Component for patient respiratory interface, patient interface and nasal cannula interface
By designing a nasal cannula interface attachment that can be releasably connected to the nasal cannula interface, the complexity of sensor installation and shedding are solved, and the sensor is easily installed and correct fixing is achieved.
Patent Information
- Application Number
- CN202420367107.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Priority Date
- 2022-07-07
- Filing Date
- 2023-02-28
- Publication Date
- 2025-03-18
- Estimated Expiration
- 2033-02-28
AI Technical Summary
When providing breathing support, the need to monitor patient parameters leads to complex installation and use of sensors, increases user workload, and may cause incorrect installation or shedding of sensors.
A nasal cannula interface attachment is designed, which includes a sensor cavity and a wire cavity, releasably connected to the nasal cannula interface, and a sensor is pre-installed in the sensor cavity, simplifying the installation and use of the sensor.
By simplifying the sensor installation process, the user's workload is reduced, the sensor is properly oriented and fixed, and the sensor is not shedding.
Smart Images

Figure CN222623477U_ABST
Abstract
Description
[0001] Divisional application
[0002] This application is a divisional application of the Chinese utility model patent application with application number 202320418053.X, filed on February 28, 2023, and entitled “PATIENT INTERFACE AND RESPIRATORY DEVICE”. Technical Field
[0003] The present disclosure relates generally to patient interfaces and respiratory apparatus for providing a flow of breathable gas to a patient for respiratory support through the patient interface, and more particularly to accessories and / or components having sensors on or near a patient interface of a respiratory apparatus. Background Art
[0004] When providing respiratory support to a patient, it may be beneficial to monitor one or more patient parameters during the course of therapy. To measure these patient parameters, one or more patient sensors are used, such as a pulse oximeter, which can be used to determine blood oxygen saturation and heart rate. These parameters can be used alone or in combination with other parameters to assess the patient's health status. Additionally, these parameters can be used to adjust one or more control parameters of a respiratory support system used to provide respiratory support to the patient. These adjustments can be made manually by a clinician or automatically by a controller of the respiratory support system, such as through feedback control. The adjusted parameters may include any one or more of the following: flow, pressure, temperature, humidity, dew point, oxygen concentration, and / or oxygen saturation. Utility Model Content
[0005] In one aspect, a nasal cannula interface accessory for attachment to a nasal cannula interface is provided, the accessory comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and at least one securing feature configured to connect the accessory to the nasal cannula interface (optionally to a strap of the nasal cannula interface).
[0006] In some configurations, at least one securing feature is configured to releasably connect the accessory to the nasal cannula interface.
[0007] In some configurations, the sensor cavity is formed on a first side of the nasal cannula interface attachment.
[0008] In some configurations, the accessory includes a wire lumen configured to provide access to the sensor cavity for one or more wires.
[0009] In some configurations, each of the one or more conductors comprises a cable, a cord, a lead, or any other conductive material.
[0010] In some configurations, the guidewire lumen is formed on the same side and / or a different side as the sensor lumen of the nasal cannula interface attachment.
[0011] In some configurations, the guidewire lumen includes multiple openings on different (optionally adjacent) sides of the attachment.
[0012] In some configurations, the guide wire cavity is formed adjacent to the sensor cavity.
[0013] In another aspect, a nasal cannula interface accessory for attachment to a nasal cannula interface is provided, the accessory comprising:
[0014] a sensor cavity configured to hold a sensor configured to measure at least one patient parameter,
[0015] a wire lumen configured to provide access to the sensor lumen for one or more wires, and
[0016] A pair of arms extending from the cannula interface attachment, the pair of arms extending toward each other and / or toward the center of the attachment, the pair of arms being configured to releasably connect the attachment to the nasal cannula interface (optionally to a strap of the nasal cannula interface).
[0017] In another aspect, a nasal cannula interface accessory for attachment to a nasal cannula interface is provided, the accessory comprising:
[0018] a sensor cavity configured to hold a sensor configured to measure at least one patient parameter,
[0019] a wire lumen configured to provide access to the sensor lumen for one or more wires, and
[0020] A clamp configured to connect to an accessory, the clamp comprising a clamp arm connected to the accessory via a biasing element, the clamp configured to secure the nasal cannula interface accessory to the nasal cannula interface (optionally to a strap of the nasal cannula interface).
[0021] In some configurations, the biasing element includes a hinge, a spring.
[0022] In some configurations, the sensor cavity is one or more of: square, rectangular, and / or circular.
[0023] In some configurations, the sensor cavity has substantially rounded edges and vertices.
[0024] In some configurations, the sensor cavity is arranged to orient the sensor into contact with the patient.
[0025] In some configurations, the sensor cavity is arranged to orient the sensor so that the transducer of the sensor faces the patient.
[0026] In some configurations, the sensor includes a light transducer (optionally an infrared transducer or a red light transducer) and / or a light source (optionally an infrared source or a red light source).
[0027] In some configurations, the sensor cavity is arranged to orient the sensor so that the optical transducer and / or light source faces the patient.
[0028] In some configurations, the sensor cavity includes an opening on a face of the attachment that is configured to face the patient during use.
[0029] In some configurations, the wire lumen extends from the outer surface to the sensor lumen.
[0030] In some configurations, the wire lumen extends from the face of the attachment to the sensor lumen.
[0031] In some configurations, the guidewire lumen includes an opening on a side of the attachment that is configured to face the patient during use.
[0032] In some configurations, the wire lumen is a slot.
[0033] In some configurations, the guidewire lumen is one or more of: square, rectangular, and / or circular.
[0034] In some configurations, the sensor is a patient sensor and the patient parameter is a physiological parameter.
[0035] In some configurations, the patient parameter is a measure of the patient's blood oxygenation.
[0036] In some configurations, an accessory can be attached to the interface at multiple interface attachment locations.
[0037] In some configurations, the accessory is configured to be adjustable between multiple interface attachment positions.
[0038] In some configurations, the accessory is configured to be adjustable between multiple interface attachment positions without being removed from the interface (optionally a strap of the interface).
[0039] In some configurations, the accessory is configured to be slidably adjustable between a plurality of interface attachment positions.
[0040] In some configurations, accessories may be attached to the interface at multiple locations on the patient's face.
[0041] In some configurations, the accessory is configured to be adjustable between multiple patient facial positions without being removed from the interface.
[0042] In some configurations, the attachment is configured such that the attachment is slidably adjustable between a plurality of patient facial positions.
[0043] In some configurations, the plurality of patient facial locations includes proximate the patient's cheek.
[0044] In some configurations, the plurality of patient facial positions includes between the patient's eyes and lips.
[0045] In some configurations, the accessory is configured to be adjustable between a plurality of attachment locations on the interface defined by at least one connection point between the strap and the body of the nasal cannula.
[0046] In some configurations, the plurality of patient facial positions corresponds to a plurality of attachment locations.
[0047] In some configurations, the attachment can be located near the patient's cheek.
[0048] In some configurations, the attachment may be located between the patient's eyes and lips.
[0049] In some configurations, the attachment is configured to be movable along the length of the strap to allow the clinician to position the sensor.
[0050] In some configurations, the securing feature or the at least one securing feature is configured as a strap to releasably retain the accessory to the nasal cannula interface.
[0051] In some configurations, the securing feature is configured to substantially prevent movement of the accessory accessory along the strap.
[0052] In some configurations, the securing feature is configured to allow relative movement of the strap and the accessory when a threshold force is applied.
[0053] In some configurations, the threshold force is based on the type of securing feature and the material of the band.
[0054] In some configurations, the at least one securing feature is configured to extend from a side of the accessory opposite the sensor cavity.
[0055] In some configurations, the at least one securing feature comprises at least one arm configured to extend around at least a portion of a band of the nasal cannula interface.
[0056] In some configurations, the at least one securing feature includes a pair of arms disposed along an axis of the accessory, the axis being configured to be parallel to an axis of the strap when the accessory is connected to the strap.
[0057] In some configurations, the arm includes a first portion extending from the attachment (optionally in a perpendicular direction outward from the attachment), and a second portion, wherein the second portion of the arm is configured to be oriented substantially perpendicular to the associated first portion and / or parallel to the attachment.
[0058] In some configurations, the at least one securing feature includes a pair of arms extending from the attachment and toward each other.
[0059] In some configurations, each arm includes a first portion and a second portion, the first portion extending from the attachment (optionally in a perpendicular direction outward from the attachment), and the second portion of each arm is configured to be oriented toward each other (optionally, the second portion of each arm is substantially perpendicular to the associated first portion and / or oriented parallel to the attachment).
[0060] In some configurations, each arm includes a first portion and a second portion, the first portion extending from the attachment (optionally in a vertical direction outward from the attachment), and the second portion of each arm is configured to be oriented toward the center of the attachment (optionally, each second portion is oriented substantially perpendicular to the associated first portion).
[0061] In some configurations, each arm includes a first portion and a second portion, the first portion extending vertically upward from the attachment and the second portion extending inward toward the center of the attachment and / or toward the second portion of the other arm, so that the first portion and the second portion of each arm form an angle, wherein the angle is less than 90 degrees, or approximately 90 degrees, or less than approximately 120 degrees.
[0062] In some configurations, the strap of the nasal cannula interface is configured to connect to an accessory.
[0063] In some configurations, the securing feature is configured to receive a strap of the nasal cannula interface.
[0064] In some configurations, a gap is defined between the pair of arms.
[0065] In some configurations, the strap or band of the nasal cannula interface is configured to be insertable into the gap (optionally defined by the arms or pair of arms) to connect to an accessory.
[0066] In some configurations, a gap is defined between the pair of arms.
[0067] In some configurations, the width of the band of the nasal cannula interface is greater than the gap.
[0068] In some configurations, the strap of the nasal cannula can only be inserted into the gap when aligned with the edge of the strap or when the strap is folded along the width of the strap.
[0069] In some configurations, the strap of the nasal cannula can only be removed from the attachment when aligned with the edge of the strap or through the gap when the strap is folded along the width of the strap.
[0070] In some configurations, the or at least one securing feature comprises a clamp.
[0071] In some configurations, the clamp includes a clamp arm.
[0072] In some configurations, the clamp arm is connected to the attachment via a biasing element (optionally an articulated portion).
[0073] In some configurations, the clamp extends from the accessory (optionally from a side of the accessory).
[0074] In some configurations, the clamp is configured to retain a strap of the nasal cannula to the accessory when the clamp is in the closed position.
[0075] In some configurations, when the clamp is in the closed position, the clamp is configured to retain the strap between the clamp and the nasal cannula to the accessory.
[0076] In some configurations, the clamp arm includes a contact surface configured to engage a strap of the nasal cannula when the clamp is in the closed position or the closed position.
[0077] In some configurations, the contact surface is located in a recess in the clamp arm.
[0078] In some configurations, the recess is shaped to receive a strap of a nasal cannula.
[0079] In some configurations, the contact surface includes at least one protrusion configured to help retain the strap when the clamp is closed.
[0080] In some configurations, the at least one protrusion includes at least one rib, and when the belt is engaged with the contact surface, the at least one rib can be positioned perpendicular to the width of the belt, and / or perpendicular to the longitudinal axis of the contact surface.
[0081] In some configurations, the at least one rib comprises a pair of ribs that are spaced apart along the length of the belt when the belt is engaged with the contact surface and / or spaced apart along a longitudinal axis of the contact surface.
[0082] In some configurations, the at least one rib includes a pair of ribs located at opposite ends of the contact surface.
[0083] In some configurations, the at least one protrusion includes one or more bumps.
[0084] In some configurations, the one or more bumps include a bump located in each corner of the contact surface.
[0085] In some configurations, the one or more bumps are patterned over at least a portion of the contact surface or over the entire contact surface.
[0086] In some configurations, the one or more bumps are patterned in offset rows or aligned rows.
[0087] In some configurations, the contact surface has a non-smooth and / or significantly rough surface.
[0088] In some configurations, when the clamp is closed and holds the strap of the nasal cannula, the accessory is prevented from sliding relative to the strap.
[0089] In some configurations, the clamp arm includes an opening extending through the clamp arm (optionally through the contact surface).
[0090] In some configurations, the aperture is configured to receive a portion of another of the at least one fixation system (optionally the other of the at least one fixation system is at least one arm).
[0091] In some configurations, the attachment includes a pair of arms located on either side of the clamp.
[0092] In some configurations, the clamp arm includes at least one retaining feature configured to engage with a corresponding feature of the accessory to retain the clamp in the closed position.
[0093] In some configurations, the strap or strap of the nasal cannula interface is configured to connect to an accessory.
[0094] In some configurations, the securing feature is configured to receive a strap or straps of the nasal cannula interface.
[0095] In some configurations, the securing feature is configured to connect to a cannula connector of a nasal cannula interface, and optionally, the body connection feature is located at a first end of the attachment.
[0096] In some configurations, the cannula connector is configured to connect the body of the nasal cannula interface to the strap of the nasal cannula interface.
[0097] In some configurations, a belt channel extends from the second end of the nasal cannula interface accessory along at least a portion of the longitudinal axis of the nasal cannula interface accessory.
[0098] In some configurations, the attachment is configured to act as a side arm (optionally for a cheek support of the interface).
[0099] In some arrangements, the or that face of the attachment that is configured to face the patient in use is substantially circular.
[0100] In some arrangements, the or that side of the accessory that is configured to face the patient during use may comprise at least one surface material.
[0101] In some configurations, the at least one surface material covers the face or face of the accessory that is configured to face the patient.
[0102] In some configurations, the at least one surface material does not cover the sensor.
[0103] In some configurations, the at least one surface material is provided with openings such that the at least one surface material does not extend across the sensor cavity of the accessory.
[0104] In some configurations, the at least one surface material is the same material as the accessory.
[0105] In some configurations, the at least one surface material is different than another material of the accessory.
[0106] In some configurations, the at least one surface material and the accessory are separable.
[0107] In some configurations, the at least one surface material and the accessory are integral.
[0108] In some configurations, the at least one surface material is a membrane or a film.
[0109] In some configurations, the at least one surface material is configured to increase friction between the attachment and the patient's face.
[0110] In some configurations, the surface material is configured to provide friction to resist movement between the accessory and the strap.
[0111] In some configurations, the at least one surface material has adhesive properties.
[0112] In some configurations, the at least one surface material has anti-slip material properties.
[0113] In some configurations, the attachment has one or more grabbing features.
[0114] In some configurations, the sensor is pre-installed in the sensor cavity of the accessory.
[0115] In another aspect, a kit is provided, the kit comprising a nasal cannula interface and accessories as described herein.
[0116] In another aspect, a nasal cannula interface component is provided, comprising: a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a wire cavity configured to provide access to the sensor cavity for one or more wires; a body connection feature configured to connect to a body of the nasal cannula interface, the body connection feature being located at a first end of the nasal cannula interface component; and a strap of the nasal cannula interface.
[0117] In some configurations, the component is a side arm (and optionally a cheek support).
[0118] In some configurations, the strap of the nasal cannula is configured to connect to the body connection feature.
[0119] In some arrangements, the strap and / or body connection features are at least partially integrally formed (optionally overmolded) with the component.
[0120] In some configurations, the sensor is pre-installed in the sensor cavity of the accessory.
[0121] In another aspect, a nasal cannula interface is provided, comprising the parts as described herein.
[0122] 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 the body of the patient respiratory interface; and a second connector configured to connect to a headgear of the patient respiratory interface.
[0123] In some configurations, the first connector is located at a first end of the component and the second connector is located at a second end of the component.
[0124] In some configurations, the first connector is configured to releasably connect the component to the body of the patient breathing interface.
[0125] In some configurations, the second connector is configured to releasably connect the component to a headgear component of the patient respiratory interface.
[0126] In some configurations, the second connector is configured to be integrally formed with the headgear component.
[0127] In some configurations, the headgear component is a strap of the patient's respiratory interface.
[0128] In some configurations, the headgear component includes at least one opening for attaching a strap.
[0129] In some configurations, the component is configured to be located between the body of the patient interface and the headgear component.
[0130] 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.
[0131] In some configurations, the sensor cavity is defined by one or more walls of the component body.
[0132] In some configurations, the sensor cavity is located between the body of the patient breathing interface and the headgear of the patient breathing interface.
[0133] In some configurations, the component body and its sensor cavity are located between the first connector and the second connector of the component.
[0134] In some configurations, the first connector, the component body, and the second connector are integrally formed with one another.
[0135] In some configurations, the component further includes a wire lumen configured to provide access to the sensor cavity for one or more wires.
[0136] In some configurations, each of the one or more conductors comprises a cable, a cord, a lead, or any other conductive material.
[0137] In some configurations, the sensor cavity is formed in the first face of the component body.
[0138] In some configurations, the wire lumen is formed in the same face and / or a different face of the component body as the sensor lumen.
[0139] In some configurations, the wire lumen includes multiple openings on different faces (optionally adjacent faces) of the component body.
[0140] In some configurations, a wire lumen is formed in the component body adjacent to the sensor lumen.
[0141] In some configurations, the sensor cavity is one or more of: square, rectangular, and / or circular.
[0142] In some configurations, the sensor cavity has substantially rounded edges and vertices.
[0143] In some configurations, the sensor includes a light transducer (optionally an infrared transducer or a red light transducer) and / or a light source (optionally an infrared source or a red light source).
[0144] In some configurations, the sensor cavity is arranged to orient the sensor so that the optical transducer and / or light source faces the patient.
[0145] In some configurations, 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 side of the component.
[0146] In some configurations, the sensor cavity includes an opening on a face of the component body that is configured to face the patient during use.
[0147] In some configurations, the sensor cavity is configured to present a transducer of the sensor at the first face of the component body.
[0148] In some configurations, the sensor cavity is arranged to orient the sensor into contact with the patient.
[0149] In some configurations, the wire lumen extends from a face of the component body to the sensor lumen.
[0150] In some configurations, the wire lumen extends from an outer surface of the component body to the sensor lumen.
[0151] In some configurations, the wire lumen includes an opening between a face of the component body and the sensor lumen.
[0152] In some configurations, the wire lumen is a slot recessed from a surface of the component body.
[0153] In some configurations, the guidewire lumen is one or more of: substantially square, rectangular, and / or circular in cross-section at at least one location along the length of the guidewire lumen.
[0154] In some configurations, the guidewire lumen is configured to face toward the patient during use.
[0155] In some configurations, the sensor is a patient sensor and the patient parameter is a physiological parameter.
[0156] In some configurations, the patient parameter is a measure of the patient's blood oxygenation.
[0157] In some arrangements, a patient contacting surface of the component body configured to face the patient in use is substantially circular.
[0158] In some arrangements, the face or face of the component body that is configured to face the patient in use comprises at least one surface material.
[0159] In some configurations, the at least one surface material covers the face or faces of the component body that is configured to face the patient.
[0160] In some configurations, the at least one surface material does not cover the sensor.
[0161] In some configurations, at least one surface material is provided with openings such that the at least one surface material does not extend across the sensor cavity of the component.
[0162] In some configurations, the at least one surface material is the same material as the component.
[0163] In some configurations, the at least one surface material is different than another material of the component.
[0164] In some configurations, the at least one surface material and the component are separable.
[0165] In some configurations, the at least one surface material and the component are integral.
[0166] In some configurations, the at least one surface material is a membrane or a film.
[0167] In some configurations, the at least one surface material is configured to increase friction between the component and the patient's face.
[0168] In some configurations, the at least one surface material has adhesive properties.
[0169] In some configurations, the at least one surface material has anti-slip material properties.
[0170] In some configurations, the component has one or more gripping features.
[0171] In some configurations, the sensor is pre-installed in the sensor cavity of the component.
[0172] In some configurations, the sensor cavity is retained on 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 portion of a headgear or system for securing the patient interface to the patient.
[0173] In some configurations, the patient breathing interface is one of the following: a nasal cannula interface, a nasal pillow interface, a nasal mask interface, a full-face mask interface, an oral interface.
[0174] In another aspect, a patient interface is provided that includes a headgear or system for securing the patient interface in place around a patient's head, and components.
[0175] In some configurations, the component includes a component body having a sensor cavity configured to hold a sensor configured to measure at least one patient parameter; a first connector configured to connect to the body of the patient respiratory interface; and a second connector configured to connect to a headgear of the patient respiratory interface.
[0176] The component may include any features and / or functionality described herein, such as the features and / or functionality described in any one or more of paragraphs
[0121] to
[0171] .
[0177] In some configurations, the headgear is in the form of at least one strap.
[0178] In some arrangements, the strap in use is separable or bifurcated to provide an upper strap portion and a lower strap portion of the headgear.
[0179] In some configurations, the patient interface is a nasal cannula.
[0180] In some configurations, the patient interface is a nasal cannula and includes one or a pair of nasal prongs.
[0181] In some configurations, the nasal cannula includes a body, and wherein one or more nasal prongs are integrally molded with the body or removably attached to the body.
[0182] In some configurations, the body includes a pair of side arms extending from opposite sides of the body.
[0183] In some configurations, the patient interface includes a sensor located in a sensor cavity of the patient respiratory interface component.
[0184] A patient breathing interface, comprising:
[0185] a first side arm, the first side arm comprising a sensor recess,
[0186] an airway conduit configured to deliver a flow of breathable gas to a patient through a body of the patient respiratory interface, and
[0187] a component having a conduit retaining portion configured to retain an intake conduit and a sensor mount configured to retain a patient sensor,
[0188] Wherein, at least a portion of the sensor mount may be inserted into the sensor recess of the first side arm so that when the patient respiratory interface is in use, the patient sensor contacts the patient's face.
[0189] The first end of the air inlet conduit is connected to the body of the patient breathing interface.
[0190] The patient breathing interface further includes a second side arm including a sensor recess configured to hold a patient sensor.
[0191] At least a portion of the sensor mount of the component is insertable into the sensor recess of the second side arm.
[0192] The first end of the inlet conduit may be connected to the body in a number of different orientations.
[0193] The first end of the air inlet conduit may be connected to the main body at each of two laterally opposite sides of the main body, namely a first side adjacent to the first side arm and a second side adjacent to the second side arm.
[0194] When the air intake duct is connected to the first side of the body, the sensor mount may be inserted into the sensor recess of the first side arm.
[0195] When the air inlet conduit is connected to the second side of the body, the sensor mount may be inserted into the sensor recess of the second side arm so that the patient sensor contacts the patient's face when the patient respiratory interface is in use.
[0196] When the intake conduit is connected to the first side of the body and the sensor mount is inserted into the sensor recess of the first side arm, the curvature of the intake conduit between the first end thereof and the conduit retaining portion of the component is less than about 90 degrees.
[0197] When the intake conduit is connected to the second side of the body and the sensor mount is inserted into the sensor recess of the second side arm, the curvature of the intake conduit between the first end thereof and the conduit retaining portion of the component is less than about 90 degrees.
[0198] The sensor recess of the first side arm and the sensor mount of the component are configured to engage with each other to prevent the sensor mount from being withdrawn from the sensor recess when the sensor mount is inserted into the sensor recess of the first side arm.
[0199] The sensor recess of the second side arm and the sensor mount of the component are configured to engage with each other to prevent the sensor mount from being withdrawn from the sensor recess when the sensor mount is inserted into the sensor recess of the second side arm.
[0200] The inlet duct includes one or more electrically conductive elements extending along at least a portion of its length.
[0201] The second end of the intake conduit is opposite to the first end, and the second end is used to connect to the inhalation conduit to receive the respiratory airflow therefrom, and the second end of the intake conduit includes one or more electrical connectors to connect with the corresponding one or more electrical connectors of the inhalation conduit when connected thereto.
[0202] The one or more conductive elements extend from the second end of the intake conduit to a location along the intake conduit at which the conduit retaining portion of the component is to retain the intake conduit.
[0203] The one or more conductive elements include one or more sensor wires that are in electrical communication with the patient sensor when the catheter retaining portion of the component retains the inlet catheter.
[0204] The intake duct includes a first portion and a second portion, and the duct holding portion of the component is connected between the first portion and the second portion of the intake duct.
[0205] The intake conduit comprises a single unitary conduit between a first end and a second end thereof.
[0206] The duct retaining portion of the component is permanently attached to the intake duct.
[0207] The conduit retaining portion of the component is removably attached to the intake conduit.
[0208] The inlet conduit may slide relative to the component along its length when retained by the conduit retaining portion.
[0209] When retained by the duct retaining portion, the inlet duct cannot slide relative to the component along its length.
[0210] The duct holding portion holds the intake duct around a periphery of the intake duct.
[0211] The duct holding portion holds the intake duct around more than half of the circumference of the intake duct.
[0212] The duct retaining portion surrounds the intake duct.
[0213] The clamp is attached around more than half of the circumference of the intake duct.
[0214] The clamp surrounds the intake duct.
