CN116650775A - Patient Interface and Respiratory Devices - Google Patents

Abstract

A nasal cannula interface accessory for attachment to a nasal cannula interface is disclosed. The accessory includes: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; and at least one fixation feature configured to connect the accessory to a nasal cannula interface (optionally Optionally connected to the nasal cannula interface).

Description

Patient Interface and Respiratory Devices

technical field

The present disclosure relates generally to patient interfaces and respiratory devices for providing a flow of breathable gas to a patient through the patient interface for respiratory support, and more particularly to accessories and/or components having sensors on or near the patient interface of the respiratory device.

Background technique

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

Contents of the invention

In one aspect, there is provided a nasal cannula interface accessory for attachment to a nasal cannula interface, the accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, And at least one securing feature configured to connect the accessory to the nasal cannula interface (and optionally to the strap of the nasal cannula interface).

In some configurations, at least one securing feature is configured to releasably connect the accessory to the nasal cannula hub.

In some configurations, the sensor cavity is formed on the first face of the nasal cannula hub attachment.

In some configurations, the accessory includes a wire lumen configured to provide access to the sensor lumen for one or more wires.

In some configurations, each of the one or more wires includes a cable, cord, lead, or any other conductive material.

In some configurations, the guidewire lumen is formed on the same face and/or a different face than the sensor lumen of the nasal cannula interface attachment.

In some configurations, the guidewire lumen includes multiple openings on different (and optionally adjacent) faces of the accessory.

In some configurations, a wire lumen is formed adjacent to the sensor lumen.

In another aspect, there is provided a nasal cannula interface accessory for attaching to a nasal cannula interface, the accessory comprising:

a sensor chamber configured to hold a sensor configured to measure at least one patient parameter,

a wire lumen configured to provide access to the sensor lumen for one or more wires, and

A pair of arms extending from the cannula interface attachment, the arms extending towards each other and/or towards the center of the attachment, the arms are configured to releasably connect the attachment to the nasal cannula interface (optionally to the strap of the nasal cannula port).

In another aspect, there is provided a nasal cannula interface accessory for attaching to a nasal cannula interface, the accessory comprising:

a sensor chamber configured to hold a sensor configured to measure at least one patient parameter,

a wire lumen configured to provide access to the sensor lumen for one or more wires, and

a clamp configured to connect to the accessory, the clamp including a clamp arm connected to the accessory via a biasing element, the clamp configured to secure the nasal cannula interface accessory to the nasal cannula interface (optionally to the nasal cannula interface belt).

In some configurations, the biasing element includes a hinge, a spring.

In some configurations, the sensor cavity is one or more of: square, rectangular, and/or circular.

In some configurations, the sensor cavity has substantially rounded edges and vertices.

In some configurations, the sensor cavity is arranged to orient the sensor into contact with the patient.

In some configurations, the sensor cavity is arranged to orient the sensor such that the transducer of the sensor faces the patient.

In some configurations, the sensor includes a light transducer (optionally an infrared transducer or a red light transducer) and/or a light source (optionally an infrared source or a red light source).

In some configurations, the sensor cavity is arranged to orient the sensor such that the optical transducer and/or light source faces the patient.

In some configurations, the sensor cavity includes an opening on a side of the accessory that is configured to face the patient in use.

In some configurations, the wire lumen extends from the outer surface to the sensor lumen.

In some configurations, the wire lumen extends from the face of the accessory to the sensor lumen.

In some configurations, the guidewire lumen includes an opening on a side of the accessory that is configured to face the patient in use.

In some configurations, the guidewire lumen is a slot.

In some configurations, the guidewire lumen is one or more of: square, rectangular, and/or circular.

In some configurations, the sensor is a patient sensor and the patient parameter is a physiological parameter.

In some configurations, the patient parameter is a measure of blood oxygenation of the patient.

In some configurations, an accessory can attach to the interface at multiple interface attachment locations.

In some configurations, the accessory is configured to be adjustable between a plurality of interface attachment positions.

In some configurations, the accessory is configured to be adjustable between multiple interface attachment positions without being removed from the interface (and optionally a strap of the interface).

In some configurations, the accessory is configured to be slideably adjustable between a plurality of interface attachment positions.

In some configurations, the accessory can attach to the interface at multiple patient facial locations.

In some configurations, the accessory is configured to be adjustable between multiple patient facial positions without being removed from the interface.

In some configurations, the attachment is configured such that the attachment is slidably adjustable between a plurality of patient facial positions.

In some configurations, the plurality of patient facial locations includes proximate to the patient's cheeks.

In some configurations, the plurality of patient facial locations is included between the patient's eyes and lips.

In some configurations, the accessory is configured to be adjustable between a plurality of attachment positions on the interface defined by at least one connection point between the strap and the body of the nasal cannula.

In some configurations, the plurality of patient face locations corresponds to a plurality of attachment locations.

In some configurations, the attachment can be located near the patient's cheek.

In some configurations, the attachment can be positioned between the patient's eyes and lips.

In some configurations, the attachment is configured to be movable along the length of the strap to allow the clinician to position the sensor.

In some configurations, the securement feature or the at least one securement feature is configured as a strap that releasably retains the accessory to the nasal cannula interface.

In some configurations, the securing feature is configured to substantially prevent movement of the accessory accessory along the strap.

In some configurations, the securing feature is configured to allow relative movement of the strap and accessory when a threshold force is applied.

In some configurations, the threshold force is based on the type of securing feature and the material of the strap.

In some configurations, at least one securing feature is configured to extend from a side of the accessory opposite the sensor cavity.

In some configurations, the at least one securing feature includes at least one arm configured to extend around at least a portion of the strap of the nasal cannula interface.

In some configurations, the at least one securing feature includes a pair of arms disposed along an axis of the accessory that is configured to be parallel to the axis of the strap when the accessory is connected to the strap.

In some configurations, the arm includes a first portion extending from the attachment (optionally in a perpendicular direction outwardly from the attachment), and a second portion, wherein the second portion of the arm is configured substantially perpendicular to the associated The first portion and/or is oriented parallel to the attachment.

In some configurations, the at least one securing feature includes a pair of arms extending from the attachment and toward each other.

In some configurations, each arm includes a first portion and a second portion, the first portion extending from the attachment (optionally in a perpendicular direction outwardly from the attachment) and the second portion of each arm configured to be oriented towards each other (Optionally, the second portion of each arm is oriented substantially perpendicular to the associated first portion and/or parallel to the attachment).

In some configurations, each arm includes a first portion and a second portion, the first portion extending from the accessory (optionally in a perpendicular direction outwardly from the accessory), and the second portion of each arm configured to face Centrally oriented (optionally, each second portion is oriented substantially perpendicular to the associated first portion).

In some configurations, each arm includes a first portion extending vertically upward from the attachment and a second portion extending inwardly towards the center of the attachment and/or towards the second portion of the other arm such that each The first portion and the second portion of each arm form an angle, wherein the angle is less than 90 degrees, or about 90 degrees, or less than about 120 degrees.

In some configurations, the strap of the nasal cannula interface is configured to connect to an accessory.

In some configurations, the securing feature is configured to receive a strap of a nasal cannula interface.

In some configurations, a gap is defined between the pair of arms.

In some configurations, the strip or strip of the nasal cannula interface is configured to be insertable into the gap (optionally defined by the arms or pair of arms) for connection to the accessory.

In some configurations, a gap is defined between the pair of arms.

In some configurations, the width of the strip of the nasal cannula interface is greater than the gap.

In some configurations, the strip of the nasal cannula can only be inserted into the gap when aligned with the edge of the strip or when the strip is folded across the width of the strip.

In some configurations, the strip of the nasal cannula can only be removed from the attachment through the gap when aligned with the edge of the strip or when the strip is folded across the width of the strip.

In some configurations, the or at least one securing feature includes a clip.

In some configurations, the clamp includes a clamp arm.

In some configurations, the clamp arm is connected to the accessory by a biasing element (optionally a hinged portion).

In some configurations, the clip extends from the accessory (optionally from a side of the accessory).

In some configurations, the clamp is configured to retain the strap of the nasal cannula to the accessory when the clamp is in the closed position.

In some configurations, the clip is configured to retain the strap between the clip and the nasal cannula to the accessory when the clip is in the closed position.

In some configurations, the clamp arm includes a contact surface configured to engage the strap of the nasal cannula when the clamp is in the closed position or the closed position.

In some configurations, the contact surface is located in a recess of the clamp arm.

In some configurations, the recess is shaped to receive a strip of a nasal cannula.

In some configurations, the contact surface includes at least one protrusion configured to help retain the strap when the clamp is closed.

In some configurations, the at least one protrusion includes at least one rib that can be positioned perpendicular to the width of the strap when the strap is engaged with the contact surface, and/or perpendicular to the longitudinal axis of the contact surface.

In some configurations, the at least one rib comprises a pair of ribs spaced apart along the length of the strap when the strap is engaged with the contact surface, and/or spaced apart along the longitudinal axis of the contact surface.

In some configurations, the at least one rib includes a pair of ribs at opposite ends of the contact surface.

In some configurations, the at least one protrusion includes one or more bumps.

In some configurations, the one or more bumps include a bump in each corner of the contact surface.

In some configurations, the one or more bumps are patterned on at least a portion of the contact surface or the entire contact surface.

In some configurations, the one or more bumps are patterned in offset or aligned rows.

In some configurations, the contact surface has a matte and/or significantly rough surface.

In some configurations, when the clamp is closed and retains the strap of the nasal cannula, the accessory is prevented from sliding relative to the strap.

In some configurations, the clamp arm includes an aperture extending through the clamp arm (optionally through the contact surface).

In some configurations, the aperture is configured to receive a portion of another of the at least one fixation system (optionally the other of the at least one fixation system is at least one arm).

In some configurations, the attachment includes a pair of arms positioned on either side of the clamp.

In some configurations, the clamp arm includes at least one retaining feature configured to engage a corresponding feature of the accessory to retain the clamp in the closed position.

In some configurations, the strap or the strap of the nasal cannula interface is configured to connect to the accessory.

In some configurations, the securing feature is configured to receive the strap or the strap of the nasal cannula interface.

In some configurations, the securement feature is configured as a cannula connector that connects to the nasal cannula interface, optionally the body connection feature is located at the first end of the accessory.

In some configurations, the cannula connector is configured as a strap that connects the body of the nasal cannula interface to the nasal cannula interface.

In some configurations, a channel extends from the second end of the nasal cannula hub attachment along at least a portion of the longitudinal axis of the nasal cannula hub attachment.

In some configurations, the attachment is configured to act as a side arm (optionally a cheek support for the interface).

In some configurations, the or that side of the attachment which is configured to face the patient in use is substantially circular.

In some arrangements, the or that side of the accessory which is configured to face the patient in use may comprise at least one surface material.

In some configurations, the at least one surface material covers the or side of the accessory that is configured to face the patient.

In some configurations, the at least one surface material does not cover the sensor.

In some configurations, the at least one surface material is provided with apertures such that the at least one surface material does not extend across the sensor cavity of the accessory.

In some configurations, the at least one surface material is the same material as the accessory.

In some configurations, the at least one surface material is different from another material of the accessory.

In some configurations, the at least one surface material and accessory are detachable.

In some configurations, the at least one surface material and accessory are integral.

In some configurations, the at least one surface material is a film or film.

In some configurations, the at least one surface material is configured to increase friction between the attachment and the patient's face.

In some configurations, the surface material is configured to provide friction to resist movement between the accessory and the strap.

In some configurations, the at least one surface material has adhesive properties.

In some configurations, the at least one surface material has non-slip material properties.

In some configurations, the attachment has one or more gripping features.

In some configurations, the sensor is pre-installed in the sensor cavity of the accessory.

In another aspect, a kit is provided that includes a nasal cannula interface and accessories as described herein.

In another aspect, a nasal cannula interface component is provided that includes: a sensor lumen configured to hold a sensor configured to measure at least one patient parameter; a guidewire lumen configured to hold a sensor configured to measure at least one patient parameter; a wire lumen configured to provide access to the sensor lumen for one or more wires; a body connection feature configured to connect to a body of a nasal cannula interface located on the nasal cannula the first end of the interface member; and the strap of the nasal cannula interface.

In some configurations, the component is a side arm (and optionally a cheek support).

In some configurations, the strap of the nasal cannula is configured to connect to the main body connection feature.

In some configurations, the strap and/or body connection features are at least partially integrally formed (optionally overmolded) with the component.

In some configurations, the sensor is pre-installed in the sensor cavity of the accessory.

In another aspect, there is provided a nasal cannula interface comprising a portion as described herein.

In another aspect, a component for a patient respiratory interface is provided that includes a component body having a sensor cavity configured to hold a sensor configured to measure at least one patient parameter a first connector configured to be connected to the body of the patient's respiratory interface; and a second connector configured to be connected to headgear of the patient's respiratory interface.

In some configurations, the first connector is located at the first end of the component and the second connector is located at the second end of the component.

In some configurations, the first connector is configured to releasably connect the component to the body of the patient respiratory interface.

In some configurations, the second connector is configured as a headgear component that releasably connects the component to the patient respiratory interface.

In some configurations, the second connector is configured to be integrally formed with the headgear component.

In some configurations, the headgear component is a strap of the patient's respiratory interface.

In some configurations, the headgear component includes at least one aperture for attaching a strap.

In some configurations, the component is configured to be located between the body of the patient interface and the headgear component.

In some configurations, the component is configured to be located between the body of the patient interface and the headgear component when connected to the body of the patient interface and the headgear component.

In some configurations, the sensor cavity is defined by one or more walls of the component body.

In some configurations, the sensor cavity is located between the body of the patient respiratory interface and the headgear of the patient respiratory interface.

In some configurations, the component body and its sensor cavity are located between the first and second connectors of the component.

In some configurations, the first connector, the component body and the second connector are integrally formed with each other.

In some configurations, the component further includes a wire lumen configured to provide access to the sensor lumen for the one or more wires.

In some configurations, each of the one or more wires includes a cable, cord, lead, or any other conductive material.

In some configurations, the sensor cavity is formed in the first face of the component body.

In some configurations, the wire cavity is formed in the same face and/or a different face of the component body as the sensor cavity.

In some configurations, the wire lumen includes multiple openings on different (optionally adjacent) faces of the component body.

In some configurations, a wire lumen is formed in the component body adjacent to the sensor lumen.

In some configurations, the sensor cavity is one or more of: square, rectangular, and/or circular.

In some configurations, the sensor cavity has substantially rounded edges and vertices.

In some configurations, the sensor includes a light transducer (optionally an infrared transducer or a red light transducer) and/or a light source (optionally an infrared source or a red light source).

In some configurations, the sensor cavity is arranged to orient the sensor such that the optical transducer and/or light source faces the patient.

In some configurations, the sensor cavity is configured such that when the sensor is disposed within the sensor cavity, the transducer of the sensor is exposed to the outside of the component.

In some arrangements, the sensor cavity comprises an opening on a side of the component body configured to face the patient in use.

In some configurations, the sensor cavity is configured to present the transducer of the sensor at the first face of the component body.

In some configurations, the sensor cavity is arranged to orient the sensor into contact with the patient.

In some configurations, the wire lumen extends from the face of the component body to the sensor lumen.

In some configurations, the wire lumen extends from the outer surface of the component body to the sensor lumen.

In some configurations, the wire cavity includes an opening between the face of the component body and the sensor cavity.

In some configurations, the wire lumen is a slot recessed from the surface of the component body.

In some configurations, the guidewire lumen is one or more of: a substantially square, rectangular, and/or circular cross-section at at least one location along the length of the guidewire lumen.

In some configurations, the guidewire lumen is configured to face the patient in use.

In some configurations, the sensor is a patient sensor and the patient parameter is a physiological parameter.

In some configurations, the patient parameter is a measure of blood oxygenation of the patient.

In some configurations, the patient contacting surface of the component body configured to face the patient in use is substantially circular.

In some arrangements, the or that side of the component body which is configured to face the patient in use comprises at least one surface material.

In some configurations, the at least one surface material covers the or that side of the component body that is configured to face the patient.

In some configurations, the at least one surface material does not cover the sensor.

In some configurations, at least one surface material is provided with openings such that the at least one surface material does not extend across the sensor cavity of the component.

In some configurations, the at least one surface material is the same material as the component.

In some configurations, the at least one surface material is different than another material of the component.

In some configurations, the at least one surface material and component are separable.

In some configurations, the at least one surface material and the component are integral.

In some configurations, the at least one surface material is a film or film.

In some configurations, the at least one surface material is configured to increase friction between the component and the patient's face.

In some configurations, the at least one surface material has adhesive properties.

In some configurations, the at least one surface material has non-slip material properties.

In some configurations, a component has one or more capture features.

In some configurations, the sensor is pre-mounted in the sensor cavity of the component.

In some configurations, the sensor cavity is held on the patient's skin surface when the first connection is connected to the body of the patient interface and the second connection is connected to a portion of headgear or system for securing the patient interface to the patient .

In some configurations, the patient respiratory interface is one of: nasal cannula interface, nasal pillow interface, nasal mask interface, full face mask interface, oral interface.

In another aspect, a patient interface is provided that includes a headgear or system, and components for securing the patient interface in position about a patient's head.

In some configurations, the component includes a component body having a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a first connection configured to A body that is connected to the patient's respiratory interface; and a second connector configured as headgear that is connected to the patient's respiratory interface.

The component may comprise any of the features and/or functions described herein, such as those described in any one or more of paragraphs [0121] to [0171].

In some configurations, the headgear is in the form of at least one strap.

In some configurations, the straps in use are detachable or divisible to provide upper and lower strap portions of the headgear.

In some configurations, the patient interface is a nasal cannula.

In some configurations, the patient interface is a nasal cannula and includes one or a pair of nasal prongs.

In some configurations, the nasal cannula includes a body, and wherein the one or more nasal prongs are integrally formed with or removably attached to the body.

In some configurations, the body includes a pair of side arms extending from sides of the body.

In some configurations, the patient interface includes a sensor located in a sensor cavity of the patient respiratory interface component.

A patient breathing interface comprising:

a first side arm comprising a sensor recess,

an intake conduit configured to deliver the flow of breathable gas to the patient through the body of the patient breathing interface, and

a component having a conduit retaining portion configured to retain an intake conduit and a sensor mount configured to retain a patient sensor,

Wherein at least a portion of the sensor mount is insertable into the sensor recess of the first side arm such that the patient sensor contacts the patient's face when the patient respiratory interface is in use.

The first end of the inlet conduit is connected to the main body of the patient breathing interface.

The patient respiratory interface further includes a second side arm including a sensor recess configured to hold a patient sensor.

At least a portion of the sensor mount of the component is insertable into the sensor recess of the second side arm.

The first end of the intake conduit can be connected to the main body in a number of different orientations.

The first end of the intake duct may be connected to the body at each of two laterally opposite sides of the body, ie a first side adjacent to the first side arm and a second side adjacent to the second side arm.

The sensor mount is insertable into the sensor recess of the first side arm when the intake duct is connected to the first side of the main body.

When the intake conduit is connected to the second side of the body, the sensor mount is insertable into the sensor recess of the second side arm such that the patient sensor contacts the patient's face when the patient breathing interface is in use.

The curvature of the intake conduit between its first end and the conduit retaining portion of the component is less than about 90 degrees when the intake conduit is attached to the first side of the body and the sensor mount is inserted into the sensor recess of the first side arm.

The curvature of the intake conduit between its first end and the conduit retaining portion of the component is less than about 90 degrees when the intake conduit is connected to the second side of the body and the sensor mount is inserted into the sensor recess of the second side arm.

The sensor recess of the first side arm and the sensor mount of the component are configured to engage each other to prevent withdrawal of the sensor mount from the sensor recess when the sensor mount is inserted into the sensor recess of the first side arm.

The sensor recess of the second side arm and the sensor mount of the component are configured to engage each other to prevent withdrawal of the sensor mount from the sensor recess when the sensor mount is inserted into the sensor recess of the second side arm.

The intake conduit includes one or more conductive elements extending along at least a portion of its length.

The second end of the intake conduit is opposite the first end, and the second end is for connecting to the inspiratory conduit to receive the respiratory flow therefrom, and the second end of the intake conduit includes one or more electrical connections To interface with corresponding one or more electrical connectors of the inspiratory conduit when connected thereto.

The one or more conductive elements extend from the second end of the intake conduit to a location along the intake conduit at which the conduit retaining portion of the component is to retain the intake conduit.

The one or more conductive elements include one or more sensor wires that are in electrical communication with the patient sensor when the catheter retaining portion of the component is holding the intake catheter.

The intake duct includes a first portion and a second portion, and the duct holding portion of the component is joined between the first portion and the second portion of the intake duct.

The intake conduit comprises a single integral conduit between its first and second ends.

The duct retaining portion of the component is permanently attached to the intake duct.

The conduit retaining portion of the component is removably attached to the intake conduit.

The intake conduit is slidable along its length relative to the component when held by the conduit retaining portion.

When held by the conduit retaining portion, the intake conduit cannot slide relative to the component along its length.

The duct holding portion holds the intake duct around the periphery of the intake duct.

The duct holding portion holds the intake duct around more than half of the circumference of the intake duct.

The duct retaining portion surrounds the intake duct.

The clamp is attached around more than half of the perimeter of the intake duct.

The clamp surrounds the intake duct.

The or each sensor recess includes an opening through the side arm between the non-patient-facing side and the patient-facing side of the side arm.

When the sensor mount is inserted and retained within the sensor well, only a portion of the patient sensor is within the sensor well.

The cross-section of the or each sensor recess is square, rectangular or circular.

The cross-section of the sensor mount or at least a part thereof substantially corresponds to the cross-sectional shape of the sensor recess.

The patient sensor includes a light transducer (optionally an infrared transducer or a red light transducer) and/or a light source (optionally an infrared source or a red light source).

The or each side arm is configured such that the or each sensor recess is located at the patient's cheek when the patient breathing interface is in use.

The or each side arm is configured such that the or each sensor recess is located between the patient's eyes and the patient's lips when the patient breathing interface is in use.

When the patient sensor is held within the sensor mount, the portion of the sensor mount insertable into the or each sensor recess includes the transducer of the patient sensor.

When held within the or each sensor well, the transducer of the patient sensor is configured to contact the patient's face while wearing the respiratory patient interface.

A nasal cannula interface and its accessories, the accessories include:

a sensor chamber configured to hold a sensor configured to measure at least one patient parameter, and

at least one securing feature configured to connect the accessory to the nasal cannula interface (optionally to the strap of the nasal cannula interface), and

The nasal cannula includes first and second nasal prongs configured to create an asymmetric gas flow at the patient's nostrils.

The first nasal prong has a first shape and the second nasal prong has a second shape.

An inner cross-sectional area of the first nasal prong in a direction transverse to gas flow through the first nasal prong is smaller than a corresponding inner cross-sectional area of the second nasal prong in a direction transverse to gas flow through the second nasal prong.

The first nasal prong and the second nasal prong are configured such that at least about 60% of a total volumetric flow rate of gas flow dispensed by the nasal cannula is delivered from the second nasal prong.

A nasal cannula interface and its components, the nasal cannula interface components include:

a sensor chamber configured to hold a sensor configured to measure at least one patient parameter,

a wire lumen configured to provide access to the sensor lumen for one or more wires, and

a body connection feature configured to connect to the body of the nasal cannula interface, the body connection feature being located at the first end of the nasal cannula interface component, and

The nasal cannula interface includes:

A first nasal prong and a second nasal prong configured to generate an asymmetric gas flow at the patient's nares, and a band.

The first nasal prong has a first shape and the second nasal prong has a second shape.

An inner cross-sectional area of the first nasal prong in a direction transverse to gas flow through the first nasal prong is smaller than a corresponding inner cross-sectional area of the second nasal prong in a direction transverse to gas flow through the second nasal prong.

The first nasal prong and the second nasal prong are configured such that at least about 60% of a total volumetric flow rate of gas flow dispensed by the nasal cannula is delivered from the second nasal prong.

