Patient Interfaces and Respiratory Devices
By designing nasal catheter interface accessories, integrating sensors and providing fixing mechanisms, the problem of difficulty in monitoring and adjusting patient parameters in the prior art is solved, and more accurate and safe respiratory assisted treatment is achieved.
Patent Information
- Application Number
- JP2024550761
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-07-07
- Filing Date
- 2023-02-28
- Publication Date
- 2025-04-10
AI Technical Summary
When providing patient respiratory assistance, it is difficult to effectively monitor and adjust patient parameters, resulting in poor treatment effects or increased safety risks.
A nasal catheter interface attachment is designed, including a sensor reservoir and fixation mechanism, for connecting to the nasal catheter interface, integrating sensors to monitor patient parameters and ensuring stable connections through an adjustable fixation mechanism.
Real-time monitoring and adjustment of patient parameters is achieved, the accuracy and safety of treatment is improved, clinical operations are simplified, and user work burden is reduced.
Smart Images

Figure 2025508892000001_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates generally to patient interfaces and respiratory apparatus for assisting breathing by providing a flow of breathable gas to a patient through a patient interface, and more particularly to accessories and / or components that include sensors at or near the patient interface of the respiratory apparatus. [Background technology]
[0002] When providing respiratory assistance to a patient, it may be beneficial to monitor one or more patient parameters during the course of treatment. To measure these patient parameters, one or more patient sensors are used, such as a pulse oximeter, which can be used to determine blood oxygen saturation and heart rate. These parameters can be used individually or in combination with additional parameters in making an assessment of the patient's health. Furthermore, these parameters can be used to adjust one or more control parameters of the respiratory assistance system being used to provide respiratory assistance to the patient. This adjustment can be made manually by a clinician or automatically by a controller of the respiratory assistance system, such as by feedback control. The adjusted parameters can include any one or more of flow rate, pressure, temperature, humidity, dew point, oxygen concentration, and / or oxygen saturation. Summary of the Invention [Means for solving the problem]
[0003] In an aspect, a nasal cannula interface accessory is provided 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 fixation mechanism configured to connect the accessory to the nasal cannula interface (and optionally a strap of the nasal cannula interface).
[0004] In some configurations, the at least one securing mechanism is configured to releasably connect the accessory to the nasal cannula interface.
[0005] In some configurations, the sensor cavity is formed in a first surface of the nasal cannula interface accessory.
[0006] In some configurations, the attachment comprises a wire cavity configured to provide a path for one or more wires to the sensor cavity.
[0007] In some configurations, each of the one or more wires includes a cable, cord, lead, or any other conductive material.
[0008] In some configurations, the wire cavity is formed on the same surface and / or a different surface than the sensor cavity of the nasal cannula interface accessory.
[0009] In some configurations, the wire cavity comprises multiple openings on different (optionally adjacent) faces of the attachment.
[0010] In some configurations, the wire cavity is formed adjacent to the sensor cavity.
[0011] In another 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; a wire cavity configured to provide a path for one or more wires to the sensor cavity; and A pair of arms extending from the cannula interface attachment, the pair of arms extending toward each other and / or toward a center of the attachment, the pair of arms configured to releasably connect the attachment to a nasal cannula interface (and optionally to a strap of the nasal cannula interface).
[0012] In another 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; a wire cavity configured to provide a path for one or more wires to the sensor cavity; and A clip is configured to be connected to the accessory, the clip comprising clip arms connected to the accessory via a biasing element, the clip configured to secure the nasal cannula interface accessory to the nasal cannula interface (optionally a strap of the nasal cannula interface).
[0013] In some configurations, the biasing element comprises a hinge or a spring.
[0014] In some configurations, the sensor cavity is one or more of a square, rectangular, and / or circular shape.
[0015] In some configurations, the sensor cavity has substantially rounded edges and apexes.
[0016] In some configurations, the sensor cavity is positioned to orient the sensor into contact with the patient.
[0017] In some configurations, the sensor cavity is positioned to orient the sensor so that its transducer faces towards the patient.
[0018] In some configurations, the sensor comprises an optical transducer (optionally an infrared or red light transducer) and / or a light source (optionally an infrared or red light source).
[0019] In some configurations, the sensor cavity is positioned to orient the sensor such that the optical transducer and / or light source faces towards the patient.
[0020] In some configurations, the sensor cavity comprises an opening on a face of the accessory configured to face the patient in use.
[0021] In some configurations, the wire cavity extends from the outer surface to the sensor cavity.
[0022] In some configurations, the wire cavity extends from the face of the accessory to the sensor cavity.
[0023] In some configurations, the wire cavity comprises an opening in a face of the accessory that is configured to face the patient during use.
[0024] In some configurations, the wire cavity is a slot.
[0025] In some configurations, the wire cavities are one or more of a square, rectangular, and / or circular shape.
[0026] In some configurations, the sensor is a patient sensor and the patient parameter is a physiological parameter.
[0027] In some configurations, the patient parameter is a measure of the patient's blood oxygenation.
[0028] In some configurations, accessories are attachable to the interface at multiple interface attachment locations.
[0029] In some configurations, the accessory is configured to be adjustable between a plurality of interface mounting positions.
[0030] 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 on the interface).
[0031] In some configurations, the accessory is configured to be slidably adjusted between a plurality of interface mounting positions.
[0032] In some configurations, the accessories are attachable to the interface at multiple patient face positions.
[0033] In some configurations, the attachment is configured to be adjustable between a plurality of patient facial positions without being removed from the interface.
[0034] In some configurations, the attachment is configured so that it can be slidably adjusted between a plurality of patient facial positions.
[0035] In some configurations, the plurality of patient facial positions includes proximate the patient's cheeks.
[0036] In some configurations, the plurality of patient facial positions includes between the patient's eyes and lips.
[0037] In some configurations, the attachment is configured to be adjustable between a plurality of attachment positions at an interface defined by at least a connection point between the strap and the main body of the nasal cannula.
[0038] In some configurations, the multiple patient face positions correspond to multiple mounting positions.
[0039] In some configurations, the attachment may be positioned proximal to the patient's cheek.
[0040] In some configurations, the attachment may be placed between the patient's eyes and lips.
[0041] In some configurations, the attachment is configured to be movable along the length of the strap to allow a clinician to position the sensor.
[0042] In some configurations, the or at least one securing mechanism is configured to hold the attachment against a strap of the nasal cannula interface.
[0043] In some configurations, the securing mechanism is configured to substantially prevent movement of the attachment along the strap.
[0044] In some configurations, the securing mechanism is configured to allow relative movement between the strap and the attachment when a threshold force is applied.
[0045] In some configurations, the threshold force is based on the type of fastening mechanism and the material of the strap.
[0046] In some configurations, the at least one securing feature is configured to extend from a side of the attachment opposite the sensor cavity.
[0047] In some configurations, the at least one securing mechanism comprises at least one arm, the arm configured to extend around at least a portion of the strap of the nasal cannula interface.
[0048] In some configurations, at least one fastening mechanism comprises a pair of arms disposed along an axis of the accessory, the axis being configured to be parallel to the axis of the strap when the accessory is connected to the strap.
[0049] In some configurations, the arm comprises a first portion extending from the attachment (optionally perpendicular to an outer surface of the attachment) and a second portion, the second portion of the arm being configured to be oriented substantially perpendicular to the associated first portion and / or parallel to the attachment.
[0050] In some configurations, at least one securing mechanism comprises a pair of arms extending from the attachment towards one another.
[0051] In some configurations, each arm comprises a first portion and a second portion, the first portion extending from the attachment (optionally perpendicular to an outer surface of the attachment) and the second portion of each arm configured to be oriented towards each other (optionally oriented substantially perpendicular to the associated first portion and / or parallel to the attachment).
[0052] In some configurations, each arm comprises a first portion and a second portion, the first portion extending from the attachment (optionally perpendicularly from an outer surface of the attachment) and the second portion of each arm configured to be oriented toward a center of the attachment (optionally oriented substantially perpendicular to the associated first portion).
[0053] In some configurations, each arm comprises a first portion and a second portion, the first portion extending vertically upward from the attachment and the second portion extending inward toward a center of the attachment and / or toward the second portion of the other arm, and the first portion and second portion of each arm form an angle, the angle being less than, or about, 90 degrees, or less than about 120 degrees.
[0054] In some configurations, the strap of the nasal cannula interface is configured to be connected to an accessory.
[0055] In some configurations, the securing mechanism is configured to receive a strap of a nasal cannula interface.
[0056] In some configurations, a gap is defined between the pair of arms.
[0057] In some configurations, a strap of the nasal cannula interface is configured to be insertable into a gap (optionally defined by an arm or pair of arms) to be connected to an accessory.
[0058] In some configurations, a gap is defined between a pair of the arms.
[0059] In some configurations, the width of the strap of the nasal cannula interface is greater than the gap.
[0060] In some configurations, the strap of the nasal cannula may only be inserted into the gap when the edge of the strap is aligned or when the strap is folded along the width of the strap.
[0061] In some configurations, the strap of the nasal cannula can only be removed from the attachment through the gap when the edge of the strap is aligned or when the strap is folded along the width of the strap.
[0062] In some configurations, the or at least one fastening mechanism comprises a clip.
[0063] In some configurations, the clip comprises clip arms.
[0064] In some configurations, the clip arm is connected to the attachment via a biasing element (optionally a hinge portion).
[0065] In some configurations, the clip extends from the attachment (and optionally from a side of the attachment).
[0066] In some configurations, the clip is configured to retain a strap of the nasal cannula to the accessory when the clip is in a closed position.
[0067] In some configurations, when the clip is in a closed position, the clip is configured to retain a strap between the clip and the nasal cannula on the accessory.
[0068] In some configurations, the clip arms include a contact surface configured to engage a strap of the nasal cannula when the clip is in the closed position.
[0069] In some configurations, the contact surface is disposed in a recess in the clip arm.
[0070] In some configurations, the recess is shaped to receive a strap of a nasal cannula.
[0071] In some configurations, the contact surface includes at least one protrusion, the at least one protrusion configured to help retain the strap when the clip is closed.
[0072] In some configurations, the at least one protrusion comprises at least one rib, the at least one rib being disposed perpendicular to a width of the strap when the strap engages the contact surface and / or perpendicular to a longitudinal axis of the contact surface.
[0073] In some configurations, the at least one rib comprises a pair of ribs spaced apart along a length of the strap when the strap engages the contact surface and / or a longitudinal axis of the contact surface.
[0074] In some configurations, the at least one rib includes a pair of ribs disposed on opposing ends of the contact surface.
[0075] In some configurations, the at least one protrusion includes one or more bumps.
[0076] In some configurations, the one or more bumps include a bump located at each corner of the contact surface.
[0077] In some configurations, one or more bumps are patterned across at least a portion or the entire contact surface.
[0078] In some configurations, the one or more bumps are patterned into offset or aligned rows.
[0079] In some configurations, the contact surface has a non-smooth and / or substantially rough surface.
[0080] In some configurations, when the clip is closed to retain the strap on the nasal cannula, the attachment is prevented from sliding relative to the strap.
[0081] In some configurations, the clip arm includes an aperture extending through the clip arm (and optionally through the contact surface).
[0082] In some configurations, the opening is configured to receive a portion of another of the at least one fastening system (optionally the other of the at least one fastening system is at least one arm).
[0083] In some configurations, the attachment comprises a pair of arms disposed on opposite sides of the clip.
[0084] In some configurations, the clip arm includes at least one retention feature configured to engage a corresponding feature on the attachment to retain the clip in a closed position.
[0085] In some configurations, the strap of the nasal cannula interface is configured to be connected to an accessory.
[0086] In some configurations, the securing mechanism is configured to receive a strap of a nasal cannula interface.
[0087] In some configurations, the securing mechanism is configured to connect to a cannula connector of a nasal cannula interface, and optionally the main body connection mechanism is located at a first end of the attachment.
[0088] In some configurations, the cannula connector is configured to connect a main body of the nasal cannula interface to a strap of the nasal cannula interface.
[0089] In some configurations, the strap passage extends from the second end of the nasal cannula interface attachment along at least a portion of the longitudinal axis of the nasal cannula interface attachment.
[0090] In some configurations, the attachments are configured to function as side arms (and optionally cheek supports for the interface).
[0091] In some configurations, the face of the accessory configured to face the patient in use is substantially circular.
[0092] In some configurations, a surface of the accessory configured to face a patient in use includes at least one surface material.
[0093] In some configurations, the at least one surface material covers a surface of the accessory configured to face the patient.
[0094] In some configurations, at least one surface material does not cover the sensor.
[0095] In some configurations, the at least one surface material is provided with an opening such that the at least one surface material does not extend over the sensor cavity of the accessory.
[0096] In some configurations, at least one surface material is the same material as the accessory.
[0097] In some configurations, at least one surface material is different from another material of the accessory.
[0098] In some configurations, at least one of the surface material and the attachment is separable.
[0099] In some configurations, at least one of the facing material and the attachment is integral.
[0100] In some configurations, at least one surface material is a film or membrane.
[0101] In some configurations, the at least one surface material is configured to increase friction between the accessory and the patient's face.
[0102] In some configurations, the facing material is configured to provide a frictional force that resists movement between the attachment and the strap.
[0103] In some configurations, at least one surface material has adhesive properties.
[0104] In some configurations, at least one surface material has anti-slip material properties.
[0105] In some configurations, the attachment has one or more gripping mechanisms.
[0106] In some configurations, the sensor is pre-installed in the sensor cavity of the accessory.
[0107] In another aspect, a kit is provided that includes a nasal cannula interface and accessories described herein.
[0108] In another aspect, a nasal cannula interface component is provided, the nasal cannula interface component comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide a pathway for one or more wires to the sensor cavity; a main body connection mechanism configured to connect to a main body of the nasal cannula interface and located at a first end of the nasal cannula interface component; and a nasal cannula interface strap.
[0109] In some configurations, the component is a side arm (optionally a cheek support).
[0110] In some configurations, the straps of the nasal cannula are configured to connect to the main body connection mechanism.
[0111] In some configurations, the straps and / or main body connection mechanisms are at least partially integrally formed (optionally overmolded) with the component.
[0112] In some configurations, the sensor is pre-installed in the sensor cavity of the accessory.
[0113] In another aspect, a nasal cannula interface is provided that includes the components described herein.
[0114] In another aspect, a component for a patient respiratory interface is provided, 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 connector configured to connect to a body of the patient respiratory interface, and a second connector configured to connect to headgear of the patient respiratory interface.
[0115] In some configurations, the first connector is disposed at a first end of the component and the second connector is disposed at a second end of the component.
[0116] In some configurations, the first connector is configured to releasably connect the component to a body of the patient respiratory interface.
[0117] In some configurations, the second connector is configured to releasably connect the component to a headgear component of the patient respiratory interface.
[0118] In some configurations, the second connector is configured to be integrally formed with the headgear component.
[0119] In some configurations, the headgear components are straps of a patient respiratory interface.
[0120] In some configurations, the headgear component includes at least one aperture for attaching a strap.
[0121] In some configurations, the component is configured to be located between a body of the patient interface and a headgear component.
[0122] 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.
[0123] In some configurations, the sensor cavity is defined by one or more walls of the component body.
[0124] In some configurations, the sensor cavity is located between the body of the patient respiratory interface and the headgear of the patient respiratory interface.
[0125] In some configurations, the component body and its sensor cavity are disposed between the first connector and the second connector of the component.
[0126] In some configurations, the first connector, the component body, and the second connector are integrally formed with one another.
[0127] In some configurations, the component further comprises a wire cavity, the wire cavity configured to provide a pathway for one or more wires to the sensor cavity.
[0128] In some configurations, each of the one or more wires includes a cable, cord, lead, or any other conductive material.
[0129] In some configurations, the sensor cavity is formed in a first surface of the component body.
[0130] 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.
[0131] In some configurations, the wire cavity includes multiple openings in different (optionally adjacent) faces of the component body.
[0132] In some configurations, the wire cavity is formed in the component body adjacent the sensor cavity.
[0133] In some configurations, the sensor cavity is one or more of a square, rectangular and / or circular shape.
[0134] In some configurations, the sensor cavity has substantially rounded edges and apexes.
[0135] In some configurations, the sensor comprises an optical transducer (optionally an infrared or red light transducer) and / or a light source (optionally an infrared or red light source).
[0136] In some configurations, the sensor cavity is positioned to orient the sensor such that the optical transducer and / or light source faces towards the patient.
[0137] In some configurations, the sensor cavity is configured such that when the sensor is disposed within the sensor cavity, a transducer of the sensor is exposed to an exterior of the component.
[0138] In some configurations, the sensor cavity comprises an opening in a face of the component body that is configured to face the patient in use.
[0139] In some configurations, the sensor cavity is configured to present a transducer of the sensor on a first surface of the component body.
[0140] In some configurations, the sensor cavity is positioned to orient the sensor into contact with the patient.
[0141] In some configurations, the wire cavity extends from the face of the component body to the sensor cavity.
[0142] In some configurations, the wire cavity extends from the outer surface of the component body to the sensor cavity.
[0143] In some configurations, the wire cavity comprises an opening between the face of the component body and the sensor cavity.
[0144] In some configurations, the wire cavity is a slot recessed from the face of the component body.
[0145] In some configurations, the wire cavity has one or more of a substantially square, rectangular, and / or circular cross-section at at least one location along the length of the wire cavity.
[0146] In some configurations, the wire cavity is configured to face the patient in use.
[0147] In some configurations, the sensor is a patient sensor and the patient parameter is a physiological parameter.
[0148] In some configurations, the patient parameter is a measure of the patient's blood oxygenation.
[0149] In some configurations, the patient-contacting surface of the component body that is configured to face the patient in use is substantially circular.
[0150] In some configurations, a face of the component body configured to face a patient in use includes at least one surface material.
[0151] In some configurations, at least one surface material covers a surface of the component body that is configured to face the patient.
[0152] In some configurations, at least one surface material does not cover the sensor.
[0153] In some configurations, the at least one surface material is provided with an opening such that the at least one surface material does not extend over the sensor cavity of the component.
[0154] In some configurations, at least one surface material is the same material as the component.
[0155] In some configurations, at least one surface material is different from another material of the component.
[0156] In some configurations, at least one of the surface material and the component are separable.
[0157] In some configurations, at least one of the surface material and the component are integral.
[0158] In some configurations, at least one surface material is a film or membrane.
[0159] In some configurations, the at least one surface material is configured to increase friction between the component and the patient's face.
[0160] In some configurations, at least one surface material has adhesive properties.
[0161] In some configurations, at least one surface material has anti-slip material properties.
[0162] In some configurations, the components have one or more gripping mechanisms.
[0163] In some configurations, the sensor is pre-installed in the sensor cavity of the component.
[0164] In some configurations, the sensor cavity is held against the patient's skin surface when the first connector is connected to the body of the patient interface and the second connector is connected to a part of headgear or a system for securing the patient interface to the patient.
[0165] In some configurations, the patient respiratory interface is one of a nasal cannula interface, a nasal pillows interface, a nasal mask interface, a full face mask interface, and an oral interface.
[0166] In another aspect, a patient interface is provided that includes headgear or a system and components for securing the patient interface in position about a patient's head.
[0167] In some configurations, the component comprises 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 connect to a body of the patient respiratory interface, and a second connector configured to connect to a headgear of the patient respiratory interface.
[0168] The components may include any of the features and / or functions described herein, for example, as described in any one or more of paragraphs
[0121] to
[0171] .
[0169] In some configurations, the headgear is in the form of at least one strap.
[0170] In some configurations, the straps in use are splittable or bifurcated to provide upper and lower strap portions of the headgear.
[0171] In some configurations, the patient interface is a nasal cannula.
[0172] In some configurations, the patient interface is a nasal cannula and includes a pair or pairs of nasal prongs.
[0173] In some configurations, the nasal cannula comprises a body and one or more nasal prongs are integrally molded with or removably attached to the body.
[0174] In some configurations, the body includes a pair of side arms extending from opposite sides of the body.
[0175] In some configurations, the patient interface includes a sensor located in a sensor cavity of the patient respiratory interface component.
[0176] 1. A patient respiratory interface, comprising: a first side arm including a sensor recess; a gas inlet conduit configured to deliver a flow of breathable gas through the main body of the patient respiratory interface to the patient; and a component having a conduit holding portion configured to hold a gas inlet conduit and a sensor mount configured to hold a patient sensor; 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.
[0177] A first end of the gas inlet conduit connects to the main body of the patient respiratory interface.
[0178] The patient respiratory interface further comprises a second side arm, the second side arm comprising a sensor recess configured to hold a patient sensor.
[0179] At least a portion of the sensor mount of the component is insertable into the sensor recess of the second side arm.
[0180] The first end of the gas inlet conduit is connectable to the main body in a number of different orientations.
[0181] A first end of the gas inlet conduit is connectable to the main body on each of two laterally opposed sides of the main body, a first side adjacent the first side arm and a second side adjacent the second side arm.
[0182] When the gas inlet conduit is connected to the main body on the first side, the sensor mount is insertable into the sensor recess in the first side arm.
[0183] When the gas inlet conduit is connected to the main body on its second side, the sensor mount is insertable into the sensor recess in the second side arm such that the patient sensor contacts the patient's face when the patient respiratory interface is in use.
[0184] When the gas inlet conduit is connected to the main body on its first side and the sensor mount is inserted into the sensor recess of the first side arm, the curvature of the gas inlet conduit between its first end and the conduit retaining portion of the component is less than about 90 degrees.
[0185] When the gas inlet conduit is connected on its second side to the main body and the sensor mount is inserted into the sensor recess of the second side arm, the curvature of the gas inlet conduit between its first end and the conduit retaining portion of the component is less than about 90 degrees.
[0186] The sensor recess of the first side arm and the sensor mount of the component are configured to engage one another when the sensor mount is inserted into the sensor recess of the first side arm to resist withdrawal of the sensor mount from the sensor recess.
[0187] The sensor recess of the second side arm and the sensor mount of the component are configured to engage one another when the sensor mount is inserted into the sensor recess of the second side arm to resist withdrawal of the sensor mount from the sensor recess.
[0188] The gas inlet conduit includes one or more electrically conductive elements extending along at least a portion of its length.
[0189] The gas inlet conduit has a second end opposite the first end, the second end for connecting to the inhalation conduit for receiving a flow of breathing gas therefrom, the second end of the gas inlet conduit comprising one or more electrical connectors for mating with corresponding one or more electrical connectors of the inhalation conduit when connected to the inhalation conduit.
[0190] The one or more electrically conductive elements extend from the second end of the gas inlet conduit to a location along the gas inlet conduit where the conduit-retaining portion of the component retains the gas inlet conduit.
[0191] The one or more conductive elements include one or more sensor wires, which are in electrical communication with a patient sensor when the conduit-retaining portion of the component retains the gas inlet conduit.
[0192] The gas inlet conduit comprises a first portion and a second portion, and the conduit retaining portion of the component interfaces between the first portion and the second portion of the gas inlet conduit.
[0193] The gas inlet conduit comprises a single integral conduit between the first and second ends thereof.
[0194] The conduit retaining portion of the component is permanently attached to the gas inlet conduit.
[0195] The conduit retaining portion of the component is removably attachable to the gas inlet conduit.
[0196] The gas inlet conduit is slidable along its length relative to the component when held by the conduit retaining portion.
[0197] The gas inlet conduit, when held by the conduit holding portion, is not slidable along its length relative to the component.
[0198] The conduit retaining portion retains the gas inlet conduit around a circumference thereof.
[0199] The conduit retaining portion retains the gas inlet conduit around more than about half the circumference of the gas inlet conduit.
[0200] The conduit retaining portion surrounds the gas inlet conduit.
[0201] The clip attaches about halfway around or more of the circumference of the gas inlet conduit.
[0202] The clip surrounds the gas inlet conduit.
[0203] The or each sensor recess comprises an opening through the side arm between the non-patient facing and patient facing sides of the side arm.
[0204] When the sensor mount is inserted and held within the sensor recess, only a portion of the patient sensor is within the sensor recess.
[0205] The or each sensor recess may be square, rectangular or circular in cross-section.
[0206] A cross-section of the sensor mount, or at least a portion thereof, substantially corresponds to a cross-sectional shape of the sensor recess.
[0207] The patient sensor comprises an optical transducer (optionally an infrared or red light transducer) and / or a light source (optionally an infrared or red light source).
[0208] The or each side arm is configured such that the or each sensor recess is located against the patient's cheek when the patient respiratory interface is in use.
[0209] 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 respiratory interface is in use.
[0210] The portion of the sensor mount insertable into the or each sensor recess contains the transducer of the patient sensor when the patient sensor is retained within the sensor mount.
[0211] When held within the or each sensor recess, the transducer of the patient sensor is configured to contact the patient's face when the respiratory patient interface is worn.
[0212] A nasal cannula interface and accessories therefor, the accessories comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; and at least one fastening mechanism configured to connect the accessory to a nasal cannula interface (and optionally to a strap of the nasal cannula interface); The nasal cannula includes a first prong and a second prong, the prongs configured to induce an asymmetric flow of gas at the patient's nares.
[0213] The first prong has a first shape and the second prong has a second shape.
[0214] The first prong has a smaller interior cross-sectional area transverse to gas flowing through the first prong than a corresponding interior cross-sectional area of the second prong transverse to gas flowing through the second prong.
[0215] The first and second prongs are configured such that at least about 60% of a total volumetric flow of gas dispensed by the nasal cannula is delivered from the second prong.
[0216] A nasal cannula interface and components therefor, the nasal cannula interface components comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide a path for one or more wires to the sensor cavity; and a main body connection mechanism configured to connect to a main body of the nasal cannula interface, the main body connection mechanism being located at a first end of the nasal cannula interface component; The nasal cannula interface is a first prong and a second prong, the prongs configured to induce an asymmetric flow of gas at the patient's nares; and Comes with a strap.
[0217] The first prong has a first shape and the second prong has a second shape.
[0218] The first prong has a smaller interior cross-sectional area transverse to gas flowing through the first prong than a corresponding interior cross-sectional area of the second prong transverse to gas flowing through the second prong.
[0219] The first and second prongs are configured such that at least about 60% of a total volumetric flow of gas dispensed by the nasal cannula is delivered from the second prong.
[0220] 1. A patient respiratory interface, comprising: a first prong and a second prong, the prongs configured to induce an asymmetric flow of gas at the patient's nares; a first side arm including a sensor recess; a gas inlet conduit configured to deliver a flow of breathable gas through the main body and the first and second prongs of the patient respiratory interface to the patient; a clip attachable to the gas inlet conduit, the clip configured to hold a patient sensor within a sensor mount of the clip; 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.
[0221] The first prong has a first shape and the second prong has a second shape.
[0222] The first prong has a smaller interior cross-sectional area transverse to gas flowing through the first prong than a corresponding interior cross-sectional area of the second prong transverse to gas flowing through the second prong.
[0223] The first and second prongs are configured such that at least about 60% of a total volumetric flow of gas dispensed by the nasal cannula is delivered from the second prong.
[0224] A nasal cannula interface and accessories therefor, the accessories comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; and at least one fastening mechanism configured to connect the accessory to a nasal cannula interface (and optionally to a strap of the nasal cannula interface); The nasal cannula includes a first prong and a second prong, the first prong having a cross-sectional area smaller than a cross-sectional area of the second prong.
[0225] A cross-sectional area of the first prong that is smaller than a cross-sectional area of the second prong is taken at corresponding locations on the first and second prongs.
[0226] The cross-sectional areas of the first and second prongs are taken at the proximal openings of each of the prongs.