[0215] The or each sensor recess comprises an opening through the side arm between the non-patient-facing side and the patient-facing side of the side arm.
[0216] When the sensor mount is inserted and retained within the sensor recess, only a portion of the patient sensor is within the sensor recess.
[0217] The or each sensor recess may be square, rectangular or circular in cross-section.
[0218] The cross-section of the sensor mounting or at least a portion thereof substantially corresponds to the cross-sectional shape of the sensor recess.
[0219] The patient sensor comprises a light transducer (optionally an infrared transducer or a red light transducer) and / or a light source (optionally an infrared source or a red light source).
[0220] The or each side arm is configured such that when the patient respiratory interface is in use, the or each sensor recess is located at the patient's cheek.
[0221] The or each side arm is configured such that when the patient respiratory interface is in use, the or each sensor recess is located between the patient's eyes and the patient's lips.
[0222] The portion of the sensor mount insertable into the or each sensor recess comprises the transducer of the patient sensor when the patient sensor is retained within the sensor mount.
[0223] When retained within the or each sensor recess, the transducer of the patient sensor is configured to contact the face of the patient when the respiratory patient interface is worn.
[0224] A nasal cannula interface and its accessories, the accessories comprising:
[0225] a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and
[0226] at least one securing feature configured to connect the accessory to the nasal cannula interface (optionally to a strap of the nasal cannula interface), and
[0227] The nasal cannula includes first and second nasal prongs configured to produce an asymmetric gas flow at the patient's nares.
[0228] The first nasal prong has a first shape and the second nasal prong has a second shape.
[0229] The inner cross-sectional area of the first nasal fork in a direction transverse to the gas flow passing through the first nasal fork is smaller than the corresponding inner cross-sectional area of the second nasal fork in a direction transverse to the gas flow passing through the second nasal fork.
[0230] The first nasal prong and the second nasal prong are configured such that at least about 60% of the total volume flow of the gas flow distributed by the nasal cannula is delivered from the second nasal prong.
[0231] A nasal cannula interface and components thereof, the nasal cannula interface components comprising:
[0232] a sensor cavity configured to hold a sensor configured to measure at least one patient parameter,
[0233] a wire lumen configured to provide access to the sensor lumen for one or more wires, and
[0234] a body connection feature configured to connect to a body of the nasal cannula interface, the body connection feature being located at a first end of the nasal cannula interface component, and
[0235] The nasal cannula interface includes:
[0236] A first nasal prong and a second nasal prong configured to produce an asymmetric gas flow at the patient's nostrils, and a band.
[0237] The first nasal prong has a first shape and the second nasal prong has a second shape.
[0238] The inner cross-sectional area of the first nasal fork in a direction transverse to the gas flow passing through the first nasal fork is smaller than the corresponding inner cross-sectional area of the second nasal fork in a direction transverse to the gas flow passing through the second nasal fork.
[0239] The first nasal prong and the second nasal prong are configured such that at least about 60% of the total volume flow of the gas flow distributed by the nasal cannula is delivered from the second nasal prong.
[0240] A patient breathing interface, comprising:
[0241] first nasal prongs and second nasal prongs configured to produce an asymmetric gas flow at a nares of the patient,
[0242] a first side arm, the first side arm comprising a sensor recess,
[0243] an airway conduit configured to deliver a flow of breathable gas to the patient through a body of the patient respiratory interface and first and second nasal prongs,
[0244] a clamp attachable to the airway conduit, the clamp being configured to retain the patient sensor within a sensor mount of the clamp,
[0245] Wherein, at least a portion of the sensor mount may be inserted into the sensor recess of the first side arm so that when the patient respiratory interface is in use, the patient sensor contacts the patient's face.
[0246] The first nasal prong has a first shape and the second nasal prong has a second shape.
[0247] The inner cross-sectional area of the first nasal fork in a direction transverse to the gas flow passing through the first nasal fork is smaller than the corresponding inner cross-sectional area of the second nasal fork in a direction transverse to the gas flow passing through the second nasal fork.
[0248] The first nasal prong and the second nasal prong are configured such that at least about 60% of the total volume flow of the gas flow distributed by the nasal cannula is delivered from the second nasal prong.
[0249] A nasal cannula interface and its accessories, the accessories comprising:
[0250] a sensor cavity configured to hold a sensor configured to measure at least one patient parameter, and
[0251] at least one securing feature configured to connect the accessory to the nasal cannula interface (optionally to a strap of the nasal cannula interface), and
[0252] The nasal cannula includes a first nasal prong and a second nasal prong, and the cross-sectional area of the first nasal prong is smaller than the cross-sectional area of the second nasal prong.
[0253] The cross-sectional area of the first nasal fork is smaller than the cross-sectional area of the second nasal fork, wherein the cross-sectional area of the first nasal fork and the cross-sectional area of the second nasal fork are taken from corresponding positions on the first nasal fork and the second nasal fork.
[0254] The cross-sectional areas of the first nasal fork and the second nasal fork are taken from the proximal openings of each nasal fork.
[0255] The difference in cross-sectional area of the first nasal prong and the second nasal prong is intended to induce asymmetric gas flow in the patient's nostrils.
[0256] A patient breathing interface and an accessory therefor, the accessory being configured to hold a patient sensor to measure a patient parameter, wherein the accessory is configured to interact with the patient breathing interface and measure a physiological parameter of the patient while the patient is wearing the patient breathing interface.
[0257] The interaction of the accessory with the patient's breathing interface includes the attachment of the accessory to the patient's breathing interface.
[0258] The interaction of the accessory with the patient's breathing interface includes the attachment of the accessory to the strap of the patient's breathing interface.
[0259] The accessory is replaceable with a first component of the patient breathing interface, and interaction of the accessory with the patient breathing interface includes replacing the first component of the nasal cannula interface with the accessory.
[0260] The interaction of the accessory with the patient respiratory interface further includes interconnection of the accessory with a second component of the patient respiratory interface.
[0261] Interaction of the accessory with the patient respiratory interface further includes the accessory simultaneously interconnecting the second component and the third component of the patient respiratory interface.
[0262] The first component of the patient breathing interface is the side arm of the patient breathing interface.
[0263] The first component of the patient breathing interface is a connector, which is used to connect the other two components of the patient breathing interface together.
[0264] The first component of the patient breathing interface is a connector for connecting the body of the patient breathing interface and the headgear of the patient breathing interface together.
[0265] Interaction of the accessory with the patient respiratory interface causes the patient sensor held by the accessory to be located on the patient's face between the mouth region and the eye region of the patient's face when associated with the patient respiratory interface and worn by the patient.
[0266] The patient breathing interface is a nasal cannula interface.
[0267] A patient breathing interface for providing respiratory therapy to a patient, the patient breathing interface comprising:
[0268] an airway conduit configured to deliver a flow of breathable gas to a patient through a body of the patient respiratory interface,
[0269] A patient sensor having a sensor mount,
[0270] a retention structure connectable to each of the first and second opposing outer sides of the body to surround the patient's head and retain the body on the head, the retention structure comprising:
[0271] A first component is located along the side of the retention structure at a location where the retention structure is connectable to the first side of the body and is configured to receive a sensor mount so that the patient sensor contacts the patient's face when the patient respiratory interface is in use.
[0272] The patient breathing interface further includes a second component located along the side of the retaining structure at a location where the retaining structure can be connected to the second side of the body and configured to receive the sensor mount so that when the patient breathing interface is in use, the patient sensor contacts the patient's face.
[0273] When the sensor mount is received by the first component and the patient respiratory interface is in use, the patient sensor contacts the first side of the patient's face.
[0274] 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, ie the side opposite the first side.
[0275] The first component has a sensor cavity into which the sensor mount can be inserted and retained.
[0276] 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 is insertable and retainable within the sensor recess.
[0277] The first component is a first side arm.
[0278] The first component is or includes a strip connection for a strap holding the structure.
[0279] The first component is or includes a connection between a strap of the retention structure and a side arm of the patient breathing interface.
[0280] The patient sensor is overmolded by the first component portion.
[0281] The second component has a sensor recess extending through the second component from the non-patient-facing side of the second component to the patient-facing side, and the sensor mount is insertable and retainable within the sensor recess.
[0282] The second component is a second side arm.
[0283] The second component is or includes a strip connection for a strap holding the structure.
[0284] The second component is or includes a connection between the strap of the retention structure and the side arm of the patient breathing interface.
[0285] The patient sensor is a first patient sensor and the patient breathing apparatus further comprises a second patient sensor, and the second patient sensor is overmolded by the first component portion.
[0286] The patient sensor contacts a first side of the patient's face when inserted and retained in the sensor cavity of the first component and the patient respiratory interface is in use, and contacts a second side of the patient's face when inserted and retained in the sensor cavity of the second component.
[0287] The patient sensor contacts a first side of the patient's face when inserted and retained in the sensor recess of the first component and the patient respiratory interface is in use, and contacts a second side of the patient's face when inserted and retained in the sensor recess of the second component.
[0288] An accessory for a patient respiratory interface, the accessory including a sensor cavity and configured to retain a sensor in the sensor cavity to measure a patient parameter, wherein the accessory is interconnectable with one or more components of the patient respiratory interface and is configured to present the patient sensor at a facial surface of the patient when interconnected with the patient respiratory system and the patient respiratory interface worn by the patient.
[0289] The accessory is configured to interconnect with a component of the patient breathing interface.
[0290] The attachment is configured to interconnect with a side arm of a patient respiratory interface, and more particularly with a sensor recess of the side arm of the patient respiratory interface.
[0291] The accessory may replace the first component of the patient breathing interface.
[0292] The first component of the patient breathing interface is the side arm of the patient breathing interface.
[0293] The first component of the patient breathing interface is a connector, which is used to connect the other two components of the patient breathing interface together.
[0294] The accessory is configured to be interconnected between the second component and the third component of the patient breathing interface.
[0295] The second component is the body of the patient breathing interface, and the third component is the headgear connection piece of the patient breathing interface.
[0296] The second component is the side arm of the patient breathing interface, and the third component is the headgear strap of the patient breathing interface.
[0297] The patient breathing interface is a nasal cannula interface. BRIEF DESCRIPTION OF THE DRAWINGS
[0298] These and other features, aspects, and advantages of the present disclosure are described with reference to the accompanying drawings of certain embodiments, which are intended to illustrate certain embodiments by way of illustration rather than to limit the present disclosure.
[0299] Figure 1 A respiratory apparatus configured to provide respiratory therapy to a patient is schematically illustrated.
[0300] Figure 2 Shown for use with Figure 1 Schematic diagram of a closed-loop control system used with a breathing apparatus.
[0301] Figure 3 A nasal cannula interface is shown in use with a patient according to an aspect of the present disclosure.
[0302] Figure 4A partial front view of a nasal cannula interface according to one aspect of the present disclosure is shown.
[0303] Figure 5 Shows Figure 4 An exploded view of the nasal cannula interface.
[0304] Fig. 6A A front view of the body of a nasal cannula interface according to one aspect of the present disclosure is shown.
[0305] Figure 6B A patient breathing interface having a nasal interface, or more specifically a nasal cannula interface, with an asymmetric delivery element is shown.
[0306] Fig. 7A and Figure 7B 1 and 2 show a perspective view and a perspective exploded view of another nasal cannula interface according to the present disclosure, respectively. Figure 7C A stereoscopic view of a headgear for a nasal cannula interface is shown.
[0307] FIG. 7D to FIG. 7F An enlarged stereoscopic view of a headgear connector connected to a nasal cannula interface according to the present disclosure is shown.
[0308] Figure 7G and Figure 7H The corresponding Fig.7D and Fig. 7E sectional view of .
[0309] Fig. 8A and Figure 8B An enlarged perspective view of the connection between the nasal cannula interface and the headgear is shown, showing the form of the side arms of the headgear of the nasal cannula interface.
[0310] 9A to 9C Shown is an enlarged perspective view of a retaining clamp of a nasal cannula interface according to the present disclosure.
[0311] Fig. 10A , 10B , 10C, 11A and Fig. 11B A view of the accessory without the sensor for use with a nasal cannula interface is shown.
[0312] Fig. 12A , 12B , 13A, 13B, 13C and Fig.13D Shown is a view of an accessory with a sensor for use with a nasal cannula interface.
[0313] Fig.14A and Fig. 14B A view of the accessory without the sensor for use with a nasal cannula interface is shown.
[0314] Fig.15A and Fig. 15B A view of the accessory without the sensor for use with a nasal cannula interface is shown.
[0315] Fig. 15C and Fig.15D Shown is a view of an accessory with a sensor for use with a nasal cannula interface.
[0316] Fig.15E and Fig.15F Shown is a view of an accessory coupled to a nasal cannula interface.
[0317] FIG. 16A to FIG. 16E A view of the accessory without the sensor for use with a nasal cannula interface is shown.
[0318] Fig.17A and Fig. 17B A view of the accessory without the sensor for use with a nasal cannula interface is shown.
[0319] Fig. 17C Shows Fig.17A and Fig. 17B Cross-section of the attachment.
[0320] 18A to 18C Shown is a view of an accessory with a sensor for use with a nasal cannula interface.
[0321] Fig.19A is a patient breathing interface including components holding the sensor.
[0322] Fig.19B yes Fig.19A Different stereoscopic views of part A of FIG.
[0323] Fig.19C yes Fig.19B A perspective view taken from the opposite side of the components shown in FIG.
[0324] Fig. 20 is a view of the components of a patient breathing interface that may hold sensors.
[0325] Fig.21 yes Fig. 20 A view of a component by which the sensor is held.
[0326] Fig. 22 is an enlarged view of a component of or for a patient breathing interface.
[0327] Fig.23 It is a three-dimensional diagram of the connecting piece.
[0328] Fig.24 Before the clamp and the jaws engage Fig.23 A cross-sectional view of a connecting piece.
[0329] Fig.25 yes Fig.23 A cross-sectional view of a connection member showing the initial stage of engagement of the clamp with the jaws.
[0330] Fig.26 yes Fig.23 sectional view of a connection member showing the slide in a fixed position.
[0331] Fig. 27 yes Fig.23 sectional view of a connection of , showing the slide in the free position.
[0332] Fig.28 yes Fig.23 sectional view of a connector showing the clamp being removed from the carrier.
[0333] Fig.29 yes Fig.23 A cross-sectional view of one half of a sliding member of a connecting member.
[0334] Fig.30 yes Fig.23 A cross-sectional view of the other half of the sliding member of the connecting member.
[0335] Fig.31 yes Fig.23 A three-dimensional view of a carrier of a connecting piece.
[0336] Fig.32 yes Fig.23 A three-dimensional view of the fixture of the connecting piece.
[0337] Fig.33 is a perspective view of a catheter and a wire clamp.
[0338] Fig.34 yes Fig.33 End view of the catheter and wire clamp.
[0339] Fig.35 is a view of a portion of a catheter and a guidewire attached together using a catheter and guidewire clamp.
[0340] Fig.36A is a view of another nasal cannula interface including components configured to retain a patient sensor.
[0341] Fig.36B is configured to hold the sensor Fig.36A A view of a component.
[0342] Fig.37 yes Fig.36A A view of a nasal cannula interface configured so that a catheter may be connected on either side of the body of the interface.
[0343] Fig.38A is a view of another nasal cannula interface including components capable of retaining a patient sensor.
[0344] Fig.38B is configured to hold the sensor Fig.38A A view of a component.
[0345] Fig.39 A headgear strap and connectors for a patient respiratory interface, wherein one of the connectors is a component capable of holding a patient sensor.
[0346] Fig.40 A partial and partially exploded view of a nasal cannula interface having a component capable of holding a patient sensor, wherein the component is configured as an intermediate connector between the side arms of the nasal cannula interface and the headgear connector.
[0347] Fig.41 is an illustration of a communication module of a component configured to hold a patient sensor according to the present disclosure.
[0348] Fig.42 is a cross-sectional view of components configured to hold a patient sensor.
[0349] Fig.43 is a partial and partially exploded view of a nasal cannula interface having components configured to retain a patient sensor.
[0350] FIG. 44A to FIG. 44C They are the top view, front view and bottom view of the nasal cannula interface with asymmetric nasal prongs. DETAILED DESCRIPTION
[0351] Certain embodiments and examples of respiratory devices for providing respiratory support to patients and patient interfaces for such systems are described herein. Those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments and / or uses and obvious modifications and equivalents thereof. Therefore, it is intended that the scope of the present disclosure disclosed herein should not be limited by any specific embodiment described herein.
[0352] Patients with various health conditions and diseases can benefit from respiratory support. For example, patients with conditions such as chronic obstructive pulmonary disease (COPD), pneumonia, asthma, bronchopulmonary dysplasia, heart failure, cystic fibrosis, sleep apnea, lung disease, respiratory trauma, acute respiratory distress, patients receiving preoperative and postoperative oxygen delivery, and patients with other conditions or diseases can benefit from respiratory support. As part of providing respiratory support to a patient, a patient sensor can be used to measure one or more physiological parameters of the patient to enable monitoring of the patient's health. The patient sensor can be a pulse oximeter that provides information related to heart rate and blood oxygen saturation (SpO2).
[0353] When providing respiratory support, especially supplemental oxygen therapy, to a patient, a common method of monitoring the patient's health is to ensure that their SpO2 does not drop too low (e.g., typically below about 90%). However, supplying too much oxygen to a patient can overoxygenate their blood and is also considered dangerous. In general, a patient's SpO2 is maintained in the range of about 80% to about 99%, preferably about 92% to about 96%, but these ranges may vary due to the patient's condition and / or between patients.
[0354] Due to various patient factors, such as respiratory rate, lung tidal volume, heart rate, activity level, height, weight, age, gender and other factors, no one prescribed level of supplemental oxygen can always achieve an SpO2 response within the target range for every patient. Individual patients regularly need to monitor and adjust the fraction of oxygen delivered to the patient (FdO2) to ensure that they receive the correct FdO2 to achieve the target SpO2. Achieving correct and consistent SpO2 is an important factor in treating patients with a variety of health conditions or diseases. Additionally, patients with these health problems can benefit from a system that automatically controls oxygen saturation. The present disclosure is applicable to a wide variety of patients who require fast and accurate oxygen saturation control.
[0355] The fraction of oxygen (FdO2) delivered to the patient can be manually controlled. For example, a user can manually adjust an oxygen supply valve to change the flow or fraction of oxygen delivered to the patient. The user can use a patient monitor (e.g., a pulse oximeter) to determine the patient's SpO2 level. The SpO2 measurement can be displayed on the respiratory 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 SpO2 level and adjusting the amount of oxygen delivered accordingly can be performed in different environments. For example: a hospital, palliative care, hospice, or a home environment (e.g., a patient's home).
[0356] A patient interface for a respiratory device (referred to elsewhere as a "patient respiratory interface") can have a body that is sized and shaped to provide respiratory support through the airway of a patient. 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 can be an indirect interface that covers the nose, mouth, or both, or an indirect interface such as an interface that includes nasal nozzles or nasal pillows or the like that enter the wearer's nares. For example, the patient interface can have a body in the form of a nasal cannula.
[0357] A patient respiratory interface including or used with an accessory or component as described herein may include a nasal interface that can be used to deliver a high flow of gas to the patient. A nasal delivery element (such as a nasal prong that may optionally include a nasal pillow) is inserted into the patient's nose to deliver the desired treatment. The nasal delivery element may be desired to seal or partially block at the nose, or may not need to seal at the nose to deliver the treatment.
[0358] Nasal prongs typically refer to nasal delivery elements that are designed to not seal or only partially block at the nose. When one or more nasal prongs include nasal pillows, the nasal delivery element is designed to seal at the nose. Nasal high flow (NHF) therapy is typically a non-sealing therapy that delivers a relatively high volume of flow to a patient through a patient interface, such as a nasal interface. A nasal interface as described herein may refer to, but is not limited to, a nasal cannula.
[0359] As described herein, an asymmetric interface or an asymmetric nasal delivery element refers to an interface in which the size (e.g., internal and / or external transverse dimensions or diameters and / or internal and / or external cross-sectional areas) of the nasal delivery element is different. The external cross-sectional area is the cross-sectional area defined by the outer wall of the nasal delivery element. For non-circular cross-sections, the diameters mentioned herein may be interpreted as transverse dimensions. In some configurations, the diameters mentioned herein include, but are not limited to, hydraulic diameters.
[0360] An asymmetric interface allows an asymmetric flow to be delivered through the interface to either or both nostrils. Asymmetric flow as described herein refers to a flow that is different in the interface, or in the nose, or in both. In this way, each nasal delivery element can deliver a different flow, or the flow between inhalation and exhalation can be different, or the delivered flow can be a combination of the above. Asymmetric flow can also include partial unidirectional flow.
[0361] Delivering an asymmetric flow can improve clearance of dead space in the upper airway, reduce peak expiratory pressure, improve the safety of therapy, especially for children and infants, and reduce flow resistance in the interface. The asymmetric nasal interface and / or nasal delivery element as described herein includes a patient interface configured to produce such an asymmetric flow through an asymmetric nasal delivery element.
[0362] The pressure produced by NHF depends on the flow through the nasal interface, the size of the nasal delivery element and / or the patient's nostrils, and the breathing cycle. If during breathing, the flow through the nasal interface, the leakage, or the combination of the flow and the leakage is asymmetric, the flow through the nose may be asymmetric. Partial unidirectional flow and total unidirectional flow can be types of asymmetric flow. Partial unidirectional flow or total unidirectional flow can provide improved clearance of anatomical dead space when air is continuously flushed from the upper airway. Partial unidirectional flow can be more comfortable than total unidirectional flow. The total unidirectional flow as described herein includes the flow entering one nostril through the nasal delivery element and leaving through the other nostril via the nasal delivery element, the flow discharged into the atmosphere due to the absence of the nasal delivery element, etc. Partial unidirectional flow as described herein includes flow that can enter the nose via both nostrils and exit the nose from one nostril, flow that can enter the nose through one nostril and exit the nose via both nostrils, or different ratios of flow that can enter the nose through both nostrils and different ratios of flow that can exit the nose through both nostrils, and can be flow that can enter the nose via both nostrils and exit the nose from one or both nostrils and optionally exit via the mouth.
[0363] NHF delivered through an asymmetric nasal interface can involve making an interface in which the nasal delivery elements have different sizes, such as different lengths, and / or inner diameters or cross-sectional areas and / or outer diameters or cross-sectional areas. Especially for children or infants, the nasal delivery element has a small inner diameter and therefore has a higher gas flow resistance. By using nasal delivery elements of different lengths, each nasal delivery element can have a different inner diameter (e.g., a minimum inner diameter or area). Longer nasal delivery elements can have a smaller inner diameter and a higher gas flow resistance; shorter nasal delivery elements can have a larger inner diameter (e.g., a larger minimum inner diameter), so the gas flow resistance at the interface is smaller. Reduced flow resistance allows the use of lower back pressure, or a lower motor speed of the gas generating device, or a combination of the two to achieve the desired flow rate.
[0364] Asymmetric nasal delivery elements may reduce peak expiratory pressure due to the different cross-sectional areas of the nasal delivery elements at the nose, which may provide a different inner diameter for each nasal delivery element.
[0365] The pressure during exhalation with an asymmetric nasal interface can be higher than that with a symmetric interface, which is beneficial because higher positive end-expiratory pressure (PEEP) is part of the treatment of COPD (pressure here refers to intrathoracic pressure). The expiratory pressure depends on the combined cross-sectional area of the two nasal prongs. Increasing the cross-sectional area of symmetric nasal prongs carries the risk of completely blocking the patient's nares. Using asymmetric nasal prongs allows the total cross-sectional area to be increased without the risk of blockage. Partial unidirectional flow can reduce turbulence in the patient's nasal cavity, which can improve comfort.
[0366] The patient interface may include a headgear (or "head fixation assembly") to hold the patient interface on the patient's face. The headgear or head fixation assembly may include one or more straps.
[0367] In some arrangements, the patient interface may include one or more components interconnected between the body of the patient interface and the headgear. For example, one or more arms and / or one or more buckles or connectors may connect the body of the patient interface and the headgear together.
[0368] When a patient sensor is used as part of a respiratory device, the user is required to mount the patient sensor on the patient. This adds another task for the user to do to the already potentially large set of tasks required to set up a respiratory device. Additionally, a separate patient sensor may cause problems such as improper sensor mounting, resulting in incorrect measurements and / or sensor dislodgment during use.
[0369] The user of the device may be, for example, a nurse, a doctor, any other clinician or the patient himself.
[0370] Thus, a patient interface incorporating a patient sensor allows the use of the patient sensor without increasing the workload of the user. In particular, the patient interface can simplify or eliminate the task of installing the sensor. This may be beneficial in a hospital setting where a single clinician may have a large group of patients to deal with. Additionally, this may be beneficial in a home setting because it simplifies the setup process for patients who may need to perform these tasks themselves. Furthermore, integrating the patient sensor into the patient interface helps ensure the correct orientation of the patient sensor during use and prevents the patient sensor from falling off.
