0106] This controller can be configured to:

[0107] Receive measurements of the composition of the gas stream from the at least one gas composition sensor;

[0108] The measured composition of the gas stream is compared with the composition of the target gas; and

[0109] The valve position is adjusted at least in part based on a comparison between these two values.

[0110] The composition of the target gas can be set by the user.

[0111] This controller can be configured to:

[0112] Receive measured values ​​of parameters from one or more sensors;

[0113] Compare the measured value of the parameter with the target value of the parameter; and

[0114] The target gas composition is adjusted at least in part based on the comparison between the measured value and the target value.

[0115] This target parameter can be set by the user.

[0116] The controller can use the measured value of this parameter to determine when a patient is using the patient interface.

[0117] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0118] One or more sensors, the sensors being configured to be placed on the patient's skin and configured to measure at least one parameter; and

[0119] The body is configured to engage with the patient's orifice and guide the gas flow to said orifice.

[0120] The one or more sensors are movable relative to the body of the patient interface.

[0121] The patient interface may further include a gas inlet conduit for receiving a gas flow from a flow source, the gas inlet conduit defining at least a portion of the gas flow path and including a patient end and a distal end.

[0122] The patient interface may further include a first set of wires.

[0123] The patient interface may further include an interface connector for receiving a gas flow from the gas inlet conduit and directing the gas flow toward the patient.

[0124] The patient end can be connected to the interface connector.

[0125] The remote end may include an interface entry point, which includes a set of electrical contacts.

[0126] The first set of wires of the patient interface can provide electrical communication between the one or more sensors and this set of electrical contacts at the interface inlet.

[0127] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0128] A gas inlet catheter for receiving a gas flow from a flow source, the gas inlet catheter defining at least a portion of a gas flow path and including a patient end and a distal end;

[0129] First set of wires;

[0130] One or more sensors, the sensors being configured to be placed on the patient's skin and configured to measure at least one parameter;

[0131] The subject; and

[0132] An interface connector for receiving gas flow from the gas inlet conduit, and

[0133] The patient end is connected to the interface connector.

[0134] The remote end includes an interface entry point, which includes a set of electrical contacts, and

[0135] The first set of wires of the patient interface provides electrical communication between the one or more sensors and this set of electrical contacts at the interface inlet.

[0136] The patient interface can be sealed to the patient's orifice.

[0137] The patient interface may include a cover.

[0138] The mask can be a nose mask.

[0139] This cover can be a face mask.

[0140] The mask can be a nose mask.

[0141] The mask can be a full-face mask.

[0142] The cover may include a cushioning pad.

[0143] The one or more sensors can be flush with the outer surface of the cushioning pad.

[0144] The patient interface may include a nasal pillow interface.

[0145] The patient interface may include a tracheostomy interface.

[0146] At least one of the sensors may be a patient sensor, and the parameter may be a physiological parameter of the patient.

[0147] This physiological parameter can be a measure of the patient's blood oxygenation.

[0148] At least one of the sensors may be a pulse oximeter.

[0149] This pulse oximeter can be a reflective pulse oximeter.

[0150] The pulse oximeter can be a transmission type pulse oximeter.

[0151] The patient interface may further include a head fixation component.

[0152] The head restraint assembly includes one or more straps.

[0153] These sensors can be moved relative to the body of the patient interface.

[0154] The patient interface may further include a sensor arm, wherein one or more sensors may be positioned on the sensor arm.

[0155] The sensor arm can be rigid, so that the user cannot easily bend it.

[0156] The sensor arm can be deformable, allowing the user to easily bend it. The sensor arm can also be non-elastically deformable, allowing it to remain bent after being deformed by the user. Alternatively, the sensor arm can be elastically deformable.

[0157] The surface of the sensor arm may include an adhesive, allowing the surface to adhere to the patient's skin.

[0158] The length of the sensor arm can be adjusted.

[0159] The length of the sensor arm is adjustable via telescopic movement.

[0160] The head fixation assembly may further include a sensor mount connected to one of these straps, wherein the sensor arm protrudes from the sensor mount.

[0161] The sensor mount can be movably attached to one of these straps.

[0162] The sensor mount can be slidably attached to one of these straps.

[0163] The sensor mount can be removably attached to one of these straps.

[0164] The patient interface may further include a sensor mount connected to one of the gas inlet conduits, wherein the sensor arm protrudes from the sensor mount.

[0165] The sensor mount can be movably connected to the gas inlet conduit.

[0166] The sensor mount can be slidably connected to the gas inlet conduit.

[0167] The sensor mount can be removably connected to the gas inlet conduit.

[0168] The sensor arm is movable relative to the sensor mount.

[0169] The sensor arm can be slidably mounted to the sensor mount.

[0170] The sensor arm can be slidably mounted to the sensor mount and can slide along a direction parallel to the length of the tether or gas inlet conduit to which the sensor mount is connected.

[0171] The sensor arm can be slidably mounted to the sensor mount and can slide in a direction transverse to the length of the tether or gas inlet conduit to which the sensor mount is connected.

[0172] The sensor arm can be configured to rotate about the axis at which it is connected to the sensor mount.

[0173] The patient interface may further include a sensor clamp configured to be clamped onto the patient, wherein one or more sensors may be positioned on the sensor clamp.

[0174] The sensor clip can be configured to clamp onto the patient's ear.

[0175] The gas inlet conduit can be substantially rigid.

[0176] The gas inlet conduit can be substantially flexible.

[0177] The gas inlet catheter can be integrally formed with the patient interface.

[0178] The gas inlet catheter can be releasably connected to the patient interface.

[0179] The set of electrical contacts at the interface entry point can include a planar surface, and

[0180] The planar surface is substantially perpendicular to the longitudinal axis of the lumen at the interface inlet.

[0181] This set of electrical contacts at the interface inlet may include pins and / or sockets for pin-to-socket electrical connections, and

[0182] The longitudinal axis of the pin and / or socket may be substantially parallel to the longitudinal axis of the lumen at the interface inlet.

[0183] This set of electrical contacts at the interface inlet can be in a fixed position relative to the rest of the interface inlet.

[0184] The patient interface may further include a mesh layer surrounding at least a portion of the outer surface of the patient interface or gas inlet conduit.

[0185] The net may include multiple interwoven filaments, and

[0186] At least a portion of the first set of wires in the patient interface can be interwoven with the filaments of the mesh layer.

[0187] At least a portion of the first set of wires of the patient interface may be embedded in the body of the patient interface, the interface connector of the patient interface, or at least a portion of the gas inlet conduit.

[0188] At least a portion of the first set of wires of the patient interface may be located on the outer surface of the body of the patient interface, the interface connector of the patient interface, or at least a portion of the gas inlet conduit.

[0189] At least a portion of the first set of wires of the patient interface may be located on the inner surface of the body of the patient interface, the patient interface connector, or at least a portion of the gas inlet conduit.

[0190] The patient interface may further include:

[0191] Wire coils, and

[0192] A second set of wires extends from the sensor to the wire coil, wherein...

[0193] The second set of wires can retract back into the wire coil.

[0194] The wire coil is connected to the first set of wires, and

[0195] At least one of the one or more sensors, or the sensor being located at the end of the second set of wires.

[0196] The second set of wires can automatically retract back into the wire coil.

[0197] When the user actuates the button, switch, or lever, the second set of wires can retract into the wire coil.

[0198] The wire coil can be installed onto one of these ties.

[0199] The wire coil can be removably attached to one of these straps.

[0200] The wire coil can be installed into the gas inlet conduit.

[0201] The wire coil can be removably installed into the gas inlet conduit.

[0202] According to this disclosure, a respiratory support system for generating a gas flow is provided, the respiratory support system comprising:

[0203] Respiratory support device, the respiratory support device comprising:

[0204] Flow generator

[0205] Export of respiratory support equipment, and

[0206] Controller;

[0207] Inhalation tubing, the inhalation tubing comprising:

[0208] The patient end with the inspiratory duct outlet, and

[0209] The end of the device has an intake duct inlet;

[0210] The patient interface as described in any of the foregoing statements, and

[0211] The outlet of the respiratory support device is configured to form a pneumatic and electrical connection with the inhalation duct inlet.

[0212] The respiratory support device's outlet is in electrical communication with the controller, and

[0213] The controller is configured to power one or more sensors and receive data from them.

[0214] The flow generator can be a blower.

[0215] The respiratory support system may further include a humidifier for adding heat and / or humidity to the gas flow.

[0216] The respiratory support system may further include an ambient air inlet.

[0217] The respiratory support system may further include one or more supplemental gas inlets for receiving supplemental gas streams.

[0218] At least one of the one or more supplementary gas inlets may be an oxygen inlet.

[0219] The respiratory support system may further include a valve to adjust the flow of supplemental gas through at least one of the one or more supplemental gas inlets.

[0220] This valve can be a proportional valve.

[0221] The respiratory support device may include one or more gas composition sensors to measure the composition of the gas flow.

[0222] The one or more gas composition sensors may include an ultrasonic sensor system.

[0223] This controller can be configured to:

[0224] Receive measurements of the composition of the gas stream from one or more gas composition sensors;

[0225] The measured composition of the gas stream is compared with the target composition; and

[0226] The valve position is adjusted at least in part based on the difference between these two values.

[0227] The composition of the target gas can be set by the user.

[0228] This controller can be configured to:

[0229] Receive measured values ​​of parameters from one or more sensors;

[0230] Compare the measured value of the parameter with the target value of the parameter; and

[0231] The target gas composition is adjusted at least in part based on the difference between the measured value and the target value.

[0232] The target value for this parameter can be set by the user.

[0233] The controller can use the measured value of this parameter to determine when a patient is using the patient interface.

[0234] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0235] A patient interface that defines at least a portion of a gas flow path and includes:

[0236] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0237] One or more sensors configured to measure parameters.

[0238] The sensor is configured to contact the patient's nose when the patient interface is in use.

[0239] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0240] A patient interface that defines at least a portion of a gas flow path and includes:

[0241] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0242] One or more sensors configured to measure parameters.

[0243] The sensor is configured to contact the patient's upper lip when the patient interface is in use.

[0244] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0245] A patient interface that defines at least a portion of a gas flow path and includes:

[0246] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0247] One or more sensors configured to measure parameters.

[0248] The sensor is configured to contact the patient's lower lip when the patient interface is in use.

[0249] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0250] A patient interface that defines at least a portion of a gas flow path and includes:

[0251] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0252] One or more sensors configured to measure parameters.

[0253] The sensor is configured to contact the patient's mouth when the patient interface is in use.

[0254] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0255] A patient interface that defines at least a portion of a gas flow path and includes:

[0256] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0257] One or more sensors configured to measure parameters.

[0258] The sensor is configured to contact the patient's cheek when the patient interface is in use.

[0259] According to this disclosure, a patient interface for supplying a gas flow to a patient is provided, the patient interface comprising:

[0260] A patient interface that defines at least a portion of a gas flow path and includes:

[0261] Body, configured to engage with a patient's orifice and direct gas flow to said orifice; and

[0262] One or more sensors configured to measure parameters.

[0263] The sensor is configured to contact the patient's neck when the patient interface is in use.

[0264] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0265] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0266] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0267] One or more sensors configured to measure parameters.

[0268] The body further includes a top surface and a rear surface, wherein the rear surface is adjacent to the patient when using the nasal cannula interface; wherein,

[0269] The outer surface of one or more sensors is flush with the top surface or the rear surface.

[0270] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0271] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0272] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0273] One or more sensors configured to measure parameters.

[0274] The sensor is embedded below the outer surface of the nasal cannula body.

[0275] At least one of the sensors may be a patient sensor, and the parameter may be a physiological parameter of the patient.

[0276] This parameter can be a measure of the patient's blood oxygenation.

[0277] The at least one fork can be configured to be received in one or more nostrils of the patient.

[0278] One or more of the forks in the at least one fork can be configured to form a seal with one of the patient's nostrils.

[0279] One or more of the forks in the at least one fork can be configured to be received in one of the patient's nostrils in an unsealed manner.

[0280] The nasal cannula may further include a head fixation component.

[0281] The head fixation component may include one or more straps.

[0282] The head fixation component may include one or more facial pads.

[0283] Each or every facial pad may include an adhesive surface that attaches to the patient's skin.

[0284] Each face pad may include two different patches.

[0285] The two different patches can be removably connected.

[0286] The nasal cannula may further include a pair of lateral arms.

[0287] The contralateral arm can be integrated with the main body of the nasal cannula.

[0288] The head fixation component can be attached to these side arms.

[0289] These face pads can be positioned on these side arms.

[0290] The outer surface of the patient sensor can be flush with the top surface, which can be the patient contact surface, or the outer surface of the patient sensor can be flush with the rear surface, which can be the patient contact surface.

[0291] The one or more sensors may be a pulse oximeter.

[0292] This pulse oximeter can be a reflective pulse oximeter.

[0293] The nasal cannula may further include a second branch extending from the base.

[0294] One or more sensors can be positioned between these two forks.

[0295] The at least one fork may extend from the top surface of the body of the nasal cannula, and the one or more sensors may be positioned on the top surface.

[0296] The one or more sensors can be arranged to contact the patient's columella when the nasal cannula is in use.

[0297] The at least one fork may extend from the top surface of the body of the nasal cannula, and the one or more sensors may be positioned on the surface of the body adjacent to the top surface.

[0298] One or more sensors can be positioned on the body of the nasal cannula so that the nasal cannula interface contacts the patient's upper lip when in use.

[0299] The nasal cannula interface may further include:

[0300] A gas inlet conduit for receiving a gas flow from a flow source, the gas inlet conduit defining at least a portion of a gas flow path; and

[0301] An interface connector for receiving a gas flow from the gas inlet conduit and directing the gas flow toward the at least one fork.

[0302] The nasal cannula interface may further include a set of wires, wherein the gas inlet catheter further includes a patient end and a distal end, and

[0303] The patient end is connected to the interface connector.

[0304] The remote end includes an interface entry point, which includes a set of electrical contacts, and

[0305] This set of wires in the nasal cannula interface provides electrical communication between the one or more sensors and this set of electrical contacts at the interface inlet.

[0306] The set of electrical contacts at the interface inlet may include a planar surface, and the planar surface may be substantially perpendicular to the longitudinal axis of the lumen of the interface inlet.

[0307] The electrical contacts at the interface inlet may include pins and / or sockets of a pin-to-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.

[0308] This set of electrical contacts at the interface inlet can be in a fixed position relative to the rest of the interface inlet.

[0309] The nasal cannula interface may further include a mesh layer surrounding at least a portion of the outer surface of the nasal cannula or the gas inlet conduit.

[0310] The net may include multiple interwoven filaments, and

[0311] At least a portion of the wires in the nasal cannula interface can be interwoven with the filaments of the mesh layer.

[0312] At least a portion of the wires of the nasal cannula interface can be embedded in the body of the nasal cannula, the interface connector of the nasal cannula, or at least a portion of the gas inlet conduit.

[0313] At least a portion of the wires of the nasal cannula interface can be positioned on the outer surface of at least a portion of the nasal cannula body, the nasal cannula interface connector, or the gas inlet conduit.

[0314] At least a portion of the wires of the nasal cannula interface can be positioned on the inner surface of the nasal cannula body, the nasal cannula interface connector, or at least a portion of the gas inlet conduit.