[0227] The difference in cross-sectional area of the first prong and the second prong is such as to cause an asymmetric flow of gas at the patient's nares.
[0228] A patient respiratory interface and accessory therefor, the accessory configured to hold a patient sensor for measuring a patient parameter, the accessory configured to interact with the patient respiratory interface and measure a physiological parameter of the patient when the patient respiratory interface is worn by a patient.
[0229] Interaction of the accessory with the patient respiratory interface includes attachment of the accessory to the patient respiratory interface.
[0230] Interaction of the accessory with the patient respiratory interface includes attachment of the accessory to a strap of the patient respiratory interface.
[0231] The attachment is substitutable for a first component of the patient respiratory interface, and interaction of the attachment with the patient respiratory interface includes substitution of the attachment for the first component of the nasal cannula interface.
[0232] The interaction of the accessory with the patient respiratory interface further includes interconnecting the accessory with a second component of the patient respiratory interface.
[0233] The interaction of the accessory with the patient respiratory interface further includes interconnecting the accessory with both the second and third components of the patient respiratory interface.
[0234] The first component of the patient respiratory interface is the patient respiratory interface side arm.
[0235] The first component of the patient respiratory interface is a connector for connecting two other components of the patient respiratory interface to each other.
[0236] The first component of the patient respiratory interface is a connector for connecting the main body of the patient respiratory interface and the headgear of the patient respiratory interface together.
[0237] The interaction of the accessory with the patient respiratory interface is such that a patient sensor carried by the accessory is associated with the patient respiratory interface and positioned against the patient's face between the mouth and eye areas when the patient respiratory interface is worn by the patient.
[0238] The patient respiratory interface is a nasal cannula interface.
[0239] 1. A patient respiratory interface for delivering respiratory therapy to a patient, the patient respiratory interface comprising: a gas inlet conduit configured to deliver a flow of breathable gas through a main body of the patient respiratory interface to a patient; a patient sensor having a sensor mount; a retention structure connectable on each of the first and second laterally opposed sides of the main body for passing around and retaining the main body on the patient's head, the retention structure comprising: The patient respiratory interface includes a first component located laterally along the retaining structure, the retaining structure connectable to a first side of the main body and configured to receive the sensor mount such that the patient sensor contacts the patient's face when the patient respiratory interface is in use.
[0240] The patient respiratory interface further comprises a second component positioned laterally along the retention structure, the retention structure connectable to a second side of the main body and configured to receive the sensor mount such that the patient sensor contacts the patient's face when the patient respiratory interface is in use.
[0241] When the sensor mount is received by the first component and the patient respiratory interface is in use, the patient sensor contacts a first side of the patient's face.
[0242] When the sensor mount is received by the second component and the patient respiratory interface is in use, the patient sensor contacts a second side of the patient's face opposite the first side.
[0243] The first component has a sensor cavity into which a sensor mount can be inserted and held.
[0244] The first component has a sensor recess extending through the first component from the non-patient-facing side to the patient-facing side of the first component, and the sensor mount can be inserted and retained within the sensor recess.
[0245] The first component is a first side arm.
[0246] The first component is or includes a strap connector for a strap of a retaining structure.
[0247] The first component is or includes a connector between a strap of the support structure and a side arm of the patient respiratory interface.
[0248] The patient sensor is partially overmolded by the first component.
[0249] The second component has a sensor recess extending through the second component from the non-patient-facing side to the patient-facing side of the second component, and the sensor mount can be inserted and retained within the sensor recess.
[0250] The second component is a second side arm.
[0251] The second component is or includes a strap connector for a strap of the retaining structure.
[0252] The second component is or includes a connector between the strap of the support structure and the side arm of the patient respiratory interface.
[0253] The patient sensor is a first patient sensor, and the patient respiratory device further comprises a second patient sensor, the second patient sensor being partially overmolded by the first component.
[0254] When inserted and held within the sensor cavity of the first component, the patient sensor contacts a first side of the patient's face when the patient respiratory interface is in use, and when inserted and held within the sensor cavity of the second component, the patient sensor contacts a second side of the patient's face.
[0255] When inserted and held within the sensor recess of the first component, the patient sensor contacts a first side of the patient's face when the patient respiratory interface is in use, and when inserted and held within the sensor recess of the second component, the patient sensor contacts a second side of the patient's face.
[0256] An accessory for a patient respiratory interface, the accessory having a sensor cavity and configured to hold a sensor therein for measuring a patient parameter, the accessory being interconnectable with one or more components of the patient respiratory interface and configured to interconnect with a patient respiratory system and present the patient sensor to a patient's face when the patient respiratory interface is worn by the patient.
[0257] The accessory is configured to interconnect with one component of a patient respiratory interface.
[0258] The accessory is configured to interconnect with a side arm of the patient respiratory interface, and more specifically with a sensor recess in the side arm of the patient respiratory interface.
[0259] The accessory is substitutable for the first component of the patient respiratory interface.
[0260] The first component of the patient respiratory interface is the patient respiratory interface side arm.
[0261] The first component of the patient respiratory interface is a connector for connecting two other components of the patient respiratory interface to each other.
[0262] The accessory is configured to interconnect between the second and third components of the patient respiratory interface.
[0263] The second component is the main body of the patient respiratory interface, and the third component is the headgear connector of the patient respiratory interface.
[0264] The second component is a side arm of the patient respiratory interface, and the third component is a headgear strap of the patient respiratory interface.
[0265] The patient respiratory interface is a nasal cannula interface.
[0266] These and other features, aspects, and advantages of the present disclosure are described with reference to the drawings of specific embodiments, which are intended to illustrate specific embodiments and are not intended to limit the present disclosure. [Brief description of the drawings]
[0267] [Figure 1] 1 illustrates generally a respiratory apparatus configured to deliver respiratory therapy to a patient. [Diagram 2] 2 shows a schematic diagram of a closed loop control system for use with the respiratory apparatus of FIG. 1; [Diagram 3] 1 illustrates a nasal cannula interface for use with a patient, according to an aspect of the present disclosure. [Figure 4] 1 illustrates a partial front view of a nasal cannula interface according to an aspect of the present disclosure. [Diagram 5] 5 illustrates an exploded view of the nasal cannula interface of FIG. 4. [Figure 6A] 1 illustrates a front view of a body of a nasal cannula interface according to an aspect of the present disclosure. [Figure 6B] 1 illustrates a patient respiratory interface having a nasal interface, or more specifically a nasal cannula interface, with asymmetric delivery elements. [Figure 7A]7A and 7B show a perspective view and a perspective exploded view, respectively, of another nasal cannula interface according to the present disclosure. [Figure 7B] 7A and 7B show a perspective view and a perspective exploded view, respectively, of another nasal cannula interface according to the present disclosure. [Figure 7C] FIG. 7C shows a perspective view of the headgear of the nasal cannula interface. [Figure 7D] 1 illustrates an enlarged perspective view of a headgear connector that connects to a nasal cannula interface according to the present disclosure. [Figure 7E] 1 illustrates an enlarged perspective view of a headgear connector that connects to a nasal cannula interface according to the present disclosure. [Figure 7F] 1 illustrates an enlarged perspective view of a headgear connector that connects to a nasal cannula interface according to the present disclosure. [Figure 7G] 7G and 7H show cross-sectional views corresponding to FIGS. 7D and 7E, respectively. [Figure 7H] 7G and 7H show cross-sectional views corresponding to FIGS. 7D and 7E, respectively. [Figure 8A] FIG. 13 illustrates an enlarged perspective view of the connection between the nasal cannula interface and the headgear, showing the configuration of the side arms of the nasal cannula interface. [Figure 8B] FIG. 13 illustrates an enlarged perspective view of the connection between the nasal cannula interface and the headgear, showing the configuration of the side arms of the nasal cannula interface. [Figure 9A] 1 illustrates an enlarged perspective view of a retaining clip of a nasal cannula interface according to the present disclosure; [Figure 9B] 1 illustrates an enlarged perspective view of a retaining clip of a nasal cannula interface according to the present disclosure; [Figure 9C] 1 illustrates an enlarged perspective view of a retaining clip of a nasal cannula interface according to the present disclosure; [Figure 10A] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 10B]13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 10C] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 11A] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 11B] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 12A] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 12B] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 13A] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 13B] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 13C] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 13D] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 14A] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 14B] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 15A] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 15B] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 15C] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 15D]1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 15E] 1 shows a diagram of an accessory that is connected to a nasal cannula interface. [Figure 15F] 1 shows a diagram of an accessory that is connected to a nasal cannula interface. [Figure 16A] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 16B] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 16C] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 16D] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 16E] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 17A] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 17B] 13 shows a diagram of a sensorless accessory for use with a nasal cannula interface. [Figure 17C] 17C shows a cross-sectional view of the attachment of FIGS. 17A and 17B. FIG. [Figure 18A] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 18B] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 18C] 1 shows a diagram of an accessory having a sensor for use with a nasal cannula interface. [Figure 19A] FIG. 1 is a diagram of a patient respiratory interface including a component that holds a sensor. [Figure 19B] FIG. 19B is a different perspective view of portion A of FIG. 19A. [Figure 19C]FIG. 19C is a perspective view of the component shown in FIG. 19B taken from the opposite side. [Figure 20] FIG. 1 illustrates a diagram of components of a patient respiratory interface that can hold a sensor. [Figure 21] FIG. 21 is a diagram of the component of FIG. 20, with a sensor held by the component. [Figure 22] FIG. 2 is an exploded view of components of or for a patient respiratory interface. [Diagram 23] FIG. [Figure 24] 24 is a cross-sectional view of the connector of FIG. 23 before the clip engages with the detent. [Diagram 25] 24 is a cross-sectional view of the connector of FIG. 23 showing an initial stage of the clip engaging the detent. [Figure 26] FIG. 24 is a cross-sectional view of the connector of FIG. 23 showing the slide in a locked position. [Figure 27] FIG. 24 is a cross-sectional view of the connector of FIG. 23 showing the slide in a free position. [Figure 28] 24 is a cross-sectional view of the connector of FIG. 23 showing the clip removed from the carrier. [Figure 29] FIG. 24 is a half cross-sectional view of a slide of the connector of FIG. 23. [Diagram 30] 24 is a cross-sectional view of the other half of the slide of the connector of FIG. 23. [Diagram 31] FIG. 24 is a perspective view of a carrier of the connector of FIG. 23. [Diagram 32] FIG. 24 is a perspective view of a clip of the connector of FIG. 23. [Diagram 33] FIG. 2 is a perspective view of a conduit and a wire clip. [Diagram 34] FIG. 34 is an end view of the conduit and wire clip of FIG. 33. [Diagram 35] FIG. 13 is a diagram of a portion of a conduit and wire attached to one another using a conduit and wire clip. [Figure 36A] FIG. 13 is a diagram of another nasal cannula interface including a component configured to hold a patient sensor. [Figure 36B] FIG. 36B is a diagram of the component of FIG. 36A configured to hold a sensor. [Figure 37] FIG. 36B is a diagram of the nasal cannula interface of FIG. 36A, configured such that conduits are connectable on both sides of the main body of the interface. [Figure 38A] FIG. 13 is a diagram of another nasal cannula interface including components capable of holding a patient sensor. [Figure 38B] FIG. 38B is a diagram of the component of FIG. 38A configured to hold a sensor. [Figure 39] FIG. 1 is a diagram of the headgear straps and connectors for the patient respiratory interface, one of which is a component that can hold a patient sensor. [Diagram 40] FIG. 13 is a partial exploded view of a nasal cannula interface having a component capable of holding a patient sensor, the component being provided as an intermediate connector between a side arm of the nasal cannula interface and a headgear connector. [Diagram 41] FIG. 13 is a diagram of a communication module for components according to the present disclosure configured to hold a patient sensor. [Diagram 42] 1 is a cross-sectional view of a component configured to hold a patient sensor. [Diagram 43] FIG. 13 is a partial exploded view of a nasal cannula interface having components configured to hold a patient sensor. [Figure 44A] 44A, 44B, and 44C are top, front, and bottom views of a nasal cannula interface having asymmetric prongs. [Figure 44B] 44A, 44B, and 44C are top, front, and bottom views of a nasal cannula interface having asymmetric prongs. [Figure 44C] 44A, 44B, and 44C are top, front, and bottom views of a nasal cannula interface having asymmetric prongs. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0268] Specific embodiments and examples of respiratory devices for providing respiratory assistance to a patient, as well as patient interfaces for such systems, are described herein. Those skilled in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Thus, it is not intended that the scope of the disclosure disclosed herein should be limited by any particular embodiments described herein.
[0269] Patients suffering from a variety of health conditions and diseases can benefit from respiratory assistance. For example, patients suffering from conditions such as chronic obstructive pulmonary disease (COPD), pneumonia, asthma, bronchopulmonary dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, trauma to the respiratory system, acute respiratory distress, receiving pre- and post-operative oxygen delivery, and other conditions or diseases can benefit from respiratory assistance. As part of providing respiratory assistance to a patient, one or more physiological parameters of the patient can be measured by a patient sensor for the purpose of monitoring the patient's health. The patient sensor can be a pulse oximeter that provides information regarding heart rate and blood oxygen saturation (SpO2).
[0270] When a patient is provided with respiratory assistance, particularly supplemental oxygen therapy, a common method of monitoring the patient's health is to ensure that the patient's SpO2 does not fall too low (e.g., typically below about 90%). However, providing the patient with too much oxygen can result in over-oxygenation of the blood, which is also considered dangerous. Generally, a patient's SpO2 is kept in the range of about 80% to about 99%, preferably about 92% to about 96%, although these ranges may vary depending on the patient's condition and / or from patient to patient.
[0271] 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 one prescribed level of supplemental oxygen that can consistently achieve SpO2 response in each patient's target range. Individual patients require periodic monitoring and adjustment of the percentage of oxygen (FdO2) delivered to the patient to ensure they receive the correct FdO2 to achieve the target SpO2. Achieving accurate and consistent SpO2 is an important factor in treating patients with various health conditions or diseases. Furthermore, patients suffering from these health problems can benefit from a system that automatically controls oxygen saturation. The present disclosure is applicable to a wide range of patients who require rapid and accurate oxygen saturation control.
[0272] The percentage of oxygen (FdO2) delivered to the patient can be manually controlled. For example, a user can manually adjust an oxygen delivery valve to change the flow rate or percentage of oxygen delivered to the patient. A user can determine the patient's SpO2 level using a patient monitor, such as a pulse oximeter. The SpO2 measurement can be displayed on the respiratory 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 determined level. The process of monitoring the level of SpO2 and adjusting the amount of oxygen delivered accordingly can be performed in a variety of settings, such as a hospital, palliative care, hospice, or domestic settings (e.g., the patient's home).
[0273] A patient interface (elsewhere "patient respiratory interface") of a respiratory device may have a main body sized and shaped to deliver respiratory assistance through a patient's airways. Patient interfaces are available in a variety of styles, including full face masks, nasal masks, direct nasal masks, and oral masks that form a substantially airtight seal with the nose and / or mouth. The patient interface may be an indirect interface that covers the nose, mouth, or both, or may be an indirect interface, such as an interface with nasal nozzles or pillows or the like that enter the wearer's nares. For example, the patient interface may have a main body in the form of a nasal cannula.
[0274] A patient respiratory interface for use with or including the accessories or components described herein may comprise a nasal interface that may be used to deliver high flow rates of gas to a patient. A nasal delivery element, such as nasal prongs, which may optionally include nasal pillows, is inserted into the patient's nose to deliver the required therapy. The nasal delivery element may be desired to seal or partially occlude with the nose to deliver therapy, or may not need to seal with the nose.
[0275] Nasal prongs typically refer to nasal delivery elements designed to not seal or only partially occlude the nose. When one or more nasal prongs comprise nasal pillows, the nasal delivery elements are designed to seal with the nose. Nasal high flow (NHF) is typically a non-sealing therapy that delivers a relatively large amount of flow to a patient through a patient interface, such as a nasal interface. The nasal interface described herein may refer to, but is not limited to, a nasal cannula.
[0276] Asymmetric interface or asymmetric nasal delivery element as described herein refers to an interface in which the nasal delivery element differs in size, such as inner and / or outer lateral dimension or diameter, and / or inner and / or outer cross-sectional area. The outer cross-sectional area is the cross-sectional area bounded by the outer wall of the nasal delivery element. In the case of a non-circular cross-section, references to diameters herein may be interpreted as lateral dimensions. In some configurations, references to diameters herein include, but are not limited to, hydraulic diameters.
[0277] The asymmetric interface allows asymmetric flow to be delivered through the interface to both or either nostrils. Asymmetric flow as described herein refers to flow that is different inside the interface or inside the nose, or inside the interface and inside the nose. In this way, different flows can be delivered by each nasal delivery element, or the flow can differ between inhalation and exhalation, or the delivered flow can be a combination of the above. Asymmetric flow can also include partial unidirectional flow.
[0278] Asymmetric flow delivery can improve upper airway dead space clearance, reduce peak expiratory pressure, increase safety of therapy, particularly for children and infants, and reduce resistance to interface flow. The asymmetric nasal interfaces and / or nasal delivery elements described herein include patient interfaces configured to generate such asymmetric flow through the asymmetric nasal delivery elements.
[0279] The pressure generated by the NHF depends on the flow through the nasal interface, the size of the patient's nasal delivery element and / or nostrils, and the breathing cycle. If the flow, leakage, or a combination of flow and leakage is asymmetric through the nasal interface, the flow through the nose may be asymmetric during breathing. Partial and total unidirectional flow may be types of asymmetric flow. Partial or total unidirectional flow may improve the clearance of anatomical dead space because air is continuously shed from the upper airway. Partial unidirectional flow may be more comfortable than total unidirectional flow. Total unidirectional flow as described herein includes flow entering one nostril by the nasal delivery element and exiting through the other nostril via the nasal delivery element, flow venting to the atmosphere due to the absence of the nasal delivery element, etc. The partial unidirectional flow described herein includes flow that can enter the nose through both nostrils and exit the nose through one nostril, flow that can enter the nose through one nostril and exit the nose through both nostrils, or flow with different ratios that can enter the nose through both nostrils, flow with different ratios that can exit the nose through both nostrils, may be flow that can enter the nose through both nostrils and exit the nose through one or both nostrils, and optionally via the mouth.
[0280] NHF delivered through an asymmetric nasal interface may include creating an interface in which the nasal delivery elements are different sizes, for example, different lengths and / or inner diameters or cross-sectional areas and / or outer diameters or cross-sectional areas. Particularly for children or infants, the nasal delivery elements have a smaller inner diameter and therefore a higher resistance to gas flow. By using nasal delivery elements of different lengths, each nasal delivery element can have a different inner diameter (e.g., minimum inner diameter or area). A longer nasal delivery element can have a smaller inner diameter and a higher resistance to gas flow, and a shorter nasal delivery element can have a larger inner diameter (e.g., a larger minimum inner diameter) and therefore a lower resistance to gas flow at the interface. The reduced resistance to flow allows a lower back pressure, or a lower motor speed of the gas generating device, or a combination of the two, to be used to achieve the desired flow.
[0281] Asymmetric nasal delivery elements can reduce peak expiratory pressures due to the different cross-sectional areas of the nasal delivery elements at the nose, which can provide different inner diameters for each nasal delivery element.
[0282] The pressure during expiration for an asymmetric nasal interface can be higher than for a symmetric one, which is beneficial since higher positive end-expiratory pressure (PEEP) is part of the treatment for COPD (pressure here refers to intrathoracic pressure). The expiratory pressure depends on the total cross-sectional area of the two prongs. Increasing the cross-section of a symmetric prong carries the risk of completely obstructing the patient's nares. The use of asymmetric prongs allows for an increase in the total cross-sectional area without the attendant risk of obstruction. The partially unidirectional flow can reduce turbulence in the patient's nasal passages, which can improve comfort.
[0283] The patient interface may include headgear (or a "head fixation assembly") for holding the patient interface on the patient's face. The headgear or head fixation assembly may include one or more straps.
[0284] In some configurations, the patient interface may include one or more components that interconnect between the main 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 main body of the patient interface and the headgear to one another.
[0285] When a patient sensor is used as part of a respiratory device, the user must attach the patient sensor to the patient. This adds another task required of the user to an already potentially large set of tasks required to set up the respiratory device. Furthermore, a separate patient sensor can cause problems such as incorrect sensor attachment leading to erroneous measurements and / or the sensor becoming dislodged during use.
[0286] The user of the device may be, for example, a nurse, a doctor, any other medical clinician, or the patient themselves.
[0287] Thus, a patient interface incorporating a patient sensor allows the use of the patient sensor without increasing the workload of the user. It may in particular simplify or eliminate the task of attaching the sensor. This may have advantages in a hospital environment where a single clinician may have a large group of patients that need to be addressed. Additionally, this may have advantages in a home environment as it simplifies the patient set-up process where the clinician may need to perform these tasks themselves. Additionally, integrating the patient sensor into the patient interface helps ensure the correct orientation of the patient sensor and prevents the patient sensor from falling off during use.
[0288] In some cases, for example, when a patient changes to a new therapy and / or requires different respiratory assistance, patient sensors may need to be added to the system, which may require a new patient interface that can accommodate the sensors.
[0289] The patient sensor may be used with the patient interface by an accessory configured to hold a patient sensor for measuring at least one patient parameter, the accessory configured to be attached to the patient interface.
[0290] For example, such an accessory may be configured to attach to a strap or arm of a patient interface to position the sensor relative to the patient's face. The accessory may also accurately position the patient sensor relative to the patient's face and the patient interface to ensure that a reproducible sensor output is obtained.
[0291] Use of the accessory also allows the patient sensors to be removed when the patient changes to a different respiratory support (e.g., when the patient is tapered) without having to replace the entire patient interface and / or when changing to a different therapy by simply removing the accessory.
[0292] The accessories may be provided separately from the patient interface or as part of a kit that includes the patient interface.
[0293] In some configurations, the accessory may be connectable to a headgear portion, such as a strap, of the device that is different from the patient interface being used by the patient.
[0294] An accessory may be described as a component of a patient interface, particularly where the accessory is substitutable for a conventional component of the patient interface, and in such a configuration, the accessory may simply be referred to as a component of the patient interface or a component for the patient interface.
[0295] For example, if the accessory includes a buckle and / or connector mechanism, the accessory may be substituted as a component of the patient interface to replace a conventional buckle or connector between two other portions of the patient interface, such as between a main body and a headgear strap. As a further example, the accessory may function as a component of the patient interface, and more specifically, as a side arm of the patient interface, as described below in connection with Figures 7A-9C. The accessory of Figures 7A-9C may replace a conventional side arm of the patient interface.
[0296] When the patient interface is delivered to a patient, an accessory that can substitute for another component of the patient interface may be provided in place of that component. In other configurations, an accessory that can substitute for another component of the patient interface may be provided in a kit that includes the patient interface, such that a user can substitute the accessory for the patient interface. In yet other configurations, an accessory that can substitute for another component of the patient interface may be provided separately to the patient interface.
[0297] Where an accessory is substitutable for a conventional component of the patient interface, the component that the accessory defines may be interconnected with one or more other components of the patient interface.
[0298] This disclosure refers to conduit heaters, which is a broad term that should be given its ordinary and customary meaning to one of ordinary skill in the art (i.e., not limited to a special or customized meaning), and includes, without limitation, one or more heater strips, one or more heater wires, and / or one or more conductive elements that generate heat when powered. Examples of such conduit heaters include wires made of conductive metals (e.g., copper), conductive polymers, conductive inks printed on the surface of a conduit, conductive materials used to create tracks in a conduit, etc.
[0299] Additionally, the present disclosure refers to conduits, limbs, and medical conduits in the context of gas delivery, for example, conduit is a broad term that should be given its ordinary and customary meaning to those of skill in the art, and includes passages having various cross sections, such as, but not limited to, cylindrical and non-cylindrical passages.
[0300] The disclosed systems, devices, and medical conduits can also be used in breathing circuits configured to provide other forms of respiratory assistance, such as continuous, variable, or bi-level positive airway pressure (PAP) therapy, or high-flow or low-flow oxygen therapy. The breathing circuit may, for example, comprise an inspiratory circuit (including all components) that includes at least an inspiratory gas path from a gas supply to a patient interface.
[0301] A schematic representation of an exemplary respiratory device 10 is shown in FIG.
[0302] The respiratory device 10 comprises a flow source 49 for supplying a high flow gas 27, such as air, oxygen, air mixed with oxygen, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the respiratory device may have a connection for coupling to the flow source. Thus, depending on the context, the flow source may form part of the device, may be considered to be separate from the device, or even part of the flow source may form part of the device, some of the flow source being external to the device. In summary, depending on the configuration (some components may be optional), the system may include a combination of components selected from the following: ·Flow source Humidifiers for humidifying the gas stream Conduits (e.g. dry lines or heated breathing tubes) Patient Interface ·non-return valve ·filter.
[0303] The conduit may include an inhalation conduit 16 , an exhalation conduit, or a gas inlet conduit 62 .
[0304] The device will now be described in more detail.
[0305] The flow source can be an in-wall supply of oxygen, a tank of oxygen 49A, a tank of other gas, and / or a high flow device with a flow generator 49B. Although FIG. 1 shows a flow source 49 with a flow generator 49B with an optional air inlet 49C and an optional connection to an oxygen (O2) source (such as a tank or O2 generator) 49A via a shutoff valve and / or regulator and / or flow controller of other gas 49D, this is just one option. The flow generator 49B can control the flow delivered to the patient 56 using one or more valves, or optionally the flow generator 49B can comprise a blower. The flow source can be one or a combination of the flow generator 49B, O2 source 49A, air source 49C, as described. Although the flow source 49 is shown as part of the device 10, if it is an external oxygen tank or an in-wall source, it can be considered a separate component, in which case the device has a connection port for connecting to such a flow source. The flow source provides a (preferably high) flow of gas that can be delivered to the patient via the inhalation conduit 16 and the patient interface 17.
[0306] The patient interface 17 may be a non-sealing interface, such as an unsealed nasal cannula (e.g., when used in high-flow therapy), or a sealed interface, such as a nasal mask, full face mask, or nasal pillows (e.g., when used in CPAP therapy). In some embodiments, the patient interface 17 is a non-sealing patient interface, which helps to prevent, for example, barotrauma (e.g., tissue damage to the lungs or other organs of the patient's respiratory system due to pressure differentials relative to the atmosphere). In some embodiments, the patient interface 17 is a sealing mask 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 pillows 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 flow rate of base gas, for example, from 0.5 liters / minute to 375 liters / minute, or any range within that range, or even a range with higher or lower limits. The range and nature of the flow rates are described in more detail below.
[0307] A humidifier 52 may optionally be provided between the flow source 49 and the patient to provide humidification of the delivered gas. One or more sensors 48A, 48B, 48C, 48D, such as flow, oxygen fraction, pressure, humidity, temperature, or other sensors, may be located throughout the system and / or at or near the patient 56. Alternatively or additionally, sensors capable of deriving such parameters may be used. Additionally or alternatively, the sensors 48A-48D may be one or more physiological sensors for sensing a patient physiological parameter, such as heart rate, oxygen saturation, blood oxygen partial pressure, respiration rate, blood CO2 partial pressure, etc. Alternatively or additionally, sensors capable of deriving such parameters may be used. Other patient sensors may include electroencephalography (EEG) sensors, torso bands for detecting respiration, and any other suitable sensors. In some configurations, the humidifier may be optional, or it may be preferred, due to the benefit that humidified gas helps maintain airway integrity. 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.