[0371] In some cases, such as when a patient changes to a new treatment and / or requires different respiratory support, it may be necessary to add patient sensors to the system and a new patient interface capable of accommodating the sensors may be required.
[0372] A patient sensor can be used with a patient interface via an accessory. The accessory is configured to hold a patient sensor for measuring at least one patient parameter. The accessory is configured to attach to the patient interface.
[0373] For example, such an accessory can be configured to attach to a band or arm of a patient interface to position the sensor on the patient's face. The accessory can also properly position the patient sensor relative to the patient's face and patient interface to ensure repeatable sensor output.
[0374] The use of accessories also allows for removal of patient sensors when a patient changes to a different respiratory support (eg, when a patient is stepped down) and / or changes to a different therapy by removing only the accessories without having to replace the entire patient interface.
[0375] The accessory may be provided separately from the patient interface or provided as part of a kit including the patient interface.
[0376] In some configurations, an accessory can be connected to a portion of the headgear, such as a strap for a device that is different from the patient interface that the patient is using.
[0377] The accessory may be described as a component of a patient interface, particularly where the accessory can replace conventional components of a patient interface. In such a configuration, the accessory may be referred to simply as a component of a patient interface or a component for a patient interface.
[0378] For example, where the accessory includes a buckle and / or connector feature, the accessory can be substituted as a component of the patient interface to replace a conventional buckle or connector between two other parts of the patient interface (such as between the body of the headgear and the connector). As another example, as described later with respect to 7A to 9C As described, the attachment may be used as a component of a patient interface, more specifically as a side arm of a patient interface. 7A to 9C The accessory can replace the regular side arms of the patient interface.
[0379] When the patient interface is supplied to the patient, an accessory that can replace another component of the patient interface can be provided to replace the component. In other arrangements, an accessory that can replace another component of the patient interface can be provided in a kit including the patient interface so that the user can replace the accessory into the patient interface. In still other arrangements, an accessory that can replace another component of the patient interface can be provided separately to the patient interface.
[0380] Where the accessory is replaceable with a conventional component of a patient interface, the component defined by the accessory may be interconnected with one or more other components of the patient interface.
[0381] The present disclosure refers to catheter heaters, which is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (i.e., it is not limited to a special or customary meaning) and includes, but is not limited to, one or more heating strips, one or more heating wires, and / or one or more conductive elements that generate heat when electrical power is supplied. Examples of such catheter heaters include wires made of conductive metal (e.g., copper), conductive polymers, conductive ink printed on the surface of the catheter, conductive materials used to make traces on the catheter, and the like.
[0382] In addition, the present disclosure refers to conduits, branches, and medical conduits in the context of gas delivery. For example, conduit is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art, and includes, but is not limited to, channels with a variety of different cross-sections, such as cylindrical channels and non-cylindrical channels.
[0383] The disclosed systems, devices, and medical catheters may also be used in a breathing circuit configured to provide continuous, variable, or bi-level positive airway pressure (PAP) therapy or other forms of respiratory support (such as high-flow or low-flow oxygen therapy). The breathing circuit may, for example, include an inspiratory circuit that includes, at a minimum, an inspiratory gas pathway (including all components) from a gas supply source to a patient interface.
[0384] Figure 1 A schematic representation of an example breathing apparatus 10 is provided in .
[0385] The breathing apparatus 10 comprises a flow source 49 for providing a high flow gas 27, such as air, oxygen, air blended with oxygen, or a mixture of air and / or oxygen with one or more other gases. Alternatively, the breathing apparatus may have a connection for coupling to the flow source. Thus, the flow source may be considered to form part of the apparatus or separate from the apparatus (depending on the context), or even part of the flow source forms part of the apparatus and part of the flow source does not belong to the apparatus. In short, depending on the configuration (some components may be optional), the system may include a combination of components selected from the following:
[0386] · Stream source,
[0387] a humidifier for humidifying the gas flow,
[0388] Tubing (e.g. dry line or heated breathing tube),
[0389] Patient interface,
[0390] Check valve,
[0391] Filters.
[0392] The conduit may include an inspiratory conduit 16 , an expiratory conduit, or an inlet conduit 62 .
[0393] The device is described in more detail.
[0394] The flow source may be a wall mounted oxygen source, an oxygen tank 49A, other gas tanks, and / or a high flow device with a flow generator 49B. Figure 1 A flow source 49 having a flow generator 49B is shown, the flow generator having 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 a regulator and / or other gas flow control member 49D, but this is only an option. The flow generator 49B can use one or more valves to control the flow delivered to the patient 56, or alternatively, the flow generator 49B can include a blower. The flow source can be one or a combination of the flow generator 49B, O2 source 49A, air source 49C as described. The flow source 49 is shown as part of the device 10, but in the case of an external oxygen tank or a wall-mounted source, it can be considered a separate component, in which case the device has a connection port to connect to such a flow source. The flow source provides a (preferably high) flow gas that can be delivered to the patient via the inspiratory conduit 16 and the patient interface 17.
[0395] The patient interface 17 can be an unsealed (non-sealed) interface (e.g., when used for high flow therapy) (e.g., a non-sealed nasal cannula), or a sealed (sealed) interface (e.g., when used for CPAP therapy) (e.g., a nasal mask, a full-face mask, or a nasal pillow). In some embodiments, the patient interface 17 is a non-sealed patient interface, which will, for example, help prevent barotrauma (e.g., tissue damage to the lungs or other organs of the patient's respiratory system due to a pressure difference relative to the atmosphere). In some embodiments, the patient interface 17 is a sealed mask that is sealed with the patient's nose and / or mouth. The patient interface can be a nasal cannula with a gas flow portion (e.g., a manifold) and a nasal prong, and / or a mask, and / or a nasal pillow mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The flow source can provide a base gas flow rate of, for example, between 0.5 liters / minute and 375 liters / minute, or any range within that range, or even within a range with a higher or lower limit. The details of the range and nature of the flow rate will be described later.
[0396] A humidifier 52 may optionally be disposed between the flow source 49 and the patient to provide humidification of the delivered gas. One or more sensors 48A, 48B, 48C, 48D (e.g., flow sensors, oxygen fraction sensors, pressure sensors, humidity sensors, temperature sensors, or other sensors) may be placed throughout the system and / or at or on or near the patient 56. Alternatively or additionally, sensors from which such parameters may be derived may be used. Additionally or alternatively, sensors 48A-48D may be one or more physiological sensors for sensing physiological parameters of the patient, such as heart rate, oxygen saturation, oxygen partial pressure in the blood, respiratory rate, CO2 partial pressure in the blood. Alternatively or additionally, sensors from which such parameters may be derived may be used. Other patient sensors may include an electroencephalogram (EEG) sensor, a trunk belt for detecting respiration, and any other suitable sensor. In some configurations, a humidifier may be optional, or a humidifier may be preferred due to the advantage of humidified gas helping to maintain airway conditions. One or more of the sensors may form part of the device, or may be external to the device, with the device having inputs for any external sensors.The sensors may be coupled to the controller 19 or send their outputs to the controller.
[0397] In some configurations, the respiratory device 10 may include a patient sensor 29 for measuring the oxygen fraction in the air inhaled by the patient. In some examples, the patient sensor 29 may be placed on the patient interface 17 to measure or otherwise determine the oxygen fraction close to the patient's mouth and / or nose (at / near / 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 assist in the control of the respiratory device 10 and / or to change the operation accordingly. The controller 19 is connected 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 device 10 as described herein. In some examples, the controller can operate the flow source 49 to provide a delivered gas flow at a desired flow rate that is high enough to meet or exceed the inhalation demand of the user (i.e., the patient). The flow rate provided is sufficient so that the ambient gas is not entrained as the user (i.e., the patient) inhales. In some configurations, patient sensor 29 may transmit measurements of the oxygen fraction at the patient's mouth and / or nose to a user, who may input the information into respiratory device 10 / controller 19 .
[0398] An optional check valve 23 may be provided in the inspiratory conduit 16. One or more filters may be provided at one and / or more air inlets 49C of the flow generator 49B to filter the incoming gas before it is pressurized into a high flow of gas 27 to the flow generator 49B.
[0399] The breathing apparatus 10 may be integral or Figure 1 104 is an arrangement based on individual components generally shown in the dashed box 104. In some configurations, the device can be a modular component arrangement. In addition, the device may include only some of the components shown; not all are necessarily essential. Moreover, the conduit and patient interface do not have to be part of the device and can be considered separate. Hereinafter, the conduit and patient interface will be referred to as respiratory devices, but this should not be considered restrictive. "Respiratory devices" will be broadly considered in this article to include anything that provides a certain flow of gas to a patient. Some such devices include a detection system that can be used to determine whether the flow of gas meets the inhalation demand.
[0400] Respiratory apparatus 10 may include a main device housing that houses the components shown within dashed box 104. The main device housing may contain a flow generator 49B, which may be in the form of a motor / impeller arrangement, an optional humidifier or humidification chamber 52, a controller 19, and an input / output (I / O) user interface 54. 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. Controller 19 may include one or more hardware and / or software processors and may be configured or programmed to control components of the system, including, but not limited to: operating flow generator 49B to generate a gas flow for delivery to a patient; operating humidifier or humidification chamber 52 (if present) to humidify and / or heat the gas flow; receiving user input from user interface 54 for reconfiguration and / or user-defined operation of respiratory apparatus 10; and outputting information to the user (e.g., on a display). The user may be a patient, a healthcare professional, or other person.
[0401] Continue to refer Figure 1 The inspiratory conduit 16 can be connected to a gas flow outlet (gas outlet or patient outlet port) 21 in the main device housing, which houses the components of the respiratory assistance apparatus 10 shown in the dashed box 104, and to a patient interface 17, which is a non-sealed interface such as a nasal cannula with a manifold and nasal prongs. The inspiratory conduit 16 can also be a tracheostomy interface, or other unsealed interface.
[0402] The gas flow can be generated by the flow generator 49B, and can be humidified and then delivered to the patient via the inspiratory conduit 16 through the patient interface 17. The controller 19 can control the flow generator 49B to produce a gas flow of a desired flow rate, and / or control one or more valves to control the mixing of air and oxygen or other breathable gases. The controller 19 can control the heating element in or associated with the humidification chamber 52 (if present) to heat the gas to a desired temperature that achieves a desired temperature and / or humidity level for delivery to the patient. The inspiratory conduit 16 can have a heating element, such as a heating wire, to heat the gas flow to the patient. The heating element can also be controlled by the controller 19.
[0403] The humidifier 52 of the device is configured to combine with the gas flow or introduce humidity into the gas flow. Various humidifier 52 configurations can be adopted. In one configuration, the humidifier 52 may include a removable humidification chamber. For example, the humidification chamber may be partially or completely removed or disconnected from the flow path and / or the device. For example, the humidification chamber may be removed for example to refill, clean, replace and / or repair. In one configuration, the humidification chamber may be received and held by a humidification compartment or bay of the device or may be received and held in a humidification compartment or bay of the device, or may be otherwise connected to the housing of the device or in the housing.
[0404] The humidification chamber of humidifier 52 may include a gas inlet and a gas outlet to enable connection to the gas flow path of the device. For example, the gas flow from flow generator 49B is received into the humidification chamber via its gas inlet and flows out of the chamber via its gas outlet after being heated and / or humidified.
[0405] The humidification chamber contains a volume of liquid, typically water or the like. In operation, the liquid in the humidification chamber is controllably heated by one or more heaters or heating elements associated with the chamber to generate water vapor or steam, thereby increasing the humidity of the gas flowing through the chamber.
[0406] In one configuration, the humidifier is a pass-over humidifier. In another configuration, the humidifier can be a non-pass-over humidifier.
[0407] In one configuration, the humidifier may include a heating plate, such as associated with or within a humidifying compartment (on which the chamber sits) for heating. The chamber may be provided with a heat transfer surface (e.g., a metal insert, plate, or the like) in a bottom surface or other surface of the chamber that interfaces or engages with the heating plate of the humidifier.
[0408] In another configuration, the humidification chamber may include one or more internal heaters or heater elements within or in the chamber. The one or more internal heaters or heater elements may be integrally mounted or disposed within the chamber, or may be removable from the chamber.
[0409] The humidification chamber can be of any suitable shape and / or size. The position, number, size and / or shape of the gas inlet and gas outlet of the chamber can be changed as needed. In one configuration, the humidification chamber can have a bottom surface, one or more side walls extending upward from the bottom surface, and an upper surface or top surface. In one configuration, the gas inlet and gas outlet can be positioned on the same side of the chamber. In another configuration, the gas inlet and gas outlet can be on different surfaces of the chamber, such as on opposite sides or positions, or in other different positions.
[0410] In some configurations, the gas inlet and the gas outlet may have parallel flow axes. In some configurations, the gas inlet and the gas outlet may be positioned at the same height above the chamber.
[0411] The respiratory device 10 may use ultrasonic transducer(s), flow sensor(s) (e.g., thermistor flow sensor), pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors in communication with the controller 19 to monitor characteristics of the gas flow and / or operate the respiratory device 10 in a manner to provide appropriate therapy. The gas flow characteristics may include gas concentration, flow rate, pressure, temperature, humidity, or other characteristics. The sensors 48A, 48B, 48C, 48D, 29 (e.g., pressure sensors, temperature sensors, humidity sensors, and / or flow sensors) may be placed at various locations in the main device housing, the inspiratory conduit 16, and / or the patient interface 17, the main device housing also housing the components shown in the dashed box 104. The controller 19 may receive outputs from the sensors to help it operate the respiratory device 10 in a manner to provide appropriate therapy, so as to determine an appropriate target temperature, flow rate, and / or pressure of the gas flow. Providing appropriate therapy may include meeting or exceeding the patient's inspiratory needs. In the illustrated embodiment, sensors 48A, 48B, and 48C are positioned in the housing of the device, sensor 48D is positioned in the inspiratory conduit 16 , and patient sensor 29 is positioned in the patient interface 17 .
[0412] The respiratory device 10 may include one or more communication modules to enable data communication or connection with one or more external devices or servers via a data or communication link or data network (whether wired, wireless or a combination thereof). For example, in one configuration, the respiratory device 10 may include a wireless data transmitter and / or receiver, or a transceiver 15, so that the controller 19 can wirelessly receive data signals from an operating sensor and / or control various components of the respiratory device 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 include a Wi-Fi modem. Additionally or alternatively, the data transmitter and / or receiver 15 may deliver data to a patient remote management system (i.e., a remote server) or enable remote control of the respiratory device 10. The respiratory device 10 may include a wired connection (e.g., using a cable or wire) so that the controller 19 can receive data signals from an operating sensor and / or control various components of the device 10. The respiratory device 10 may include one or more wireless communication modules. For example, the device may include a cellular communication module, such as a 3G, 4G or 5G module. Module 15 may be or may include a modem that enables the device to communicate with a patient remote management system (not shown) using an appropriate communication network. The remote management system may include a single server or multiple servers or multiple computing devices implemented in a cloud computing network. The communication may be a two-way communication between the respiratory device and the patient management system (e.g., a server) or other remote system. The respiratory device 10 may also include other wireless communication modules, such as a Bluetooth module and / or a Wi-Fi module. The Bluetooth and / or Wi-Fi modules allow the device to send information wirelessly to another device (e.g., a smartphone or tablet), or operate via a LAN (local area network) or a wireless LAN (WLAN). The device may additionally or alternatively include a near field communication (NFC) module to allow data transfer and / or data communication.
[0413] For example, the measured patient breathing parameter data (e.g., inspiration, exhalation and / or total breathing time ratio) can be transmitted to a patient remote management system (i.e., a remote server). The patient remote management system can be a single server or a server network or a cloud computing system or other suitable architecture for operating a patient remote management system. The patient remote management system (i.e., a remote server) further includes a memory for storing the received data and various software applications or services executed to perform a variety of functions. Then, for example, the patient remote management system (i.e., a remote server) can transmit information or instructions to the respiratory device 10 based 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 transmit an alert, alarm or notification to the respiratory device 10. The patient remote 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 patient remote management system can be further configured to generate a report in response to a request from an authorized party, and the breathing parameter data (e.g., inspiration, exhalation and / or total breathing time ratio) can be included in the generated report. The report may further include other patient respiratory parameters (eg, respiratory rate or SpO2) and / or device parameters (eg, flow, humidity level).
[0414] The respiratory apparatus 10 may include a high flow therapy device. The high flow therapy discussed herein is intended to be given its typical ordinary meaning as understood by those skilled in the art, which generally refers to a respiratory apparatus that delivers a target flow of humidified respiratory gases via an intentionally unsealed patient interface at a flow rate that is generally intended to meet or exceed the user's peak inspiratory flow (also known as inspiratory demand). Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from, but are not limited to, about 15 liters / minute to about 60 liters / minute or more. Typical flow rates for pediatric patients (e.g., newborns, infants, and children) often range from, but are not limited to, about one liter per minute per kilogram of user body weight to about three liters per minute per kilogram of user body weight or more.
[0415] High flow therapy may also optionally include gas mixture compositions that include supplemental oxygen and / or the administration of therapeutic drugs.
[0416] High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), nasal high flow oxygen therapy (HFNO), high flow therapy (HFT) or transtracheal high flow (THF) and other common names. For example, in some configurations, for adult patients, "high flow therapy" can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 49 LPM and about 60 LPM. In some configurations, for a neonatal, infant, or pediatric patient, "high flow therapy" may refer to delivering gas to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. A high flow therapy device for an adult patient, neonatal, infant, or pediatric patient may deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at a flow rate in any of the subranges outlined above.
[0417] High flow quality can be effective in meeting or exceeding the patient's inspiratory needs, improving the patient's oxygenation and / or reducing their work of breathing. Additionally, high flow therapy can produce a flushing effect in the nasopharynx, so that the anatomical dead space of the upper airway is flushed by the incoming high gas flow. The flushing effect can form a reservoir of fresh gas available for each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc. High flow therapy can also increase the patient's exhalation time due to pressure during exhalation. This in turn reduces the patient's respiratory rate.
[0418] The patient interface for high flow therapy may be a non-sealed interface to prevent barotrauma (which may include tissue damage to the lungs or other organs of the patient's respiratory system due to pressure differences 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 an unsealed tracheostomy interface, or any other suitable type of patient interface.
[0419] Respiratory apparatus 10 may measure and control the oxygen content of the gas delivered to the patient, and therefore the oxygen content of the gas breathed in by the patient. The oxygen concentration measured in respiratory apparatus 10 may be equivalent to the fraction of oxygen delivered (FdO2) and may be substantially the same as the oxygen concentration breathed by the patient, the fraction of inspired oxygen (FiO2), and as such these terms may be considered equivalent.
[0420] Sensor 29 is a patient sensor. When patient sensor 29 is disconnected during operation (either from the patient or from the respiratory device), respiratory device 10 may continue to operate in its previous operating state for a predefined time. After the predefined time, respiratory device 10 may trigger an alarm, transition from automatic mode to manual mode, and / or exit a control mode (e.g., automatic mode or manual mode) entirely.
[0421] The respiratory device 10 may be configured to identify whether the patient sensor 29 is a stand-alone patient sensor or a patient sensor located on or included by the patient interface 17. The respiratory device 10 may identify the sensor type by receiving identification information upon initial connection of the patient sensor 29. The respiratory device 10 may identify the sensor type by means of a signal received from the patient sensor 29. For example, an integrated patient sensor 29 may be configured to communicate with the respiratory device 10 via an electrical connection located at a gas outlet of the respiratory device 10 (as will be described herein), while a stand-alone patient sensor may be configured to connect to the respiratory device via a separate connection port.
[0422] The patient sensor 29 may include other associated processors or circuitry. Alternatively, the associated processor and / or circuitry may be located in another location.
[0423] The patient sensor 29 may include a housing. The housing may include the sensor transducer and any associated processor and / or circuitry.
[0424] The patient sensor 29 may be a skin contact sensor that contacts the skin when in the operative position within the sensor cavity.
[0425] As described above, the patient sensor 29 can be a pulse oximeter sensor configured to measure heart rate and / or blood oxygen saturation (SpO2). The pulse oximeter sensor can be provided as part of a pulse oximeter for measuring heart rate and / or blood oxygen saturation. The pulse oximeter can include a pulse oximeter sensor and a processor and / or circuit to control the pulse oximeter sensor by operating the pulse oximeter sensor and receiving sensor information therefrom. The processor and / or circuit can be integrated with the pulse oximeter sensor or can be separated therefrom. The processor and / or circuit can additionally process the signal received from the pulse oximeter sensor and can transmit the processed signal or other result information to another device.
[0426] The connection between the pulse oximeter sensor and other processors and / or circuitry of the pulse oximeter can be wired and / or wireless, for example, in the same manner as described elsewhere herein with respect to potential configurations of the communication module of respiratory apparatus 10. In the event that the pulse oximeter sensor is wirelessly connected to other processors and / or circuitry of the pulse oximeter, the pulse oximeter sensor can be powered by the wired connection or can be powered by a power source (e.g., a battery) that is integrated with the pulse oximeter sensor. In at least some configurations where the pulse oximeter sensor is wirelessly connected to other processors and / or circuitry of the pulse oximeter, battery power can be provided with the pulse oximeter sensor. The battery power can be user-rechargeable.
[0427] The pulse oximeter sensor may be a reflective pulse oximeter sensor.
[0428] The respiratory device 10 can be configured to use the output of a patient sensor 29 located on or included in the patient interface 17 to determine whether the patient is wearing the patient interface 17. In this context, "wearing" means that the patient interface 17 is mounted at a certain position on the patient's face so that the patient interface 17 can deliver a gas flow to the patient and the patient sensor 29 can measure one or more patient parameters. When the patient sensor 29 cannot reliably measure the one or more patient parameters, the patient sensor can generate a signal indicating such a situation. Additionally or alternatively, the patient sensor 29 can transmit a separate parameter, such as signal quality. The respiratory device 10 can check this parameter against a threshold to determine whether the patient sensor 29 can reliably measure the one or more patient parameters. The respiratory device 10 can use the determination that the patient sensor 29 cannot reliably measure the one or more patient parameters to further determine that the patient is not wearing the patient interface 17.
[0429] The respiratory device 10 may use the determination of whether the patient is wearing the patient interface 17 to enable or disable certain control algorithms, such as a closed loop SpO2 controller, which will be described in detail later in this specification. The respiratory device 10 may use this indication to increase or decrease the flow rate. For example, the respiratory device 10 may reduce the flow rate to reduce noise and power consumption when the patient is not wearing the patient interface 17. The respiratory device 10 may use this indication to generate an alarm, such as when the patient has removed the patient interface 17. This alarm may occur immediately after the output of the patient sensor 29 is lost or within a set time.
[0430] In another configuration, the respiratory device 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 device 10 can be configured to control the blower to operate at a reduced motor speed. The reduced motor speed can be the lowest operating speed of the blower. The reduced motor speed can be between about 1000RPM-2000RPM. In the standby mode, the respiratory device 10 can be configured to control the blower to deliver a reduced flow rate. The reduced motor speed can be between about 1LPM and 2LPM.
[0431] The blower can be operated at a motor speed greater than about 1,000RPM and less than about 30,000RPM, greater than about 2,000RPM and less than about 21,000RPM, greater than 4,000RPM and less than 19,000RPM, or any of the foregoing values. The operation of the blower can mix the gas streams entering the blower through these inlet ports. Using a blower as a mixer can reduce the pressure drop that would occur in a breathing apparatus with a separate mixer (such as a static mixer including baffles) because mixing requires energy. Having a static mixer can also increase the volume of the gas flow path between the valve and the gas composition sensor, which can further increase the delay between the time when the valve flow changes and the time when the corresponding oxygen concentration change is measured.
[0432] Controller 19 may determine a target output parameter for the blower based on user input and therapy provided by respiratory apparatus 10. The controller may receive a measurement of the target output parameter and based on the difference between the determined flow and the measured flow, the controller may adjust the speed of the blower.
[0433] Reference again Figure 1 , the controller 19 can be programmed with or configured to execute a closed-loop control system to control the operation of the respiratory device. The closed-loop control system can be configured to ensure that the patient's SpO2 reaches a target level and consistently remains at or near this level.