[0315] According to this disclosure, a respiratory support system for generating a gas flow is provided, the respiratory support system comprising:

[0316] Respiratory support device, the respiratory support device comprising:

[0317] Flow generator

[0318] Export of respiratory support equipment, and

[0319] Controller;

[0320] Inhalation tubing, the inhalation tubing comprising:

[0321] The patient end with the inspiratory duct outlet, and

[0322] The end of the device has an intake duct inlet;

[0323] Nasal intubation interface as described in any of the foregoing statements;

[0324] The outlet of the respiratory support device is configured to form a pneumatic and electrical connection with the inhalation duct inlet.

[0325] The respiratory support device's outlet is in electrical communication with the controller, and

[0326] The controller is configured to power one or more sensors and receive data from them.

[0327] The flow generator can be a blower.

[0328] The respiratory support system may further include a humidifier for adding heat and / or humidity to the gas flow.

[0329] The respiratory support system may further include an ambient air inlet.

[0330] The respiratory support system may further include at least one supplemental gas inlet for receiving a supplemental gas flow.

[0331] The respiratory support system may further include a valve to adjust the flow of supplemental gas through the at least one supplemental gas inlet.

[0332] This valve can be a proportional valve.

[0333] The at least one supplemental gas inlet may be an oxygen inlet.

[0334] The respiratory support device may include at least one gas composition sensor to measure the composition of the gas flow.

[0335] The at least one gas composition sensor may include an ultrasonic sensor system.

[0336] This controller can be configured to:

[0337] Receive measurements of the composition of the gas stream from the at least one gas composition sensor;

[0338] The measured composition of the gas stream is compared with the composition of the target gas; and

[0339] The valve position is adjusted at least in part based on a comparison between these two values.

[0340] The composition of the target gas can be set by the user.

[0341] This controller can be configured to:

[0342] Receive measured values ​​of parameters from one or more sensors;

[0343] Compare the measured value of the parameter with the target value of the parameter; and

[0344] The target gas composition is adjusted at least in part based on the comparison between the measured value and the target value.

[0345] This target parameter can be set by the user.

[0346] The controller can use the measured value of this parameter to determine when a patient is using a nasal cannula.

[0347] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0348] One or more sensors, the sensors being configured to be placed on the patient's skin and configured to measure at least one parameter; and

[0349] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0350] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0351] The one or more sensors are movable relative to the body of the nasal cannula.

[0352] The nasal cannula interface may further include a gas inlet catheter for receiving a gas flow from a flow source, the gas inlet catheter defining at least a portion of the gas flow path and including a patient end and a distal end.

[0353] The nasal cannula interface may further include a first set of wires.

[0354] The nasal cannula may further include an interface connector for receiving a gas flow from the gas inlet conduit and guiding the gas flow toward the at least one fork.

[0355] The patient end can be connected to the interface connector.

[0356] The remote end may include an interface entry point, which includes a set of electrical contacts.

[0357] The first set of wires of the nasal cannula interface can provide electrical communication between the one or more sensors and this set of electrical contacts at the interface inlet.

[0358] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0359] A gas inlet catheter for receiving a gas flow from a flow source, the gas inlet catheter defining at least a portion of a gas flow path and including a patient end and a distal end;

[0360] First set of wires;

[0361] One or more sensors, the sensors being configured to be placed on the patient's skin and configured to measure at least one parameter; and

[0362] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0363] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0364] An interface connector for receiving gas flow from the gas inlet conduit and guiding the gas flow toward the at least one fork, and

[0365] The patient end is connected to the interface connector.

[0366] The remote end includes an interface entry point, which includes a set of electrical contacts, and

[0367] The first set of wires of the nasal cannula interface provides electrical communication between the one or more sensors and this set of electrical contacts at the interface inlet.

[0368] The at least one fork can be configured to be received in one or more nostrils of the patient.

[0369] The at least one fork can be configured to form a seal with one of the patient's nostrils.

[0370] The at least one fork can be configured to be received in one of the patient's nostrils in an unsealed manner.

[0371] The nasal cannula interface may further include a second fork extending from the base portion.

[0372] At least one of the sensors may be a patient sensor, and the parameter may be a physiological parameter of the patient.

[0373] This physiological parameter can be a measure of the patient's blood oxygenation.

[0374] At least one of the sensors may be a pulse oximeter.

[0375] This pulse oximeter can be a reflective pulse oximeter.

[0376] The pulse oximeter can be a transmission type pulse oximeter.

[0377] The body of the nasal cannula further includes a pair of side arms.

[0378] The nasal cannula interface may further include a head fixation component.

[0379] The head fixation component can be attached to these side arms.

[0380] The head restraint assembly includes one or more straps.

[0381] These sensors are movable relative to the body of the nasal cannula interface.

[0382] The nasal cannula interface may further include a sensor arm, wherein one or more sensors may be positioned on the sensor arm.

[0383] The sensor arm can be rigid, so that the user cannot easily bend it.

[0384] The sensor arm can be elastically deformable, allowing the user to easily bend it.

[0385] The surface of the sensor arm may include an adhesive, allowing the surface to adhere to the patient's skin.

[0386] The length of the sensor arm can be adjusted.

[0387] The length of the sensor arm is adjustable via telescopic movement.

[0388] The head fixation assembly may further include a sensor mount connected to one of these straps, wherein the sensor arm protrudes from the sensor mount.

[0389] The sensor mount can be movably attached to one of these straps.

[0390] The sensor mount can be slidably attached to one of these straps.

[0391] The sensor mount can be removably attached to one of these straps.

[0392] The nasal cannula interface may further include a sensor mount connected to one of the gas inlet conduits, wherein the sensor arm protrudes from the sensor mount.

[0393] The sensor mount can be movably connected to the gas inlet conduit.

[0394] The sensor mount can be slidably connected to the gas inlet conduit.

[0395] The sensor mount can be removably connected to the gas inlet conduit.

[0396] The sensor arm is movable relative to the sensor mount.

[0397] The sensor arm can be slidably mounted to the sensor mount.

[0398] The sensor arm can be slidably mounted to the sensor mount and can slide along a direction parallel to the length of the tether or gas inlet conduit to which the sensor mount is connected.

[0399] The sensor arm can be slidably mounted to the sensor mount and can slide in a direction transverse to the length of the tether or gas inlet conduit to which the sensor mount is connected.

[0400] The sensor arm can be configured to rotate about the axis at which it is connected to the sensor mount.

[0401] The nasal cannula interface may further include a sensor clamp configured to clamp onto the patient, wherein one or more sensors may be positioned on the sensor clamp.

[0402] The sensor clip can be configured to clamp onto the patient's ear.

[0403] The gas inlet conduit can be substantially rigid.

[0404] The gas inlet conduit can be substantially flexible.

[0405] The gas inlet catheter can be integrated with the nasal cannula.

[0406] The gas inlet catheter can be releasably connected to a nasal cannula.

[0407] The set of electrical contacts at the interface entry point can include a planar surface, and

[0408] The planar surface is substantially perpendicular to the longitudinal axis of the lumen at the interface inlet.

[0409] This set of electrical contacts at the interface inlet may include pins and / or sockets for pin-to-socket electrical connections, and

[0410] The longitudinal axis of the pin and / or socket may be substantially parallel to the longitudinal axis of the lumen at the interface inlet.

[0411] This set of electrical contacts at the interface inlet can be in a fixed position relative to the rest of the interface inlet.

[0412] The nasal cannula interface may further include a mesh layer surrounding at least a portion of the outer surface of the nasal cannula or the gas inlet conduit.

[0413] The net may include multiple interwoven filaments, and

[0414] At least a portion of the first set of wires of the nasal cannula interface can be interwoven with the filaments of the mesh layer.

[0415] At least a portion of the first set of wires of the nasal cannula interface can be embedded in the body of the nasal cannula, the interface connector of the nasal cannula, or at least a portion of the gas inlet conduit.

[0416] At least a portion of the first set of wires of the nasal cannula interface can be positioned on the outer surface of the nasal cannula body, the nasal cannula interface connector, or at least a portion of the gas inlet conduit.

[0417] At least a portion of the first set of wires of the nasal cannula interface may be positioned on the inner surface of the nasal cannula body, the nasal cannula interface connector, or at least a portion of the gas inlet conduit.

[0418] The nasal cannula interface may further include:

[0419] Wire coils, and

[0420] A second set of wires extends from the sensor to the wire coil, wherein...

[0421] The second set of wires can retract back into the wire coil.

[0422] The wire coil is connected to the first set of wires, and

[0423] At least one of the one or more sensors, or the sensor being located at the end of the second set of wires.

[0424] The second set of wires can automatically retract back into the wire coil.

[0425] When the user actuates the button, switch, or lever, the second set of wires can retract into the wire coil.

[0426] The wire coil can be installed onto one of these ties.

[0427] The wire coil can be removably attached to one of these straps.

[0428] The wire coil can be installed into the gas inlet conduit.

[0429] The wire coil can be removably installed into the gas inlet conduit.

[0430] The nasal cannula interface can be configured such that the one or more sensors are connected to one or more sensor wires via an inductive connection. For example, the one or more sensors can be configured to be connected to one or more sensor wires in a gas delivery conduit via an inductive connection. Such a connection eliminates the need for physical electrical connections and exposed electrical contacts.

[0431] According to another aspect of this disclosure, a headgear for a patient interface is provided, the headgear comprising:

[0432] The ties, which form part of the headgear, help hold or stabilize the patient interface on the user.

[0433] A first connector, located at a first end of the tether, is used to connect the tether to the patient interface.

[0434] A first cheek engagement member is adapted to enclose the first connector and has a surface area adapted to be positioned between the user's cheek and the connector to minimize direct contact between the connector and the user's skin during use.

[0435] One or more sensors are configured to be placed on or near the patient's skin and configured to measure at least one parameter; the one or more sensors are mounted on the first cheek joint member.

[0436] The cap may further include a second connector located 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 cheeks to minimize direct contact between the connector and the user's skin during use.

[0437] Each cheek joint component can be configured to be removably coupled around the corresponding connector.

[0438] The surface area of ​​each cheek joint component may include a material that is significantly softer than the material of the corresponding connector.

[0439] Each cheek joint component may include a surface area with a relatively higher frictionality than the corresponding connector to help hold or stabilize the patient interface on the user's face.

[0440] The material can be a thermoplastic elastomer.

[0441] The surface area of ​​each cheek joint member is shown in the table below. The surface area of ​​the cheek joint member at the end adjacent to the patient interface is wider than the surface area of ​​the cheek joint member at the opposite end further away from the patient interface.

[0442] The surface area of ​​each cheek joint component can taper from a relatively wide end to a relatively small end.

[0443] Each cheek joint member can be a sleeve configured to acceptably retain the corresponding connector therein.

[0444] The sleeve can be configured to removably connect around the corresponding connector.

[0445] The connector can be adapted to extend through a passage in the sleeve.

[0446] The sensor can be connected to one or more sensor wires, which extend through a passage in the sleeve.

[0447] Each connector can be essentially housed by a corresponding sleeve in an area adapted to be positioned near the user's cheek during use.

[0448] Each sleeve may be bent along at least a portion of its length to complement the contour of the corresponding cheek.

[0449] Each connector may be a portion of the connector that is adapted to be positioned adjacent to the corresponding cheek and is curved along the length of the connector.

[0450] The connector can be pre-formed into a curved shape.

[0451] Each sleeve can be pre-shaped into a curved form.

[0452] Each sleeve can be bent when encapsulating the corresponding connector.

[0453] Each connector includes a clamp for releasable connection to the patient interface.

[0454] Once in place, each connector can be frictionally or mechanically engaged with the corresponding cheek engagement component.

[0455] One or more sensors can be mounted on the sleeve.

[0456] The one or more sensors can be removably mounted on the cheek component.

[0457] The outer surface of one or more sensors may be flush with the surface area of ​​the cheek component.

[0458] According to this disclosure, a respiratory support system for generating a gas flow is provided, the respiratory support system comprising:

[0459] Respiratory support device, the respiratory support device comprising:

[0460] Flow generator

[0461] Export of respiratory support equipment, and

[0462] Controller

[0463] Inhalation tubing, the inhalation tubing comprising:

[0464] The patient end with the inspiratory duct outlet, and

[0465] The end of the device has an intake duct inlet;

[0466] As described in any of the foregoing statements regarding the nasal cannula interface or headgear, and

[0467] The outlet of the respiratory support device is configured to form a pneumatic and electrical connection with the inhalation duct inlet.

[0468] The respiratory support device's outlet is in electrical communication with the controller, and

[0469] The controller is configured to power one or more sensors and receive data from them.

[0470] The flow generator can be a blower.

[0471] The respiratory support system may further include a humidifier for adding heat and / or humidity to the gas flow.

[0472] The respiratory support system may further include an ambient air inlet.

[0473] The respiratory support system may further include one or more supplemental gas inlets for receiving supplemental gas streams.

[0474] At least one of the one or more supplementary gas inlets may be an oxygen inlet.

[0475] The respiratory support system may further include a valve to adjust the flow of supplemental gas through at least one of the one or more supplemental gas inlets.

[0476] This valve can be a proportional valve.

[0477] The respiratory support device may include one or more gas composition sensors to measure the composition of the gas flow.

[0478] The one or more gas composition sensors may include an ultrasonic sensor system.

[0479] This controller can be configured to:

[0480] Receive measurements of the composition of the gas stream from one or more gas composition sensors;

[0481] The measured composition of the gas stream is compared with the target composition; and

[0482] The valve position is adjusted at least in part based on the difference between these two values.

[0483] The composition of the target gas can be set by the user.

[0484] This controller can be configured to:

[0485] Receive measured values ​​of parameters from one or more sensors;

[0486] Compare the measured value of the parameter with the target value of the parameter; and

[0487] The target gas composition is adjusted at least in part based on the difference between the measured value and the target value.

[0488] The target value for this parameter can be set by the user.

[0489] The controller can use the measured value of this parameter to determine when a patient is using a nasal cannula.

[0490] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0491] A nasal cannula defining at least a portion of a gas flow path and comprising: a body having a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide gas flow to the patient's orifice, the body including a lateral mounting member; and

[0492] The headgear described in any of the foregoing statements; wherein the first connector of the headgear is connected to the lateral mounting of the body.

[0493] The body may include a recess located between a pair of forks extending from the body. The sensor may be positioned within the recess between the forks.

[0494] The nasal cannula interface may include a manifold portion, i.e. a face mounting portion, received within an opening of the body, wherein the manifold portion includes a recess, wherein when the manifold is inserted into the body, the recess in the manifold portion aligns with a recess in the body.

[0495] According to an aspect of this disclosure, a nasal cannula interface for supplying a gas flow to a patient is provided, including a nasal cannula defining at least a portion of a gas flow connection and comprising:

[0496] The body has a base portion and a pair of forks extending from the base portion, the forks being configured to guide a gas flow to the patient's orifice;

[0497] A gas flow manifold includes a gas inlet for receiving a gas flow from a gas source and a gas outlet for delivering the gas flow to the body via a fork.

[0498] The nasal cannula interface includes a patient sensor configured to measure parameters; the patient sensor is positioned between the forks, and the body includes a recess adjacent to the patient's face.

[0499] The patient sensor may include a pulse oximeter.

[0500] The nasal cannula interface can include multiple patient sensors.

[0501] The gas flow manifold may include recessed portions between these forks and sensors positioned within the recesses, and

[0502] The nasal cannula further includes a manifold portion, i.e. a face mounting portion, received within an opening of the body, wherein the manifold portion includes a recess, wherein when the manifold is inserted into the body, the recess in the manifold portion aligns with a recess in the body.

