EP4724128A1 - Patient interface - Google Patents

Patient interface

Info

Publication number
EP4724128A1
EP4724128A1 EP25811515.3A EP25811515A EP4724128A1 EP 4724128 A1 EP4724128 A1 EP 4724128A1 EP 25811515 A EP25811515 A EP 25811515A EP 4724128 A1 EP4724128 A1 EP 4724128A1
Authority
EP
European Patent Office
Prior art keywords
gases
port
nasal
nasal interface
delivery element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP25811515.3A
Other languages
German (de)
French (fr)
Inventor
Andre VAN SCHALKWYK
Kevin Peter O'donnell
Andrew Paul Maxwell Salmon
Ashley Xin Yi LENG
Natasha Gail LUST
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fisher and Paykel Healthcare Ltd
Original Assignee
Fisher and Paykel Healthcare Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fisher and Paykel Healthcare Ltd filed Critical Fisher and Paykel Healthcare Ltd
Publication of EP4724128A1 publication Critical patent/EP4724128A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0666Nasal cannulas or tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0666Nasal cannulas or tubing
    • A61M16/0672Nasal cannula assemblies for oxygen therapy
    • AHUMAN NECESSITIES
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    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • AHUMAN NECESSITIES
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    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875Connecting tubes
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    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/14Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16Devices to humidify the respiration air
    • AHUMAN NECESSITIES
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    • A61M16/0057Pumps therefor
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    • A61M16/0069Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
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    • A61M16/021Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022Control means therefor
    • A61M16/024Control means therefor including calculation means, e.g. using a processor
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    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0616Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A61M16/0622Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
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    • A61M16/0683Holding devices therefor
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    • A61M16/1065Filters in a path in the expiratory path
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    • A61M16/107Filters in a path in the inspiratory path
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    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/14Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16Devices to humidify the respiration air
    • A61M16/161Devices to humidify the respiration air with means for measuring the humidity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/1005Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102Measuring a parameter of the content of the delivered gas
    • A61M2016/1025Measuring a parameter of the content of the delivered gas the O2 concentration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/02Gases
    • A61M2202/0208Oxygen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/02Gases
    • A61M2202/0225Carbon oxides, e.g. Carbon dioxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3358Measuring barometric pressure, e.g. for compensation
    • AHUMAN NECESSITIES
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    • A61M2205/3365Rotational speed
    • AHUMAN NECESSITIES
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    • A61M2205/3368Temperature
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    • A61M2205/3546Range
    • A61M2205/3553Range remote, e.g. between patient's home and doctor's office
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    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
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    • A61M2205/502User interfaces, e.g. screens or keyboards
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    • AHUMAN NECESSITIES
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    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7518General characteristics of the apparatus with filters bacterial
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    • A61M2205/7545General characteristics of the apparatus with filters for solid matter, e.g. microaggregates
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    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0618Nose
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    • A61M2230/205Blood composition characteristics partial oxygen pressure (P-O2)
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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

A nasal interface (100) comprising an interface body (110) configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel (125), a first delivery element (111) or a first delivery element portion, a second delivery element (112) or a second delivery element portion, a first gases port (121) in the interface body and a second gases port (122) in the interface body. The first gases port (121) and the second gases port (122) have substantially the same configuration such that a first respiratory component (331) can be selectively connected to each of the first gases port (121) and the second gases port (122), and such that a second respiratory component (332) can be selectively connected to each of the first gases port (121) and to the second gases port (122).

Description

PATIENT INTERFACE
[0001] This application claims priority from United States Provisional Application No. 63/686581 filed on 23 August 2024, entitled 'Patient Interface', the entire contents of which are hereby incorporated by reference.
TECHNICAL FIELD
[0002] The present disclosure generally relates to a patient interface for delivering breathing gases to airways of a patient.
BACKGROUND
[0003] Humidifiers and flow generators are used to provide respiratory gases to a patient. When a humidifier is used, the respiratory gases are humidified. Gases are delivered to the patient via a patient interface. Examples of a patient interface include an oral mask, a nasal mask, a nasal cannula, a combination of oral and nasal mask, and the like.
[0004] Patient interfaces comprising nasal interfaces can be used to deliver a flow of gases to a patient. Nasal delivery elements are inserted into the nose of a patient to deliver the required therapy. The nasal delivery elements may be required to seal or semiseal at the nose, or may not be required to seal at the nose, to deliver the therapy.