[0308] In some configurations, the respiratory apparatus 10 may include a patient sensor 29 for measuring the oxygen fraction of the air the patient inhales. In some examples, the patient sensor 29 may be located at the patient interface 17 to measure or otherwise determine the percentage of oxygen near the patient's mouth and / or nose. In some configurations, the output from the patient sensor 29 is sent to the controller 19 to help control the respiratory apparatus 10 and / or modify operation accordingly. The controller 19 is coupled to the flow source 49, the humidifier 52, and the patient sensor 29. In some configurations, the controller 19 controls these and other aspects of the respiratory apparatus 10 described herein. In some examples, the controller may operate the flow source 49 to provide a flow of gas delivered at a desired flow rate high enough to meet or exceed the inhalation needs of the user (i.e., the patient). The flow rate is provided sufficiently such that ambient gas is not entrained when the user (i.e., the patient) blows. In some configurations, the patient sensor 29 can communicate a measurement of the patient's oral and / or nasal oxygen fraction to a user, who can input the information into the respiratory device 10 or controller 19.
[0309] An optional check valve 23 may be provided in the intake conduit 16. A filter may be provided at the air inlet 49C and / or at the inlet to the flow generator 49B to filter the incoming gas before it is pressurized into high flow gas 27 by the flow generator 49B.
[0310] The respiratory apparatus 10 may be an integrated or separate component-based arrangement, generally shown in dashed box 104 in FIG. 1. In some configurations, the apparatus may be a modular arrangement of components. Furthermore, the apparatus may include only some of the components shown, although not all are required. Also, the conduits and patient interfaces need not be part of the apparatus and may be considered separate. Although hereinafter referred to as a respiratory apparatus, this should not be considered limiting. "Respiratory apparatus" is considered broadly herein to include those that deliver a flow of gas to a patient. Some such apparatus include a detection system that can be used to determine whether the flow of gas meets the inhalation demand.
[0311] The respiratory apparatus 10 may include a main device housing that houses the components shown within the dashed box 104. The main device housing may include a motor / impeller arrangement, an optional humidifier or humidification chamber 52, a controller 19, and a flow generator 49B, which may be in the form of an input / output (I / O) user interface 54. The user interface 54 may include a display and input devices, such as buttons, a touch screen (e.g., an LCD screen), a combination of a touch screen and buttons, etc. The controller 19 may include one or more hardware and / or software processors and may be configured or programmed to control the components of the system, including, but not limited to, operating the flow generator 49B to generate a flow of gas for delivery to the patient, operating the humidifier or humidification chamber 52 (if present) to humidify and / or heat the flow of gas, receiving user input from the user interface 54 for reconfiguration and / or user-defined operation of the respiratory apparatus 10, and outputting information (e.g., on a display) to a user. The user may be a patient, a health care professional, or otherwise.
[0312] 1, the inhalation conduit 16 may be coupled to a gas flow outlet (gas outlet or patient outlet port) 21 of a main device housing that houses the components shown inside the dashed box 104 of the respiratory apparatus 10, and may be coupled to a patient interface 17, such as a non-sealing interface, such as a nasal cannula having a manifold and nasal prongs. The inhalation conduit 16 may also be a tracheostomy interface, or other non-sealed interface.
[0313] The flow of gas may be generated by a flow generator 49B and may be humidified before being delivered to the patient via the inhalation conduit 16 through the patient interface 17. The controller 19 may control the flow generator 49B to generate a flow of gas at a desired flow rate and / or may control one or more valves to control the mixture of air with oxygen or other breathable gas. The controller 19 may control a heating element in or associated with the humidification chamber 52, if present, to heat the gas to a desired temperature that achieves a desired level of temperature and / or humidity for delivery to the patient. The inhalation conduit 16 may have a heating element, such as a heater wire, to heat the flow of gas flowing to the patient. The heating element may also be under the control of the controller 19.
[0314] The humidifier 52 of the device is configured to combine or introduce humidity into the gas flow. Various humidifier 52 configurations can be employed. In one configuration, the humidifier 52 can comprise a removable humidification chamber. For example, the humidification chamber can be partially or entirely removed or separated from the flow path and / or the device. By way of example, the humidification chamber can be removed, for example, for refilling, cleaning, replacement, and / or repair. In one configuration, the humidification chamber can be received and held by or within a humidification compartment or bay of the device, or can otherwise be coupled on or within a housing of the device.
[0315] The humidification chamber of the humidifier 52 may include a gas inlet and a gas outlet that allow connection to a gas flow path of the apparatus, for example, a gas flow from the flow generator 49B, after being heated and / or humidified, is admitted into the humidification chamber via its gas inlet and exits the chamber via its gas outlet.
[0316] The humidification chamber contains a volume of liquid, typically water, etc. In operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber to produce water vapor or steam, increasing the humidity of gases flowing through the chamber.
[0317] In one configuration, the humidifier is a pass-over humidifier. In another configuration, the humidifier can be a non-pass-over humidifier.
[0318] In one configuration, the humidifier may include, for example, a heater plate associated with or within a humidification bay in which the chamber is placed for heating. The chamber may include a heat transfer surface, such as, for example, a metal insert, plate, etc., at a base or other surface of the chamber that interfaces or engages with the heater plate of the humidifier.
[0319] In another configuration, the humidification chamber may include an internal heater or heater element within or on the inside of the chamber, which may be integrally attached or provided on the inside of the chamber, or may be removable from the chamber.
[0320] The humidification chamber may be of any suitable shape and / or size. The location, number, size, and / or shape of the gas inlet and gas outlet of the chamber may be varied as needed. In one configuration, the humidification chamber may have a base surface, one or more sidewalls extending upwardly from the base surface, and a top surface or top surface. In one configuration, the gas inlet and gas outlet may 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 opposing sides or locations, or other different locations.
[0321] In some configurations, the gas inlet and the gas outlet may have parallel flow axes, hi some configurations, the gas inlet and the gas outlet may be positioned at the same height of the chamber.
[0322] The respiratory apparatus 10 may use ultrasonic transducers, flow sensors such as thermistor flow sensors, pressure sensors, temperature sensors, humidity sensors, or other sensors in communication with the controller 19 to monitor characteristics of the gas flow and / or operate the respiratory apparatus 10 to administer an appropriate therapy. Characteristics of the gas flow may include gas concentration, flow rate, pressure, temperature, humidity, etc. Sensors 48A, 48B, 48C, 48D, 29, such as pressure, temperature, humidity, and / or flow sensors, may be located at various locations in the main device housing, which also houses the components shown within the dashed box 104, the inhalation conduit 16, and / or the patient interface 17. The controller 19 may receive output from the sensors to assist in operating the respiratory apparatus 10 to administer an appropriate therapy, such as determining an appropriate target temperature, flow rate, and / or pressure of the gas flow. Delivering an appropriate therapy may include meeting or exceeding the patient's inhalation demands. In the illustrated embodiment, sensors 48A, 48B, and 48C are positioned on the device housing, sensor 48D is positioned on the inhalation conduit 16, and patient sensor 29 is positioned on the patient interface 17.
[0323] The respiratory apparatus 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. In one configuration, for example, the respiratory apparatus 10 may include a wireless data transmitter and / or receiver, or transceiver 15, that enables the controller 19 to wirelessly receive data signals from the motion sensors and / or control various components of the respiratory apparatus 10. The transceiver 15 or data transmitter and / or receiver module may have an antenna 15a as shown. In one example, the transceiver 15 may comprise a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may deliver data to a remote patient management system (i.e., a remote server) or enable remote control of the respiratory apparatus 10. The respiratory apparatus 10 may include a wired connection, for example using cables or wires, to enable the controller 19 to receive data signals from the motion sensors and / or control various components of the apparatus 10. The respiratory device 10 may comprise one or more wireless communication modules. For example, the device may comprise a cellular communication module, such as a 3G, 4G or 5G module. The module 15 may be or comprise a modem that allows the device to communicate with a remote patient management system (not shown) using a suitable communication network. The remote management system may comprise a single server or multiple servers or multiple computing devices implemented in a cloud computing network. The communication may be two-way communication between the respiratory device and the patient management system (e.g., server) or other remote systems. The respiratory device 10 may also comprise other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or Wi-Fi modules allow the device to wirelessly transmit information to another device, such as a smartphone or tablet, or to operate via a LAN (Local Area Network) or a wireless LAN (WLAN).The device may additionally or alternatively comprise a Near Field Communication (NFC) module for enabling data transfer and / or data communication.
[0324] For example, the measured patient respiratory parameter data (e.g., inspiration time ratio, expiration time ratio, and / or total breath time ratio) can be communicated to a remote patient management system (i.e., a remote server). The remote patient management system can be a single server or a network of servers or a cloud computing system or other suitable architecture for operating a remote patient management system. The remote patient management system (i.e., the remote server) further includes a memory for storing the received data and various software applications or services implemented to perform a number of functions. For example, the remote patient management system (i.e., the remote server) can then communicate information or instructions to the respiratory device 10 depending at least in part on the received data. For example, the nature of the received data can trigger the remote server (or a software application running on the remote server) to communicate an alert, alarm, or notification to the respiratory device 10. The remote patient management system can further store the received data for access by an authorized party, such as a clinician or a patient or another authorized party. The remote patient management system may be further configured to generate a report in response to a request from a certification body, and the respiratory parameter data (e.g., inspiration time ratio, expiration time ratio, and / or total breathing time ratio) may be included in the generated report. The report may further include other patient respiratory parameters (e.g., respiratory rate or SpO2) and / or device parameters (e.g., flow rate, humidity level).
[0325] The respiratory device 10 may comprise a high-flow therapy device. High-flow therapy as discussed herein is intended to give its typical ordinary meaning, generally referring to a respiratory device that delivers a targeted flow rate of humidified respiratory gas through an intentionally unsealed patient interface at a flow rate generally intended to meet or exceed the peak inspiratory flow rate (also referred to as inspiratory demand) of the user, as understood by those skilled in the art. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from about 15 liters / minute to about 60 liters / minute or more. Typical flow rates for pediatric users (e.g., neonates, infants, and children, etc.) often range from about 1 liter / minute per kilogram of user body weight to about 3 liters / minute per kilogram of user body weight or more, but are not limited to these.
[0326] High flow therapy may also optionally include gas mixture compositions including supplemental oxygen and / or administration of therapeutic agents.
[0327] High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (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" can refer to the delivery of gas to a patient at a flow rate of about 10 liters per minute (10 LPM) or greater, 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 neonatal, infant, or pediatric patients, "high flow therapy" can refer to the delivery of gas to the patient at a flow rate of greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and about 15 LPM, or between about 20 LPM and 25 LPM. High flow therapy devices for adult, neonatal, infant, or pediatric patients can deliver gas to the patient at a flow rate of between about 1 LPM and about 100 LPM, or any of the subranges outlined above.
[0328] High flow therapy can be effective in meeting or exceeding the patient's inspiratory demand, increasing the patient's oxygenation, and / or decreasing the patient's work of breathing. Additionally, high flow therapy can create a flushing effect in the nasopharynx such that the anatomical dead space in the upper airway is flushed by the high inflow of gas. The flushing effect can create a reservoir of fresh gas available with every breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. High flow therapy can also increase the patient's expiratory time due to pressure during exhalation, which in turn decreases the patient's respiratory rate.
[0329] A patient interface for use with high flow therapy may be a non-sealing interface 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 the atmosphere. The patient interface may be a nasal cannula having a gas flow portion (e.g., a manifold) and nasal prongs, and / or a non-sealing tracheostomy interface, or any other suitable type of patient interface.
[0330] Respiratory device 10 is capable of measuring and controlling the oxygen content of the gas delivered to the patient, and therefore the oxygen content of the gas inhaled by the patient. The oxygen concentration measured by respiratory device 10, the fraction of oxygen delivered (FdO2), may be substantially the same as the oxygen concentration the patient is breathing, the fractional inspired oxygen (FiO2), and therefore these terms may be considered equivalent.
[0331] The sensor 29 is a patient sensor. If the patient sensor 29 is disconnected (either from the patient or the respiratory apparatus) during operation, the respiratory apparatus 10 may continue to operate in its previous operating state for a predetermined period of time. After the predetermined period of time, the respiratory apparatus 10 may trigger an alarm, transition from automatic to manual mode, and / or exit a control mode (e.g., automatic or manual mode) entirely.
[0332] The respiratory apparatus 10 may be configured to recognize whether the patient sensor 29 is a stand-alone patient sensor or a patient sensor located or included in the patient interface 17. The respiratory apparatus 10 may recognize the type of sensor by receiving identification information upon initial connection of the patient sensor 29. The respiratory apparatus 10 may recognize the type of sensor by the way in which a signal from the patient sensor 29 is received. For example, an integrated patient sensor 29 may be configured to communicate with the respiratory apparatus 10 via an electrical connection located at the gas outlet of the respiratory apparatus 10 (as described herein), while a stand-alone patient sensor may be configured to connect to the respiratory apparatus via a separate connection port.
[0333] The patient sensor 29 may include other associated processors or circuitry, or the associated processors and / or circuitry may be located elsewhere.
[0334] The patient sensor 29 may include a housing that may contain the sensor transducer and any associated processor and / or circuitry.
[0335] The patient sensor 29 may be a skin contact sensor that contacts the skin when in the operative position of the sensor cavity.
[0336] As mentioned above, the patient sensor 29 may be a pulse oximeter sensor configured to measure heart rate and / or blood oxygen saturation (SpO2). The pulse oximeter sensor may be provided as part of a pulse oximeter for measuring heart rate and / or blood oxygen saturation. The pulse oximeter may include a pulse oximeter sensor and a processor and / or circuitry for controlling 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 from the pulse oximeter sensor. The processor and / or circuitry may further process signals received from the pulse oximeter sensor and may communicate the processed signals or other resulting information to another device.
[0337] The connection between the pulse oximeter sensor and other processors and / or circuitry of the pulse oximeter may be wired and / or wireless, for example, in the same manner as described elsewhere herein in connection with potential configurations of the communications module of the respiratory device 10. If 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 the wired connection or may be powered by a power source, such as a battery, that is integral with the pulse oximeter sensor. In at least some configurations in which the pulse oximeter sensor is wirelessly connected to other processors and / or circuitry of the pulse oximeter, a battery power source may be provided with the pulse oximeter sensor. The battery power source may be rechargeable by the user.
[0338] The pulse oximeter sensor may be a reflectance type pulse oximeter sensor.
[0339] The respiratory apparatus 10 may be configured to use the output of a patient sensor 29 located on or included in the patient interface 17 to determine whether the patient is wearing the patient interface 17. In this context, "wearing" refers to the patient interface 17 being worn on the patient's face in a position such that the patient interface 17 can deliver a flow of gas to the patient and the patient sensor 29 can measure one or more patient parameters. If the patient sensor 29 is unable to reliably measure one or more patient parameters, it may generate a signal indicative thereof. Additionally or alternatively, the patient sensor 29 may communicate a separate parameter, such as signal quality. The respiratory apparatus 10 may check this parameter against a threshold value in determining whether the patient sensor 29 is able to reliably measure one or more patient parameters. The respiratory apparatus 10 may use the determination that the patient sensor 29 is unable to reliably measure one or more patient parameters in further determining that the patient interface 17 is not being worn by the patient.
[0340] The respiratory device 10 may use the determination of whether the patient is wearing the patient interface 17 to activate or deactivate certain control algorithms, such as a closed loop SpO2 controller, as will be described in more detail later in this specification. The respiratory device 10 may use the instructions when to increase or decrease the flow rate. For example, the respiratory device 10 may reduce the flow rate when the patient is not wearing the patient interface 17 to reduce noise and power consumption. The respiratory device 10 may use the instructions to generate an alarm, such as a warning if the patient removes the patient interface 17. This alarm may occur instantaneously or within a set period of time after the output of the patient sensor 29 is lost.
[0341] In a further configuration, the respiratory apparatus 10 is configured to switch to a standby mode when the output of the patient sensor 29 indicates that the patient is not wearing the patient interface 17. In the standby mode, the respiratory apparatus 10 may be configured to control the blower to operate at a reduced motor speed. The reduced motor speed may be a minimum operating speed of the blower. The reduced motor speed may be approximately 1000 RPM to 2000 RPM. In the standby mode, the respiratory apparatus 10 may be configured to control the blower to deliver a reduced flow rate. The reduced flow rate may be approximately 1 LPM to 2 LPM.
[0342] The blower can operate at a motor speed between about 1,000 RPM and about 30,000 RPM, between about 2,000 RPM and about 21,000 RPM, between about 4,000 RPM and about 19,000 RPM, or between any of the aforementioned values. The operation of the blower can mix the flow of gas entering the blower through the inlet port. Using the blower as a mixer can reduce the pressure drop that occurs in respiratory devices with separate mixers, such as static mixers that include 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, further increasing the delay between when the valve current changes and when the corresponding change in oxygen concentration is measured.
[0343] Based on user input and the therapy delivered by respiratory apparatus 10, the controller 19 can determine a target output parameter for the blower. The controller can receive measurements of the target output parameter, and based on the difference between the determined flow rate and the measured flow rate, the controller can adjust the blower speed.
[0344] 1, the controller 19 may be programmed or configured to implement a closed loop control system for controlling the operation of the respiratory apparatus. The closed loop control system may be configured to ensure that the patient's SpO2 reaches and consistently remains at or near a target level.
[0345] The controller 19 can receive inputs from a user that can be used by the 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 can be preset, selected by a clinician, or determined based on the type of patient, which can refer to current pain and / or information about the patient such as age, weight, height, sex, and other patient characteristics. The target SpO2 value can be entered by a clinician or a user via a user interface of the device and received by the controller 19. Similarly, the target SpO2 can be two values, each selected in any of the ways described above. The two values represent a range of acceptable values for the patient's SpO2. The controller can target a value within said range. The target value can be the midpoint of the range, or any other value within the range, which can be preset or selected by the user. Alternatively, the range can be set automatically based on the target value of SpO2. The controller can be configured to have one or more set responses when the patient's SpO2 value moves outside of the range. The responses may include an alarm, a change to manual control of FdO2, a change to a particular value of FdO2, and / or other responses. The controller may have one or more ranges, and moving outside of each range will result in one or more different responses.
[0346] Typically, SpO2 is controlled to about 80% to about 100%, or about 80% to about 90%, or about 88% to about 92%, or about 90% to about 99%, or about 92% to about 96%. SpO2 can be controlled between any two suitable values from any two of the aforementioned ranges. The target SpO2 can be about 80% to about 100%, or about 80% to about 90%, or about 88% to about 92%, or about 90% to about 99%, or about 92% to about 96%, or about 94%, or 94%, or about 90%, or 90%, or about 85%, or 85%. The SpO2 target can be any value between any two suitable values from any two of the aforementioned ranges. The SpO2 target can correspond to the middle of the defined range of SpO2.
[0347] FdO2 can be configured to be controlled within a range. As previously mentioned, the oxygen concentration measured by the device (FdO2) is substantially the same as the oxygen concentration (FiO2) the patient is inhaling as long as the flow rate meets or exceeds the patient's peak inhalation demand, and therefore these terms can be considered equivalent. The limits of the range can be preset, selected by the user, or determined based on the type of patient, which may refer to information about the patient, such as current pain and / or age, weight, height, sex, and / or other patient characteristics. Alternatively, a single value of FdO2 can be selected and the range can be determined based at least in part on this value. For example, the range can be a set amount above and below the selected FdO2. The selected FdO2 can be used as a starting point for the controller. If the controller attempts to move the FdO2 out of the range, the system can have one or more responses. These responses may include an alarm, preventing the FdO2 from moving out of range, switching to manual control of the FdO2, and / or switching to a particular FdO2. The respiratory apparatus 10 may have one or more ranges where reaching the limit of each range results in one or more different responses.
[0348] Referring to FIG. 2, a schematic diagram of a closed loop control system is shown. The closed loop control system may utilize two control loops. The first control loop may be implemented by an SpO2 controller. The SpO2 controller determines the target SpO2. O The target FdO2 may be determined based in part on the FdO2 and / or the measured SpO2. As discussed above, the target SpO2 value may be a single value or a range of acceptable values. The value may be preset, selected by a clinician, or automatically determined based on patient characteristics. Generally, the target SpO2 value is received or determined prior to or at the beginning of a therapy session, although the target SpO2 value may be received at any time during a therapy session. During a therapy session, the SpO2 may be measured based on the FdO2 and / or the measured SpO2. O The second controller may also receive as inputs: a measured FdO2 reading from the gas composition sensor, and a measured SpO2 reading and signal quality reading from the patient sensor 29. In some configurations, the SpO2 controller may receive a target FdO2 as an input, in which case the output of the SpO2 controller may be fed directly back as an input to the SpO2 controller. Based at least in part on the input, the SpO2 controller may output a target FdO2 to the second control loop.
[0349] During the therapy session, the SpO2 and FdO2 controllers may continue to automatically control the operation of the respiratory apparatus until the therapy session ends or an event triggers a change from automatic to manual mode.
[0350] For example, a respiratory assistance system that uses blood oxygen saturation (SpO2) measurements from a pulse oximeter to automatically adjust the oxygen fraction (FdO2) of a flow of gas delivered to a patient via a patient interface is described in PCT Publication WO 2019 / 070136, filed October 5, 2018 (herein "WO 136"), the entirety of which is incorporated herein by reference.
[0351] The respiratory assistance system described in WO 136 uses a separate pulse oximeter sensor and patient interface, which requires the clinician to separately attach both the pulse oximeter sensor and the patient interface to the patient, and both of these components are also separately connected to the respiratory apparatus.
[0352] Referring again to FIG. 1, the controller 19 may be programmed or configured to implement an FdO2 control system for controlling the operation of the respiratory apparatus.
[0353] The FdO2 control system can be configured to ensure that the instantaneous FdO2 is maintained at the target level at all times during the therapy session. The controller can measure the FdO2, compare it to the target FdO2, and then adjust the oxygen inlet valve accordingly. However, if the FdO2 sensor is located only a small distance away from the valve, there is a time delay between when a change is made to the valve and when the corresponding change in FdO2 is measured. The controller can adjust the valve after the time delay. However, if the flow rate is fluctuating, the controller can achieve the target FdO2 on average, but not continuously and substantially instantaneously. As shown in FIG. 2, in order to maintain the FdO2 at the target level continuously and substantially instantaneously without having to place the FdO2 sensor close to the valve, the FdO2 controller can incorporate a measurement of the total flow rate into the control of the valve.
[0354] The patient interface 17 is connected to one end of the inhalation conduit 16 and is used to deliver a flow of breathable gas to the patient. During set-up of the respiratory apparatus 10, the clinician or patient will be required to attach the patient interface 17 to the patient. Additionally, if a stand-alone patient sensor 29 is also used, the clinician or patient will also be required to attach this to the patient. In that case, both the patient interface 17 and the patient sensor 29 will also need to be attached to the respiratory apparatus 10 itself. Making these various connections may not be desirable.
[0355] The 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 (SpO2). The one or more integrated patient sensors 29 are positioned on the patient interface 17 to facilitate measuring the patient's blood oxygen saturation (SpO2).
[0356] The patient interface 17 may be used with the respiratory device 10 described above, or may be used with any other respiratory device that may utilize a patient interface 17 having patient sensors 29, such as a ventilator, a CPAP device, a stand-alone humidifier, and / or an oxygen blender.
[0357] The patient interface 17 may comprise a nasal cannula interface, as shown in Figures 3-7. In this configuration, the nasal cannula interface broadly comprises a head fixation assembly (also referred to as headgear) and a nasal cannula 30, and also includes a gas inlet conduit 62. The head fixation assembly allows the user to place and maintain the nasal cannula 30 in the correct operating position. The gas inlet conduit 62 forms a fluid or gas connection between the outlet end of the inhalation conduit 16 and the nasal cannula 30, allowing fluid or gas to flow between the inhalation conduit and the nasal cannula. Details of the gas inlet conduit 62 and the main parts of the nasal cannula 30 are described in detail below.
[0358] The head securement assembly of the 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 an upper strap 53b, as shown in FIG. 3. 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. The rear strap 53a and the upper strap 53b extend between the distal ends of the front straps 50. In use, the rear strap 53a wraps around the back of the patient's head. In use, the upper strap 53b wraps around the top of the patient's head. In some configurations, the head securement assembly is adjustable to allow patients with different head shapes and sizes to use the nasal cannula 30. For example, an adjuster, such as an adjustment buckle 54, may be included to allow the patient to loosen or tighten the upper strap 53b.
[0359] In some configurations, one or more of the straps are substantially elastic (i.e., made from an elastic material, e.g., elastane, that can stretch to accommodate 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 are made from a substantially rigid material. In some configurations, one or more of the straps are substantially inextensible. In some configurations, one or more of the straps are made from 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 maintain their shape when not in use.
[0360] Alternatively, the patient interface 17 is secured to the patient's head and face by a front strap 50 and a single rear strap 53a attached to the front strap 50. The rear strap is attached to the front strap 50 via a buckle 54. Alternatively, the rear strap 53a is integral with the front strap 50. The buckle 54 allows the patient to loosen or tighten the front strap 50 based on individual preference. Alternatively, the integral front strap 50 and rear strap 53a are elastic and can stretch across the patient's head. The elasticity of the straps exerts a force on the head to hold the nasal cannula 30 in an optimal position during use. The elastic front straps 50, 53a can be used with the adjustment buckle 54 or the elastic front straps 50, 53a can be used alone without the buckle 54.
[0361] The head fixation assembly may also include a loop 55 that holds and supports the gas inlet conduit 62 at or near the inlet end, as shown in FIG. 3. The loop 55 has a first end connected to one of the front straps 50. The first end may be slidably connected to the front strap 50. The loop 55 has a second end connected to the gas inlet conduit 62. The second end may be removably connected to the gas inlet conduit 62. Alternatively, the interface may include a tube clip that is connected to the tube and may be removably coupled to the cannula. The tube clip supports the weight of the gas inlet conduit 62 and reduces the moment caused by the gas inlet conduit 62, thereby improving the stability of the patient interface 17. The clip helps reduce dislodgment of the patient interface 17. The clip may be formed of a rigid material.
[0362] The lanyard 63 may also comprise the patient interface 17. FIG. 3 shows an example of the lanyard 63. In the illustrated configuration, the lanyard 63 is connected to the gas inlet conduit 62. Alternatively, the lanyard 63 is connected to a location at or near the junction between the inhalation conduit 16 and the gas inlet conduit 62. In use, the lanyard 63 supports the weight of the inhalation conduit 16 and the gas inlet conduit 62. The lanyard 63 is provided with a toggle 64 to allow adjustment of the length of the lanyard. The toggle 64 makes the lanyard 63 suitable for use with the patient interface 17 by any size patient. The lanyard 63 supports at least a portion of the weight of the inhalation conduit 16 in use, so that the weight does not act on the patient or the nasal cannula 30. The use of the lanyard 63 reduces some of the combined weight of the inhalation conduit 16 and the gas inlet conduit 62 that pulls the nasal cannula 30 and helps prevent the nasal prongs 33, 34 from interfering with the sensitive insides of the nasal passages or becoming displaced or misaligned during use. In the configuration shown, the lanyard 63 fits loosely around the neck to reduce the possibility of strangulation of the patient. The lanyard 63 also provides a convenient way to support the inhalation conduit 16 and the gas inlet conduit 62. This allows the patient to turn over in their sleep without jerking or pulling on the inhalation conduit 16 and encourages the gas inlet conduit 62 to avoid overheating under a blanket. In one configuration, the lanyard 63 has a clip that allows the lanyard to be opened and closed by the user to position and secure the lanyard 63 around the patient's neck. The clip includes male and female connectors that snap together. The clip is cut by pulling on one end of the lanyard 63. The clip is easily severable and separates when the user pulls on one side of the lanyard, allowing the lanyard 63 to be quickly removed in an emergency situation, for example when a patient needs to be intubated.