[0503] According to this disclosure, a nasal cannula interface is provided, the nasal cannula interface comprising: a face mounting portion having a base portion and at least one fork extending from the base portion and capable of fitting into at least one nostril of a user; and

[0504] A gas flow manifold 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 nose fork of the face mount, the manifold being adapted to be received by a base portion of the face mount to fluidly connect the outlet of the manifold to the at least one nose fork of the face mount, and wherein the manifold further includes a recess; a patient sensor positioned in the recess.

[0505] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0506] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0507] A body having a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice; and

[0508] One or more sensors configured to measure parameters;

[0509] The sensor is configured to contact the patient's nose when the nasal cannula is in use.

[0510] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0511] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0512] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0513] One or more sensors configured to measure parameters.

[0514] The sensor is configured to contact the patient's upper lip when the nasal cannula is in use.

[0515] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0516] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0517] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0518] One or more sensors configured to measure parameters.

[0519] The sensor is configured to contact the patient's lower lip when the nasal cannula is in use.

[0520] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0521] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0522] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0523] One or more sensors configured to measure parameters.

[0524] The sensor is configured to contact the patient's mouth when the nasal cannula is in use.

[0525] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0526] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0527] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0528] One or more sensors configured to measure parameters.

[0529] The sensor is configured to contact the patient's cheek when the nasal cannula is in use.

[0530] According to this disclosure, a nasal cannula interface is provided for supplying a gas flow to a patient, the nasal cannula interface comprising:

[0531] A nasal cannula that defines at least a portion of a gas flow path and includes:

[0532] The body has a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow to the patient's orifice.

[0533] One or more sensors configured to measure parameters.

[0534] The sensor is configured to contact the patient's neck when the nasal cannula is in use. Attached Figure Description

[0535] Reference numerals may be used repeatedly throughout the accompanying drawings to indicate general correspondences between referenced elements. The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of this disclosure.

[0536] Figure 1 The respiratory support device is illustrated in diagram form.

[0537] Figure 2 It shows the relationship with Figure 1 A schematic diagram of a closed-loop control system used in conjunction with respiratory support equipment.

[0538] Figure 3 The nasal cannula is shown in use by a patient according to one aspect of this disclosure.

[0539] Figure 4 A partial front view of a nasal cannula according to one aspect of this disclosure is shown.

[0540] Figure 5 It shows Figure 4 Exploded view of the nasal cannula.

[0541] Figure 6 A front view of the body of a nasal cannula according to one aspect of this disclosure is shown.

[0542] Figure 7 It shows Figure 6 Rear view of the body of the nasal cannula, including the patient sensors.

[0543] Figure 8 It shows Figure 6 Rear view of the nasal cannula body, including alternative placement of patient sensors.

[0544] Figure 9 It shows Figure 6 Rear view of the nasal cannula body, including an alternative placement of the patient sensor.

[0545] Figure 10 It shows direct from Figure 6 The view from the rear of the nasal cannula body includes an alternative placement of the patient sensors.

[0546] Figure 11 A perspective front view of an alternative configuration of the nasal cannula body according to one aspect of this disclosure is shown, including a facial pad.

[0547] Figure 12 It shows direct from Figure 11 A view of the nasal cannula from the rear.

[0548] Figure 13 A perspective front view of an alternative configuration of the nasal cannula body according to one aspect of this disclosure is shown, including a two-part facial pad.

[0549] Figure 14 It shows Figure 13 Side view of the nasal cannula.

[0550] Figure 15 It shows Figure 13 Exploded view of the nasal cannula.

[0551] Figure 16 An alternative configuration of a nasal cannula for use by a patient, including a patient sensor, is shown according to one aspect of this disclosure.

[0552] Figure 17 It shows Figure 16 An enlarged view of section B.

[0553] Figure 18 An alternative configuration of a nasal cannula connected to a patient, including a patient sensor, is shown according to one aspect of this disclosure.

[0554] Figure 19 It shows Figure 15 An enlarged view of section B.

[0555] Figure 20 An alternative configuration of a nasal cannula for use by a patient, including a patient sensor, is shown according to one aspect of this disclosure.

[0556] Figure 21 It shows Figure 19 An enlarged view of section B.

[0557] Figure 22 It shows Figure 20 and Figure 21 The possible range of motion of the patient's sensor.

[0558] Figure 23 It shows Figure 20 and Figure 21 The patient's sensor has another possible range of movement.

[0559] Figure 24 It shows Figure 20 and Figure 21 The patient's sensor has another possible range of movement.

[0560] Figure 25 It shows Figure 20 and Figure 21 The patient's sensor has another possible range of movement.

[0561] Figures 26 to 28 The nasal cannula, as shown in one aspect of this disclosure, is used by a patient and includes an alternative placement of an electrical coil.

[0562] Figure 29 It shows Figure 27 An enlarged view of section D.

[0563] Figures 30 to 32 A nasal cannula, including an electrical coil, is shown for use by a patient according to one aspect of this disclosure.

[0564] Figure 33 A nasal cannula, including a patient sensor on the forehead frenulum, is shown in one aspect of this disclosure when used by a patient.

[0565] Figure 34 A cover assembly for use by a patient, according to one aspect of this disclosure, is shown, including a patient sensor on the forehead ties.

[0566] Figure 35 A tracheostomy interface for use by a patient, according to one aspect of this disclosure, is shown, including a patient sensor on a cervical ligament.

[0567] Figure 36 A tracheostomy interface for use by a patient, according to one aspect of this disclosure, is shown, including a patient sensor on a neck bandage.

[0568] Figure 37A and Figure 37B A perspective view and an exploded perspective view of another nasal cannula according to this disclosure are shown, respectively. Figure 37C A perspective view of the cap of the nasal cannula is shown.

[0569] Figure 38A and Figure 38B An enlarged perspective view of the connection between the nasal cannula and the hood is shown, illustrating a preferred form of the hood's sleeve.

[0570] Figures 39A to 39B An enlarged perspective view of the retention clamp for the nasal cannula according to this disclosure is shown.

[0571] Figures 40A to 40C An enlarged perspective view of the cap connector for the nasal cannula, as disclosed herein, is shown.

[0572] Figure 41A and Figure 41B They respectively showed the same as Figure 40A and Figure 40BThe corresponding cross-sectional view.

[0573] Figure 42 This is a perspective view of another embodiment of the nasal cannula according to this disclosure.

[0574] Figure 43 yes Figure 42 A perspective view of the manifold portion of a nasal cannula. Detailed description

[0575] This document describes certain embodiments and examples of respiratory support systems and patient interfaces for such systems. Those skilled in the art will recognize that this disclosure extends beyond the specific embodiments and / or uses disclosed herein, as well as their obvious modifications and equivalents. Therefore, it is intended that the scope of this disclosure herein should not be limited to any particular embodiment described herein.

[0576] Patients with a variety of health conditions and illnesses can benefit from respiratory support. For example, patients with conditions such as chronic obstructive pulmonary disease (COPD), pneumonia, asthma, bronchopulmonary dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, respiratory trauma, acute respiratory distress, those receiving pre- and post-operative oxygen therapy, and those with other conditions or illnesses can benefit from respiratory support. As part of providing respiratory support to patients, patient sensors can be used to measure one or more physiological parameters to monitor the patient's health. Patient sensors can be pulse oximeters, which provide information related to heart rate and blood oxygen saturation (SpO2).

[0577] When providing respiratory support, especially supplemental oxygen therapy, a common method for monitoring a patient's health is to ensure that their SpO2 does not drop too low (e.g., typically below about 90%). However, supplying a patient with too much oxygen can over-oxygenate their blood and is also considered dangerous. Generally, a patient's SpO2 is maintained within the range of about 80% to about 99%, and preferably about 92% to about 96%, but these ranges may vary depending on the patient's condition and / or between patients.

[0578] Due to a variety of patient factors, such as respiratory rate, lung tidal volume, heart rate, activity level, height, weight, age, sex, and others, no single prescribed level of supplemental oxygen can consistently achieve a target SpO2 response for every patient. Individual patients require periodic monitoring and adjustment of the fractional oxygen (FdO2) delivered to them to ensure they receive the correct FdO2 to achieve the target SpO2. Achieving correct and consistent SpO2 is a critical factor in treating patients with a wide range of health conditions or diseases. Furthermore, patients with these health issues can benefit from systems that automatically control oxygen saturation. This disclosure applies to a wide variety of patients who require rapid and accurate oxygen saturation control.

[0579] The fractional 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 fraction of oxygen delivered to the patient. The user can use a patient monitor (e.g., a pulse oximeter) to determine the patient's SpO2 level. 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.

[0580] When a patient sensor is used as part of a respiratory support system, the user needs to attach the sensor to the patient. This adds another task to the already potentially large set of tasks required to set up a respiratory support system. Furthermore, individual patient sensors can cause problems such as incorrect installation, leading to inaccurate measurements and / or sensor detachment during use.

[0581] Thus, the patient interface incorporating patient sensors allows for their use without increasing the user's workload. This can be beneficial in hospital environments where a single clinician may need to manage a large number of patients. Additionally, it can be beneficial in home environments as it simplifies the setup process for patients who might otherwise need to perform these tasks themselves. Furthermore, integrating patient sensors into the patient interface helps ensure proper orientation of the sensors during use and prevents them from falling out.

[0582] This disclosure refers to conduit heaters, which is a broad term and will be given its usual and conventional meaning to those skilled in the art (i.e., it is not limited to a specific or custom meaning) and includes, but is not limited to, one or more heating bars, one or more heating wires, and / or one or more conductive elements that generate heat when electrical power is supplied. Examples of such conduit heaters include wires made of conductive metals (e.g., copper), conductive polymers, conductive ink printed on the surface of a conduit, conductive materials used to create traces on a conduit, and so on.

[0583] Furthermore, this disclosure refers to catheters, branches, and medical catheters in the context of gas delivery. For example, catheter is a broad term and will be given its usual and conventional meaning to those skilled in the art, and includes, but is not limited to, channels with various cross-sections, such as cylindrical channels and non-cylindrical channels.

[0584] The disclosed systems, devices, and medical catheters can also be used in breathing circuits configured to provide continuous, variable, or bilevel positive airway pressure (PAP) therapy or other forms of respiratory support, such as high-flow or low-flow oxygen therapy. The breathing circuit may, for example, include an inspiratory circuit that at a minimum includes an inhaled gas pathway (including all components) from a gas supply source to a patient interface.

[0585] The respiratory support system may include a respiratory support device 10 and a patient interface with integrated sensors, such as Figure 1 As shown. For example, respiratory support device 10 can be configured to provide high-flow therapy. Respiratory support device 10 may include a main housing 100, which includes, for example, a flow generator 11 (e.g., a blower) arranged in a motor / impeller configuration, an optional humidifier 12, a controller 13, and a user interface 14 (including, for example, a display and, for example, multiple buttons, a touchscreen, etc., input devices). The humidifier may include a heater base that includes a heating element, such as a heating plate, and is configured to receive a humidification chamber. In use, the humidification chamber receives heat from the heating element to raise the temperature of the water contained within the humidification chamber. A gas flow passes over the water to increase the heat and humidity of the gas flow.

[0586] 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, including but not limited to: operating the flow generator 11 to generate a flow of gas for delivery to the patient (gas flow); operating the humidifier 12 (if present) to humidify and / or heat the generated gas flow; controlling the oxygen flow into the flow generator; receiving user input from the user interface 14 to reconfigure and / or perform user-defined operations on the device 10; and outputting information to the user (e.g., on a display). The user can be a patient, a healthcare professional, or any other person interested in using the device. As used herein, “gas flow” can refer to any gas flow that can be used in the respiratory assist or respiratory support device 10, such as an ambient air flow, a flow containing essentially 100% oxygen, a flow containing some combination of ambient air and oxygen, etc.

[0587] One end of the inspiratory conduit 16 is connected to a gas outlet 21 in the housing 100 of the respiratory support device 10. In an alternative configuration, one end of the inspiratory conduit 16 is connected to a gas outlet of a humidifier 12. The other end of the inspiratory conduit 16 is connected to a patient interface 17, such as a non-sealed nasal cannula, the body 19 of which includes one or more nasal forks 18. Alternatively or additionally, the inspiratory conduit 16 may 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 via the inspiratory conduit 16 through the cannula 17. The inspiratory conduit 16 may have a conduit heater, such as one or more heating wires 16a, to heat the gas flow traveling to the patient. The conduit heater may be controlled by a controller 13. The respiratory support device 10, the inspiratory conduit 16, and the patient interface 17 together form a respiratory support system.

[0588] Controller 13 can control flow generator 11 to generate a gas flow with a desired flow rate. Controller 13 can also control supplemental oxygen inlet to allow delivery of supplemental oxygen, humidifier 12 (if present) to humidify the gas flow and / or heat the gas flow to an appropriate level, etc. The gas flow is drawn through inspiratory tubing 16 and cannula 17 to reach the patient. Controller 13 can also control heating elements in humidifier 12 and / or heating elements 16a in inspiratory tubing 16 to heat the gas to a desired temperature to achieve a desired therapeutic and / or comfort level for the patient. Controller 13 can be programmed with a suitable target temperature for the gas flow or can determine a suitable target temperature for the gas flow.

[0589] Oxygen inlet port 28 may include a valve through which pressurized gas can enter the respiratory support device 10. The valve controls the flow rate of oxygen into the respiratory support device 10. The valve can be any type of valve, including proportional valves or two-position valves. The oxygen source can be an oxygen cylinder or a hospital oxygen supply source. Medical-grade oxygen typically has a purity between 95% and 100%. Lower purity oxygen sources may also be used. Examples of valve modules and filters are disclosed in U.S. Provisional Application No. 62 / 409,543, filed October 18, 2016, entitled “Valve Modules and Filter,” and U.S. Provisional Application No. 62 / 488,841, filed April 23, 2017, entitled “Valve Modules and Filter,” which are incorporated herein by reference in their entirety.

[0590] The respiratory support device 10 can measure and control the oxygen content of the gas delivered to the patient, and therefore measure and control the oxygen content of the gas inhaled by the patient. During high-flow therapy, the high flow rate of the delivered 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. Therefore, high-flow therapy helps prevent entrainment of ambient air during the patient's inhalation and flushes out exhaled air from the patient's airway. As long as the flow rate of the delivered gas meets or exceeds the patient's peak inspiratory requirement, entrainment 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 in the respiratory support device 10 (delivered oxygen fraction (FdO2)) will be substantially the same as the oxygen concentration inhaled by the user (inhaled oxygen fraction (FiO2)), and thus such terms can be considered equivalent.

[0591] Operating sensors 3a, 3b, 3c (e.g., flow sensors, temperature sensors, humidity sensors, and / or pressure sensors) can be placed in various locations within the respiratory support device 10. Additional sensors (e.g., sensors 20, 25) can be placed in various locations on the inspiratory tubing 16 and / or cannula 17 (e.g., a temperature sensor may be present at or near the end of the inspiratory tubing 16). Sensors 20, 25 can also be CO2 sensors, pressure sensors, flow sensors, or oxygen sensors. Outputs from the sensors can be received by the controller 13 to assist the controller in operating the respiratory support device 10 in a manner that provides appropriate therapy. In some configurations, providing appropriate therapy includes meeting the patient's peak inspiratory demand. The device 10 may have a transmitter and / or receiver 15 to 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, including but not limited to the flow generator 11, humidifier 12, and heating wire 16a, or accessories or peripheral devices associated with the respiratory support device 10. Alternatively or concurrently, transmitter and / or receiver 15 may deliver data to a remote server or enable remote control of device 10.