A patient breathing interface comprising:

a first nasal prong and a second nasal prong, the nasal prongs configured to create an asymmetric gas flow at the patient's nostrils,

a first side arm comprising a sensor recess,

an air intake conduit configured to deliver a flow of breathable gas to the patient through the body of the patient breathing interface and the first and second nasal prongs,

a clamp attachable to the intake conduit, the clamp configured to retain the patient sensor within the sensor mount of the clamp, wherein at least a portion of the sensor mount is insertable into the sensor recess of the first side arm such that when the patient breathes When the interface is in use, the patient sensor contacts the patient's face.

The first nasal prong has a first shape and the second nasal prong has a second shape.

An inner cross-sectional area of the first nasal prong in a direction transverse to gas flow through the first nasal prong is smaller than a corresponding inner cross-sectional area of the second nasal prong in a direction transverse to gas flow through the second nasal prong.

The first nasal prong and the second nasal prong are configured such that at least about 60% of a total volumetric flow rate of gas flow dispensed by the nasal cannula is delivered from the second nasal prong.

A nasal cannula interface and its accessories, the accessories include:

a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and at least one fixation feature configured to connect an accessory to a nasal cannula interface (optionally to a nasal cannula port), and

The nasal cannula includes a first nasal prong and a second nasal prong, and the cross-sectional area of the first nasal prong is smaller than that of the second nasal prong.

The cross-sectional area of the first nasal prong that is smaller than the cross-sectional area of the second nasal prong is taken from corresponding locations on the first and second nasal prongs.

The cross-sectional areas of the first and second nasal prongs are taken from the respective proximal openings of the nasal prongs.

The difference in the cross-sectional area of the first nasal prong and the second nasal prong is to induce an asymmetric gas flow in the patient's nostrils.

A patient respiratory interface and an accessory thereof configured to hold patient sensors to measure a patient parameter, wherein the accessory is configured to interact with the patient respiratory interface and measure a physiological parameter of the patient while the patient is breathing on the patient.

Interaction of the accessory with the patient respiratory interface includes attachment of the accessory with the patient respiratory interface.

Interaction of the accessory with the patient respiratory interface includes attachment of the accessory with a strap of the patient respiratory interface.

The accessory can replace the first component of the patient respiratory interface, and the interaction of the accessory with the patient respiratory interface includes replacing the first component of the nasal cannula interface with the accessory.

Interaction of the accessory with the patient respiratory interface further includes interconnection of the accessory with the second component of the patient respiratory interface.

The interaction of the accessory with the patient respiratory interface further includes interconnecting the accessory with both the second component and the third component of the patient respiratory interface.

The first component of the patient breathing interface is the side arm of the patient breathing interface.

The first component of the patient breathing interface is the connector that connects the other two components of the patient breathing interface together.

A first component of the patient respiratory interface is a connector for connecting the body of the patient respiratory interface and the headgear of the patient respiratory interface together.

The accessory interacts with the patient respiratory interface such that patient sensors held by the accessory are located on the patient's face between the mouth and eye regions of the patient's face when associated with the patient respiratory interface and worn by the patient.

The patient breathing interface is a nasal cannula interface.

A patient respiratory interface for providing respiratory therapy to a patient, the patient respiratory interface comprising:

an intake conduit configured to deliver a flow of breathable gas to the patient through the body of the patient breathing interface,

patient sensor with sensor mount,

A retaining structure connectable to each of the first and second opposing outer sides of the body to surround the patient's head and retain the body on the head, the retaining structure comprising:

A first component laterally along the retention structure at a location where the retention structure is attachable to the first side of the body and configured to receive a sensor mount such that the patient sensor contacts the patient's face when the patient breathing interface is in use .

The patient respiratory interface further includes a second member laterally along the retention structure at a location where the retention structure is connectable to the second side of the body and configured to receive the sensor mount such that when the patient respiratory interface is in use, the patient The sensor touches the patient's face.

The patient sensor contacts the first side of the patient's face when the sensor mount is received by the first component and the patient respiratory interface is in use.

When the sensor mount is received by the second component and the patient breathing interface is in use, the patient sensor contacts a second side of the patient's face, ie, the side opposite the first side.

The first part has a sensor cavity into which the sensor mount can be inserted and held.

The first component has a sensor recess extending through the first component from its non-patient-facing side to the patient-facing side, and the sensor mount is insertable and retainable within the sensor recess.

The first component is the first side arm.

The first part is or includes a strip connector for the strap of the holding structure.

The first component is or includes a connection between the strap of the retaining structure and the side arm of the patient breathing interface.

The patient sensor is partially overmolded from the first component.

The second component has a sensor recess extending through the second component from its non-patient-facing side to the patient-facing side, and the sensor mount is insertable and retained within the sensor recess.

The second component is the second side arm.

The second component is or includes a strip connector for the strap of the holding structure.

The second component is or includes a connection between the strap of the retaining structure and the side arm of the patient breathing interface.

The patient sensor is a first patient sensor and the patient breathing apparatus further includes a second patient sensor, and the second patient sensor is partially overmolded from the first component.

When inserted and retained within the sensor cavity of the first component and the patient breathing interface is in use, the patient sensor contacts the first side of the patient's face, and when inserted and retained within the sensor cavity of the second component, the patient sensor contacts the patient the second side of the face.

When inserted and retained within the sensor recess of the first component and the patient breathing interface is in use, the patient sensor contacts the first side of the patient's face, and when inserted and retained within the sensor recess of the second component, the patient sensor contacts the patient the second side of the face.

An accessory for a patient respiratory interface, the accessory including a sensor cavity and configured to retain a sensor in the sensor cavity to measure a patient parameter, wherein the accessory is interconnectable with one or more components of the patient respiratory interface and is A patient sensor is configured to be presented at the patient's facial surface when interconnected with the patient's respiratory system and a patient respiratory interface worn by the patient.

The accessory is configured to interconnect with a component of the patient respiratory interface.

The accessory is configured to interconnect with a side arm of the patient respiratory interface, more particularly a sensor recess of the side arm of the patient respiratory interface.

The accessory can replace the first part of the patient breathing interface.

The first component of the patient breathing interface is the side arm of the patient breathing interface.

The first component of the patient breathing interface is the connector that connects the other two components of the patient breathing interface together.

The accessory is configured to be interconnected between the second component and the third component of the patient respiratory interface.

The second component is the body of the patient breathing interface, and the third component is the headgear connection of the patient breathing interface.

The second component is the side arm of the patient breathing interface, and the third component is the headgear strap of the patient breathing interface.

The patient breathing interface is a nasal cannula interface.

Description of drawings

These and other features, aspects and advantages of the present disclosure are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate certain embodiments rather than limit the present disclosure.

Figure 1 schematically illustrates a respiratory apparatus configured to provide respiratory therapy to a patient.

FIG. 2 shows a schematic diagram of a closed loop control system for use with the respiratory apparatus of FIG. 1 .

3 illustrates a nasal cannula interface in use with a patient according to an aspect of the present disclosure.

4 illustrates a partial front view of a nasal cannula interface according to an aspect of the present disclosure.

FIG. 5 shows an exploded view of the nasal cannula interface of FIG. 4 .

6A illustrates a front view of a body of a nasal cannula interface according to an aspect of the present disclosure.

Figure 6B shows a patient breathing interface having a nasal interface, or more specifically a nasal cannula interface, with an asymmetrical delivery element.

7A and 7B show a perspective view and a perspective exploded view, respectively, of another nasal cannula interface according to the present disclosure, while FIG. 7C shows a perspective view of a nasal cannula interface headgear.

7D-7F show enlarged perspective views of a headgear connection connected to a nasal cannula interface according to the present disclosure.

Figures 7G and 7H show cross-sectional views corresponding to Figures 7D and 7E, respectively.

8A and 8B show enlarged perspective views of the connection between the nasal cannula interface and the headgear, showing the nasal cannula interface in the form of a side arm of the headgear.

9A-9C illustrate enlarged perspective views of a retaining clip of a nasal cannula interface according to the present disclosure.

10A-11B show views of a sensorless accessory for use with a nasal cannula interface.

12A-13D show views of an accessory with a sensor for use with a nasal cannula interface.

14A and 14B show views of a sensorless accessory for use with a nasal cannula interface.

15A and 15B show views of a sensorless accessory for use with a nasal cannula interface.

15C and 15D show views of an accessory with a sensor for use with a nasal cannula interface.

15E and 15F show views of an accessory coupled to a nasal cannula interface.

16A and 16E show views of a sensorless accessory for use with a nasal cannula interface.

17A and 17B show views of a sensorless accessory for use with a nasal cannula interface.

Figure 17C shows a cross-section of the attachment of Figures 17A and 17B.

18A-18C show views of an accessory with a sensor for use with a nasal cannula interface.

19A is a patient respiratory interface including components to hold a sensor.

Fig. 19B is a different perspective view of part A of Fig. 19A.

Figure 19C is a perspective view taken from the opposite side of the components shown in Figure 19B.

20 is a view of components of a patient respiratory interface that may hold a sensor.

Fig. 21 is a view of the component of Fig. 20, by which the sensor is held.

22 is an enlarged view of components of or for a patient breathing interface.

Fig. 23 is a perspective view of a connector.

24 is a cross-sectional view of the connector of FIG. 23 prior to engagement of the clamp with the jaws.

Figure 25 is a cross-sectional view of the connector of Figure 23 showing the initial stages of clamp and jaw engagement.

26 is a cross-sectional view of the connector of FIG. 23 showing the slider in a fixed position.

Figure 27 is a cross-sectional view of the connector of Figure 23, showing the slider in a free position.

28 is a cross-sectional view of the connector of FIG. 23 showing the clip removed from the carrier.

29 is a cross-sectional view of one half of the slider of the connector of FIG. 23 .

30 is a cross-sectional view of the other half of the slider of the connector of FIG. 23 .

FIG. 31 is a perspective view of the carrier of the connector of FIG. 23 .

FIG. 32 is a perspective view of the clamp of the connector of FIG. 23 .

Figure 33 is a perspective view of a catheter and wire clamp.

FIG. 34 is an end view of the catheter and wire clamp of FIG. 33. FIG.

35 is a view of a portion of a catheter and wire attached together using a catheter and wire clamp.

36A is a view of another nasal cannula interface including components configured to hold patient sensors.

36B is a view of the components of FIG. 36A configured to hold a sensor.

37 is a view of the nasal cannula interface of FIG. 36A configured such that a catheter can be attached to either side of the body of the interface.

38A is a view of another nasal cannula interface including features capable of holding patient sensors.

38B is a view of the components of FIG. 38A configured to hold a sensor.

Figure 39 is a headgear strap and connectors for a patient breathing interface, where one of the connectors is a component capable of holding a patient sensor.

Fig. 40 is a partial and partially exploded view of a nasal cannula interface with components capable of holding patient sensors provided as an intermediate connection between the side arms of the nasal cannula interface and the headgear attachment.

41 is a view of a communication module of a component configured to hold patient sensors according to the present disclosure.

42 is a cross-sectional view of a component configured to hold a patient sensor.

43 is a partial and partially exploded view of a nasal cannula interface with components configured to hold patient sensors.

44A-44C are top, front and bottom views, respectively, of a nasal cannula interface with asymmetric nasal prongs.

Detailed ways

Certain embodiments and examples of respiratory apparatus for providing respiratory support to a patient and patient interfaces for such systems are described herein. Those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Therefore, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments described herein.

Patients with various health conditions and diseases 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, etc. , patients receiving preoperative and postoperative oxygen delivery, and patients with other conditions or diseases can benefit from respiratory support. As part of providing respiratory support to a patient, patient sensors may be used to measure one or more physiological parameters of the patient to enable monitoring of the patient's health. The patient sensor may be a pulse oximeter, which provides information related to heart rate and blood oxygen saturation (SpO2).

When providing patients with respiratory support, especially supplemental oxygen therapy, a common method of monitoring the health of patients is to ensure that their Sp02 does not drop too low (eg, typically below about 90%). However, supplying a patient with too much oxygen can hyperoxygenate their blood and is also considered dangerous. Generally, a patient's SpO2 is maintained in the range of about 80% to about 99%, preferably about 92% to about 96%, although these ranges may vary due to patient condition and/or between patients.

Due to various patient factors such as respiratory rate, lung tidal volume, heart rate, activity level, height, weight, age, sex, and other factors, there is no single prescribed level of supplemental oxygen that can consistently achieve an SpO2 response within the target range for each patient. Individual patients periodically need to monitor and adjust the fraction of oxygen (FdO2) delivered to the patient to ensure they are receiving the correct FdO2 to achieve the target SpO2. Achieving correct and consistent SpO2 is an important factor in treating patients with various health conditions or diseases. Additionally, patients with these health issues could benefit from a system that automatically controls oxygen saturation. The present disclosure is applicable to a wide variety of patients requiring rapid and accurate oxygen saturation control.

The fraction of oxygen delivered to the patient (FdO2) can be manually controlled. For example, a user may manually adjust an oxygen supply valve to vary the flow or fraction of oxygen delivered to a patient. A user may use a patient monitor, such as a pulse oximeter, to determine the patient's Sp02 level. The SpO2 measurement can be displayed on the respiratory 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 a defined level. The process of monitoring SpO2 levels and adjusting the amount of oxygen delivered accordingly can be done in different settings. Examples: Hospitals, palliative care, hospice, or home settings (such as a patient's home).

A patient interface for a respiratory device (referred to elsewhere as a "patient respiratory interface") may have a body sized and shaped to provide respiratory support through a patient's airway. Patient interfaces are available in a variety of styles, including full face masks, nasal masks, direct nasal masks, and face masks that form a substantially airtight seal with the nose and/or mouth. The patient interface may be an indirect interface covering the nose, mouth, or both, or an indirect interface such as an interface including nasal nozzles or nasal pillows or the like that enter the wearer's nostrils. For example, the patient interface may have a body in the form of a nasal cannula.

A patient respiratory interface that includes or is used with an accessory or component as described herein may include a nasal interface, which may be used to deliver a high flow of gas to a patient. A nasal delivery element, such as a nasal prong, which may optionally include nasal pillows, is inserted into the patient's nose to deliver the desired therapy. The nasal delivery element may desirably seal or be partially blocked at the nose, or may not need to seal at the nose, to deliver therapy.

Nasal prongs typically refer to nasal delivery elements designed to leak or only partially block at the nose. When one or more nasal prongs include nasal pillows, the nasal delivery element is designed to seal at the nose. Nasal high flow (NHF) therapy is typically a non-sealed therapy that delivers a relatively high volume of flow to a patient through a patient interface, such as a nasal interface. A nasal interface as described herein may refer to, but is not limited to, a nasal cannula.

An asymmetrical interface or asymmetrical nasal delivery element as described herein refers to an interface in which the nasal delivery element differs in size (eg, inner and/or outer transverse dimension or diameter and/or inner and/or outer cross-sectional area). The external cross-sectional area is the cross-sectional area bounded by the outer walls of the nasal delivery element. For non-circular cross-sections, diameters mentioned herein may be interpreted as transverse dimensions. In some configurations, diameters referred to herein include, but are not limited to, hydraulic diameters.

The asymmetric interface allows asymmetrical flow to be delivered to either or both nostrils through the interface. Asymmetric flow as described herein refers to flow that is different in the interface, or in the nose, or different in the interface and in the nose. In this way, each nasal delivery element may deliver a different flow rate, or the flow rate may differ between inhalation and exhalation, or the delivered flow rate may be a combination of the above. Asymmetric traffic can also include partially unidirectional traffic.

Delivery of asymmetric flow can improve clearance of dead space in the upper airway, reduce peak expiratory pressure, improve safety of therapy especially in children and infants, and reduce flow resistance in interfaces. Asymmetric nasal interfaces and/or nasal delivery elements as described herein include patient interfaces configured to generate such asymmetric flow through the asymmetric nasal delivery elements.

The pressure generated by the NHF depends on the flow through the nasal interface, the size of the nasal delivery element and/or the patient's nostrils, and the breathing cycle. If the flow, leakage, or combination of flow and leakage through the nasal interface is asymmetric during breathing, the flow through the nose may be asymmetric. Partial unidirectional traffic and total unidirectional traffic may be of the type of asymmetrical traffic. Partial unidirectional flow or total unidirectional flow may provide improved clearance of anatomical dead space as air continues to flush from the upper airway. Partial one-way flow can be more comfortable than total one-way flow. Total unidirectional flow as described herein includes flow entering one nostril through the nasal delivery element and exiting the other nostril via the nasal delivery element, flow exiting to atmosphere due to the absence of the nasal delivery element, and so on. Partial unidirectional flow as described herein includes flow that can enter the nose via both nostrils and exit the nose from one nostril, flow that can enter the nose through one nostril and exit the nose via both nostrils, or flow that can enter through both nostrils. Different proportions of flow in the nose and different proportions of flow that can exit the nose through the two nostrils and can be flow that can enter the nose via both nostrils and exit the nose from one or both nostrils and optionally exit via the mouth.

NHF delivered through an asymmetrical nasal interface may involve making an interface with nasal delivery elements of different sizes, eg, different lengths, and/or inner diameters or cross-sectional areas and/or outer diameters or cross-sectional areas. Especially for children or infants, the nasal delivery element has a small inner diameter and thus a high resistance to gas flow. By using nasal delivery elements of different lengths, each nasal delivery element can have a different inner diameter (eg, smallest inner diameter or area). Longer nasal delivery elements can have smaller inner diameters and higher resistance to gas flow; shorter nasal delivery elements can have larger inner diameters (e.g., larger minimum inner diameters), so gas at the interface Less resistance to flow. The reduced resistance to flow allows the use of lower back pressure, or lower motor speed of the gas generating device, or a combination of both, to achieve the desired flow.

Asymmetrical nasal delivery elements may reduce peak expiratory pressure due to different cross-sectional areas of the nasal delivery elements at the nose, which may provide different inner diameters for each nasal delivery element.

Exhalation with an asymmetrical nasal port can be at a higher pressure than with a symmetrical port, which is beneficial because a higher positive end-expiratory pressure (PEEP) is part of COPD treatment (here pressure refers to intrathoracic pressure). The exhalation pressure depends on the combined cross-sectional area of the two nasal prongs. Increasing the cross-section of the symmetrical nasal prongs carries the risk of complete obstruction of the patient's nares. The use of asymmetric nose prongs allows increasing the overall cross-sectional area without the risk of blockage. Partial unidirectional flow reduces turbulence in the patient's nasal cavity, which improves comfort.

The patient interface may include headgear (or "head fixation assembly") to hold the patient interface on the patient's face. The headgear or head restraint assembly may include one or more straps.

In some arrangements, the patient interface may include one or more components interconnected between the body of the patient interface and the headgear. For example, one or more arms and/or one or more buckles or connectors may connect the body of the patient interface and the headgear together.

When a patient sensor is used as part of a respiratory device, the user needs to attach the patient sensor to the patient. This adds another task for the user to the already potentially large set of tasks required to set up the respiratory device. Additionally, individual patient sensors may cause problems such as improper sensor installation, resulting in incorrect measurements and/or sensor detachment during use.

The user of the device may be eg a nurse, a doctor, any other clinician or the patient himself.

In this way, a patient interface incorporating a patient sensor allows the patient sensor to be used without increasing the user's workload. In particular, the patient interface can simplify or eliminate the task of installing sensors. This can be beneficial in a hospital setting where a single clinician may have a large group of patients that the clinician needs to deal with. Additionally, this may be beneficial in a home setting as it simplifies the setup process for patients who may need to perform these tasks themselves. Additionally, integrating the patient sensor into the patient interface helps ensure proper orientation of the patient sensor and prevents the patient sensor from falling out during use.

In some cases, for example, when a patient changes to a new therapy and/or requires different respiratory support, it may be necessary to add patient sensors to the system, and a new patient interface capable of accommodating the sensors may be required.

Patient sensors can be used with the patient interface through accessories. The accessory is configured to hold patient sensors for measuring at least one patient parameter. The accessory is configured to attach to the patient interface.

For example, such an accessory may be configured to attach to a strap or arm of a patient interface to position the sensor on the patient's face. The accessory also properly positions the patient sensor relative to the patient's face and patient interface to ensure repeatable sensor output.

The use of accessories also allows patient sensors to be removed by removing only the accessories without replacing the entire patient interface when the patient changes to a different respiratory support (eg, when the patient steps down) and/or changes to a different therapy.

The accessory may be provided separately with the patient interface or provided as part of a kit including the patient interface.

In some configurations, accessories may be attached to headgear portions, such as straps of a different device than the patient interface the patient is using.

An accessory may be described as a component of a patient interface, especially where the accessory may replace a regular component of the patient interface. In such configurations, the accessory may be referred to simply as a component of or for a patient interface.

For example, where the accessory includes buckle and/or connector features, the accessory may be replaced as part of the patient interface between two other parts of the patient interface (such as between the body of the headgear and the connector) conventional buckles or connectors. As another example, an accessory may be used as a component of a patient interface, more particularly as a side arm of a patient interface, as subsequently described with respect to FIGS. 7A-9C . The attachment of Figures 7A-9C can replace the conventional side arms of the patient interface.

An accessory that can replace another component of the patient interface may be provided in place of the component when the patient interface is supplied to the patient. In other arrangements, an accessory that can replace another component of the patient interface may be provided in a kit including the patient interface, so that the user may substitute the accessory into the patient interface. In yet other arrangements, the patient interface may be provided separately with an accessory that may replace another component of the patient interface.

Where an accessory can replace regular components of the patient interface, the component defined by the accessory can be interconnected with one or more other components of the patient interface.

This disclosure refers to duct heaters, which is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (ie, it is not limited to a specific or custom meaning) and includes, but does not Limited to one or more heating strips, one or more heating wires, and/or one or more conductive elements that generate heat when supplied with electrical power. Examples of such catheter heaters include wires made of conductive metals (eg, copper), conductive polymers, conductive inks printed on the surface of the catheter, conductive materials used to make traces on the catheter, and the like.

Additionally, this disclosure refers to catheters, branches and medical catheters in the context of gas delivery. For example, conduit is a broad term and will be given its plain and customary meaning to those of ordinary skill in the art, and includes, but is not limited to, channels of various cross-sections, such as cylindrical channels and non-cylindrical channels.

The disclosed systems, devices, and medical catheters can also be used 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) in the breathing circuit. A breathing circuit may, for example, include an inspiratory circuit comprising, at a minimum, an inspiratory gas pathway (including all components) from a gas supply source to a patient interface.

A schematic representation of an example respiratory apparatus 10 is provided in FIG. 1 .

Respiratory apparatus 10 includes a flow source 49 for providing a high flow gas 27, such as air, oxygen, air blended with oxygen, or a mixture of air and/or oxygen with one or more other gases. Alternatively, the breathing apparatus may have connections for coupling to a flow source. Thus, a stream source may be considered to form part of a device or be separate from the device (depending on the context), or even a part of the stream source forms part of the device and a part of the stream source does not belong to the device. In short, depending on the configuration (some components may be optional), the system may include a combination of components selected from:

· stream source,

Humidifiers for humidifying gas streams,

Catheters (for example, dry lines or heated breathing tubes),

Patient interface,

· Check valve,

·filter.

The conduits may include the inspiratory conduit 16 , the expiratory conduit, or the intake conduit 62 .

Describe the device in more detail.

The flow source may be an in-wall oxygen source, an oxygen tank 49A, another gas tank, and/or a high flow device with a flow generator 49B. Figure 1 shows a flow source 49 having a flow generator 49B with an optional air inlet 49C and connection to an oxygen (O2) source via a shutoff valve and/or regulator and/or other gas flow control 49D (Like a tank or O2 generator) Optional connection for 49A, but that's just an option. Flow generator 49B may use one or more valves to control the flow delivered to patient 56, or alternatively, flow generator 49B may include a blower. The flow source may be one or a combination of flow generator 49B, O2 source 49A, air source 49C as described. The flow source 49 is shown as part of the device 10, but in the case of an external oxygen tank or in-wall source it could be considered a separate component, in which case the device has a connection port to connect to such flow source. The flow source provides a (preferably high) flow rate of gas that can be delivered to the patient via the inspiratory conduit 16 and patient interface 17 .