SUMMARY
[0005] A respiratory interface and respiratory therapy system are disclosed that may use nasal flow, e.g. through nasal delivery elements, in a nasal interface to deliver respiratory gases to a patient. This delivery may be via an asymmetrical flow. Asymmetrical flow can provide the patient with increased dead space clearance in the upper airways. Due to a decrease in peak expiratory pressure, noise can be reduced.
[0006] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port configured for connecting to a first respiratory component for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port for enabling exhaled gases to be expelled out of the interface body, the second gases port configured for connecting to a second respiratory component, wherein the first gases port and the second gases port have substantially the same configuration such that the first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that the second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
[0007] In some configurations, the first gases port and the second gases port have substantially the same sized openings.
[0008] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[0009] In some configurations, same sized openings have the same geometry in a direction transverse to gases flow through the first and second gases ports.
[0010] In some configurations, the first gases port points substantially toward the first delivery element or first delivery element portion and the second gases port points substantially toward the second delivery element or second delivery element portion.
[0011] In some configurations, the first gases port has a first gases port connection feature for connecting to either of the first and second respiratory system component and wherein the second gases port has a second gases port connection feature for connecting to either of the first and second respiratory system component, and wherein the first gases port connection feature is substantially the same as the second gases port connection feature.
[0012] In some configurations, at least one of the first gases port connection feature and second gases port connection feature is a clip or a lip for engaging with the first and/or second respiratory component.
[0013] In some configurations, the first gases port and second gases port are substantially circular.
[0014] In some configurations, the first respiratory system component is a first gases conduit for delivery of respiratory gases into the nasal interface, and wherein the second respiratory system component is a diffuser or a second gases conduit.
[0015] In some configurations, the diffuser is a bias flow diffuser. [0016] In some configurations, the diffuser comprises diffuser material.
[0017] In some configurations, the diffuser comprises clamping portions to hold the diffuser material therebetween.
[0018] In some configurations, the diffuser comprises at least one aperture.
[0019] In some configurations, the first respiratory component and second respiratory component are tethered.
[0020] In some configurations, at least one of the first respiratory component and second respiratory component are tethered to the interface body.
[0021] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
[0022] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[0023] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be provided to the first naris of the patient in use and a second flow stream of gases configured to be provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[0024] In some configurations, the first gases port and the second gases port are symmetrical about a midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[0025] In some configurations, the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect. The first axis may align with a first outflow axis defined by the first delivery element or first delivery element portion and/or the second axis may align with a second outflow axis defined by the second delivery element or second delivery element portion. Accordingly, the angle between the first axis and the first outflow axis and/or the angle between the second axis and the second outflow axis may be 0 degrees.
[0026] In some configurations, the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees. [0027] In some configurations, the angle between the first axis and the second axis is more than 15 degrees and up to about 80 degrees.
[0028] In some configurations, the angle between the first axis and the second axis is more than 30 degrees and up to about 75 degrees.
[0029] In some configurations, the angle between the first axis and the second axis is more than 40 degrees and up to about 60 degrees.
[0030] In some configurations, the angle between the first axis and the second axis is about 50 degrees.
[0031] In some configurations, the interface body comprises: a first body portion comprising the first gases port; and a second body portion comprising the second gases port, and wherein the first body portion and second body portion are angled relative to one another.
[0032] In some configurations, the first outlet and the second outlets are symmetrical about the midline plane of the interface body.
[0033] In some configurations, the first and second nasal delivery elements are angled towards the midline plane such that the first and second outlets are positioned closer together than base portions of the first and second nasal delivery elements distal from the first and second outlets.
[0034] In some configurations, the first and second nasal delivery elements each comprise a pillow.
[0035] In some configurations, the interface body comprises a frame portion and a cushion portion.
[0036] In some configurations, the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
[0037] In some configurations, the frame and cushion configuration allow the subconfigurations relating to the interconnect ability of these features described below.
[0038] In some configurations, the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[0039] In some configurations, the interface body comprises a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface. [0040] In some configurations, the baffles allow the further sub-configurations relating to this feature described below.
[0041] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[0042] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets. The first axis and the second axis may lie within the second midline plane.