[0592] The respiratory support device 10 can receive measurements from one or more gas composition sensors. The gas composition sensors can be located within the respiratory support device 10, the inspiratory tubing 16, the patient interface, or any other suitable location. The gas composition sensors can be located at or downstream of where ambient air and any supplemental gas stream (such as oxygen) have been mixed. The gas composition sensors can be configured to measure oxygen concentration. The gas composition sensors can be ultrasonic transducer systems, also referred to herein as ultrasonic sensor systems.

[0593] The respiratory support device 10 can be configured to connect to a patient sensor 29 (e.g., a pulse oximeter or patient monitoring system) to measure one or more physiological parameters of the patient (e.g., the patient's oxygen saturation (SpO2) (i.e., peripheral arterial oxygenated hemoglobin), heart rate, respiratory rate, perfusion index) and provide a measure of signal quality. The patient sensor 29 can be part of additional sensors 20, 25, or can be a separate additional sensor that can be positioned on or within a patient interface or delivery catheter. The sensor can communicate with the controller 13 via a wired connection or via communication through a wireless transmitter on the sensor. Sensors designed for different age groups and to be attached to different locations on the patient are available for use with the respiratory support device.

[0594] The pulse oximeter is connected to the processor in 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 interchanged during operation of the respiratory support device 10. For example, the patient sensor 29 may use a USB interface with leads or wires or a wireless communication protocol (such as near-field communication, WiFi, or...). It is connected to the respiratory support device 10. The output of the pulse oximeter can be displayed on the graphical user interface 14. The measurement value from the pulse oximeter 29 can also be transmitted to a remote patient management system (e.g., a remote server system) via a suitable wireless protocol, such as GSM.

[0595] When the patient sensor 29 is disconnected during operation (with the patient or with the respiratory support device), the respiratory support device 10 can continue operating in its previous operating state for a predetermined period of time. After the predetermined period of time, the respiratory support device 10 can trigger an alarm, switch from automatic mode to manual mode, and / or exit control mode completely (e.g., automatic or manual mode).

[0596] The respiratory support device 10 can be configured to identify whether the patient sensor 29 is a standalone patient sensor or a patient sensor located on or contained within the patient interface 17. The respiratory support device 10 can identify the sensor type by receiving identification information upon initial connection of the patient sensor 29. The respiratory support device 10 can also identify the sensor type by receiving signals from the patient sensor 29. For example, an integrated patient sensor 29 can be configured to communicate with the respiratory support device 10 via an electrical connection (as described herein) located at the gas outlet of the respiratory support device 10, while a standalone patient sensor can be configured to connect to the respiratory support device via a separate connection port.

[0597] The respiratory support device 10 can be configured to use the output of a patient sensor 29 positioned on or contained in the patient interface 17 to determine whether a patient is wearing the patient interface 17. In this context, "wearing" means that the patient interface 17 is mounted at a location on the patient's face such that the patient interface 17 can deliver a flow of gas to the patient, and the patient sensor 29 can measure one or more patient parameters. When the patient sensor 29 cannot reliably measure the one or more patient parameters, it can generate a signal indicating such a situation. Alternatively or concurrently, the patient sensor 29 can transmit individual parameters, such as signal quality. The respiratory support device 10 can check this parameter against a threshold to determine whether the patient sensor 29 can reliably measure the one or more patient parameters. The respiratory support device 10 can use the determination that the patient sensor 29 cannot reliably measure the one or more patient parameters to further determine that the patient is not wearing the patient interface 17.

[0598] The respiratory support device 10 can use a determination of whether the patient is wearing the patient interface 17 to enable or disable certain 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 this indication to increase or decrease the flow rate. For example, the respiratory support device 10 can reduce the flow rate to reduce noise and power consumption when the patient is not wearing the patient interface 17. The respiratory support device 10 can use this indication to generate an alarm, such as when the patient has removed the patient interface 17. This alarm can occur immediately after the output of the patient sensor 29 is lost or within a set time period.

[0599] In another configuration, the respiratory support device 10 is configured to switch to standby mode when 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 can be configured to control the blower to operate at a reduced motor speed. The reduced motor speed can be the lowest operating speed of the blower. The reduced motor speed can be approximately 1000 RPM to 2000 RPM. In standby mode, the respiratory support device 10 can also be configured to control the blower to deliver a reduced flow rate. The reduced motor speed can be between approximately 1 LPM and 2 LPM.

[0600] The respiratory support device 10 may include a high-flow-rate respiratory support device. The high-flow-rate therapy discussed herein is intended to be given its typical, general meaning as understood by those skilled in the art, and generally refers to a respiratory support system that delivers a target flow rate of humidified respiratory gas at a flow rate generally designed to meet or exceed the patient's inspiratory flow rate via an intentionally unsealed patient interface. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults typically range from about fifteen liters per minute (LPM) to about seventy liters per minute or greater. Typical flow rates for pediatric patients (such as newborns, infants, and children) typically range from about one liter per kilogram of patient body weight to about three liters per kilogram of patient body weight or greater. High-flow-rate therapy may also optionally include a gas mixture composition comprising supplemental oxygen and / or administration of therapeutic drugs. High-flow therapy typically refers to nasal high-flow oxygen therapy (NHF), humidified high-flow nasal cannula oxygen therapy (HHFNC), high-flow nasal cannula oxygen therapy (HFNO), high-flow therapy (HFT), or tracheal high-flow oxygen therapy (THF), etc. The flow rate used to achieve "high flow" can be any of the flow rates listed below. For example, in some configurations, for adult patients, “high-flow therapy” can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 75 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, "high-flow therapy" can refer to delivering gas to the patient at flow rates greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and about 15 LPM, or between about 20 LPM and 25 LPM. High-flow respiratory support devices for adult, neonatal, infant, or pediatric patients can deliver gas to the patient at flow rates between about 1 LPM and about 100 LPM or any of the subranges listed above. Respiratory support device 10 can deliver up to 100% of any concentration of oxygen (e.g., FdO2) at any flow rate between about 1 LPM and about 100 LPM.In some configurations, any of these flow rates can be combined with oxygen concentrations (FdO2) of approximately 20% to 30%, 21% to 30%, 21% to 40%, 30% to 40%, 40% to 50%, 50% to 60%, 60% to 70%, 70% to 80%, 80% to 90%, and 90% to 100%. In some combinations, the flow rate can be between approximately 25 LPM and 75 LPM and combined with oxygen concentrations (FdO2) of approximately 20% to 30%, 21% to 30%, 21% to 40%, 30% to 40%, 40% to 50%, 50% to 60%, 60% to 70%, 70% to 80%, 80% to 90%, and 90% to 100%. In some configurations, the respiratory support device 10 may include safety thresholds when operating in manual mode to prevent the user from delivering too much oxygen to the patient.

[0601] High-flow therapy can be administered through the user's nostrils and / or mouth, or via a tracheostomy port. High-flow therapy delivers gas to the user at a flow rate at or above the user's expected peak inspiratory flow rate requirement. High-flow therapy can create a flushing effect in the nasopharynx, flushing the anatomical dead space of the upper airway with a high-flow-rate approach. This creates a reserve of fresh gas available for each breath while minimizing rebreathing of nitrogen and carbon dioxide. Furthermore, meeting inspiratory needs and flushing the airway are important when attempting to control a patient's FdO2. High-flow therapy can be delivered using an unsealed patient interface (e.g., a nasal cannula). A nasal cannula can be configured to deliver breathing gas to the user's nostrils at a flow rate exceeding the user's expected peak inspiratory flow rate requirement.

[0602] As used herein, the term "unsealed patient interface" can refer to an interface that provides a pneumatic link between a patient's airway and a source of airflow (such as from flow generator 11) that does not completely obstruct the patient's airway. An unsealed pneumatic link may include an obstruction of less than approximately 95% of the patient's airway. An unsealed pneumatic link may include an obstruction of less than approximately 90% of the patient's airway. An unsealed pneumatic link may include an obstruction between approximately 40% and approximately 80% of the patient's airway. The airway may include one or more of the patient's nostrils or mouth. For nasal intubation, the airway passes through the nostrils.

[0603] The respiratory support device 10 may include an ambient air inlet port 27 to entrain ambient indoor 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 controls the flow rate of oxygen entering the respiratory support device 10. The valve can be any type of valve, including a proportional valve or a two-position valve.

[0604] In another configuration, the respiratory support device 10 includes two or more oxygen inlet ports. A first oxygen inlet port (also referred to as a high-pressure oxygen inlet) receives oxygen at a set pressure from an oxygen source. The flow rate of oxygen from the first oxygen inlet port is then adjusted by a valve, as described above. A second oxygen inlet port (also referred to as a low-pressure oxygen inlet) receives oxygen at a set flow rate from an oxygen source. The flow rate of oxygen through the second oxygen inlet port can then be adjusted by regulating an external flow regulator on the oxygen source.

[0605] The blower can operate at motor speeds greater than about 1,000 RPM and less than about 30,000 RPM, greater than about 2,000 RPM and less than about 21,000 RPM, greater than 4,000 RPM and less than 19,000 RPM, or any of the foregoing values. The operation of the blower can mix the gas streams entering the blower through these inlet ports. Using a blower as a mixer can reduce the pressure drop that occurs in systems with separate mixers (such as static mixers including baffles), since mixing requires energy. Having a static mixer also increases the volume of the gas flow path between the valve and the gas composition sensor, which can further increase the time delay between a change in valve current and the measurement of the corresponding change in oxygen concentration.

[0606] Based on user input and the therapy provided by the respiratory support device 10, the controller 13 can determine the target output parameters for the blower. The controller can receive the measured values ​​of the target output parameters, and based on the difference between the determined flow rate and the measured flow rate, the controller can adjust the speed of the blower.

[0607] See you again Figure 1 The controller 13 can be programmed to have or be configured to execute a closed-loop control system to control the operation of the respiratory support device. The closed-loop control system can be configured to ensure that the patient's SpO2 reaches a target level and is consistently maintained at or near that level.

[0608] Controller 13 may receive from the user multiple inputs that it can use to execute a closed-loop control system. The target SpO2 value may be a single value or a range of values. The multiple values ​​may be preset, selected by a clinician, or determined based on patient type, where patient type may refer to current ailment and / or information about the patient (e.g., age, weight, height, sex, and other patient characteristics). The target SpO2 value may be input by a clinician or user via a user interface on the device and received by controller 13. Similarly, the target SpO2 may be two values, each selected in any of the ways described above. These two values ​​will represent a range of acceptable SpO2 values ​​for the patient. The controller may target one of the values ​​within the range. The target value may be the middle of the range or any other value within the range, which 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 have one or more preset responses when the patient's SpO2 value moves outside the range. Responses may include issuing an alarm, switching to manual control of FdO2, changing FdO2 to a specific value, and / or other responses. The controller may have one or more ranges, where one or more different responses occur when the value moves outside each range.

[0609] Overall, SpO2 is controlled between approximately 80% and approximately 100%, or between approximately 80% and approximately 90%, or between approximately 88% and approximately 92%, or between approximately 90% and approximately 99%, or between approximately 92% and approximately 96%. SpO2 can be controlled between any two suitable values ​​from any two of the above ranges. Target SpO2 can be between approximately 80% and approximately 100%, or between approximately 80% and approximately 90%, or between approximately 88% and approximately 92%, or between approximately 90% and approximately 99%, or between approximately 92% and approximately 96%, or approximately 94%, or 94%, or approximately 90%, or 90%, or approximately 85%, or 85%. The SpO2 target can be any value between any two suitable values ​​from any two of the above ranges. For the defined range, the SpO2 target can correspond to the median SpO2.

[0610] FdO2 can be configured to be controlled within a range. As previously discussed, as long as the flow rate meets or exceeds the patient's peak inspiratory demand, the oxygen concentration (FdO2) measured in the device will be substantially the same as the oxygen concentration (FiO2) breathed by the patient, and thus such terms can be considered equivalent. Each limit of the range can be preset, user-selected, or determined based on patient type, where patient type can refer to current ailment and / or information about the patient (e.g., age, weight, height, sex, and / or other patient characteristics). Alternatively, a single value of FdO2 can be selected, and the range can be determined at least in part based on that value. For example, the range can be set amounts above and below the selected FdO2. The selected FdO2 can be used as the starting point for the controller. If the controller attempts to move FdO2 out of the range, the system can have one or more responses. These responses can include issuing an alarm, preventing FdO2 from moving out of the range, switching to manual control of FdO2, and / or switching to a specific FdO2. The respiratory support device 10 may have one or more ranges, wherein one or more different responses occur when the device reaches the limit value of each range.

[0611] refer to Figure 2 The diagram illustrates a schematic of a closed-loop control system 1000. The closed-loop control system can utilize two control loops. The first control loop can be implemented by an SpO2 controller. The SpO2 controller can determine the target FdO2 in part based on the target SpO2 and / or the measured SpO2. As discussed above, the target SpO2 value can be a single value or a range of acceptable values. The values ​​(multiple) can be preset, selected by the clinician, or automatically determined based on client characteristics. Generally, the target SpO2 value is received or determined before or at the start of the treatment period, but it can be received at any time during the treatment period. During the treatment period, the SpO2 controller can also receive the following as inputs: measured FdO2 readings from the gas composition sensor, and measured SpO2 readings and signal quality readings from the patient sensor 29. In some configurations, the SpO2 controller can receive the target FdO2 as input; in such cases, the output of the SpO2 controller can be directly provided back to the SpO2 controller as input. Based at least in part on these inputs, the SpO2 controller can output the target FdO2 to the second control loop.

[0612] During the treatment period, the SpO2 controller and FdO2 controller can continue to automatically control the operation of the respiratory support device until the end of the treatment period or an event triggers a change from automatic mode to manual mode.

[0613] For example, our earlier PCT application WO 2019 / 070136 (WO'136 here), filed on October 5, 2018, the entire contents of which are incorporated herein by reference, describes a respiratory support system that uses oxygen saturation measurements from a pulse oximeter to automatically adjust the oxygen fraction of the airflow delivered to the patient via a patient interface.

[0614] The respiratory support system described in WO'136 uses a separate pulse oximeter and patient interface. This requires the clinician to attach the pulse oximeter and patient interface separately to the patient, with each component also connected to the respiratory support device.

[0615] Refer again Figure 1 The controller 13 can be programmed to have or be configured to run an FdO2 control system to control the operation of the respiratory support device.

[0616] An FdO2 control system can be configured to ensure that FdO2 is momentarily maintained at the target level at all points during therapy. The controller measures FdO2, compares it to the target FdO2, and then adjusts the oxygen inlet valve accordingly. However, when the FdO2 sensor is positioned at a not insignificant distance from the valve, there is a time delay between changing the valve and measuring the corresponding change in FdO2. The controller can adjust the valve after this time delay. However, if the flow rate fluctuates, the controller may be able to achieve the target FdO2 on an average, but not continuously and substantially instantaneously, basis. Figure 2 As shown, in order to maintain FdO2 at the target level on a continuous and essentially instantaneous basis without moving the FdO2 sensor closer to the valve, the FdO2 controller can take into account the measurement of the total flow rate to control the valve.

[0617] The patient interface 17 connects to one end of the inspiratory tubing 16 and is used to provide a flow of breathable gas to the patient. During setup of the respiratory support device 10, a clinician or patient needs to attach the patient interface 17 to the patient. Additionally, if a separate patient sensor 29 is also to be used, a clinician or patient needs to attach it to the patient. Then, both the patient interface 17 and the patient sensor 29 also need to be attached to the respiratory support device 10 itself. Forming these different connections may be undesirable.