[0434] The controller 19 may receive (multiple) inputs from the user that the controller 19 may use to execute a closed-loop control system. The target SpO2 value may be a single value or a range of values. The (multiple) values may be preset, selected by a clinician, or determined based on a patient type, where the patient type may refer to a current ailment and / or information about the patient (e.g., age, weight, height, gender, and other patient characteristics). The target SpO2 value may be input by a clinician or user via a user interface on the device and received by the controller 19. Similarly, the target SpO2 may be two values, each selected in any of the above-described ways. These two values will represent a range of acceptable values for the patient's SpO2. The controller may target a value within the range. The target value may be the middle value of the range or any other value within the range, which may be preset or selected by the user. Alternatively, the range may be automatically set based on the target value of SpO2. The controller may be configured to have one or more set responses when the patient's SpO2 value moves outside the range. Responses may include sounding an alarm, changing to manual control of FdO2, changing FdO2 to a specific value, and / or other responses. The controller may have one or more ranges, where one or more different responses occur when the value moves outside of each range.
[0435] In general, SpO2 is controlled between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, or between about 92% and about 96%. SpO2 can be controlled between any two suitable values from any two ranges in the above ranges. The target SpO2 can be between about 80% and about 100%, or between about 80% and about 90%, or between about 88% and about 92%, or between about 90% and about 99%, or between about 92% and about 96%, or about 94%, or 94%, or about 90%, or 90%, or about 85%, or 85%. The SpO2 target can be any value between any two suitable values from any two ranges in the above ranges. For a defined range, the SpO2 target can correspond to the median value of SpO2.
[0436] FdO2 can be configured to be controlled within a certain range. As previously discussed, as long as the flow meets or exceeds the patient's peak inspiratory demand, the oxygen concentration measured in the device (FdO2) will be substantially the same as the oxygen concentration (FiO2) inhaled by the patient, and so these terms can be considered equivalent. Each limit of the range can be preset, selected by the user, or determined based on the patient type, where the patient type can refer to the current ailment and / or information about the patient (such as age, weight, height, gender and / or other patient characteristics). Alternatively, a single value of FdO2 can be selected, and the range can be determined at least in part based on 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 FdO2 out of the range, the system can have one or more responses. These responses can include sounding an alarm, preventing FdO2 from moving out of the range, switching to manual control of FdO2, and / or switching to a specific FdO2. Respiratory device 10 may have one or more ranges in which one or more different responses occur when the limits of each range are reached.
[0437] refer to Figure 2 , shows a schematic diagram of a closed-loop control system. The closed-loop control system can utilize two control loops. The first control loop can be implemented by an SpO2 controller. The SpO2 controller can determine a target FdO2 based in part on the target SpO2 and / or the measured SpO2. As discussed above, the target SpO2 value can be a single value or a range of acceptable values. (Multiple) values can be preset, selected by a clinician, or automatically determined based on patient characteristics. Generally speaking, the target SpO2 value is received or determined before or at the beginning of the treatment period, but the target SpO2 value can be received at any time during the treatment period. During the treatment period, the SpO2 controller can also receive the following as input: a measured FdO2 reading from a gas composition sensor, and a measured SpO2 reading and a signal quality reading from a patient sensor 29. In some configurations, the SpO2 controller can receive a target FdO2 as an input, in which case the output of the SpO2 controller can be provided directly back to the SpO2 controller as an input. Based at least in part on these inputs, the SpO2 controller may output a target FdO2 to the second control loop.
[0438] During the therapy session, the SpO2 controller and the FdO2 controller may continue to automatically control the operation of the respiratory device until the therapy session ends or an event triggers a change from automatic mode to manual mode.
[0439] For example, in our earlier PCT application publication WO 2019 / 070136 (herein "WO'136"), filed on October 5, 2018, and incorporated herein by reference in its entirety, a respiratory support system is described that uses blood oxygen saturation (SpO2) measurements from a pulse oximeter to automatically adjust the oxygen fraction (FdO2) of a gas flow delivered to a patient via a patient interface.
[0440] The respiratory support system described in WO '136 uses a separate pulse oximeter sensor and patient interface. As such, the clinician is required to separately attach the pulse oximeter sensor and the patient interface to the patient, wherein both components are also separately connected to the respiratory device.
[0441] Reference again Figure 1 , the controller 19 may be programmed with or configured to operate a FdO2 control system to control the operation of the respiratory apparatus.
[0442] The FdO2 control system can be configured to ensure that the instantaneous FdO2 is maintained at a target level at all points during treatment. The controller can measure the FdO2, compare it to the target FdO2, and then adjust the oxygen inlet valve accordingly. However, when the FdO2 sensor is located a not insignificant distance away from the valve, there is a time delay between changing the valve and the time when the corresponding FdO2 change is measured. The controller can adjust the valve after the time delay. However, if the flow rate is fluctuating, the controller may be able to achieve the target FdO2 on an average but not on a continuous and substantially instantaneous basis. As Figure 2 As shown, in order to maintain FdO2 at a target level on a continuous and substantially instantaneous basis without moving the FdO2 sensor closer to the valve, the FdO2 controller may consider the measurement of the total flow rate to control the valve.
[0443] Patient interface 17 is connected to one end of inspiratory conduit 16 and is used to provide a flow of breathable gas to the patient. During the setup of respiratory apparatus 10, a clinician or patient is required to attach patient interface 17 to the patient. Additionally, if a separate patient sensor 29 is also required to be used, this is also required to be attached to the patient by the clinician or patient. Then, both patient interface 17 and patient sensor 29 also need to be attached to respiratory apparatus 10 itself. Making these different connections may be undesirable.
[0444] The patient interface 17 has one or more patient sensors 29. The one or more integrated patient sensors 29 can 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).
[0445] Patient interface 17 may be used with the above-described respiratory device 10. Alternatively, patient interface 17 may be used with any other respiratory device that may utilize a patient interface 17 having a patient sensor 29, such as a ventilator, a CPAP device, a stand-alone humidifier, and / or an oxygen blender.
[0446] The patient interface 17 may include a nasal cannula interface, such as Figure 3 As shown in Figure 7. In this configuration, the nasal cannula interface broadly includes a head fixing assembly (or headgear) and a nasal cannula 30, and also includes an air intake duct 62. The head fixing assembly enables the user to place and maintain the nasal cannula 30 in the correct operating position. The air intake duct 62 forms a fluid or gas connection between the outlet end of the inspiratory duct 16 and the nasal cannula 30 to allow fluid or gas to flow between the inspiratory duct and the nasal cannula. The details of the air intake duct 62 and the main part of the nasal cannula 30 will now be described in detail.
[0447] The head fixing 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 a top strap 53b, such as Figure 3 As shown. 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 top strap 53b extend between the distal ends of the front strap 50. In use, the rear strap 53a is wrapped around the back of the patient's head. In use, the top strap 53b is wrapped around the top of the patient's head. In some configurations, the head fixation assembly is adjustable to allow patients with different head shapes and sizes to use the nasal cannula 30. For example, an adjuster such as an adjustment buckle 54 may be included to allow the patient to loosen or tighten the top strap 53b.
[0448] In some configurations, one or more of the straps are substantially elastic (i.e., made of an elastic material, such as Lycra, that can be stretched to fit the patient's head). In some configurations, one or more of the straps are substantially rigid. In some configurations, one or more of the straps are made of 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 of a substantially inextensible material. In some configurations, one or more of the straps are self-supporting. In some configurations, one or more of the straps maintain their shape when not in use.
[0449] Alternatively, the patient interface 17 is secured to the patient's head and face by a plurality of front straps 50 and a single rear strap 53a attached to the front straps 50. The rear strap is attached to the front strap 50 via a buckle 54. Alternatively, the rear strap 53a is integral with the front strap 50. The buckle 54 allows the patient to loosen or tighten the front strap 50 based on personal preference. Alternatively, the integral front strap 50 and rear strap 53a are elastic and can be stretched over the patient's head. The elasticity of the strap applies force to the head to hold the nasal cannula 30 in an optimal position when in 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.
[0450] The head mount assembly may also include a ring 55 that holds and supports the intake duct 62 at or near the inlet end, such as Figure 3 As shown. The ring 55 includes a first end connected to one of the front straps 50. The first end can be slidably connected to the front strap 50. The ring 55 includes a second end connected to the air intake conduit 62. The second end can be removably connected to the air intake conduit 62. Alternatively, the interface may include a tube clamp that is connected to the tube and can be removably connected to the cannula. The tube clamp supports the weight of the air intake conduit 62 and reduces the moment caused by the air intake conduit 62, thereby improving the stability of the patient interface 17. The clamp helps reduce the detachment of the patient interface 17. The clamp can be made of a rigid material.
[0451] The patient interface 17 may also be provided with a strap 63 . Figure 3An example of a sling 63 is shown. In the configuration shown, the sling 63 is connected to the inlet duct 62. Alternatively, the sling 63 is connected at a location at or near the connection between the inlet duct 16 and the inlet duct 62. In use, the sling 63 supports the weight of the inlet duct 16 and the inlet duct 62. The sling 63 is provided with a buckle 64 to allow the length of the sling to be adjusted. The buckle 64 makes the sling 63 suitable for patients of any size to use the patient interface 17. The sling 63 supports at least a portion of the weight of the inlet duct 16 in use so that the weight does not act on the patient or the nasal cannula 30. The use of the sling 63 reduces the portion of the combined total amount of the inlet duct 16 and the inlet duct 62 that pulls on the nasal cannula 30, thereby helping to prevent the nasal prongs 33, 34 from interfering with the sensitive lining of the nasal passage, or shifting or misaligning during use. In the configuration shown, the sling 63 fits loosely around the neck to reduce the chance of strangulation of the patient. The lanyard 63 also provides a convenient way to support the inspiratory duct 16 and the inlet duct 62. This allows the patient to turn over in bed without pulling or tugging on the inspiratory duct 16, and helps to avoid overheating of the inlet duct 62 under the felt. In one configuration, the lanyard 63 has a clamp that allows the user to open and close the lanyard to place and secure the lanyard 63 around the patient's neck. The clamp includes a male connector and a female connector that snap together. The clamp is disconnected by pulling on one end of the lanyard 63. The clamp is easy to disconnect and is untied when the user pulls on one side of the lanyard. This allows the lanyard 63 to be quickly removed, for example in an emergency situation, such as when the patient needs intubation.
[0452] The inlet conduit 62 will now be described in detail. The inlet conduit 62 is a conduit or tube of short length relative to the inhalation conduit 16, extending between the outlet of the inhalation conduit 16 and the nasal cannula 30. In use, the inlet conduit 62 forms a lumen that defines a gas passage between the inhalation conduit 16 and the patient interface 17, so that the gas flow leaves the inhalation conduit 16 and enters the inlet conduit 62, thereby traveling along the inhalation conduit 62 to the patient interface 17 and being delivered to the patient. One reason why a secondary conduit such as the inlet conduit 62 can be used is as follows: the inhalation conduit 16 is relatively heavy and cumbersome because it is used to deliver the gas flow over a considerable distance (from the humidifier unit 2 to a point close to the patient). Therefore, the inhalation conduit 16 needs to have a wall that is strong enough to support its own weight without collapsing. Since the inhalation conduit 16 is typically relatively long (e.g., 8 to 10 feet), this additional length and thicker wall structure increase the weight of the inhalation conduit 16. If the outlet of the inspiratory conduit 16 is directly connected to the patient interface in a manner such that the patient needs to support this weight, this may cause discomfort to the patient due to the weight of the inspiratory conduit 16 acting on the patient. In addition, the weight of the inspiratory conduit 16 may pull on the patient interface 17 and cause it to become dislocated or misplaced. A lighter, shorter secondary conduit (e.g., inlet conduit 62) extending between the outlet of the inspiratory conduit 16 and the patient interface 17 may be used.
[0453] The inlet conduit 62 is lighter and shorter than the inlet conduit 16, and as described above is typically used with a sling 63 connected to the inlet conduit 62 or to the connection between the inlet conduit 16 and the inlet conduit 62. In use, the sling 63 (as described above) supports at least a portion of the weight of the inlet conduit 16, so that the patient interface 17 only needs to support the relatively light inlet conduit 62. In addition, in a configuration where the sling 63 is connected to the end of the inlet conduit 62, the patient does not need to remove the sling 63 when disconnecting the inlet conduit 62 from the inlet conduit.
[0454] See now Figures 4 to 6B The various aspects of the nasal cannula 30 are described in more detail. Unless otherwise described, Figures 4 to 6B The illustrated nasal cannula 30 includes a Figure 3 All features of the generalized nasal cannula described.
[0455] The nasal cannula 30 includes two main parts: an interface connector 35 and a body 32. Figure 4 and Figure 5 To describe an exemplary configuration of these two parts.
[0456] The interface connection 35 is connected in use to and in fluid communication with the intake conduit 62 as already described above. However, in an alternative embodiment, the interface connection may be connected directly to the inhalation conduit 16.
[0457] Figure 5 The configuration shows that the interface connector 35 is detachable from the rest of the nasal cannula 30. Alternatively, the interface connector 35 can be an integral part of the nasal cannula 30. Alternatively, the interface connector 35 and the nasal cannula 30 form a disposable fit, thereby preventing the user from disassembling the two components after initial assembly. In the integrated or disposable fit configuration, a continuous gas flow path is formed through the inspiratory conduit 16, the inlet conduit 62, the interface connector 35, and to the nasal prong of the nasal cannula 30.
[0458] In some configurations, the interface connector 35 is generally tubular in shape, with a substantially circular inlet 59 on one side that curves into an oval or elliptical outlet 37 formed on one side of the interface connector 35 so that it is perpendicular to the inlet 59. The circular inlet 59 in the illustrated form receives the patient end of the inlet conduit 62 so that a flow of gas from the inlet conduit 62 can pass through the interface connector 35.
[0459] In some configurations, the interface connector 35 is integrated with or permanently coupled to the air intake conduit 62. Alternatively, the interface connector 35 is removably attached to the air intake conduit 62. The interface connector 35 engages the body 32 so that the flow of gas can pass through the outlet 37 and from the air intake conduit 62 through the nasal prongs 33, 34 (described in detail below) to the patient.
[0460] In some configurations, the interface connector 35 is made of a hard plastic material that deforms only under relatively high load conditions (ie, cannot be easily crushed by a user's hand). The interface connector 35 may be formed, injection molded, machined, or cast.
[0461] The interface connection 35 is connected to the body 32 in use so that a flow of gas leaving the interface connection 35 enters the body 32. The body 32 will now be described in detail.
[0462] The body 32 includes nasal prongs 33, 34 extending from a bottom portion 39 of the body 32. The gas flow passes through the body 32 to the nasal prongs 33, 34 and is delivered to the patient. In some configurations, the nasal prongs 33, 34 extend parallel to each other. In some configurations, the nasal prongs 33, 34 are bent backward from the facial mounting portion 32. In some configurations, the nasal prongs 33, 34 are bent toward each other. The structure of the nasal prongs 33, 34 will be described in detail below.
[0463] The body 32 of the illustrated embodiment includes a side arm 31 and a tubular member 38 formed integrally together, the tubular member including a recess, such as Figure 4 and Figure 5As shown. The tubular member 38 extends below the body 32 and is adapted to receive the interface connector 35 (for configurations where the body 32 and the interface connector 35 are separable or separate items). The body 32 has a lip 39 that extends around the upper edge of the tubular member 38. The interface connector 35 is connected to the body 32 by a friction fit, and the lip 39 on the body 32 helps 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 extending below the body 32. The rib 40 helps to rest and hold the interface connector in the correct position when the interface connector 35 is engaged with the body 32, and the rib 40 extends around the outside of the interface connector 35. When the interface connector 35 is connected to the body 32, the outlet 37 on the interface connector 35 is aligned with the bottom side of the face mounting portion or body 32 in use. This alignment reduces the amount of gas that leaks from the nasal cannula 30, thereby allowing effective treatment of the patient by delivering a maximum amount of humidified gas.
[0464] The side arms 31 are used to attach the front strap 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 strap 50 is attached to the side arms 31 so that the patient can put on the patient interface. In some configurations, the ends of the front strap 50 are looped through a pair of slits on the side arms 31, where the ends include hook-and-loop fasteners or the like to hold the ends in place when they are looped themselves. Alternatively, the front strap 50 or the loop 66 can be clamped to the side arms 31, for example, by cooperating male-female clamps, or adhesively attached to the side arms 31.
[0465] In some configurations, the body 32, nose forks 33, 34, side arms 31 and tubular member 38 are all made as one continuous article. The body 32, nose forks 33, 34, side arms 31 and tubular member 38 are all made of a flexible polymer material, such as a soft thermoplastic elastomer (TPE) or silicone.
[0466] The nasal prongs are described below. In the following description, the term "rear" or "back" or any such synonyms refers to the portion of the structure that faces the patient's face and is closest to the patient's face when the nasal cannula is in use. The term "front" or "forward" or any such synonyms refers to the side, face or portion that faces away from and is farthest from the patient's face when in use. The term "top" or "upper" refers to the side, face or portion that points away from the floor when a patient wearing the patient interface stands or sits upright and looks forward. The term "bottom" or "lower" refers to the side, face or portion that is toward or pointed toward the ground when the patient wearing the interface stands or sits upright and looks forward. For example, Figure 3The patient interface 17 is shown worn by a patient, wherein the directions described above can be assessed with reference to this figure. The definition of these directions remains consistent throughout, including in figures showing the patient interface 17 without a patient.
[0467] In some configurations, the body 32 includes two nose prongs 33, 34, which extend upward from the upper surface of the body 32 and bend inwardly, such as Figures 4 to 6B Reference Figures 4 to 6B The nasal prongs 33 and 34 extend from the upper surface of the body 32, and when the nasal cannula is used, one nasal prong is placed in each nostril of the patient. The nasal prongs 33 and 34 are configured to deliver the gas flow to the patient. The nasal prongs 33 and 34 receive the humidified gas flow from the inlet conduit 62 via the inlet conduit 62, the interface connector 35, and the body 32. Therefore, the nasal prongs 33 and 34 are fluidly connected to the interface connector 35 and receive the gas flow from the inlet conduit 62.
[0468] refer to Fig. 7A and Figure 7B , the patient sensor 29 is located on the body 32 of the nasal cannula 30. In some configurations, the patient sensor 29 is located on the nasal cannula 30 so that during use, it contacts the patient's skin. The patient sensor 29 may have an adhesive surface so that it can be fixed in contact with the patient's skin.
[0469] The outer surface of the body 32 of the nasal cannula 30 can be generally divided into an outward-facing surface and an inward-facing surface. The term "outward-facing surface" as used herein can refer to the outer surface of the body 32 that faces away from the patient when the nasal cannula 30 is in use. The term "inward-facing surface" as used herein can refer to the outer surface of the body 32 that faces the patient when the nasal cannula 30 is in use. The front side and the bottom side of the body 32 can be considered as outward-facing surfaces, while the back side can be considered as an inward-facing surface. The central portion of the top side of the body 32 that is located below the patient's nose in use can be considered as an inward-facing surface, while the remaining side portions of the top side can be considered as outward-facing surfaces.
[0470] Figure 6B An exemplary patient respiratory interface 1000 is shown that includes a nasal cannula 30 having asymmetric nasal delivery elements 111 , 112 .
[0471] The nasal cannula 30 provides a patient interface for the patient that is suitable for delivering a high air flow, high humidity gas flow to the patient's nasal cavity / nostril. In some configurations, the nasal cannula 30 is adapted to deliver high flow gas over a wide flow range (e.g., about 8 lpm or higher, depending on other therapeutic applications, approximately 10-50 lpm or higher). In some configurations, the nasal cannula 30 is adapted to deliver relatively low pressure gas.
[0472] like Figure 6B As seen in FIG. 1 , the air intake conduit 62 delivers incoming gas to the nasal cannula 30. The headgear 200 is shown provided with a patient respiratory interface 1000 to hold the nasal cannula 30 on the patient's face when in use. The retaining clamp 280 is shown to hold the air intake conduit 62 to the headgear 200. The nasal prongs 111, 112 are associated with the body 110 of the nasal cannula 30.
[0473] The nasal prongs 111 and 112 are curved and extend into the patient's nostrils during use and provide a smooth flow path for gas to flow through. The contours of the inner surfaces of the nasal prongs 111 and 112 can be configured to reduce noise. The bottom of the nasal prongs 111 and 112 may include a curved surface to provide a smoother gas flow. This can reduce the noise level during operation.
[0474] The nose prongs 111 and 112 are substantially hollow and substantially tubular in shape.
[0475] The diameter of the nasal prongs 111 and 112 can be consistent along their length, or alternatively can be shaped to accommodate the contour of the nostrils.
[0476] The body 110 is shaped to generally follow the contours of the patient's face around the upper lip area. The facial mount 110 is molded or preformed so as to be able to conform to the contours of the patient's face and / or is flexible so as to adapt, accommodate and / or correspond to the contours of the patient's face in the area of the face where the cannula is positioned.
[0477] The asymmetry of the nasal prongs 111 and 112 can reduce the chance of accidental obstruction of both nostrils. Therefore, at least one of the nasal prongs 111 and 112 is sized to maintain sufficient clearance between the outer surface of the nasal prongs 111 and 112 and the patient's skin to avoid sealing the gas path between the nasal cannula 30 and the patient. It should be understood that in the context of the present disclosure, the nasal prongs 111 and 112 are asymmetric, as described below.
[0478] exist FIG. 44A to FIG. 44C Another example of a patient interface with asymmetric nasal prongs is shown in .
[0479] As in Fig. 6A and FIG. 44A to FIG. 44C As seen in FIG. 1 , in some configurations, the nasal cannula 30 of the present disclosure includes a first nasal prong 111 and a second nasal prong 112 that are asymmetric to each other, and a body 110 that includes a gas inlet. The first nasal prong 111 and the second nasal prong 112 are in fluid communication with the gas inlet. The nasal cannula is configured such that at least about 60% of the total volume flow of the gas flow flowing into the gas inlet is delivered out of the nasal cannula through the second nasal prong 112.
[0480] like Figure 6B and FIG. 44A to FIG. 44C The first nasal prong 111 and the second nasal prong 112 shown can be considered as asymmetric nasal delivery elements.
[0481] The first nose fork 111 and the second nose fork 112 are asymmetrical to each other, and / or are not symmetrical to each other, and / or are different in shape and configuration from each other, and / or are asymmetrical when compared to each other.
[0482] The nasal cannula 30 is configured to achieve asymmetric gas flow at, within, and / or outside of the patient's nares.
[0483] In some configurations, the nasal cannula 30 includes a body 110 having a first nasal prong 111 and a second nasal prong 112 .
[0484] In some configurations, the first nasal prong 111 and the second nasal prong 112 are configured to engage with the nasal passage in an unsealed (non-sealed) manner. In some configurations, at least the second nasal prong 112 is configured to engage with the nasal passage in a non-sealed manner.
[0485] In some configurations, the first nasal prong 111 and the second nasal prong 112 allow exhaled gas to escape around the first nasal prong and the second nasal prong.
[0486] In some configurations, the first nasal prong 111 and the second nasal prong 112 are configured to provide gas to the patient without interfering with the patient's spontaneous breathing.
[0487] The first nasal prong 111 has a first nasal prong outlet 111a defined by an opening at a tip or end 111b thereof for conveying gas from the first nasal prong 111. The gas conveyed through the first nasal prong 111 leaves the first nasal prong via the first nasal prong outlet 111a.
[0488] The second nasal prong 112 has a second nasal prong outlet 112a defined by an opening at a tip or end 112b thereof for delivering gas from the second nasal prong 112. The gas delivered through the second nasal prong 112 exits the second nasal prong via the second nasal prong outlet 112a.
[0489] Reference now 7A to 9C These embodiments show or illustrate portions of a patient interface 17 configured to deliver breathing gases from a gas supply and humidification source (not shown) to a patient, and portions of a headgear 200 configured to support the patient interface and hold it on the patient's face during use. Fig. 7A and Figure 7BAs seen in the figure, the patient interface 17 is in the form of a nasal cannula interface 1000 adapted to be coupled to the inspiratory conduit 16 via the inlet conduit 62 and comprising at least one (but preferably two) nasal prongs 111 and 112 configured to fit within the patient's nostrils to deliver a gas flow to the patient. The headgear 200 is in the form of a headband 200, the length of which is preferably adjustable to customize the size of the band to the patient.
[0490] The nasal cannula interface 1000 includes: a body 110, which includes at least one, but preferably a pair of tubular nasal prongs 111 and 112, which are integrally formed with the body 110 or removably attached to the body (i.e., the body); and a gas flow portion 120, which is removably attached to the intake conduit 62 or integrally formed to the intake conduit. The gas flow portion 120 can be inserted into the body from either of two opposite horizontal directions (i.e., from the left or from the right). In this way, the position or positioning of the gas flow portion 120 is reversible relative to the body 110 (i.e., the body). In other words, the user can choose to have the gas flow portion 120 (and essentially the intake conduit 62 extending therefrom) extend from the left or right side of the nasal cannula interface 1000, depending on what is most convenient, for example, depending on which side of the patient the gas source or ventilator is located.