[0043] In some configurations, the interface body comprises a first side at which the first and second nasal delivery elements or delivery element portions are provided and an opposite second side at which the first and second gases ports are provided. The first side may be oriented towards the face of the user during use of the nasal interface and the second side may be oriented away from the face of the user during use of the nasal interface. The interface body as a whole may be curved, wherein a radial inner surface may form the first side and a radial outer surface may form the second side.
[0044] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[0045] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[0046] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[0047] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[0048] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[0049] In some configurations, side arms or headgear arms comprise cheek pads. [0050] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0051] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[0052] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0053] In some configurations, the cheek pad is formed as a hollow body.
[0054] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[0055] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0056] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[0057] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[0058] In some configurations, wherein the second direction is a laterally outward direction.
[0059] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port for delivery of respiratory gases into the nasal interface, wherein the first gases port is in fluid communication with the interface body to deliver the respiratory gases from the first gases port through the interface body to the first naris and second naris of the patient in use, a second gases port for expelling exhaled gases out of the nasal interface, wherein the second gases port is in fluid communication with the interface body to expel the exhaled gases substantially from the second naris of the patient through the interface body to the second gases port in use, wherein the interface body comprises a cushion portion and a frame portion, the first gases port formed as a first cushion opening in the cushion portion and a first frame opening formed in the frame portion, and the second gases port formed as a second cushion opening in the cushion portion and a second frame opening formed in the frame portion, wherein the first cushion opening and first frame opening are inter-engageable, and wherein the second cushion opening and second frame opening are inter-engageable to attach the cushion portion to the frame portion.
[0060] In some configurations, the frame portion comprises a first protrusion comprising the first frame opening and a second protrusion comprising the second frame opening, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion.
[0061] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[0062] In some configurations, the cushion portion comprises a first protrusion comprising the first cushion opening and a second protrusion comprising the second cushion opening, wherein the first and second protrusions are receivable in respective first and second apertures in the frame portion.
[0063] In some configurations, the first protrusion and second protrusion are generally circular in cross-section.
[0064] In some configurations, the first aperture and second aperture is formed as a generally C-shaped opening.
[0065] In some configurations, the first protrusion and the second protrusion is formed as a bead at and edge of the cushion portion.
[0066] In some configurations, the frame portion comprises an outwardly extended periphery portion.
[0067] In some configurations, the frame portion comprises a pair of side arms on either side of the interface body.
[0068] In some configurations, the side arms are each angled respectively toward the proximal first delivery element or first delivery element portion and the second delivery element or second delivery element portion.
[0069] In some configurations, the sides arms each comprise an elongate slot for engaging with a strap. [0070] In some configurations, a first outlet is provided in the first delivery element and a second outlet is provided in the second delivery element.
[0071] In some configurations, a base of each first and second delivery element is thicker than a tip of the first and second delivery element, wherein the first outlet and second outlet is located at the respective tip of the first and second delivery element.
[0072] In some configurations, the first delivery element and the second delivery element each have a wall thickness at the base and a wall thickness adjacent the first and second outlets, and wherein the wall thickness at the base is larger than the wall thickness adjacent the first and second outlets.
[0073] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
[0074] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[0075] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[0076] In some configurations, the nasal interface comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[0077] In some configurations, the interface body comprises a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[0078] In some configurations, the baffles allow the further sub-configurations relating to this feature described below.
[0079] In some configurations, the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
[0080] In some configurations, the same configuration allows the subconfigurations relating to this feature described above.
[0081] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[0082] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
[0083] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[0084] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[0085] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[0086] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[0087] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[0088] In some configurations, side arms or headgear arms comprise cheek pads.
[0089] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[0090] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm. [0091] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[0092] In some configurations, the cheek pad is formed as a hollow body.
[0093] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[0094] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[0095] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[0096] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[0097] In some configurations, wherein the second direction is a laterally outward direction.
[0098] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port for delivery of respiratory gases into the nasal interface, wherein the first gases port is in fluid communication with the gases flow channel, and a second gases port for expelling exhaled gases out of the nasal interface, wherein the second gases port is in fluid communication with the gases flow channel, and at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[0099] In some configurations, the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the first gases port, they pass along the baffle to the first delivery element or the first delivery element portion and along the baffle to the second delivery element or the second delivery element portion, and such that exhaled gases substantially pass along the baffle to the second gases port. [OO1OO] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[00101] In some configurations, the nasal interface comprises a plurality of the baffles.