[0618] The patient interface 17 has one or more patient sensors 29. These one or more integrated patient sensors 29 can be configured to measure a patient's blood oxygen saturation. The 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.

[0619] 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 the patient sensor 29, such as a ventilator, CPAP device, stand-alone humidifier, and / or oxygen mixer.

[0620] Patient interface 17 may include a nasal intubation interface, such as Figures 3 to 33 As shown. In this configuration, the nasal cannula interface broadly includes a head fixation assembly and a nasal cannula 30, and also includes a gas inlet conduit 62. The head fixation assembly allows the user to position and maintain the nasal cannula 30 in the correct operating 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 to allow fluid or gas to flow between the inspiratory conduit and the nasal cannula. Details of the gas inlet conduit 62 and the main portion of the nasal cannula 30 will now be described in detail.

[0621] The head fixation assembly of the nasal cannula 30 may include one or more frenulums. These one or more frenulums may include two anterior frenulums 50, a posterior frenulum 53a, and a top frenulum 53b, as shown below. Figure 3 As shown. In some configurations, the proximal end of the anterior frenulum 50 is removably connected to the nasal cannula 30. In other configurations, the proximal end of the anterior frenulum 50 is non-removably connected to the nasal cannula 30. The posterior frenulum 53a and the top frenulum 53b extend between the distal ends of the anterior frenulum 50. In use, the posterior frenulum 53a wraps around the back of the patient's head. In use, the top frenulum 53b wraps around the top of the patient's head. In some configurations, the head fixation assembly is adjustable to allow patients with different head shapes and sizes to use the nasal cannula 30. For example, an adjuster such as an adjusting buckle 54 may be included to allow the patient to loosen or tighten the top frenulum 53b.

[0622] In some configurations, one or more frenulums are substantially elastic (i.e., made of an elastic material, such as Lycra, that can stretch to fit the patient's head). In some configurations, one or more frenulums are substantially rigid. In some configurations, one or more frenulums are made of a substantially rigid material. In some configurations, one or more frenulums are substantially inextensible. In some configurations, one or more frenulums are made of a substantially inextensible material. In some configurations, one or more frenulums are self-supporting. In some configurations, one or more frenulums maintain their shape when not in use.

[0623] Alternatively, the patient interface 17 is secured to the patient's head and face via multiple anterior frenulum 50s and a single posterior frenulum 53a attached to the anterior frenulum 50s. The posterior frenulum is attached to the anterior frenulum 50 via a buckle 54. Alternatively, the posterior frenulum 53a is integral with the anterior frenulum 50s. The buckle 54 allows the patient to loosen or tighten the anterior frenulum 50s according to personal preference. Alternatively, the integral anterior frenulum 50s and posterior frenulum 53a are elastic and can be stretched over the patient's head. The elasticity of the frenulum applies force to the head to hold the nasal cannula 30 in the optimal position during use. The elastic frenulum 50s, 53a can be used with the adjustable buckle 54, or the elastic frenulum 50s, 53a can be used alone without the buckle 54.

[0624] The head fixation assembly may also include a ring 55 that secures and supports the gas inlet conduit 62 at or near the inlet end, such as Figure 3 As shown. Ring 55 includes a first end connected to one of the anterior frenulum 50. This first end is slidably connected to the anterior frenulum 50. Ring 55 includes a second end connected to the gas inlet catheter 62. This second end is removably connected to the gas inlet catheter 62. Alternatively, the interface may include a tube clamp connected to the tube and removably coupled to the cannula. The tube clamp supports the weight of the inlet catheter 62 and reduces the torque induced by the catheter 62, thereby improving the stability of the patient interface 17. The clamp helps reduce disengagement of the patient interface 17. The clamp may be made of a rigid material.

[0625] The patient interface 17 may also be equipped with a strap 63. Figure 3An example of a lanyard 63 is shown. In the illustrated configuration, the lanyard 63 is connected to the gas inlet tube 62. Alternatively, the lanyard 63 is attached at or near the junction between the inspiratory tube 16 and the gas inlet tube 62. In use, the lanyard 63 supports the weight of the inspiratory tube 16 and the gas inlet tube 62. The lanyard 63 is provided with a buckle 64 to allow adjustment of the lanyard length. The buckle 64 allows the lanyard 63 to be adapted to patients of any size using the patient interface 17. The lanyard 63 supports at least a portion of the weight of the inspiratory tube 16 in use so that this weight does not act on the user or the nasal cannula 30. Using the lanyard 63 reduces the portion of the total weight of the inspiratory tube 16 and the gas inlet tube 62 that pulls on the nasal cannula 30, thereby helping to prevent the nasal forks 33, 34 from interfering with the sensitive lining of the nasal passage, or from shifting or misaligning during use. In the illustrated configuration, the lanyard 63 is loosely fitted around the neck to reduce the chance of strangulation on the user. The sling 63 also provides a convenient way to support the inspiratory tube 16 and the gas inlet tube 62. This allows the patient to turn over in bed without pulling or tugging on the inspiratory tube 16 and helps prevent the gas inlet tube 62 from overheating under the felt. In one configuration, the sling 63 has a clamp to allow the user to open and close the sling to position and secure it around the user's neck. The clamp includes convex and concave connectors that snap together. The clamp is disengaged by pulling one end of the sling 63. The clamp is easy to disengage and is released when the user pulls one side of the sling. This allows for quick removal of the sling 63, for example, in emergency situations such as when the patient requires intubation.

[0626] The gas inlet conduit 62 will now be described in detail. The gas inlet conduit 62 is a shorter conduit or tube relative to the inspiratory conduit 16, extending between the outlet of the inspiratory conduit 16 and the nasal cannula 30. In use, the gas inlet conduit 62 forms a lumen that defines a gas passage between the inspiratory conduit 16 and the patient interface 17, allowing gas to exit the inspiratory conduit 16 and enter the gas inlet conduit 62, thus traveling along the gas inlet conduit 62 to the patient interface 17 and being delivered to the patient. One reason a secondary conduit, such as the gas inlet conduit 62, can be used is that the inspiratory conduit 16 is relatively heavy and bulky because it is used to deliver a gas flow over a considerable distance (from the humidifier unit 2 to a point near the patient). Therefore, the inspiratory conduit 16 needs to have sufficiently robust walls to support its own weight without collapsing. Since the inspiratory conduit 16 is typically relatively long (e.g., 8 to 10 feet), this additional length and thicker wall structure increases the weight of the inspiratory conduit 16. If the outlet of the inspiratory conduit 16 is connected directly to the patient interface in a way that requires the patient to support this weight, this could cause discomfort to the patient due to the weight of the inspiratory conduit 16 acting on the patient. Furthermore, the weight of the inspiratory conduit 16 could pull on the patient interface 17 and cause it to become dislodged or misaligned. A lighter, shorter secondary conduit (e.g., a gas inlet conduit 62) extending between the outlet of the inspiratory conduit 16 and the patient interface 17 could be used.

[0627] The gas inlet catheter 62 is lighter and shorter than the inspiratory catheter 16, and is typically used with a strap 63, as described above, attached to the gas inlet catheter 62 or to the connection between the inspiratory catheter 16 and the gas inlet catheter 62. In use, the strap 63 (as described above) supports at least a portion of the weight of the inspiratory catheter 16, so that the patient interface 17 only needs to support the relatively lighter gas inlet catheter 62. Furthermore, in the configuration where the strap 63 is attached to the end of the gas inlet catheter 62, the patient does not need to remove the strap 63 when the inlet catheter 62 is disconnected from the inspiratory catheter.

[0628] See now Figures 4 to 33 To describe the various aspects of the nasal cannula 30 in more detail. Unless otherwise stated, Figures 4 to 33 The nasal cannula 30 shown includes (see also) Figure 3 All the characteristics of a generalized nasal cannula are described.

[0629] The nasal cannula 30 comprises two main parts: an interface connector 35 and a body 32. See now for details. Figure 4 and Figure 5 To describe an exemplary configuration of these two parts.

[0630] The interface connector 35 is connected to and in fluid communication with the gas inlet conduit 62 as described above during use. However, in an alternative embodiment, the interface connector may be directly connected to the intake conduit 16.

[0631] Figure 5 The configuration shows that the interface connector 35 can be detached from the rest of the nasal cannula 30. Alternatively, the interface connector 35 can be an integral part of the nasal cannula 30. Alternatively, the interface connector 35 and the nasal cannula 30 form a disposable assembly, thereby preventing the user from disassembling the two components after initial assembly. In the integrated or disposable assembly configuration, a continuous gas flow path is formed through the inhalation conduit 16, the gas inlet conduit 62, the interface connector 35, and to the fork of the nasal cannula 30.

[0632] In some configurations, the interface connector 35 is generally tubular in shape, having a substantially circular inlet 59 on one side, which is bent into an oval or elliptical outlet 37 formed on one side of the interface connector 35 such that it is perpendicular to the inlet 59. The circular inlet 59, as shown, receives the patient end of the gas inlet catheter 62, allowing a flow of gas from the gas inlet catheter 62 to pass through the interface connector 35.

[0633] 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 removably attached to the gas inlet conduit 62. The interface connector 35 engages with the body 32 so that gas flow can pass through the outlet 37 and from the gas inlet conduit 62 through the nasal forks 33, 34 (described in detail below) to the patient.

[0634] In some configurations, the interface connector 35 is made of a hard plastic material that deforms only under relatively high load conditions (i.e., it cannot be easily crushed by the user's hand). The interface connector 35 can be molded, injection molded, machined, or cast.

[0635] The interface connector 35 is connected to the body 32 during use, allowing the gas flow leaving the interface connector 35 to enter the body 32. The body 32 will now be described in detail.

[0636] The body 32 includes nasal forks 33 and 34 extending from the base portion 39 of the body 32. Gas flows through the body 32 to the nasal forks 33 and 34 and is delivered to the patient. In some configurations, the nasal forks 33 and 34 extend parallel to each other. In some configurations, the nasal forks 33 and 34 curve rearward from the facial mounting portion 32. In some configurations, the nasal forks 33 and 34 curve toward each other. The structure of the nasal forks 33 and 34 will be described in detail below.

[0637] The body 32 of the illustrated embodiment includes a side arm 31 and a tubular member 38 integrally molded together, the tubular member including recesses, such as... Figure 4 and Figure 5 As shown. A tubular member 38 extends below the body 32 and is adapted to receive an interface connector 35 (in a configuration where the body 32 and the interface connector 35 are separable or detachable 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 engagement, and the lip 39 on the body 32 helps to grip the interface connector 35 and form a sealing connection between the interface connector 35 and the body 32. The tubular member 38 includes a rib 40 extending below the body 32. The rib 40 helps to hold and hold the interface connector 35 in the correct position when it is engaged with the body 32, and extends around the outer side of the interface connector 35. When the interface connector 35 is connected to the body 32, the outlet 37 on the interface connector 35 aligns with the underside of the face mount portion 32 in use. This alignment reduces the amount of gas leaking from the nasal cannula 30, thereby allowing for effective treatment of the user by delivering the maximum amount of humidified gas.

[0638] Side arms 31 are used to attach the anterior frenulum 50 to the body 32. Side arms 31 extend from each side of the body 32. In some configurations, the side arms 31 are formed as an integral part of the body 32. In use, the anterior frenulum 50 is attached to the side arms 31, allowing the user to wear the patient interface. In some configurations, the ends of the anterior frenulum 50 are looped through a pair of slits on the side arms 31, wherein the ends include hook-and-loop fasteners or the like to hold the ends in place when they loop themselves. Alternatively, the anterior frenulum 50 or the loop 66 may be clamped to the side arms 31, for example, by a cooperating convex-concave clamp, or adhesively attached to the side arms 31.

[0639] In some configurations, the body 32, nose forks 33, 34, side arms 31, and tubular member 38 are all manufactured as a single continuous article. The body 32, nose forks 33, 34, side arms 31, and tubular member 38 are all made of flexible polymer materials, such as soft thermoplastic elastomers (TPE) or silicone resins.

[0640] The following describes the nasal fork. In this description, the terms "rear" or "back" or any such synonym refer to the structural portion facing the patient's face and closest to the patient's face when the nasal cannula is in use. The terms "front" or "forward" or any such synonym refer to the side, face, or portion facing away from and furthest from the patient's or user's face during use. The terms "top" or "upper" refer to the side, face, or portion pointing away from the floor when the user or patient wearing the interface is standing or sitting upright and looking forward. The terms "bottom" or "lower" refer to the side, face, or portion facing or pointing towards the ground when the user or patient wearing the interface is standing or sitting upright and looking forward. For example, Figure 3 The patient interface 17 worn by the patient is shown, and this diagram can be used to assess the aforementioned orientations. The definitions of these orientations remain consistent throughout, including in the diagram showing the patient interface 17 in the absence of a patient.

[0641] In some configurations, the body 32 includes two nose forks 33 and 34, which extend upward from the upper surface of the body 32 and curve inward, such as... Figures 4 to 10 As shown. See also Figures 4 to 10 Nose forks 33 and 34 extend from the upper surface of the body 32, and each fork is placed in each nostril of the patient when the nasal cannula is used. Forks 33 and 34 are configured to deliver a gas flow to the patient. Forks 33 and 34 receive a humidified gas flow from the gas inlet conduit 62 via the gas inlet conduit 62, the interface connector 35, and the body 32. Therefore, nose forks 33 and 34 are fluidly connected to the interface connector 35 and receive a gas flow from the gas inlet conduit 62.

[0642] See Figures 7 to 8 and Figure 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 such that it comes into contact with the patient's skin during use. The patient sensor 29 may have an adhesive surface, allowing it to be fixed in contact with the patient's skin.

[0643] The outer surface of the body 32 of the nasal cannula 30 can be generally divided into an outward-facing surface and an inward-facing surface. As used herein, the term "outward-facing surface" refers to the outer surface of the body 32 facing away from the patient when the nasal cannula 30 is in use. As used herein, the term "inward-facing surface" refers to the outer surface of the body 32 facing the patient when the nasal cannula 30 is in use. The anterior and posterior sides of the body 32 can be considered outward-facing surfaces, while the posterior side can be considered inward-facing surfaces. The central portion of the top side of the body 32, located below the patient's nose during use, can be considered an inward-facing surface, while the remaining lateral portions of the top side can be considered outward-facing surfaces.

[0644] See now Figure 7 The diagram shows a first location of the patient sensor 29. In this configuration, the patient sensor 29 is positioned on the rear surface 103 of the body 32. In the illustrated configuration, the patient sensor 29 is positioned at the center of the rear surface 103. Alternatively, the patient sensor 29 can be positioned at any location on the rear surface 103 (e.g., the rear surface is the surface closest to or in contact with the patient when the interface 17 is in use), such as any location along one of the two side arms 31. Positioning the patient sensor 29 on the rear surface 103 such that the patient sensor 29 is in contact with the patient's upper lip when the cannula is worn.

[0645] See now Figure 8 and Figure 9 The second position of the patient sensor 29 is shown. In this configuration, the patient sensor 29 is positioned on the top surface 104 of the body 32, between the nasal forks 33 and 34. Providing the patient sensor 29 to this surface ensures that it contacts the patient's columella when the cannula is worn.

[0646] In some configurations, the patient sensor 29 is a pulse oximeter.