[0363] The gas inlet conduit 62 will now be described in detail. The gas inlet conduit 62 is a short length of conduit or tube relative to the inhalation conduit 16 that passes between the outlet of the inhalation conduit 16 and the nasal cannula 30. In use, the gas inlet conduit 62 forms a lumen that defines a gas path between the inhalation conduit 16 and the patient interface 17, whereby a flow of gas leaves the inhalation conduit 16, enters the gas inlet conduit 62, travels along the gas inlet conduit 62 to the patient interface 17 for delivery to the patient. One reason that a secondary conduit such as the gas inlet conduit 62 may be used is as follows: the inhalation conduit 16 is used to transport a flow of gas over a reasonably long distance (from the humidifier unit 2 to a point close to the patient), and is therefore relatively heavy and cumbersome. The inhalation conduit 16 must therefore have walls strong enough to support its own weight without collapsing. Because the inhalation conduit 16 is typically relatively long (e.g., 8 to 10 feet), this additional length and thicker wall construction increases the weight of the inhalation conduit 16. If the outlet of the inhalation conduit 16 were directly connected to a patient interface in a manner that required the patient to support this weight, this could cause discomfort to the patient due to the weight of the inhalation conduit 16 acting on the patient. Furthermore, the weight of the inhalation conduit 16 could pull on the patient interface 17, displacing or dislocating it. A lighter, shorter secondary conduit (e.g., gas inlet conduit 62) could be used that extends between the outlet of the inhalation conduit 16 and the patient interface 17.
[0364] The gases inlet conduit 62 is lighter and shorter than the inhalation conduit 16 and, as outlined above, is typically used with a lanyard 63 connected, for example, to the gases inlet conduit 62 or to the connection between the inhalation conduit 16 and the gases inlet conduit 62. In use, the lanyard 63 (as outlined above) supports at least a portion of the weight of the inhalation conduit 16 such that the patient interface 17 only needs to support the relatively light gases inlet conduit 62. Furthermore, in the configuration in which the lanyard 63 connects to the end of the gases inlet conduit 62, the patient does not need to remove the lanyard 63 when disconnecting the gases inlet conduit 62 from the inhalation conduit.
[0365] Various embodiments of nasal cannula 30 will now be described in more detail with reference to Figures 4-6B. Unless otherwise indicated, nasal cannula 30 shown in Figures 4-6B includes all of the features of the generalized nasal cannula described with reference to Figure 3.
[0366] The nasal cannula 30 comprises two main parts: an interface connector 35 and a body 32. An exemplary configuration of these two parts will now be described with particular reference to FIGS.
[0367] The interface connector 35 is used to be connected to and in fluid communication with the gas inlet conduit 62 as described above, however, it may be connected directly to the intake conduit 16 in alternative embodiments.
[0368] The configuration of Figure 5 shows the interface connector 35 as being detachable from the remainder of the nasal cannula 30. Alternatively, the interface connector 35 may be an integral part of the nasal cannula 30. Alternatively, the interface connector 35 and the nasal cannula 30 form a one-time fit such that the user is prevented from disassembling the two components after initial assembly. In the integral or one-time fit configuration, a continuous gas flow path is formed through the inhalation conduit 16, the gas inlet conduit 62, the interface connector 35, and to the prongs of the nasal cannula 30.
[0369] 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, which is formed on one side of the interface connector 35 so as to be perpendicular to the inlet 59. The circular inlet 59 in the illustrated form receives the patient end of a gas inlet conduit 62 such that gas flow from the gas inlet conduit 62 can pass through the interface connector 35.
[0370] In some configurations, the interface connector 35 is integral with or permanently coupled to the gases inlet conduit 62. Alternatively, the interface connector 35 is removably attached to the gases inlet conduit 62. The interface connector 35 engages the body 32 such that gas flow can pass through the outlet 37 and from the gases inlet conduit 62 through the nasal prongs 33, 34 (described in more detail below) to the patient.
[0371] In some configurations, the interface connector 35 is manufactured from a hard plastic material that deforms only under relatively high load conditions (i.e., it cannot be easily crushed by a user's hand.) The interface connector 35 can be molded, injection molded, machined, or cast.
[0372] In use, the interface connector 35 is connected to the body 32 such that the flow of gas exiting the interface connector 35 enters the body 32. The body 32 will now be described in detail.
[0373] The body 32 includes nasal prongs 33, 34 that extend from a base 39 of the body 32. Gas flow passes through the body 32 to the nasal prongs 33, 34 for delivery to the patient. In some configurations, the nasal prongs 33, 34 extend parallel to one another. In some configurations, the nasal prongs 33, 34 curve back from the face mounting portion or body 32. In some configurations, the nasal prongs 33, 34 curve toward one another. The structure of the prongs 33, 34 is described in more detail below.
[0374] The body 32 in the illustrated embodiment includes a side arm 31 and a tubular member 38 that includes a recess integrally molded therewith, as shown in Figures 4 and 5. The tubular member 38 extends below the body 32 and is adapted to receive the interface connector 35 (for configurations in which the body 32 and the interface connector 35 are separable or separate items). The body 32 has a lip 39 that extends around an upper edge of the tubular member 38. The interface connector 35 is connected to the body 32 by a friction fit, and the lip 39 of the body 32 serves to grip the interface connector 35 and form a sealed connection between the interface connector 35 and the body 32. The tubular member 38 includes a rib 40 that extends below the body 32. The rib 40 serves to cradle and hold the interface connector 35 in place when engaged with the body 32, and the rib 40 extends around the outside of the interface connector 35. The outlet 37 of the interface connector 35 aligns in use with the face mount portion or underside of the body 32 when the interface connector 35 is connected to the body 32. This alignment reduces the amount of gas that escapes from the nasal cannula 30 and allows for effective treatment of the patient by delivering a maximum amount of humidified gas.
[0375] The side arms 31 are used to attach the front straps 50 to the body 32. The 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 straps 50 are attached to the side arms 31 so that the patient interface can be worn by the patient. In some configurations, the ends of the front straps 50 are looped through a pair of slits in the side arms 31, and the ends include hook-and-loop fasteners or the like to hold the ends in place when they are unlooped. Alternatively, the front straps 50 or loops 66 may be clipped to the side arms 31, for example, by cooperating male-female clips or by being adhesively attached to the side arms 31.
[0376] In some configurations, the body 32, nasal prongs 33, 34, side arms 31, and tubular member 38 are all manufactured as one continuous piece. The body 32, nasal prongs 33, 34, side arms 31, and tubular member 38 are all manufactured from a flexible polymeric material, such as a soft thermoplastic elastomer (TPE) or silicone.
[0377] The nasal prongs are described below. In the following description, the term "rear" or "rearward" or any such synonym refers to the portion of the structure that faces and is closest to the patient's face when the nasal cannula is in use. The term "front" or "forward" or any such synonym refers to the surface, surface, or portion that faces away from and is furthest from the face of the patient in use. The term "upper" or "top" refers to the surface, surface, or portion that faces away from the floor when the patient wearing the patient interface is standing or sitting upright and looking forward. The term "bottom" or "lower" refers to the surface, surface, or portion that is oriented or facing the ground when the patient wearing the interface is standing or sitting upright and looking forward. For example, FIG. 3 shows the patient interface 17 being worn by a patient, and the above-mentioned directions can be evaluated with reference to this figure. The definitions of these directions are consistent throughout, including in figures in which the patient interface 17 is shown without a patient.
[0378] In some configurations, the body 32 includes two nasal prongs 33, 34 that extend upwardly from the top surface of the body 32 and curve inwardly, as shown in Figures 4-6B. With reference to Figures 4-6B, the nasal prongs 33, 34 extend from the top surface of the body 32, with each prong positioned within a respective nostril of the patient when the nasal cannula is in use. The prongs 33, 34 are configured to deliver a flow of gas to the patient. The prongs 33, 34 receive a flow of humidified gas from the gas inlet conduit 62 through the gas inlet conduit 62, the interface connector 35, and the body 32. Thus, the nasal prongs 33, 34 are in fluid communication with the interface connector 35 and receive a flow of gas from the gas inlet conduit 62.
[0379] 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 positioned on the nasal cannula 30 such that it contacts the patient's skin during use. The patient sensor 29 can have an adhesive surface such that it can be secured in contact with the patient's skin.
[0380] The exterior surface of the body 32 of the nasal cannula 30 may generally be divided into an outwardly facing surface and an inwardly facing surface. As used herein, the term "outwardly facing surface" may refer to the exterior surface of the body 32 that faces away from the patient while the nasal cannula 30 is in use. As used herein, the term "inwardly facing surface" may refer to the exterior surface of the body 32 that faces towards the patient while the nasal cannula 30 is in use. The front and bottom surfaces of the body 32 may be considered to be outwardly facing surfaces, while the rear surface may be considered to be an inwardly facing surface. The central portion of the top surface of the body 32 that is located under the patient's nose in use may be considered to be an inwardly facing surface, and the remaining surface portions of the top surface may be considered to be outwardly facing surfaces.
[0381] FIG. 6B illustrates an exemplary patient respiratory interface 1000 comprising a nasal cannula 30 having asymmetric nasal delivery elements 111,112.
[0382] The nasal cannula 30 provides the patient with a patient interface suitable for delivery of high airflow, high humidity gas flows to the patient's nasal cavities / nostrils. In some configurations, the nasal cannula 30 is adapted to deliver high flow rates of gas over a wide range of flow rates (e.g., about 81 lpm or more, and in some cases 10-50 lpm or more depending on other therapeutic indications). In some configurations, the nasal cannula 30 is adapted to deliver relatively low pressure gas.
[0383] As seen in Fig. 6B, the gases inlet conduit 62 delivers inlet gases to the nasal cannula 30. Headgear 200 is shown with a patient respiratory interface 1000 for holding the nasal cannula 30 on the patient's face during use. A retaining clip 280 is shown holding the gases inlet conduit 62 to the headgear 200. Nasal prongs 111, 112 are associated with the main body 110 of the nasal cannula 30.
[0384] The nasal prongs 111 and 112 extend into the patient's nares in use and are curved to provide a smooth flow path for gas to flow. The inner surface of the prongs 111 and 112 may be contoured to reduce noise. The base of the prongs 111 and 112 may include a curved surface to provide a smoother gas flow. This may reduce noise levels during operation.
[0385] The nasal prongs 111 and 112 are substantially hollow and substantially tubular in shape.
[0386] The nasal prongs 111 and 112 may be of constant diameter along their length or may be shaped to fit the contours of the nostrils.
[0387] The main body 110 is shaped to generally follow the contours of the patient's face around the upper lip area, and the face mounting portion 110 is shaped or preformed to be conformable to and / or compliant to conform, accommodate, and / or correspond to the contours of the patient's face in the area of the face where the cannula is to be placed.
[0388] The asymmetry of the nasal prongs 111 and 112 can reduce the likelihood of accidental obstruction of both nares. Thus, to avoid sealing the gas path between the nasal cannula 30 and the patient, at least one of the nasal prongs 111 and 112 is sized to maintain a sufficient gap between the exterior surface of the prongs 111 and 112 and the patient's skin. In the context of the present disclosure, it should be understood that the nasal prongs 111 and 112 are asymmetrical as described below.
[0389] A further example of a patient interface having asymmetric prongs is shown in Figures 44A-C.
[0390] 6A and 44A-C, in some configurations, a nasal cannula 30 of the present disclosure comprises a first prong 111 and a second prong 112 that are asymmetrical with respect to one another, and a main body 110 that comprises a gas inlet. The first prong 111 and the second prong 112 are in fluid communication with the gas inlet. The nasal cannula is configured such that at least about 60% of the total volumetric flow of gas entering the gas inlet is delivered from the nasal cannula through the second prong 112.
[0391] The first prong 111 and the second prong 112 as shown in Figure 6B and Figures 44A-C can be considered as asymmetric nasal delivery elements.
[0392] The first prong 111 and the second prong 112 are asymmetrical with respect to one another, and / or are not symmetrical with respect to one another, and / or have different shapes and configurations with respect to one another, and / or are asymmetrical when compared to one another.
[0393] The nasal cannula 30 is configured to induce asymmetric flow of gas into and / or out of the patient's nares.
[0394] In some configurations, the nasal cannula 30 comprises a main body 110 comprising a first prong 111 and a second prong 112 .
[0395] In some configurations, the first and second prongs 111, 112 are configured to engage the nasal passages in a non-sealing manner. In some configurations, at least the second prong 112 is configured to engage the nasal passages in a non-sealing manner.
[0396] In some configurations, the first and second prongs 111, 112 allow exhaled gases to escape around the first and second prongs.
[0397] In some configurations, the first and second prongs 111, 112 are configured to deliver gas to the patient without interfering with the patient's spontaneous breathing.
[0398] The first prong 111 has a first prong outlet 111a defined by an opening at its tip or end 111b for delivery of gas from the first prong 111. Gas delivered through the first prong 111 exits the first prong via the first prong outlet 111a.
[0399] The second prong 112 has a second prong outlet 112a defined by an opening at its tip or end 112b for delivery of gas from the second prong 112. Gas delivered through the second prong 112 exits the second prong via the second prong outlet 112a.
[0400] Reference is now made to Figures 7A-9C, which illustrate or show portions of a patient interface 17 configured to deliver respiratory gases from a gas supply and humidification source (not shown) to a patient, and headgear 200 configured to support and hold the patient interface against the patient's face during use. As can be seen, for example in Figures 7A and 7B, the patient interface 17 is in the form of a nasal cannula interface 1000 adapted to couple an inhalation conduit 16 via a gas inlet conduit 62 and comprising at least one, but preferably two, nasal prongs 111 and 112 configured to fit inside the patient's nares to deliver a flow of gases 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 for the patient.
[0401] The nasal cannula interface 1000 comprises a main body 110 including at least one, but preferably a pair of tubular nasal prongs 111 and 112 either integrally molded with or removably attached to the main body 110 (i.e., the body), and a gas flow section 120 either removably attached to or integrally molded with the gas inlet conduit 62. The gas flow section 120 is insertable into the main body from either one of two opposite horizontal directions, i.e., from either the left or right side. In this manner, the positioning or location of the gas flow section 120 is reversible with respect to the main body 110 (i.e., the body). In other words, the user can choose to have the gas flow section 120 (and the gas inlet conduit 62 essentially extending therefrom) extend from either 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.
[0402] The gas flow section 120 may be configured to fluidly couple the prongs of the patient interface 1000 to the gas inlet conduit 62. In some embodiments, the gas flow section 120 may be a manifold.
[0403] The main body 110 is formed from a soft, flexible material such as silicone or other cannula materials known in the art. The nasal prongs 111 and 112 are preferably flexible and may be formed from a layer of silicone that is thin enough to achieve this characteristic.
[0404] The gas flow portion 120 is formed from a relatively rigid material such as polycarbonate, high density polyethylene (HDPE), or any other suitable plastic material known in the art. The main body 110 provides a soft interface component for the patient to comfortably deliver the flow of gases through the nasal prongs 111 and 112, and the gas flow portion 120 fluidly couples the gas inlet conduit 62 to the nasal prongs 111 and 112 of the main body 110.
[0405] A patient sensor 29 , such as a pulse oximeter sensor or sensors, may be located on or in the gas flow portion 120 .
[0406] The patient sensors 29 may be integrated into the gas flow section 120 and therefore may be disposable. Alternatively, the patient sensors 29 may be removably attached to the gas flow section 120. The gas flow section 120 may have a suitable recess or receiving port / opening for receiving the one or more patient sensors 29. The one or more patient sensors 29 may be removable and reusable.
[0407] As previously mentioned, the patient sensor(s) 29 may be wireless and / or wired. The patient sensor(s) 29 wire(s) may be routed through the gas flow section 120 via the inlet and back to the controller via the inhalation conduit 16 or 62. The controller may include circuitry for operating the patient sensors, e.g., one or more pulse oximeter sensors. The controller controlling the patient sensors may be a separate controller from the controller 19 that controls the respiratory device. In other configurations, the controller 19 that controls the respiratory device may also control the patient sensors.
[0408] The sensor or sensors are positioned in gas flow section 120 to position patient sensor 29 in contact with or adjacent to the upper lip area, for example the oral region of the face. The upper lip has many blood vessels and patient sensor 29 can be used to determine blood oxygen by contacting or being in close proximity to the upper lip area via gas flow section 120.
[0409] The gas flow portion 120 may be formed from a hard plastic material when received in the soft silicone body of the cannula. The rigidity of the gas flow portion 120 makes it easier to insert the manifold portion into the face mount portion and hold the manifold portion in its operative position (i.e., inserted within the face mount portion). The manifold portion is inserted into the main body and in fluid communication with the prongs to direct gas from the inlet conduit to the prongs. A patient sensor 29 disposed on the manifold portion and positioned on the main body places the patient sensor 29 in a sensing position, i.e., the sensor is positioned adjacent to or in contact with the upper lip.
[0410] A patient's nasal septum and / or bridge of the nose are generally very sensitive areas and can be a source of discomfort when exposed to excessive contact pressure for extended periods of time. The nasal cannula of the present disclosure can relieve or reduce this pressure by providing a cushioned area of the nasal cannula interface 1000 adjacent the patient's nasal septum / bridge.
[0411] A patient sensor 29, for example a pulse oximeter sensor, may be placed between the nasal prongs 111, 112 on the upper surface of the cannula so as to contact the nasal septum / columella.
[0412] A patient sensor 29, such as a pulse oximeter sensor, may be disposed in an accessory 400 (e.g., as a nasal cannula interface accessory) and / or in a nasal cannula component, as described in more detail below. For example, as shown in Figures 15C and 15F, the pulse oximeter sensor 29 is disposed in the accessory 400.
[0413] In the embodiment of Figures 7A-9C, the headgear used to hold the nasal cannula interface 1000 against the patient's face comprises a single continuous length of head strap 200 which is adapted to extend along the patient's cheeks, above the ears and around the back of the head in use.
[0414] Main ends 201 and 202 of strap 200 are adapted to releasably connect to respective formations 101 and 102 (see, e.g., FIG. 8A) on either side of nasal cannula 100 to hold cannula 100 in place during use.
[0415] A strap connector 230 is provided at each of the secondary ends 203 / 204 of the main strap 210 and at each end 203 / 204 of the strap segment 220.
[0416] 7C illustrates a nasal cannula interface headgear in which strap segment 220 of FIG. 7B is provided as three different sized strap segments 220a, 220b, and 220c, each having a respective end 221a, 221b, and 221c, which correspond to ends 203 and 204 of main strap 210.
[0417] Each connector 230 includes a strap connection mechanism on one end for coupling to strap material and a coupling mechanism on the opposite end for releasably coupling the respective ends of like connectors 230 together.
[0418] Cannula connectors 240 are provided at the major ends 201, 202 of the major strap 210. These connectors 240 have a strap connection mechanism similar to the strap connectors 230 at the minor ends 203 and 204, but include a clip member, such as a push-fit clip 241, at the end of the connector 240 opposite the strap end. The clip 241 is configured to releasably connect the respective formations 101 / 102 at the side of the nasal cannula interface 1000. The clip 241 is preferably a bendable portion, such as a plastic portion that forms a hinge portion for the strap. The clip 241 is preferably preformed to have a curved shape along its length, such as one having an angle between flat and 20 degrees. This curve allows the clip 241 to conform to the contours of the patient's face in the region of the clip 241.
[0419] 7D-7H, a method of engaging and disengaging each connector 240 of the head strap 200 with the nasal cannula interface 1000 will now be described. Each connector 240 comprises a clip 241 having an elongated connector body 242 and a lateral projection 243 at the end of the body 242. The lateral projection 243 has an inwardly facing engagement surface 243a. The surface 244 of the connector 240 opposite the surface 245 from which the projection 243 extends is preferably substantially smooth or flat. The corresponding formation 101 / 102 of the nasal cannula interface 1000 comprises a channel 101a / 102a having an inlet 101b / 102b and an outlet 101c / 102c opening at either end of the channel 101a / 102a. The peripheral wall of the exit opening 101c / 102c defines an abutment 101ci / 102ci configured to engage a surface 243a of the protrusion 243 of the clip 241. The peripheral edge 101bi / 102bi of the entry opening 101b / 102b defines an abutment for engaging a flange 246 on the end of the body 242 opposite the protrusion 243. This acts to limit the extent of insertion of the connector 240 into the corresponding channel 101a / 102a. The flange 246 may be provided by a terminal end and / or a side arm 270 of the strap connection mechanism.
[0420] Each portion of the head strap 200 adjacent its respective main end 201 / 202 includes or has applied to it a side arm 270 with at least a face-contacting surface for frictionally engaging the patient's face to stabilize the headgear 200 on the face at or below the cheekbone, both during coupling of the headgear to the nasal cannula interface 1000 and after in use. The face-contacting surface is preferably constructed of a relatively higher friction surface material than the remainder of the strap 200.
[0421] The side arms 270 may be cheek supports and / or sleeves.
[0422] The face-contacting surface is adapted to extend across a portion of the surface of the patient's face, preferably at or at least substantially towards the patient's cheek, during use, to aid in holding or stabilizing the nasal cannula interface 1000 on the patient's face. The face-contacting surface is positionable against the patient's cheek and further helps space the remaining portions of the head straps 200 away from, and preferably extend below, the patient's eyes or eye orbits, thereby preventing visual obstruction and / or discomfort resulting from the head straps 200 bridging at or near the eyes or eye orbits.
[0423] It will be appreciated that the facial contacting surface may be adapted to extend across a portion of the patient's facial surface during use, for example extending backward and upward across the left and right cheeks, from at or near or above the left and right outer upper lips.
[0424] The friction surface material may be provided in the form of an elongated side arm 270 configured to receive each main end 201 / 202 of the strap 200. The side arm 270 is configured to removably couple (or alternatively be permanently coupled) around the strap 200, a portion of the strap 200, and / or the cannula connector 240 / 260 at the main end of the strap.
[0425] A side arm (e.g., sleeve) 270 is coupled around the strap 210 at the main end 201 / 202 and around a portion of the connector 240. The strap 210 extends through a passage 272 in the side arm 270, as seen in FIG. 7B. The strap 210 is adapted to be threaded through this passage and preferably remains free to stretch or elasticized or elongated when in the sleeved configuration. The connector 240 is substantially contained by the side arm 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. The clip 241 extends from an end 273 of the side arm 270. In another embodiment, the side arm 270 can be overmolded onto the connector 240 and / or the strap 210.
[0426] 8A and 8B, the side arms 270 may be coupled around a connector 260 extending from the strap 210 at the main end 201 / 202. In this embodiment, the connector 260 is substantially contained by the side arms 270 to minimize direct contact with the patient's skin or covered by the face, thereby improving stability and comfort of the headgear 200. In other words, the connector 260 extends completely through the passage 272 of the side arms 270. The buckles 251 / 252 extend from an end 274 of the side arms 270 and the clips 261 extend from an opposing end 273.
[0427] The side arms 270 may be preformed to have a curved shape along their length, such as, for example, one that has an angle between flat and 20 degrees. The curvature allows the side arms 270 to conform to the contours of the patient's face or cheeks in the region of the sleeve during use. Alternatively, the side arms 270 may be elastically or inelastically deformed to assume the shape of a curved sleeve upon engagement with the main ends 201 / 202 or connector 260 of the head strap 200.
[0428] The side arms 270 provide a face-contacting surface of a relatively high friction surface material for frictionally engaging the patient's face or facial skin. This face-contacting surface should be positioned to frictionally engage the cheek skin of the patient's face. The face-contacting surface is at least localized to the strap or portion of the strap that is to be positioned against the patient's cheek. The face-contacting surface provided with the relatively high friction surface material is preferably constructed of a material that is smooth and comfortable on the patient's skin. Thus, the side arms 270, or at least the face-contacting surface, are formed from a relatively softer material than the connectors 240 and 260.
[0429] In a preferred embodiment, the face-contacting surface or side arm 270 is formed from a soft thermoplastic elastomer (TPE), but may alternatively be formed from another plastic material such as silicone, or any other biocompatible material.
[0430] In addition to nasal cannulae, headgear for other forms of patient interfaces may include side arms 270 as described above or similar cheek supports at or near either end of the straps of the patient interface headgear that connect to the mask for frictional engagement with the patient's face to stabilize the mask on the cheeks, in particular direct nasal masks, for example, with nozzles or pillows that enter or engage the wearer's nares. Such headgear may again include a single head strap adapted to extend along the patient's cheeks, over the ears and around the back of the head in use, with the ends provided with any suitable form of clip that couples to (or is permanently attached to) the mask on either side.
[0431] A patient sensor 29, for example in the form of a pulse oximeter sensor, may be provided in the nasal cannula interface 1000 of Figures 7-9.
[0432] The patient sensors 29 may be provided in the nasal cannula interface 1000 according to any of the configurations described with reference to the nasal cannula 100 of Figures 1 to 6B.
[0433] The patient sensor 29 may be provided on the headgear 200 or other removable portion of the nasal cannula interface 1000 that connects to the main body 110, or on the gas flow portion 120 of the nasal cannula interface 1000. In this manner, when the main body 110 and / or gas flow portion 120 is replaced or discarded, the patient sensor 29 may be retained on the headgear 200 or other removable portion such that the patient sensor 29 may be reused without being discarded. For example, the patient sensor 29 may be provided on the headgear 200 that is configured to connect to a number of different sized main bodies 110 and / or gas flow portions 120. This allows a user to replace or replace portions of the cannula without having to dispose of the patient sensor 29.
[0434] 7A-9C, the patient sensor 29 may be provided on a side arm 270. Any wiring associated with the patient sensor 29 may extend through a passage 272 in the side arm 270 and extend from an end 274.
[0435] The patient sensor 29 may be recessed into or flush with the face-contacting surface of the side arm 270. The patient sensor 29 may be located at any suitable location along the length of the side arm 270, for example adjacent to the formations 101, 102 or adjacent to the headgear straps 210.
[0436] The patient sensor 29 may be permanently attached to the side arm, for example, the patient sensor 29 may be overmolded onto the side arm 270.
[0437] The patient sensor 29 may be removably attached to the side arm 270 such that the patient sensor 29 may be replaced or reused if the side arm 270 is disposed of. The patient sensor 29 may be removed, wiped, and installed 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 for patients, thereby reducing costs to the medical facility.
[0438] Alternatively, the patient sensor 29 can be provided in a complementary sensor body that can be permanently or removably attached to the side arm 270, such as in a corresponding recess in the side arm 270. The recess and complementary body can include one or more retention features configured to hold the body in the recess. The patient sensor 29 incorporated in the side arm 270 includes the patient sensor 29 in contact with the cheek region, such as the cheek or temporal region of the face. This area of the face has blood vessels adjacent to which the sensor can be positioned and used to detect blood oxygen saturation of the patient.
[0439] A patient interface, such as the nasal cannula interface 1000 according to any of FIGS.
[0440] For example, the patient interface may include multiple patient sensors 29 (i.e., 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 the side arm 270 (i.e., sleeve). Measurements from these multiple sensors 29 may be averaged by the controller to provide a blood oxygen (SpO2) reading.
[0441] Thus, each side arm 270 may include a single patient sensor 29 .
[0442] In a further alternative, each side arm 270 of the cannula (i.e., each side arm) may include multiple patient sensors. One, some, or all of the multiple patient sensors may be removable. Each side arm 270 may include multiple recesses or openings for receiving the patient sensors 29.