[00102] In some configurations, the baffles extend substantially parallel to one another.
[00103] In some configurations, the nasal interface comprises between 1 and 7 baffles.
[00104] In some configurations, the nasal interface comprises between 2 and 5 baffles.
[00105] In some configurations, the nasal interface comprises either 3 or 4 baffles.
[00106] In some configurations, each baffle is equally spaced from one another.
[00107] In some configurations, the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00108] In some configurations, the at least one baffle extends substantially a full length of the gases flow channel such that gases cannot pass around ends of the at least one baffle.
[00109] In some configurations, the at least one baffle has a depth that terminates before the first and second delivery elements.
[00110] In some configurations, the at least one baffle has a constant thickness along its length.
[00111] In some configurations, the at least one baffle has a thickness that varies along its length.
[00112] In some configurations, a middle of the at least one baffle baffles is thicker than the ends of the at least one baffle.
[00113] In some configurations, the flow area at the middle of the at least one baffle is between about 50 mm2 and about 300 mm2.
[00114] In some configurations, is between about 50 mm2 and about 80 mm2.
[00115] In some configurations, the flow area at the middle of the at least one baffle is about 65 mm2.
[00116] In some configurations, the flow area at the middle of the at least one baffle is between about 100 mm2 and about 200 mm2. [00117] In some configurations, the flow area at the middle of the at least one baffle is between about 150 mm2 and about 200 mm2.
[00118] In some configurations, the flow area at the middle of the at least one baffle is about 180 mm2.
[00119] In some configurations, the at least one baffle is configured to create a flow restriction in the gases flow channel.
[00120] In some configurations, the interface body comprises a frame portion and a cushion portion.
[00121] In some configurations, the at least one baffle is formed as part of the frame portion or the cushion portion.
[00122] In some configurations, the at least one baffle is formed as a separate part to the interface body and is inserted therein.
[00123] In some configurations, the nasal interface comprises a support rib, the support rib positioned transverse to the at least one baffle in the interface body and configured to support the at least one baffle.
[00124] the frame and cushion configuration allow the sub-configurations relating to the interconnect ability of these features described below.
[00125] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient.
[00126] In some configurations, the at least one baffle creates or contributes to the asymmetric flow.
[00127] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[00128] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00129] In some configurations, the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
[00130] In some configurations, the same configuration allows the subconfigurations relating to this feature described above.
[00131] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00132] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
[00133] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00134] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[00135] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00136] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[00137] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00138] In some configurations, side arms or headgear arms comprise cheek pads.
[00139] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00140] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm. [00141] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00142] In some configurations, the cheek pad is formed as a hollow body.
[00143] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00144] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[00145] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[00146] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[00147] In some configurations, wherein the second direction is a laterally outward direction.
[00148] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port directly connected to or configured to directly connect to a first gases conduit for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port directly connected to or configured to directly connect to a second gases conduit for enabling exhaled gases to be expelled out of the interface body, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. [00149] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
[00150] In some configurations, the nasal interface comprises a diffuser, wherein the diffuser is directly connected or configured to directly connect to the second gases port of an end of the second conduit distal from the interface body.
[00151] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[00152] In some configurations, the diffuser is a bias flow diffuser.
[00153] In some configurations, the diffuser comprises a diffuser material.
[00154] In some configurations, the diffuser comprises clamping portions to hold the diffuser material therebetween.
[00155] In some configurations, the diffuser comprises at least one aperture.
[00156] In some configurations, the nasal interface comprises a Y-piece connector directly connected or configured to be directly connected to the first and second gases ports and first gases conduit.
[00157] In some configurations, the nasal interface comprises a 3-way adaptor configured to be interchangeably connected at its first end to an end of the first conduit distal from the interface body or a further respiratory device, and to be connected at its second end to a respiratory tubing.
[00158] In some configurations, at least one flow restriction creates or contributes to the asymmetric flow.
[00159] In some configurations, at least one flow restriction is formed by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[00160] In some configurations, the interface body comprises a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00161] In some configurations, the at least one baffle has a thickness that varies along its length.
[00162] In some configurations, a middle of the at least one baffle baffles is thicker than the ends of the at least one baffle. [00163] In some configurations, the flow area at the middle of the at least one baffle is between about 50 mm2 and about 300 mm2.
[00164] is between about 50 mm2 and about 80 mm2.