[0647] exist Figures 7 to 9 In the illustrated configuration, the patient sensor 29 is a reflective pulse oximeter. The reflective pulse oximeter includes a transmitter 29a and a receiver 29b. During use, light emitted by the transmitter 29a is reflected off the patient's skin and then received by the receiver 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 transmitter 29a and receiver 29b shown can also be reversed. Furthermore, for the first position, the transmitter 29a and receiver 29b are shown as horizontally spaced apart. In an alternative configuration, the transmitter 29a and receiver 29b are vertically spaced apart. Figure 8 In the alternative configuration shown, the transmitter 29a and receiver 29b are horizontally spaced apart in the second position. Figure 9 In the alternative configuration shown, the transmitter 29a and receiver 29b are spaced apart from each other in the second position. Other orientations are also applicable.

[0648] In some configurations of the nasal cannula 30, the patient sensor 29 may be positioned within a recess in the body 32 of the nasal cannula 30. The shape of this recess corresponds to the shape of the patient sensor 29, such that the outward-facing surface of the patient sensor 29 is flush 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 operating surface of the patient sensor 29, i.e., the transmitter 29a and the receiver 29b.

[0649] When the adjacent portions of the outward-facing surface of the patient sensor 29 and the surface of the body 32 form a smooth combined surface, the patient sensor 29 can be considered "flush" with that surface of the body 32. The combined surface is considered smooth when there are no significant indentations or protrusions at the boundary between the patient sensor 29 and the body 32. Indentations or protrusions are considered significant only if they are perceptible to the user visually and / or tactilely.

[0650] In some configurations, the composite surface is flat. In other configurations, the composite surface is curved. In still other configurations, the composite surface is a mixture of curved and flat portions. In some configurations, the outward-facing surface of the patient sensor 29 is tangent to an adjacent portion of that surface of the body 32.

[0651] See now Figure 10 This illustrates another configuration of the patient sensor 29. In this configuration, the patient sensor 29 is positioned on the outer surface of one or more of the nasal forks 33, 34. In a configuration where the patient sensor 29 is a pulse oximeter, a transmission-type pulse oximeter is used. The transmission-type pulse oximeter includes a transmitter 29a and a receiver 29b. During use, light emitted by the transmitter 29a is transmitted through a portion of the patient's body and then received by the receiver 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 transmitter 29a is positioned on the center-facing outer surface of one of the nasal forks 33, 34, and the receiver 29b is positioned on the center-facing, opposite outer surface of the other nasal fork 33, 34, such that light transmission passes through the patient's nasal septum.

[0652] Each of the nose forks 33 and 34 may have an imaginary central axis extending from its base to its tip through the center of the lumen of each nose fork 33 and 34 to its end. During use, the central axis is parallel to the direction of gas flow. When a section of the nose fork 33 and 34 is taken perpendicular to the central axis defined above, the section may have at least one flat edge. For example, the section may be a shape with curved flat edges, such as a rectangle or a triangle. Alternatively, the shape of the section may be a mixture of one or more curved edges and at least one flat edge, such as a semicircle. This flat edge creates a flat surface along one face of each nose fork 33 and 34. In some configurations, the section is consistent over the entire length of each nose fork 33 and 34. In other configurations, the size and / or dimensions of the section vary over the entire length of each nose fork 33 and 34. For example, each nose fork 33 and 34 may taper inward along its length but always maintain a semicircular section. In yet another configuration, the nose forks 33 and 34 do not have a consistent cross-sectional shape over their entire length, but instead have at least one flat outer surface.

[0653] The patient sensor 29 is positioned on the flat outer surface of the nasal forks 33 and 34. The flat surfaces of the nasal forks 33 and 34 can also be positioned on their inner surfaces, such that the two surfaces face each other. Using a flat surface as the location for the patient sensor 29 allows for a more consistent orientation, as slight placement offsets during manufacturing do not result in orientation changes. This is particularly useful in the case of transmission pulse oximeters, which rely on proper alignment of the transmitter 29a and receiver 29b. In some configurations, placing the patient sensor 29 on a flat surface helps facilitate contact between the patient sensor and the patient's nasal septum.

[0654] When not in use, the nasal forks 33 and 34 can tilt toward each other. Once the nasal cannula 30 is inserted into the patient, the nasal forks 33 and 34 can elastically deform to conform to the patient's nasal passages. This deformation creates a clamping force on the patient's nasal septum. This clamping force helps to provide consistent contact between the patient's nasal septum and the patient sensor 29.

[0655] Alternatively, a transmissive pulse oximeter can be configured to transmit light through the outer wall of the patient's nose. In this configuration, during use, the transmitter 29a or receiver 29b is positioned on the outward-facing outer surface of one of the nasal forks 33, 34, while another component of the transmitter 29a and receiver 29b is positioned on an additional protrusion that clamps onto the outer surface of the patient's nasal passage. In some configurations, the additional protrusion extends from the body 32 of the nasal cannula 30. In some configurations, the additional protrusion has a flat outer surface parallel to the flat outer surface on one of the nasal forks 33, 34. The flat outer surfaces of the nasal forks 33, 34 face the additional protrusion. Each transmitter 29a and receiver 29b is positioned on each of the flat surfaces.

[0656] In another alternative configuration, a reflective pulse oximeter can be used instead of a transmissive pulse oximeter. In this configuration, both the transmitter 29a and the receiver 29b are positioned on the same nasal fork 33, 34. Alternatively, a reflective pulse oximeter can be used by including both the transmitter 29a and the receiver 29b on a supplementary protrusion on the outer surface of the nasal wall that contacts the patient. In some configurations, the supplementary protrusion extends from the body 32 of the nasal cannula 30.

[0657] Now see Figure 11 and Figure 12To describe an alternative configuration of the nasal cannula 30. In this configuration, the head fixation assembly includes one or more facial pads 44 positioned on the lateral arm 31. During use, the facial pads 44 can be attached to the patient's cheek. In some configurations, the facial pads 44 have an adhesive surface to allow the facial pads 44 to attach to the patient's cheek. In some cases, this may be more comfortable for the patient and may reduce the chance of the nasal cannula 30 shifting from its correct position. To allow the patient sensor 29 to contact the patient's skin, one or more incisions may be present in the facial pads 44 corresponding to the location of the patient sensor 29.

[0658] exist Figure 12 In the configuration shown, the patient sensor 29 is positioned on the side arm 31 of the body 32 of the nasal cannula 30, in the same area as the face pad 44. Since the face pad 44 is in contact with the patient's skin, a reflective pulse oximeter (as described above) can be implemented. A transmitter 29a and a receiver 29b are positioned side-by-side within the face pad 44. The transmitter 29a and receiver 29b are flush with the surface of the face pad 44.

[0659] exist Figures 13 to 15 In the alternative configuration shown, the facial pad may include a two-part releasable attachment or connection arrangement 551. The releasable connection arrangement 551 functions between a pair of patches respectively attached to the patient and the patient interface 17 and releasably connects the patches.

[0660] The first patch is a skin patch 550 that is attached or otherwise bonded to the patient's skin. The skin patch has a patient side facing the patient's skin and an interface side facing the patient interface 17. The patient side of the skin patch 550 can be attached to the patient's skin using a skin-sensitive adhesive, such as a hydrocolloid. The patient interface side of the skin patch has a first part 553 of a two-part releasable attachment or connection system 551.

[0661] The second patch is a patient interface patch 552. The patient interface patch 552 also has a patient side and an interface side. When the patient interface 17 is engaged, the patient side of the patient interface patch 552 is arranged adjacent to the skin patch. A complementary second part 553 of the two-part releasable attachment or connection system is attached to the patient side of the patient interface patch 552, such that when the patches 550, 552 are placed together, the corresponding parts of the two-part releasable attachment or connection system 551 can be easily engaged. The interface side of the patient interface patch 552 is attached to the patient interface 17. The patient interface patch can be integral with the user interface or suitably attached to the patient interface 17.

[0662] A portion or corner of the patient interface patch 552 may include an area not attached to the skin patch 550. The general purpose of this is to allow the area (or patch) to be more easily grasped by the patient to remove or detach the patient interface 17 from the skin patch. For example, the backing 2004 may also include such a corner area.

[0663] The two-part releasable attachment or connection arrangement 551 may include hook and loop material (such as Velcro). TM The skin patch 550 may have a magnet or an array of magnets arranged on the respective patch (with poles appropriately arranged), an adhesive arrangement activated when the patches are pushed together, or any other suitable releasable connection. The interface side of the skin patch 550 may have one of hook or loop materials, and the patient side of the patient interface patch 552 may have the other of hook or loop materials, such that the skin patch and the patient interface patch are releasably attached to each other.

[0664] In this configuration, the aforementioned patient sensor 29 is still positioned on the side arm 31 of the body 32 of the nasal cannula 30, in the same area as the facial pad.

[0665] To power the patient sensor 29 and receive data from it, one or more wires 46 connect the patient sensor 29 to the controller 13. The wires 46 may be attached to or mounted on or in the body 32, interface connector 35, and / or gas inlet catheter 62 of the nasal cannula 30, for example, see [reference needed]. Figures 16 to 20 .

[0666] According to this disclosure, there are various ways in which the wire 46 can be attached to or mounted on or in 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 the 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 wrapping comprising interwoven 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 of natural fibers. In some configurations, the wire 46 is interwoven with the filaments of the mesh wrapping. Alternatively, any two or more of these configurations can be combined. For example, wiring 46 can be embedded in the material of body 32 and then attached to the outer surface of interface connector 35 and gas inlet conduit 62.

[0667] In a configuration where the interface connector 35 is removably attached to the body 32, both the interface connector 35 and the body 32 include one or more electrical contacts to allow an electrical connection to be formed between the wires 46 on the interface connector 35 and the body 32 when the nasal cannula 30 is assembled. The wires 46 in the interface connector 35 enter the gas inlet conduit 65, wherein 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 inhalation conduit 16. The electrical contacts of the gas inlet conduit 62 and the inhalation conduit 16 can be configured such that an electrical connection is automatically formed if the two components are pneumatically connected. For example, the electrical contacts of the gas inlet conduit 62 and the inhalation conduit 16 can be configured such that a pneumatic connection cannot be formed if an electrical connection is not formed. Additionally, the electrical contacts of the gas inlet conduit 62 and the inhalation conduit 16 can be configured such that an electrical connection cannot be formed if a pneumatic connection is not formed. Corresponding electrical contacts can be configured to contact each other when a pneumatic connection is formed. The corresponding electrical contacts may include planar surfaces. 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, as it eliminates the need to establish a separate electrical connection between the respiratory support device 10 and the patient sensor 29.

[0668] Since the electrical contacts of the gas inlet conduit 62 and the intake conduit 16 can automatically form an electrical connection when the two components are pneumatically connected, the electrical contacts of the gas inlet conduit can be immovable relative to the rest of the connector.

[0669] In another configuration, the patient interface 17 includes one or more patient sensors 29 positioned on the sensor arm 47, which will now be referred to... Figures 16 to 25 The sensor arm 47 can be relatively rigid, preventing the user from easily deforming it. Alternatively, the sensor arm 47 can be elastically deformable, allowing the user to easily deform it. The sensor arm 47 can have a patient contact surface configured to contact the patient's skin. The patient contact surface can be coated with an adhesive to ensure contact between the sensor arm 47 and the patient's skin.

[0670] 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 transmitter 29a and a receiver 29b as described above. Unless otherwise stated, the wiring 46 for the sensor arm 47 configuration is substantially the same as described above for the previous configuration without the sensor arm 47.

[0671] exist Figure 16 and Figure 17In the configuration shown, sensor arm 47 is positioned on the underside of nasal cannula 30. Sensor arm 47 can be positioned near the center of nasal cannula 30. The position and size of sensor arm 47 are designed such that when nasal cannula 30 is in use, patient sensor 29 contacts the patient's upper lip. Alternatively, in Figure 18 and Figure 19 In the configuration shown, the position and size of the sensor arm 47 are designed such that when the nasal cannula 30 is in use, the patient sensor 29 contacts the skin above the patient's upper lip.

[0672] In another configuration, sensor arm 47 extends from sensor mount 48, which will now be referred to... Figures 20 to 25 Detailed description. In Figure 20 and Figure 21 In the illustrated configuration, the nasal cannula 30 further includes a sensor mount 48 positioned on one or more frenulums, such as one of the anterior frenulums 50. The sensor mount 48 may be fixedly attached to one of the anterior frenulums 50. Alternatively, the sensor mount 48 may be removably attached to one of the anterior frenulums 50. Additionally or alternatively, the sensor mount 48 may be slidably attached to one of the anterior frenulums 50. Alternatively, the sensor mount 48 may be removably attached to the gas inlet conduit 62. Additionally or alternatively, the sensor mount 48 may be slidably attached to the gas inlet conduit 62. A slidable pulse oximeter can slide along the face to position the sensor appropriately on the face to obtain a pulse oximeter (i.e., SpO2) reading. For example, these sensors may be positioned in the cheek region.

[0673] A sensor arm 47 extends from a sensor mount 48 and is configured to contact the patient's skin during use of the nasal cannula 30. The sensor arm 47 can be arranged such that it extends from the sensor mount 48 perpendicular to the anterior frenulum 50. In a configuration where the sensor mount 48 is slidably mounted to one of the anterior frenulum 50, this orientation is perpendicular to the direction of travel of the sensor mount 48.

[0674] The sensor arm 47 can be securely attached to the sensor mount 48.

[0675] Alternatively, such as Figure 22 and Figure 23 As shown, sensor arm 47 can be slidably attached to sensor mount 48. (As indicated...) Figure 22 As shown, the sensor arm 47 may be able to slide in the same direction as the direction in which the front tether strap 50 extends. Alternatively, the sensor arm 47 may be able to slide in a direction perpendicular to the direction in which the sensor arm 47 extends from the sensor mount 48. Alternatively, as... Figure 23As shown, the sensor arm 47 may be able to slide in a direction perpendicular to the direction in which the front tether 50 extends. Alternatively, the sensor arm 47 may be able to slide in the same direction as the direction in which the sensor arm 47 extends from the sensor mount 48.

[0676] Alternatively or alternatively, such as Figure 24 As shown, sensor arm 47 can be rotatably mounted to sensor mount 48. Alternatively or alternatively, such as Figure 25 As shown, the sensor arm 47 may be able to extend and retract telescopically relative to the sensor mount 48.

[0677] By using one or more of the aforementioned techniques to removably and / or slidably attach the sensor mount 48 to one of the anterior ties 50, and / or to movably attach the sensor arm 47 to the sensor mount, the user can adjust the position of the patient sensor as needed while still being able to set up the system relatively quickly. Additionally, the system allows the user to adjust the patient sensor as needed while still benefiting from the integrated electrical and pneumatic connections of the nasal cannula 30. The sensor and sensor mount are adjustable to allow the sensor to be positioned on the patient's face to obtain accurate SpO2 measurements.

[0678] In another configuration, sensor arm 47 is replaced by a sensor clamp, thereby allowing patient sensor 29 to be clamped onto a part of the patient, such as the earlobe. In this configuration, a transmissive pulse oximeter is used instead of a reflective pulse oximeter.

[0679] See now Figures 26 to 28 To describe a further possible configuration involving the wire coil. In this configuration, the sensor mount 48 is replaced by a wire coil 49. The wiring 46 resulting in the wire coil 49 is substantially the same as the previously described configuration.