[0491] The gas flow portion 120 can be configured to fluidly couple the nasal prongs of the patient interface 1000 to the intake conduit 62. In some embodiments, the gas flow portion 120 can be a manifold.
[0492] The body 110 is formed of a soft and flexible material, such as silicone or other cannula materials known in the art. The nasal prongs 111 and 112 are preferably flexible and may be formed of a sufficiently thin layer of silicone to achieve this property.
[0493] The gas flow portion 120 is formed of a relatively hard material such as polycarbonate, high density polyethylene (HDPE), or any other suitable plastic material known in the art. The body 110 provides a soft interface component to the patient for comfortably delivering a flow of gas through the nasal prongs 111 and 112, while the gas flow portion 120 fluidly couples the inlet conduit 62 to the nasal prongs 111 and 112 of the body 110.
[0494] A patient sensor 29 , such as a pulse oximeter sensor or multiple pulse oximeter sensors, may be located on or in the gas flow portion 120 .
[0495] The patient sensor 29 may be integrated into the gas flow section 120 and thus may be disposable. Alternatively, the patient sensor 29 may be removably mounted on the gas flow section 120. The gas flow section 120 may have an appropriate recess or receiving port / opening to receive one or more patient sensors 29. One or more patient sensors 29 may be removable and reusable.
[0496] As previously described, the one or more patient sensors 29 may be wireless and / or wired. A wire or wires of the patient sensor 29 may be routed through the gas flow portion 120 via an inlet and returned to the controller via the inspiratory conduit 16 or 62. The controller may include circuitry for operating the patient sensor, which may be, for example, one or more pulse oximeter sensors. The controller that controls the patient sensor may be a separate controller from the controller 19 that controls the respiratory apparatus. In other arrangements, the controller 19 that controls the respiratory apparatus may also control the patient sensor.
[0497] The one or more sensors are positioned on the gas flow portion 120 to position the patient sensor 29 in contact with or adjacent to the upper lip region, such as in the mouth region of the face. There are many blood vessels in the upper lip, and the patient sensor 29 can be used to determine blood oxygen by contacting or approaching the upper lip region via the gas flow portion 120.
[0498] The gas flow portion 120 can be formed of a rigid plastic material because it is received in the soft silicone body of the cannula. The fact that the gas flow portion 120 is rigid makes it easier to insert the manifold portion into the facial mounting portion and to maintain the manifold portion in its operative position (i.e., inserted into the facial mounting). The manifold portion is inserted into the body and is in fluid communication with the nasal prongs to direct gas from the inlet conduit to the nasal prongs. The patient sensor 29 located on or in the manifold portion positioned in the body positions the patient sensor 29 in a sensing position, i.e., the sensor is positioned adjacent to or in contact with the upper lip.
[0499] The nasal septum and / or columella of a patient are generally quite sensitive areas and can be a source of discomfort when subjected to excessive contact pressure for a long time. The nasal cannula of the present disclosure can eliminate or reduce this pressure by arranging a cushioning area of the nasal cannula interface 1000 adjacent to the patient's nasal septum / columella.
[0500] A patient sensor 29 (eg, a pulse oximeter) may be placed between the nasal prongs 111, 112 on the upper surface of the cannula such that the patient sensor contacts the nasal septum / columella.
[0501] The patient sensor 29 (e.g., a pulse oximeter sensor) may be located in an accessory 400 (e.g., as a nasal cannula interface accessory) and / or a nasal cannula component as described in more detail below. Fig. 15C and Fig.15F As shown in , the pulse oximeter sensor 29 is located in the accessory 400.
[0502] exist 7A to 9C In an embodiment of the present invention, a headgear for holding the nasal cannula interface 1000 on the patient's face includes a headband 200 having a single continuous length and adapted to extend along the patient's cheeks, over the ears and around the back of the head during use.
[0503] The main end portions 201 and 202 of the band 200 are adapted to be releasably connected to corresponding structures 101 and 102 on either side of the nasal cannula 100 (see, for example, Fig. 8A ) to hold the cannula 100 in place during use.
[0504] A belt connector 230 is provided at each of the minor end portions 203 , 204 of the primary belt 210 and the corresponding end portions 203 , 204 of the belt segments 220 .
[0505] Figure 7C A headgear for a nasal cannula interface is shown, wherein Figure 7B The band segment 220 is configured as three band segments 220a, 220b and 220c of different sizes. Each band segment of different sizes has respective end portions 221a, 221b and 221c, which correspond to the end portions 203 and 204 of the main band 210.
[0506] Each connector 230 is provided at one end with a strap connection mechanism that couples to the strap material, and at an opposite end is provided with a connection mechanism that releasably couples a corresponding end of a similar connector 230 .
[0507] Cannula connectors 240 are provided at the major end portions 201 and 202 of the main band 210. These connectors 240 have similar band connection mechanisms to the band connectors 230 of the minor end portions 203 and 204, but include a clamp member, such as a push-fit clamp 241, at the end of the connector 240 opposite the band end. The clamp 241 is configured to releasably couple a corresponding structure 101, 102 on one side of the nasal cannula interface 1000. The clamp 241 is preferably a bendable portion, such as a plastic portion, which forms a hinged portion relative to the band. For example, the clamp 241 is preferably preformed to have a curved shape along its length, such as a curved shape having an angle between, for example, flat and 20 degrees. This bend allows the clamp 241 to adapt to the facial contours of the patient in the area of the clamp 241.
[0508] refer to Fig.7D and Figure 7H , a method for engaging and disengaging each connector 240 of the headband 200 with the nasal cannula interface 1000 will now be described. Each connector 240 includes a clamp 241 having an elongated connector body 242 and a lateral protrusion 243 at the end of the body 242. The lateral protrusion 243 includes an inwardly facing engagement surface 243a. The face 244 of the connector 240 opposite the face 245 from which the protrusion 243 extends is preferably substantially smooth or planar. The corresponding construction 101 / 102 of the nasal cannula interface 1000 includes a channel 101a / 102a having an entry opening 101b / 102b and an exit opening 101c / 102c at both ends of the channel 101a / 102a. The peripheral wall of the exit opening 101c / 102c defines an abutment 101ci / 102ci configured to engage with the surface 243a of the protrusion 243 of the clamp 241. The periphery 101bi / 102bi of the entry opening 101b / 102b defines an abutment for engaging the flange 246 at the opposite end of the body 242 to the protrusion 243. This is used to limit the insertion of the connector 240 into the corresponding channel 101a / 102a. The flange 246 can be provided by the end and / or the side arm 270 of the belt connection mechanism.
[0509] Each section on either side of the headband 200 and adjacent to the respective main end portion 201 / 202 includes or has applied thereto a side arm 270 that includes at least a face contacting surface for frictionally engaging with the patient's face to stabilize the headgear 200 at or below the cheeks (e.g., cheekbones) or regions of the face during and after coupling of the headgear to the nasal cannula interface 1000 during use. The face contacting surface is preferably made of a relatively more frictional surface material than the rest of the band 200.
[0510] The side arms 270 may be cheek supports and / or sleeves.
[0511] The face contact surface is adapted to extend over a portion of the side of the patient's face in use, preferably to the patient's cheek or at least substantially toward the patient's cheek, so as to help hold or stabilize the nasal cannula interface 1000 on the patient's face. The face contact surface, which may be located on the patient's cheek, further helps to keep the remainder of the headband 200 separated from the user's eyes or eye sockets and preferably extends to below the patient's eyes or eye sockets to prevent visual obstruction and / or discomfort caused by the headband 200 bridging at or near the eyes or eye sockets.
[0512] It will be appreciated that the facial contact surface may be adapted to extend over a portion of the side of the patient's face during use, for example, from at or near or above the left outer upper lip and the right outer upper lip, extending rearwardly and upwardly across the left and right cheeks.
[0513] The friction surface material may be provided in the form of an elongated side arm 270 configured to receive the respective major end portions 201 / 202 of the strap 200. The side arm 270 is configured to be removably coupled (or alternatively permanently coupled) around the strap 200, segments of the strap 200, and / or cannula connectors 240 / 260 at the major end portions of the strap.
[0514] The side arm 270 (eg, as a sleeve) is coupled around the belt 210 at the main end portion 201 / 202 and also around a portion of the connector 240. The belt 210 extends through a channel 272 in the side arm 270, as can be seen from Figure 7B The strap 210 is adapted to be threaded through this passage and preferably remains free to stretch or retract or extend when in the sleeved configuration. The connector 240 is substantially contained by the side arm 270 or covered by the face contact surface to minimize direct contact with the patient's skin, thereby improving the stability and comfort of the headgear 200. The clamp 241 extends from the end 273 of the side arm 270. In another embodiment, the side arm 270 can be overmolded on the connector 240 and / or the strap 210.
[0515] refer to Fig. 8A and Figure 8B , the side arm 270 can be coupled at the main end portion 201 / 202 around a connector 260 extending from the strap 210. In this embodiment, the connector 260 is substantially contained by the side arm 270 or covered by the face to minimize direct contact with the patient's skin, thereby improving the stability and comfort of the headgear 200. In other words, the connector 260 extends completely through the channel 272 of the side arm 270. The buckle 251 / 252 extends from the end 274 of the side arm 270 and the clamp 261 extends from the opposite end 273.
[0516] The side arm 270 may be preformed to have a curved shape along its length, such as a curved shape having an angle between flat and 20 degrees. This curvature allows the side arm 270 to adapt to the contours of the patient's face or cheek in the sleeve area during use. Alternatively, the side arm 270 may be elastically or non-elastically deformed to take the shape of a curved sleeve when engaged with the main end portion 201 / 202 of the headband 200 or the connector 260.
[0517] The side arm 270 provides a face contact surface made of a relatively high friction surface material for frictional engagement with the patient's face or facial skin. This face contact surface will be positioned for frictional engagement with the patient's facial cheek skin. The face contact surface is at least localized to the band or the section of the band that will be positioned on the patient's cheek. The face contact surface provided with the relatively high friction surface material is preferably made of a material that is smooth and comfortable on the patient's skin. Therefore, the side arm 270 or at least the face contact surface is formed of a relatively softer material than the connectors 240 and 260.
[0518] In a preferred embodiment, the face contacting surface or side-arm 270 is formed of a soft thermoplastic elastomer (TPE), but may alternatively be formed of another plastic material, such as silicone, or any other biocompatible material.
[0519] In addition to nasal cannulas, headgear for other forms of patient interfaces may also include side arms 270 as described or similar cheek supports at or near the two side ends of the band of the headgear of the patient interface, the side arms connected to the mask for frictional engagement with the patient's face to stabilize the mask at the cheeks of the face, particularly for example to guide a nasal mask including nozzles or nasal pillows that enter or engage the wearer's nostrils. Such headgear may also include a single headband that is adapted to extend along the patient's cheeks, above the ears and around the back of the head in use, with the ends including any suitable form of clamps that are coupled to the mask on both sides (or permanently attached to the mask).
[0520] A patient sensor 29 (eg, in the form of a pulse oximeter sensor) may be provided on the nasal cannula interface 1000 of FIGS. 7-9 .
[0521] According to reference Figures 1 to 6B In any of the configurations described for the nasal cannula 100 , a patient sensor 29 may be provided on the nasal cannula interface 1000 .
[0522] The patient sensor 29 may be disposed on the headgear 200, or on another removable portion of the nasal cannula interface 1000 that is connected to the body 110 or gas flow portion 120 of the nasal cannula interface 1000. In this way, if the body 110 and / or gas flow portion 120 is replaced or discarded, the patient sensor 29 may be retained with the headgear 200 or other removable portion so that the patient sensor 29 is not discarded and can be reused. For example, the patient sensor 29 may be disposed on a headgear 200 that is configured to connect to a plurality of different sized bodies 110 and / or gas flow portions 120. This allows the user to exchange or replace portions of the cannula without having to discard the patient sensor 29.
[0523] refer to 7A to 9C , the patient sensor 29 can be disposed on the side arm 270. Any wiring associated with the patient sensor 29 can extend through the channel 272 of the side arm 270 and extend from the end 274.
[0524] The patient sensor 29 can be recessed into and flush with the face contact surface of the side arm 270. The patient sensor 29 can be located at any suitable position along the length of the side arm 270, such as adjacent to the structure 101, 102 or adjacent to the headgear strap 210.
[0525] The patient sensor 29 may be permanently mounted on the side arm, for example the patient sensor 29 may be overmolded onto the side arm 270 .
[0526] The patient sensor 29 may be removably mounted on the side arm 270 so that if the side arm 270 is discarded, the patient sensor 29 may be replaced or reused. The patient sensor 29 may be removed, wiped, and incorporated into a different cannula having a similar recess in the side arm 270 to receive the patient sensor 29. This allows the sensor to be reused with a patient, thereby reducing costs to the healthcare facility.
[0527] Alternatively, the patient sensor 29 may be provided in a complementary sensor body that may be permanently or removably mounted on the side arm 270, such as in a corresponding recess on the side arm 270. The recess and complementary body may be provided with one or more retaining formations configured to retain the body in the recess. Incorporating the patient sensor 29 into the side arm 270 places the patient sensor 29 in contact with the cheek region, such as the cheek region or the temporal region of the face. In this region of the face there are blood vessels, the sensor may be positioned near these blood vessels and these blood vessels may be used to detect the patient's blood oxygen saturation.
[0528] Patient interface, such as 7A to 9C The nasal cannula interface 1000 of any of the Figures may include a plurality of patient sensors 29 .
[0529] 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 or in the side arm 270 (i.e., sleeve). The measurements from these multiple sensors 29 may be averaged by the controller to provide a blood oxygen (SpO2) reading.
[0530] Thus, each side arm 270 may include a single patient sensor 29 .
[0531] In another alternative form, each side arm 270 of the cannula (i.e., each side arm) can include multiple patient sensors. One, some, or all of the multiple patient sensors can be removable. Each side arm 270 can include multiple recesses or openings to receive patient sensors 29.
[0532] Multiple patient sensors 29 may be advantageous because averaging the measurements may provide a more accurate SpO2 reading and reduce noise in the sensor readings received by the controller.
[0533] As about 7A to 8B As described in the arrangement, the patient sensor can be retained within a component of the patient interface, namely, the side arm 270. The side arm 270 housing one or more patient sensors can be provided as part of a patient interface kit, or can be provided as a separate part that the user can replace with a conventional side arm of a patient interface.
[0534] refer to 9A to 9C , a retaining fixture 280 may be provided that includes a tubular body 281 for receiving and accommodating a portion of the air intake conduit 62 therein. A hook 282 protrudes from the tubular body 281 to couple with a strap, or other component of the headgear 200. In this way, the air intake conduit 62 may be coupled or tied to the head strap 210 or the headgear 200 during use. If the air intake conduit 62 is pulled, force will be applied to the head strap 210 rather than directly to the cannula 100. This relocation of force will reduce the likelihood that the nasal prongs 111 and 112 of the cannula 100 will pop out of the patient's nostrils.
[0535] One or more tie points for connecting the clamp 280 may be used on the headgear 200, wherein preferably there are at least two symmetrical tie points on both sides of the headgear to improve usability.
[0536] It should also be appreciated that the retaining clip 280 may be removable from the intake conduit 62 or may be a permanent fit on the intake conduit.
[0537] The retaining clamp 280 can be connected to or retained to a portion of the patient interface, such as a portion of the patient interface that provides a relatively more rigid area (to facilitate supporting the inlet conduit 62).
[0538] The retaining clamp 280 may also be positioned or attached at a specific location on the intake duct 62 , for example, a predetermined position may be provided to hold the retaining clamp 280 in place.
[0539] The retaining fixture 280 can be configured to retain the wiring of the patient sensor 29 to secure the wiring to the intake conduit 62. Thus, the patient sensor wiring can extend parallel to the longitudinal axis of the intake conduit 62.
[0540] The intake conduit 62 may be provided with one or more sensor wires, for example in the wall of the conduit or extending through a hole of the conduit. The one or more sensor wires may be configured to be electrically coupled to the patient sensor 29.
[0541] Such electrical coupling may be provided by a physical electrical coupling between the wiring of patient sensor 29 and one or more sensor wires in intake conduit 62 , such as via an electrical connector.
[0542] Such electrical coupling may be provided via an inductive coupling. For example, patient sensor wiring may extend along the side arm 270 and / or may be disposed in the 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 inlet conduit 62 where the inlet conduit 62 connects to the inlet of the nasal cannula. The inlet conduit 62 and the nasal cannula interface 1000 may be provided with inductive couplers configured to electrically couple the inlet conduit 62 to the patient sensor wiring.
[0543] Such an arrangement eliminates or reduces the need for physical electrical connectors or the like and the need for one or more exposed electrical contacts. Such an arrangement also eliminates or reduces the number of connections that a user needs to make when using the nasal cannula interface 1000. For example, if the patient sensor 29 and headgear 200 are to be reused, the user does not have to physically disconnect the patient sensor wiring from the intake conduit 62.
[0544] The inlet duct 62 may be a heated or unheated duct. The duct may be an extension of any desired length.
[0545] As described above, patient sensor 29 may be configured to contact the patient's face.
[0546] Patient sensor 29 can be optionally added to the patient interface. As a supplement to the patient interface, the patient sensor can be combined with the patient interface through 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.
[0547] The accessory 400 may be configured as a nasal cannula interface accessory, such as, for example, the nasal cannula interface accessories shown in FIGS. 10 to 16 .
[0548] The accessory 400 can be configured to be attached to the nasal cannula interface 1000. For example, as shown in FIG. Fig.15F and Fig.15D As shown, accessories may be connected to the strap 200 of the nasal cannula interface 1000 .
[0549] It should be appreciated that the accessory 400 may be used on any suitable patient interface with a strap (and is not limited to a nasal cannula interface). However, as an example patient interface, a nasal cannula interface is used below.
[0550] like Fig. 12A As shown in FIG. 4 , the accessory 400 includes a sensor cavity 500, at least one fixing feature 610, 650, and a guide wire cavity 700. Fig. 12A As shown in the view of FIG. 1 , the sensor cavity 500 is configured to hold the patient sensor 29. As described in more detail above, the patient sensor 29 can be configured to measure at least one patient parameter. At least one securing feature 610, 650 is configured to connect the accessory 400 to the nasal cannula interface 1000; for example, at least one securing feature 610, 650 can be releasably connected to the band 200 of the nasal cannula interface 1000, as shown in FIG. Fig.11A and Fig. 11B as well as Fig.13A and Fig. 13B shown.
[0551] The accessory 400 may include a main body 401 .
[0552] The sensor cavity 500 and / or the guide wire cavity 700 may be disposed in the body 401 of the accessory 400 .
[0553] The securing features 610 , 650 may also extend from the body 401 .
[0554] At least one securing feature 610, 650 can be configured to releasably connect the accessory 400 to the nasal cannula interface 1000. In some configurations, at least one securing feature 610, 650 can be configured to permanently connect the accessory 400 to the nasal cannula interface 1000 so as to be non-removable (though optionally still movable along the strap as described in more detail below).
[0555] like Fig. 12A As shown, the wire lumen 700 can be configured to provide access to the sensor lumen 500 for one or more wires 710 .
[0556] The accessory 400 may include one or more gripping features. The gripping features may include, for example, protrusions, core protrusions that may help or improve the gripping of the accessory 400 to the nasal cannula interface 1000. The gripping features may help a user move the accessory 400 relative to the nasal cannula interface 1000 to position the accessory 400 (as described in more detail below).
[0557] like Fig.15E and Fig.15F As shown, a nasal cannula interface 1000 may be provided. The nasal cannula interface 1000 may include a nasal cannula interface attachment 400.
[0558] Accessory 400 may be releasably connected to interface 1000 .
[0559] Accessory 400 may replace components of interface 1000, for example, FIG. 17A to FIG. 18C As shown, the attachment replaces the side arms (as cheek supports). In this case, an interface without side arms can be provided.
[0560] As described in more detail below, components may be provided that replace existing components of an interface.
[0561] FIG. 17A to FIG. 17C and 18A to Fig.18C An example of an accessory in is a side arm 270, such as 7A to 8B As shown, the side arm can be part of the nasal cannula.
[0562] As described above, the side arm 270 can be a cheek support configured to rest at least partially against the patient's cheek during use.
[0563] like FIG. 17A to FIG. 18C As shown, accessory 400 includes a sensor cavity 500 , a guide wire cavity 700 , and a belt channel 950 .
[0564] In some configurations, the accessory 400 can include a securing feature. The securing feature can be located at or near the first end 810 of the accessory 400.
[0565] As mentioned above about FIG. 7D to FIG. 7H As described, the securing feature may be configured to connect to the cannula connector 240 .
[0566] In some embodiments, the securing feature is connected to the strap 210 (with FIG. 10A to FIG. 16E Implementation example).
[0567] like FIG. 17A to FIG. 18C As shown, the sensor cavity 500 can be configured to hold a patient sensor 29 (eg, Fig. 17B and Fig. 17C ), the patient sensor is configured to measure at least one patient parameter. The wire lumen 700 can be configured to provide access to the sensor lumen 500 for one or more wires 710.
[0568] The accessory 400 may include a main body 401 .
[0569] The sensor cavity 500 and / or the guide wire cavity 700 may be disposed in the body 401 of the accessory 400 .
[0570] In some configurations, the accessory 400 can have a securing feature configured to connect to the cannula connector 240 .
[0571] In some configurations, for example, FIG. 17A to FIG. 18CAs shown, the accessory 400 includes a belt channel 950. The belt channel 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.
[0572] Strap channel 950 may allow a strap to pass through accessory 400 to body 110 (or another component of a patient interface).
[0573] The strap channel 950 can allow the strap to pass through the accessory 400 to reach the body connection feature, which is configured to connect the strap of the nasal cannula interface 1000 to the body 120. The connection feature can be as described above with respect to FIG. 7D to FIG. 7H A cannula connector 240 is depicted.
[0574] The belt channel 950 can be located in the body 401 of the accessory 400.
[0575] The belt channel 950 can be configured to contain the belt 200 of the nasal cannula interface 1000.
[0576] The belt channel 950 can be shaped to contain the belt 200. That is, the shape of the belt channel 950 can correspond to the shape of the belt 200. For example, Fig. 17C , Fig.18B and Fig.18C As shown, the belt channel 950 may include a rectangular cross-section to correspond to the substantially flat rectangular belt 200. In some configurations, the belt channel 950 may have a circular and / or oval cross-section.
[0577] In some configurations, the belt channel 950 can have an opening at a first end of the accessory 400, an opening at a second end of the accessory 400, and an enclosed portion between the two ends. In some configurations, the belt channel 950 can be at least partially exposed to the exterior of the accessory 400. For example, in 18A to 18C In, especially Fig.18B In the embodiment of the present invention, at least a portion of the belt channel 950 is exposed to the outside of the accessory 400.
[0578] In some configurations, for example, Fig. 17C In some embodiments, the belt channel 950 can be separate from the sensor cavity 500. In some configurations, the belt channel 950 can be part of the sensor cavity 500. For example, as shown in Fig.18B and Section Fig.18C As shown, the belt channel 950 is at least partially located in the sensor cavity 500.
[0579] In some configurations, the strap 200 can be adhered or otherwise connected to at least one surface of the strap channel 950. For example, the strap 200 can be connected to at least one surface of the strap channel 950 via an adhesive; or by further example, the strap 200 can be overmolded within the strap channel 950. In some configurations, the strap 200 can be physically retained 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 channel 950.
[0580] It will be appreciated that the following disclosure regarding sensor cavity 500 may be applied to accessory 400 and component 2000 (as described in more detail below), where appropriate.
[0581] like Fig. 10A , Fig.11A , Fig. 12A , Fig.13A and Fig. 16B As shown, the sensor cavity 500 is formed on the first surface 410 of the nasal cannula interface accessory 400, as shown in FIG. Fig. 10A , Fig.11A , Fig. 12A , Fig.13A and Fig. 16B shown.
[0582] The sensor cavity 500 may be formed within the body 401 of the accessory 400 .
[0583] like Fig. 17B , Fig.18B and Fig.18C As shown, the sensor cavity 500 is formed on the first surface 410 of the accessory 400. Fig. 17B , Fig.18B and Fig.18C shown.
[0584] The sensor cavity 500 may be formed within the body 401 of the accessory 400. Fig. 17C As shown, the sensor cavity 500 can be a substantially enclosed interior space of the body 401 of the accessory 400. In other configurations, the sensor cavity can extend at least partially outside of the accessory.
[0585] 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 vertices. Rounded edges and vertices can help position the sensor in the sensor cavity 500 and prevent damage to the sensor. Fig. 10A , Fig.11A and Fig. 16B In the example shown, the sensor cavity 500 may be rectangular with substantially rounded edges and vertices.
[0586] The sensor cavity 500 can be friction fit with the patient sensor 29 (eg, the housing of the sensor). In some configurations, an adhesive can be used to hold the patient sensor 29 in the sensor cavity 500.