Patient interface 17 may be an unsealed (unsealed) interface (e.g., when used for high flow therapy) (e.g., an unsealed nasal cannula), or a sealed (sealed) interface (e.g., when used for CPAP therapy) ) (for example, nasal mask, full face mask or nasal pillows). In some embodiments, patient interface 17 is a non-sealed patient interface, which will, for example, help prevent barotrauma (eg, tissue damage to the lungs or other organs of the patient's respiratory system due to a pressure differential relative to atmosphere). In some embodiments, patient interface 17 is a sealing cap that seals against the patient's nose and/or mouth. The patient interface may be a nasal cannula, and/or a face mask, and/or a nasal pillow mask, and/or a nasal mask, and/or a tracheostomy interface, or Any other suitable type of patient interface. The flow source may provide a base gas flow between, for example, 0.5 liters/minute to 375 liters/minute, or any range within that range, or even ranges with higher or lower limits. Details of the scope and nature of the traffic will be described later.

A humidifier 52 may optionally be positioned between the flow source 49 and the patient to provide humidification of the delivered gas. One or more sensors 48A, 48B, 48C, 48D (e.g., flow sensors, oxygen fraction sensors, pressure sensors, humidity sensors, temperature sensors, or other sensors) may be placed throughout the system and/or at or on the patient 56 or nearby. Alternatively or additionally, sensors can be used from which such parameters can be derived. Additionally or alternatively, sensors 48A-48D may be one or more physiological sensors for sensing physiological parameters of the patient, such as heart rate, oxygen saturation, partial pressure of oxygen in blood, respiration rate, CO2 partial pressure. Alternatively or additionally, sensors can be used from which such parameters can be derived. Other patient sensors may include electroencephalogram (EEG) sensors, torso straps for detecting respiration, and any other suitable sensors. In some configurations, a humidifier may be optional, or preferred due to the advantage of humidifying the gas to help maintain airway conditions. One or more of the sensors may form part of the device, or may be external to the device, with the device having inputs for any external sensors. The sensors may be coupled to or send their output to the controller 19 .

In some configurations, respiratory apparatus 10 may include patient sensor 29 for measuring the oxygen fraction in air inhaled by the patient. In some examples, a patient sensor 29 may be placed on the patient interface 17 to measure or otherwise determine the proximity of (at/near/near the patient's mouth and/or nose) the patient's mouth and/or nose. or nose) oxygen fraction. In some configurations, output from patient sensors 29 is sent to controller 19 to assist in the control of respiratory apparatus 10 and/or alter operation accordingly. Controller 19 is coupled to flow source 49 , humidifier 52 and patient sensor 29 . In some configurations, controller 19 controls these and other aspects of respiratory apparatus 10 as described herein. In some examples, the controller may operate the flow source 49 to provide the delivered gas flow at a desired flow rate high enough to meet or exceed the inspiratory demand of the user (ie, the patient). The flow provided is sufficient so that ambient gas is not entrained as the user (ie, patient) inhales. In some configurations, patient sensors 29 may communicate measurements of the oxygen fraction at the patient's mouth and/or nose to a user, who may input the information into respiratory device 10/controller 19 .

An optional check valve 23 may be provided in the suction conduit 16 . One or more filters may be provided at the one and/or more air inlets 49C of the flow generator 49B to condition the incoming gas before it is pressurized into the high flow gas 27 to the flow generator 49B. filter.

Respiratory apparatus 10 may be unitary or a separate component based arrangement shown generally in dashed box 104 in FIG. 1 . In some configurations, the device may be an arrangement of modular components. Additionally, the device may include only some of the components shown; not all are necessarily required. Also, the catheter and patient interface need not be part of the device and can be considered separate. In the following, the catheter and patient interface will be referred to as respiratory equipment, but this should not be considered limiting. "Respiratory equipment" will be taken broadly herein to include anything that provides a flow of gas to a patient. Some such devices include a detection system that can be used to determine whether the flow of gas meets the inspiratory demand.

Respiratory apparatus 10 may include a main device housing that houses the components shown within dashed box 104 . The main device housing may contain a flow generator 49B, which may be in the form of a motor/impeller arrangement, an optional humidifier or humidification chamber 52 , a controller 19 , and an input/output (I/O) user interface 54 . The user interface 54 may include a display and an input device such as buttons, a touch screen (eg, an LCD screen), a combination of a touch screen and buttons, or the like. Controller 19 may include one or more hardware and/or software processors and may be configured or programmed to control components of the system, including but not limited to: operating flow generator 49B to generate a flow of gas for delivery to the patient; operating humidification Humidifier or humidification chamber 52 (if present) humidifies and/or heats the gas stream; receives user input from user interface 54 for reconfiguring and/or user-defined operations on respiratory device 10; and outputs information to the user (for example, on a monitor). Users can be patients, healthcare professionals, or others.

With continued reference to FIG. 1 , the inspiratory conduit 16 may be coupled to a gas outflow port (gas outlet or patient outlet port) 21 in the main device housing, which houses the external ports of the respiratory assistance apparatus 10 , and to the patient interface 17 . Components shown within dashed box 104, the patient interface is eg a non-sealed interface like a nasal cannula with manifold and nasal prongs. The suction catheter 16 may also be a tracheostomy port, or other non-sealed port.

A flow of gas may be generated by flow generator 49B and may be humidified and then delivered to the patient via patient interface 17 via inspiratory catheter 16 . Controller 19 may control flow generator 49B to generate a desired flow of gas flow, and/or control one or more valves to control the mixing of air and oxygen or other breathable gas. Controller 19 may control heating elements in or associated with humidification chamber 52 (if present) to heat the gas to a desired temperature that achieves the desired temperature for delivery to the patient and/or humidity level. The inspiratory conduit 16 may have a heating element, such as a heating wire, to heat the flow of gas to the patient. The heating elements can also be controlled by the controller 19 .

The humidifier 52 of the device is configured to combine with or introduce humidity into the gas flow. Various humidifier 52 configurations may be employed. In one configuration, humidifier 52 may include a removable humidification chamber. For example, the humidification chamber may be partially or completely removed or disconnected from the flow path and/or device. For example, the humidification chamber can be removed for refilling, cleaning, replacement and/or repair, for example. In one configuration, the humidification chamber may be received and held by or within a humidification compartment or bay of the device, or may be otherwise coupled to the housing of the device. on the body or in the shell.

The humidification chamber of humidifier 52 may include a gas inlet and a gas outlet to enable connection into the gas flow path of the device. For example, the gas flow from the flow generator 49B after being heated and/or humidified is received into the humidification chamber via its gas inlet and flows out of the chamber via its gas outlet.

The humidification chamber contains a volume of liquid, typically water or the like. In operation, liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber to generate water vapor or steam, thereby increasing the humidity of the gas flowing through the chamber.

In one configuration, the humidifier is a pass-over humidifier. In another configuration, the humidifier can be a non-passover humidifier.

In one configuration, the humidifier may include a heating plate, for example associated with or within the humidification compartment on which the chamber is seated, for heating. The chamber may be provided with a heat transfer surface (eg, a metal insert, plate or the like) in the bottom surface or other surface of the chamber that interfaces or engages with the heater plate of the humidifier.

In another configuration, the humidification chamber may include one or more internal heaters or heater elements within or within the chamber. The one or more internal heaters or heater elements may be integrally mounted or provided inside the chamber, or may be removable from the chamber.

The humidification chamber can be of any suitable shape and/or size. The location, number, size and/or shape of the gas inlets and gas outlets of the chamber can be varied as desired. In one configuration, the humidification chamber may have a bottom surface, one or more side walls extending upwardly from the bottom surface, and an upper or top surface. In one configuration, the gas inlet and gas outlet can be positioned on the same side of the chamber. In another configuration, the gas inlet and gas outlet may be on different surfaces of the chamber, such as on opposite sides or locations, or at other different locations.

In some configurations, the gas inlet and gas outlet may have parallel flow axes. In some configurations, the gas inlet and gas outlet can be positioned at the same height on the chamber.

Respiratory apparatus 10 may use ultrasonic transducer(s), flow sensor(s) (e.g., a thermistor flow sensor), pressure sensor(s), temperature sensor(s), in communication with controller 19, Humidity sensor(s), or other sensors, to monitor gas flow characteristics and/or operate respiratory apparatus 10 in a manner to provide appropriate therapy. Gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or other characteristics. Sensors 48A, 48B, 48C, 48D, 29 (such as pressure sensors, temperature sensors, humidity sensors, and/or flow sensors) may be placed at various locations in the main device housing, inspiratory conduit 16, and/or patient interface 17, the main device The device housing also houses the components shown in dashed box 104 . Controller 19 may receive output from the sensors to assist it in operating respiratory apparatus 10 in a manner to provide appropriate therapy in order to determine an appropriate target temperature, flow and/or pressure of the gas flow. Providing appropriate therapy may include meeting or exceeding the patient's inspiratory needs. In the illustrated embodiment, sensors 48A, 48B, and 48C are located in the housing of the device, sensor 48D is located in inspiratory conduit 16 , and patient sensor 29 is located in patient interface 17 .

Respiratory device 10 may include one or more communication modules to enable data communication or connection with one or more external devices or servers via a data or communication link or data network (whether wired, wireless, or a combination thereof). For example, in one configuration, the respiratory device 10 may include a wireless data transmitter and/or receiver, or transceiver 15, so that the controller 19 can wirelessly receive data signals from operational sensors and/or control the movement of the respiratory device 10. various parts. The transceiver 15 or data transmitter and/or receiver module may have an antenna 15a as shown. In one example, transceiver 15 may include a Wi-Fi modem. Additionally or alternatively, the data transmitter and/or receiver 15 may transmit data to a remote patient management system (ie, a remote server) or enable remote control of the respiratory device 10 . Respiratory device 10 may include wired connections (eg, using cables or wires) to enable controller 19 to receive data signals from operational sensors and/or to control various components of device 10 . Respiratory device 10 may include one or more wireless communication modules. For example, a device may include a cellular communication module, such as a 3G, 4G or 5G module. Module 15 may be or may include a modem that enables the device to communicate with a patient remote management system (not shown) using a suitable communication network. The remote management system may include a single server or multiple servers or multiple computing devices implemented in a cloud computing network. Communication can be two-way between the respiratory device and a patient management system (eg, server) or other remote system. The respiratory device 10 may also include other wireless communication modules, such as a Bluetooth module and/or a Wi-Fi module. Bluetooth and/or Wi-Fi modules allow the device to send information wirelessly to another device (eg, smartphone or tablet), or to operate over a LAN (Local Area Network) or Wireless LAN (WLAN). The device may additionally or alternatively include a near field communication (NFC) module to allow data transfer and/or data communication.

For example, measured patient breathing parameter data (eg, inspiration, expiration, and/or total breath time ratio) may be transmitted to a remote patient management system (ie, a remote server). The patient remote management system may be a single server or a network of servers or a cloud computing system or other suitable architecture for operating the patient remote management system. The patient remote management system (ie, remote server) further includes a memory for storing received data and various software applications or services executed to perform various functions. A patient remote management system (ie, a remote server), for example, may then communicate information or instructions to respiratory device 10 based at least in part on the received data. For example, the nature of the data received may trigger the remote server (or a software application running on the remote server) to transmit an alert, alarm, or notification to respiratory device 10 . The patient remote management system may further store the received data for access by an authorized party, such as a clinician or patient or another authorized party. The patient remote management system may be further configured to generate a report in response to a request from an authorized party, and breathing parameter data (eg, inspiration, expiration, and/or total breathing time ratio) may be included in the generated report. The report may further include other patient breathing parameters (eg, breathing rate or Sp02) and/or device parameters (eg, flow, humidity level).

Respiratory device 10 may comprise a high flow therapy device. High-flow therapy as discussed herein is intended to be given its typical ordinary meaning as understood by those skilled in the art, which generally refers to respiratory equipment that, via an intentionally unsealed patient interface, is generally designed to meet or exceed user The flow of peak inspiratory flow (also known as inspiratory demand) delivers a target flow of humidified breathing gas. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range, but are not limited to, from about 15 liters/minute to about 60 liters/minute or more. Typical flow rates for pediatric patients (eg, neonates, infants, and children) often range from, but are not limited to, about one liter per minute per kilogram of user body weight to about three liters per minute per kilogram of user body weight or greater.

High flow therapy may also optionally include gas mixture compositions including supplemental oxygen and/or administering therapeutic drugs.

High-flow therapy is often referred to as high-flow nasal flow (NHF), humidified high-flow nasal cannula (HHFNC), high-flow nasal oxygen therapy (HFNO), high-flow therapy (HFT), or high-tracheal flow (THF), among other common names . For example, in some configurations, for an adult patient, "high flow therapy" may refer to delivering gas to the patient at a 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 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 49 LPM and about 60 LPM. In some configurations, for a neonatal, infant, or pediatric patient, "high flow therapy" may refer to delivering gas to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about Between 25LPM, or between about 2LPM and about 5LPM, or between about 5LPM and about 25LPM, or between about 5LPM and about 10LPM, or between about 10LPM and about 25LPM, or between about 10LPM and about Between 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. High flow therapy devices for adult, neonatal, infant or pediatric patients may deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at a flow rate in any of the subranges outlined above.

A high flow mass can be effective in meeting or exceeding a patient's inspiratory demand, increasing the patient's oxygenation, and/or reducing his work of breathing. Additionally, high flow therapy can produce an irrigation effect in the nasopharynx such that the anatomically dead space of the upper airway is flushed by the incoming high gas flow. The flushing effect may create a reservoir of fresh gas available for each breath, while minimizing rebreathing of carbon dioxide, nitrogen, etc. High flow therapy can also increase the patient's exhalation time due to pressure during exhalation. This in turn reduces the patient's breathing rate.

Patient interfaces for high flow therapy may be non-sealed to prevent barotrauma (which may include tissue damage to the lungs or other organs of the patient's respiratory system due to pressure differentials relative to atmosphere). The patient interface may be a nasal cannula with a gas flow portion (eg, manifold) and nasal prongs, and/or an unsealed tracheostomy interface, or any other suitable type of patient interface.

Respiratory apparatus 10 may measure and control the oxygen content of gas delivered to the patient, and thus measure and control the oxygen content of gas inhaled by the patient. The oxygen concentration measured in the respiratory apparatus 10 may be equivalent to the fraction of oxygen delivered (FdO2) and may be substantially the same as the fraction of oxygen breathed by the patient, the fraction of inspired oxygen (FiO2), and as such these terms may be considered equivalent.

Sensor 29 is a patient sensor. When the patient sensor 29 is disconnected during operation (either from the patient or from the respiratory device), the respiratory device 10 may continue to operate in its previous operating state for a predefined time. After a predefined time, respiratory device 10 may trigger an alarm, transition from automatic mode to manual mode, and/or exit a control mode entirely (eg, automatic or manual).

Respiratory apparatus 10 may be configured to identify whether patient sensor 29 is a stand-alone patient sensor or a patient sensor located on or included by patient interface 17 . Respiratory device 10 may identify the sensor type by receiving identification information upon initial connection of patient sensor 29 . Respiratory device 10 may identify the sensor type by receiving signals from patient sensors 29 . For example, integrated patient sensor 29 may be configured to communicate with respiratory device 10 via an electrical connection at the gas outlet of respiratory device 10 (as will be described herein), while a separate patient sensor may be configured to communicate with respiratory device 10 via a separate The connection port is connected to a breathing device.

Patient sensors 29 may include other associated processors or circuits. Alternatively, the associated processor and/or circuitry may be located at another location.

Patient sensor 29 may include a housing. The housing may include the sensor transducer and any associated processor and/or circuitry.

The patient sensor 29 may be a skin contact sensor that contacts the skin when in the operative position in the sensor cavity.

As noted above, patient sensor 29 may be a pulse oximeter sensor configured to measure heart rate and/or blood oxygen saturation (SpO2). A pulse oximeter sensor can be provided as part of a pulse oximeter to measure heart rate and/or oxygen saturation. A pulse oximeter may include a pulse oximeter sensor and a processor and/or circuitry to control the pulse oximeter sensor by operating the pulse oximeter sensor and receiving sensor information therefrom. The processor and/or circuitry may be integrated with the pulse oximeter sensor or may be separate therefrom. The processor and/or circuitry may additionally process signals received from the pulse oximeter sensor and may communicate the processed signals or other resulting information to another device.

The connection between the pulse oximeter sensor and other processors and/or circuits of the pulse oximeter may be wired and/or wireless, for example in the manner described elsewhere herein with regard to potential configurations of the communication module of respiratory device 10 same. Where the pulse oximeter sensor is wirelessly connected to other processors and/or circuitry of the pulse oximeter, the pulse oximeter sensor may be powered by a wired connection or may be powered by a power source (such as a battery) integrated with the pulse oximeter sensor. )powered by. In at least some configurations in which the pulse oximeter sensor is wirelessly connected to other processors and/or circuitry of the pulse oximeter, battery power may be provided along with the pulse oximeter sensor. The battery power source may be user rechargeable.

The pulse oximeter sensor may be a reflective pulse oximeter sensor.

Respiratory apparatus 10 may be configured to use the output of patient sensor 29 located on or included by patient interface 17 to determine whether patient interface 17 is being worn by the patient. In this context, "worn" means that patient interface 17 is mounted on the patient's face in a location such that patient interface 17 can deliver gas flow to the patient and patient sensor 29 can measure one or more patient parameters. When the patient sensor 29 is unable to reliably measure the one or more patient parameters, the patient sensor may generate a signal indicative of such a condition. Additionally or alternatively, patient sensor 29 can transmit individual parameters, such as signal quality. Respiratory device 10 may check this parameter against a threshold to determine whether patient sensor 29 is able to reliably measure the one or more patient parameters. Respiratory apparatus 10 may use the determination that patient sensor 29 cannot reliably measure the one or more patient parameters to further determine that patient interface 17 is not being worn by the patient.

Respiratory device 10 may use the determination of whether the patient is wearing patient interface 17 to enable or disable certain control algorithms, such as a closed-loop Sp02 controller, as will be described in detail later in this specification. Respiratory device 10 may use this indication to increase or decrease flow. For example, respiratory device 10 may reduce flow to reduce noise and power consumption when the patient is not wearing patient interface 17 . Respiratory device 10 may use this indication to generate an alarm, such as when the patient has removed patient interface 17 . This alarm can occur immediately or within a set time after the output of the patient sensor 29 is lost.

In another configuration, respiratory apparatus 10 is configured to switch to a standby mode when the output of patient sensor 29 indicates that the patient is not wearing patient interface 17 . In the standby mode, respiratory apparatus 10 may be configured to control the blower to operate at a reduced motor speed. The reduced motor speed may be the lowest operating speed of the blower. The reduced motor speed may be between about 1000RPM - 2000RPM. In the standby mode, respiratory device 10 may be configured to control the blower to deliver a reduced flow. The reduced motor speed may be between about 1 LPM and 2 LPM.

The blower may be operated at a motor speed 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 between any of the foregoing values. The operation of the blower can mix the gas flow entering the blower through these inlet ports. Using a blower as a mixer can reduce the pressure drop that would occur in a breathing apparatus with a separate mixer, such as a static mixer including baffles, because mixing requires energy. Having a static mixer can also increase the volume of the gas flow path between the valve and the gas composition sensor, which can further increase the delay between when a change in valve flow occurs and when a corresponding change in oxygen concentration is measured.

Based on user input and therapy provided by respiratory device 10, controller 19 may determine target output parameters for the blower. A controller can receive the measured value of the target output parameter, and based on the difference between the determined flow and the measured flow, the controller can adjust the speed of the blower.

Referring again to FIG. 1 , the controller 19 may be programmed with or configured to implement a closed loop control system to control the operation of the breathing apparatus. The closed-loop control system can be configured to ensure that the patient's SpO2 reaches a target level and remains consistently at or near that level.

Controller 19 may receive input(s) from a user that may be used by controller 19 to implement a closed loop control system. The target SpO2 value can be a single value or a range of values. The value(s) may be preset, selected by the 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, gender, and other patient characteristics). The target SpO2 value may be entered by a clinician or user via a user interface on the device and received by controller 19 . Similarly, the target SpO2 can be two values, each selected in any of the ways described above. These two values will represent the range of acceptable values for the patient's Sp02. The controller can target a value within said range. The target value can be the middle value of the range, or any other value within the range, which can be preset or selected by the user. Alternatively, the range may be automatically set based on a target value for SpO2. The controller can be configured to have one or more set responses when the patient's SpO2 value moves out of range. Responses may include sounding an alarm, changing to manual control of FdO2, changing FdO2 to a specific value, and/or other responses. A controller can have one or more ranges, where when a value moves outside of each range, one or more different responses occur.

Generally, SpO2 is controlled between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99% , or between about 92% and about 96%. SpO2 may be controlled between any two suitable values from any two of the above ranges. The target SpO2 may be between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, Or between about 92% and about 96%, or about 94%, or 94%, or about 90%, or 90%, or about 85%, or 85%. The Sp02 target may be any value between any two suitable values from any two of the above ranges. For a defined range, the SpO2 target may correspond to a median SpO2.

FdO2 can be configured to be controlled within a certain range. As previously discussed, as long as the flow meets or exceeds the patient's peak inspiratory demand, the oxygen concentration measured in the device (FdO2) will be substantially the same as the patient's inhaled oxygen concentration (FiO2), and as such these terms can be viewed as for the 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 and/or other patient characteristics). Alternatively, a single value for FdO2 may be selected, and the range may be determined based at least in part on this value. For example, the range may be a set amount above and below a selected FdO2. The selected FdO2 can be used as a starting point for the controller. If the controller tries to move FdO2 out of range, the system can have one or more responses. These responses may include sounding an alarm, preventing the Fd02 from moving out of range, switching to manual control of the Fd02, and/or switching to a specific Fd02. Respiratory device 10 may have one or more ranges in which one or more different responses occur when the limit values of each range are reached.

Referring to FIG. 2 , a schematic diagram of a closed-loop control system is shown. A closed-loop control system may utilize two control loops. The first control loop can be implemented by a SpO2 controller. The SpO2 controller may determine the target FdO2 based in part 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 value(s) may be preset, selected by a clinician, or automatically determined based on patient characteristics. In general, the target SpO2 value is received or determined before or at the beginning of the treatment period, although the target SpO2 value can be received at any time during the treatment period. During a treatment session, the SpO2 controller may also receive as input the measured FdO2 reading from the gas composition sensor, and the measured SpO2 reading and the signal quality reading from the patient sensor 29 . In some configurations, the SpO2 controller may receive the target FdO2 as input, in which case the output of the SpO2 controller may be provided directly back to the SpO2 controller as input. Based at least in part on these inputs, the SpO2 controller can output the target FdO2 to a second control loop.

During a therapy session, the SpO2 controller and the FdO2 controller may continue to automatically control the operation of the breathing apparatus until the therapy session ends or an event triggers a change from automatic mode to manual mode.

Respiratory support systems are described, for example, in our earlier PCT Application Publication WO 2019/070136 (herein "WO '136"), filed October 5, 2018 and incorporated herein by reference in its entirety. The oxygen saturation (SpO2) measurement from the pulse oximeter is used to automatically adjust the oxygen fraction (FdO2) of the gas flow delivered to the patient via the patient interface.

The respiratory support system described in WO'136 uses a separate pulse oximeter sensor and patient interface. This requires the clinician to separately attach the pulse oximeter sensor and the patient interface to the patient, where these two components are also separately connected to the breathing apparatus.

Referring again to FIG. 1 , the controller 19 may be programmed with or configured to operate an FdO2 control system to control the operation of the breathing apparatus.

The FdO2 control system can be configured to ensure that instantaneous FdO2 is maintained at target levels at all points during treatment. The controller can measure the FdO2, compare it to a target FdO2, and then adjust 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 when the corresponding FdO2 change is measured. The controller can adjust the valve after a time delay. However, if the flow is fluctuating, the controller may be able to achieve the target FdO2 on an average but not on a continuous and substantially instantaneous basis. As shown in Figure 2, in order to maintain FdO2 at a target level on a continuous and substantially instantaneous basis without moving the FdO2 sensor closer to the valve, the FdO2 controller can take the measurement of total flow into account to control the valve.

A patient interface 17 is connected to one end of the inspiratory conduit 16 and is used to provide a flow of breathable gas to the patient. During setup of respiratory apparatus 10, a clinician or patient is required to attach patient interface 17 to the patient. Additionally, if a separate patient sensor 29 is also to be used, it would also require the clinician or patient to attach this to the patient. Then, both the patient interface 17 and the patient sensor 29 also need to be attached to the respiratory apparatus 10 itself. Forming these various connections may not be desirable.