[0680] like Figures 26 to 29 As shown, sensor arm 47 can be connected to wire coil 49 via secondary wire 46a. Sensor arm 47 can have any of the features described for sensor arm 47 in the previous configuration. In this particular configuration, sensor arm 47 can have an adhesive surface to allow it to adhere to the patient's skin. This arrangement of the sensor allows sensor 29 to be positioned in the temporal region of the face, on the forehead region, or on the chin region near the lower lip, where the blood vessels present can be used to obtain blood oxygen (i.e., SpO2) readings. The structure of the wire coil provides adjustability for positioning sensor 29 in a region of the face where larger blood vessels are present for obtaining SpO2 readings.

[0681] like Figure 26As shown, sensor arm 47 starts from an initial position, in which the sensor arm is positioned on or near wire coil 49, wherein secondary wire 46a is substantially completely retracted into wire coil 49. Then, as... Figure 27 and Figure 28 As shown, the sensor arm 47 can be moved to a position on the patient's skin, allowing the patient sensor 29 to begin measuring one or more patient parameters. As the sensor arm 47 moves onto the patient's skin, the secondary wire 46a unwinds as much as possible from the wire coil 49. This arrangement provides the user with increased flexibility in placing the patient sensor 29. For example, Figure 27 and Figure 28 An example is shown of how the patient sensor 29 can be placed on the patient's cheek or temporal region according to the user's and / or patient's preferences.

[0682] 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 for compact storage of the secondary wire 46a without much user input when rewinding is required. The coil spring mechanism can be configured to automatically retract the secondary wire 46a. This is advantageous because it reduces the chance of the user forgetting to rewind the secondary wire 46a. Furthermore, automatic retraction means that the secondary wire 46a is only unwound to the minimum required length, thereby reducing the chance of it becoming tangled with other components. Alternatively, the coil spring mechanism can be configured to retract the secondary wire 46a only when the user actuates a component such as a switch, button, lever, or the like. This is advantageous because there is no tension in the secondary wire 46a during use, thereby potentially improving patient comfort and reducing the chance of the sensor arm 47 disengaging.

[0683] The wire coil 49 may be fixedly attached to one of the front tether straps 50. Alternatively, the wire coil 49 may be removably mounted to one of the front tether straps 50, allowing it to be removed and replaced on a separate section of one of the front tether straps 50 and / or on a separate portion of the nasal cannula 30 using a clamp or any other suitable connector. To facilitate this effect, the wire coil 49 may have a second coil spring mechanism corresponding to a second wire connecting 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.

[0684] In another configuration, the wire coil 49 can be fixedly or removably attached to the gas inlet conduit 62, such as... Figures 30 to 32As shown. In this configuration, the wire coil 49 can be connected to the wire when the wire 46 passes through the gas inlet conduit 62. This configuration is more suitable for situations where the user wants 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 readings by moving the sensor 29 to multiple positions.

[0685] The maximum length of the secondary wire 46a is set based on the expected maximum required length. The expected maximum required length depends on the intended location where the user may wish to place the patient sensor 29. For example, a longer maximum length may be provided to allow the user to 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.

[0686] In another configuration, sensor arm 47 is replaced by a sensor clamp, thereby allowing patient sensor 29 to be clamped onto 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 change can be applied to any of the wire coil configurations described above.

[0687] Now see Figures 33 to 36 To describe another configuration in which the patient sensor 29 is integrated into the head fixation assembly.

[0688] See now Figure 33 This illustration shows a configuration in which the patient sensor 29 is incorporated into a forehead tether 53c. The patient sensor 29 may be a reflective pulse oximeter as previously described. The forehead tether 53c may be made of an elastic material, thereby helping to stabilize the head fixation assembly and maintain contact between the patient sensor 29 and the patient's forehead. In this configuration, a wire 46 extends from the side arm 31 into the head fixation assembly to the location of the patient sensor 29. In a configuration where the side arm 31 is removably attached to the head fixation assembly, both the head fixation assembly and the side arm 31 include corresponding electrical contacts.

[0689] In the previously listed configurations, the patient interface 17 is the nasal cannula 30. See now. Figure 34 The diagram illustrates a configuration where the patient interface 17 is a sealed nasal mask 80. Alternatively, the patient interface can be another type of sealed interface, such as a mask, full-face mask, nasal pillow interface, or the like. The sealed interface typically utilizes a forehead support 81, in which the patient sensor 29 can be positioned. The patient sensor 29 can be a reflective pulse oximeter as previously described. In this configuration, a wire 46 extends from the patient interface 17 into the head restraint assembly to the location of the patient sensor 29. In a configuration where the patient interface 17 is removably attached to the head restraint assembly, both the head restraint assembly and the patient interface 17 include corresponding electrical contacts.

[0690] See now Figure 35 and Figure 36 This illustrates the configuration of the patient interface as a tracheostomy interface 90. For example... Figure 35 As shown, the patient sensor 29 can be placed in the neck tether 91. Alternatively, the patient sensor 29 can be placed in a sensing neck bandage 92. The sensing neck bandage 92 can be made of an elastic material to facilitate contact between the patient sensor 29 and the patient's skin. Wiring 46 of the patient sensor 29 can be integrated into the neck tether 91 and / or the neck bandage 92, as described for the previous configuration. The patient sensor 29 can be a reflective pulse oximeter as previously described.

[0691] The aforementioned features of the patient sensor 29 can be used in conjunction with a nasal cannula, substantially as described in our earlier international patent application WO 2014 / 182179, filed on 7 May 2014, the entire contents of which are incorporated herein by reference.

[0692] For example, a nasal cannula as described in WO 2014 / 182179 can be provided, comprising a body configured to engage with a patient's orifice and to direct a flow of gas to said orifice. Such a nasal cannula may include, for example, see [reference needed] Figures 1 to 3 Part of the described respiratory therapy system. See also Figures 3 to 36 As described, the nasal cannula may be equipped with one or more sensors configured to measure parameters. These sensors are mounted (i.e., positioned) on the nasal cannula. Such embodiments are described in more detail below.

[0693] Now refer to Figure 37 to Figure 43 These embodiments illustrate a patient interface 101 configured to deliver breathing gas from a gas supply and humidification source (not shown) to a patient, and a headgear 200 configured to support and hold the patient interface on the patient's face during use. The patient interface 101 takes the form of a nasal cannula 1000 adapted to connect to an inspiratory conduit 300 and includes at least one (but preferably two) nose forks 111 and 112 configured to fit within the patient's nostrils to deliver a flow of gas to the patient. The headgear 200 takes the form of a head strap 200, the length of which is preferably adjustable to customize the size according to the patient.

[0694] The nasal cannula 1000 includes: a face mount 110 (i.e., the body) comprising at least one (but preferably a pair) tubular nose forks 111 and 112, which are integrally molded to or removably attached to the face mount 110 (i.e., the body); and a gas flow manifold 120, which is removably attached to or integrally molded to the catheter 300. The gas flow manifold 120 can be inserted into the face mount from either of two opposite horizontal directions (i.e., from the left or from the right). In this way, the position or orientation of the gas flow manifold 120 is reversible relative to the face mount 110 (i.e., the body). In other words, the user can choose to have the manifold 120 (and in fact, the catheter 300 extending from it) extend from the left or right side of the cannula 1000, depending on what is most convenient, for example, depending on which side the gas source or respirator is positioned on the user.

[0695] The facial mounting portion 110 is made of a soft and flexible material, such as silicone or other cannulation materials known in the art. The nose forks 111 and 112 are preferably flexible and can be formed from a sufficiently thin layer of silicone to achieve this property.

[0696] The gas flow manifold 120 is formed of a relatively rigid material such as polycarbonate, high-density polyethylene (HDPE), or any other suitable plastic material known in the art. The face mount 110 provides a soft docking component with the patient to comfortably deliver gas flow through the nose forks 111 and 112, while the gas flow manifold 120 fluidly connects the catheter 300 to the nose forks 111 and 112 of the face mount 110.

[0697] The patient sensor 29 (e.g., a pulse oximeter or multiple pulse oximeter sensors) may be located on or in the manifold 120.

[0698] Sensor 29 can be integrated into manifold 120 and therefore can be disposable. Alternatively, sensor 29 can be removably mounted on manifold 120. Manifold 120 can have suitable recesses or receiving ports / openings to receive one or more sensors 29. The one or more sensors 29 can be removable and reusable.

[0699] The one or more sensors 29 can be wireless or wired. The one or more wires of the (multiple) sensors 29 can pass through the manifold 120 via the inlet 122 and return to the system controller via the intake duct 300.

[0700] The one or more sensors are positioned on the manifold 120 to position the sensors(s)29 in contact with or near the upper lip region, such as in the oral region of the face. Numerous blood vessels exist in the upper lip, and the sensors(s)29 can be used to determine blood oxygenation by contacting or being near the upper lip region via the manifold 120.

[0701] The manifold 120 can be formed of a rigid plastic material because it is received within the soft silicone body of the cannula. The rigidity of the manifold 120 facilitates insertion into the face mount portion and holds the manifold in its operational position (i.e., inserted into the face mount). The manifold is inserted into the face mount portion and is in fluid communication with the fork to guide gas from the inlet conduit to the fork. A sensor 29 located on or within the manifold portion positioned in the face mount portion positions the sensor 29 in a sensing position, i.e., the sensor is positioned adjacent to or in contact with the upper lip.

[0702] The nasal septum and / or columella are generally quite sensitive areas and can be a source of discomfort when subjected to excessive contact pressure over prolonged periods. The nasal intubation disclosed herein can eliminate or reduce this pressure by elevating the intubation area by 1000 degrees adjacent to the patient's nasal septum / columella. See also Figure 42 and Figure 43 In one embodiment, the outlet 123 includes a pair of opposing recesses or grooves 124 / 125 at its periphery, which are used to form a dimple or recess 127 in the area adjacent to the nasal septum / columella for positioning during use. When coupled to the face mount portion 110, this recess 127 forms a gap between the base portion 118 and the outlet 123 of the manifold 120. In use, this gap cushions / softens the area of ​​the cannula 100 directly adjacent to the nasal septum / columella. This allows pressure from the stiffer manifold portion 120 to disengage from the nasal septum / columella and allows the nasal septum / columella to rest solely on the soft base of the face mount portion 110.

[0703] The base portion 118 is preferably also shaped to have a hollow outer portion and / or a recessed outer contour 118b between the forks 111 and 112 to relieve pressure at the nasal septum / columella. The hollowing should be as extensive as possible without (significantly) reducing the flow delivered to the patient. The recessed portion 118b is preferably also complementary to the periphery of the outlet 123 to maintain an effective seal between the two portions of the cannula.

[0704] The pulse oximeter 29 can be positioned between the forks 111 and 112 on the upper surface of the cannula, such that it contacts the nasal septum / columella. For example, the pulse oximeter 29 is positioned within a recessed portion 118b between these forks. A recessed manifold is advantageous when the sensor 29 is positioned between the forks 111 and 112 to reduce pressure sores or other pressure injuries caused by contact between the sensor 29 and the nasal septum / columella. The recessed portion, i.e., the recess 127 in the face mount portion 110, allows the cannula to be modified into a recessed section, thereby ensuring sensor contact while mitigating pressure injuries. Therefore, if the pulse oximeter 29 is located on the top surface of the base portion 118 (e.g., in a recessed portion 118b), it is advantageous. Figure 9 If the position shown is between the two forks 111 and 112, then the recess 127 can be beneficial.

[0705] In the embodiments of Figures 37 to 41, the headgear for securing the patient interface 100 to the patient's face includes a head strap 200 having a single continuous length and being adapted to extend along the patient's cheek, above the ears, and around the back of the head in use.

[0706] The main ends 201 and 202 of the tether 200 are adapted to be releasably connected to corresponding configurations 101 and 102 on either side of the nasal cannula 100 (see, for example, see...). Figure 38A ( ), so as to hold the cannula 100 in place during use.

[0707] The tie connector 230 is provided at each of the secondary ends 203 / 204 of the main tie 210 and the corresponding ends 203 / 204 of the tie segment 220.

[0708] Each connector 230 has a tie connection mechanism at one end that connects to the tie material, and a connection mechanism at the opposite end that releasably connects to the corresponding end of a similar connector 230.

[0709] Cannula connectors 240 are located at the main ends 201 and 202 of the main frenulum 210. These connectors 240 have a similar frenulum connection mechanism to the frenulum connectors 230 at the secondary ends 203 and 204, but include a clamping member, such as a push-fit clamp 241, at the end of the connector 240 opposite the frenulum end. The clamp 241 is configured to releasably engage a corresponding configuration 101 / 102 on one side of the cannula 110. The clamping member 241 is preferably a bendable portion, such as a plastic portion, which forms a hinged portion relative to the frenulum. For example, the clamp 241 is preferably pre-formed to have a curved shape along its length, such as a curved shape with an angle between, for example, flat and 20 degrees. This curvature allows the clamp 241 to adapt to the patient's facial contour in the area of ​​the clamp 241.

[0710] Referring now to Figures 40 and 41, methods for engaging and disengaging each connector 240 of the head strap 200 from and from the patient interface 110 will be described. Each connector 240 includes a clamping member 241 having an elongated connector body 242 and a lateral protrusion 243 at the end of the body 242. The lateral protrusion 243 includes an inwardly facing engagement surface 243a. The face 244 of the connector 240 opposite to the face 245 from which the protrusion 243 extends is preferably substantially smooth or planar. The corresponding configuration 101 / 102 of the cannula 110 includes channels 101a / 102a having an entry opening 101b / 102b and an exit opening 101c / 102c at each end of the channels 101a / 102a. The outer walls of the exit openings 101c / 102c define abutments 101ci / 102ci, which are configured to engage with the surface 243a of the protrusion 243 of the clamping member 241. The outer walls 101bi / 102bi of the entry openings 101b / 102b define abutments for engaging flanges 246 at opposite ends of the body 242 onto the protrusions 243. This limits the insertion depth of the connector 240 into the corresponding channels 101a / 102a. The flanges 246 may be provided by the end of a tethered connection mechanism and / or a sleeve 270.

[0711] On each side of the headband 200 and in each segment adjacent to the respective main ends 201 / 202, a cheek support 270 is included or applied thereon. This cheek support includes at least a surface area 271 for frictionally engaging with the user's face to stabilize the headband 200 on the face at the cheek (e.g., cheekbone or below, or in the area thereof) during attachment to the patient interface 100 and in subsequent use. The surface area 270 preferably has a surface material with relatively higher friction compared to the rest of the headband 200.

[0712] The high-friction surface material 271 is adapted to extend and cover a portion of the patient's face during use, preferably at or at least substantially toward the patient's cheek, to help keep or stabilize the patient interface 100 on the patient's face. The high-friction surface material, which can be positioned on the user's cheek, further helps to keep the remainder of the head strap 200 separate from the user's eyes or eye sockets and preferably extends below the user's eyes or eye sockets to prevent visual obstruction and / or discomfort caused by the head strap 200 bridging on or near the eyes or eye sockets.

[0713] It should be understood that the high-friction surface material 271 can be adapted to extend and cover a portion of the patient's face during use, for example, extending backward and upward across the left and right cheeks from or near the left and right outer upper lips and the upper left and right outer lips.

[0714] The friction surface material may be provided in the form of an elongated sleeve 270 configured to receive the respective main ends 201 / 202 of the tether 200. The sleeve 270 is configured to removably engage (or alternatively permanently engage) around the tether 200, sections of the tether 200, and / or the insertion connectors 240 / 260 at the main ends of the tether.