[0587] As described in more detail above, the patient sensor 29 may be a patient sensor configured to measure a patient parameter. The patient parameter may be a physiological parameter. For example, the patient parameter may be a measure and indication of the patient's blood oxygenation.
[0588] The sensor cavity 500 may be arranged to orient the patient sensor 29 to contact the patient. Fig. 10A , Fig.11A , Fig. 12A , Fig.13A , Fig. 16B , Fig. 17B , Fig.18B and Fig.18C As shown, the sensor cavity 500 includes an opening on the first side 410 of the accessory 400, which is configured to face the patient during use. For example, when the patient sensor 29 is a pulse oximeter sensor, the patient sensor 29 may include a transducer (not shown), and the sensor cavity 500 may be arranged to orient the sensor so that the transducer of the patient sensor 29 faces the patient (such that the transducer contacts the skin or a position adjacent to the skin). In some configurations, the transducer of the patient sensor may include an optical transducer. The optical transducer may be an infrared transducer and / or a red light transducer. The optical transducer may be a photodiode or a phototransistor.
[0589] In some configurations, the patient sensor includes 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 light source and / or a red light source. The light source may be an LED. In some configurations, the light source may include a plurality of light sources, each emitting light of a different wavelength. For example, the light source may include at least one red LED and at least one infrared LED. Each light source may have a corresponding transducer.
[0590] The guidewire cavity 700 may be formed on the same surface as the sensor cavity 500 of the accessory 400 or on a different surface. The sensor cavity 500 may be formed on the first surface 410 of the accessory 400, and the guidewire cavity 700 may be located on the second surface (e.g., adjacent to the first surface) 420 of the accessory 400. By way of further example, Fig. 12A , Fig.13A and Fig. 16B As shown, the sensor cavity 500 and the wire cavity 700 can be formed on the first surface 410 of the accessory; or, as shown in FIG. Fig. 17B , Fig.18B and Fig.18C As shown, both the sensor cavity 500 and the wire cavity 700 may be formed on the first side 410 of the accessory.
[0591] like Fig. 12A , Fig.13A , Fig. 16B , Fig. 17B , Fig.18B and Fig.18C As shown, the guide wire cavity 700 can be formed adjacent to the sensor cavity 500.
[0592] The guide wire cavity 700 may extend from the outside to the sensor cavity 500. The guide wire cavity 700 may extend from the face of the attachment 400 to the sensor cavity 500.
[0593] The guidewire lumen 700 may include an opening on a side of the accessory 400 that is configured to face the patient during use. Fig.18A and Fig.18B As shown, the guidewire cavity 700 may include an opening on the first side 410 of the accessory 400 so as to face the patient during use - this may facilitate assembly of the patient sensor 29 and the sensor cavity 500 by allowing the guidewire to be easily inserted into the guidewire cavity 700. By way of further example, Fig. 10A , Fig.11A , Fig. 12A , Fig.13A and Fig. 16B As shown, the guidewire lumen 700 may include an opening 651 on the first side 410 of the attachment 400 so as to face the patient.
[0594] In some configurations, the guidewire lumen 700 may include multiple openings on different (optionally adjacent) sides of the appendage, such as Fig. 16B As shown, where the guidewire lumen 700 has an opening on the side surface and an opening on the patient surface. This allows the guidewire to enter a different face of the accessory than the face that contacts the patient during use.
[0595] The guidewire lumen 700 may extend through a single face of the accessory to the sensor lumen 500 .
[0596] The guidewire cavity 700 may include a slot. Further, the guidewire cavity may be one or more of the following: square, rectangular, and / or circular. For example, Fig. 12A , Fig.13A , Fig. 16B , Fig.17A , Fig.18B and Fig.18C As shown, the guidewire lumen is substantially rectangular.
[0597] The guidewire cavity 700 can be, for example, a groove and / or cutout of the accessory (eg, the body of the accessory). In some configurations, the guidewire cavity can extend from the side or back of the accessory 400.
[0598] In some configurations, the wire lumen 700 may include one or more retention features. Once installed, the retention features may help retain the wire in the wire lumen 700. The retention feature may include at least one protrusion extending from the perimeter of the wire lumen 700. The at least one protrusion may extend from alternating sides of the wire lumen (so as not to overlap).
[0599] The wire 710 to which the wire lumen 700 is configured to provide a passageway may include a cable, cord, lead, cable bundle, or any other insulated assembly of conductive material. In some configurations, a single wire 710 may be housed in the wire lumen 700. In other configurations, more than one wire 710 of the same type or different types may be housed in the wire lumen 700.
[0600] In some configurations, the wire lumen 700 can be an opening that allows passage to the sensor lumen 500 for one or more wires 710 , for example.
[0601] The accessory 400 may be attached to the nasal cannula interface 1000 via at least one securing feature 610, 650. The at least one securing feature 610, 650 may be configured to retain the accessory 400 to the strap 200 of the nasal cannula interface 1000.
[0602] At least one securing feature 610, 650 can be configured to extend from a side (eg, face) of the accessory 400 opposite the sensor cavity 500. Fig. 10B , Fig. 11B , Fig. 12B , Fig. 13B and FIG. 16A to FIG. 16E As shown, at least one securing feature 610 , 650 may be configured to extend from a second face 420 of the accessory 400 , the second face 420 being disposed on a side opposite to the first face 410 .
[0603] The securing features 610, 650 can hold the accessory 400 while allowing the 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 features 610, 650 can be configured to both substantially prevent the accessory 400 from moving along the strap 200 and allow relative movement of the strap 200 and the accessory 400. The securing features 610, 650 can be configured to allow relative movement of the strap 200 and the accessory 400 (e.g., by allowing the accessory 400 to move relative to the strap 200) when a threshold force is applied. By configuring the accessory 400 to be movable along the length of the strap 200, the clinician is able to position the patient sensor 29 at a desired location. The type and degree of threshold force required can depend on the type of securing features 610, 650 and the material of the strap 200. It should be understood that the fixing features 610, 650 can include one or more features, such as: a fastener (i.e., hook and loop - including multiple hooks and multiple loops, the hooks and loops can be configured to engage with each other; the hooks and / or loops can be set on a base), a magnet, one or more hooks, and / or a geometric feature.
[0604] The securing feature 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).
[0605] Reference now FIG. 16A to FIG. 16E , at least one securing feature 610, 650 can include at least one arm 611. The at least one arm 611 can be configured to extend around at least a portion of the band 200 of the nasal cannula interface 1000.
[0606] At least one wall 611 may have a first portion 611a and a second portion 611b. The first portion 611a may extend from the accessory 400: Optionally, the first portion 611a may extend in a vertical direction from the second face 420 of the accessory 400. The second portion 611b may be configured to be oriented substantially perpendicular to the first portion 611a and / or parallel to the accessory 400 and / or parallel to the second face 420 of the accessory 400.
[0607] At least one securing feature 610, 650 may include a pair of arms 611, such as FIG. 16A to FIG. 16D The pair of arms 611 can be configured to releasably connect the accessory 400 to the nasal cannula interface 1000 and / or optionally to the strap 200 of the nasal cannula interface 1000 .
[0608] like FIG. 16A to FIG. 16EAs shown, the pair of arms 611 can extend from the accessory 400, and each arm 611 can extend toward the other arm and / or toward the center of the accessory 400. The arms 611 can be arranged along the axis of the accessory; the axis can, for example, be configured to be parallel to the axis of the belt 200 when the accessory 400 is connected to the belt 200.
[0609] Each arm 611 of the pair of arms 611 may include a first portion 611a and a second portion 611b. The first portion 611a of each arm 611 may extend from the accessory 400: Optionally, the first portion 611b may extend in a direction perpendicular to the second face 420 of the accessory 400. The second portion 611b of each arm may be configured to be oriented toward each other and / or the second portion 611b may be configured to be oriented toward the center of the accessory. Optionally, the second portion 611b of each arm 611 may be substantially perpendicular to the associated first portion 611a and / or parallel to the accessory 400 and / or oriented parallel to the second face 420 of the accessory 400. In some configurations, the first portion 611a may extend vertically upward from the accessory 400, and the second portion 611b may extend inwardly toward the center of the accessory 400. In some configurations, the first portion 611a may extend vertically upward from the accessory 400, and the second portion 611b may extend toward the second portion 611b of the other arm 611. The first portion 611a and the second portion 611b of each arm 611 may form an angle of less than 90 degrees, or about 90 degrees, or less than about 120 degrees.
[0610] Each arm 611 can form a "U" shape with the second side 420 of the attachment. The U-shape formed by one arm can face the U-shape formed by the other arm to hold the strap of the nasal cannula interface.
[0611] At least one arm 611 can be configured to receive the strap 200 of the nasal cannula interface 1000. For example, in a configuration where the securing features 610, 650 include a pair of arms 611, a gap 630 can be defined between the pair of arms 611. The strap 200 of the nasal cannula interface 1000 can be configured to be insertable into the gap 630 to connect to the accessory 400. The pair of arms 611 of the securing features 610, 650 can be configured to receive the strap 200 of the nasal cannula interface 1000 to connect to the nasal cannula interface 1000. The width of the strap 200 of the nasal cannula interface 1000 can be greater than the gap 630. The strap 200 can be inserted into and / or removed from the gap 630 / accessory 400 only when aligned with the edge of the strap 200 or when the strap 200 is folded along the width of the strap 200.
[0612] At least one arm 611 may include a plurality of structures.
[0613] Reference now FIG. 10A to FIG. 15F , at least one securing feature 610 , 650 may include a clamp 650 .
[0614] The clip 650 can be connected to the accessory 400 ; the clip can be configured to secure the accessory 400 to the nasal cannula interface 1000 , for example, the clip can secure the accessory 400 to the strap 200 of the nasal cannula interface 1000 .
[0615] The clamp 650 may extend from the accessory 400. In some configurations, the clamp 650 may extend from the second side 420 of the accessory 400, such as FIG. 10A to FIG. 15F shown.
[0616] The clamp 650 may include a clamp arm 660. The clamp arm 660 may be connected to the attachment 400 by a biasing element 670. The biasing element 670 may include a hinge or a spring or a geometric feature. The biasing element 670 may bias the clamp arm 660 to a closed position or an open position. FIG. 10A to FIG. 15F An exemplary configuration of a clamp arm 660 including a hinge 670 in an open position is shown.
[0617] like FIG. 10A to FIG. 15B As shown, hinge 670 is a living hinge.
[0618] The clamp 650 can be configured to hold the strap 200 of the nasal cannula interface 1000 to the accessory 400 when the clamp is in the closed position. Fig.13D and Fig.15D As shown), the clamp can hold the belt 200 to the accessory 400 between the clamp 650 and the nasal cannula interface 1000. When the clamp 650 is closed and holds the belt 200 of the nasal cannula interface 1000, the accessory 400 can be prevented from sliding relative to the belt 200.
[0619] like Fig. 10B , Fig. 11B , Fig. 12B , Fig. 13B , Fig. 14B and Fig. 15B As shown, the clamp 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 clamp 650 is in the closed position.
[0620] like Fig. 10B , Fig. 11B , Fig. 12B , Fig. 13B , Fig. 14B and Fig. 15B As shown, the contact surface 680 can be located within a recess 690 of the clamp arm 660. The recess 690 can be shaped to receive the strap 200 of the nasal cannula interface 1000.
[0621] The contact surface 680 may include at least one protrusion. The at least one protrusion may be configured to be in a closed position when the clamp 650 is in a closed position (e.g., Fig. 13C , Fig.13D , Fig. 15C and Fig.15D ) helps retain the belt 200.
[0622] At least one protrusion may include at least one rib 682. When the belt 200 is engaged with the contact surface 680, the at least one rib 682 may be positioned perpendicular to the width of the belt 200, and / or perpendicular to the longitudinal axis of the contact surface 680. In some configurations, such as Fig. 10B , Fig. 11B , Fig. 12B and Fig. 13B As shown, at least one rib 682 includes a pair of ribs 682. The pair of ribs 682 can be located at opposite ends of the contact surface. When the belt 200 is engaged with the contact surface 680, the pair of ribs 682 can be spaced apart along the length of the belt 200 and / or the longitudinal axis of the contact surface 680.
[0623] The at least one protrusion may include one or more bumps 683. The one or more bumps 683 may, for example, include a bump 683 located at each corner of the contact surface, such as Fig. 14B As shown. For example, Fig. 15B As shown, one or more bumps 683 can be patterned on the entire contact surface 680 or on at least a portion of the contact surface 680. As another example, one or more bumps 683 can be patterned in offset rows, such as Fig. 15B As shown, alternatively the bumps can be patterned in aligned rows.
[0624] The contact surface 680 may have a non-smooth and / or significantly rough surface.
[0625] The surface that contacts the strap of the accessory 400 (e.g., the rear of the accessory 400) may include at least one protrusion. The at least one protrusion may be configured to be in a closed position (e.g., as shown in FIG. Fig. 13C , Fig.13D , Fig. 15C and Fig.15D 680) helps retain the belt 200. The protrusion can be a protrusion as described above and can be configured to complement at least one protrusion of the contact surface 680.
[0626] Reference now Fig.15A and Fig. 15B, the clamp arm 660 may include an opening 695 that may extend through the clamp arm 650 and, optionally, may extend through the contact surface 680. The opening 695 may be configured to receive a portion of another of the at least one fixing system: optionally, the other of the at least one fixing system may be at least one arm 610, e.g. Fig.15A and Fig. 15B shown.
[0627] The attachment 400 may include a pair of arms 610 located on either side of a clamp 650, such as FIG. 10A to FIG. 14B As shown (as described in more detail above), the second portions 630 of the arms are oriented in the same direction (and are optionally parallel).
[0628] This is similar to FIG. 16A to FIG. 16B In contrast, the arms 610 have second portions 630 extending toward each other.
[0629] The clamp arm 660 may include at least one retaining feature 640. The retaining feature 640 may be configured to engage with a mating portion 645 of the accessory 400 that is configured to retain the clamp 650 in a closed position. Fig. 10B , Fig. 11B , Fig. 12B , Fig. 13B , Fig. 14B and Fig. 15B As shown, the retention feature 640 includes a protrusion, and the mating portion 645 includes a corresponding recess. By way of further example, the retention feature 640 may include a recess, and the mating portion 645 may include a corresponding feature, such as a protrusion.
[0630] The accessory 400 can be attached to the nasal cannula interface 1000 at multiple interface attachment locations and / or multiple patient facial locations. The multiple patient facial locations can correspond to the multiple attachment locations.
[0631] The multiple attachment locations on the nasal cannula interface 1000 may be defined by at least the connection points between the strap 200 and the body 110 of the nasal cannula interface 1000 .
[0632] The patient's facial position can be a position where the attachment 400 is located near the patient's face. For example, the patient's facial position can be a position close to the patient's cheek, or, for further example, a position close to the space between the patient's eyes and lips.
[0633] The accessory 400 can be configured to be adjustable between multiple attachment positions. In some configurations, the accessory 400 can be adjusted between attachment positions without being removed from the nasal cannula interface 1000 or, optionally, without being removed from the band 200. For example, the accessory 400 can be configured to be slidably adjustable between multiple attachment positions.
[0634] In some configurations, the accessory 400 can be adjustable between attachment positions by disconnecting the clamp and the user moving the accessory to a new position and then reengaging the clamp (e.g., by moving the clamp to a closed position).
[0635] The accessory 400 can be configured to be adjustable between multiple patient facial positions. In some configurations, the accessory 400 can be adjustable between patient facial positions without being removed from the nasal cannula interface 1000. For example, the accessory 400 can be configured so that the accessory can be slidably adjusted between multiple patient facial positions (e.g., between Fig.15E and Fig.15F in the direction along the belt as indicated by the arrow in the figure).
[0636] The attachment may be located, for example, near the patient's cheek. By way of further example, the attachment may be located near the space between the patient's eyes and lips.
[0637] The attachment 400 may be attached to the nasal cannula interface 1000 at multiple locations along the strap 200 and 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 devices (e.g., a nasogastric tube). For example, the attachment 400 may be moved to the other side of the nasal cannula.
[0638] The attachment 400 may be attached to the nasal cannula interface 1000 at multiple locations along the strap 200 and may also allow the patient sensor 29 to be retrofitted to the nasal cannula interface 1000. This allows the patient sensor 29 to be added to the nasal cannula interface 1000 on an as-needed basis.
[0639] In some configurations, the accessory 400 can include an extension portion that extends away from the body of the accessory 400. The extension portion can include a sensor cavity 500 and a guidewire cavity 700 to allow the patient sensor 29 to be located in a specific location—for example, in the patient's earlobe.
[0640] like FIG. 16A to FIG. 16C As shown, the face of the accessory 400 configured to face the patient in use is substantially circular. The face of the accessory 400 configured to face the patient in use may be other shapes, such as oval or rectangular.
[0641] like Fig.16EAs shown, the face of the accessory 400 that is configured to face the patient during use may include at least one surface material 277. At least one surface material 277 may cover the face of the accessory 400 that is configured to face the patient.
[0642] As described above, the surface material 277 can be located on or be the face contacting surface.
[0643] At least one surface material 277 can be in some configurations (e.g., Fig.16E ) does not cover the patient sensor 29, while in some configurations, the surface material may cover the patient sensor 29. At least one surface material may be provided with an opening such that at least one surface material does not extend across the sensor cavity of the accessory.
[0644] At least one surface material may be the same material as the accessory 400, or the surface material may be a different material from the accessory 400. For example, at least one surface material may be a fabric material and / or silicone and / or thermoplastic elastomer, and the accessory 400 may be plastic.
[0645] The at least one surface material and the accessory 400 may be, for example, separate from the accessory 400 or integrated with the accessory 400 .
[0646] At least one of the surface materials may be a membrane or film.
[0647] At least one surface material can be configured to increase friction between the accessory 400 and the patient's face. At least one surface material can have sticky or anti-slip material properties. Further, the surface material can be configured to provide friction to prevent movement between the accessory 400 and the belt 200.
[0648] As described above, a component may be provided to replace a patient interface, or as a component of a patient interface (eg, nasal cannula 100).
[0649] The component can replace existing components of the nasal cannula interface 1000. The component can be provided as an add-on component that a user can optionally add to a patient interface (e.g., as a replacement component), or as a component that is part of a pre-assembled patient interface.
[0650] In some configurations, this component can be connected as an intermediate component between other components of the nasal cannula interface 1000. For example, this component can be connected between the side arm 270 and the body 110.
[0651] The component can be connected to the belt. The component can be connected to the belt 210 at any point, but in some configurations, it is connected to the belt at a second end. The second end can be opposite to the first end.
[0652] The component may include a connection feature.
[0653] The connection feature may be configured to connect to the nasal cannula interface 1000 .
[0654] This component may be a side arm as described above.
[0655] The connection feature can be configured to connect directly to the body of the nasal cannula interface 1000 (as a body connection feature). In these embodiments, the body connection feature can be or include as described above with respect to FIG. 7D to FIG. 7H Features of the cannula connector 240 .
[0656] The component can be integrally formed with the connection feature and / or the strap (e.g., by overmolding). In some configurations, the strap 210 can be connected to the connection feature (e.g., as described above with respect to FIG. 7D to FIG. 7H ), and then overmolding the part.
[0657] The connecting feature may alternatively or additionally be a fastener (eg, hook and loop—comprising a first substrate having a plurality of hooks and a second substrate comprising a plurality of loops), a magnet, or a geometric feature.
[0658] The component may include any of the features of the accessory described above.
[0659] In some configurations, this component can be FIG. 17A to FIG. 18C accessories, but are permanently attached to the belt and / or cannula connector.
[0660] As previously described, as part of providing respiratory support to a patient, one or more physiological parameters of the patient may be measured by a patient sensor. Some patient sensors may need to be placed on or near the patient's body in order to measure the desired physiological parameters. Accordingly, as previously described, a patient respiratory interface may be combined with a patient sensor.
[0661] In the various configurations that have been 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 body of the patient interface itself. The accessory is configured so that one or more patient sensors can be mounted to the accessory. For example, the accessory can be configured so that one or more patient sensors can be held by the accessory. The accessory can include one or more sensor cavities to hold one or more patient sensors.
[0662] As previously mentioned, in some forms, an accessory may be provided as a component of or as part of a component of a patient respiratory interface. In particular, an accessory referred to as a component of a patient interface may replace a conventional component of a patient interface. When replacing a conventional component, the accessory as a component may provide the functionality of the conventional component and in addition provide the sensor holding functionality of the accessory.
[0663] An accessory as a component may be a patient interface or a part of a patient interface, such as Figure 3 The patient interface 17 shown in FIG. For example, the accessory as a component can be a headgear of a patient interface or a part of a headgear for a patient interface, for example, as 7A to 7H As another example, the accessory as a component may be a side arm of a patient interface or a portion of a side arm of a patient interface, such as Figure 4 The side arm 31 shown in Figure 7C , Fig. 8A and Figure 8B One or more of the side arms 270 shown in FIG. 17A to FIG. 17C or 18A to 18C Attachment 400.
[0664] For example, as already described with respect to accessory 400 that can replace a side arm of a patient interface, such a component can replace another portion of a patient interface.
[0665] In some configurations, the component to which the sensor can be mounted can be an intermediate component between the headgear and the rest of the patient interface to which it is attached. More specifically, the accessory that is a component of the patient interface can be provided as part of the headgear interface connector, or can include connector features for connecting the headgear and another portion of the patient interface together.
[0666] In the case where the accessory is replaceable for a conventional component of the patient interface, the accessory component may be interconnected with at least one other portion of the patient interface. Through the interconnection, the accessory component and the at least one other component may be interconnected. When interconnected, the components may not be able to move freely relative to each other. In contrast, in other configurations where the accessory is not interconnected with another component of the patient interface, relative movement of the accessory and / or the portion of the patient interface to which it is attached may be possible. For example, FIG. 10A to FIG. 10C The accessory 400 may be configured to slide along a strap to which it is attached during use. As another example, FIG. 16A to FIG. 16E The accessory 400 can be configured such that the accessory can slide along the belt to be received within the securing feature 610.
[0667] The accessory component may replace, for example, a side arm, a buckle, a tube clamp, or any other conventional component of a patient interface. Where an accessory component (hereinafter simply referred to as a component) is substituted into a patient interface, the component may be connected to other components of the patient interface. For example, where the component may replace a side arm, the component may be connected to both the body of the patient interface and another portion of the patient interface, such as a headgear strap or headgear connector. The component may be interconnected to one or each other portion of the patient interface to which it is connected.
[0668] By way of example, various arrangements of components for a patient interface configured to hold patient sensors will now be described.
[0669] like Fig.19A As shown, 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 a headgear 200 having a first band 211 and a second band 212.
[0670] 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 via a connector 3200. The connector 3200 allows both the side arm 270 and the second strap 212 to be connected to the connector.
[0671] exist Fig.19A The other side of the nasal cannula interface 1000 is provided with a component 2000. The component 2000 is connected to the other side arm 270 of the headgear and the first belt 211. The component 2000 also has a component body that can hold the patient sensor 29.
[0672] Despite Fig.19A Component 2000 is shown as being provided on only one side of the connection between the side arm 270 of the patient interface and the headgear 200, but in other configurations, component 2000 may be provided on both sides of the patient interface.
[0673] In the case where both sides of the patient interface are provided with components 2000, the patient or clinician can be provided with options as to where the patient sensor is located. For example, the location of the patient sensor can be changed between components 2000 on both sides of their face. This can improve patient comfort. This can also allow for the use of multiple identical or different patient sensors at the same time.
[0674] Although in Fig.19A 2000 is shown as being connected between the side arm 270 and the first band 211 of the headgear, but the component 2000 can be connected between any other two desired components of the patient interface. For example, the component 2000 can be disposed between two portions of the headgear, or as previously described can be provided in the form of a side arm 270 to connect between the body of the patient interface and a portion of the headgear of the patient interface.
[0675] Component 2000 may include one or more of the same connector features as a connector that is not configured to hold patient sensor 29. For example, Fig.19A Configuration of component 2000 may include one or both of the connector features of connector 3200 .
[0676] Fig.19B Shows Fig.19A A perspective view of the portion of the patient interface 1000 marked A in FIG.
[0677] exist Fig.19B , component 2000 is shown connected to the side arm 270 at one end and to the first band 211 of the headgear at the other end. Component 2000 has a first connector 2010 connected to the side arm 270 and a second connector 2020 connected to the first band 211 of the headgear.
[0678] like Fig.19B As shown, the first connector 2010 is located at the first end 2001 of the component 2000, and the second connector 2020 is located at the second end 2002 of the component.
[0679] Fig.19C Shows Fig.19A The details marked A in Fig.19B The opposite side of component 2000 is shown.