Patient interface 17 has one or more patient sensors 29 . The one or more integrated patient sensors 29 may be configured to measure the patient's blood oxygen saturation (Sp02). The one or more integrated patient sensors 29 are positioned on the patient interface 17 to facilitate measurement of the patient's blood oxygen saturation (Sp02).

Patient interface 17 may be used with respiratory apparatus 10 described above. Alternatively, patient interface 17 may be used with any other respiratory device that may utilize patient interface 17 with patient sensor 29 , such as a ventilator, CPAP device, stand-alone humidifier, and/or oxygen blender.

Patient interface 17 may include a nasal cannula interface, as shown in FIGS. 3-7 . In this configuration, the nasal cannula interface broadly includes a head mount assembly (or headgear) and nasal cannula 30 , and also includes an air inlet conduit 62 . The head fixation assembly enables the user to place and maintain the nasal cannula 30 in the correct operating position. Inlet conduit 62 forms a fluid or gas connection between the outlet end of inspiratory conduit 16 and nasal cannula 30 to allow fluid or gas to flow between the inspiratory conduit and the nasal cannula. Details of the intake conduit 62, and the main portion of the nasal cannula 30 will now be described in detail.

The head fixation assembly of nasal cannula 30 may include one or more straps. The one or more straps may include two front straps 50, a rear strap 53a, and a top strap 53b, as shown in FIG. In some configurations, the proximal end of the front strap 50 is removably connected to the nasal cannula 30 . In other configurations, the proximal end of the front strap 50 is non-removably connected to the nasal cannula 30 . Rear strap 53a and top strap 53b extend between the distal ends of front strap 50 . In use, the posterior strap 53a encircles the back of the patient's head. In use, the crown strap 53b encircles the top of the patient's head. In some configurations, the head fixation assembly is adjustable to allow use of the nasal cannula 30 with patients of different head shapes and sizes. For example, an adjuster such as an adjustment buckle 54 may be included to allow the patient to loosen or tighten the top strap 53b.

In some configurations, one or more of the straps is substantially elastic (ie, made of an elastic material, such as Lycra, that stretches to fit the patient's head). In some configurations, one or more of the straps are substantially rigid. In some configurations, one or more of the straps is made of a substantially rigid material. In some configurations, one or more of the straps is substantially inextensible. In some configurations, one or more of the straps is made of a substantially inextensible material. In some configurations, one or more of the straps are self-supporting. In some configurations, one or more of the straps maintains its shape when not in use.

Alternatively, the patient interface 17 is secured to the patient's head and face by a plurality of front straps 50 and a single rear strap 53a attached to the front straps 50 . The rear strap is attached to the front strap 50 via a buckle 54 . Alternatively, the rear strap 53a is integral with the front strap 50 . The buckle 54 allows the patient to loosen or tighten the front strap 50 based on personal preference. Alternatively, the one-piece front and rear straps 50, 53a are elastic and can stretch over the patient's head. The elasticity of the strap applies force to the head to hold the nasal cannula 30 in an optimal position during use. The elastic front strap 50 , 53 a can be used with an adjustment buckle 54 , or the elastic front strap 50 , 53 a can be used alone without the buckle 54 .

The head fixation assembly may also include a ring 55 that holds and supports the intake conduit 62 at or near the inlet end, as shown in FIG. 3 . The loop 55 includes a first end connected to one of the front straps 50 . The first end may be slidably connected to the front strap 50 . Ring 55 includes a second end connected to intake conduit 62 . The second end may be removably connected to the intake conduit 62 . Alternatively, the interface may include a tube clamp that is connected to the tube and may be removably coupled to the cannula. The tube clamp supports the weight of the intake conduit 62 and reduces moments caused by the intake conduit 62 , thereby increasing the stability of the patient interface 17 . The clamp helps reduce disengagement of the patient interface 17 . The clamp can be made of rigid material.

Patient interface 17 may also be provided with a strap 63 . FIG. 3 shows an example of the lanyard 63 . In the configuration shown, the lanyard 63 is connected to the intake conduit 62 . Alternatively, the lanyard 63 is attached at a location at or near the connection between the suction duct 16 and the intake duct 62 . In use, the harness 63 supports the weight of the inspiratory conduit 16 and the intake conduit 62 . The lanyard 63 is provided with a clasp 64 to allow the length of the lanyard to be adjusted. The tether 64 allows the strap 63 to be adapted to use the patient interface 17 with any size patient. The strap 63 supports at least a portion of the weight of the inspiratory catheter 16 in use so that the weight does not rest on the patient or the nasal cannula 30 . Use of the lanyard 63 reduces the portion of the combined inspiratory conduit 16 and intake conduit 62 that pulls on the nasal cannula 30, thereby helping to prevent the nasal prongs 33, 34 from interfering with the sensitive lining of the nasal passage, or dislodging during use. bit or misplaced. In the configuration shown, the lanyard 63 fits loosely around the neck to reduce the chance of strangling the patient. The lanyard 63 also provides a convenient way of supporting the suction duct 16 and intake duct 62 . This allows the patient to turn over in bed without tugging or pulling on the inspiratory conduit 16 and helps avoid overheating of the intake conduit 62 under the felt. In one configuration, the strap 63 has a clip that allows the user to open and close the strap to place and secure the strap 63 around the patient's neck. The clamp includes male and female connectors that snap fit together. The clamp is disconnected by pulling one end of the lanyard 63 . The clamp is easy to break and uncoils when the user pulls on one side of the lanyard. This allows for quick removal of the lanyard 63 eg in an emergency situation such as when a patient requires intubation.

The intake duct 62 will now be described in detail. The intake conduit 62 is a short length 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, intake conduit 62 forms a lumen that defines a gas pathway between inspiratory conduit 16 and patient interface 17 such that gas flow exits inspiratory conduit 16 and enters intake conduit 62, thereby along the The intake conduit 62 travels to the patient interface 17 for delivery to the patient. One reason why a secondary conduit such as the intake conduit 62 may be used is as follows: The inspiratory conduit 16 is relatively heavy and cumbersome since it is used to deliver gas over a considerable distance (from the humidifier unit 2 to a point close to the patient) flow. Therefore, the inspiratory conduit 16 needs to have walls that are strong enough to support its own weight without collapsing. This extra length and thicker wall construction increases the weight of the suction conduit 16 since the suction conduit 16 is typically relatively long (eg, 8 to 10 feet). If the outlet of the inspiratory conduit 16 is connected directly to the patient interface in such a way that the patient needs to support this weight, this may be uncomfortable for the patient due to the weight of the inspiratory conduit 16 acting on the patient. Additionally, the weight of the inspiratory conduit 16 may pull on the patient interface 17 and cause it to become disengaged or misaligned. A lighter, shorter secondary conduit (eg, intake conduit 62 ) extending between the outlet of inspiratory conduit 16 and patient interface 17 may be used.

The intake conduit 62 is lighter and shorter than the intake conduit 16 and is typically used with a lanyard 63 connected to the intake conduit 62 or to the connection between the intake conduit 16 and the intake conduit 62 as described above . In use, strap 63 (as described above) supports at least a portion of the weight of inspiratory conduit 16 such that patient interface 17 need only support relatively light intake conduit 62 . Furthermore, in configurations in which the strap 63 is connected to the end of the intake conduit 62, the patient does not need to remove the strap 63 when disconnecting the intake conduit 62 from the inspiratory conduit.

Referring now to FIGS. 4-6B , various aspects of the nasal cannula 30 will be described in more detail. Unless otherwise stated, the nasal cannula 30 illustrated in FIGS. 4-6B includes all of the features of the generalized nasal cannula described with reference to FIG. 3 .

The nasal cannula 30 includes two main parts: an interface connection 35 and a body 32 . Exemplary configurations of these two parts will now be described with specific reference to FIGS. 4 and 5 .

The interface connection 35 is in use connected to and in fluid communication with the intake conduit 62 as already described above. However, in alternative embodiments, the interface connection may be directly connected to the inspiratory conduit 16 .

The configuration of FIG. 5 shows that the interface connection 35 is detachable from the remainder of the nasal cannula 30 . Alternatively, interface connector 35 may be an integral part of nasal cannula 30 . Alternatively, the interface connector 35 and the nasal cannula 30 form a one-time fit, preventing the user from disassembling the two components after initial assembly. In an integrated or single-fit configuration, a continuous gas flow path is formed through the inspiratory conduit 16 , the intake conduit 62 , the interface connection 35 , and to the nasal prongs of the nasal cannula 30 .

In some configurations, the interface connector 35 is generally tubular in shape with a substantially circular inlet 59 on one side that curves into an oval or elliptical outlet 37 formed in the mouth of the interface connector 35. on one side so that it is perpendicular to the inlet 59 . A circular inlet 59 in the form shown receives the patient end of the intake conduit 62 so that gas flow from the intake conduit 62 can pass through the interface connection 35 .

In some configurations, interface connection 35 is integrated with or permanently coupled with intake conduit 62 . Alternatively, interface connection 35 is removably attached to intake conduit 62 . The interface connection 35 engages the body 32 so that gas flow can pass through the outlet 37 and from the intake conduit 62 through the nasal prongs 33, 34 (described in detail below) to the patient.

In some configurations, the interface connection 35 is fabricated from a hard plastic material that only deforms under relatively high load conditions (ie, cannot be easily crushed by a user's hand). The interface connector 35 may be formed, injection molded, machined or cast.

The interface connection 35 is connected to the body 32 in use such that gas flow leaving the interface connection 35 enters the body 32 . The body 32 will now be described in detail.

Body 32 includes nose prongs 33 , 34 extending from a bottom portion 39 of body 32 . The gas flow passes through the body 32 to the nasal prongs 33, 34 and is delivered to the patient. In some configurations, the nose prongs 33, 34 extend parallel to each other. In some configurations, nose prongs 33 , 34 curve back from face mounting portion 32 . In some configurations, the nose prongs 33, 34 are curved towards each other. The structure of the nose prongs 33, 34 will be described in detail below.

The body 32 of the illustrated embodiment includes integrally formed side arms 31 and a tubular member 38 including a recess, as shown in FIGS. 4 and 5 . Tubular member 38 extends below body 32 and is adapted to receive interface connector 35 (for configurations in which body 32 and interface connector 35 are separable or separable items). The body 32 has a lip 39 that extends around the upper edge of the tubular member 38 . The interface connection 35 is connected to the body 32 by a friction fit, and a lip 39 on the body 32 assists in gripping the interface connection 35 and forming a sealed connection between the interface connection 35 and the body 32 . Tubular member 38 includes ribs 40 extending below body 32 . Ribs 40 help to rest and hold the interface connector 35 in the correct position when it is engaged with the body 32 , and the ribs 40 extend around the outside of the interface connector 35 . When the interface connector 35 is connected to the body 32, the outlet 37 on the interface connector 35 is aligned with the underside of the face mounting portion or body 32 in use. This alignment reduces the amount of gas leaking from the nasal cannula 30, allowing effective treatment of the patient by delivering the maximum amount of humidified gas.

The side arms 31 are used to attach the front strap 50 to the body 32 . Side arms 31 extend from both sides of the body 32 . In some configurations, the side arms 31 are formed as an integral part of the body 32 . In use, the front strap 50 is attached to the side arm 31 so that the patient interface can be donned by the patient. In some configurations, the ends of the front strap 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 are looped themselves. Alternatively, the front strap 50 or loop 66 may be clamped to, or adhesively attached to, the side arm 31 , such as by cooperating male-female clips.

In some configurations, the body 32, nose prongs 33, 34, side arms 31 and tubular member 38 are all manufactured as one continuous item. The body 32, nose prongs 33, 34, side arms 31 and tubular member 38 are all manufactured from a flexible polymer material, such as soft thermoplastic elastomer (TPE) or silicone.

The nose prongs are described below. In the following description, the term "posterior" or "dorsal" or any such synonymous means the part of the structure facing and closest to the patient's face when the nasal cannula is in use. The term "front" or "forward" or any such synonymous means the side, face or portion, when used, facing away from and furthest away from the patient's face. The terms "top" or "upper" refer to the side, face or portion that points away from the floor when a patient wearing the patient interface is standing or sitting upright and looking forward. The terms "bottom" or "lower" refer to a side, face or portion that is also toward or directed towards the ground when the patient wearing the interface is standing or sitting upright and looking forward. For example, FIG. 3 shows a patient interface 17 worn by a patient, with reference to which the orientations described above can be assessed. The definition of these directions remains consistent throughout, including in the figures showing patient interface 17 without the patient.

In some configurations, the body 32 includes two nose prongs 33, 34 extending upwardly from the upper surface of the body 32 and curving inwardly, as shown in FIGS. 4-6B. Referring to Figures 4 to 6B, nasal prongs 33, 34 extend from the upper surface of the body 32 and, when the nasal cannula is in use, place one prong in each nostril of the patient. The nasal prongs 33, 34 are configured to deliver the flow of gas to the patient. The nose prongs 33 , 34 receive the flow of humidified gas from the intake conduit 62 via the intake conduit 62 , the interface connection 35 , and the body 32 . Thus, the nose prongs 33 , 34 are fluidly connected with the interface connection 35 and receive gas flow from the intake conduit 62 .

Referring to FIGS. 7A and 7B , the patient sensor 29 is located on the body 32 of the nasal cannula 30 . In some configurations, the patient sensor 29 is located on the nasal cannula 30 such that, during use, it contacts the patient's skin. Patient sensor 29 may have an adhesive surface so that it may be secured in contact with the patient's skin.

The exterior surface of the body 32 of the nasal cannula 30 can be generally divided into an exterior-facing surface and an interior-facing surface. The term "outward facing surface" as used herein may refer to the outer surface of the body 32 that faces away from the patient when the nasal cannula 30 is in use. The term "inner facing surface" as used herein may refer to the outer surface of the body 32 that faces the patient when the nasal cannula 30 is in use. The front and bottom sides of body 32 may be considered as outwardly facing surfaces, while the rear side may be considered as inwardly facing surfaces. The central portion of the top side of the body 32 which in use is located under the patient's nose may be considered an inwardly facing surface, while the remaining sides of the top side may be considered as outwardly facing surfaces.

FIG. 6B shows an exemplary patient respiratory interface 1000 including a nasal cannula 30 with asymmetrical nasal delivery elements 111 , 112 .

Nasal cannula 30 provides the patient with a patient interface adapted to deliver a high air flow, high humidity gas flow to the patient's nasal cavity/nostrils. In some configurations, the nasal cannula 30 is adapted to deliver high flow gases over a wide flow range (eg, about 8 lpm or higher, perhaps 10-50 lpm or higher depending on other therapeutic applications). In some configurations, nasal cannula 30 is adapted to deliver relatively low pressure gas.

As seen in FIG. 6B , intake conduit 62 delivers incoming gas to nasal cannula 30 . The headgear 200 is shown provided with a patient breathing interface 1000 to hold the nasal cannula 30 on the patient's face when in use. A retaining clip 280 is shown retaining the air intake conduit 62 to the headgear 200 . Nasal prongs 111 , 112 are associated with the main body 110 of the nasal cannula 30 .

Nasal prongs 111 and 112 extend curvedly into the nares of the patient in use and provide a smooth flow path for gas to flow therethrough. The inner surfaces of nose prongs 111 and 112 may be contoured to reduce noise. The bottoms of nose prongs 111 and 112 may include curved surfaces to provide smoother gas flow. This reduces noise levels during operation.

Nose prongs 111 and 112 are substantially hollow and substantially tubular in shape.

The diameter of the nasal prongs 111 and 112 may be uniform along their length, or alternatively may be shaped to fit the contour of the nostrils.

Body 110 is shaped to generally follow the contours of the patient's face around the upper lip region. In the area of the face where the cannula is positioned, the face mounting portion 110 is molded or preformed so as to be able to conform to the contours of the patient's face and/or flexible so as to conform, accommodate and/or correspond to the contours of the patient's face .

The asymmetry of the nasal prongs 111 and 112 reduces the chance of accidental blockage of both nostrils. Accordingly, at least one of nasal prongs 111 and 112 is sized to maintain sufficient clearance between the outer surfaces of nasal prongs 111 and 112 and the patient's skin to avoid sealing the gas path between nasal cannula 30 and the patient. It should be understood that in the context of the present disclosure, nose prongs 111 and 112 are asymmetrical, as described below.

Another example of a patient interface with asymmetrical nasal prongs is shown in FIGS. 44A-44C .

As seen in FIGS. 6A and 44A-44C , in some configurations, the nasal cannula 30 of the present disclosure includes a first nasal prong 111 and a second nasal prong 112 that are asymmetrical to each other, and a body 110 that includes a gas inlet. . The first nasal prong 111 and the second nasal prong 112 are in fluid communication with the gas inlet. The nasal cannula is configured such that at least about 60% of the total volume flow of gas flow into the gas inlet is delivered out of the nasal cannula through the second nasal prong 112 .

The first nasal prong 111 and the second nasal prong 112 as shown in Figures 6B and 44A-44C may be considered as asymmetrical nasal delivery elements.

The first nasal prong 111 and the second nasal prong 112 are asymmetrical to each other, and/or are not symmetrical to each other, and/or differ in shape and configuration from each other, and/or are asymmetrical when compared to each other.

Nasal cannula 30 is configured to achieve an asymmetric gas flow at, within, and/or outside the patient's nostrils.

In some configurations, the nasal cannula 30 includes a body 110 having a first nasal prong 111 and a second nasal prong 112 .

In some configurations, first nasal prong 111 and second nasal prong 112 are configured to engage the nasal passages in an unsealed (unsealed) manner. In some configurations, at least the second nasal prong 112 is configured to engage the nasal passage in a non-sealing manner.

In some configurations, first nasal prong 111 and second nasal prong 112 allow exhaled air to escape around the first and second nasal prongs.

In some configurations, first nasal prong 111 and second nasal prong 112 are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.

The first nasal prong 111 has a first nasal prong outlet 111a defined by an opening at its tip or end 111b for delivering gas from the first nasal prong 111 . Gas delivered through the first nasal prong 111 exits the first nasal prong via the first nasal prong outlet 111a.

The second nasal prong 112 has a second nasal prong outlet 112a defined by an opening at its tip or tip 112b for delivering gas from the second nasal prong 112 . Gas delivered through the second nasal prong 112 exits the second nasal prong via the second nasal prong outlet 112a.

Reference is now made to FIGS. 7A-9C . These embodiments illustrate or illustrate portions of the patient interface 17 configured to deliver breathing gas from a gas supply and humidification source (not shown) to the patient, and configured to support and hold the patient interface in use. The portion of headgear 200 on the patient's face. As seen, for example, in FIGS. 7A and 7B , the patient interface 17 is in the form of a nasal cannula interface 1000 adapted to couple to the inspiratory conduit 16 via the intake conduit 62 and comprising at least one (but preferably ground two) nasal prongs 111 and 112, which are configured to fit within the patient's nostrils to deliver the flow of gas to the patient. The headgear 200 is in the form of a head strap 200 which is preferably adjustable in length to customize the size of the strap to the patient.

Nasal cannula interface 1000 includes: a body 110 including at least one, but preferably a pair of tubular nasal prongs 111 and 112 integrally formed with or removably attached to the body (i.e., the body) and a gas flow portion 120 that is removably attached to the intake conduit 62 or integrally formed on the intake conduit. The gas flow part 120 may be inserted into the main body from either of two opposite horizontal directions (ie, from the left side or from the right side). In this way, the position or positioning of the gas flow portion 120 is reversible relative to the main body 110 (ie, the body). In other words, the user may choose to have the gas flow portion 120 (and substantially the inlet conduit 62 extending therefrom) extend from the left or right side of the nasal cannula interface 1000, depending on what is most convenient, e.g. , depending on which side of the patient the gas source or ventilator is located.

Gas flow portion 120 may be configured to fluidly couple the nasal prongs of patient interface 1000 to intake conduit 62 . In some embodiments, gas flow portion 120 may be a manifold.

Body 110 is formed from a soft and flexible material, such as silicone or other cannula materials known in the art. Nose prongs 111 and 112 are preferably flexible and may be formed from a sufficiently thin layer of silicone to achieve this property.

The gas flow portion 120 is formed from a relatively stiff material such as polycarbonate, high density polyethylene (HDPE), or any other suitable plastic material known in the art. Main body 110 provides a soft interface member to the patient for comfortable delivery of gas flow through nasal prongs 111 and 112 , while gas flow portion 120 fluidly couples intake conduit 62 to nasal prongs 111 and 112 of main body 110 .

A patient sensor 29 , such as a pulse oximeter sensor or pulse oximeter sensors, may be located on or in the gas flow portion 120 .

The patient sensor 29 can be integrated into the gas flow part 120 and thus can be disposable. Alternatively, patient sensor 29 may be removably mounted on gas flow portion 120 . The gas flow portion 120 may have suitable recesses or receiving ports/openings to receive one or more patient sensors 29 . One or more patient sensors 29 may be removable and reusable.

As previously mentioned, one or more patient sensors 29 may be wireless and/or wired. The wire or wires of the patient sensor 29 may be routed through the gas flow portion 120 via the inlet and returned to the controller via the inspiratory conduit 16 or 62 . The controller may include circuitry for operating patient sensors, such as one or more pulse oximeter sensors. The controller controlling the patient sensors may be a separate controller from the controller 19 controlling the breathing apparatus. In other arrangements, the controller 19 controlling the breathing apparatus may also control the patient sensors.

The one or more sensors are positioned on the gas flow portion 120 to position the patient sensor 29 in contact with or adjacent to the upper lip area, such as in the mouth area of the face. There are many blood vessels in the upper lip, and blood oxygen can be determined using the patient sensor 29 by contacting or proximate to the upper lip area via the gas flow portion 120 .

The gas flow portion 120 may be formed from a rigid plastic material as it is received in the soft silicone body of the cannula. Having the gas flow portion 120 rigid makes it easier to insert the manifold portion into the face mount portion and maintain the manifold portion in its operative position (ie, inserted into the face mount). A manifold portion is inserted into the body and is in fluid communication with the nasal prongs to direct gas from the inlet conduits to the nasal prongs. Patient sensor 29 on or in the manifold portion positioned in the main body Positions the patient sensor 29 in a sensing position, ie the sensor is positioned adjacent or in contact with the upper lip.

A patient's nasal septum and/or columella are generally quite sensitive areas and can be a source of discomfort when subjected to excessive contact pressure for prolonged periods of time. The nasal cannula of the present disclosure can eliminate or reduce this pressure by placing a cushioned region of the nasal cannula interface 1000 adjacent to the patient's nasal septum/columella.

A patient sensor 29 (eg, a pulse oximeter) may be placed between the nasal prongs 111, 112 on the upper surface of the cannula such that the patient sensor contacts the septum/columella.

Patient sensors 29 (eg, pulse oximeter sensors) may be located in attachment 400 (eg, as a nasal cannula interface attachment) and/or in a nasal cannula assembly as described in more detail below. For example, pulse oximeter sensor 29 is located in accessory 400 as shown in FIGS. 15C and 15F .

In the embodiment of FIGS. 7A-9C , the headgear for holding the nasal cannula interface 1000 on the patient's face includes a head strap 200 that has a single continuous length and is adapted to Run along the patient's cheeks, over the ears and around the back of the head.

The main end portions 201 and 202 of the strap 200 are adapted to releasably connect to corresponding formations 101 and 102 on either side of the nasal cannula 100 (see, for example, FIG. 8A ) to hold the cannula 100 during use. reign.

At each of the secondary end portions 203 , 204 of the primary strap 210 and the respective end portions 203 , 204 of the strap segments 220 are provided strap connectors 230 .

FIG. 7C shows a nasal cannula interface headgear, wherein the strap segment 220 of FIG. 7B is provided as three strap segments 220a, 220b and 220c of different sizes. Each of the differently sized strap segments has respective end portions 221 a , 221 b and 221 c corresponding to the end portions 203 and 204 of the main strap 210 .

Each connector 230 is provided at one end with a strap connection mechanism that couples to the strap material and at the opposite end with a coupling mechanism that releasably couples a corresponding end of a similar connector 230 .