[0443] Multiple patient sensors 29 may be advantageous as averaging of the measurements may provide a more accurate SpO2 reading and reduce noise in the sensor readings received by the controller.
[0444] 7A-8B, the patient sensors may be held within a component of the patient interface, namely side arm 270. Side arm 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 that a user can switch out for a conventional side arm of the patient interface.
[0445] 9A-9C, a retaining clip 280 may be provided that includes a tubular body 281 for receiving and housing a portion of the gases inlet conduit 62 therein. Hooks 282 protrude from the tubular body 281 to couple a strap or other component of the headgear 200. In this manner, the gases inlet conduit 62 may be coupled or tethered to the head strap 210 or headgear 200 during use. When the gases inlet conduit 62 is pulled, the force is applied to the head strap 210 and not directly to the cannula 100. This relocation of force reduces the likelihood that the nasal prongs 111 and 112 of the cannula 100 will become dislodged from the patient's nares.
[0446] One or more tethering points for connecting clips 280 may be available on the headgear 200, with at least two symmetrical tethering points on each side of the headgear being preferred for ease of use.
[0447] It will also be appreciated that the retaining clip 280 may be removable from the gas inlet conduit 62 or may be a permanent attachment thereof.
[0448] The retaining clip 280 may be connected to or retained by a portion of the patient interface, such as a portion of the patient interface that provides a relatively rigid area (such as to facilitate supporting the gas inlet conduit 62).
[0449] The retaining clip 280 may also be positioned or secured to a particular location on the gas inlet conduit 62, for example, to provide a predetermined location that holds the retaining clip 280 in place.
[0450] The retaining clip 280 may be configured to hold the wiring of the patient sensor 29 to secure the wiring relative to the gas inlet conduit 62. Thus, the patient sensor wiring may extend parallel to the longitudinal axis of the gas inlet conduit 62.
[0451] The gas inlet conduit 62 may be provided with one or more sensor wires, for example extending in a wall of the conduit or through a bore of the conduit. The one or more sensor wires may be configured to be electrically coupled to a patient sensor 29.
[0452] Such electrical coupling may be provided by a physical electrical coupling between the wiring of the patient sensor 29 and one or more sensor wires in the gas inlet conduit 62, such as via an electrical connector.
[0453] Such electrical coupling may be provided via inductive coupling. For example, the patient sensor wiring may extend along the arm 270 and / or may be provided in the main body 110 and / or gas flow portion 120 of the nasal cannula interface 1000. The conduit wiring may extend to a location at or near the end of the gas inlet conduit 62 where the gas inlet conduit 62 connects to the inlet of the nasal cannula. The gas inlet conduit 62 and the nasal cannula interface 1000 may be provided with an inductive coupler configured to electrically couple the gas inlet conduit 62 to the patient sensor wiring.
[0454] Such a configuration eliminates or reduces the need for physical electrical connectors and the like, and the need for one or more exposed electrical contacts. Such a configuration also eliminates or reduces the number of connections that must be made by a user in using the nasal cannula interface 1000. For example, if the patient sensor 29 and headgear 200 are reused, the user does not need to physically disconnect the patient sensor wiring from the gas inlet conduit 62.
[0455] The gas inlet conduit 62 may be a heated or unheated conduit. The conduit may be an extension of any desired length.
[0456] As mentioned above, the patient sensor 29 may be configured to contact the patient's face.
[0457] The patient sensor 29 may be an optional addition to the patient interface. In addition to the patient interface, the patient sensor may be incorporated into the patient interface by an accessory. The accessory is configured to hold a sensor for measuring at least one patient parameter. The accessory is configured to be attached to the patient interface.
[0458] The attachment 400 may be provided as a nasal cannula interface attachment, for example as shown in Figures 10-16.
[0459] The accessory 400 may be configured to attach to the nasal cannula interface 1000. For example, it may be connected to the strap 200 of the nasal cannula interface 1000 as shown in Figures 11, 13, 15F and 15D.
[0460] It will be appreciated that the accessory 400 may be used with any suitable patient interface having a strap (not limited to a nasal cannula interface), however, a nasal cannula interface is used below as an exemplary patient interface.
[0461] As shown in FIG. 12A, the accessory 400 includes a sensor cavity 500, at least one securing mechanism 610, 650, and a wire cavity 700. The sensor cavity 500 is configured to hold a patient sensor 29, as shown in the diagram of FIG. 12A. As described in more detail above, the patient sensor 29 can be configured to measure at least one patient parameter. The at least one securing mechanism 610, 650 is configured to connect the accessory 400 to the nasal cannula interface 1000. For example, the at least one securing mechanism 610, 650 can be releasably connected to a strap 200 of the nasal cannula interface 1000, as shown in FIGS. 11A and 11B and 13A and 13B.
[0462] The accessory 400 may include a main body 401 .
[0463] The sensor cavity 500 and / or the wire cavity 700 may be provided in the main body 401 of the accessory 400 .
[0464] The securing mechanisms 610 , 650 may also extend from the main body 401 .
[0465] At least one securing mechanism 610, 650 may be configured to releasably connect the accessory 400 to the nasal cannula interface 1000. In some configurations, at least one securing mechanism 610, 650 may be configured to permanently connect the accessory 400 to the nasal cannula interface 1000 such that it is not detachable (but is still optionally movable along a strap, as described in more detail below).
[0466] The wire cavity 700 can be configured to provide a path for one or more wires 710 to the sensor cavity 500, as shown in FIG. 12A.
[0467] The accessory 400 can have one or more gripping mechanisms. The gripping mechanisms can include, for example, protrusions that can aid or improve gripping of the accessory 400 onto the nasal cannula interface 1000. The gripping mechanisms can aid a user in moving and positioning the accessory 400 relative to the nasal cannula interface 1000 (as described in more detail below).
[0468] 15E and 15F, a nasal cannula interface 1000 may be provided. The nasal cannula interface 1000 may include a nasal cannula interface attachment 400.
[0469] The accessory 400 may be releasably connectable to the interface 1000 .
[0470] The attachment 400 can be substituted for components of the interface 1000, for example as shown in Figures 17A-18C, where the attachment is replaced by a side arm (as a cheek support), in which case the interface can be provided without the side arm.
[0471] As will be explained in more detail below, alternative components to those of the interface may be provided.
[0472] An example of an attachment in Figures 17A-C and 18A-C is a side arm 270 that may be part of a nasal cannula, as shown in Figures 7A-8B.
[0473] As mentioned above, the side arm 270 may be a check support configured to rest at least partially against the patient's cheek during use.
[0474] As shown in FIGS. 17A-18C, the accessory 400 includes a sensor cavity 500, a wire cavity 700, and a strap passage 950. As shown in FIG.
[0475] In some configurations, the attachment 400 may include a securing mechanism. The securing mechanism may be located at or near the first end 810 of the attachment 400.
[0476] The fixation mechanism may be configured to connect to the cannula connector 240, as described above in connection with Figures 7D-7H.
[0477] In some embodiments, the fastening mechanism is connected to a strap 210 (similar to the embodiment of FIGS. 10A-16E).
[0478] 17A-18C, the sensor cavity 500 can be configured to hold a patient sensor 29 (shown in FIGS. 17B and 17C) configured to measure at least one patient parameter. The wire cavity 700 can be configured to provide a pathway for one or more wires 710 into the sensor cavity 500.
[0479] The accessory 400 may include a main body 401 .
[0480] The sensor cavity 500 and / or the wire cavity 700 may be provided in the main body 401 of the accessory 400 .
[0481] In some configurations, the accessory 400 may have a securing mechanism configured to connect to the cannula connector 240 .
[0482] 17A-18C, the accessory 400 includes a strap passage 950. The strap passage 950 can extend from the second end 820 of the accessory 400 along at least a portion of the longitudinal axis of the accessory 400.
[0483] The strap passages 950 may allow straps to pass through the attachment 400 and into the main body 110 (or other components of a patient interface).
[0484] The strap passages 950 may allow passage of the straps through the attachment 400 to a main body connection mechanism configured to connect the straps of the nasal cannula interface 1000 to the main body 120. The connection mechanism may be the cannula connector 240 described above in connection with Figures 7D-7H.
[0485] The strap passage 950 may be disposed in the main body 401 of the accessory 400 .
[0486] The strap passage 950 may be configured to accommodate the strap 200 of the nasal cannula interface 1000 .
[0487] The strap passage 950 may be shaped to accommodate the strap 200. That is, the strap passage 950 may have a shape that corresponds to the shape of the strap 200. For example, as shown in Figures 17C, 18B, and 18C, the strap passage 950 may have a rectangular cross-section that corresponds to the substantially flat rectangular strap 200. In some configurations, the strap passage 950 may have a circular and / or elliptical cross-section.
[0488] In some configurations, the strap passage 950 can have an opening at a first end of the accessory 400, an opening at a second end of the accessory 400, and an enclosed portion between the ends. In some configurations, the strap passage 950 can be at least partially exposed to an exterior surface of the accessory 400. For example, in Figures 18A-C, and particularly Figure 18B, at least a portion of the strap passage 950 is exposed to the exterior surface of the accessory 400.
[0489] 17C, the strap passage 950 may be separate from the sensor cavity 500. In some configurations, the strap passage 950 may be part of the sensor cavity 500. For example, the strap passage 950 may be at least partially disposed in the sensor cavity 500, such as shown in FIG. 18B and cross-sectional view 18C.
[0490] In some configurations, the strap 200 may be adhered or otherwise connected to at least one surface of the strap passage 950. For example, the strap 200 may be connected to at least one surface of the strap passage 950 by an adhesive. Or as a further example, the strap 200 may be overmolded within the strap passage 950. In some configurations, the strap 200 may be physically held by another portion of the accessory 400, e.g., the strap 200 may not be adhered or otherwise attached to at least one surface of the strap passage 950.
[0491] It will be appreciated that, where appropriate, the following disclosure regarding sensor cavity 500 may be applied to both accessory 400 and component 2000 (as described in more detail below).
[0492] As shown in Figures 10A, 11A, 12A, 13A, and 16B, a sensor cavity 500 is formed in a first surface 410 of the nasal cannula interface attachment 400, as shown in Figures 10A, 11A, 12A, 13A, and 16B.
[0493] The sensor cavity 500 may be formed within the main body 401 of the accessory 400 .
[0494] As shown in Figures 17B, 18B, and 18C, a sensor cavity 500 is formed in the first surface 410 of the attachment 400, as shown in Figures 17B, 18B, and 18C.
[0495] The sensor cavity 500 may be formed within the main body 401 of the accessory 400. As shown in Figure 17C, the sensor cavity 500 may be a substantially enclosed interior space of the main body 401 of the accessory 400. In other configurations, the sensor cavity may extend at least partially to an exterior surface of the accessory.
[0496] The sensor cavity 500 can be shaped to receive the sensor. In some configurations, the sensor cavity 500 is square, rectangular, and / or circular. The sensor cavity 500 can have substantially rounded edges and apexes. The rounded edges and apexes can aid in positioning 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 can be rectangular with substantially rounded edges and apexes.
[0497] The sensor cavity 500 can be a friction fit with the patient sensor 29 (e.g., the housing of the sensor). In some configurations, an adhesive can be used to hold the patient sensor 29 in the sensor cavity 500.
[0498] The patient sensor 29 may be a patient sensor configured to measure a patient parameter, as described in more detail above. The patient parameter may be a physiological parameter. For example, the patient parameter may be a measurement or indication of the patient's blood oxygenation.
[0499] The sensor cavity 500 can be positioned to orient the patient sensor 29 to contact the patient. As shown in Figures 10A, 11A, 12A, 13A, 16B, 17B, 18B, and 18C, the sensor cavity 500 includes an opening in the first side 410 of the accessory 400 that is configured to face the patient during use. For example, if the patient sensor 29 is a pulse oximeter sensor, the patient sensor 29 may include a transducer (not shown) and the sensor cavity 500 can be positioned to orient the sensor such that the transducer of the patient sensor 29 faces the patient (so that the transducer contacts the skin or adjacent skin). In some configurations, the transducer of the patient sensor can include an optical transducer. The optical transducer can be an infrared transducer and / or a red light transducer. The optical transducer can be a photodiode or a phototransistor.
[0500] In some configurations, the patient sensor comprises at least one light source. The light source is configured to be directed toward the patient's skin. The light source may be an infrared source and / or a red light source. The light source may comprise an LED. In some configurations, the light source may include multiple light sources, each emitting a different wavelength of light. 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.
[0501] The wire cavity 700 may be formed in the same face as the sensor cavity 500 of the accessory 400, or in a different face. The sensor cavity 500 may be formed in the first face 410 of the accessory 400, and the wire cavity 700 may be disposed in the second face (e.g., adjacent to the first face) 420 of the accessory 400. As a further example, the sensor cavity 500 and the wire cavity 700 may both be formed in the first face 410 of the accessory, as shown in Figures 12A, 13A, and 16B. Or, the sensor cavity 500 and the wire cavity 700 may both be formed in the first face 410 of the accessory, as shown in Figures 17B, 18B, and 18C.
[0502] The wire cavity 700 can be formed adjacent to the sensor cavity 500 as shown in Figures 12A, 13A, 16B, 17B, 18B, and 18C.
[0503] The wire cavity 700 may extend from the outer surface to the sensor cavity 500. The wire cavity 700 may extend from the face of the accessory 400 to the sensor cavity 500.
[0504] The wire cavity 700 can include an opening in a side of the accessory 400 that is configured to face the patient during use. As shown in Figures 18A and 18B, the wire cavity 700 can include an opening in a first side 410 of the accessory 400 to face the patient during use, which can aid in assembly of the patient sensor 29 and the sensor cavity 500 by allowing a wire to be easily inserted into the wire cavity 700. As a further example, as shown in Figures 10A, 11A, 12A, 13A, and 16B, the wire cavity 700 can include an opening 651 in a first side 410 of the accessory 400 to face the patient.
[0505] In some configurations, the wire cavity 700 can include multiple openings on different (optionally adjacent) faces of the accessory, for example as shown in Figure 16B, where the wire cavity 700 has an opening on a side and an opening on the patient surface, allowing the wire to enter a different face of the accessory than the face that contacts the patient during use.
[0506] The wire cavity 700 may extend through a single face of the attachment to the sensor cavity 500.
[0507] The wire cavity 700 may comprise a slot. Additionally, the wire cavity may be one or more of a square, rectangular, and / or circular shape. For example, as shown in Figures 12A, 13A, 16B, 17A, 18B, and 18C, the wire cavity is substantially rectangular.
[0508] The wire cavity 700 can be, for example, a groove and / or notch in the accessory (e.g., a main body of the accessory). In some configurations, the wire cavity can extend from a side or rear surface of the accessory 400.
[0509] In some configurations, the wire cavity 700 can include one or more retention features. The retention features can help retain the wire in the wire cavity 700 after it is installed. The retention features can include at least one ledge extending from the perimeter of the wire cavity 700. The at least one ledge can extend from alternating sides of the wire cavity (without overlapping).
[0510] The wire 710 that the wire cavity 700 is configured to route may include a cable, cord, lead, cable harness, or any other insulated assembly of conductive material. In some configurations, a single wire 710 may be accommodated in the wire cavity 700. In other configurations, multiple of the same or different types of wires 710 may be accommodated in the wire cavity 700.
[0511] In some configurations, the wire cavity 700 may be, for example, an opening that allows a path for one or more wires 710 into the sensor cavity 500 .
[0512] The accessory 400 may be attached to the nasal cannula interface 1000 via at least one fastening mechanism 610, 650. The at least one fastening mechanism 610, 650 may be configured to hold the accessory 400 to the strap 200 of the nasal cannula interface 1000.
[0513] At least one fastening feature 610, 650 can be configured to extend from a side (e.g., face) of the accessory 400 opposite the sensor cavity 500. As shown in Figures 10B, 11B, 12B, 13B and 16A-E, at least one fastening feature 610, 650 can be configured to extend from a second side 420 of the accessory 400, the second side 420 being disposed opposite the first side 410.
[0514] The securing mechanism 610, 650 may hold the accessory 400 while allowing a user to move the accessory 400 relative to the nasal cannula interface 1000 and / or remove the accessory 400 from the nasal cannula interface 1000. The securing mechanism 610, 650 may be configured to substantially prevent movement of the accessory 400 along the strap 200 while allowing relative movement between the strap 200 and the accessory 400. The securing mechanism 610, 650 may be configured to allow relative movement between the strap 200 and the accessory 400 (e.g., by moving the accessory 400 relative to the strap 200) when a threshold force is applied. Configuring the accessory 400 to be movable along the length of the strap 200 may allow a clinician to position the patient sensor 29 at a desired location. The type and degree of threshold force required may depend on the type of securing mechanism 610, 650 and the material of the strap 200. As will be appreciated, the fastening mechanisms 610, 650 can comprise one or more mechanisms such as, for example: a fastener (i.e., a hook-and-loop fastener - comprising a number of hooks and a number of loops configured to engage with one another. The hooks and / or loops can be provided on a substrate), a magnet, one or more hooks, and / or a geometric feature.
[0515] The fastening mechanism may allow the accessory 400 to be connected and disconnected from the strap 200 so as to be repositioned along the length of the strap 200 (as described in more detail below).
[0516] 16A-E, the at least one securing mechanism 610, 650 may include at least one arm 611. The 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.
[0517] At least one arm 611 can include a first portion 611a and a second portion 611b. The first portion 611a can extend from the attachment 400, and optionally the first portion 611a can extend perpendicularly from the second side 420 of the attachment 400. The second portion 611b can be configured to be oriented generally perpendicular to the first portion 611a and / or parallel to the attachment 400 and / or the second side 420 of the attachment 400.
[0518] At least one securing mechanism 610, 650 may comprise a pair of arms 611, as shown in the configuration illustrated by Figures 16A-16D. The pair of arms 611 may be configured to releasably connect the accessory 400 to the nasal cannula interface 1000 and / or optionally the strap 200 of the nasal cannula interface 1000.
[0519] 16A-E, a pair of arms 611 may extend from the accessory 400, with each arm 611 extending toward the other arm and / or toward a center of the accessory 400. The arms 611 may be disposed along an axis of the accessory. The axis may be configured, for example, to be parallel to the axis of the strap 200 when the accessory 400 is connected to the strap 200.
[0520] 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 attachment 400, and optionally the first portion 611b may extend perpendicular to the second face 420 of the attachment 400. The second portion 611b of each arm may be configured to be oriented toward each other and / or toward the center of the attachment. 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 attachment 400 and / or the second face 420 of the attachment 400. In some configurations, the first portion 611a may extend vertically upward from the attachment 400, and the second portion 611b may extend inward toward the center of the attachment 400. In some configurations, the first portion 611a can extend vertically upward from the attachment 400, and the second portion 611b can extend toward the second portion 611b of the other arm 611. The first portion 611a and second portion 611b of each arm 611 can form an angle less than, or about, 90 degrees, or less than about 120 degrees.
[0521] Each arm 611 may form a "U" shape with the second surface 420 of the attachment. The U shape formed by one arm may face the U shape formed by the other arm to hold a strap of a nasal cannula interface.
[0522] At least one arm 611 may be configured to receive the strap 200 of the nasal cannula interface 1000. For example, in a configuration in which the securing mechanism 610, 650 includes a pair of arms 611, a gap 630 may be defined between the pair of arms 611. The strap 200 of the nasal cannula interface 1000 may be configured to be insertable into the gap 630 to be connected to the attachment 400. The pair of arms 611 of the securing mechanism 610, 650 may be configured to receive the strap 200 of the nasal cannula interface 1000 to be connected to the nasal cannula interface 1000. The width of the strap 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 / attachment 400 only when an edge of the strap 200 is aligned or when the strap 200 is folded along the width of the strap 200.
[0523] The at least one arm 611 may include multiple arms.
[0524] 10A-15F, at least one of the fastening mechanisms 610, 650 may comprise a clip 650.
[0525] The clip 650 may be connected to the accessory 400. It may be configured to secure the accessory 400 to the nasal cannula interface 1000, for example, it may secure the accessory 400 to the strap 200 of the nasal cannula interface 1000.
[0526] The clip 650 can extend from the attachment 400, and in some configurations, the clip 650 can extend from the second surface 420 of the attachment 400, as shown in Figures 10A-15F.
[0527] The clip 650 can include a clip arm 660. The clip arm 660 can be connected to the attachment 400 via a biasing element 670. The biasing element 670 can include a hinge or a spring or a geometric feature. The biasing element 670 can bias the clip arm 660 to a closed position or an open position. Figures 10A-15F show an example configuration of the clip arm 660 with the hinge 670 in an open position.
[0528] As shown in Figures 10A-15B, hinge 670 is a living hinge.
[0529] The clip 650 may be configured to hold the strap 200 of the nasal cannula interface 1000 to the accessory 400 when the clip 650 is in a closed position. When the clip 650 is in a closed position (e.g., as shown in FIGS. 13D and 15D ), the clip may hold the strap 200 to the accessory 400 between the clip 650 and the nasal cannula interface 1000. When the clip 650 is closed and holds the strap 200 of the nasal cannula interface 1000, the accessory 400 may be prevented from sliding relative to the strap 200.
[0530] 10B, 11B, 12B, 13B, 14B, and 15B, the clip arm 660 can include a contact surface 680. The contact surface 680 can be configured to engage the strap 200 of the nasal cannula interface 1000 when the clip 650 is in the closed position.
[0531] The contact surface 680 can be disposed within a recess 690 in the clip arm 660, as shown in Figures 10B, 11B, 12B, 13B, 14B, and 15B. The recess 690 can be shaped to receive the strap 200 of the nasal cannula interface 1000.
[0532] The contact surface 680 may include at least one protrusion that may be configured to help retain the strap 200 when the clip 650 is in a closed position (e.g., as shown in FIGS. 13C, 13D, 15C, and 15D).
[0533] The at least one protrusion may include at least one rib 682. The at least one rib 682 may be disposed perpendicular to a width of the strap 200 when the strap 200 engages the contact surface 680 and / or perpendicular to a longitudinal axis of 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 disposed at opposing ends of the contact surface. The pair of ribs 682 may be spaced apart along a length of the strap 200 and / or a longitudinal axis of the contact surface 680 when the strap 200 engages the contact surface 680.
[0534] At least one protrusion may include one or more bumps 683. The one or more bumps 683 may include, for example, bumps 683 located at each corner of the contact surface, as shown in FIG 14B. As a further example, the one or more bumps 683 may be patterned across the entire contact surface 680, or at least a portion of the contact surface 680, as shown in FIG 15B. As yet another example, the one or more bumps 683 may be patterned in offset rows, as shown in FIG 15B, or they may be patterned in aligned rows.
[0535] The contact surface 680 may have a non-smooth and / or substantially rough surface.
[0536] The strap-contacting surface of the accessory 400 (e.g., the rear surface of the accessory 400) can include at least one protrusion. The at least one protrusion can be configured to help retain the strap 200 when the clip 650 is in the closed position (e.g., as shown in FIGS. 13C, 13D, 15C, and 15D). The protrusion can be as described above and can be configured to be complementary to the at least one protrusion of the contact surface 680.
[0537] 15A and 15B, clip arm 660 can include an aperture 695 that can extend through clip arm 650 and optionally through contact surface 680. Aperture 695 can be configured to receive a portion of another of the at least one fastening system. Optionally, the other of the at least one fastening system can be at least one arm 610, for example, as shown in FIGS.
[0538] The accessory 400 may, for example, comprise a pair of arms 610 disposed on either side of a clip 650, as shown in Figures 10A-14B (and as described in more detail above). Second portions 630 of the arms are oriented in the same direction (and optionally parallel).
[0539] This is in contrast to the arms 610 of Figures 16A-16B, in which the second portions 630 extend towards each other.
[0540] The clip arm 660 may include at least one retention feature 640. The retention feature 640 may be configured to engage with a mating portion 645 of the attachment 400 configured to retain the clip 650 in a closed position. For example, as shown in Figures 10B, 11B, 12B, 13B, 14B, and 15B, the retention feature 640 may include a protrusion and the mating portion 645 may include a corresponding recess. As a further example, the retention feature 640 may include a recess and the mating portion 645 may include a corresponding feature, such as a protrusion.
[0541] The accessory 400 may be attachable to the nasal cannula interface 1000 at multiple interface attachment locations and / or multiple patient facial positions. Multiple patient facial positions may correspond to multiple attachment locations.
[0542] The multiple attachment locations of the nasal cannula interface 1000 may be defined by at least the connection points between the straps 200 and the main body 110 of the nasal cannula interface 1000 .
[0543] A patient facial position may be a position where the accessory 400 is placed proximate to the patient's face. For example, the patient facial position may be a position proximate to the patient's cheek, or, as a further example, a position proximate to the space between the patient's eyes and lips.
[0544] The accessory 400 may be configured to be adjustable between a plurality of attachment positions. In some configurations, the accessory 400 may be adjustable between the attachment positions without being removed from the nasal cannula interface 1000, or, optionally, without being removed from the strap 200. For example, the accessory 400 may be configured to be slidably adjusted between a plurality of attachment positions.
[0545] In some configurations, the attachment 400 may be adjustable between attachment positions by cutting the clip and having the user move the attachment to a new position (e.g., by moving the clip to a closed position) before re-engaging the clip.
[0546] The accessory 400 may be configured to be adjustable between a plurality of patient facial positions. In some configurations, the accessory 400 may be adjustable between a plurality of patient facial positions without being removed from the nasal cannula interface 1000. For example, the accessory 400 may be configured to be slidably adjusted between a plurality of patient facial positions (e.g., in a direction along a strap as shown by the arrows in FIGS. 15E and 15F).
[0547] The attachment may be positioned, for example, proximate the patient's cheek. As a further example, it may be positioned proximate the space between the patient's eye and lips.
[0548] The attachment 400 being attachable to the nasal cannula interface 1000 at multiple positions along the strap 200 may allow for easier positioning of the patient sensor 29 relative to the patient. This allows for the position of the sensor to be changed based on, for example, the patient's facial structure or the position of other medical equipment (e.g., a nasogastric tube). For example, the attachment 400 may be moved to another side of the nasal cannula.
[0549] The accessory 400, which is attachable to the nasal cannula interface 1000 at multiple locations along the strap 200, may also allow patient sensors 29 to be retrofitted to the nasal cannula interface 1000. This allows patient sensors 29 to be added to the nasal cannula interface 1000 as needed.
[0550] In some configurations, the accessory 400 may include an extension portion that extends away from the main body of the accessory 400. The extension portion may include a sensor cavity 500 and a wire cavity 700 to allow for placement of the patient sensor 29 in a specific location, for example, on the patient's earlobe.
[0551] 16A-16C, the face of the accessory 400 that is configured to face the patient in use is substantially circular. The face of the accessory 400 that is configured to face the patient in use may be other shapes, such as oval or rectangular.
[0552] 16E, the side of the accessory 400 configured to face a patient in use can include at least one surface material 277. The at least one surface material 277 can cover the side of the accessory 400 configured to face a patient.
[0553] The facing material 277 may be disposed on or may be a face-contacting surface, as described above.
[0554] The at least one surface material 277 may not cover the patient sensor 29 in some configurations (e.g., as shown in FIG. 16E) and may cover the patient sensor 29 in some configurations. The at least one surface material may be provided with an opening such that the at least one surface material does not extend over the sensor cavity of the accessory.
[0555] The at least one surface material may be the same material as the accessory 400, or it may be a different material than the accessory 400. For example, the at least one surface material may be a fabric material and / or silicone and / or a thermoplastic elastomer, and the accessory 400 may be plastic.
[0556] At least one of the surface materials and the attachment 400 may, for example, be separable from the attachment 400 or may be integral with the attachment 400 .