[0680] Component 2000 includes component body 2005. Fig.19C As seen in FIG. 5 , the component body has a sensor cavity 500 within which the patient sensor 29 is retained.
[0681] The component body 2005 may be located between the first end 2001 and the second end 2002 of the component. Fig.19B and Fig.19C As shown, the component body 2005 can be disposed between the first connector 2010 and the second connector 2020 of the component, so that the first connector 2010 and the second connector 2020 are respectively located on corresponding sides of the component body 2005 .
[0682] One or both of the first connector 2010 and the second connector 2020 may be configured to releasably connect the component with a corresponding other portion of the patient interface.
[0683] For example, especially in Fig.19BAs can be seen, the second connector 2020 includes a buckle 2021 through which the end of the first strap 211 of the headgear can be passed. The length of the strap can be adjusted by sliding it through the buckle 2021. The first strap 211 can be removed from the buckle 2021 to disconnect the second end 2002 and the first strap 211 from each other.
[0684] Likewise, Fig.19B and Fig.19C As seen in the drawings, 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. The portions of the first connector 2010 can move relative to each other to release engagement with the side arm 270 and allow the side arm 270 and the first connector 2010 to be disconnected from each other.
[0685] like FIG. 19A to FIG. 19C As shown, the opening of the sensor cavity 500 is disposed at the inner surface of the nasal cannula interface 1000, which is adjacent to the patient's face in use. With this configuration, a portion of the patient sensor 29 can be directly exposed to the patient's body.
[0686] Since the opening of the sensor cavity 500 is disposed toward the patient's face during use, the patient's face may be used to further retain the patient sensor 29 within the sensor cavity 500 .
[0687] Fig. 20 is a view of component 2000 without patient sensor 29 being retained, and Fig.21 is a view of component 2000 while retaining patient sensor 29.
[0688] like Fig. 20 As shown, the component body 2005 is located between the first connecting member 2010 and the second connecting member 2020. The component body 2005 has a sensor cavity 500. Fig. 20 In the configuration of , the sensor cavity 500 is formed in the first face 2007 of the component body 2005 .
[0689] The sensor cavity 500 is defined by one or more walls 2006 of the component body 2005 .
[0690] The component body includes a wire lumen 700. The wire lumen 700 may extend between the sensor cavity 500 and the outside of the component body 2005 to provide a passage to the sensor cavity 500 for one or more wires.
[0691] As previously discussed, the conductors for which the conductor lumen 700 is configured to provide passageways may include cables, cords, leads, cable harnesses, or any other insulated assembly of conductive materials.
[0692] like Fig. 20As can be seen in FIG. 2 , the wire cavity 700 is disposed at the first face 2007 of the component body 2005. The wire cavity 700 has an opening at the first face 2007 of the component body 2005. The wire cavity 700 is open between the sensor cavity 500 and an outer surface of the component body 2005 adjacent to the first face 2007.
[0693] The wire cavity 700 may take the form of a slot that is recessed from the surface of the component body and provides a passage between the sensor cavity 500 and the outside of the component body.
[0694] The guidewire lumen 700 can have a variety of cross-sectional configurations. For example, the guidewire lumen 700 can have a substantially square, rectangular, or circular cross-section. The guidewire lumen 700 can have more than one cross-sectional configuration along its length. The guidewire lumen 700 can have any of the foregoing cross-sectional configurations at any one or more locations along its length.
[0695] like Fig. 20 As seen in FIG. 1 , the buckle 2021 of the second connecting member 2020 includes two openings 2022 through which the ends of the headgear strap can be pressed to connect the strap to the second connecting member 2020.
[0696] Fig.21 2005. The shape of the sensor cavity 500 can be defined to be complementary to the shape of the patient sensor 29. For example, Fig. 20 and Fig.21 As seen in , the perimeter of the sensor cavity 500 surrounding the wall 2006 of the component body corresponds to the outer shape of the patient sensor 29.
[0697] like Fig.21 As seen in FIG. 2000 , sensor cavity 500 has a substantially rectangular shape with rounded edges. Sensor cavity 500 may have a variety of other shapes, such as a square or circular shape. The configuration of the sensor cavity, or at least at least one dimension of the sensor cavity, may correspond to the size of an intended patient sensor for use with component 2000.
[0698] The sensor cavity 500 may provide an interference fit with the patient sensor to help retain the patient sensor 29 at or within the sensor cavity 500. This interference fit may be in the form of a friction fit. Additionally or alternatively, the interference fit may include a snap fit arrangement between the sensor and the sensor cavity.
[0699] An adhesive may be disposed between the patient sensor and a portion of the sensor cavity to retain the patient sensor within the sensor cavity.
[0700] Where the opening of the sensor cavity is adjacent to the patient's face during use, the patient's face may also help retain the sensor within the sensor cavity.
[0701] The guidewire lumen 700 may also correspond in shape to the portion of the guidewire 710 that the guidewire lumen is to receive. Fig.21 As seen in FIG. 7 , patient sensor 29 includes an extension portion 710a surrounding a proximal portion of lead 710. The dimensions of lead lumen 700 are configured to correspond to the dimensions of extension portion 710a.
[0702] The sensor cavity 500 of component 2000 can be such that when a patient sensor is disposed in the sensor cavity, a portion of the patient sensor can be exposed to the outside of the component. For example, the patient sensor can include a transducer and / or a light source. Component body 2005 and the sensor cavity 500 therein can be arranged such that when component 2000 is used by a patient as part of a patient interface, one or both of the transducer and the light source face the patient. More particularly, component body 2005 and the sensor cavity can be arranged such that the transducer and / or the light source are exposed to the outside of component 2000.
[0703] In some configurations, the first face 2007 of the component body 2005 in which the sensor cavity 500 is formed can be the face of the component body that is oriented toward the patient when the component 2000 is used as part of the patient interface 1000 .
[0704] In such a configuration, the body of the patient sensor 29 will be arranged adjacent to the patient in use. Accordingly, where the patient sensor 29 includes a transducer and / or a light source, these may be arranged so that they face the patient.
[0705] With the opening of the sensor cavity oriented towards the patient in use, the patient sensor may be retained in the sensor cavity 500 by or in addition to the presence of the patient's face.
[0706] In other configurations, the first face 2007 of the component body 2005 in which the sensor cavity 500 is formed may be the face of the component body that is not oriented toward the patient when the component is used as part of the patient interface 1000. In some configurations, the first face 2007 and the opening of the sensor cavity 500 may be oriented away from the patient in use.
[0707] In such a configuration, the component body 2005 may include one or more holes through the component body 2005 at the wall 2006 of the body to allow the transducer and / or light source of the patient sensor 29 to face the patient during use.
[0708] The sensor cavity 500 may be arranged to hold a portion of the patient sensor 29 in contact with the patient when the component 2000 is used as part of a patient interface.
[0709] The opening of the guidewire lumen 700 may be oriented to face the patient in use. More particularly, the opening of the guidewire lumen 700 in a direction transverse to the length of the guidewire lumen 700 between the sensor cavity 500 and the outside of the component body 2005 may face the patient in use.
[0710] Fig.19A and Fig.19B The patient-facing face of the component body 2005 of the component 2000 shown in FIG. 2 is substantially rectangular. In other configurations, the patient-facing face of the component body 2005 can have a substantially circular shape.
[0711] The component 2000, or at least the component body 2005 and any parts integrally formed therewith, may be formed of a biocompatible material. For example, they may be formed of a biocompatible plastic material, such as a thermoplastic elastomer (TPE) or silicone, or liquid silicone rubber (LSR).
[0712] As previously mentioned with respect to Annex 400, in particular with reference to Fig.16E As described, the face of component 2000 or in particular component body 2005 configured to face the patient in use may comprise at least one surface material, such as previously described surface material 227. The surface material may be provided across a portion or the entirety of the face of component 2000 facing the patient.
[0713] The surface material may be the same material from which component 2000, or in particular component body 2005, is made. In other configurations, the surface material may be a different material.
[0714] The surface material of component 2000 may function to provide a desired coefficient of friction between component 2000 and the patient's face.
[0715] The surface material of component 2000 can be used to retain the sensor in the sensor cavity. For example, once the sensor has been placed in the sensor cavity, the surface material can be placed across part or all of the opening of the sensor cavity.
[0716] The patient sensor 29 may be disposed within the sensor cavity 500 as part of the component 2000. In other configurations, an appropriate patient sensor 29 may be fitted to the component 2000 by a user.
[0717] The component 2000 may be provided as a separate element for use with a patient interface. Alternatively, the component 2000 may be provided as part of a patient interface.
[0718] Fig. 22The exploded view of FIG. 20 shows various components of the configuration of component 2000 including the first connector 2010 and the second connector 2020. Fig. 22 As seen in FIG. 2 , the second connecting member has a buckle 2021 to which the strap of the headgear can be attached.
[0719] The first connector 2010 includes a first connector body 2013. Fig. 22 In the configuration of FIG. 20 , the first connector body 2013 is integrally formed with the component body 2005. The component body 2005 is also integrally formed with the second connector 2020.
[0720] exist Fig. 22 In the exploded view of FIG. 20 , the first connector 2010 also includes a second body having a pair of claws 3205 and a biasing device 3207. The first connector 2010 also includes a sliding member 3209 having a first sliding portion 3209a and a second sliding portion 3209b. The portions of the first connector 2010 can cooperate to allow another portion of the patient interface (such as the end of the side arm 270) to be received and retained by the first connector and then selectively released.
[0721] Component 2000 may have Figures 23 to 32 Connector features of connector 3200 are shown. Further details of the configuration of first connector 2010 of component 2000 are provided below through the description of connector 3200.
[0722] about Figures 23 to 32 Depicted is a first connector portion 3201 that may be secured to connector 3200 by means of claws 3205 and / or protrusions 3215. Figures 23 to 32 Described as a first connector portion 3201 or clamp 3301, but elsewhere in this document reference will be made to a first connector. A first connector may generally be understood to refer to a portion of a patient interface in which a first connection with another portion of the patient interface (e.g., a body of the patient interface) may be made. For example, Fig.19A and Fig.19B , the component 2000 has a first connector 2010 connected to the body of the patient interface 1000. More specifically, the first connector 2010 is connected to the side arm 270 of the patient interface 1000.
[0723] about Figures 23 to 32 Depicted is a second connector portion 3203 as part of connector 3200. Such a portion is described elsewhere herein as a second connector. A second connector may generally be understood to relate to a portion of a component of a patient interface in which a second connection may be made to another portion of the patient interface (e.g., to a headgear or a portion of a headgear). For example, in Fig.19Aand Fig.19B In the embodiment, component 2000 has a second connector 2020 that is connected to the headgear 200 of the patient interface.
[0724] refer to Figures 23 to 32 , a first preferred embodiment of a connector 3200 will now be described. The connector 3200 has a first connector portion in the form of a clamp 3201, a second connector portion in the form of a carrier 3203, a claw 3205 for fixing the clamp and the carrier together, a biasing device 3207, and a slide 3209. The slide 3209 is movable between a fixed position and a free position relative to the clamp 3201 and / or the carrier 3203. In the fixed position, the claw 3205 is substantially inhibited from moving and cannot release the clamp 3201 from the carrier 3203. In the free position, the claw 3205 can move so as to release the clamp 3201 from the carrier 3203. The biasing device 3207 pushes the slide toward the fixed position.
[0725] In the preferred embodiment shown, the biasing device 3207 and the claw 3205 are integrally formed together. The biasing device 3207 includes a pair of resilient legs 3208, and the claw includes a pair of resilient arms 3211. These arms and legs are obviously resistant to deformation or are resiliently flexible. The arms 3211 are flexible to allow insertion of the clamp 3201 when the slide 3209 is in a fixed position, as described below. These arms and legs extend from the body portion 3210.
[0726] As described in more detail below, the resilient legs 3208 push the slide toward a fixed position. The legs extend from the body portion 3210 in the same direction and are the same length as each other. The side 3208a of each leg is slightly tapered so 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 side surface, top surface 3208d, and bottom surface 3208e of each leg are generally planar surfaces.
[0727] The resilient arms 3211 are spaced apart and extend from the body portion 3210 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 toward each other. As described in more detail below, when the clamp 3201 is inserted into the carrier 3203, the pair of resilient arms 3211 are biased toward engagement with the notches of the clamp.
[0728] Each arm has a straight portion closest to the body portion 3210, extending into the arc portion 3212. The arc portion 3212 allows the arm 3211 to bend when the clamp 3201 is inserted into the carrier 3203, wherein the slide 3209 is in a fixed position. When viewed from the position of the slide, the arc portion 3212 is concave. The arc portion 3212 has a width narrower than the straight portion. The side surface, top surface and bottom surface of each arm are generally planar surfaces. These top and bottom surfaces act as bearing surfaces between the slide 3209 and the subassembly of the carrier having the biasing device 3207 / claw 3205.
[0729] Each resilient arm 3211 includes a protrusion 3215 for engaging with a complementary recess of the clamp 3201. The protrusion 3215 is located at the free end of each arm. Each protrusion 3215 has a generally triangular shape (eg, Fig.24 As shown), and the recess has a complementary triangular shape for a secure engagement between the protrusion and the recess. In an alternative embodiment, the recess can be a shoulder.
[0730] The slide 3209 has a lug 3217 for engaging with the biasing means and a Fig.25 A stop 3227 is shown for positioning the slide and carrier 3203 in a fixed position. Another stop may be provided near the stop 3227 to control the range of movement of the slide in the free position. Additional stops may be present, or the stop 3227 may be enlarged. In the preferred embodiment shown, the slide 3209 is a sleeve. The sleeve has a first inner surface and a second inner surface spaced apart from the first surface. The stop 3227 is formed on the first surface and the lug 3217 is formed on the second surface. In an alternative embodiment, the stop and lug may be formed on the same surface. Figures 24 to 28 are cross-sectional views through the center plane of the connector. Thus, these figures show the lugs, the stop, and the biasing means.
[0731] like Figures 24 to 28 As shown, the lug 3217 is centrally located within the slide 3209. The lug 3217 includes two outwardly tapered surfaces 3219 having a circular nose 3221.
[0732] When viewed from the side (such as Fig.30 The stopper has a wedge-shaped profile. The stopper cooperates with a slot in the carrier. When the slider is in the fixed position, a surface of the stopper engages a surface of the slot, thereby preventing the stopper from moving beyond the fixed position. The wedge-shaped shape of the stopper assists in assembling the slider to the carrier.
[0733] The slide 3209 has two protrusions 3223 for engaging with the claws to substantially inhibit the movement of the clamp 3201 and prevent the clamp from being released from the carrier 3203. These protrusions are generally semicircular, such as Figures 24 to 28 As shown. The slider 3209 has a pair of longitudinally extending guide rails 3225. The slider may have a scalloped portion that facilitates the user to grasp the slider. The slider may be equipped with a soft sleeve component to allow the user to better grip to operate the connector, and the soft sleeve component is also more comfortable for the patient to press it against their skin. The sleeve can be overmolded or co-molded with the slider, or can be a separately formed component assembled with the slider.
[0734] The clamp 3201 is a substantially planar and rigid component. The clamp 3201 includes a pair of notches 3213. The notches 3213 are positioned toward the nose section 3201a of the clamp 3201 and are generally triangular in shape. The angle of a first side 3213a of the notch 3213 closest to the nose of the clamp 3201 is steeper than a second side 3213b of the notch 3213. The first side is relatively steep to help prevent the clamp 3201 from being removed when the slide is in a fixed position.
[0735] The carrier has been described as a separate component relative to the combined claw / biasing means component. Alternatively, the carrier may be formed integrally with the claw / biasing means component.
[0736] The biasing means has been described as comprising a pair of resilient legs. Alternatively, the biasing means may comprise a single leg or more than two legs. In other alternatives, the leg biasing means may comprise any other type of spring element to act as a return mechanism for the slide.
[0737] The jaw has been described as comprising a pair of resilient arms. Alternatively, the jaw may comprise a single arm or more than two arms. The clamp has been described as having a pair of notches. Alternatively, the clamp may have a single notch or more than one notch. The number and position of these notches will correspond to the number and position of complementary protrusions on the resilient arms.
[0738] The biasing device has been described as having two legs that move away from each other and are biased toward each other to urge the slide to a fixed position. Alternatively, the legs may be deformed in another direction to provide a similar return action. For example, the legs may be twisted or bent along their length.
[0739] The features and properties of these legs can be modified to suit the application; that is, they can be modified to adjust the force on the slide when moving between the fixed position and the free position. Features and properties that can be selected or designed to be modified include the angle of the legs, the thickness of the legs, and the angle of the lugs.
[0740] In another alternative embodiment, the combined claw / biasing device component may be formed as two pieces. Each piece will have an arm and a leg and will be held in position relative to the carrier by a locating feature. In another alternative embodiment, the claw / biasing device may be a single leg and arm combination that acts on only one side of the clamp. In this embodiment, the connector will have locating features for securing the claw / biasing device in position as well as guide features and / or abutment features to ensure that the components are correctly positioned relative to each other in view of the forces acting on the arms / legs on the components of the connector.
[0741] The biasing means and the claw have been described as being integrally formed together. Alternatively, they may be separately formed components which may or may not be connected together.
[0742] Embodiments of the connector have been described as having a biasing device for urging the slide toward a fixed position. In alternative embodiments, the connector may not have a biasing device, but the slide may be retained in the free position and / or the fixed position by other suitable mechanisms. For example, the connector may have one or more catches that hold the slide in the free position and / or the fixed position. Such catches may automatically engage the slide and / or the carrier or may be a user-controlled feature.
[0743] The present disclosure also provides a catheter and lead clamp 4000. The clamp 4000 can be used to connect the catheter of the patient interface with the lead (such as the lead of the patient sensor 29).
[0744] Fig.33 A perspective view of the fixture 4000 is shown, and Fig.34 An end view of the clamp 4000 is shown. The clamp 4000 has a wire receptacle 4006 for receiving a wire and a catheter receptacle 4007 for receiving a catheter.
[0745] The catheter receptacle 4005 is defined by two walls 4001 and 4002. The guidewire receptacle 4006 is defined by two walls 4003 and 4004. Each receptacle has an opening across its length that is narrower than the corresponding maximum width of the receptacle. Pairs of walls 4001 and 4002 and 4003 and 4004 are curved toward each other at their distal extents.
[0746] The cross-sectional size and shape of each receptacle may correspond to the cross-sectional size and shape of the expected sensor wire and catheter, respectively.
[0747] Fig.33 and Fig.34 The clamp 4000 can be used to connect to wires and catheters that each have a substantially circular cross-section.
[0748] The width of each of the receptacles 4006 and 4007 can be made to be the same as or preferably smaller than the corresponding width of the wire or conduit to which the clamp is to be connected. By this configuration, an interference fit can be provided between the wire or conduit and the clamp when the corresponding elements are located in the corresponding receptacles.
[0749] Although in Fig.33 and Fig.34 4000 is illustrated as having a length approximately equal to its overall lateral dimension, but the clamp 4000 may have a length that is relatively larger or smaller than one or both of its lateral dimensions.
[0750] like Fig.33 , a corner 4010 of the first wall 4001 is rounded between its edge at the opening of the catheter receptacle 4007 and its edge at the proximal end of the clamp 4000. The rounded corner provides a local increase in the width of the opening of the catheter receptacle 4007. This local increase in width can help the user connect the clamp to the catheter.
[0751] The corresponding corner of the other wall 4002 of the catheter receptacle 4007 may be rounded in the same manner to further increase the width of the opening of the catheter receptacle 4007 at its end.
[0752] Only one end of the catheter receptacle 4007 of the clamp 4000 may have rounded corners, or both ends may have rounded corners.
[0753] Rounded corners may similarly be provided on one or more corners or one or both ends of the wire receptacle 4006 of the clamp 4000 .
[0754] One or more clamps such as clamp 4000 can be used with a patient interface, particularly with a patient interface that can hold a patient sensor as described herein. Where the patient sensor includes wires, the trailing wires can be inconvenient for the patient or clinician. By using one or more clamps, one or more sensor wires can be secured to the conduit of the patient interface. This can reduce clutter and improve the simplicity of the overall patient interface and the patient or clinician's interaction therewith.
[0755] Fig.35 A portion of a conduit 62 for a patient interface is shown, as well as a lead 710, for example, for a patient sensor. The clamp 4000 is simultaneously attached to the conduit 62 and the lead 710, such that a portion of the conduit 62 is received with the conduit receptacle of the clamp and a portion of the lead 710 is received within the lead receptacle of the clamp.
[0756] like Fig.35 As seen in FIG. 4 , the clamp 4000 orients the longitudinal axes of the catheter 6 and the guide wire 710 to be parallel to each other in the connected position of the clamp 4000 .
[0757] Fig.19A Also shown are two clamps 4000 as part of a patient breathing interface 1000 with conduit 16. Fig.19A , the opening of each catheter receptacle is shown. A wire 710 extending from the patient sensor extends along the length of the catheter 16 and is shielded by the catheter.
[0758] In some arrangements, a component of or for a patient interface configured to hold a patient sensor may be a connector including a catheter holding portion or a tube clamp. The component may have a sensor mount configured to hold a patient sensor. The sensor mount may be configured to couple to a sensor mount receiving portion of another component of the patient interface.
[0759] Fig.36A A patient respiratory interface in the form of a nasal cannula interface 1000 is shown. Although shown as a nasal cannula interface, it should be understood that the interface can be other types of interfaces disclosed herein. The nasal cannula interface 1000 has a nasal cannula 30 and an associated inlet conduit 62 for supplying a flow of breathable gas. The nasal cannula interface 1000 has corresponding side arms 270 extending on either side of the nasal cannula 30.
[0760] In some arrangements, the intake duct 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 together at or through the component 2000, more particularly at or through the duct holding portion 2100.
[0761] 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 the component 2000. The component 2000 has a conduit holding portion 2100 for holding a portion of the inlet conduit 62. The component 2000 has a sensor mount 2200 configured to hold the patient sensor 29.
[0762] The duct holding portion 2100 may have a shape surrounding the entire intake duct 62, such as Fig.36A , is in the form of a collar around the intake duct 62. In other arrangements, the duct holding portion 2100 may be in other forms that do not completely surround the intake duct 62. For example, the duct holding portion 2100 may be, for example, as described with reference to Figure 33 to Figure 35 A form of or part of a pipe clamp as described elsewhere herein.
[0763] In some arrangements, the conduit retaining portion 2100 can be removably attached to the intake conduit 62. For example, in the case where the conduit retaining portion 2100 is Figure 33 to Figure 35In the form of a conduit receptacle 4007 of the conduit clamp 4000 , the conduit retaining portion 2100 may be removably attached to the intake conduit 62 .
[0764] In other arrangements, such as where the conduit retaining portion 2100 completely surrounds the conduit, the conduit retaining portion 2100 may only be removed by sliding over the end of the intake conduit 62 or may not be non-destructively removable from the conduit.
[0765] In some arrangements, the conduit retaining portion 2100 can be fixedly associated with the intake conduit 62 when retaining the intake conduit. In such an arrangement, the conduit retaining portion cannot move relative to the intake conduit, such as translating along the intake conduit or rotating around the intake conduit, either or both. In such an arrangement, the component 2000 can be provided as a portion of the intake conduit 62.
[0766] In other arrangements, the conduit retaining portion 2100 may be at least partially movably associated with the intake conduit 62, such as one or both of being translatable along the intake conduit or rotatable about the intake conduit.
[0767] At least one side arm 270 of the patient interface has a sensor recess 2050. The sensor recess 2050 is sized and configured to receive a sensor mount 2200 of the component 2000. The sensor recess is configured so 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 itself is inserted into the sensor recess 2050.
[0768] The sensor recess 2050 can be configured and located 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 into the sensor recess. More particularly, the sensor recess 2050 can be configured and located on the side arm 270 such that a portion of the patient's face between the eyes and the patient's lips is at least optically exposed through the sensor recess.
[0769] In some arrangements, the sensor recess 2050 can be a windowed recess in the side arm. The sensor recess can extend from the non-patient-facing side of the side arm 270 into the side arm, and an at least partially transparent window can be provided at the bottom of the sensor recess 2050. The sensor mount 2200 can be inserted into the sensor recess 2050 up to the window of the recess.
[0770] In other arrangements, for example Fig.36AAs shown, 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 arrangements, when the patient interface 1000 is worn, the portion of the patient's face beneath the sensor recess 2050 is physically exposed. The sensor recess 2050 is arranged so 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.
[0771] Where 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 may be arranged to contact the patient's face when the patient is wearing the patient interface.
[0772] When the sensor mount 2200 is inserted into the sensor recess 2050, the sensor mount 2200 and the sensor recess 2050 may be engaged by an interference fit.