At the main end portions 201 and 202 of the main belt 210 is provided a cannula connection 240 . These connectors 240 have a similar strap connection mechanism to the strap connectors 230 of the secondary end portions 203 and 204, but include a clamp member, such as a push-fit clamp, at the end of the connector 240 opposite the strap end. 241. Clamp 241 is configured to releasably couple with corresponding formations 101 , 102 on one side of nasal cannula interface 1000 . Clamp 241 is preferably a bendable part, such as a plastic part, which forms a hinge relative to the strap. 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 conform to the contours of the patient's face in the area of the clamp 241 .

Referring to Figures 7D and 7H, a method for engaging and disengaging each connector 240 of the headgear 200 with the nasal cannula interface 1000 will now be described. Each link 240 includes a clamp 241 having an elongated link body 242 with 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 the face 245 from which the protrusion 243 extends is preferably substantially smooth or planar. The corresponding configuration 101/102 of the nasal cannula interface 1000 includes a channel 101a/102a with an entry aperture 101b/102b and an exit aperture 101c/102c at both ends of the channel 101a/102a. The peripheral wall of the exit aperture 101c / 102c defines an abutment 101ci / 102ci configured to engage the surface 243a of the protrusion 243 of the clamp 241 . The periphery 101bi/102bi of the access aperture 101b/102b defines an abutment for engaging the flange 246 at the opposite end of the body 242 to the protrusion 243 . This serves to limit the extent of insertion of the connector 240 into the respective channel 101a/102a. Flange 246 may be provided by a tip with attachment mechanism and/or side arm 270 .

Each section on both sides of the headband 200 and adjacent to the respective main end portion 201/202 includes or has applied thereon a side arm 270 comprising at least a face contacting surface for Frictionally engages with the patient's face to stabilize the headgear 200 at or below the cheeks (such as the cheekbones) or areas of the face during coupling of the headgear to the nasal cannula interface 1000 and thereafter in use. The face-contacting surface is preferably made of a relatively higher friction surface material than the rest of the strap 200 .

Side arms 270 may be cheek supports and/or sleeves.

The face contacting surface is adapted to extend in use to a portion of the side of the patient's face, preferably to the patient's cheek or at least substantially towards the patient's cheek, so as to help hold or stabilize the nasal cannula interface 1000 on the patient's face. on the face. The face-contacting surface, which may be located on the patient's cheek, further helps to keep the rest of the headgear 200 separate from the user's eyes or eye sockets and preferably extends below the patient's eyes or eye sockets to prevent the 200 Visual obstruction and/or discomfort caused by bridging at or near the eye or orbit of the eye.

It should be appreciated that the face-contacting surface may be adapted to extend in use onto a portion of the side of the patient's face, for example extending back and up across from or near or above the left and right outer upper lips. Left cheek and right cheek.

The friction surface material may be provided in the form of elongated side arms 270 configured to receive respective main end portions 201 / 202 of the strap 200 . The side arms 270 are configured to be removably coupled (or alternatively permanently coupled) at the main end portion of the band around the band 200 , sections of the band 200 and/or the cannula connector 240 / 260 .

Side arms 270 (eg, as sleeves) are coupled around the strap 210 at the main end portions 201 / 202 and also around a portion of the connector 240 . The strap 210 extends through a channel 272 in the side arm 270, as can be seen from Figure 7B. The strap 210 is adapted to be threaded through this passage and, when in the telescopic configuration, is preferably left free to stretch or telescoply or extend. The connectors 240 are substantially housed by the side arms 270 or covered by the face-contacting surface to minimize direct contact with the patient's skin, thereby improving the stability and comfort of the headgear 200 . Clamp 241 extends from end 273 of side arm 270 . In another embodiment, side arms 270 may be overmolded onto connector 240 and/or strap 210 .

Referring to FIGS. 8A and 8B , side arms 270 may be coupled at main end portions 201 / 202 around connectors 260 extending from strap 210 . In this embodiment, the connectors 260 are substantially housed by the side arms 270 or covered by the face to minimize direct contact with the patient's skin, thereby enhancing the stability and comfort of the headgear 200 . In other words, the link 260 extends completely through the channel 272 of the side arm 270 . Buckles 251 / 252 extend from end 274 of side arm 270 and clip 261 extends from opposite end 273 .

Sidearm 270 may be pre-shaped 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 sidearm 270 to conform to the contours of the patient's face or cheek in the region of the sleeve in use. Alternatively, the side arms 270 may be elastically or non-elastically deformable to adopt the shape of a curved sleeve when engaged with the main end portion 201 / 202 of the head strap 200 or the connector 260 .

The side arms 270 provide face-contacting surfaces made of a relatively high friction surface material for frictional engagement with the patient's face or facial skin. This face contacting surface will be positioned for frictional engagement with the patient's facial cheek skin. The face contacting surface is localized at least to the strap or the section of the strap that is to be positioned on the patient's cheek. The face contacting surface provided with a relatively high friction surface material is preferably made of a material that is smooth and comfortable on the patient's skin. Thus, the side arms 270 or at least the face-contacting surfaces are formed from a relatively softer material than the connectors 240 and 260 .

In a preferred embodiment, the face contacting surface or side arms 270 are formed from soft thermoplastic elastomer (TPE), but could alternatively be another plastic material such as silicone, or any other biocompatible Sexual material formation.

In addition to nasal cannulae, headgear for other forms of patient interface may also include side arms 270 as cheek supports as described or similar at or near the side ends of the strap of the patient interface headgear. , side arms attached to the mask for frictional engagement with the patient's face in order to stabilize the mask at the cheeks of the face, particularly such as guiding nasal masks that include nozzles or nasal pillows that enter or engage the wearer's nostril. Such headgear may likewise comprise a single headband adapted to extend, in use, along the patient's cheeks, above the ears and around the back of the head, wherein the ends include any suitable form of clips which are positioned at the back of the head. Both sides are coupled to (or permanently attached to) the cover.

A patient sensor 29 (eg, in the form of a pulse oximeter sensor) may be provided on the nasal cannula interface 1000 of FIGS. 7-9 .

Patient sensors 29 may be provided on nasal cannula interface 1000 according to any of the configurations described with reference to nasal cannula 100 of FIGS. 1 to 6B .

The patient sensor 29 may be provided on the headgear 200 or on another removable portion of the nasal cannula interface 1000 that is connected to the main body 110 or the gas flow portion 120 of the nasal cannula interface 1000 . In this manner, if the body 110 and/or gas flow portion 120 are replaced or discarded, the patient sensors 29 may remain with the headgear 200 or other removable portion such that the patient sensors 29 are not discarded and may be reused. For example, patient sensors 29 may be provided on a headgear 200 that is configured to connect to multiple differently sized bodies 110 and/or gas flow portions 120 . This allows the user to exchange or replace parts of the cannula without having to discard the patient sensor 29 .

Referring to FIGS. 7A-9C , patient sensors 29 may be disposed on side arms 270 . Any wiring associated with patient sensors 29 may extend through channel 272 of side arm 270 and from end 274 .

Patient sensor 29 may be recessed into the face-contacting surface of side arm 270 and may be flush with the face-contacting surface. The patient sensor 29 may be located at any suitable location along the length of the side arm 270 , such as adjacent to the formations 101 , 102 or adjacent to the headgear strap 210 .

The patient sensor 29 may be permanently mounted on the side arm, for example the patient sensor 29 may be overmolded onto the side arm 270 .

Patient sensor 29 may be removably mounted on side arm 270 so that if side arm 270 is discarded, patient sensor 29 may be replaced or reused. The patient sensor 29 can be removed, wiped, and incorporated into a different cannula that has a similar recess in the side arm 270 to receive the patient sensor 29 . This allows the sensor to be reused on the patient, thereby reducing the cost of the healthcare facility.

Alternatively, patient sensor 29 may be provided in a complementary sensor body, which may be permanently or removably mounted on side arm 270 , for example in a corresponding recess on side arm 270 . The recess and complementary body may be provided with one or more retaining formations configured to retain the body in the recess. Incorporating the patient sensor 29 into the side arm 270 places the patient sensor 29 in contact with a cheek region, such as the buccal or temporal region of the face. In this area of the face there are blood vessels near which sensors can be positioned and which can be used to detect the patient's blood oxygen saturation.

A patient interface, such as nasal cannula interface 1000 according to any of FIGS. 7A to 9C , may include a plurality of patient sensors 29 .

For example, the patient interface may include multiple patient sensors 29 (ie, multiple pulse oximeter sensors) incorporated into the patient interface. For example, each or at least one side arm 270 may have one or more pulse oximeter sensors 29 positioned on or in the side arm 270 (ie, sleeve). Measurements from the plurality of sensors 29 may be averaged by the controller to provide a blood oxygen (SpO2) reading.

Accordingly, each side arm 270 may include a single patient sensor 29 .

In another alternative form, each side arm 270 (ie, each side arm) of the cannula may include multiple patient sensors. One, some or all of the plurality of patient sensors may be removable. Each side arm 270 may include a plurality of recesses or openings to receive patient sensors 29 .

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

As described with respect to the arrangement of FIGS. 7A-8B , the patient sensor may remain within a component of the patient interface, ie, within the side arm 270 . Sidearm 270 housing one or more patient sensors may be provided as part of a patient interface kit, or may be provided as a separate part of a conventional sidearm that the user may exchange for a patient interface.

Referring to FIGS. 9A-9C , a retaining fixture 280 may be provided that includes a tubular body 281 for receiving and accommodating a portion of the intake conduit 62 therein. Hooks 282 protrude from the tubular body 281 to couple straps, or other components of the headgear 200 . In this way, the air intake conduit 62 may be coupled or tethered to the headband 210 or headgear 200 in use. If the intake conduit 62 is pulled, force will be applied to the head strap 210 rather than directly to the cannula 100 . This repositioning of force will reduce the likelihood that nasal prongs 111 and 112 of cannula 100 will snap out of the patient's nostrils.

One or more tie points for attaching the clip 280 may be used on the headgear 200, with at least two symmetrical tie points on both sides of the headgear being preferred for increased usability.

It should also be appreciated that the retaining clip 280 may be removable from the intake conduit 62 or may be a permanent fit on the intake conduit.

Retaining clip 280 may be attached or retained to a portion of the patient interface, such as a portion of the patient interface that provides a relatively more rigid area (to facilitate support of intake conduit 62).

The retaining clip 280 may also be positioned or attached at a specific location on the intake conduit 62 , for example, a predetermined location may be provided to hold the retaining clip 280 in place.

Retention clamp 280 may be configured to hold the wiring of patient sensor 29 to secure the wiring to intake conduit 62 . Accordingly, the patient sensor wiring may run parallel to the longitudinal axis of the intake conduit 62 .

The intake conduit 62 may be provided with one or more sensor wires, for example in the wall of the conduit or extending through a bore of the conduit. The one or more sensor wires may be configured to be electrically coupled to patient sensors 29 .

Such electrical coupling may be provided by a physical electrical coupling, such as via an electrical connection, between the wiring of patient sensors 29 and one or more sensor wires in intake conduit 62 .

Such electrical coupling may be provided via an inductive coupling. For example, patient sensor wiring may extend along side arm 270 and/or may be disposed within body 110 and/or gas flow portion 120 of nasal cannula interface 1000 . The conduit wiring may extend to a location at or near the end of the intake conduit 62 where it connects to the inlet of the nasal cannula. The intake conduit 62 and the nasal cannula interface 1000 may be provided with inductive couplings configured to electrically couple the intake conduit 62 to patient sensor wiring.

Such an arrangement eliminates or reduces the need for physical electrical connections or the like as well as the need for one or more exposed electrical contacts. Such an arrangement also eliminates or reduces the number of connections a user needs to make when using nasal cannula interface 1000 . For example, the user does not have to physically disconnect the patient sensor wiring from the intake conduit 62 if the patient sensor 29 and headgear 200 are to be reused.

The intake conduit 62 may be a heated or unheated conduit. The conduit may be an extension of any desired length.

As noted above, patient sensor 29 may be configured to contact the patient's face.

Patient sensors 29 may optionally be added to the patient interface. As a complement to the patient interface, patient sensors can be combined with the patient interface via accessories. The accessory is configured to hold a sensor for measuring at least one patient parameter. The accessory is configured to attach to the patient interface.

The accessory 400 may be configured as a nasal cannula interface accessory, such as the nasal cannula interface accessory shown in FIGS. 10 to 16 , for example.

Accessory 400 may be configured to attach to nasal cannula interface 1000 . For example, an accessory can be attached to the strap 200 of the nasal cannula interface 1000 as shown in FIGS. 11 , 13 , 15F and 15D.

It should be appreciated that accessory 400 may be used on any suitable patient interface with straps (and is not limited to nasal cannula interfaces). However, as an example patient interface, a nasal cannula interface is used below.

As shown in FIG. 12A , accessory 400 includes sensor lumen 500 , at least one securing feature 610 , 650 , and wire lumen 700 . As shown in the view of FIG. 12A , sensor cavity 500 is configured to hold patient sensor 29 . As described in more detail above, patient sensor 29 may be configured to measure at least one patient parameter. At least one securing feature 610, 650 is configured to connect accessory 400 to nasal cannula interface 1000; for example, at least one securing feature 610, 650 can be releasably attached to strap 200 of nasal cannula interface 1000, as shown in Figures 11A and 1000. 11B and Figures 13A and 13B.

Accessory 400 may include a body 401 .

The sensor cavity 500 and/or the wire cavity 700 may be provided in the body 401 of the accessory 400 .

The securing features 610 , 650 may also extend from the body 401 .

At least one securing feature 610 , 650 can be configured to releasably connect accessory 400 to nasal cannula interface 1000 . In some configurations, at least one securing feature 610, 650 may be configured to permanently connect accessory 400 to nasal cannula interface 1000 so as not to be removable (although optionally still movable along the strap as described in more detail below) .

As shown in FIG. 12A , wire lumen 700 may be configured to provide access to sensor lumen 500 for one or more wires 710 .

Accessory 400 may be one or more gripping features. The gripping features may include, for example, protrusions, the core protrusions may assist or improve the gripping of the accessory 400 to the nasal cannula interface 1000 . The grab feature can assist the user in moving the accessory 400 relative to the nasal cannula interface 1000 to position the accessory 400 (as described in more detail below).

As shown in Figures 15E and 15F, a nasal cannula interface 1000 may be provided. Nasal cannula interface 1000 may include nasal cannula interface attachment 400 .

Accessory 400 can be releasably connected to interface 1000 .

The attachment 400 can replace components of the interface 1000, for example, the attachment replaces a side arm (as a cheek support) as shown in Figures 17A-18C. In this case, the interface can be provided without side arms.

As described in more detail below, components that replace components of the interface may be provided.

An example of an accessory in FIGS. 17A-17C and 18A-18C is a side arm 270 which, as shown in FIGS. 7A-8B , may be part of a nasal cannula.

As mentioned above, the side arm 270 may be a cheek support configured to rest at least partially on the patient's cheek in use.

As shown in FIGS. 17A-18C , accessory 400 includes sensor lumen 500 , wire lumen 700 and ribbon channel 950 .

In some configurations, accessory 400 can include securing features. The securing feature may be located at or near the first end 810 of the accessory 400 .

The securing feature may be configured to connect to cannula connector 240 as described above with respect to FIGS. 7D-7H .

In some embodiments, the securing features are attached to strap 210 (as in the embodiments of FIGS. 10A-16E ).

As shown in FIGS. 17A-18C , the sensor cavity 500 may be configured to hold a patient sensor 29 (as shown in FIGS. 17B and 17C ) configured to measure at least one patient parameter. Wire lumen 700 may be configured to provide access to sensor lumen 500 for one or more wires 710 .

Accessory 400 may include a body 401 .

The sensor cavity 500 and/or the wire cavity 700 may be provided in the body 401 of the accessory 400 .

In some configurations, accessory 400 may have securing features configured to connect to cannula connector 240 .

In some configurations, for example, as shown in FIGS. 17A-18C , the accessory 400 includes a ribbon channel 950 . Belt channel 950 may extend from second end 820 of accessory 400 along at least a portion of the longitudinal axis of accessory 400 .

Strap channel 950 may allow a strap to pass through accessory 400 to body 110 (or another component of the patient interface).

Strap channel 950 may allow the strap to pass through accessory 400 to body connection features configured to connect the strap of nasal cannula interface 1000 to body 120 . The connection feature may be a cannula connection 240 as described above with respect to FIGS. 7D-7H .

Band channel 950 may be located in body 401 of accessory 400 .

Strap channel 950 may be configured as strap 200 containing nasal cannula interface 1000 .

Belt channel 950 may be shaped to contain belt 200 . That is, the shape of the belt channel 950 may correspond to the shape of the belt 200 . For example, as shown in FIGS. 17C , 18B, and 18C , ribbon channel 950 may include a rectangular cross-section to correspond to substantially flat rectangular ribbon 200 . In some configurations, ribbon channel 950 may have a circular and/or oval cross-section.

In some configurations, the strap channel 950 can have an opening at a first end of the accessory 400, an opening at a second end of the accessory 400, and a surrounded portion between the two ends. In some configurations, strap channel 950 can be at least partially exposed outside of accessory 400 . For example, in FIGS. 18A-18C , and particularly in FIG. 18B , at least a portion of strap channel 950 is exposed outside of accessory 400 .

In some configurations, for example, in FIG. 17C , ribbon channel 950 may be separate from sensor cavity 500 . In some configurations, ribbon channel 950 may be part of sensor cavity 500 . For example, ribbon channel 950 is located at least partially within sensor cavity 500 as shown, for example, in FIG. 18B and cross-sectional view 18C.

In some configurations, strap 200 may be adhered or otherwise connected to at least one surface of strap channel 950 . For example, strap 200 may be attached to at least one surface of strap channel 950 by an adhesive; or, by further example, strap 200 may be overmolded within strap channel 950 . In some configurations, strap 200 may be physically retained by another portion of accessory 400 , eg, strap 200 may not be adhered or otherwise attached to at least one surface of strap channel 950 .

It should be appreciated that the following disclosure with respect to sensor cavity 500 can be applied to accessory 400 and (as described in more detail below) component 2000, where appropriate.

As shown in Figure 10A, Figure 11A, Figure 12A, Figure 13A and Figure 16B, the sensor chamber 500 is formed on the first face 410 of the nasal cannula interface attachment 400, as shown in Figure 10A, Figure 11A, Figure 12A, Figure 13A and Figure 16B.

The sensor cavity 500 may be formed in the main body 401 of the accessory 400 .

As shown in Figures 17B, 18B and 18C, the sensor cavity 500 is formed on the first side 410 of the attachment 400, as shown in Figures 17B, 18B and 18C.

The sensor cavity 500 may be formed in the main body 401 of the accessory 400 . As shown in FIG. 17C , sensor chamber 500 may be a substantially enclosed interior space of body 401 of accessory 400 . In other configurations, the sensor cavity may extend at least partially outside the accessory.

The sensor cavity 500 may be shaped to receive a sensor. In some configurations, sensor cavity 500 is: square, rectangular and/or circular. The sensor cavity 500 may have substantially rounded edges and vertices. Rounding the edges and vertices can help position the sensor in the sensor cavity 500 and prevent damage to the sensor. In the example shown in FIGS. 10A , 11A, and 16B, the sensor cavity 500 may be rectangular with substantially rounded edges and vertices.

The sensor cavity 500 may be a friction fit with the patient sensor 29 (eg, the housing of the sensor). In some configurations, an adhesive may be used to retain patient sensor 29 in sensor cavity 500 .

As described in more detail above, patient sensor 29 may be a patient sensor configured to measure a patient parameter. A patient parameter may be a physiological parameter. For example, a patient parameter may be a measure or indication of the patient's blood oxygenation.

The sensor cavity 500 may be arranged to orient the patient sensor 29 into contact with the patient. As shown in FIGS. 10A, 11A, 12A, 13A, 16B, 17B, 18B, and 18C, the sensor chamber 500 includes an opening on a first face 410 of the accessory 400 configured to Facing the patient during use. For example, when patient sensor 29 is a pulse oximeter sensor, patient sensor 29 may include a transducer (not shown), and sensor cavity 500 may be arranged to orient the sensor such that the transducer of patient sensor 29 faces the patient. (This places the transducer in contact with the skin or adjacent to the skin). In some configurations, the transducers of the patient sensors may include light transducers. The light transducers may be infrared transducers and/or red light transducers. The light transducers can be photodiodes or phototransistors.

In some configurations, the patient sensor includes at least one light source. The light source is configured to be directed at the patient's skin. The light source can be an infrared light source and/or a red light source. The light source may be an LED. In some configurations, the light source may include multiple light sources, each emitting light at a different wavelength. For example, the light source may include at least one red LED and at least one infrared LED. Each light source may have a corresponding transducer.

The wire cavity 700 may be formed on the same face as the sensor cavity 500 of the accessory 400 or on a different face. The sensor cavity 500 may be formed on the first side 410 of the accessory 400 and the wire cavity 700 may be located on the second side (eg, adjacent to the first side) 420 of the accessory 400 . For further example, as shown in FIGS. 12A, 13A and 16B, both the sensor chamber 500 and the wire chamber 700 can be formed on the first side 410 of the accessory; or, as shown in FIGS. 17B, 18B and 18C, Both the sensor cavity 500 and the wire cavity 700 may be formed on the first side 410 of the accessory.

As shown in FIGS. 12A , 13A, 16B, 17B, 18B, and 18C, a wire lumen 700 may be formed adjacent to the sensor lumen 500 .

The wire lumen 700 may extend to the sensor lumen 500 from the outside. Wire lumen 700 may extend from the face of accessory 400 to sensor lumen 500 .

The guidewire lumen 700 may include an opening on a side of the accessory 400 that is configured to face the patient in use. As shown in FIGS. 18A and 18B , the guidewire lumen 700 may include an opening on the first side 410 of the attachment 400 so as to face the patient in use—this may help assemble the patient sensor 29 and sensor cavity 500 . As a further example, as shown in FIGS. 10A , 11A, 12A, 13A, and 16B, guidewire lumen 700 may include an opening 651 on first side 410 of attachment 400 so as to face the patient.

In some configurations, guidewire lumen 700 may include multiple openings on different (optionally adjacent) sides of the accessory, such as shown in FIG. has an opening. This allows the wire to enter a different side of the accessory than the side that contacts the patient in use.

Wire lumen 700 may extend through a single face of the accessory to sensor lumen 500 .

Guidewire lumen 700 may include a slot. Further, the guide wire lumen may be one or more of the following: square, rectangular and/or circular. For example, as shown in Figures 12A, 13A, 16B, 17A, 18B, and 18C, the guidewire lumen is substantially rectangular.

The guidewire lumen 700 can be, for example, a groove and/or a cutout in the accessory (eg, the body of the accessory). In some configurations, the wire lumen can extend from the side or rear of the accessory 400 .

In some configurations, guidewire lumen 700 may include one or more retention features. Once installed, retention features can help retain the wire within the wire lumen 700 . The retention feature may include at least one protrusion extending from the perimeter of the guidewire lumen 700 . At least one protrusion may extend from alternate sides of the guidewire lumen (so as not to overlap).

The wires 710 to which the wire lumen 700 is configured to provide passage may include cables, cords, leads, cable bundles, or any other insulated assembly of conductive material. In some configurations, a single lead 710 may be housed in lead lumen 700 . In other configurations, more than one lead 710 of the same or different type may be housed in lead lumen 700 .

In some configurations, the wire lumen 700 may be, for example, an opening allowing access to the sensor lumen 500 for one or more wires 710 .

Accessory 400 can be attached to nasal cannula interface 1000 by at least one securing feature 610 , 650 . At least one securing feature 610 , 650 may be configured to retain attachment 400 to strap 200 of nasal cannula interface 1000 .

At least one securing feature 610 , 650 may be configured to extend from a side (eg, face) of accessory 400 opposite sensor cavity 500 . As shown in FIGS. 10B, 11B, 12B, 13B and 16A-16E, at least one securing feature 610, 650 can be configured to extend from the second side 420 of the accessory 400, the second side 420 being disposed in relation to the second side 420. One side 410 the opposite side.