[0557] At least one of the surface materials may be a film or membrane.
[0558] At least one surface material may be configured to increase friction between the accessory 400 and the patient's face. At least one surface material may have adhesive or non-slip material properties. Additionally, the surface material may be configured to provide a frictional force that resists movement between the accessory 400 and the strap 200.
[0559] As mentioned above, the components may be provided to replace or be components of a patient interface, such as nasal cannula 100 .
[0560] The components may be able to replace existing components of the nasal cannula interface 1000. The components may be provided as additional components (e.g., as replacement components) that a user can optionally add to the patient interface, or as components that are part of a pre-assembled patient interface.
[0561] In some configurations, the component may be connectable as an intermediate component between other components of the nasal cannula interface 1000. For example, the component may be connectable between the side arm 270 and the main body 110.
[0562] The component may be connected to the strap. The component may be connected to the strap 210 at any point, but in some configurations may be connected to the strap at a second end. The second end may be opposite the first end.
[0563] The components may include a connection mechanism.
[0564] The connection mechanism may be configured to connect to the nasal cannula interface 1000 .
[0565] The component may be a side arm as described above.
[0566] The connection mechanism may be configured to connect directly to the main body of the nasal cannula interface 1000 (as a main body connection mechanism). In these embodiments, the main body connection mechanism may be or include the mechanism of the cannula connector 240 described above in connection with Figures 7D-7H.
[0567] The components may be formed integrally (e.g., by overmolding) with the connection mechanism and / or the strap. In some configurations, the strap 210 may be connected to the connection mechanism (e.g., as described above in connection with FIGS. 7D-7H) and then the components may be overmolded.
[0568] The connection mechanism may alternatively or additionally be a fastener (eg, a hook-and-loop fastener - comprising a first substrate having a number of hooks and a second substrate comprising a number of loops), a magnet, or a geometric mechanism.
[0569] The components may include any of the accessory features described above.
[0570] In some configurations, the components may be accessories as in Figures 17A-18C, but may be permanently attached to the straps and / or cannula connectors.
[0571] As discussed above, as part of providing respiratory assistance to a 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 to measure the desired physiological parameters. Thus, as discussed above, the patient respiratory interface may incorporate patient sensors.
[0572] In the various configurations described, an accessory can be provided for the patient respiratory interface. The accessory can be attached to the patient respiratory interface. For example, the accessory can be connected to a portion of the headgear or can be attached to another portion of the patient interface, such as the main body of the patient interface itself. The accessory can be configured such that one or more patient sensors can be attached to the accessory. For example, the accessory can be configured such that one or more patient sensors can be held by the accessory. The accessory can include one or more sensor cavities for holding one or more patient sensors.
[0573] As previously mentioned, in some configurations, the accessory may be provided as a component or part of the patient respiratory interface. In particular, the accessory, referred to as a component of the patient interface, may be substitutable for a conventional component of the patient interface. In substitution for a conventional component, the accessory as a component may provide the functionality of the conventional component and may also provide the sensor holding functionality of the accessory.
[0574] The component accessory may be or be part of a patient interface, such as the patient interface 17 shown in Figure 3. For example, the component accessory may be or be part of headgear of or for a patient interface, such as part of the head strap 200 shown in Figures 7A-H. As a further example, the component accessory may be or be part of a side arm of a patient interface, such as the side arm 31 shown in Figure 4, the side arm 270 shown in one or more of Figures 7C, 8A and 8B, or the accessory 400 of Figures 17A-C or 18A-C.
[0575] Such components may replace other portions of the patient interface, for example, as described in connection with attachment 400, which may replace a side arm of the patient interface.
[0576] In some configurations, the component to which the sensor can be attached may be an intermediate component between the headgear and the remainder of the patient interface to which it is attached. More specifically, the accessory as a component of the patient interface may be provided as part of the headgear interface connector or may include a connector mechanism for connecting the headgear and other portions of the patient interface together.
[0577] When the accessory is substitutable for a conventional component of the patient interface, the accessory component may interconnect with at least one other portion of the patient interface. The interconnection may be achieved by interconnecting the accessory component with at least one other component. When interconnected, the components cannot move freely relative to one another. In contrast, in other configurations where the accessory does not interconnect with other components 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 such that, in use, it is slidable along a strap to which it is attached. As a further example, the accessory 400 of FIGS. 16A-E may be configured such that it is slidable along a strap received within the securing mechanism 610.
[0578] The accessory component may be, for example, substitutable for a side arm, a buckle, a tube clip, or any other conventional component of a patient interface. When an accessory component (hereinafter simply referred to as a component) is substituted for a patient interface, the component may connect to other components of the patient interface. For example, when a component is substituted for a side arm, the component may connect to both the main body of the patient interface and to other parts of the patient interface, such as headgear straps or headgear connectors. The component may interconnect with one or each of the other parts of the patient interface to which it connects.
[0579] By way of example, various arrangements of components for a patient interface configured to hold a patient sensor are described herein.
[0580] 19A, the nasal cannula interface 1000 includes a main body 110. A pair of side arms 270 extend laterally from the main body 110. The nasal cannula interface 1000 also includes headgear 200 with a first strap 211 and a second strap 212.
[0581] 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.
[0582] On the other side of the nasal cannula interface 1000 of Fig. 19A is provided a component 2000. The component 2000 is connected to both the other arm 270 of the headgear and the first strap 211. The component 2000 also has a component body that can hold a patient sensor 29.
[0583] Although FIG. 19A is shown having only component 2000 provided on one side of the connection between side arm 270 and headgear 200 of the patient interface, in other configurations, component 2000 can be provided on both sides of the patient interface.
[0584] When components 2000 are provided on both sides of the patient interface, the patient or clinician has the option of where the patient sensors are placed. For example, the location of the patient sensors can be varied between components 2000 on either side of the face. This can improve patient comfort. It can also allow multiple same or different patient sensors to be utilized simultaneously.
[0585] 19A as a connection between a side arm 270 of the headgear and a first strap 211, the component 2000 may connect between any other two desired components of the patient interface. For example, the component 2000 may be provided between two pieces of headgear, or, as previously described, can be provided in the form of a side arm 270 to connect between a main body of the patient interface and a portion of the headgear of the patient interface.
[0586] Component 2000 can include one or more of the same connector features as a connector that is not configured to hold a patient sensor 29. For example, component 2000 in the configuration of FIG.
[0587] FIG. 19B shows a perspective view of the portion of the patient interface 1000 marked A in FIG. 19A.
[0588] 19B, component 2000 is shown with one end connected to side arm 270 and the other end connected to a first strap of headgear 211. Component 2000 has a first connector 2010 that connects to side arm 270 and a second connector 2020 that connects to the first strap of headgear 211.
[0589] As shown in FIG. 19B, the first connector 2010 is located at a first end 2001 of the component 2000, and the second connector 2020 is located at a second end 2002 of the component.
[0590] FIG. 19C shows a detail marked A in FIG. 19A, but from the opposite side of component 2000 as shown in FIG. 19B.
[0591] Component 2000 comprises a component body 2005. As seen in Figure 19C, the component body has a sensor cavity 500 in which a patient sensor 29 is held.
[0592] The component body 2005 can be located between the first end 2001 and the second end 2002 of the component. For example, as shown in Figures 19B and 19C, the component body 2005 can be disposed between the first connector 2010 and the second connector 2020 of the component such that the first connector 2010 and the second connector 2020 are located on respective sides of the component body 2005.
[0593] One or both of the first connector 2010 and the second connector 2020 may be configured to releasably connect the components with respective other portions of the patient interface.
[0594] For example, as seen particularly in FIG. 19B, the second connector 2020 includes a buckle 2021 through which an end of a 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 one another.
[0595] 19B and 19C, the first connector 2010 is configured to be releasably connected to the side arm 270. The first connector 2010 can receive and hold a portion of the side arm 270. By moving the portions of the first connector 2010 relative to each other, the engagement with the side arm 270 can be released, and the connection between the side arm 270 and the first connector 2010 can be released from each other.
[0596] 19A-C, the opening of the sensor cavity 500 is provided on the inner surface of the nasal cannula interface 1000 that is adjacent the patient's face in use. This configuration allows a portion of the patient sensor 29 to be directly exposed to the patient's body.
[0597] When the opening of the sensor cavity 500 is directed towards the patient's face in use, the patient's face can act to further retain the patient sensor 29 within the sensor cavity 500.
[0598] FIG. 20 is a diagram of the component 2000 without a patient sensor 29 held thereon, and FIG. 21 is a diagram of the component 2000 with a patient sensor 29 held thereon.
[0599] As shown in Fig. 20, the component body 2005 is located between a first connector 2010 and a second connector 2020. The component body 2005 has a sensor cavity 500. In the configuration of Fig. 20, the sensor cavity 500 is formed in a first surface 2007 of the component body 2005.
[0600] The sensor cavity 500 is defined by one or more walls 2006 of the component body 2005 .
[0601] The component body includes a wire cavity 700. The wire cavity 700 can extend between the sensor cavity 500 and the exterior of the component body 2005 to provide a path for one or more wires to the sensor cavity 500.
[0602] As previously mentioned, the wires that the wire cavity 700 is configured to route may include cables, cords, leads, cable harnesses, or any other insulated assembly of electrically conductive material.
[0603] 20 , the wire cavity 700 is disposed in the first face 2007 of the component body 2005. The wire cavity 700 has an opening in the first face 2007 of the component body 2005. The wire cavity 700 opens between the sensor cavity 500 and an exterior surface of the component body 2005 adjacent the first face 2007.
[0604] The wire cavity 700 may take the form of a slot recessed from the face of the component body to provide a passageway between the sensor cavity 500 and the exterior of the component body.
[0605] The wire cavity 700 may be of various cross-sectional configurations. For example, the wire cavity 700 may have a substantially square, rectangular, or circular cross-section. The wire cavity 700 may be configured with multiple cross-sectional configurations along its length. The wire cavity 700 may have any of the aforementioned cross-sectional configurations at any one or more locations along its length.
[0606] As can be 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 passed to connect the straps to the second connector 2020.
[0607] The patient sensor 29 is shown in Figure 21 held within a sensor cavity 500 of the component body 2005. The shape of the sensor cavity 500 can be defined to complement the shape of the patient sensor 29. For example, as seen in Figures 20 and 21, the perimeter of the sensor cavity 500 about the wall 2006 of the component body corresponds to the outer shape of the patient sensor 29.
[0608] 21, the sensor cavity 500 has a substantially rectangular shape with rounded edges. The sensor cavity 500 can have a variety of other shapes, such as, for example, square or circular. At least one of the configuration of the sensor cavity, or at least one dimension of the sensor cavity, can correspond to the dimensions of an intended patient sensor for use with the component 2000.
[0609] The sensor cavity 500 can provide an interference fit with the patient sensor 29 to aid in retaining the patient sensor at or within the sensor cavity 500. Such an interference fit can be in the form of a friction fit. Additionally or alternatively, the interference fit can include a snap fit arrangement between the sensor and the sensor cavity.
[0610] An adhesive may be provided between the patient sensor and a portion of the sensor cavity to hold the patient sensor within the sensor cavity.
[0611] When used with the sensor cavity opening adjacent to the patient's face, the patient's face can also help hold the sensor inside the sensor cavity.
[0612] The wire cavity 700 may also correspond in shape to the portion of the wire 710 that it is to receive. As seen in Figure 21, the patient sensor 29 includes an extension portion 710a about a proximal portion of the wire 710. The dimensions of the wire cavity 700 are configured to correspond to the dimensions of the extension portion 710a.
[0613] The sensor cavity 500 of the component 2000 may be such that when the patient sensor is disposed in the sensor cavity, a portion of the patient sensor may be exposed to the exterior of the component. For example, the patient sensor may include a transducer and / or a light source. The component body 2005 and the sensor cavity 500 therein may be positioned such that when the component 2000 is used by a patient as part of a patient interface, one or both of the transducer and the light source face toward the patient. More specifically, the component body 2005 and the sensor cavity may be positioned such that the transducer and / or the light source are exposed to the exterior of the component 2000.
[0614] In some configurations, the first surface 2007 of the component body 2005 in which the sensor cavity 500 is formed may be the surface of the component body that is oriented toward the patient when the component 2000 is used as part of the patient interface 1000.
[0615] In such a configuration, the body of the patient sensor 29 is disposed adjacent to the patient in use, and thus, if the patient sensor 29 includes a transducer and / or a light source, these may be disposed facing the patient.
[0616] When the opening of the sensor cavity is directed towards the patient in use, the patient sensor may be or may additionally be held in the sensor cavity 500 by the presence of the patient's face.
[0617] In other configurations, the first side 2007 of the component body 2005 in which the sensor cavity 500 is formed may be the side of the component body that is not oriented towards the patient when the component is used as part of the patient interface 1000. In some configurations, the first side 2007 and the opening of the sensor cavity 500 may be oriented away from the patient in use.
[0618] In such a configuration, the component body 2005 may include one or more holes extending through the component body 2005 in the body wall 2006 to allow the transducer and / or light source of the patient sensor 29 to face towards the patient during use.
[0619] The sensor cavity 500 may be positioned to provide a portion of the patient sensor 29 that is held in contact with the patient when the component 2000 is used as part of a patient interface.
[0620] The opening of the wire cavity 700 can be oriented to face the patient in use. More specifically, the opening of the wire cavity 700 in a direction transverse to the length of the wire cavity 700 between the sensor cavity 500 and the exterior of the component body 2005 can face the patient in use.
[0621] The patient-facing surface of the component body 2005 of the component 2000 shown in Figures 19A and 19B is substantially rectangular. In other configurations, the patient-facing surface of the component body 2005 can have a substantially circular shape.
[0622] The component 2000, or at least the component body 2005 and any portions integrally formed therewith, may be formed from a biocompatible material. For example, they may be formed from a biocompatible plastic material such as, for example, a thermoplastic elastomer (TPE), or silicone, or liquid silicone rubber (LSR).
[0623] As previously discussed in relation to the accessory 400, and particularly with reference to Figure 16E, the face of the component 2000, or particularly the component body 2005, that is configured to face the patient during use may include at least one surface material, such as the above-mentioned surface material 227. The surface material may be provided over part or all of the face of the component 2000 that faces the patient.
[0624] The surface material may be the same material that the component 2000, or particularly the component body 2005, is made of. In other configurations, the surface material may be a different material.
[0625] The surface material of component 2000 can function to provide a desired coefficient of friction between component 2000 and the patient's face.
[0626] The surface material of component 2000 can act to retain the sensor within the sensor cavity. For example, the surface material can be disposed over some or all of the opening of the sensor cavity once the sensor is disposed therein.
[0627] The patient sensor 29 may be provided within the sensor cavity 500 as part of the component 2000. In other configurations, a suitable patient sensor 29 may be attached to the component 2000 by a user.
[0628] The component 2000 may be provided as a separate component for use with a patient interface, or the component 2000 may be provided as part of the patient interface.
[0629] The exploded view of Figure 22 shows various components of the configuration of component 2000, including a first connector 2010 and a second connector 2020. As seen in Figure 22, the second connector has a buckle 2021 to which a strap of headgear can be attached.
[0630] 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 a component body 2005. The component body 2005 is also integrally formed with a second connector 2020.
[0631] 22, the first connector 2010 also includes a second body having a pair of detents 3205 and a biasing means 3207. The first connector 2010 also includes a slide 3209 having a first slide portion 3209a and a second slide portion 3209b. The portions of the first connector 2010 may cooperate to allow another portion of the patient interface, such as an end of the side arm 270, to be selectively released after being received and held by the first connector.
[0632] The component 2000 may have a connector mechanism of a connector 3200, as shown in Figures 23-32. Further details of the configuration of the first connector 2010 of the component 2000 are provided below as a description of the connector 3200.
[0633] 23-32, a first connector portion 3201 is described which may be secured to the connector 3200 by a detent 3205 and / or protrusion 3215. Although described as a first connector portion 3201 or clip 3301 in relation to FIGS. 23-32, it is referred to elsewhere herein as a first connector. A first connector may be understood to generally relate to a portion of a patient interface where a first connection may be made with another portion of the patient interface, e.g., a body of the patient interface. For example, in FIGS. 19A and 19B, the component 2000 has a first connector 2010 which connects to a body of the patient interface 1000. More specifically, the first connector 2010 connects to a side arm 270 of the patient interface 1000.
[0634] 23-32, a second connector portion 3203 is described as part of the connector 3200. Such a portion is described elsewhere herein as a second connector. A second connector may be understood to generally relate to a portion of a component of a patient interface where a second connection may be made with another portion of the patient interface, such as headgear or a headgear portion. For example, in FIGS. 19A and 19B, component 2000 has a second connector 2020 that connects to headgear 200 of the patient interface.
[0635] A first preferred embodiment of the connector 3200 will now be described with reference to Figures 23 to 32. The connector 3200 comprises a first connector part in the form of a clip 3201, a second connector part in the form of a carrier 3203, a detent 3205 for fixing the clip and the carrier to each other, a biasing means 3207 and a slide 3209. The slide 3209 is movable relative to the clip 3201 and / or the carrier 3203 between a fixed position and a free position. In the fixed position the detent 3205 is substantially prevented from moving and releasing the clip 3201 from the carrier 3203. In the free position the detent 3205 can be moved to release the clip 3201 from the carrier 3203. The biasing means 3207 biases the slide towards the fixed position.
[0636] In the preferred embodiment shown, the biasing means 3207 and the detent 3205 are integrally formed. The biasing means 3207 comprises a pair of resilient legs 3208, and the detent comprises a pair of resilient arms 3211. The arms and legs are substantially resistant to deformation or are resiliently flexible. The arms 3211 are flexible to allow the clip 3201 to be inserted when the slider 3209 is in a fixed position, as described below. The arms and legs extend from the body portion 3210.
[0637] As will be described in more detail below, the resilient legs 3208 bias the slide towards a locked position. The legs extend in the same direction from the body portion 3210 and are 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 that joins the body portion 3210. The free end 3208b of each leg is rounded. The sides, top surface 3208d and bottom surface 3208e of each leg are generally planar.
[0638] The resilient arms 3211 are spaced apart from the body portion 3210 and extend in the same direction as the legs 3208. The arms are the same length as each other and are longer than the legs. The arms 3211 are biased towards each other. As will be explained in more detail below, when the clip 3201 is inserted into the carrier 3203, the pair of resilient arms 3211 are biased towards engagement with notches in the clip.
[0639] Each arm has a straight portion closest to the body portion 3210 that extends into an arcuate portion 3212. The arcuate portion 3212 allows the arm 3211 to bend when the clip 3201 is inserted into the carrier 3203 with the slide 3209 in a fixed position. The arcuate portion 3212 is concave from the position of the slide. The arcuate portion 3212 is narrower than the straight portions. The sides, top and bottom of each arm are substantially planar. The top and bottom surfaces act as bearing surfaces between the slide 3209 and the carrier subassembly with the biasing means 3207 / detent 3205.
[0640] Each resilient arm 3211 includes a protrusion 3215 for engaging a complementary notch in the clip 3201. The protrusion 3215 is at a 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 the notch. In an alternative embodiment, the notch may be a shoulder.
[0641] The slide 3209 has a lug 3217 for engaging the biasing means and a stopper 3227 for placing the slide and carrier 3203 in a fixed configuration, as shown in FIG. 25. Another stopper can be provided near the stopper 3227 to control the degree of movement of the slider in the free position. There may be additional stops or the stopper 3227 may be extended. 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. The stopper 3227 is formed on the first surface and the lug 3217 is formed on the second surface. In an alternative embodiment, the stopper and lug may be formed on the same surface. FIGS. 24-28 are cross-sectional views through the mid-plane of the connector. Thus, these figures show the lug, the stopper and the biasing means.
[0642] 24-28, the lug 3217 is centrally positioned within the slide 3209. The lug 3217 has two outwardly tapered surfaces 3219 with rounded noses 3221.
[0643] The stopper has a wedge-shaped profile when viewed from the side as shown in FIG. 30. The stopper cooperates with a slot in the carrier. When the slide is in the locked position, a surface of the stopper engages a surface of the slot, preventing the slide from passing the locked position. The wedge shape of the stopper aids in assembling the slide to the carrier.
[0644] The slide 3209 has two protrusions 3223 for engaging detents to substantially prevent movement and release of the clip 3201 from the carrier 3203. The protrusions are generally semicircular in shape, as shown in FIGS. 24-28. The slide 3209 has a pair of rails 3225 extending longitudinally. The slide may have a scalloped portion for a user to grip the slider. The slider may be fitted with a soft sleeve component that gives the user a better grip to manipulate the connector, which may also be more comfortable for the patient to have against the skin. The sleeve may be overmolded or co-molded with the sleeve, or may be a separately formed component that is assembled with the slider.
[0645] The clip 3201 is a substantially flat, rigid component. The clip 3201 includes a pair of notches 3213. The notches 3213 are positioned toward a nose section 3201a of the clip 3201 and are generally triangular in shape. A first side 3213a of the notch 3213 closest to the nose of the clip 3201 is at a steeper angle 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 slide is in a locked position.
[0646] The carrier has been described as a separate component from the combined detent / biasing means component, or the carrier may be integrally formed with the detent / biasing means component.
[0647] The biasing means has been described as comprising a pair of resilient legs. Alternatively, the biasing means may comprise a single leg or three or more legs. In a further alternative, the leg biasing means may comprise any other type of spring element that acts as a return mechanism for the slider.
[0648] The detent has been described as having a pair of resilient arms. Alternatively, the detent may have a single arm or three or more arms. The clip has been described as having a pair of notches. Alternatively, the clip may have a single notch or two or more notches. The number and location of the notches correspond to the number and location of complementary protrusions on the resilient arms.
[0649] The biasing means has been described as having two legs that move away from each other and are biased towards each other to urge the slider towards a fixed position. Alternatively, the legs may be deformed in another direction to provide a similar return motion. For example, the legs may be twisted or bent along their length.
[0650] The features and characteristics of the legs can be altered to suit the application, i.e., they can be modified to adjust the force on the slide when moving between the fixed and free positions. Features and characteristics that can be selected or designed to be altered include leg angle, leg thickness, and lug angle.
[0651] In a further alternative embodiment, the combined detent / biasing means component may be formed in two parts, each having an arm and a leg, and held in place relative to the carrier by a positioning feature. In a further alternative embodiment, the detent / biasing means may be a single leg and arm combination that acts on only one side of the clip. In this embodiment, the connector has a positioning mechanism to lock the detent / biasing means in place together with a guide and / or abutment mechanism to ensure that the connector components are accurately positioned relative to each other, taking into account the forces acting on the components by the arms / legs.
[0652] The biasing means and the detent have been described as being integrally formed, or they may be separately formed components that may or may not be connected to one another.
[0653] Embodiments of the connector have been described as having a biasing means for urging the slider towards the fixed position. In alternative embodiments, the connector may not have a biasing means, but the slider may be held in the free and / or fixed position by other suitable mechanisms. For example, the connector may have one or more catches that hold the slider in the free and / or fixed position. Such catches may automatically engage the slider and / or carrier, or may be mechanisms controlled by the user.
[0654] The present disclosure also provides a conduit and wire clip 4000. The clip 4000 may be used to attach the conduits of the patient interface together with wires, for example the wires of the patient sensor 29.
[0655] Figure 33 shows a perspective view of clip 4000 and Figure 34 shows an end view of clip 4000. Clip 4000 has a wire receptacle 4006 for receiving a wire and a conduit receptacle 4007 for receiving a conduit.
[0656] The conduit 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 over its length that is narrower than the corresponding maximum width of the receptacle. The pair of walls 4001 and 4002, and 4003 and 4004, respectively, are curved toward each other at their distal extents.
[0657] The cross-sectional size and shape of each receptacle may be adapted to correspond to the cross-sectional size and shape of the intended sensor wire and conduit, respectively.
[0658] The clip 4000 of Figures 33 and 34 may be for connecting to wires and conduits, each having a substantially circular cross-section.
[0659] The width of each of the receptacles 4006 and 4007 may be the same as, or preferably smaller than, the corresponding width of the wire or conduit to which the clip is to be coupled. This configuration allows for an interference fit to be provided between the wire or conduit and the clip when the respective elements are placed within their respective receptacles.
[0660] Although clip 4000 is shown in Figures 33 and 34 as having a length generally equal to its overall lateral dimension, it may have a length that is relatively greater or less than one or both of its lateral dimensions.
[0661] 33, the corner 4010 of the first wall 4001 is rounded between its edge at the opening of the conduit receptacle 4007 and its edge at the proximal end of the clip 4000. The rounded corner locally increases the width of the opening of the conduit receptacle 4007. This locally increased width can assist a user in attaching the clip to a conduit.
[0662] The corresponding corner of the other wall 4002 of the conduit receptacle 4007 may be similarly rounded to further increase the width of the opening at the end of the conduit receptacle 4007.
[0663] Only one end of the conduit receptacle 4007 of the clip 4000 may have rounded corners, or both may.
[0664] Rounded corners may likewise be provided at one or more of the corners or one or both ends of the wire receptacle 4006 of the clip 4000.
[0665] One or more clips, such as clip 4000, may be used with a patient interface, particularly with a patient interface that may hold a patient sensor as described herein. If the patient sensor includes a wire, the trailing wire may cause inconvenience to the patient or clinician. One or more clips may be used to secure one or more sensor wires to a conduit of the patient interface. This may reduce clutter and increase the simplicity of the overall patient interface and the patient or clinician's interaction therewith.
[0666] 35 shows, for example, a portion of a conduit 62 for a patient interface along with a wire 710 for a patient sensor. A clip 4000 is attached to both the conduit 62 and the wire 710 such that a portion of the conduit 62 is received in a conduit receptacle of the clip and a portion of the wire 710 is received within a wire receptacle of the clip.
[0667] As can be seen in FIG. 35, the clip 4000 orients the longitudinal axes of the conduit 6 and wire 710 parallel to one another in the position where the clip 4000 is connected.
[0668] Figure 19A also shows two clips 4000 as part of a patient respiratory interface 1000 with a conduit 16. The openings of each of the conduit receptacles are shown in Figure 19A. The wires 710 from the patient sensors run along the length of the conduit 16 and are hidden by the conduit.
[0669] In some configurations, the component of or for the patient interface configured to hold a patient sensor may be a connector including a conduit holding portion or a tubing clip. The component may have a sensor mount configured to hold the patient sensor. The sensor mount may be configured to mate with a sensor mount receiving portion of another component of the patient interface.
[0670] 36A shows a patient respiratory interface in the form of a nasal cannula interface 1000. Although illustrated as a nasal cannula interface, it is understood that the interface may be of other types as disclosed herein. The nasal cannula interface 1000 has a nasal cannula 30 and an associated gas inlet conduit 62 for providing a flow of breathable gas. The nasal cannula interface 1000 has respective side arms 270 extending on either side of the nasal cannula 30.
[0671] In some configurations, the gas inlet conduit 62 may be provided as a first portion 62a and a second portion 62b. The first portion 62a and the second portion 62b may be connected to one another at or by a component 2000, more specifically at or by a conduit-holding portion 2100.
[0672] The nasal cannula interface 1000 includes a component 2000 configured to hold a patient sensor 29. The component 2000 is provided in the form of a component 2000. The component 2000 has a conduit holding portion 2100 for holding a portion of the gas inlet conduit 62. The component 2000 has a sensor mount 2200 configured to hold the patient sensor 29.