[0773] In some arrangements, the sensor mount 2200 and the sensor recess 2050 may be configured to engage one another to prevent the sensor mount 2200 from being withdrawn from the sensor recess 2050 once the sensor mount 2200 is inserted into the sensor recess 2050 to a certain extent or fully.
[0774] The sensor mount 2200 and the sensor recess 2050 may have mutual engagement features that engage together when the sensor mount 2200 is inserted to a predetermined depth in the sensor recess 2050. The predetermined depth may allow the sensor mount to contact the patient's face when the patient wears the patient interface. Such mutual engagement features may be, for example, snap-fit features, interference fit features, or magnetic engagement features.
[0775] In some arrangements, the sensor mount 2200 may be configured to irreversibly connect with the sensor recess 2050 when inserted into the sensor recess. In other arrangements, the sensor mount 2200 may be prevented from being removed when inserted into the sensor recess 2050, but may be repeatedly inserted and removed therefrom.
[0776] The sensor recess 2050 of the side arm can be of any shape, but in particular corresponds to the shape of the sensor mount 2200 that the sensor recess is to receive. For example, the sensor mount 2200 can have a square, rectangular, oval, or circular cross-section, and the sensor recess 2050 can have a corresponding square, rectangular, oval, or circular cross-section.
[0777] In some arrangements, it may be desirable to restrict or prevent the sensor mount 2200 and the sensor recess 2050 from rotating relative to each other about an insertion axis 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 each other and may be more than just circular in shape. More than just a circular shape may include a circular cross-section with one or more detents or notches and corresponding protrusions to work together to prevent relative rotation between the components during use.
[0778] The side arm 270 with the sensor recess 2050 can be configured as a conventional side arm that can replace another patient interface to provide integration of sensing of one or more patient parameters with the patient interface. In the case where it is desired to sense the patient parameters, the user can disconnect the existing side arm from the patient interface and the headgear or headgear connector and reconnect the side arm 270 with the sensor mount 2200 after it is in place. In the case where the patient interface includes the component 2000, the sensor mount 2200 can then be inserted into the sensor recess 2050 for monitoring the patient parameters. In the case where a particular patient interface does not include the component 2000, the component 2000 can be provided to the intake conduit 62, or the intake conduit 62 with the component 2000 can be provided to connect to the patient interface, and the sensor mount 2200 is then inserted into the sensor recess 2050.
[0779] Because the sensor mount 2200 can be inserted into the sensor recess 2050 from the side of the side arm 270 that contacts the patient's face during use, the sensor mount 2200 can be inserted into and removed from the sensor recess 2050 while the patient interface 1000 is being used by a patient.
[0780] like Fig.36A As shown in the configuration of , both side arms 270 of the nasal cannula interface 1000 have corresponding sensor recesses 2050 and 2051. Such a configuration can allow the sensor mount 2200 to be selectively inserted into the sensor recess 2050 or 2051, so that the patient sensor 29 can be positioned on either side of the patient's face.
[0781] exist Fig.36A In the configuration shown, the patient gas conduit 62 away from its connection to the body 110 can be bent to 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 .
[0782] In other arrangements, e.g. Fig.37As shown, the patient interface 1000 can be configured so that the air inlet conduit 62 can be selectively connected to either side of the body 110 of the interface. In such an arrangement, the air inlet conduit can be said to be connectable to the body in a plurality of different directions. Fig.36A In the configuration of FIG. 1 , the catheter 62 is connected to the left side of the body 110 from the patient's perspective. Fig.37 As shown, the body 110 has connection ports 110a and 110b for the intake duct 62 on the left and right sides of the body 110, and the intake duct 62 is shown as being connected at the connection port 110b on the right side of the body 110. When connected at the connection port 110b, the sensor mount 2200 of the component 2000 can be inserted into the sensor recess 2051 of the right arm 270. The connection port 110a, to which no intake duct 62 is connected, can be sealed by a plug or other closure.
[0783] This arrangement allows the user to conveniently select the side of the patient's face on which the patient sensor 29 is disposed by switching the side of the main body 110 to which the intake duct 62 is connected.
[0784] By connecting the intake duct to the side of the body 110 corresponding to the sensor recess 2050 or 2051 into which the sensor mount 2200 is to be inserted, the amount of curvature of the intake duct can be minimized. Specifically, the curvature of the intake duct 62 between its first end connected to the body 110 and the position where the duct is held by the duct holding portion 2100 can be less than about 90 degrees. More specifically, the curvature can be less than about 45 degrees.
[0785] Further details of component 2000 are provided in Fig.36B . Component 2000 has a catheter retaining portion 2100 and a sensor mount 2200. The sensor mount 2200 is configured to retain a patient sensor 29. The patient sensor 29 may be removably retained by the sensor mount 2200. In other forms, the patient sensor 29 may be non-removably retained by the sensor mount 2200, such as by being integrally formed therewith. The sensor mount 2200 may serve as a portion of a housing in which the patient sensor 29 is retained. The sensor mount 2200 may have one or more openings 2201 through which the patient sensor 29 may be exposed to the patient when the sensor mount 2200 is inserted into the sensor recess 2050 of the side arm 270.
[0786] As about FIG. 36A to FIG. 37The inlet conduit 62 shown and described for being held by the component 2000 may include one or more conductive elements. The conductive elements may extend along part or all of the length of the inlet conduit 62. For example, in some arrangements, the one or more conductive elements may extend from a first end of the tube for connecting to the body 110 of the patient interface 1000 and a second end opposite the first end, the second end being for connecting to a body 110 of the patient interface 1000. Figure 3 Inhalation duct 16 shown. In other arrangements, one or more conductive elements may extend partially along the length of the intake duct from one of its ends. For example, one or more conductive elements may extend from the second end of the intake duct 62 to a position along the intake duct at which the duct holding portion 2100 is configured to hold the duct. In the case where the intake duct 62 has a first portion 62a extending from the first end and a second portion 62b extending from the second end, one or more connecting elements may be associated with only one of the first portion 62a and the second portion 62b. One or more conductive elements associated with the intake duct 62 or at least a portion thereof may be used for the operation of the patient sensor 29. For example, the conductive element may provide power to the patient sensor 29 and / or receive a sensor signal from the patient sensor 29.
[0787] One or more conductive elements may be disposed in the rim or lumen of the catheter. In other examples, the conductive element may be associated with the catheter but located outside the catheter. The one or more conductive elements may, for example, include one or more wires, cables, leads, or other insulated conductive materials.
[0788] Fig.36A The conductive element 710 associated with the intake duct 62 is shown. Fig.36A In the illustrated configuration, one or more conductive elements 710 may extend only in the second portion 62b of the inlet conduit 62 and may interface with the component 2000, and more particularly with the patient sensor 29 retained in the sensor mount 2200 of the component.
[0789] Where the inlet duct 62 has a first portion 62a and a second portion 62b, a component 2000 having a duct holding portion 2100 and a sensor mount 2200 may be provided at the interface between the first portion 62a and the second portion 62b. The duct holding portion 2100 itself may be connected between the first portion 62 and the second portion 62b of the inlet duct 62. The first portion 62a and the second portion 62b may be connected to each other when the patient wears the interface 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.
[0790] In a case where the intake duct 62 has a first portion 62a and a second portion 62b and component 2000 is located at or provides their interface, the length of the first portion 62a can position the sensor mount 2200 adjacent to the sensor recess 2050 of the side arm 270 that is laterally located on the body 110 adjacent to the connection port for the duct 62.
[0791] Although in FIG. 36A to FIG. 37 270, but the one or more sensor recesses may additionally or alternatively be provided in one or more other components of the patient interface. For example, the one or more sensor recesses may additionally or alternatively be provided in a band of the headgear, or in a portion of the headgear that has been described with respect to the patient interface. Figures 23 to 32 In the described headgear and side arm connector components.
[0792] As about FIG. 36A to FIG. 37 As described with reference to component 2000 , in different arrangements, the duct retaining portion may be movable along the intake duct 62 or may be fixedly associated with a particular location along the intake duct 62 .
[0793] Fig.38A A partial view of a nasal cannula interface 1000 having another configuration of a component 2000 for holding a patient sensor 29 is shown. The nasal cannula interface 1000 includes a cannula 30 associated with a body 110. A side arm 270 is shown associated with a side of the body 110, and an inlet conduit 62 is connected to the body 110 to supply breathable gas. The component 2000 holds the inlet conduit 62 at the conduit holding portion 2100. The component 2000 has a hook portion 2400 at which the component 2000 can be attached to another portion of the patient interface 1000. For example, the hook portion 2400 can extend over the side arm or headgear strap to associate the component 2000 with the rest of the patient respiratory interface 1000. As shown in FIG. Fig.38A As shown, the hook portion 2400 is located on the headgear strap 210. Fig.38B 2000 including its hook portion 2400. On the side of the hook portion 2400 opposite the catheter holding portion 2100, the component 2000 has a sensor mount 2200 configured to hold a patient sensor 29. When the component 2000 is hooked on another portion of a patient interface worn by a patient, the sensor mount 2200 can be placed adjacent to or in contact with the patient's face. The hook portion 2400 can be repositioned along the side arm or headgear strap to place the sensor mount 2200 at a desired location on the patient's face.
[0794] The patient sensor 29 may be removably or non-removably held by the sensor mount 2200 .
[0795] Fig.38A and Fig.38B Component 2000 is shown having a sensor lead 2060 extending from a sensor mount 2200. In other arrangements, patient sensor 29 may be provided with a power source and configured to communicate wirelessly with a processor and / or control circuitry (such as a pulse oximeter's processing and / or control circuitry).
[0796] The hook portion 2400 is sized and configured to correspond to a portion of the patient interface upon which it is to be hooked.
[0797] Fig.39 Another configuration of component 2000 is shown, which is configured as part of a connector between two other parts of the patient respiratory interface 1000. Component 2000 has a first connector portion 2081, where the side arm can be connected to component 2000, and a second connector portion 2082, where the headgear portion can be connected. Fig.39 , the headgear strap 210 is shown as being threaded through the buckle of the second connector portion 2082. Between the first connector portion 2081 and the second connector portion 2082 is a sensor mount 2200 that is configured to hold a patient sensor 29. The patient sensor 29 may be exposed to the patient-facing side of the component 2000 through one or more openings 2201 of the sensor mount 2200.
[0798] like Fig.39 As seen in FIG. 1 , at the other end of the belt 210, there is provided a Figures 23 to 32 The connector 3200 of the described form. In other arrangements, the component 2000 can be provided at both ends of the belt 210.
[0799] exist Fig.39 When the component 2000 is used as part of a patient respiratory interface, the component and any 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 where the patient sensor 29 is located. In the event that flipping the headgear is not desired, the same function can be achieved by unhooking the headgear strap 210 from the buckles of the component 2000 and connector 3200, switching the side arms associated with each of the component 2000 and connector 3200, and then reconnecting the ends of the headgear strap 210 to the buckles.
[0800] In some arrangements, the component 2000 configured to hold the patient sensor 29 may be provided as an intermediate component insertable between two other portions of a patient interface. Fig.40An example of such an arrangement is illustrated, showing component 2000 being insertable between side arm 270 and connector 3200. Without component 2000, end 4020 of side arm 270 may be inserted into receiving portion 3230 of connector 3200 to attach the two parts together.
[0801] Fig.40 The component 2000 of the side arm 270 has a first end 2083 configured to receive and couple with the end 4020 of the side arm 270. The component 2000 has a second end 2084 configured to be inserted into the receiving portion 3230 of the connector 3200. Between the first end 2083 and the second end 2084, the component 2000 has a sensor mount 2200 at which a patient sensor can be retained.
[0802] Although in Fig.40 While shown having corresponding 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 should be understood that the order of one or both of these connections may be rearranged as required by the particular patient interface.
[0803] Fig.40 Component 2000 can be repositioned between the two sides of the patient interface for sensing on either side of the patient's face by disconnecting 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.
[0804] 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 via a wired or wireless connection with a processor and / or control circuit. In the event that the patient sensor 29 is to communicate wirelessly, the wireless communication circuitry and optionally the power source may be retained with the patient sensor in the sensor mount 2200. In other arrangements, the wireless communication circuitry and power source may be provided as part of a communication module.
[0805] Fig.40 The communication module 2090 is shown in FIG. The communication module is used to associate with the sensor mount 2200 to enable wireless communication from the patient sensor 29 to the processor and / or other sensor control circuits. Fig.40 As shown, component 2000 has ports 2085 at which communication modules 2090 can be connected to component 2000 or retained patient sensors 29 .
[0806] It should be appreciated that the communication module 2090 may be implemented with other forms of the component 2000 described herein where wireless communication is desired with the patient sensors.
[0807] Fig.41 Two example configurations of communication modules 2090a and 2090b are shown. In a first configuration, communication module 2090a includes a power source for powering the communication module. Communication module 2090a is configured to wirelessly transmit sensor information from a patient sensor. In a second configuration, communication module 2090b does not include a power source and is connected to a remote power source via sensor lead 2060. Communication module 2090b can be arranged to wirelessly transmit sensor information or can transmit sensor information along sensor lead 2060.
[0808] like Fig.41 The communication modules 2090a and 2090b shown in FIG. 2 each include a pin 2091 for interfacing with a corresponding port 2085 of the component 2000 to connect to the patient sensor 29 .
[0809] For example, about Figure 7C and Figure 8B Configurations have been described previously in which the patient sensor 29 can be held by a side arm 270 that is connected to one or both of the body 110 or the headgear strap 210 by a connector that is particularly suitable for use as a patient sensor. Figure 7F The form of push-fit clamp 241 is shown. Fig.43 Another arrangement of a patient respiratory interface 1000 is shown having side arms 270 and a headgear strap 210 that may be connected by a component 2000 including a push-fit clamp 241. The component 2000 is configured to hold a patient sensor 29. The headgear strap 210 may be associated with the component in any of the previously described ways, such as by a buckle or other means of retaining the strap 210, such as Figure 7G and Figure 7H The toothed portion is shown in a cross-sectional view.
[0810] The push-fit clamp 241 can be inserted into the channel of the side arm 270. When fully inserted into the channel of the side arm 270, the clamp 241 can be withdrawn from the channel so that the engagement surface 243a of the clamp 241 engages the stop surface 247 of the side arm 270 and prevents the clamp 241 from being withdrawn from the side arm 270. Fig.43 As shown, the side arm 270 can have an opening so that a user can press the end of the clamp 241 to disengage the engagement surface 243a and the stop surface 247, thereby allowing the headgear strap 210 and the side arm 270 to separate.
[0811] Although in Fig.432. The push-fit clamp 241 is shown in FIG. 2 as being associated with the headgear strap 210 and insertable into the channel of the side arm 270, but it will be appreciated that the association of the connector portion with the headgear strap 210 and the side arm 270 can be reversed if desired.
[0812] like Fig.43 As seen in FIG. 19 , the component 2000 has a sensor mount 2200 for holding a patient sensor 29. The sensor mount 2200 is configured to hold the patient sensor 29 and, in use, expose at least a portion of the patient sensor to the patient's face on the patient-facing side of the component 2000. In some arrangements, the sensor mount 2200 may be in the form of a sensor cavity 500 as has been previously described, for example, with respect to FIGS. 19 to 21 . In other arrangements, the patient sensor 29 may be integrally provided as part of the component 2000. As shown in FIG. Fig.43 As seen in FIG. 2 , component 2000 may include port 2085 for connecting to communication module 2090 as previously described.
[0813] Fig.42 is a cross-sectional view of an illustrative configuration of a component 2000 for holding a patient sensor 29 including a connector 241 . Fig.42 The component 2000 has a sensor mounting member 2200 in which the patient sensor 29 is mounted. Fig.42 In an arrangement of , 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 into the component 2000. The patient sensor 29 is integrally formed such that a portion of the patient sensor 29 is directly exposed at the patient-facing side 2202 of the component 2000.
[0814] Sensor mountings for components according to the present disclosure, such as those related to Figures 36A to 40 and Fig.41 The component 2000 shown and described may include, for example, Figures 10A to 22 Where component 2000 is powered and / or communicates via wires, sensor mount 2200 of component 2000 according to the present disclosure may include one or more sensor chambers such as those previously described with respect to FIG. FIG. 10A to FIG. 22 A guidewire lumen 700 is depicted.
[0815] (For example, the previous FIG. 10A to FIG. 22 The fixing features described herein may generally include any disclosed features for attaching an accessory or component to another portion of a patient's respiratory interface. For example, Fig.37 The sensor mounting member 2200 of the component 2000 can be understood as a fixing feature for fixing the component 2000 to the sensor opening 2050 of the side arm 270. As another example, Fig.38A and Fig.38BThe hook portion 2400 of the component 2000 may be understood as a securing feature for securing the component 2000 to a strap or side arm of the patient respiratory interface 1000 .
[0816] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise", "comprising", etc. are to be interpreted in an inclusive sense rather than in an exclusive or exhaustive sense, that is, in the sense of "including, but not limited to".
[0817] Although the present disclosure has been described in the context of certain embodiments and examples, it should be understood by those skilled in the art that the present disclosure extends to other alternative embodiments and / or uses and obvious changes and equivalents thereof outside the specifically disclosed embodiments. In addition, although several changes 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 apparent to those skilled in the art. It is also contemplated that various combinations or sub-combinations of specific features and aspects of the embodiments can be performed and are still within the scope of the present disclosure. For example, the features described above in conjunction with one embodiment can be used with different embodiments described herein, and the combination is still within the scope of the present disclosure. It should be understood that the various features and aspects of the disclosed embodiments can be combined or replaced with each other to form a variation pattern of the embodiments of the present disclosure. Therefore, it is intended that the scope of the disclosure herein should not be limited by the specific embodiments described above. Therefore, unless otherwise stated or unless clearly incompatible, each embodiment of the present utility model may also include one or more features as described herein from each other embodiment of the present utility model disclosed herein in addition to its basic features described herein.
[0818] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example should be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification, unless incompatible therewith. All features disclosed in this specification (including any attached claims, abstracts and drawings), and / or all steps of any method or process disclosed may be combined in any combination, unless the combination of at least some of such features and / or steps is mutually exclusive. The scope of protection is not limited to the details of any of the foregoing embodiments. The scope of protection extends to any novel feature or any novel combination of the features disclosed in this specification (including any attached claims, abstracts and drawings), or to any novel step or any novel combination of the steps of any method or process so disclosed.
[0819] In addition, certain features described in the disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features may be described above as functioning in certain combinations, one or more features from a claimed combination may be deleted from the combination in some circumstances, and the combination may be claimed as a subcombination or a variation of a subcombination.
[0820] In addition, although the operations may be depicted in the drawings or described in the specification in a specific order, such operations need not be performed in the specific order shown or in a sequential order, or all operations need not be performed to achieve the desired result. Other operations not depicted or described may be incorporated into the example methods and programs. For example, one or more additional operations may be performed before, after, at the same time, or between any of the described operations. In addition, the operations may be reconfigured or reordered in other implementations. It should be understood by those skilled in the art that in some embodiments, the actual steps taken in the procedures described and / or disclosed may be different from those steps shown in the figures. Depending on the embodiment, some of the steps described above may be removed, and other steps may be added. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, and all of the above embodiments are within the scope of this disclosure. Moreover, the separation of the various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may be generally integrated together in a single product or packaged into multiple products.
[0821] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Thus, for example, one skilled in the art will recognize that this disclosure may be implemented or practiced in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
[0822] Unless expressly stated otherwise, or otherwise understood within the context in which it is used, conditional language such as "may," "could," "might," or "can" is generally intended to convey that some embodiments include and other embodiments do not include certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or prompting, whether such features, elements, and / or steps are included or will be implemented in any particular embodiment.
[0823] Language of degree used herein, such as the terms "approximately," "about," "generally," and "substantially" as used herein, means that a value, amount, or characteristic close to the stated value, amount, or characteristic still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" may refer to an amount within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.
[0824] The scope of the present disclosure is not intended to be limited by the specific disclosure of the embodiments in this section or elsewhere in this specification, and may be limited by the claims as in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims, and not limited to the examples described in this specification or during the prosecution of the application, which examples should be interpreted as non-exclusive.
Claims
1. A component for a patient breathing interface, characterized in that The components include: 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 a patient respiratory interface; and A second connector is configured to be connected to a headgear of a patient's respiratory interface.
2. The component of claim 1, wherein the first connector is located at a first end of the component and the second connector is located at a second end of the component.
3. A component as claimed in claim 1 or 2, wherein the first connector is configured to releasably connect the component to a body of a patient breathing interface.
4. The component of claim 1, wherein the second connector is configured to releasably connect the component to a headgear component of a patient respiratory interface.
5. The component of claim 4, wherein the second connector is configured to be integrally formed with the headgear component.
6. A component as described in claim 4 or 5, wherein the headgear component is a strap of a patient respiratory interface.
7. The component of claim 1, wherein the component is configured to be located between a body of the patient interface and a headgear component when connected to the body of the patient interface and the headgear component.
8. The component of claim 1, wherein the sensor cavity is defined by one or more walls of the component body.
9. A component as described in claim 1, wherein the sensor cavity is located between the body of the patient respiratory interface and the headgear of the patient respiratory interface.
10. The component of claim 1, wherein the first connector, the component body, and the second connector are integrally formed with each other.
11. The component of claim 1, wherein the component further comprises a wire lumen configured to provide access to the sensor cavity for one or more wires.
12. The component of claim 11, wherein the sensor cavity is formed in a first face of the component body.
13. A component as claimed in claim 11 or 12, wherein the wire cavity is formed in the same face and / or a different face of the component body as the sensor cavity.
14. The component of claim 11, wherein the wire lumen extends from an outer surface of the component body to the sensor lumen.
15. The component of claim 11, wherein the wire lumen is a slot recessed from a surface of the component body.
16. The component of claim 1, wherein the sensor is a patient sensor and the patient parameter is a physiological parameter.
17. The component of claim 16, wherein the patient parameter is a measure of the patient's blood oxygenation.
18. A component as claimed in claim 1, wherein the or that face of the component body which is arranged to face the patient in use comprises at least one surface material.
19. A component as claimed in claim 18, wherein the at least one surface material covers a face of the component body which is configured to face the patient in use.
20. The component of claim 18 or 19, wherein the at least one surface material does not cover the sensor and the at least one surface material is provided with openings such that the at least one surface material does not extend across the sensor cavity of the component.
21. The component of claim 18, wherein the at least one surface material is different than another material of the component.
22. The component of claim 18, wherein the at least one surface material and the component are separable.
23. The component of claim 18, wherein the at least one surface material is a membrane or a film.
24. The component of claim 18, wherein the at least one surface material is configured to increase friction between the component and the patient's face.
25. The component of claim 18, wherein the at least one surface material has adhesive properties.
26. A component as described in claim 1, wherein the sensor cavity is retained on the skin surface of the patient when the first connector is connected to the body of the patient interface and the second connector is connected to a portion of a headgear or system for securing the patient interface to the patient.
27. The component of claim 1, wherein the patient breathing interface is one of: (a) Nasal cannula interface; (b) Nasal pillow interface; (c) Nasal mask interface; (d) full-face mask interface; and (e) Oral interface.
28. A component as described in claim 1, wherein the sensor includes an optical transducer, and (a) the sensor cavity is arranged to orient the sensor so that the optical transducer and / or light source faces the patient; (b) the sensor cavity is configured so that when a sensor is disposed in the sensor cavity, the transducer of the sensor is exposed to the outside of the component; and (c) the sensor cavity includes an opening on one side of the component body, the side being configured to face the patient during use.
29. The component of claim 28, wherein the sensor cavity is arranged to orient the sensor in contact with a patient.
30. A patient interface, characterized in that: The patient interface comprises: A headgear or system for securing the patient interface in place about the patient's head; and A component for a patient breathing interface as claimed in any one of claims 1 to 29.
31. A patient interface as described in claim 30, wherein the headgear is in the form of at least one strap.
32. A nasal cannula interface, characterized in that: Comprises a component as described in any one of claims 1 to 29, wherein the nasal cannula interface includes a first nasal prong and a second nasal prong configured to produce an asymmetric gas flow at the patient's nares.
33. A nasal cannula interface as described in claim 32, wherein the cross-sectional area of the first nasal fork is smaller than the cross-sectional area of the second nasal fork, wherein the cross-sectional area of the first nasal fork and the cross-sectional area of the second nasal fork are taken from corresponding positions on the first nasal fork and the second nasal fork.
34. A nasal cannula interface as described in claim 32 or 33, wherein the cross-sectional area of the first nasal prong and the second nasal prong are taken from the proximal opening of each nasal prong.
35. A nasal cannula interface as described in claim 32, wherein the difference in cross-sectional area of the first nasal prong and the second nasal prong is to induce asymmetric gas flow in the patient's nares.
Citation Information
Patent Citations
Closed loop oxygen control
WO2019070136A1