The securing features 610 , 650 can hold the accessory 400 while allowing the user to move the accessory 400 relative to and/or remove the accessory 400 from the nasal cannula interface 1000 . The securing features 610 , 650 can be configured to both substantially prevent movement of the accessory 400 along the strap 200 while allowing relative movement of the strap 200 and accessory 400 . Securement features 610, 650 may be configured to allow relative movement of strap 200 and accessory 400 (eg, by allowing accessory 400 to move relative to strap 200) when a threshold force is applied. By configuring attachment 400 to be movable along the length of belt 200, the clinician is able to position patient sensor 29 at a desired location. The type and degree of threshold force required may depend on the type of securing feature 610 , 650 and the strap 200 material. It should be appreciated that the securing features 610, 650 may include one or more features, such as: a fastener (i.e., a hook and loop - comprising a plurality of hooks and a plurality of loops, the hooks and loops may be configured to engage each other; hooks and/or The ring can be disposed on a base), a magnet, one or more hooks, and/or a geometric feature.

The securing feature may allow attachment 400 to be connected and disconnected from strap 200 for repositioning along the length of strap 200 (as described in more detail below).

Referring now to FIGS. 16A-16E , at least one securing feature 610 , 650 may include at least one arm 611 . At least one arm 611 may be configured to extend around at least a portion of the strap 200 of the nasal cannula interface 1000 .

At least one wall 611 may have a first portion 611a and a second portion 611b. The first portion 611a may extend from the accessory 400 : Optionally, the first portion 611a may extend from the second face 420 of the accessory 400 in a vertical direction. The second portion 611b can be configured to be oriented substantially perpendicular to the first portion 611a and/or parallel to the accessory 400 and/or parallel to the second face 420 of the accessory 400 .

At least one securing feature 610, 650 may include a pair of arms 611, as shown in the configuration depicted in Figures 16A-16D. The pair of arms 611 can be configured to releasably connect the accessory 400 to the nasal cannula interface 1000 and/or optionally to the strap 200 of the nasal cannula interface 1000 .

As shown in FIGS. 16A-16E , the pair of arms 611 can extend from the accessory 400 , and each arm 611 can extend toward the other arm and/or toward the center of the accessory 400 . The arm 611 may be arranged along the axis of the accessory; the axis may eg be configured to be parallel to the axis of the band 200 when the accessory 400 is connected to the band 200 .

Each arm 611 of the pair of arms 611 may include a first portion 611a and a second portion 611b. The first portion 611a of each arm 611 may extend from the accessory 400 : optionally, the first portion 611b may extend in a direction perpendicular to the second face 420 of the accessory 400 . The second portions 611b of each arm can be configured to be oriented towards each other and/or the second portions 611b can be configured to be oriented towards the center of the accessory. Optionally, the second portion 611b of each arm 611 may be oriented substantially perpendicular to the associated first portion 611a and/or parallel to the accessory 400 and/or parallel to the second face 420 of the accessory 400 . In some configurations, the first portion 611a can extend vertically upward from the accessory 400 and the second portion 611b can extend inwardly towards the center of the accessory 400 . In some configurations, the first portion 611a can extend vertically upward from the accessory 400 and the second portion 611b can extend towards the second portion 611b of the other arm 611 . The first portion 611a and the second portion 611b of each arm 611 may form an angle of less than 90 degrees, or about 90 degrees, or less than about 120 degrees.

Each arm 611 can form a "U" shape with the second face 420 of the accessory. The U-shape formed by one arm may face the U-shape formed by the other arm to retain the strap of the nasal cannula hub.

At least one arm 611 may be configured to receive the strap 200 of the nasal cannula interface 1000 . For example, in configurations where the securing features 610 , 650 include a pair of arms 611 , a gap 630 may be defined between the pair of arms 611 . Strap 200 of nasal cannula interface 1000 can be configured to be inserted into gap 630 for connection to accessory 400 . The pair of arms 611 of the securing features 610 , 650 may be configured to receive the strap 200 of the nasal cannula interface 1000 for connection to the nasal cannula interface 1000 . The width of the strip 200 of the nasal cannula interface 1000 may be greater than the gap 630 . The strap 200 may be inserted into and/or removed from the gap 630 /accessory 400 only when aligned with the edge of the strap 200 or when the strap 200 is folded along the width of the strap 200 .

At least one arm 611 may include multiple structures.

Referring now to FIGS. 10A-15F , at least one securing feature 610 , 650 may include a clip 650 .

Clamp 650 can be connected to accessory 400 ; the clamp can be configured to secure accessory 400 to nasal cannula interface 1000 , for example, the clamp can secure accessory 400 to strap 200 of nasal cannula interface 1000 .

The clip 650 can extend from the accessory 400, and in some configurations, the clip 650 can extend from the second side 420 of the accessory 400, as shown in FIGS. 10A-15F.

Clamp 650 may include a clamp arm 660 . Clamp arm 660 may be connected to accessory 400 by biasing element 670 . The biasing element 670 may include a hinge or a spring or a geometric feature. Biasing element 670 may bias clamp arm 660 to a closed position or an open position. 10A-15F illustrate exemplary configurations of the clamp arm 660 including the hinge 670 in the open position.

As shown in FIGS. 10A-15B , hinge 670 is a living hinge.

Clamp 650 may be configured to retain strap 200 of nasal cannula interface 1000 to attachment 400 when the clamp is in the closed position. When the clamp 650 is in the closed position (eg, as shown in FIGS. 13D and 15D ), the clamp can hold the strap 200 to the attachment 400 between the clamp 650 and the nasal cannula interface 1000 . When the clamp 650 is closed and holds the strap 200 of the nasal cannula interface 1000, the attachment 400 is prevented from sliding relative to the strap 200.

As shown in FIGS. 10B , 11B, 12B, 13B, 14B, and 15B , the clamp arm 660 may include a contact surface 680 . Contact surface 680 may be configured to engage strap 200 of nasal cannula interface 1000 when clamp 650 is in the closed position.

As shown in FIGS. 10B , 11B, 12B, 13B, 14B, and 15B , contact surface 680 may be located within recess 690 of clamp arm 660 . Recess 690 may be shaped to receive strap 200 of nasal cannula interface 1000 .

The contact surface 680 may include at least one protrusion. At least one protrusion may be configured to help retain strap 200 when clamp 650 is in a closed position (eg, as shown in FIGS. 13C , 13D, 15C, and 15D).

At least one protrusion may include at least one rib 682 . At least one rib 682 may be positioned perpendicular to the width of the strap 200 and/or perpendicular to the longitudinal axis of the contact surface 680 when the strap 200 is engaged with the contact surface 680 . In some configurations, as shown in FIGS. 10B , 11B, 12B, and 13B , the at least one rib 682 includes a pair of ribs 682 . The pair of ribs 682 may be located at opposite ends of the contact surface. The pair of ribs 682 may be spaced apart along the length of the strap 200 and/or the longitudinal axis of the contact surface 680 when the strap 200 is engaged with the contact surface 680 .

At least one protrusion may include one or more bumps 683 . The one or more bumps 683 may, for example, include a bump 683 at each corner of the contact surface, as shown in FIG. 14B . As a further example, one or more bumps 683 may be patterned over the entire contact surface 680 or over at least a portion of the contact surface 680 as shown in FIG. 15B . As yet another example, one or more bumps 683 may be patterned in offset rows, such as shown in FIG. 15B, or the bumps may be patterned in aligned rows.

Contact surface 680 may have a matte and/or significantly rough surface.

A surface in contact with the belt of the accessory 400 (eg, the rear of the accessory 400 ) may include at least one protrusion. At least one protrusion may be configured to help retain strap 200 when clamp 650 is in a closed position (eg, as shown in FIGS. 13C , 13D, 15C, and 15D). The protrusions may be protrusions as described above and may be configured to complement at least one protrusion of the contact surface 680 .

Referring now to FIGS. 15A and 15B , clamp arm 660 may include an aperture 695 that may extend through clamp arm 650 and, optionally, through contact surface 680 . The opening 695 may be configured to receive a portion of another of the at least one fixation system: Optionally, the other of the at least one fixation system may be at least one arm 610, for example, as shown in FIGS. 15A and 15B shown.

Attachment 400 may include a pair of arms 610 located on either side of clamp 650, eg, as shown in FIGS. 10A-14B (described in more detail above). The second portions 630 of the arms are oriented in the same direction (and optionally parallel).

This is in contrast to the arms 610 of FIGS. 16A-16B , where the second portions 630 extend toward each other.

Clamp arm 660 may include at least one retention feature 640 . Retaining feature 640 may be configured to engage a mating portion 645 of accessory 400 configured to retain clamp 650 in the closed position. For example, as shown in FIGS. 10B, 11B, 12B, 13B, 14B, and 15B, retention feature 640 includes a protrusion and mating portion 645 includes a corresponding recess. By way of further example, retention feature 640 may include a recess, and mating portion 645 may include a corresponding feature, such as a protrusion.

Accessory 400 can attach to nasal cannula interface 1000 at multiple interface attachment locations and/or multiple patient facial locations. Multiple patient face locations may correspond to multiple attachment locations.

A plurality of attachment locations on nasal cannula interface 1000 may be defined by at least the connection point between strap 200 and body 110 of nasal cannula interface 1000 .

The patient's face location may be a location where accessory 400 is located near the patient's face. For example, the patient's facial location may be a location near the patient's cheek, or, by further example, may be a location near the space between the patient's eyes and lips.

Accessory 400 may be configured to be adjustable between multiple attachment positions. In some configurations, the accessory 400 can be adjusted between attachment positions without being removed from the nasal cannula interface 1000 , or alternatively without being removed from the strap 200 . For example, accessory 400 may be configured to be slideably adjustable between multiple attachment positions.

In some configurations, accessory 400 may be adjustable between attached positions by disconnecting the clamp and the user moving the accessory to a new position and then re-engaging the clamp (e.g., by moving the clamp to a closed position). .

The accessory 400 can be configured to be adjustable between a plurality of patient facial positions. In some configurations, accessory 400 may be adjustable between patient facial positions without being removed from nasal cannula interface 1000 . For example, the attachment 400 can be configured such that the attachment is slidably adjustable between multiple patient facial positions (eg, in the direction along the belt as indicated by the arrows in FIGS. 15E and 15F ).

The attachment can be located near the patient's cheek, for example. By way of further example, the attachment may be located near the space between the patient's eyes and lips.

Attachment 400 may be attached to nasal cannula interface 1000 at various locations along strap 200 may allow for easier positioning of patient sensors 29 relative to the patient. This allows changing the position of the sensor based on, for example, the patient's facial structure or the position of other medical devices such as a nasogastric tube. For example, attachment 400 can be moved to the other side of the nasal cannula.

Attachment 400 may be attached to nasal cannula interface 1000 at various locations along strap 200 and may also allow patient sensor 29 to be retrofitted to nasal cannula interface 1000 . This allows patient sensors 29 to be added to nasal cannula interface 1000 on an as-needed basis.

In some configurations, the accessory 400 can include an extension that extends away from the body of the accessory 400 . The extension may include sensor lumen 500 and wire lumen 700 to allow patient sensor 29 to be positioned at a specific location—for example, at the patient's earlobe.

As shown in Figures 16A-16C, the face of the attachment 400 which is configured to face the patient in use is substantially circular. The face of the accessory 400 configured to face the patient in use may be other shapes, such as oval or rectangular.

As shown in FIG. 16E , the side of the accessory 400 configured to face the patient in use may comprise at least one surface material 277 . At least one surface material 277 can cover the side of the accessory 400 that is configured to face the patient.

As noted above, the surface material 277 may be on or be the face-contacting surface.

The at least one surface material 277 may not cover the patient sensor 29 in some configurations (eg, as shown in FIG. 16E ), while in some configurations the surface material may cover the patient sensor 29 . The at least one surface material may be provided with openings such that the at least one surface material does not extend across the sensor cavity of the accessory.

At least one surface material may be the same material as the accessory 400 , or the surface material may be a different material than the accessory 400 . For example, at least one surface material may be a fabric material and/or silicone and/or a thermoplastic elastomer, and the attachment 400 may be plastic.

The at least one surface material and the accessory 400 can eg be separate from the accessory 400 or integrated with the accessory 400 .

At least one surface material may be a film or film.

At least one surface material can be configured to increase friction between attachment 400 and the patient's face. At least one surface material may have adhesive or non-slip material properties. Further, the surface material may be configured to provide friction to resist movement between the accessory 400 and the strap 200 .

As noted above, a component may be provided in place of, or as part of, a patient interface such as nasal cannula 100 .

This component can replace existing components of the nasal cannula interface 1000 . This component may be provided as an add-on component that the user may optionally add to the patient interface (eg, as a replacement component), or as a component that is part of a pre-assembled patient interface.

In some configurations, this component may be connected as an intermediate component between other components of nasal cannula interface 1000 . For example, the component may be connected between the side arm 270 and the main body 110 .

The part can be attached to a belt. The member can be attached to the strap 210 at any point, but in some configurations is attached to the strap at the second end. The second end may be opposite to the first end.

The component may include connection features.

The connection features may be configured to connect to nasal cannula interface 1000 .

This part may be a side arm as described above.

The connection feature may be configured to connect directly to the body of nasal cannula interface 1000 (as a body connection feature). In these embodiments, the body connection features may be or include features of cannula connection 240 as described above with respect to FIGS. 7D-7H .

The component may be integrally formed (eg, by overmolding) with the connection feature and/or strap. In some configurations, strap 210 may be attached to attachment features (eg, as described above with respect to FIGS. 7D-7H ), and then the component overmolded.

The attachment feature may alternatively or additionally be a fastener (eg, a hook and loop - comprising a first base having a plurality of hooks and a second base comprising a plurality of loops), a magnet, or a geometric feature.

The component may include any of the features of the accessories described above.

In some configurations, this component may be the accessory of Figures 17A-18C, but permanently attached to the strap and/or cannula connector.

As previously mentioned, as part of providing respiratory support to the patient, one or more physiological parameters of the patient may be measured by patient sensors. Some patient sensors may need to be placed on or near the patient's body in order to measure desired physiological parameters. Accordingly, the patient respiratory interface may incorporate patient sensors, as previously described.

In the various configurations that have been described, accessories may be provided for the patient breathing interface. The accessory is attachable to the patient breathing interface. For example, an accessory may be connected to a portion of the headgear or may be attached to another portion of the patient interface, such as the body of the patient interface itself. The accessory is configured such that one or more patient sensors can be mounted to the accessory. For example, an accessory can be configured such that one or more patient sensors can be held by the accessory. The accessory may include one or more sensor cavities to hold one or more patient sensors.

As previously mentioned, in some forms the accessory may be provided as or as part of a component of the patient respiratory interface. In particular, accessories called components of the patient interface can replace regular components of the patient interface. When replacing a conventional component, the accessory as a component can provide the function of the conventional component and also provide the sensor holding function of the accessory.

The accessory as a component may be or be part of a patient interface, such as patient interface 17 shown in FIG. 3 . For example, the accessory as a component may be a patient interface headgear or part of a headgear for a patient interface, for example, as part of the headgear 200 shown in FIGS. 7A-7H . As another example, the accessory as a component may be or be part of a side arm of the patient interface, such as side arm 31 shown in FIG. 4, one or more of FIGS. 7C, 8A and 8B. The side arm 270 shown therein, or the attachment 400 of FIGS. 17A-17C or 18A-18C.

For example, as has been described with respect to attachment 400 which may replace a side arm of a patient interface, such a component may replace another portion of the patient interface.

In some configurations, the component to which the sensor may be mounted may be an intermediate component between the headgear and the rest of the patient interface to which it is attached. More specifically, accessories that are part of the patient interface may be provided as part of the headgear interface connection, or may include connection features for connecting the headgear and another part of the patient interface together.

Where an accessory can replace a regular component of the patient interface, the accessory component can be interconnected with at least one other portion of the patient interface. By interconnecting, the accessory part and at least one other part can be interconnected. When interconnected, these components cannot move freely relative to each other. In contrast, in other configurations where the accessory is not interconnected with another component of the patient interface, relative movement of the accessory and/or the portion of the patient interface to which it is attached may be possible. For example, the accessory 400 of FIGS. 10A-10C may be configured to slide along a strap to which it is attached, in use. As another example, the accessory 400 of FIGS. 16A-16E can be configured such that the accessory can slide along a strap to be received within the securing feature 610 .

The accessory components may replace, for example, side arms, buckles, tube clamps, or any other conventional components of the patient interface. In case an accessory part (hereinafter simply referred to as a part) is replaced in the patient interface, this part can be connected with other parts of the patient interface. For example, where a component may replace a side arm, the component may be connected to both the body of the patient interface and another portion of the patient interface, such as a headgear strap or a headgear connector. The component may be interconnected with one or every other part of the patient interface to which it is connected.

By way of example, various arrangements of components for a patient interface configured to hold patient sensors will now be described.

Nasal cannula interface 1000 includes body 110 as shown in FIG. 19A . A pair of side arms 270 extend laterally from the main body 110 . Nasal cannula interface 1000 also includes headgear 200 having a first strap 211 and a second strap 212 .

On one side of the nasal cannula interface 1000 , one of the side arms 270 is connected to the second strap 212 of the headgear by a connector 3200 . The connector 3200 allows both the side arm 270 and the second strap 212 to be connected to the connector.

On the other side of the nasal cannula interface 1000 of FIG. 19A is provided a component 2000 . Part 2000 is connected to the other side arm 270 and the first strap 211 of the headgear. The component 2000 also has a component body that can hold the patient sensor 29 .

Although shown in FIG. 19A as having component 2000 provided on only one side of the connection between side arm 270 of the patient interface and headgear 200, in other configurations component 2000 may be provided on both sides of the patient interface. .

With component 2000 provided on both sides of the patient interface, the patient or clinician may be provided with the option of where the patient sensors are located. For example, the position of the patient's sensors may vary between components 2000 on either side of its face. This can improve patient comfort. This also allows multiple identical or different patient sensors to be used simultaneously.

Although shown in FIG. 19A as being connected between the side arm 270 and the first strap 211 of the headgear, the component 2000 may be connected between any other two desired components of the patient interface. For example, member 2000 may be disposed between two portions of headgear, or may be provided in the form of side arm 270 as previously described to connect the body of the patient interface with a portion of the headgear of the patient interface.

Component 2000 may include one or more of the same connection features as connections that are not configured to hold patient sensors 29 . For example, component 2000 of the configuration of FIG. 19A may include one or both of the connector features of connector 3200 .

Figure 19B shows a perspective view of the portion of patient interface 1000 labeled A in Figure 19A.

In Fig. 19B, component 2000 is shown connected at one end to side arm 270 and at the other end to first strap 211 of the headgear. The part 2000 has a first connection 2010 to the side arm 270 and a second connection 2020 to the first strap 211 of the headgear.

As shown in FIG. 19B , the first connector 2010 is located at the first end 2001 of the component 2000 and the second connector 2020 is located at the second end 2002 of the component.

Figure 19C shows a detail labeled A in Figure 19A, but from the opposite side of the component 2000 as shown in Figure 19B.

Part 2000 includes a part body 2005 . As seen in Figure 19C, the component body has a sensor cavity 500 within which the patient sensor 29 is retained.

The component body 2005 may be located between the first end 2001 and the second end 2002 of the component. For example, as shown in FIG. 19B and FIG. 19C , the component body 2005 may be disposed between the first connector 2010 and the second connector 2020 of the component, so that the first connector 2010 and the second connector 2020 are respectively located on the component body 2005 the corresponding side.

One or both of the first connector 2010 and the second connector 2020 may be configured to releasably connect a component with a corresponding other portion of the patient interface.

For example, as seen particularly in FIG. 19B , the second connector 2020 includes a buckle 2021 through which the end of the first strap 211 of the headgear can be threaded. The length of the strap can be adjusted by sliding through the buckle 2021. The first strap 211 can be removed from the buckle 2021 to disconnect the second end 2002 and the first strap 211 from each other.

As also seen in FIGS. 19B and 19C , the first link 2010 is configured to be releasably connected to the side arm 270 . The first link 2010 may receive and retain a portion of the side arm 270 . Portions of the first link 2010 can move relative to each other to release the engagement with the side arm 270 and allow the side arm 270 and the first link 2010 to be disconnected from each other.

As shown in Figures 19A-19C, the opening of the sensor lumen 500 is provided at the inner surface of the nasal cannula interface 1000 which, in use, is adjacent the patient's face. With this configuration, a portion of patient sensor 29 can be directly exposed to the patient's body.

Since the opening of the sensor cavity 500 is positioned towards the patient's face in use, the patient's face can be used to further retain the patient sensor 29 within the sensor cavity 500 .

FIG. 20 is a view of component 2000 without patient sensor 29 held, and FIG. 21 is a view of component 2000 with patient sensor 29 held.

As shown in FIG. 20 , the component body 2005 is located between the first connecting piece 2010 and the second connecting piece 2020 . The component body 2005 has a sensor cavity 500 . In the configuration of FIG. 20 , the sensor cavity 500 is formed in the first face 2007 of the component body 2005 .

The sensor cavity 500 is defined by one or more walls 2006 of the component body 2005 .

The component body includes a wire lumen 700 . Wire lumen 700 may extend between sensor lumen 500 and the outside of component body 2005 to provide access to sensor lumen 500 for one or more wires.

As previously mentioned, the wires for which the wire lumen 700 is configured to provide passage may include cables, cords, leads, cable harnesses, or any other insulated assembly of conductive material.

As seen in FIG. 20 , the wire lumen 700 is provided at the first face 2007 of the component body 2005 . The wire lumen 700 has an opening at the first face 2007 of the component body 2005 . The wire lumen 700 opens between the sensor lumen 500 and the outer surface of the component body 2005 adjacent the first face 2007 .

The wire lumen 700 may take the form of a slot that is recessed from the surface of the component body and provides a passageway between the sensor cavity 500 and the outside of the component body.

The guidewire lumen 700 can have various cross-sectional configurations. For example, guidewire lumen 700 may have a substantially square, rectangular, or circular cross-section. The guidewire lumen 700 may have more than one cross-sectional configuration along its length. The guidewire lumen 700 may have any of the foregoing cross-sectional configurations at any one or more locations along its length.

As seen in FIG. 20 , the buckle 2021 of the second connector 2020 includes two openings 2022 through which the ends of the headgear straps can be pressed to connect the strap to the second connector 2020 .

Patient sensor 29 is shown held within sensor cavity 500 of component body 2005 in FIG. 21 . The shape of sensor cavity 500 may be defined to be complementary to the shape of patient sensor 29 . For example, as seen in FIGS. 20 and 21 , the perimeter of the sensor cavity 500 around the wall 2006 of the component body corresponds to the contour of the patient sensor 29 .

As seen in Figure 21, the sensor cavity 500 has a substantially rectangular shape with rounded edges. The sensor cavity 500 may have various other shapes, such as a square or a circular shape. The configuration of the sensor cavity, or at least at least one dimension of the sensor cavity, may correspond to the size of an intended patient sensor with which component 2000 is used.

The sensor cavity 500 may provide an interference fit with the patient sensor to help retain the patient sensor 29 at or within the sensor cavity 500 . This interference fit may be in the form of a friction fit. Additionally or alternatively, the interference fit may comprise a snap fit arrangement between the sensor and the sensor cavity.

Adhesive may be provided between the patient sensor and a portion of the sensor cavity to retain the patient sensor within the sensor cavity.

Where the opening of the sensor cavity is adjacent to the patient's face in use, the patient's face may also help retain the sensor within the sensor cavity.

The guidewire lumen 700 may also correspond in shape to the portion of the guidewire 710 that the guidewire lumen is to receive. As seen in FIG. 21 , patient sensor 29 includes an extension 710 a surrounding a proximal portion of lead 710 . The size of the guide wire lumen 700 is configured to correspond to the size of the extension portion 710a.

The sensor cavity 500 of the component 2000 may be such that when a patient sensor is disposed in the sensor cavity, a portion of the patient sensor may be exposed outside of the component. For example, patient sensors may include transducers and/or light sources. The component body 2005 and the sensor cavity 500 therein may be arranged such that one or both of the transducer and the light source face the patient when the component 2000 is used by the patient as part of a patient interface. More particularly, the component body 2005 and sensor cavity may be arranged such that the transducer and/or light source are exposed on the outside of the component 2000 .

In some configurations, the first face 2007 of the component body 2005 in which the sensor cavity 500 is formed may be the face of the component body that is oriented towards the patient when the component 2000 is used as part of the patient interface 1000 .

In such a configuration, the body of the patient sensor 29 will be positioned adjacent to the patient in use. Accordingly, where patient sensors 29 comprise transducers and/or light sources, these may be arranged such that they face the patient.