[0715] The sleeve 270 is connected at the main ends 201 / 202, surrounding the tie 210 and also a portion of the connector 240. The tie 210 extends through a channel 272 in the sleeve 270, as if from... Figure 37B See. The strap 210 is adapted to spiral through this channel and, when in a sleeve configuration, preferably remains free to stretch, elasticize, or extend. The connector 240 is substantially received by the sleeve 270 or covered by a surface area to minimize direct contact with the user's skin, thereby improving the stability and comfort of the cap 200. The clamp 241 extends from the end 273 of the sleeve 270. In another embodiment, the sleeve 270 may be overmolded onto the connector 240 and / or the strap 210.

[0716] See Figure 38A The sleeve 270 can be engaged at the main ends 201 / 202 around the connector 260 extending from the strap 210. In this embodiment, the connector 260 is substantially received by the sleeve 270 or covered by a surface area to minimize direct contact with the user's skin, thereby improving the stability and comfort of the cap 200. In other words, the connector 260 extends fully through the channel 272 of the sleeve 270. Buckles 251 / 252 extend from the end 274 of the sleeve 270 and clamps 261 extend from the opposite end 273.

[0717] The sleeve 270 can be pre-formed to have a curved shape along its length, such as a curved shape with an angle between flat and 20 degrees. This curvature allows the sleeve 270 to adapt to the contours of the patient's face or cheek in the sleeve area during use. Alternatively, the sleeve 270 can be elastically or inelastically deformed to take the shape of a curved sleeve when engaged with the main ends 201 / 202 of the head strap 200 or the connector 260.

[0718] The sleeve 270 provides a surface area 271 with a relatively high-friction surface material for frictional engagement with the user's face or facial skin. This surface area 271 will be positioned for frictional engagement with the user's facial cheek skin. The surface area 271 is concentrated at least in the lacing or the lacing segment to be positioned on the user's cheek. The surface area 271 with the relatively high-friction surface material preferably has a material that is smooth and comfortable on the patient's skin. Therefore, the sleeve 270 or at least the surface area 271 is formed of a material that is relatively softer than the connectors 240 and 260.

[0719] In a preferred embodiment, the surface region 271 or sleeve 270 is formed of a soft thermoplastic elastomer (TPE), but may alternatively be formed of another plastic material (such as silicone) or any other biocompatible material.

[0720] In addition to nasal cannulas, headgear for other forms of interfaces may include, at or near either end of the headgear's strap, multiple cheek supports 270, as described or similar, attached to the mask for frictional engagement with the user's face to stabilize the mask on the cheek, particularly for guiding, for example, nasal masks including nozzles or cushions that enter or engage the wearer's nostrils. Such headgear may further include a single head strap adapted to extend along the patient's cheek above the ear and around the back of the head during use, with the end including clips of any suitable form attached to (or permanently attached to) the mask on either side.

[0721] The patient sensor 29 (e.g., in the form of a pulse oximeter) can be mounted on the nasal cannula 1000 of Figures 37 to 41.

[0722] Patient sensor 29 can be referenced from Figures 1 to 36 Any configuration of the nasal cannula 100 described is provided on the nasal cannula 1000.

[0723] The patient sensor 29 can be disposed on the head cap 200, or on another removable portion of the nasal cannula 1000 connected to the face mount 110 or the gas flow manifold 120. In this way, if the face mount 110 and / or the gas flow manifold 120 are replaced or discarded, the patient sensor 29 can be retained with the head cap 200 or other removable portion, so that the patient sensor 29 is not discarded and can be reused. For example, the patient sensor 29 can be disposed on the head cap 200, which is configured to connect to multiple face mounts 110 and / or gas flow manifolds 120 of different sizes. This allows the user to exchange or replace a portion of the cannula without discarding the patient sensor 29.

[0724] Referring to Figures 37 through 41, the patient sensor 29 may be disposed on the sleeve 270. Any wiring associated with the patient sensor 29 may extend through the channel 272 of the sleeve 270 and extend from the end 274.

[0725] The patient sensor 29 may be recessed into and flush with the face contact surface 271 of the sleeve 270. The patient sensor 29 may be positioned at any suitable location along the length of the sleeve 270, such as adjacent to the structures 101, 102 or adjacent to the headgear strap 210.

[0726] The patient sensor 29 can be permanently mounted on the sleeve, for example, the patient sensor 29 can be overmolded onto the sleeve 270.

[0727] The patient sensor 29 can be removably mounted on the sleeve 270, 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 that have similar recesses in the sleeve 270 to receive the sensor 29. This allows the sensor to be reused on patients, thereby reducing costs for healthcare facilities.

[0728] Alternatively, the patient sensor 29 can be disposed within a complementary sensor body, which can be permanently or removably mounted on the sleeve 270, for example, in a corresponding recess on the sleeve 270. The recess and the complementary body may have one or more retention features configured to hold the body in the recess. Incorporating the sensor 29 into the sleeve 270 brings the sensor 29 into contact with a cheek region, such as the cheek or temporal region of the face. Blood vessels exist in this region of the face, and the sensor can be placed near these vessels, which can then be used to detect blood oxygenation.

[0729] Patient interface, for example, according to Figure 37 to Figure 43 Any nasal cannula in any of the diagrams may include multiple patient sensors 29.

[0730] For example, the 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). Measurements from these multiple sensors 29 may be averaged by the controller to provide a blood oxygen (SpO2) reading.

[0731] Therefore, each sleeve 270 may include a single sensor 29.

[0732] In another alternative form, each sleeve 270 of the cannula (i.e., each side arm) may include multiple sensors. One, some, or all of these sensors may be removable. Each sleeve 270 may include multiple recesses or openings to receive sensors 29.

[0733] Multiple sensors 29 may be advantageous because averaging the measurements can provide more accurate SpO2 readings and reduce noise in the sensor readings received by the controller.

[0734] Referring to Figure 39, a retention clamp 280 may be provided, comprising a tubular body 281 for receiving and housing a portion of the catheter 300 therein. A hook 282 protrudes from the body 281 to engage other components of the tether or cap 200. In this manner, the catheter 300 can be attached or secured to the head tether 210 or cap 200 during use. If the catheter 300 is pulled, the force will be applied to the head tether 210 and not directly to the cannula 100. This repositioning of the force will reduce the likelihood of the forks 111 and 112 of the cannula 100 protruding outside the patient's nostrils.

[0735] One or more tethering points for connecting the clamp 280 may be available on the cap 200, wherein preferably there are at least two symmetrical tethering points on either side of the cap to improve usability.

[0736] It should also be understood that the retaining clamp 280 may be removable from the gas supply line 300 or may be a permanent fixture thereon.

[0737] The retention clamp 280 can be attached to or secured to a portion of the patient interface, such as an interface portion that provides a relatively rigid area (e.g., to facilitate support for the gas supply tube article 300).

[0738] The retaining clamp 280 can also be positioned or attached to a specific location on the gas supply pipe article 300, for example, a predetermined position can be set to hold the retaining clamp 280 in place.

[0739] The retention clamp 280 can be configured to retain the wiring of the patient sensor 29 to secure the wiring to the catheter 300. Therefore, the patient sensor wiring can typically extend parallel to the longitudinal axis of the catheter 300.

[0740] The catheter 300 may be provided with one or more sensor wires, which may be embedded in the wall of the catheter or extend through the bore of the catheter. These one or more sensor wires may be configured to be electrically connected to the patient sensor 29.

[0741] Such electrical connection can be provided by physical electrical connection between the wiring of the patient sensor 29 and one or more sensor wires in the catheter 300, for example via an electrical connector.

[0742] Such electrical connection can be provided via inductive connection. For example, patient sensor wiring may extend along sleeve 270 and / or may be disposed in the face mounting portion 110 and / or gas flow manifold portion 120 of cannula 1000. Catheter wiring may extend to or near the end of catheter 300, where catheter 300 connects to the inlet of nasal cannula. Catheter 300 and cannula 1000 may be provided with inductive connectors configured to electrically connect catheter 300 to patient sensor wiring.

[0743] This arrangement eliminates or reduces the need for physical electrical connections or the like, as well as one or more exposed electrical contacts. It also eliminates or reduces the number of connections required when using the nasal cannula 1000. For example, if the patient sensor 29 and the cap 200 are to be reused, the user does not need to physically disconnect the patient sensor wiring from the catheter 300.

[0744] The conduit 300 can be a heated or unheated conduit. The conduit can be an extension of any desired length.

[0745] Unless the context clearly requires otherwise, throughout the specification and claims, the terms “comprise”, “comprising”, etc., shall be interpreted in a sense of inclusion, not in a sense of exclusion or exhaustion, that is, in the sense of “including but not limited to”.

[0746] In this document, references to directional terms such as “up,” “down,” “forward,” “backward,” “horizontal,” and “vertical” are used to indicate the situation when the device is in a typical position of use and to show and / or describe relative direction or orientation.

[0747] As used herein, the terms “about,” “approximately,” and “substantially” mean an amount that is close to the stated amount and still performs the desired function or achieves the desired result. For example, in some embodiments, as the context permits, the terms “about,” “approximately,” and “substantially” may refer to an amount that is less than or equal to 10%, less than or equal to 5%, and less than or equal to 1% of the stated amount.

[0748] Any reference to prior art in this specification is not and should not be construed as an admission or in any way implying that such prior art is part of common general knowledge in the relevant field in any country of the world.

[0749] The disclosed devices and systems can also be broadly referred to as the parts, elements and features that are individually or jointly mentioned or indicated in the specification of the application, and any or all combinations of two or more of said parts, elements or features.

[0750] In the above description, reference has been made to components in whole or in part having known equivalents thereof, which are incorporated herein as if described separately.

[0751] Depending on the implementation, certain actions, events, or functions of any algorithm, method, or process described herein may be performed in a different sequence, and may be added, combined, or omitted entirely (e.g., not all described actions or events are necessary for the practice of the algorithm). Furthermore, in some embodiments, actions or events may be performed simultaneously rather than sequentially, for example, through multithreading, interrupt handling, or on multiple processors or processor cores or other parallel architectures.

[0752] It should be noted that various variations and modifications to the embodiments currently described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the disclosed apparatus and systems, and without diminishing their accompanying advantages. For example, various components may be repositioned as needed. Therefore, such changes and modifications are contemplated to be included within the scope of the disclosed apparatus and systems. Furthermore, not all of these features, aspects, and advantages are necessary for practicing the disclosed apparatus and systems. Therefore, the scope of the disclosed apparatus and systems is intended to be defined solely by the appended claims.

Claims

1. A nasal cannula interface for supplying a gas flow to a patient, comprising: A gas inlet catheter configured to receive a gas flow from a flow source via an inspiratory catheter, the gas inlet catheter defining at least a portion of a gas flow path and including a patient end and a distal end; First set of wires; One or more sensors, the sensors being configured to be placed on the patient's skin and configured to measure at least one parameter; as well as Nasal intubation, the nasal intubation tube comprising: A body having a base portion and at least one fork extending from the base portion, the at least one fork being configured to guide a gas flow into the patient's airway, and An interface connector for receiving gas flow from the gas inlet conduit and guiding the gas flow toward the at least one fork, and The patient end is connected to the interface connector. The remote end includes an interface entry point, which 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; The electrical contacts of the gas inlet conduit and the intake conduit are configured such that if the gas inlet conduit and the intake conduit are pneumatically connected, an electrical connection is automatically formed.

2. The nasal cannula interface as described in claim 1, wherein, The at least one fork is configured to be received in one or more of the patient's nostrils; and / or, the at least one fork is configured to be received in one of the patient's nostrils in an unsealed manner.

3. The nasal cannula interface as described in any one of claims 1 to 2, wherein, At least one of the sensors is a patient sensor, and the parameter is a physiological parameter of the patient.

4. The nasal cannula interface as described in any one of claims 1 to 2, wherein, At least one of the sensors is a pulse oximeter.

5. The nasal cannula interface as described in claim 4, wherein, This pulse oximeter is a reflective pulse oximeter.

6. The nasal cannula interface as described in any one of claims 1 to 2, wherein, The body of the nasal cannula further includes a pair of side arms.

7. The nasal cannula interface as described in any one of claims 1 to 2, further comprising a head fixation component.

8. The nasal cannula interface as described in claim 6 further includes a head fixation component, wherein, The head fixation assembly is attached to these side arms.

9. The nasal cannula interface as described in claim 7, wherein, The head restraint assembly includes one or more straps.

10. The nasal cannula interface as described in any one of claims 1 to 2, wherein, These sensors are movable relative to the body of the nasal cannula interface.

11. The nasal cannula interface as claimed in claim 9, further comprising a sensor arm, wherein, One or more sensors are positioned on the sensor arm.

12. The nasal cannula interface as described in claim 11, wherein, The sensor arm is either rigid, preventing the user from easily bending it, or elastically deformable, allowing the user to easily bend it.

13. The nasal cannula interface as described in claim 11, wherein, The surface of the sensor arm includes an adhesive that allows it to adhere to the patient's skin.

14. The nasal cannula interface as described in claim 11, wherein, The length of the sensor arm is adjustable.

15. The nasal cannula interface as described in claim 14, wherein, The length of the sensor arm can be adjusted by telescopic movement.

16. The nasal cannula interface as described in claim 11, wherein, The head fixation assembly further includes a sensor mount connected to one of the straps, wherein the sensor arm protrudes from the sensor mount.

17. The nasal cannula interface as described in claim 16, wherein, The sensor mount is movably connected to one of the straps.

18. The nasal cannula interface as described in claim 17, wherein, The sensor mount is slidably connected to one of the straps.

19. The nasal cannula interface as described in any one of claims 16 to 18, wherein, The sensor mount is removably connected to one of the straps.

20. The nasal cannula interface as described in any one of claims 16 to 18, wherein, The sensor arm is movable relative to the sensor mount.

21. The nasal cannula interface as described in claim 20, wherein, The sensor arm can be slidably mounted to the sensor mount.

22. The nasal cannula interface as described in claim 21, wherein, The sensor arm is slidably mounted to the sensor mount and is capable of sliding in a direction parallel to the length of the tether or gas inlet conduit to which the sensor mount is connected; and / or, the sensor arm is slidably mounted to the sensor mount and is capable of sliding in a direction transverse to the length of the tether or gas inlet conduit to which the sensor mount is connected.

23. The nasal cannula interface as described in claim 20, wherein, The sensor arm is configured to rotate about the axis at which it is connected to the sensor mount.

24. The nasal cannula interface as described in any one of claims 1 to 2, wherein, At least a first portion of the first set of wires of the nasal cannula interface is embedded in the body of the nasal cannula, the interface connector of the nasal cannula, or at least a portion of the gas inlet conduit; and / or, at least a second portion of the first set of wires of the nasal cannula interface is positioned on the outer surface of the body of the nasal cannula, the interface connector of the nasal cannula, or at least a portion of the gas inlet conduit; and / or, at least a third portion of the first set of wires of the nasal cannula interface is positioned on the inner surface of the body of the nasal cannula, the interface connector of the nasal cannula, or at least a portion of the gas inlet conduit.

25. A respiratory support system for generating a gas flow, the respiratory support system comprising: Respiratory support device, the respiratory support device comprising: Flow generator Export of respiratory support equipment, and Controller; Inhalation tubing, the inhalation tubing comprising: The patient end with the inspiratory duct outlet, and The end of the device has an intake duct inlet; The nasal cannula interface as described in any one of claims 1-24; The outlet of the respiratory support device is configured to form a pneumatic and electrical connection with the inhalation duct inlet. The respiratory support device's outlet is in electrical communication with the controller, and The controller is configured to power one or more sensors and receive data from them.

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