[0673] The conduit retaining portion 2100 may have a shape that encircles the entire gas inlet conduit 62, such as in the form of a collar that surrounds the gas inlet conduit 62, as shown in Figure 36A. In other configurations, the conduit retaining portion 2100 may have other forms that do not completely surround the gas inlet conduit 62. For example, the conduit retaining portion 2100 may be in the form of a tube clip or a portion thereof, as described elsewhere herein, for example in connection with Figures 33-35.
[0674] In some configurations, the conduit retaining portion 2100 may be removably attachable to the gas inlet conduit 62. For example, where the conduit retaining portion 2100 is in the form of a conduit receptacle 4007 of the tube clip 4000 of Figures 33-35, the conduit retaining portion 2100 may be removably attachable to the gas inlet conduit 62.
[0675] In other configurations, for example where the conduit retaining portion 2100 completely surrounds the conduit, the conduit retaining portion 2100 may only be removable by sliding the end of the gas inlet conduit 62 or may not be removable non-destructively from the conduit.
[0676] In some configurations, the conduit retaining portion 2100, when retaining the gas inlet conduit 62, may be fixedly associated with the conduit. In such configurations, the conduit retaining portion may not be able to move relative to the gas inlet conduit, for example, by either or both of translation along or rotation about the gas inlet conduit. In such configurations, the component 2000 may be provided as part of the gas inlet conduit 62.
[0677] In other configurations, the conduit retaining portion 2100 may be at least partially movably associated with the gas inlet conduit 62, for example, by being translatable along the gas inlet conduit or rotatable around it, or both.
[0678] At least one side arm 270 of the patient interface has a sensor recess 2050 that is sized and configured to receive a sensor mount 2200 of the component 2000. The sensor recess is configured such that when the patient interface is worn by the patient, a portion of the patient's face is optically exposed to the patient sensor 29 held in the sensor mount 2200, which is itself inserted into the sensor recess 2050.
[0679] The sensor recess 2050 can be configured and positioned on the side arm 270 such that a portion of the patient's cheek is at least optically exposed to the sensor mount 2200 inserted therein. More specifically, the sensor recess 2050 can be configured and positioned on the side arm 270 such that a portion of the patient's face between the eyes and lips is at least optically exposed through the sensor recess.
[0680] In some configurations, the sensor recess 2050 can be a windowed recess in the side arm. The sensor recess can extend into the side arm from the non-patient facing side of the side arm 270 and can be provided with an at least partially transparent window at the base of the sensor recess 2050. The sensor mount 2200 can be insertable into the sensor recess 2050 up to the window in the recess.
[0681] In other configurations, for example as shown in FIG 36A, the sensor recess 2050 can be an opening extending through the side arm 270 between the non-patient facing side and the patient facing side of the side arm 270. In these configurations, when the patient interface 1000 is worn, a portion of the patient's face below the sensor recess 2050 is physically exposed. The sensor recess 2050 is positioned such that when the patient interface is worn by the patient, the sensor recess exposes a portion of the patient's face that would otherwise be covered by the interface.
[0682] When the sensor recess 2050 is in the form of an opening through the side arm 270, the sensor mount 2200 inserted into the sensor recess 2050 can be positioned to contact the patient's face when the patient interface is worn by the patient.
[0683] The sensor mount 2200 and the sensor recess 2050 may engage with an interference fit when the sensor mount 2200 is inserted into the sensor recess 2050 .
[0684] In some configurations, the sensor mount 2200 and the sensor recess 2050 can be configured to engage with one another to resist the sensor mount 2200 being pulled out of the sensor recess 2050 when the sensor mount 2200 is inserted a particular degree or fully into the sensor recess 2050.
[0685] The sensor mount 2200 and the sensor recess 2050 may have an interengagement mechanism that engages with one another upon insertion of the sensor mount 2200 to a predetermined depth within the sensor recess 2050. The predetermined depth may be such that the sensor mount contacts the patient's face when the patient interface is worn by the patient. Such an interengagement mechanism may be, for example, a snap fit mechanism, an interference fit mechanism, or a magnetic engagement mechanism.
[0686] In some configurations, the sensor mount 2200 may be configured to irreversibly connect with the sensor recess 2050 when inserted therein. In other configurations, the sensor mount 2200 may resist removal when inserted into the sensor recess 2050, but may be repeatedly insertable and removable therefrom.
[0687] The side arm sensor recess 2050 may be of any shape, particularly one that corresponds to the shape of the sensor mount 2200 that it is to receive. For example, the sensor mount 2200 may have a square, rectangular, oval, or circular cross-section, and the sensor recess 2050 may have a corresponding square, rectangular, oval, or circular cross-section.
[0688] In some configurations, it may be desirable to limit or prevent rotation of the sensor mount 2200 and the sensor recess 2050 relative to one another about the axis of insertion of the sensor mount 2200 into the sensor recess 2050. In these cases, the cross sections of the sensor mount 2200 and the sensor recess 2050 may closely correspond to one another and may not simply be circular. In addition to being circular, they may include circular cross sections with one or more detents or notches and corresponding protrusions, which together act to resist relative rotation between the parts in use.
[0689] The side arm 270 with the sensor recess 2050 may be configured to be substituted for a conventional side arm of another patient interface to provide integration of sensing of one or more patient parameters with the patient interface. When sensing of a patient parameter is desired, the user can remove the existing side arm from the patient interface and headgear or headgear connector and reconnect the side arm 270 with the sensor mount 2200 in its place. If the patient interface includes the component 2000, the sensor mount 2200 may then be inserted into the sensor recess 2050 for use in monitoring the patient parameter. If the particular patient interface does not include the component 2000, the component 2000 may be provided in the gas inlet conduit 62 or else the gas inlet conduit 62 with the component 2000 may be provided for connection to the patient interface and then the sensor mount 2200 may be inserted into the sensor recess 2050.
[0690] Because the sensor mount 2200 is insertable into the sensor recess 2050 from the side of the side arm 270 that contacts the patient's face during use, the sensor mount 2200 may be insertable and removable from the sensor recess 2050 while the patient interface 1000 is being used by the patient.
[0691] 36A configuration, both of the side arms 270 of the nasal cannula interface 1000 have respective sensor recesses 2050 and 2051. Such a configuration may allow the sensor mount 2200 to be selectively inserted into either the sensor recess 2050 or 2051 such that the patient sensors 29 may be positioned on either side of the patient's face.
[0692] In the configuration shown in FIG. 36A , the patient gas conduit 62, away from its connection to the main body 110, can be curved around the other side of the interface so that the illustrated sensor mount 2200 of the component 2000 can be inserted into the sensor recess 2051.
[0693] In other configurations, such as shown in FIG. 37, the patient interface 1000 may be configured such that the gas inlet conduit 62 is optionally connectable to either side of the main body 110 of the interface. In such configurations, the gas inlet conduit may be said to be connectable to the main body in a number of different orientations. In the configuration of FIG. 36A, the conduit 62 is connected to the left side of the main body 110 as viewed from the patient's perspective. As shown in FIG. 37, the main body 110 has connection ports 110a and 110b for the gas inlet conduit 62 on both the left and right sides of the main body 110, with the gas inlet conduit 62 shown connected to the right side of the main body 110 at connection port 110b. Once connected at connection port 110b, the sensor mount 2200 of the component 2000 may be insertable into the sensor recess 2051 of the right arm 270. The connection port 110a to which the gas inlet conduit 62 is not connected may be sealed by a plug or other closure.
[0694] This arrangement allows a user to conveniently select the side of the patient's face on which the patient sensor 29 is located by switching the side of the main body 110 to which the gas inlet conduit 62 is connected.
[0695] By connecting the gas inlet conduit to the side of the main body 110 that corresponds to the sensor recess 2050 or 2051 into which the sensor mount 2200 is to be inserted, the degree of curvature of the gas inlet conduit can be minimized. In particular, the curvature of the gas inlet conduit between the first end where the gas inlet conduit 62 connects to the main body 110 and where the conduit is held by the conduit retaining portion 2100 can be less than about 90 degrees. More specifically, the curvature can be less than about 45 degrees.
[0696] Further details of the component 2000 are shown in FIG. 36B. The component 2000 has a conduit holding portion 2100 and a sensor mount 2200. The sensor mount 2200 is configured to hold a patient sensor 29. The patient sensor 29 may be removably held by the sensor mount 2200. In other forms, the patient sensor 29 may be non-removably held by the sensor mount 2200, for example by being integrally formed therewith. The sensor mount 2200 may function as a partial housing within which the patient sensor 29 is held. The sensor mount 2200 may have one or more openings 2201 that may expose the patient sensor 29 to the patient when the sensor mount 2200 is inserted into the sensor recess 2050 of the side arm 270.
[0697] As shown and described in connection with FIGS. 36A-37, the gas inlet conduit 62 for being held by the component 2000 can include one or more conductive elements. The conductive elements can extend along part or all of the length of the gas inlet conduit 62. For example, in some configurations, the one or more conductive elements can extend from a first end of the tube for connection to the main body 110 of the patient interface 1000 and a second end opposite the first end, which can be for connection to the inhalation conduit 16 as shown in FIG. 3. In other configurations, the one or more conductive elements can extend partially along the length of the gas inlet conduit from one of its ends. For example, the one or more conductive elements can extend from the second end of the gas inlet conduit 62 to a location along the gas inlet conduit where the conduit holding portion 2100 is configured to hold the conduit. Where the gas inlet 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 connection elements may be associated with only one of the first portion 62a and the second portion 62b. One or more of the conductive elements associated with the gas inlet conduit 62, or at least a portion thereof, may be for operation of the patient sensor 29. For example, the conductive elements may provide power to the patient sensor 29 and / or receive a sensor signal from the patient sensor 29.
[0698] The one or more conductive elements may be provided on a bead or lumen of the conduit. In other examples, the conductive elements may be associated with the conduit but disposed externally to the conduit. The one or more conductive elements may include, for example, one or more wires, cables, leads, or other insulated conductive material.
[0699] Fig. 36A shows conductive elements 710 associated with the gas inlet conduit 62. In the configuration shown in Fig. 36A, one or more of the conductive elements 710 may extend only to the second portion 62b of the gas inlet conduit 62 and may interface with a patient sensor 29 held in the component 2000, and more specifically, in a sensor mount 2200 of the component.
[0700] Where the gas inlet conduit 62 has a first portion 62a and a second portion 62b, the component 2000 having the conduit retaining portion 2100 and the sensor mount 2200 may be provided at the interface between the first portion 62a and the second portion 62b. The conduit retaining portion 2100 may itself interface between the first portion 62a and the second portion 62b of the gas inlet conduit 62. The first portion 62a and the second portion 62b may interface with one another when the interface is worn by the patient at a position above the patient's chest, near the patient's face, near the patient's cheek, or more specifically between the patient's eyes and mouth.
[0701] When the gas inlet conduit 62 has a first portion 62a and a second portion 62b, and the component 2000 is positioned at or provided at their interface, the length of the first portion 62a may be such as to position the sensor mount 2200 adjacent to a sensor recess 2050 in a side arm 270 that is positioned transversely to an adjacent connection port of the main body 110 for the conduit 62.
[0702] Although the sensor recess(es) are shown in Figures 36A-37 as being formed in the side arm(s) 270, they may additionally or alternatively be provided in one or more other components of the patient interface. For example, the sensor recess(es) may additionally or alternatively be provided in a headgear strap or a headgear to side arm connector component, for example as described in connection with Figures 23-32.
[0703] As described in connection with component 2000 of Figures 36A-37, in different arrangements, the conduit retaining portion may be movable along the gas inlet conduit 62 or may be fixedly associated with a particular position along the gas inlet conduit 62.
[0704] FIG. 38A shows a partial view of the nasal cannula interface 1000 with another configuration of a component 2000 for holding the patient sensor 29. The nasal cannula interface 1000 includes a cannula 30 associated with a main body 110. A side arm 270 is shown in association with one side of the main body 110, and a gas inlet conduit 62 is connected to the main body 110 for supplying breathable gas. The component 2000 holds the gas inlet conduit 62 in a conduit holding portion 2100. The component 2000 has a hook portion 2400 that can attach the component 2000 to another portion of the patient interface 1000. For example, the hook portion 2400 can pass through the side arm or a headgear strap to associate the component 2000 with the remainder of the patient respiratory interface 1000. As shown in FIG. 38A, the hook portion 2400 is positioned over the headgear strap 210. Further details of component 2000, including its hook portion 2400, are shown in FIG. 38B. On the opposite side of hook portion 2400 from conduit holding portion 2100, component 2000 has a sensor mount 2200 configured to hold a patient sensor 29. When component 2000 is hooked to another portion of a patient interface worn by the patient, sensor mount 2200 can be provided adjacent to or in contact with the patient's face. Hook portion 2400 may be repositionable along a side arm or headgear strap to provide sensor mount 2200 at a desired location on the patient's face.
[0705] The patient sensor 29 may be removably or non-removably held by the sensor mount 2200.
[0706] 38A and 38B are shown with sensor wires 2060 extending from the sensor mount 2200. In other configurations, the patient sensor 29 may be powered and configured to communicate wirelessly with a processor and / or control circuitry, such as a processor and / or control circuitry of a pulse oximeter.
[0707] The hook portion 2400 may be sized and configured to correspond to a portion of a patient interface to which it is hooked.
[0708] FIG. 39 shows another configuration of a component 2000 provided as part of a connector between two other parts of the patient respiratory interface 1000. The component 2000 has a first connector portion 2081 to which a side arm can be connected to the component 2000, and a second connector portion 2082 to which a headgear portion can be connected. As seen in FIG. 39, a headgear strap 210 is shown threaded through a buckle in 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. The patient sensor 29 can be exposed on the patient-facing side of the component 2000 through one or more openings 2201 in the sensor mount 2200.
[0709] As seen in Figure 39, the other end of the strap 210 is provided with a connector 3200 in the form previously described in connection with Figures 23 to 32. In other configurations, the components 2000 can be provided on both ends of the strap 210.
[0710] 39 is used as part of a patient respiratory interface, the component and optional connector 3200 can be disconnected from a side arm of the interface and reconnected to the opposite side arm to change the side of the patient's face on which the patient sensors 29 are located. If it is not desired to invert the headgear, this same function can be accomplished by unbuckling the headgear straps 210 from the buckles of the component 2000 and connector 3200, switching the side arm with which each of the component 2000 and connector 3200 is associated, and then reattaching the ends of the headgear straps 210 to the buckles.
[0711] In some configurations, a component 2000 configured to hold a patient sensor 29 can be provided as an intermediate component that can be inserted between two other portions of the patient interface. Figure 40 shows an example of such a configuration, showing a component 2000 insertable between a side arm 270 and a connector 3200. Without the component 2000, an end 4020 of the side arm 270 can be inserted into a receiving portion 3230 of the connector 3200, and the two portions can be attached together.
[0712] 40 has a first end 2083 configured to receive and couple to the end 4020 of the side arm 270. The component 2000 has a second end 2084 configured to be inserted into a 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 on which a patient sensor may be held.
[0713] Although shown in FIG. 40 as having respective male and female connections between the end 4020 of the side arm 270 and the first end 2083 of the component 2000, and between the second end 2084 of the component 2000 and the receiving portion 3230 of the connector 3200, it will be understood that the order of one or both sets of connections may be rearranged as desired for a particular patient interface.
[0714] The component 2000 of FIG. 40 may be repositionable between both 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 connector 3200 on one side of the interface and reconnecting it on the other side of the interface.
[0715] The components 2000 described herein may be powered by a power source directly associated with the patient sensor 29 or may be powered by a remote power source. Similarly, the components 2000 may be configured to communicate with the processor and / or control circuitry by a wired or wireless connection. If the patient sensor 29 communicates wirelessly, the wireless communication circuitry, and optionally a power source, may be carried in the sensor mount 2200 along with the patient sensor. In other configurations, the wireless communication circuitry and power source may be provided as part of the communication module.
[0716] A communications module 2090 is shown in Figure 40. The communications module is for association with the sensor mount 2200 to enable wireless communication from the patient sensor 29 to a processor and / or other sensor control circuitry. As shown in Figure 40, the component 2000 has a port 2085 through which the communications module 2090 can be connected to the component 2000 or a held patient sensor 29.
[0717] It will be appreciated that the communications module 2090 may be implemented in other forms of components 2000 described herein where wireless communication is desired for patient sensors.
[0718] 41 shows two exemplary configurations of the communications modules 2090a and 2090b. In a first configuration, the communications module 2090a includes a power source for powering the communications module. The communications module 2090a is configured to wirelessly communicate sensor information from the patient sensor. In a second configuration, the communications module 2090b does not include a power source and is connected to a remote power source by the sensor wires 2060. The communications module 2090b may be configured to wirelessly communicate the sensor information or may transmit the sensor information along the sensor wires 2060.
[0719] The communications modules 2090a and 2090b shown in FIG. 41 each include a prong 2091 for interfacing with a corresponding port 2085 of the component 2000 for connection to the patient sensor 29.
[0720] A configuration has been described above, for example in connection with Figures 7C and 8B, in which the patient sensor 29 may be held by a side arm 270 that connects to one or both of the main body 110 or the headgear strap 210 by a connector in the form of a push-fit clip 241, as shown in particular in Figure 7F. Figure 43 shows a further configuration of a patient respiratory interface 1000 having a side arm 270 and a headgear strap 210 connectable by a component 2000 that includes a push-fit clip 241. The component 2000 is configured to hold the patient sensor 29. The headgear strap 210 may be associated with the component in any of the ways previously described, such as by a buckle or other portion that holds the strap 210, for example as the toothed portion shown in the cross-sectional views of Figures 7G and 7H.
[0721] The push-fit clip 241 is insertable within a channel of the side arm 270. When fully inserted within the channel of the side arm 270, pulling the clip 241 out of the channel can cause an engagement surface 243a of the clip 241 to engage a limiting surface 247 of the side arm 270, preventing pulling of the clip 241 from the side arm 270. As shown in FIG. 43, the side arm 270 can have an opening so that a user can push down an end of the clip 241 to disengage the engagement surface 243a from the limiting surface 247 to allow separation of the headgear strap 210 and the side arm 270.
[0722] Although shown in FIG. 43 as having a push-fit clip 241 associated with the headgear strap 210 and insertable into a channel in the side arm 270, it will be understood that the association of the connector portions with the headgear strap 210 and side arm 270 can be reversed if desired.
[0723] As seen in FIG. 43, the component 2000 has a sensor mount 2200 for holding the patient sensor 29. The sensor mount 2200 is configured to hold the patient sensor 29 and expose at least a portion of the patient sensor to the patient's face during use on a patient-facing side of the component 2000. In some configurations, the sensor mount 2200 can be in the form of a sensor cavity 500, such as described above in connection with FIGS. 19-21. In other configurations, the patient sensor 29 can be integrally provided as part of the component 2000. As seen in FIG. 43, the component 2000 can include a port 2085 for connecting with a communication module 2090, as described above.
[0724] 42 is a cross-sectional view of an exemplary configuration of a component 2000 for holding a patient sensor 29 including a connector 241. The component 2000 of FIG. 42 has a sensor mount 2200 to which the patient sensor 29 is attached. In the configuration of FIG. 42, the patient sensor 29 is integrally formed with the remainder of the component 2000. For example, the patient sensor 29 may be at least partially overmolded onto the component 2000. The integral formation of the patient sensor 29 is such that a portion of the patient sensor 29 is directly exposed at the patient-facing side 2202 of the component 2000.
[0725] A sensor mount of a component according to the present disclosure, such as component 2000 as shown and described in connection with Figures 36A-40 and 41, can include a sensor cavity, for example, as described above in connection with Figures 10A-22. If component 2000 is powered and / or communicates by wires, a sensor mount 2200 of component 2000 according to the present disclosure can include one or more wire cavities 700, for example, as described above in connection with Figures 10A-22.
[0726] 10A-22, the securing mechanisms described herein may generally include any disclosed mechanism for attaching an accessory or component to another portion of a patient respiratory interface. For example, the sensor mount 2200 of component 2000 in FIG. 37 may be understood to be a securing mechanism for securing component 2000 to the sensor opening 2050 of the side arm 270. As a further example, the hook portion 2400 of component 2000 in FIG. 38A-B may be understood to be a securing mechanism for securing component 2000 to a strap or side arm of the patient respiratory interface 1000.
[0727] Unless the context clearly dictates otherwise, throughout this specification and the claims, the words "comprise", "comprising", and the like, are to be construed in their inclusive sense, i.e., "including without limitation," as opposed to their exclusive or exhaustive sense.
[0728] Although 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 beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and their obvious modifications and equivalents. Moreover, 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. Also, various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still be considered to fall within the scope of the present disclosure. For example, features described above in connection with one embodiment may be used in different embodiments described herein, and the combinations will still fall within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for one another to form various modes of the embodiments of the present disclosure. Therefore, it is not intended that the scope of the disclosure herein should be limited by the specific embodiments described above. Thus, unless otherwise specified or clearly contradictory, each embodiment of the present invention may include, in addition to its essential features described herein, one or more features described herein from each of the other embodiments of the present invention disclosed herein.
[0729] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless in conflict therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel, or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process so disclosed.
[0730] Moreover, certain features described in this disclosure in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination, one or more features from a claimed combination can, in some cases, be deleted from the combination, and the combination can be claimed as a subcombination or a variation of the subcombination.
[0731] Furthermore, although operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown, or in sequential order, or all operations need not be performed to achieve desirable results. Other operations not shown or described may be incorporated into the exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be omitted and other steps may be added. Furthermore, the features and attributes of certain embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, it should be understood that the separation of various system components in the above implementations should not be understood to require such separation in all implementations, and that the described components and systems may generally be integrated together in a single product or packaged in multiple products.
[0732] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or implemented to achieve one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.
[0733] Conditional language such as "can," "could," "might," or "may," unless otherwise specified or understood otherwise in the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but other embodiments do not. Thus, such conditional language is generally not intended to imply that the features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps should be included in or performed in any particular embodiment, with or without user input or prompting.
[0734] As used herein, terms expressing degrees, such as the terms "approximately," "about," "generally," and "substantially," refer to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% less than the stated amount.
[0735] The scope of the present disclosure is not intended to be limited by the specific disclosure of embodiments in this section or elsewhere herein, but may be defined by the claims, as presented in this section or elsewhere herein, or as presented in the future. The language of the claims should be interpreted broadly based on the language used in the claims, and not limited to the examples or during the examination of the application described herein, and the examples should not be interpreted as being exclusive.
Claims
1. 1. A nasal cannula interface accessory for attachment to a nasal cannula interface, said accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; and An accessory comprising at least one fastening mechanism configured to connect said accessory to a nasal cannula interface (and optionally to a strap of the nasal cannula interface).
2. The accessory of claim 1 , wherein the at least one securing mechanism is configured to releasably connect the accessory to a nasal cannula interface.
3. The accessory of claim 1 or claim 2, wherein the sensor cavity is formed in a first surface of the nasal cannula interface accessory.
4. An accessory according to any preceding claim, wherein the accessory comprises a wire cavity, the wire cavity configured to provide a path for one or more wires to the sensor cavity.
5. The accessory of claim 4 , wherein each of the one or more wires comprises a cable, cord, lead, or any other conductive material.
6. 6. The accessory of claim 4 or claim 5, wherein the wire cavity is formed in the same and / or a different surface of the nasal cannula interface accessory as the sensor cavity.
7. An accessory according to any one of claims 4 to 6, wherein the wire cavity comprises a plurality of openings in different (optionally adjacent) faces of the accessory.
8. An accessory according to any one of claims 4 to 6, wherein the wire cavity is formed adjacent to the sensor cavity.
9. 1. A nasal cannula interface accessory for attachment to a nasal cannula interface, said accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide a path for one or more wires to the sensor cavity; and An accessory comprising: a pair of arms extending from the cannula interface accessory, the pair of arms extending toward each other and / or toward a center of the accessory, the pair of arms configured to releasably connect the accessory to a nasal cannula interface (and optionally a strap of a nasal cannula interface).
10. 1. A nasal cannula interface accessory for attachment to a nasal cannula interface, said accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide a path for one or more wires to the sensor cavity; and An accessory comprising a clip, the clip configured to be connected to the accessory, the clip comprising clip arms connected to the accessory via a biasing element, the clip configured to secure the nasal cannula interface accessory to a nasal cannula interface (and optionally a strap of the nasal cannula interface).
11. The accessory of claim 10 , wherein the biasing element comprises a hinge and a spring.
12. An accessory according to any preceding claim, wherein the sensor cavity is one or more of square, rectangular and / or circular.
13. An accessory according to any preceding claim, wherein the sensor cavity has substantially rounded edges and apexes.
14. An accessory according to any preceding claim, wherein the sensor cavity is arranged to orient the sensor into contact with a patient.
15. An accessory according to any preceding claim, wherein the sensor cavity is arranged to orient the sensor such that a transducer of the sensor faces towards the patient.
16. An accessory according to any one of the preceding claims, wherein the sensor comprises an optical transducer (optionally an infrared or red light transducer) and / or a light source (optionally an infrared or red light source).
17. An accessory according to any preceding claim, wherein the sensor cavity is arranged to orient the sensor such that the optical transducer and / or light source faces towards the patient.
18. 18. An accessory according to any preceding claim, wherein the sensor cavity comprises an opening in a face of the accessory adapted to face a patient in use.
19. An accessory according to any one of claims 4 to 18, wherein the wire cavity extends from an outer surface to the sensor cavity.
20. An accessory according to any one of claims 4 to 19, wherein the wire cavity extends from a face of the accessory to the sensor cavity.
21. 21. An accessory according to any one of claims 4 to 20, wherein the wire cavity comprises an opening in a face of the accessory arranged to face a patient during use.
22. An accessory according to any one of claims 4 to 21, wherein the wire cavity is a slot.
23. An attachment according to any one of claims 4 to 22, wherein the wire cavities are one or more of square, rectangular and / or circular.
24. An accessory according to any preceding claim, wherein the sensor is a patient sensor and the patient parameter is a physiological parameter.
25. An accessory according to any preceding claim, wherein the patient parameter is a measure of the patient's blood oxygenation.
26. An accessory according to any preceding claim, wherein the accessory is attachable to the interface at a plurality of interface attachment locations.
27. 27. The accessory of any one of claims 26, wherein the accessory is configured to be adjustable between the plurality of interface mounting positions.
28. 28. The accessory of claim 26 or claim 27, wherein the accessory is configured to be adjustable between the plurality of interface attachment positions without being detached from the interface (and optionally a strap of the interface).
29. 29. The accessory of any one of claims 26 to 28, wherein the accessory is configured for slidable adjustment between the plurality of interface mounting positions.
30. The accessory of any one of claims 1 to 29, wherein the accessory is attachable to the interface in a plurality of patient face positions.
31. 31. The accessory of claim 30, wherein the accessory is configured to be adjustable between the plurality of patient facial positions without being detached from the interface.
32. 32. The accessory of claim 30 or claim 31, wherein the accessory is configured to be slidably adjusted between the plurality of patient face positions.
33. The accessory of any one of claims 30 to 32, wherein the plurality of patient facial positions includes proximate the patient's cheeks.
34. The accessory of any one of claims 30 to 33, wherein the plurality of patient face positions includes between the patient's eyes and lips.
35. 30. The accessory of any one of claims 26 to 29, wherein the accessory is configured to be adjustable between a plurality of attachment positions of the interface defined by at least a connection point between a strap and a main body of the nasal cannula.
36. The accessory of any one of claims 30 to 35, wherein the plurality of patient face positions corresponds to a plurality of attachment positions.
37. The accessory of any one of claims 1 to 34, wherein the accessory can be positioned proximate the patient's cheek.
38. 28. The accessory of any one of claims 1 to 27, wherein the accessory is capable of being positioned between the patient's eye and lips.