With the opening of the sensor cavity oriented towards the patient in use, the patient sensor may be held or additionally held in the sensor cavity 500 by the presence of the patient's face.

In other configurations, the first face 2007 of the component body 2005 in which the sensor cavity 500 is formed may be a face of the component body that is not oriented toward the patient when the component is used as part of the patient interface 1000 . In some configurations, the first face 2007 and the opening of the sensor cavity 500 may be oriented away from the patient in use.

In such a configuration, the component body 2005 may include one or more holes through the component body 2005 at the body's wall 2006 to allow the transducer and/or light source of the patient sensor 29 to face the patient in use.

The sensor cavity 500 may be arranged to hold a portion of the patient sensor 29 in contact with the patient when the component 2000 is used as part of a patient interface.

The opening of the guidewire lumen 700 may be oriented to face the patient in use. More particularly, the opening of the guidewire lumen 700 in a direction transverse to the length of the guidewire lumen 700 between the sensor lumen 500 and the outside of the component body 2005 may face the patient in use.

The patient-facing face of the component body 2005 of the component 2000 shown in FIGS. 19A and 19B is substantially rectangular. In other configurations, the patient-facing face of the component body 2005 may have a substantially circular shape.

The component 2000, or at least the component body 2005 and any portion integrally formed therewith, may be formed from a biocompatible material. For example, they may be formed from a biocompatible plastic material, such as thermoplastic elastomer (TPE) or silicone, or liquid silicone rubber (LSR).

As previously described with respect to the attachment 400, particularly with reference to FIG. 16E , the face of the component 2000 or in particular the component body 2005 configured to face the patient in use may comprise at least one surface material, such as a surface material as previously described. 227. The surface material may be disposed across some or all of the face of the patient-facing component 2000 .

The surface material may be the same material from which the component 2000 or in particular the component body 2005 is made. In other configurations, the surface material can be a different material.

The surface material of component 2000 may function to provide a desired coefficient of friction between component 2000 and the patient's face.

The surface material of component 2000 may be used to retain the sensor within the sensor cavity. For example, once the sensor has been disposed in the sensor cavity, the surface material may be provided across part or the entire opening of the sensor cavity.

Patient sensor 29 may be disposed within sensor cavity 500 as part of component 2000 . In other configurations, appropriate patient sensors 29 may be fitted to component 2000 by the user.

Component 2000 may be provided as a separate component for use with a patient interface. Alternatively, component 2000 may be provided as part of a patient interface.

The exploded view of FIG. 22 shows various components of the configuration of component 2000 including first connector 2010 and second connector 2020 . As seen in Figure 22, the second connector has a buckle 2021 to which the strap of the headgear can be attached.

The first connector 2010 includes a first connector body 2013 . In the configuration of FIG. 22 , the first connector body 2013 is integrally formed with the component body 2005 . The component body 2005 is also integrally formed with the second connector 2020 .

In the exploded view of FIG. 22 , the first connector 2010 also includes a second body having a pair of claws 3205 and a biasing device 3207 . The first connecting part 2010 further includes a sliding part 3209, which has a first sliding part 3209a and a second sliding part 3209b. Portions of the first link 2010 may cooperate to allow another portion of the patient interface, such as the end of the side arm 270, to be received and retained by the first link and then selectively released.

Component 2000 may have the connector features of connector 3200 as shown in FIGS. 23-32 . Additional details of the configuration of the first connector 2010 of the component 2000 are provided below by the description of the connector 3200 .

Described with respect to FIGS. 23-32 is a first connector portion 3201 that may be secured to connector 3200 by detents 3205 and/or protrusions 3215 . Although described with respect to FIGS. 23-32 as first connector portion 3201 or clamp 3301 , reference will be made to the first connector elsewhere herein. A first connection may generally be understood to refer to a part of a patient interface in which a first connection can be made with another part of the patient interface, eg the body of the patient interface. For example, in FIGS. 19A and 19B , component 2000 has first connector 2010 connected to the body of patient interface 1000 . More particularly, first link 2010 is connected to side arm 270 of patient interface 1000 .

Described with respect to FIGS. 23-32 is a second connector portion 3203 that is part of the connector 3200 . Such a portion is described elsewhere herein as a second connector. A second connection may generally be understood as relating to a part of a component of a patient interface in which a second connection may be made to another part of the patient interface, eg to a headgear or a part of the headgear. For example, in FIGS. 19A and 19B , the component 2000 has a second connector 2020 that connects to the headgear 200 of the patient interface.

Referring to Figures 23 to 32, a first preferred embodiment of a connector 3200 will now be described. The connector 3200 has a first connector part in the form of a clamp 3201 , a second connector part in the form of a carrier 3203 , jaws 3205 for securing the clamp and carrier together, a biasing means 3207 , and a slide 3209 . Slider 3209 is movable relative to clamp 3201 and/or carrier 3203 between a fixed position and a free position. In the fixed position, the jaws 3205 are substantially restrained from moving and from releasing the clamp 3201 from the carrier 3203 . In the free position, the jaws 3205 are movable in order to release the clamp 3201 from the carrier 3203 . Biasing means 3207 pushes the slide towards the fixed position.

In the preferred embodiment shown, the biasing means 3207 and the pawl 3205 are integrally formed together. The biasing means 3207 includes a pair of resilient legs 3208 and the jaw includes a pair of resilient arms 3211 . These arms and legs are apparently resistant to deformation or elastically flexible. Arm 3211 is flexible to allow insertion of clamp 3201 when slider 3209 is in a fixed position, as described below. These arms and legs extend from body portion 3210 .

As described in more detail below, the resilient legs 3208 push the slider toward the fixed position. The legs extend from the body portion 3210 in the same direction and have the same length as each other. The sides 3208a of each leg are slightly tapered such that the free end 3208b of each leg is narrower than the end 3208c of the joining body portion 3210 . The free end 3208b of each leg is rounded. The side surfaces, top surface 3208d, and bottom surface 3208e of each leg are generally planar surfaces.

Resilient arms 3211 are spaced apart and extend from body portion 3210 in the same direction as legs 3208 . The arms are the same length as each other and longer than the legs. The arms 3211 are biased towards each other. As described in more detail below, when the clip 3201 is inserted into the carrier 3203, the pair of resilient arms 3211 are biased toward engagement with the notches of the clip.

Each arm has a straight portion extending into arcuate portion 3212 closest to body portion 3210 . The arcuate portion 3212 allows the arm 3211 to flex when the clamp 3201 is inserted into the carrier 3203 with the slider 3209 in a fixed position. The arcuate portion 3212 is concave when viewed from the position of the slider. The arc portion 3212 has a narrower width than the straight portion. The side, top and bottom surfaces of each arm are generally planar surfaces. These top and bottom surfaces act as bearing surfaces between the slider 3209 and the subassembly of the carrier with the biasing means 3207 /jaw 3205 .

Each resilient arm 3211 includes a protrusion 3215 for engaging a complementary notch of the clamp 3201 . A protrusion 3215 is located at the free end of each arm. Each protrusion 3215 has a generally triangular shape (as shown in FIG. 24 ), and the notch has a complementary triangular shape for secure engagement between the protrusion and notch. In an alternate embodiment, the notch may be a shoulder.

The slide 3209 has lugs 3217 for engaging a biasing means and stops 3227 as shown in FIG. 25 for positioning the slide and carrier 3203 in a fixed position. Another stop may be provided near the stop 3227 in order to control the range of movement of the slider in the free position. Additional stops may be present, or stop 3227 may be enlarged. In the preferred embodiment shown, the slide 3209 is a sleeve. The sleeve has a first inner surface and a second spaced apart inner surface opposite the first surface. A stop 3227 is formed on the first surface and a lug 3217 is formed on the second surface. In alternative embodiments, the detent and lug may be formed on the same surface. 24-28 are cross-sectional views through the center plane of the connector. Thus, these figures show the lugs, stops, and biasing means.

As shown in FIGS. 24-28 , the lug 3217 is centrally positioned within the slider 3209 . The lug 3217 includes two outwardly tapering surfaces 3219 with rounded noses 3221 .

When viewed from the side (as shown in Figure 30), the stop has a wedge-shaped profile. The stops fit into slots in the carrier. When the slider is in the fixed position, the surface of the stop engages the surface of the slot, thereby preventing movement of the stop beyond the fixed position. The wedge shape of the stop assists in assembling the slider to the carrier.

The slider 3209 has two protrusions 3223 for engaging the claws to substantially inhibit movement of the clamp 3201 and prevent release of the clamp from the carrier 3203 . These protrusions are generally semicircular, as shown in FIGS. 24-28 . Slider 3209 has a pair of longitudinally extending rails 3225 . The slider may have a scalloped portion that facilitates gripping of the slider by a user. The slider may be fitted with a soft sleeve part to give the user a better grip to manipulate the connection, which is also more comfortable for the patient to place it against their skin. The sleeve may be overmolded or co-molded with the slide, or may be a separately formed component that is assembled with the slide.

Clamp 3201 is a substantially planar and rigid component. Clamp 3201 includes a pair of notches 3213 . The notch 3213 is positioned towards the nose section 3201a of the clip 3201 and is generally triangular in shape. A first side 3213a of the notch 3213 closest to the nose of the clamp 3201 is angled steeper than a second side 3213b of the notch 3213 . The first side is relatively steep to help prevent the clip 3201 from being removed when the slider is in a fixed position.

The carrier has been described as a separate component from the combined jaw/biasing device component. Alternatively, the carrier may be integrally formed with the jaw/biasing means component.

The biasing means has been described as comprising a pair of resilient legs. Alternatively, the biasing means may comprise a single leg or more than two legs. In other alternatives, the leg biasing means may comprise any other type of spring element to act as a return mechanism for the slider.

The jaws have been described as comprising a pair of resilient arms. Alternatively, the jaw may comprise a single arm or more than two arms. The clamp has been described as having a pair of notches. Alternatively, the clamp may have a single notch or more than one notch. The number and position of these notches will correspond to the number and position of the complementary protrusions on the spring arm.

The biasing means has been described as having two legs that move away from each other and are biased towards each other in order to urge the slider to a fixed position. Alternatively, the legs could be deformed in the other direction to provide a similar return action. For example, the legs can be twisted or bent along their length.

The features and characteristics of these legs can be modified to suit the application; that is, they can be modified to adjust the force on the slider when moving between a fixed position and a free position. Features and characteristics that may be selected or designed to be modified include the angle of the legs, the thickness of the legs, and the angle of the lugs.

In another alternative embodiment, the combined jaw/biasing device component may be formed in two pieces. Each piece will have arms and legs and will be held in place relative to the carrier by locating features. In another alternative embodiment, the jaw/biasing means may be a single leg and arm combination acting on only one side of the clamp. In this embodiment, the link will have locating features for securing the detent/biasing means in place as well as guide and/or abutment features to ensure that the arm/leg acts on the part of the link forces to properly position these components relative to each other.

The biasing means and the jaws have been described as being integrally formed together. Alternatively, they may be separately formed components that may be connected together or may be connected together.

Embodiments of the link have been described with biasing means for urging the slide towards the fixed position. In alternative embodiments, the link may have no biasing means, but the slide may be held in the free position and/or in the fixed position by other suitable mechanisms. For example, the connection may have one or more snaps that hold the slide in a free position and/or in a fixed position. Such snaps may automatically engage the slide and/or carrier or may be a user controlled feature.

The present disclosure also provides a catheter and wire clamp 4000 . Clamp 4000 may be used to connect conduits and leads of a patient interface (eg, leads of patient sensor 29 ) together.

FIG. 33 shows a perspective view of the jig 4000 , and FIG. 34 shows an end view of the jig 4000 . Clamp 4000 has a wire receptacle 4006 for receiving a wire and a catheter receptacle 4007 for receiving a catheter.

Catheter receptacle 4005 is defined by two walls 4001 and 4002 . The wire receptacle 4006 is defined by two walls 4003 and 4004 . Each receptacle has an opening across its length that is narrower than a corresponding maximum width of the receptacle. Pairs of walls 4001 and 4002 and 4003 and 4004 are each curved towards each other at their distal extents.

The cross-sectional size and shape of each receptacle may correspond to the cross-sectional size and shape of the intended sensor wire and conduit, respectively.

The clamp 4000 of Figures 33 and 34 may be used to connect to wires and conduits each having a substantially circular cross-section.

Each of the receptacles 4006 and 4007 may be manufactured to have a width equal to or preferably less than the corresponding width of the wire or conduit to which the clamp is to be coupled. With this arrangement, an interference fit may be provided between the wire or conduit and the clamp when the corresponding element is seated within the corresponding receptacle.

Although shown in FIGS. 33 and 34 as having a length approximately equal to its overall transverse dimension, the jig 4000 may have a length that is relatively greater or less than one or both of its transverse dimensions.

As seen in FIG. 33 , the corner 4010 of the first wall 4001 is rounded between its edge at the opening of the catheter receptacle 4007 and its edge at the proximal end of the clamp 4000 . The rounded corners locally increase the width of the opening of the catheter receptacle 4007 . This locally increased width assists the user in attaching the clamp to the conduit.

The corresponding corners of the other wall 4002 of the catheter receptacle 4007 may be rounded in the same manner to further increase the width of the opening of the catheter receptacle 4007 at its end.

Only one end of the catheter receptacle 4007 of the clamp 4000 may have rounded corners, or both ends may have rounded corners.

Rounding may similarly be provided on one or more corners or one or both ends of the wire receptacle 4006 of the clamp 4000 .

One or more clips such as clip 4000 may be used with a patient interface, particularly a patient interface that may hold a patient sensor as described herein. Where the patient sensor includes wires, the dragging wires can be inconvenient to the patient or clinician. One or more sensor wires may be secured to the catheter of the patient interface using one or more clamps. This reduces confusion and improves the overall patient interface and the simplicity with which the patient or clinician interacts.

Figure 35 shows a portion of the conduit 62 for the patient interface, and wires 710, for example, for the patient sensors. The clamp 4000 is attached to both the catheter 62 and the wire 710 such that a portion of the catheter 62 is received with the catheter receptacle of the clamp and a portion of the wire 710 is received within the wire receptacle of the clamp.

As seen in FIG. 35 , clamp 4000 orients the longitudinal axes of catheter 6 and lead wire 710 parallel to each other in the connected position of clamp 4000 .

FIG. 19A also shows two clamps 4000 as part of patient breathing interface 1000 with conduit 16 . In Fig. 19A, the opening of each catheter receptacle is shown. Lead wires 710 extending from the patient sensors run along the length of the catheter 16 and are shielded by the catheter.

In some arrangements, a component of or for a patient interface configured to hold a patient sensor may be a connection including a catheter retaining portion or a tube clamp. The component may have a sensor mount configured to hold a patient sensor. The sensor mount may be configured to couple to a sensor mount receiving portion of another component of the patient interface.

FIG. 36A illustrates a patient breathing interface in the form of a nasal cannula interface 1000 . While shown as a nasal cannula interface, it should be understood that the interface can be other types of interfaces disclosed herein. Nasal cannula interface 1000 has nasal cannula 30 and an associated intake conduit 62 for supplying a flow of breathable gas. The nasal cannula interface 1000 has corresponding side arms 270 which extend on both sides of the nasal cannula 30 .

In some arrangements, the intake conduit 62 may be configured as a first portion 62a and a second portion 62b. The first portion 62a and the second portion 62b may be joined together at or through the component 2000 , more particularly at or through the catheter retaining portion 2100 .

Nasal cannula interface 1000 includes a component 2000 configured to hold patient sensor 29 . Part 2000 is provided in the form of part 2000 . The component 2000 has a duct holding portion 2100 for holding a part of the intake duct 62 . The component 2000 has a sensor mount 2200 configured to hold a patient sensor 29 .

The duct holding portion 2100 may have a shape surrounding the entire intake duct 62 , as shown in FIG. 36A , in the form of a collar surrounding the intake duct 62 . In other arrangements, the conduit retaining portion 2100 may be in other forms that do not completely surround the intake conduit 62 . For example, catheter retaining portion 2100 may be in the form of, or be part of, a tube clamp as described elsewhere herein, for example, with respect to FIGS. 33-35 .

In some arrangements, conduit retaining portion 2100 may be removably attachable to intake conduit 62 . For example, where conduit retaining portion 2100 is in the form of conduit receptacle 4007 of tube clamp 4000 of FIGS. 33-35 , conduit retaining portion 2100 may be removably attachable to intake conduit 62 .

In other arrangements, such as where the conduit retaining portion 2100 completely surrounds the conduit, the conduit retaining portion 2100 can only be removed by sliding over the end of the intake conduit 62, or cannot be removed non-destructively from the conduit.

In some arrangements, conduit retaining portion 2100 may be fixedly associated with intake conduit 62 while retaining the conduit. In such an arrangement, the duct retaining portion cannot move relative to the intake duct, eg cannot either or both translate along the intake duct or rotate about the intake duct. In such an arrangement, component 2000 may be provided as part of intake conduit 62 .

In other arrangements, the conduit retaining portion 2100 may be at least partially movably associated with the intake conduit 62, eg, one or both of translating along the intake conduit or rotatable thereabout.

At least one side arm 270 of the patient interface has a sensor recess 2050 . Sensor recess 2050 is sized and configured to receive sensor mount 2200 of component 2000 . The sensor recess is configured such that when the patient is wearing the patient interface, a portion of the patient's face is optically exposed to the patient sensors 29 held in the sensor mount 2200 , which itself is inserted into the sensor recess 2050 .

The sensor recess 2050 can be configured and located on the side arm 270 such that at least a portion of the patient's cheek is optically exposed to the sensor mount 2200 inserted into the sensor recess. More particularly, sensor recess 2050 may be configured and located on side arm 270 such that at least a portion of the patient's face between the eyes and the patient's lips is optically exposed through the sensor recess.

In some arrangements, the sensor recess 2050 may be a windowed recess in the side arm. A sensor recess may extend into the side arm 270 from the non-patient-facing side of the side arm, and an at least partially transparent window may be provided at the bottom of the sensor recess 2050 . The sensor mount 2200 can be inserted into the sensor recess 2050 up to the window of the recess.

In other arrangements, such as shown in FIG. 36A , the sensor recess 2050 may be an aperture extending through the side arm 270 between the non-patient-facing side and the patient-facing side of the side arm 270 . In these arrangements, when the patient interface 1000 is worn, the portion of the patient's face below the sensor recess 2050 is physically exposed. The sensor recess 2050 is arranged such that when the patient is wearing the patient interface, the sensor recess exposes a portion of the patient's face that would otherwise be covered by the interface.

Where sensor recess 2050 is in the form of an opening through side arm 270, sensor mount 2200 inserted into sensor recess 2050 may be placed in contact with the patient's face while the patient is wearing the patient interface.

When the sensor mount 2200 is inserted into the sensor recess 2050, the sensor mount 2200 and the sensor recess 2050 may engage by an interference fit.

In some arrangements, the sensor mount 2200 and the sensor recess 2050 may be configured to engage each other to prevent withdrawal of the sensor mount 2200 from the sensor recess 2050 once the sensor mount 2200 is inserted into the sensor recess 2050 to a certain degree or fully.

The sensor mount 2200 and the sensor recess 2050 may have interengaging features that engage together when the sensor mount 2200 is inserted into the sensor recess 2050 to a predetermined depth. The predetermined depth may be such that the sensor mount is in contact with the patient's face when the patient is wearing the patient interface. Such interengaging features may be, for example, snap fit features, interference fit features or magnetic engagement features.

In some arrangements, sensor mount 2200 may be configured to irreversibly connect with sensor recess 2050 when inserted into the sensor recess. In other arrangements, the sensor mount 2200 may be prevented from being removed when inserted into the sensor recess 2050, but may be repeatedly inserted and removed therefrom.

The sensor recess 2050 of the side arm may be of any shape, but in particular a shape corresponding to the shape of the sensor mount 2200 that the sensor recess is to receive. For example, sensor mount 2200 may have a square, rectangular, oval, or circular cross-section, and sensor recess 2050 may have a corresponding square, rectangular, oval, or circular cross-section.

In some arrangements, it may be desirable to limit or prevent sensor mount 2200 and sensor recess 2050 from rotating relative to each other about the axis of insertion of sensor mount 2200 into sensor recess 2050 . In these cases, the cross-sections of the sensor mount 2200 and the sensor recess 2050 may closely correspond to each other and may be more than circular in shape. Not only circular shapes may include circular cross-sections with one or more detents or notches and corresponding protrusions to co-act in use to prevent relative rotation between the parts.

Side arm 270 with sensor recess 2050 may be configured to replace a conventional side arm of another patient interface to provide integration of sensing of one or more patient parameters with the patient interface. Where sensing of a patient parameter is desired, the user may disconnect the existing sidearm from the patient interface and headgear or headgear connector and reconnect the sidearm 270 to the sensor mount after it is in place 2200. Where the patient interface includes component 2000, sensor mount 2200 may then be inserted into sensor recess 2050 for monitoring patient parameters. Where a particular patient interface does not include component 2000, component 2000 may be provided to intake conduit 62, or intake conduit 62 may be provided with component 2000 for connection to the patient interface, and sensor mount 2200 then inserted into sensor recess 2050 .

Because the sensor mount 2200 can be inserted into the sensor recess 2050 from the side of the side arm 270 that contacts the patient's face in use, the sensor mount 2200 can be inserted into and out of the sensor recess 2050 while the patient interface 1000 is being used by the patient. remove.

As shown in the configuration of FIG. 36A , both side arms 270 of nasal cannula interface 1000 have corresponding sensor recesses 2050 and 2051 . Such a configuration may allow sensor mount 2200 to be selectively inserted into sensor recess 2050 or 2051 such that patient sensor 29 may be positioned on either side of the patient's face.

In the configuration shown in FIG. 36A , patient gas conduit 62 away from its connection to body 110 can be bent to the other side of the interface so that sensor mount 2200 of component 2000 can be inserted into sensor recess 2051 .

In other arrangements, such as shown in FIG. 37 , patient interface 1000 may be configured such that inlet conduit 62 is optionally connectable to either side of body 110 of the interface. In such an arrangement, the intake duct may be said to be connectable to the main body in a number of different directions. In the configuration of Fig. 36A, catheter 62 is connected to the left side of main body 110 from the perspective of the patient. As shown in FIG. 37, the main body 110 has connection ports 110a and 110b for the intake duct 62 on the left and right sides of the main body 110, and the intake duct 62 is shown as being connected to the main body 110 at the connection port 110b. Right. The sensor mount 2200 of the component 2000 may be inserted into the sensor recess 2051 of the right side arm 270 when connected at the connection port 110b. The connection port 110a to which the intake conduit 62 is not connected may be sealed by a plug or other closure.

This arrangement allows the user to conveniently select the side of the patient's face where the patient sensor 29 is provided by switching the side of the main body 110 to which the intake duct 62 is connected.

By connecting the intake duct to a side of the main body 110 corresponding to the sensor recess 2050 or 2051 into which the sensor mount 2200 is inserted, the amount of bending of the intake duct can be minimized. In particular, the curvature of intake conduit 62 between its first end connected to body 110 and the location where the conduit is retained by conduit retaining portion 2100 may be less than about 90 degrees. More particularly, the curvature may be less than about 45 degrees.

Further details of component 2000 are shown in Figure 36B. The component 2000 has a catheter holding portion 2100 and a sensor mount 2200 . Sensor mount 2200 is configured to hold patient sensors 29 . Patient sensors 29 may be removably retained by sensor mount 2200 . In other forms, the patient sensor 29 may be non-removably retained by the sensor mount 2200, such as by being integrally formed therewith. The sensor mount 2200 may serve as a partial housing in which the patient sensors 29 are held. The sensor mount 2200 may have one or more openings 2201 through which the patient sensors 29 may be exposed to the patient when the sensor mount 2200 is inserted into the sensor recess 2050 of the side arm 270 .

The intake conduit 62 for retention by the component 2000 as shown and described with respect to FIGS. 36A-37 may include one or more conductive elements. The conductive element may extend along some or all of the length of the intake conduit 62 . For example, in some arrangements, one or more conductive elements may extend from a first end of the tube for connection to the body 110 of the patient interface 1000 and a second end opposite the first end, which may be used for connection to the inspiratory conduit 16 as shown in FIG. 3 . In other arrangements, one or more conductive elements may extend partially along the length of the intake conduit from one of its ends. For example, one or more conductive elements may extend from the second end of the intake conduit 62 to a location along the intake conduit where the conduit retention portion 2100 is configured to retain the conduit. Where the intake conduit 62 has a first portion 62a extending from a first end and a second portion 62b extending from a second end, one or more connecting elements may be connected to only one of the first portion 62a and the second portion 62b. Associated. One or more conductive elements associated with intake conduit 62 or at least a portion thereof may be used for operation of patient sensors 29 . For example, conductive elements may provide power to patient sensors 29 and/or receive sensor signals from patient sensors 29 .

One or more conductive elements may be disposed within the collar or lumen of the catheter. In other examples, the conductive element may be associated with but external to the catheter. The one or more conductive elements may, for example, include one or more wires, cables, leads, or other insulated conductive materials.

FIG. 36A illustrates the conductive element 710 associated with the intake conduit 62 . In the configuration shown in FIG. 36A, the one or more conductive elements 710 may extend only in the second portion 62b of the intake conduit 62 and may interface with the component 2000, more particularly with the sensor mount 2200 retained at the component. The patient sensor 29 in is connected.

Where the intake conduit 62 has a first portion 62a and a second portion 62b, a component 2000 having a conduit retaining portion 2100 and a sensor mount 2200 may be provided at the interface between the first portion 62a and the second portion 62b. The duct holding portion 2100 itself may be connected between the first portion 62 and the second portion 62b of the intake duct 62 . The first portion 62a and the second portion 62b may meet each other when the patient wears the interface over the patient's chest, near the patient's face, near the patient's cheeks, or more specifically between the patient's eyes and mouth.

Where the intake duct 62 has a first portion 62a and a second portion 62b and the component 2000 is located at or provides an interface between them, the length of the first portion 62a may be such that the sensor mount 2200 is positioned adjacent to the sensor of the side arm 270 The recess 2050 , the side arm is located laterally on the adjacent connection port of the main body 110 for the catheter 62 .

Although shown in FIGS. 36A-37 as being formed in one or more side arms 270 , one or more sensor recesses may additionally or alternatively be provided in one or more other components of the patient interface. For example, one or more sensor recesses may additionally or alternatively be provided in the strap of the headgear, or in the headgear and sidearm connector components such as already described with respect to FIGS. 23 to 32 .

As described with respect to component 2000 of FIGS. 36A-37 , in different arrangements, the conduit retaining portion may move along the intake conduit 62 or may be fixedly associated with a particular location along the intake conduit 62 .

FIG. 38A illustrates a partial view of nasal cannula interface 1000 with another configuration of member 2000 for holding patient sensors 29 . Nasal cannula interface 1000 includes cannula 30 associated with body 110 . Side arm 270 is shown associated with one side of main body 110 and intake conduit 62 is connected to main body 110 for supplying breathable gas. Part 2000 holds intake duct 62 at duct holding portion 2100 . The component 2000 has a hook portion 2400 at which the component 2000 can be attached to another part of the patient interface 1000 . For example, hook portion 2400 may go over a side arm or headgear strap to associate component 2000 with the rest of patient respiratory interface 1000 . As shown in FIG. 38A , the hook portion 2400 is located on the headgear strap 210 . Further details of the component 2000 including its hook portion 2400 are shown in FIG. 38B. On an opposite side of the hook portion 2400 from the catheter holding portion 2100 , the component 2000 has a sensor mount 2200 configured to hold a patient sensor 29 . The sensor mount 2200 may be positioned adjacent or in contact with the patient's face when the component 2000 is hooked onto another portion of the patient interface worn by the patient. The hook portion 2400 can be repositioned along the side arm or headgear strap to place the sensor mount 2200 at a desired location on the patient's face.

Patient sensors 29 may be removably or non-removably retained by sensor mount 2200 .

Component 2000 of FIGS. 38A and 38B is shown with sensor wires 2060 extending from sensor mount 2200 . In other arrangements, the patient sensor 29 may be provided with a power source and configured to communicate wirelessly with a processor and/or control circuitry, such as a pulse oximeter process and/or control circuitry.

Hook portion 2400 is sized and configured to correspond to the portion of the patient interface on which it is to be hung.

FIG. 39 illustrates another configuration of a component 2000 configured as part of a connection between two other parts of a patient respiratory interface 1000 . The part 2000 has a first connector part 2081 at which the side arm can be connected to the part 2000 and a second connector part 2082 at which the headgear part can be connected. As seen in FIG. 39 , the headgear strap 210 is shown passing through the buckle of the second connector portion 2082 . Between the first connector portion 2081 and the second connector portion 2082 is a sensor mount 2200 configured to hold a patient sensor 29 . Patient sensors 29 may be exposed on the patient-facing side of component 2000 through one or more openings 2201 of sensor mount 2200 .

As seen in Figure 39, at the other end of the strap 210 there is provided a connector 3200 of the form previously described with respect to Figures 23-32. In other arrangements, component 2000 may be provided at both ends of belt 210 .

When the component 2000 of FIG. 39 is used as part of a patient breathing interface, the component and any connectors 3200 can be disconnected from the side arm of the interface and reconnected to the opposite side arm in order to change the position of the patient's face where the patient sensor 29 is located. side. In the event that it is not desired to flip the headgear over, this can be done by unfastening the headgear strap 210 from the buckle of the part 2000 and the connector 3200, switching the side arms associated with each of the part 2000 and the connector 3200, The ends of the headgear strap 210 are then reattached to the buckle to perform the same function.

In some arrangements, the part 2000 configured to hold the patient sensor 29 may be provided as an intermediate part insertable between two other parts of the patient interface. An example of such an arrangement is shown in FIG. 40 , which shows a component 2000 that can be inserted between the side arm 270 and the connector 3200 . In the absence of part 2000, end 4020 of side arm 270 may be inserted into receiving portion 3230 of connector 3200 to attach the two parts together.

Component 2000 of FIG. 40 has a first end 2083 configured to receive and couple with end 4020 of side arm 270 . The component 2000 has a second end 2084 configured to be inserted into the receiving portion 3230 of the connector 3200 . Between the first end 2083 and the second end 2084, the component 2000 has a sensor mount 2200 at which a patient sensor can be held.

Although shown in FIG. With corresponding male and female connections, it should be appreciated that the order of one or both sets of these connections may be rearranged as desired for a particular patient interface.

The component 2000 of FIG. 40 can be repositioned between the two sides of the patient interface for sensing on either side of the patient's face by disconnecting the component 2000 from the side arm 270 and the connector 3200 on one side of the interface. and reconnect on the other side of the interface.

The components 2000 described herein may be powered by a power source directly associated with the patient sensors 29, or may be powered by a remote power source. Similarly, component 2000 may be configured to communicate with a processor and/or control circuitry via wired or wireless connections. In the event that the patient sensor 29 is to communicate wirelessly, the wireless communication circuitry and optionally a power supply may be held in the sensor mount 2200 along with the patient sensor. In other arrangements, wireless communication circuitry and power supply may be provided as part of the communication module.

A communication module 2090 is shown in FIG. 40 . A communication module is used in association with the sensor mount 2200 to enable wireless communication from the patient sensors 29 to the processor and/or other sensor control circuitry. As shown in FIG. 40 , the component 2000 has ports 2085 at which the communication module 2090 can be connected to the component 2000 or the patient sensor 29 held.

It should be appreciated that the communication module 2090 may be implemented with other forms of the component 2000 described herein where patient sensors require wireless communication.

Figure 41 illustrates two example configurations of communication modules 2090a and 2090b. In a first configuration, the communications module 2090a includes a power supply to power the communications module. The communication module 2090a is configured to wirelessly communicate sensor information from the patient sensors. In a second configuration, the communication module 2090b does not include a power source and is connected to a remote power source through sensor wires 2060 . Communication module 2090b may be arranged to communicate sensor information wirelessly or may transmit sensor information along sensor wire 2060 .

Both communication modules 2090a and 2090b as shown in FIG.

Configurations have been described previously, for example with respect to FIGS. 7C and 8B , in which the patient sensor 29 may be held by a side arm 270 connected to one or both of the main body 110 or the headgear strap 210 by a connector that is in the form of a push-fit clamp 241 as shown in particular in FIG. 7F . FIG. 43 illustrates another arrangement of a patient breathing interface 1000 with side arms 270 and headgear straps 210 that may be connected by a component 2000 comprising a push-fit clip 241 . Component 2000 is configured to hold patient sensors 29 . The headgear strap 210 may be associated with the components in any of the previously described ways, such as by a buckle or other component that retains the strap 210, like the toothed portion shown in the cross-sectional views of FIGS. 7G and 7H .

The push-fit clip 241 is insertable into the channel of the side arm 270 . When fully inserted into the channel of the side arm 270 , withdrawal of the clip 241 from the channel allows the engagement surface 243 a of the clip 241 to engage the stop surface 247 of the side arm 270 and prevent withdrawal of the clip 241 from the side arm 270 . As shown in FIG. 43 , side arm 270 may have openings so that a user may press on the end of clip 241 to disengage engagement surface 243 a and stop surface 247 , thereby allowing headgear strap 210 and side arm 270 to separate.

Although shown in FIG. 43 as a push fit clip 241 associated with the headgear strap 210 and insertable into the channel of the side arm 270, it will be appreciated that the association of the connector portion with the headgear strap 210 and the side arm 270 is Reverse when needed.

As seen in FIG. 43 , component 2000 has sensor mount 2200 for holding patient sensor 29 . The sensor mount 2200 is configured to hold the patient sensor 29 and to expose at least a portion of the patient sensor to the patient's face on the patient-facing side of the component 2000 in use. In some arrangements, the sensor mount 2200 may be in the form of a sensor cavity 500 as has been previously described, for example, with respect to FIGS. 19-21 . In other arrangements, patient sensors 29 may be integrally provided as part of component 2000 . As seen in FIG. 43, component 2000 may include port 2085 for connection to communication module 2090 as previously described.

FIG. 42 is a cross-sectional view of an illustrative arrangement for holding a component 2000 of a patient sensor 29 including a connection 241 . The component 2000 of FIG. 42 has a sensor mount 2200 in which a patient sensor 29 is mounted. In the arrangement of FIG. 42 , the patient sensor 29 is integrally formed with the remainder of the component 2000 . For example, patient sensor 29 may be at least partially overmolded into component 2000 . Patient sensor 29 is integrally formed such that a portion of patient sensor 29 is directly exposed at patient-facing side 2202 of component 2000 .

A sensor mount of a component according to the present disclosure, such as component 2000 shown and described with respect to FIGS. 36A-40 and 41 , may include a sensor cavity such as previously described with respect to FIGS. 10A-22 . Where component 2000 is powered and/or communicates via wires, sensor mount 2200 of component 2000 according to the present disclosure may include one or more wire lumens 700 such as previously described with respect to FIGS. 10A-22 .

Securement features described herein (such as previously described with respect to FIGS. 10A-22 ) may generally include any of the features disclosed for attaching an accessory or component to another portion of a patient respiratory interface. For example, sensor mount 2200 of component 2000 of FIG. As another example, hook portion 2400 of component 2000 of FIGS. 38A and 38B may be understood as a securing feature for securing component 2000 to a strap or side arm of patient respiratory interface 1000 .

Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise, comprising", etc., are to be interpreted in an inclusive sense, rather than in an exclusive or exhaustive sense, i.e. , construed in the sense "including but not limited to".

While the present disclosure has been described in the context of certain embodiments and examples, it will be understood by those skilled in the art that the present disclosure extends to other alternative embodiments and/or uses and other alternatives beyond the specifically disclosed embodiments. Obvious modifications and equivalents. In addition, while several variations of the embodiments of the present disclosure have been shown and described in detail, other modifications within the scope of the present disclosure will be readily apparent to those skilled in the art. It is also contemplated that various combinations or subcombinations of specific features and aspects of the embodiments can be made and still be within the scope of the present disclosure. For example, features described above in connection with one embodiment can be used with a different embodiment described herein and the combination remains within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form variations of the disclosed embodiments. Therefore, it is intended that the scope of the disclosure herein should not be limited by the specific embodiments described above. Accordingly, unless otherwise stated or unless clearly incompatible, each embodiment of the invention may include, in addition to its essential features described herein, the features as described herein from every other embodiment of the invention disclosed herein. one or more features of .

Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith . All features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all steps of any disclosed method or process may be combined in any combination, unless such features and/or steps Combinations of at least some of are mutually exclusive. The scope of protection is not limited to the details of any foregoing embodiments. The scope of protection extends to any novel feature or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any step in any method or process so disclosed. Novel steps or any novel combination.

Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features above may be described as functioning in certain combinations, one or more features from a claimed combination may in some cases be deleted from that combination and that combination may be claimed as a sub-combination or subgroup changes.

In addition, while operations may be depicted in the figures or described in the specification, such operations need not be performed in the specific order shown or in sequential order, or that all operations need to be performed, to achieve desirable results. Other operations not depicted or described can be incorporated into the example methods and procedures. For example, one or more additional operations may be performed before, after, concurrently with, or between any of the described operations. Additionally, operations may be reconfigured or reordered in other implementations. Those skilled in the art will appreciate that, in some embodiments, the actual steps taken in the illustrated and/or disclosed procedures may differ from those shown in the various figures. Depending on the embodiment, some of the steps described above may be removed and others may be added. Furthermore, the features and attributes of the particular embodiments disclosed above may be combined in various ways to form additional embodiments, all of which are within the scope of the present disclosure. Furthermore, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may often be integrated together in a single product Or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages can be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the present disclosure may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein .

Unless expressly stated otherwise, or otherwise understood within the context in which it is used, conditional language such as "may," "could," "may," or "could" is generally intended to convey that certain embodiments include and other embodiments do not. Include certain features, elements and/or steps. Thus, such conditional language is generally not intended to imply that features, elements, and/or steps are anyway required by one or more embodiments, or that one or more embodiments must include Input or prompt is the logic that determines whether such features, elements and/or steps are included or will be implemented in any particular embodiment.

Language of degree as used herein, such as the terms "about", "approximately", "generally" and "substantially" means a value, amount or characteristic that is close to a stated value, amount or characteristic is still To perform a desired function or achieve a desired result. For example, the terms "about," "approximately," "generally," and "substantially" can mean within less than 10%, within less than 5%, within less than 1%, within less than 0.1%, and within less than 0.01% of the stated amount amount within.

The scope of the disclosure is not intended to be limited by the specific disclosure of embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims, and not limited to the examples described in this specification or during the prosecution of the application, which examples should be construed as non-exclusive.

Claims (45)

1. A patient breathing interface comprising: a first side arm including a sensor recess, an air intake conduit configured to deliver the flow of breathable gas to the patient through the body of the patient breathing interface, and a component having a conduit retaining portion configured to retain the intake conduit and a sensor mount configured to retain a patient sensor, Wherein at least a portion of the sensor mount is insertable into the sensor recess of the first side arm such that the patient sensor contacts the patient's face when the patient respiratory interface is in use. 2. The patient breathing interface of claim 1, wherein the first end of the inlet conduit is connected to the main body of the patient breathing interface. 3. The patient respiratory interface of claim 2, wherein the patient respiratory interface further comprises a second side arm comprising a sensor recess configured to hold a patient sensor. 4. A patient breathing interface as claimed in claim 3, wherein at least a portion of the sensor mount of the component is insertable into the sensor recess of the second side arm. 5. A patient breathing interface as claimed in claim 3 or 4, wherein the first end of the inlet conduit is connectable to the body in a plurality of different orientations. 6. A patient breathing interface as claimed in any one of claims 3 to 5, wherein the first end of the inlet conduit is at each of two laterally opposite sides of the body, i.e. A first side adjacent to the first side arm and a second side adjacent to the second side arm are connected to the body. 7. A patient breathing interface as claimed in claim 6, wherein the sensor mount is insertable into the sensor recess of the first side arm when the inlet conduit is connected to the first side of the body. 8. A patient breathing interface as claimed in claim 6 or 7, wherein the sensor mount is insertable into the sensor recess of the second side arm when the inlet conduit is connected to the second side of the body , such that the patient sensor contacts the patient's face when the patient respiratory interface is in use. 9. A patient breathing interface as claimed in any one of claims 6 to 8, wherein when the inlet conduit is connected to the first side of the body and the sensor mount is inserted into the first side arm When in the sensor recess, the inlet conduit has a curvature between its first end and the conduit retaining portion of the component of less than about 90 degrees. 10. A patient breathing interface as claimed in any one of claims 6 to 9, wherein when the inlet conduit is connected to the second side of the body and the sensor mount is inserted into the second side arm When in the sensor recess, the inlet conduit has a curvature between its first end and the conduit retaining portion of the component of less than about 90 degrees. 11. A patient breathing interface as claimed in any one of claims 3 to 10, wherein the sensor recess of the first side arm and the sensor mount of the component are configured so that when the sensor mount is inserted into the When inserted into the sensor recess of the first side arm, engage each other to prevent withdrawal of the sensor mount from the sensor recess. 12. A patient breathing interface as claimed in any one of claims 3 to 11 wherein the sensor recess of the second side arm and the sensor mount of the component are configured so that when the sensor mount is inserted into the When placed in the sensor recess of the second side arm, engage each other to prevent withdrawal of the sensor mount from the sensor recess. 13. A patient breathing interface as claimed in any one of claims 1 to 12, wherein the inlet conduit comprises one or more electrically conductive elements extending along at least part of its length. 14. A patient breathing interface as claimed in claim 13, wherein the second end of the inlet conduit is opposite the first end, and the second end is adapted to be connected to an inspiratory conduit to receive air therefrom. respiratory airflow, and the second end of the intake conduit includes one or more electrical connections to interface with corresponding one or more electrical connections of the inspiratory conduit when connected thereto. 15. The patient breathing interface of claim 14, wherein one or more conductive elements extend from the second end of the intake conduit to a location along the intake conduit at which the The duct retaining portion of the component is to retain the intake duct. 16. A patient breathing interface as claimed in any one of claims 13 to 15, wherein said one or more conductive elements comprise one or more sensor wires, The one or more sensor wires are in electrical communication with the patient sensors when the airway is in place. 17. A patient breathing interface as claimed in any one of claims 13 to 16, wherein the inlet conduit comprises a first portion and a second portion, and the conduit retaining portion of the component abuts at the inlet conduit between the first part and the second part of . 18. A patient breathing interface as claimed in any one of claims 13 to 16, wherein the inlet conduit comprises a single integral conduit between its first and second ends. 19. A patient breathing interface as claimed in any one of claims 1 to 18, wherein the conduit retaining portion of the component is permanently attached to the intake conduit. 20. A patient breathing interface as claimed in any one of claims 1 to 18, wherein the conduit retaining portion of the component is removably attachable to the intake conduit. 21. A patient breathing interface as claimed in any one of claims 1 to 20, wherein the inlet conduit is slidable along its length relative to the component when retained by the conduit retaining portion. 22. A patient breathing interface as claimed in any one of claims 1 to 21 wherein the inlet conduit cannot slide relative to the component along its length when retained by the conduit retaining portion. 23. A patient breathing interface as claimed in any one of claims 1 to 22, wherein the conduit retaining portion retains the intake conduit around its periphery. 24. A patient breathing interface as claimed in claim 23, wherein the conduit retaining portion retains the intake conduit around more than half of the circumference of the intake conduit. 25. A patient breathing interface as claimed in claim 23, wherein the conduit retaining portion surrounds the inlet conduit. 26. A patient breathing interface as claimed in claim 23, wherein the clamp is attached around more than half of the circumference of the inlet conduit. 27. A patient breathing interface as claimed in claim 23, wherein the clamp surrounds the inlet conduit. 28. A patient breathing interface as claimed in any one of claims 1 to 27, wherein the or each sensor recess comprises a cross section between the non-patient facing side and the patient facing side of the side arm. openings in the side arms. 29. A patient breathing interface as claimed in any one of claims 1 to 28 wherein only a portion of the patient sensor is within the sensor recess when the sensor mount is inserted and retained within the sensor recess. Inside. 30. A patient breathing interface as claimed in any one of claims 1 to 29, wherein the or each sensor well is square, rectangular or circular in cross-section. 31. A patient breathing interface as claimed in any one of claims 1 to 29, wherein a cross-section of the sensor mount, or at least a portion thereof, substantially corresponds to the cross-sectional shape of the sensor recess. 32. A patient breathing interface as claimed in any one of claims 1 to 31, wherein the patient sensor comprises a light transducer (optionally an infrared transducer or a red light transducer) and/or a light source ( Optional infrared source or red light source). 33. A patient breathing interface as claimed in any one of claims 1 to 32, wherein the or each side arm is configured such that when the patient breathing interface is in use, the sensor recess or Each sensor well is located at the patient's cheek. 34. A patient breathing interface as claimed in any one of claims 1 to 33, wherein the or each side arm is configured such that when the patient breathing interface is in use, the sensor recess or Each sensor well is located between the patient's eye and the patient's lip. 35. A patient breathing interface as claimed in any one of claims 1 to 34, wherein a sensor insertable in the or each sensor well is insertable when the patient sensor is retained within the sensor mount. The mount portion includes the transducer of the patient sensor. 36. A patient respiratory interface as claimed in claim 35, wherein, when retained within the or each sensor well, the transducer of the patient sensor is configured to touching the patient's face. 37. A nasal cannula interface accessory for attaching to a nasal cannula interface, the accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and At least one securing feature configured to connect the accessory to the nasal cannula interface (and optionally to the strap of the nasal cannula interface). 38. A nasal cannula interface accessory for attaching to a nasal cannula interface, the accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, a wire lumen configured to provide access to the sensor lumen for one or more wires, and A pair of arms extending from the cannula interface attachment, the arms extending towards each other and/or towards the center of the attachment, the arms are configured to releasably connect the attachment to the nasal cannula interface (optionally to the strap of the nasal cannula port). 39. A nasal cannula interface accessory for attaching to a nasal cannula interface, the accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, a wire lumen configured to provide access to the sensor lumen for one or more wires, and a clamp configured to connect to the accessory, the clamp including a clamp arm connected to the accessory via a biasing element, the clamp configured to secure the nasal cannula interface accessory to the nasal Cannula hub (optionally secured to the strap of the nasal cannula hub). 40. A nasal cannula interface component comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, a wire lumen configured to provide access to the sensor lumen for one or more wires, a body connection feature configured to connect to the body of the nasal cannula interface, the body connection feature being located at the first end of the nasal cannula interface component, and The strap of the nasal cannula interface. 41. A component for a patient respiratory interface, the component comprising: a component body having a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, a first connection configured to connect to the body of the patient breathing interface, and A second connector configured to connect to headgear of the patient respiratory interface. 42. A nasal cannula interface and accessories thereof, said accessories comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and at least one securing feature configured to connect the accessory to the nasal cannula interface (optionally to the strap of the nasal cannula interface), and The nasal cannula includes first and second nasal prongs configured to create an asymmetric gas flow at the patient's nostrils. 43. A nasal cannula interface and components thereof, the nasal cannula interface components comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, a wire lumen configured to provide access to the sensor lumen for one or more wires, and a body connection feature configured to connect to the body of the nasal cannula interface, the body connection feature being located at the first end of the nasal cannula interface component, and The nasal cannula interface includes: a first nasal prong and a second nasal prong configured to create an asymmetric gas flow at the patient's nostrils, and bring. 44. A patient breathing interface comprising: a first nasal prong and a second nasal prong, the nasal prongs configured to create an asymmetric gas flow at the patient's nostrils, a first side arm including a sensor recess, an air intake conduit configured to deliver a flow of breathable gas to a patient through the body of the patient breathing interface and the first and second nasal prongs, a clamp attachable to the intake conduit, the clamp configured to hold the patient sensor within the sensor mount of the clamp, Wherein at least a portion of the sensor mount is insertable into the sensor recess of the first side arm such that the patient sensor contacts the patient's face when the patient respiratory interface is in use. 45. A nasal cannula interface and accessories thereof, said accessories comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and at least one securing feature configured to connect the accessory to the nasal cannula interface (optionally to the strap of the nasal cannula interface), and The nasal cannula includes a first nasal prong and a second nasal prong, and the cross-sectional area of the first nasal prong is smaller than that of the second nasal prong.