39. The accessory of any one of claims 1 to 38, wherein the accessory is configured to be movable along a length of the strap to allow a clinician to position the sensor.
40. The accessory of any one of claims 1 to 8, wherein the or said at least one fixing mechanism is configured to hold the accessory against a strap of a nasal cannula interface.
41. 41. The accessory of claim 40, wherein the securing mechanism is configured to substantially prevent movement of the accessory along the strap.
42. 42. The accessory of claim 40 or claim 41, wherein the securing mechanism is configured to allow relative movement between the strap and the accessory upon application of a threshold force.
43. 43. The accessory of claim 42, wherein the threshold force is based on the type of fastening mechanism and the material of the strap.
44. 44. The accessory of any one of claims 40 to 43, wherein the at least one securing feature is configured to extend from a side of the accessory opposite the sensor cavity.
45. 45. An accessory according to claim 9 or any one of claims 40 to 44, wherein the at least one fixing mechanism comprises at least one arm, the arm configured to extend around at least a portion of a strap of a nasal cannula interface.
46. 46. The accessory of any one of claims 9 or 40-45, wherein the at least one fastening mechanism comprises a pair of arms arranged along an axis of the accessory, the arms configured to be parallel to an axis of the strap when the accessory is connected to the strap.
47. 47. An accessory as claimed in claim 45 or 46, wherein the arm comprises a first portion extending from the accessory (optionally perpendicular to an outer surface of the accessory) and a second portion, the second portion of the arm being configured to be oriented substantially perpendicular to the associated first portion and / or parallel to the accessory.
48. 48. An attachment according to any one of claims 45 to 47, wherein the at least one securing mechanism comprises a pair of arms extending towards each other from the attachment.
49. 49. The accessory of claim 48, wherein each arm comprises a first portion and a second portion, the first portion extending from the accessory (optionally in a direction perpendicular to an outer surface of the accessory) and the second portion of each arm is configured to be oriented towards each other (optionally oriented substantially perpendicular to the associated first portion and / or parallel to the accessory).
50. 49. The accessory of claim 48, wherein each arm comprises a first portion and a second portion, the first portion extending from the accessory (optionally in a direction perpendicular to an outer surface of the accessory) and the second portion of each arm configured to be oriented toward a center of the accessory (optionally each second portion is oriented substantially perpendicular to the associated first portion).
51. 49. The accessory of claim 48, wherein each arm comprises a first portion and a second portion, the first portion extending vertically upwardly from the accessory and the second portion extending inwardly towards a center of the accessory and / or towards the second portion of the other arm, the first portion and the second portion of each arm forming an angle, the angle being less than, or about 90 degrees, or less than about 120 degrees.
52. 52. An attachment as claimed in any one of claims 48 to 51, wherein a gap is defined between the pair of arms.
53. 53. The accessory of claim 52, configured such that the or said strap of the nasal cannula interface is insertable into the gap (optionally defined by the pair of arms or a pair of arms) to be connected to the accessory.
54. 54. The accessory of claim 53, wherein a width of the strap of the nasal cannula interface is greater than the gap.
55. 55. The accessory of claim 53 or claim 54, wherein the strap of the nasal cannula can only be inserted into the gap when an edge of the strap is aligned or when the strap is folded along the width of the strap.
56. 56. The accessory of any one of claims 48 to 55, wherein the strap of the nasal cannula can be removed from the accessory through the gap only when aligned with an edge of the strap or when the strap is folded along the width of the strap.
57. The accessory of any one of the preceding claims, wherein the or at least one fastening mechanism comprises a clip.
58. 60. The accessory of claim 10, 11 or 57, wherein the clip comprises a clip arm.
59. 60. The accessory of claim 10, 11, 57, or 58, wherein the clip arm is connected to the accessory via a biasing element (optionally a hinge portion).
60. 60. An accessory according to any one of claims 10, 11 or claims 57 to 59, wherein the clip extends from the accessory (and optionally a side of the accessory).
61. 61. The accessory of any one of claims 10, 11 or 57-60, wherein the clip is configured to retain the strap of the nasal cannula to the accessory when the clip is in a closed position.
62. 62. The accessory of any one of claims 10, 11 or 57-61, wherein the clip arms have contact surfaces configured to engage a strap of a nasal cannula when the clip is in or at the closed position.
63. 63. The accessory of claim 62, wherein the contact surface is disposed in a recess in the clip arm.
64. 64. The accessory of claim 63, wherein the recess is shaped to receive a strap of the nasal cannula.
65. 65. An accessory according to any one of claims 62 to 64, wherein the contact surface comprises at least one protrusion, the at least one protrusion configured to assist in retaining the strap when the clip is closed.
66. 66. The accessory of claim 65, wherein the at least one protrusion comprises at least one rib, the at least one rib being arranged perpendicular to a width of the strap when the strap engages the contact surface and / or perpendicular to a longitudinal axis of the contact surface.
67. 67. The accessory of claim 66, wherein the at least one rib comprises a pair of ribs spaced apart along a length of the strap when the strap is engaged with the contact surface and / or a longitudinal axis of the contact surface.
68. 68. An attachment as claimed in claim 66 or 67, wherein the at least one rib comprises a pair of ribs disposed on opposite ends of the contact surface.
69. 69. An accessory according to any one of claims 65 to 68, wherein the at least one protrusion comprises one or more bumps.
70. 70. The accessory of claim 69, wherein the one or more bumps include a bump located at each corner of the contact surface.
71. 71. An accessory as claimed in claim 69 or claim 70, wherein the one or more bumps are patterned over at least a portion or the entire contact surface.
72. 72. The accessory of claim 71, wherein the one or more bumps are patterned in offset rows or aligned rows.
73. 73. An accessory according to any one of claims 62 to 72, wherein the contact surface has a non-smooth and / or substantially rough surface.
74. 74. The accessory of any one of claims 10, 11 or 57-73, wherein when the clip is closed to retain the strap of the nasal cannula, the accessory is prevented from sliding relative to the strap.
75. An accessory according to any one of claims 10, 11 or 57-74, wherein the clip arm comprises an aperture extending therethrough (and optionally through the contact surface).
76. 76. The accessory of claim 75, wherein the opening is configured to receive a portion of another of the at least one fastening system (optionally, the other of the at least one fastening system is at least one arm).
77. 77. The attachment of any one of claims 10, 11 or 57-76, wherein the attachment comprises a pair of arms located on either side of the clip.
78. 80. The accessory of any one of claims 10, 11 or 57-77, wherein the clip arm comprises at least one retaining feature configured to engage with a corresponding feature on the accessory to retain the clip in a closed position.
79. 79. The accessory of any one of claims 1 to 78, configured such that a strap or straps of the nasal cannula interface are connected to the accessory.
80. 80. The accessory of any one of claims 1 to 8 or 40 to 79, wherein the fixing mechanism is configured to receive a strap or straps of the nasal cannula interface.
81. 80. The accessory of any one of claims 1-8 or 40-79, wherein the fixing mechanism is configured to connect to a cannula connector of the nasal cannula interface, and optionally a main body connection mechanism is located at a first end of the accessory.
82. 82. The accessory of claim 81, wherein the cannula connector is configured to connect a main body of the nasal cannula interface to the straps of the nasal cannula interface.
83. 83. The accessory of any one of claims 1 to 82, comprising a strap passageway extending from a second end of the nasal cannula interface accessory along at least a portion of a longitudinal axis of the nasal cannula interface accessory.
84. 84. The attachment of any one of claims 1 to 83, wherein the attachment is configured to function as a side arm (and optionally a cheek support for the interface).
85. 85. An accessory according to any one of the preceding claims, wherein the or said face of the accessory configured to face a patient in use is substantially circular.
86. 86. An accessory according to any one of the preceding claims, wherein the or said surface of the accessory configured to face a patient in use comprises at least one surface material.
87. 87. The accessory of claim 86, wherein the at least one surface material covers a surface or surfaces of the accessory configured to face a patient.
88. 88. The accessory of claim 86 or claim 87, wherein the at least one surface material does not cover the sensor.
89. 89. An accessory according to any one of claims 86 to 88, wherein at least one surface material is provided with an aperture such that the at least one surface material does not extend over the sensor cavity of the accessory.
90. 90. An accessory according to any one of claims 86 to 89, wherein the at least one surface material is the same material as the accessory.
91. 90. An accessory according to any one of claims 86 to 89, wherein the at least one surface material is different from another material of the accessory.
92. 92. The accessory of any one of claims 86 to 91, wherein the at least one surface material and the accessory are separable.
93. 92. An accessory according to any one of claims 86 to 91, wherein the at least one surface material and the accessory are integral.
94. 94. An accessory according to any one of claims 86 to 93, wherein the at least one surface material is a film or membrane.
95. 94. The accessory of any one of claims 86 to 93, wherein the at least one surface material is configured to increase friction between the accessory and a patient's face.
96. 94. The accessory of any one of claims 86 to 93, wherein the surface material is configured to provide a frictional force resisting movement between the accessory and the strap.
97. An accessory according to any one of claims 86 to 96, wherein the at least one surface material has adhesive properties.
98. An accessory according to any one of claims 86 to 97, wherein the at least one surface material has anti-slip material properties.
99. 99. The attachment of any one of claims 1 to 98, wherein the attachment has one or more gripping mechanisms.
100. 100. An accessory according to any preceding claim, wherein a sensor is pre-installed in the sensor cavity of the accessory.
101. A kit comprising a nasal cannula interface and an accessory according to any one of claims 1 to 100.
102. A nasal cannula interface component, the nasal cannula interface component comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide a path for one or more wires to the sensor cavity; a main body connection mechanism configured to connect to a main body of the nasal cannula interface, the main body connection mechanism being located at a first end of the nasal cannula interface component; and A nasal cannula interface component comprising: a strap of the nasal cannula interface.
103. 103. The component of claim 102, wherein the component is a side arm (and optionally a cheek support).
104. 104. A component according to claim 102 or 103, wherein the nasal cannula strap is configured to be connected to the main body connection mechanism.
105. A component according to any one of claims 102 to 104, wherein the strap and / or the main body connection mechanism are at least partly integrally formed (optionally overmolded) with the component.
106. A component according to any one of claims 102 to 105, wherein a sensor is pre-installed in the sensor cavity of the accessory.
107. A nasal cannula interface comprising a component according to any one of claims 102 to 106.
108. 1. A component for a patient respiratory interface, said component comprising: 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 connect to a body of the patient respiratory interface; and a second connector configured to connect to a headgear of the patient respiratory interface.
109. 109. The component of claim 108, wherein the first connector is disposed at a first end of the component and the second connector is disposed at a second end of the component.
110. 110. The component of claim 108 or 109, wherein the first connector is configured to releasably connect the component to the body of the patient respiratory interface.
111. A component according to any one of claims 108 to 110, wherein the second connector is configured to releasably connect the component to the headgear component of the patient respiratory interface.
112. 112. The component of claim 111, wherein the second connector is configured to be integrally formed with the headgear component.
113. 113. The component of claim 111 or 112, wherein the headgear component is a strap of the patient respiratory interface.
114. A component according to any one of claims 111 to 113, wherein the headgear component comprises at least one aperture for attaching a strap.
115. A component according to any one of claims 108 to 114, wherein the component is configured to be located between the body of the patient interface and the headgear component.
116. A component according to any one of claims 108 to 115, wherein the component is configured to be positioned between the body of the patient interface and the headgear component when connected to the body of the patient interface and the headgear component.
117. A component according to any one of claims 108 to 116, wherein the sensor cavity is defined by one or more walls of the component body.
118. A component according to any one of claims 108 to 117, wherein the sensor cavity is located between the body of the patient respiratory interface and the headgear of the patient respiratory interface.
119. A component according to any one of claims 108 to 118, wherein the component body and its sensor cavity are located between the first connector and the second connector of the component.
120. A component according to any one of claims 108 to 119, wherein the first connector, the component body and the second connector are integrally formed with one another.
121. A component according to any one of claims 108 to 120, further comprising a wire cavity, the wire cavity configured to provide a path for one or more wires to the sensor cavity.
122. 122. The component of claim 121, wherein each of the one or more wires comprises a cable, cord, lead, or any other conductive material.
123. 123. A component as claimed in claim 121 or 122, wherein the sensor cavity is formed in a first surface of the component body.
124. A component according to any one of claims 121 to 123, wherein the wire cavity is formed in the same face of the component body as the sensor cavity and / or in a different face.
125. A component according to any one of claims 121 to 124, wherein the wire cavity comprises a plurality of openings in different (optionally adjacent) faces of the component body.
126. A component according to any one of claims 121 to 125, wherein the wire cavity is formed in the component body adjacent the sensor cavity.
127. A component according to any one of claims 121 to 126, wherein the sensor cavity is one or more of a square, rectangular and / or circular shape.
128. Component according to any one of claims 108 to 127, wherein the sensor comprises an optical transducer (optionally an infrared transducer or a red light transducer) and / or a light source (optionally an infrared source or a red light source).
129. 129. The component of claim 128, wherein the sensor cavity is positioned to orient the sensor such that the optical transducer and / or light source faces towards the patient.
130. 130. A component as claimed in claim 128 or 129, wherein the sensor cavity is configured such that when a sensor is disposed within the sensor cavity, a transducer of the sensor is exposed to an exterior of the component.
131. A component according to any one of claims 128 to 130, wherein the sensor cavity comprises an opening in a face of the component body configured to face a patient in use.
132. A component according to any one of claims 128 to 131, wherein the sensor cavity is configured to present the transducer of the sensor on the first face of the component body.
133. A component according to any one of claims 121 to 132, wherein the sensor cavity is positioned to orient the sensor into contact with a patient.
134. A component according to any one of claims 121 to 133, wherein the wire cavity extends from a face of the component body to the sensor cavity.
135. A component according to any one of claims 121 to 134, wherein the wire cavity extends from an outer surface of the component body to the sensor cavity.
136. A component according to any one of claims 121 to 135, wherein the wire cavity comprises an opening between a face of the component body and the sensor cavity.
137. A component according to any one of claims 121 to 136, wherein the wire cavity is a slot recessed from a face of the component body.
138. A component as claimed in any one of claims 121 to 137, wherein the wire cavity has a cross-section at at least one location along the length of the wire cavity that is substantially one or more of square, rectangular and / or circular.
139. A component according to any one of claims 121 to 138, wherein the wire cavity is configured to face the patient during use.
140. A component according to any one of claims 121 to 139, wherein the sensor is a patient sensor and the patient parameter is a physiological parameter.
141. 141. The component of claim 140, wherein the patient parameter is a measure of blood oxygenation of the patient.
142. A component according to any one of claims 108 to 141, wherein a patient contacting surface of the component body configured to face a patient in use is substantially circular.
143. Component according to any one of claims 108 to 142, wherein the or said face of the component body configured to face a patient in use comprises at least one surface material.
144. 144. The component of claim 143, wherein the at least one surface material covers a face or faces of the component body configured to face a patient.
145. 145. The component of claim 143 or 144, wherein the at least one surface material does not cover the sensor.
146. A component according to any one of claims 143 to 145, wherein at least one surface material is provided with an opening such that the at least one surface material does not extend over the sensor cavity of the component.
147. Component according to any one of claims 143 to 146, wherein the at least one surface material is the same material as the component.
148. 147. A component according to any one of claims 143 to 146, wherein the at least one surface material is different from another material of the component.
149. 149. The component of any one of claims 143 to 148, wherein the at least one surface material and the component are separable.
150. The component of any one of claims 143 to 148, wherein the at least one surface material and the component are integral.
151. Component according to any one of claims 143 to 150, wherein the at least one surface material is a film or membrane.
152. 152. A component according to any one of claims 143 to 151, wherein the at least one surface material is configured to increase friction between the component and a patient's face.
153. Component according to any one of claims 143 to 152, wherein the at least one surface material has adhesive properties.
154. Component according to any one of claims 143 to 153, wherein the at least one surface material has anti-slip material properties.
155. 155. A component according to any one of claims 143 to 154, wherein the component has one or more gripping mechanisms.
156. A component according to any one of claims 108 to 155, wherein a sensor is pre-installed in the sensor cavity of the component.
157. A component described in any one of claims 108 to 156, wherein the sensor cavity is held against a patient's skin surface when the first connector is connected to a body of the patient interface and the second connector is connected to a part of the headgear or system for securing the patient interface to a patient.
158. The patient respiratory interface includes: a) a nasal cannula interface; b) a nasal pillows interface; c) a nasal mask interface; d) a full face mask interface; and e) an oral cavity interface.
159. 1. A patient interface, comprising: a headgear or system for securing the patient interface in place around the patient's head; and A patient interface comprising a patient respiratory interface component as defined in any one of claims 108 to 173.
160. 160. A patient interface according to claim 159, wherein the headgear is in the form of at least one strap.
161. 161. A patient interface as described in claim 160, wherein the straps, in use, are splittable or bifurcated to provide upper and lower strap portions of the headgear.
162. 162. A patient interface according to any one of claims 159 to 161, wherein the patient interface is a nasal cannula.
163. 163. A patient interface according to any one of claims 159 to 162, wherein the patient interface is a nasal cannula and comprises a pair or pairs of nasal prongs.
164. 164. A patient interface according to claim 163, wherein the nasal cannula comprises a body and the one or more nasal prongs are integrally molded with or removably attached to the body.
165. 165. A patient interface according to claim 164, wherein the body includes a pair of side arms extending from opposite sides of the body.
166. A patient interface according to any one of claims 159 to 165, wherein the patient interface comprises a sensor positioned in the sensor cavity of the patient respiratory interface component.
167. 1. A patient respiratory interface, comprising: a first side arm including a sensor recess; a gas inlet conduit configured to deliver a flow of breathable gas through a main body of the patient respiratory interface to a patient; and a component having a conduit holding portion configured to hold the gas inlet conduit and a sensor mount configured to hold a patient sensor; A patient respiratory interface, 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.
168. 168. A patient respiratory interface according to claim 167, wherein a first end of the gas inlet conduit connects to the main body of the patient respiratory interface.
169. 169. A patient respiratory interface according to claim 168, further comprising a second side arm, the second side arm comprising a sensor recess configured to hold a patient sensor.
170. 170. A patient respiratory interface as described in claim 169, wherein at least a portion of the sensor mount of the component is insertable into the sensor recess of the second side arm.
171. 171. A patient respiratory interface according to claim 169 or 170, wherein the first end of the gases inlet conduit is connectable to the main body in a number of different orientations.
172. A patient respiratory interface according to any one of claims 169 to 171, wherein the first end of the gas inlet conduit is connectable to the main body on each of two laterally opposed sides of the main body, a first side adjacent the first side arm and a second side adjacent the second side arm.
173. 173. A patient respiratory interface as described in claim 172, wherein the sensor mount is insertable into the sensor recess of the first side arm when the gas inlet conduit is connected to the main body on its first side.
174. A patient respiratory interface as described in claim 172 or 173, wherein when the gas inlet conduit is connected to the main body on its second side, 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 respiratory interface is in use.
175. A patient respiratory interface as described in any one of claims 172 to 174, wherein when the gas inlet conduit is connected to the main body on its first side and the sensor mount is inserted into the sensor recess of the first side arm, the curvature of the gas inlet conduit between its first end and the conduit retaining portion of the component is less than about 90 degrees.
176. A patient respiratory interface as described in any one of claims 172 to 175, wherein when the gas inlet conduit is connected to the main body on its second side and the sensor mount is inserted into the sensor recess of the second side arm, the curvature of the gas inlet conduit between its first end and the conduit retaining portion of the component is less than about 90 degrees.
177. A patient respiratory interface according to any one of claims 169 to 176, wherein the sensor recess of the first side arm and the sensor mount of the component are configured to engage one another when the sensor mount is inserted into the sensor recess of the first side arm to resist withdrawal of the sensor mount from the sensor recess.
178. A patient respiratory interface according to any one of claims 169 to 177, wherein the sensor recess of the second side arm and the sensor mount of the component are configured to engage one another when the sensor mount is inserted into the sensor recess of the second side arm to resist withdrawal of the sensor mount from the sensor recess.
179. A patient respiratory interface according to any one of claims 167 to 178, wherein the gas inlet conduit comprises one or more electrically conductive elements extending along at least a portion of its length.
180. 180. A patient respiratory interface as described in claim 179, wherein the gas inlet conduit has a second end opposite the first end, the second end for connecting to an inhalation conduit for receiving a flow of respiratory gas therefrom, the second end of the gas inlet conduit comprising one or more electrical connectors for mating with corresponding one or more electrical connectors of the inhalation conduit when connected to the inhalation conduit.
181. 181. A patient respiratory interface as described in claim 180, wherein the one or more conductive elements extend from the second end of the gas inlet conduit to a position along the gas inlet conduit where the conduit retaining portion of the component retains the gas inlet conduit.
182. A patient respiratory interface as described in any one of claims 179 to 180, wherein the one or more conductive elements include one or more sensor wires, and when the conduit holding portion of the component holds the gas inlet conduit, the one or more sensor wires are in electrical communication with the patient sensor.
183. 183. A patient respiratory interface according to any one of claims 179 to 182, wherein the gas inlet conduit comprises a first portion and a second portion, the conduit retaining portion of the component joining between the first portion and the second portion of the gas inlet conduit.
184. A patient respiratory interface according to any one of claims 179 to 182, wherein the gas inlet conduit comprises a single integral conduit between its first and second ends.
185. A patient respiratory interface according to any one of claims 167 to 184, wherein the conduit retaining portion of the component is permanently attached to the gas inlet conduit.
186. A patient respiratory interface according to any one of claims 167 to 184, wherein the conduit retaining portion of the component is removably attachable to the gas inlet conduit.
187. A patient respiratory interface according to any one of claims 167 to 186, wherein the gas inlet conduit is slidable along its length relative to the component when held by the conduit retaining portion.
188. A patient respiratory interface according to any one of claims 167 to 187, wherein the gas inlet conduit is not slidable along its length relative to the component when held by the conduit retaining portion.
189. A patient respiratory interface according to any one of claims 167 to 188, wherein the conduit retaining portion retains the gas inlet conduit around its circumference.
190. 190. A patient respiratory interface as described in claim 189, wherein the conduit retaining portion retains the gas inlet conduit around more than about half of its circumference.
191. 190. A patient respiratory interface according to claim 189, wherein the conduit retaining portion surrounds the gas inlet conduit.
192. 190. A patient respiratory interface according to claim 189, wherein the clip attaches around more than about half of a circumference of the gas inlet conduit.
193. 190. A patient respiratory interface according to claim 189, wherein the clip surrounds the gas inlet conduit.
194. 194. A patient respiratory interface according to any one of claims 167 to 193, wherein the or each sensor recess comprises an opening through the side arm between a non-patient facing side and a patient facing side of the side arm.
195. A patient respiratory interface according to any one of claims 167 to 194, wherein only a portion of the patient sensor is within the sensor recess when the sensor mount is inserted and held within the sensor recess.
196. A patient respiratory interface according to any one of claims 167 to 195, wherein the or each sensor recess is square, rectangular or circular in cross-section.
197. A patient respiratory interface according to any one of claims 167 to 195, 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.
198. A patient respiratory interface according to any one of claims 167 to 197, wherein the patient sensor comprises an optical transducer (optionally an infrared transducer or a red light transducer) and / or a light source (optionally an infrared source or a red light source).
199. A patient respiratory interface according to any one of claims 167 to 198, wherein the or each side arm is configured such that the or each sensor recess is located against the cheek of the patient when the patient respiratory interface is in use.
200. A patient respiratory interface according to any one of claims 167 to 199, wherein 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 respiratory interface is in use.
201. A patient respiratory interface according to any one of claims 167 to 200, wherein the portion of the sensor mount insertable into the or each sensor recess includes a transducer of the patient sensor when the patient sensor is held within the sensor mount.
202. 202. A patient respiratory interface as described in claim 201 , wherein the transducer of the patient sensor, when held within the or each sensor recess, is configured to contact a patient's face when the respiratory patient interface is worn.
203. A nasal cannula interface and accessories therefor, said accessories comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; and at least one fastening mechanism configured to connect the accessory to a nasal cannula interface (and optionally to a strap of the nasal cannula interface); A nasal cannula interface and accessories therefor, wherein the nasal cannula comprises a first prong and a second prong, the prongs configured to induce asymmetric flow of gas at the patient's nares.
204. 204. A nasal cannula interface and accessory as described in claim 203, wherein the first prong has a first shape and the second prong has a second shape.
205. 205. A nasal cannula interface and accessory as described in claim 203 or 204, wherein the first prong has an inner cross-sectional area transverse to gas flow through the first prong that is smaller than a corresponding inner cross-sectional area of the second prong transverse to gas flow through the second prong.
206. 206. A nasal cannula interface and accessory according to any one of claims 203 to 205, wherein the first and second prongs 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 prong.
207. A nasal cannula interface and components therefor, the nasal cannula interface components comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide a path for one or more wires to the sensor cavity; and a main body connection mechanism configured to connect to a main body of the nasal cannula interface, the main body connection mechanism being located at a first end of the nasal cannula interface component; The nasal cannula interface comprises: a first prong and a second prong, the prongs configured to induce an asymmetric flow of gas at the patient's nares; and A nasal cannula interface and components therefor, comprising:
208. 208. A nasal cannula interface and components as described in claim 207, wherein the first prong has a first shape and the second prong has a second shape.
209. 209. A nasal cannula interface and accessory as described in claim 207 or 208, wherein the first prong has an inner cross-sectional area transverse to gas flow through the first prong that is smaller than a corresponding inner cross-sectional area of the second prong transverse to gas flow through the second prong.
210. 210. A nasal cannula interface and accessory according to any one of claims 207 to 209, wherein the first and second prongs 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 prong.
211. 1. A patient respiratory interface, comprising: a first prong and a second prong, the prongs configured to induce an asymmetric flow of gas at the patient's nares; a first side arm including a sensor recess; a gas inlet conduit configured to deliver a flow of breathable gas through the main body and the first and second prongs of the patient respiratory interface to a patient; a clip attachable to the gas inlet conduit, the clip configured to hold a patient sensor within a sensor mount of the clip; A patient respiratory interface, 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.
212. 212. A patient respiratory interface as described in claim 211, wherein the first prong has a first shape and the second prong has a second shape.
213. 213. A patient respiratory interface as described in claim 211 or 212, wherein the first prong has an inner cross-sectional area transverse to gas flow through the first prong that is smaller than a corresponding inner cross-sectional area of the second prong transverse to gas flow through the second prong.
214. A patient respiratory interface according to any one of claims 211 to 213, wherein the first and second prongs are configured such that at least about 60% of a total volumetric flow of gas flow distributed by the nasal cannula is delivered from the second prong.
215. A nasal cannula interface and accessories therefor, said accessories comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; and at least one fastening mechanism configured to connect the accessory to a nasal cannula interface (and optionally to a strap of the nasal cannula interface); A nasal cannula interface and accessories therefor, wherein the nasal cannula includes a first prong and a second prong, the first prong having a cross-sectional area smaller than a cross-sectional area of the second prong.
216. 216. A nasal cannula interface and accessories therefor as described in claim 215, wherein the cross-sectional area of the first prong that is smaller than the cross-sectional area of the second prong is taken at corresponding locations of the first and second prongs.
217. 217. A nasal cannula interface and accessories therefor as described in claim 215 or 216, wherein the cross-sectional areas of the first and second prongs are taken at the proximal openings of each of the prongs.
218. 218. A nasal cannula interface and accessories therefor as described in any one of claims 215 to 217, wherein a difference in cross-sectional area of the first prong and the second prong is such as to cause asymmetric flow of gas at the patient's nares.