[00165] In some configurations, the flow area at the middle of the at least one baffle is about 65 mm2.
[00166] In some configurations, the flow area at the middle of the at least one baffle is between about 100 mm2 and about 200 mm2.
[00167] In some configurations, the flow area at the middle of the at least one baffle is between about 150 mm2 and about 200 mm2.
[00168] In some configurations, the flow area at the middle of the at least one baffle is about 180 mm2.
[00169] In some configurations, the at least one baffle is configured to create a flow restriction in the gases flow channel.
[00170] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[00171] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00172] In some configurations, the interface body comprises a frame portion and a cushion portion.
[00173] In some configurations, the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
[00174] In some configurations, the cushion portion and frame portion are inter- engageable to form the interface body.
[00175] In some configurations, the interface body comprises a cushion portion and a frame portion, the first gases port formed as a first cushion opening in the cushion portion and a first frame opening formed in the frame portion, and the second gases port formed as a second cushion opening in the cushion portion and a second frame opening formed in the frame portion, wherein the first cushion opening and first frame opening are inter-engageable, and wherein the second cushion opening and second frame opening are inter-engageable to attach the cushion portion to the frame portion.
[00176] In some configurations, the frame portion comprises a first protrusion comprising the first frame opening and a second protrusion comprising the second frame opening, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion.
[00177] In some configurations, the cushion portion comprises a first protrusion comprising the first cushion opening and a second protrusion comprising the second cushion opening, wherein the first and second protrusions are receivable in respective first and second apertures in the frame portion.
[00178] In some configurations, the first protrusion and second protrusion are generally circular in cross-section.
[00179] In some configurations, the first aperture and second aperture is formed as a generally C-shaped opening.
[00180] In some configurations, the first protrusion and the second protrusion is formed as a bead at and edge of the cushion portion.
[00181] In some configurations, at least a portion of the first conduit and second conduit extend away from the interface body in a divergent direction.
[00182] In some configurations, the first conduit and second conduit are interchangeable with one another.
[00183] In some configurations, the first gases port and the second gases port have substantially the same sized openings.
[00184] In some configurations, the same sized openings have the same cross section and/or geometry in a direction transverse to gases flow through the first and second gases ports.
[00185] In some configurations, the first gases port points substantially toward the first delivery element or first delivery element portion and the second gases port points substantially toward the second delivery element or second delivery element portion.
[00186] In some configurations, the first gases port has a first gases port connection feature for connecting to either of the first and second respiratory system component and wherein the second gases port has a second gases port connection feature for connecting to either of the first and second respiratory system component, and wherein the first gases port connection feature is substantially the same as the second gases port connection feature. [00187] In some configurations, at least one of the first gases port connection feature and second gases port connection feature is a clip or a lip for engaging with the first and/or second respiratory component.
[00188] In some configurations, the first gases port and second gases port are substantially circular.
[00189] In some configurations, the first respiratory component and second respiratory component are tethered.
[00190] In some configurations, at least one of the first respiratory component and second respiratory component are tethered to the interface body.
[00191] In some configurations, the first gases port and the second gases port are symmetrical about a midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00192] In some configurations, the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect.
[00193] In some configurations, the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
[00194] In some configurations, the angle between the first axis and the second axis is more than 15 degrees and up to about 80 degrees.
[00195] In some configurations, the angle between the first axis and the second axis is more than 30 degrees and up to about 75 degrees.
[00196] In some configurations, the angle between the first axis and the second axis is more than 40 degrees and up to about 60 degrees.
[00197] In some configurations, the angle between the first axis and the second axis is about 50 degrees.
[00198] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00199] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
[00200] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00201] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[00202] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00203] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[00204] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00205] In some configurations, side arms or headgear arms comprise cheek pads.
[00206] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00207] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[00208] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00209] In some configurations, the cheek pad is formed as a hollow body.
[00210] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00211] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[00212] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[00213] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[00214] In some configurations, wherein the second direction is a laterally outward direction.
[00215] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, and a second gases port in the interface body and in fluid communication with the gases flow channel, wherein the first gases port and second gases port are removably connectable between a first gases conduit, a second gases conduit and a diffuser, and wherein the nasal interface is reconfigurable between at least two of the following configurations wherein: a) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body; b) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body, wherein the diffuser or a filter is directly attached to an end of the second gases conduit distal to the second gases port; c) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the second gases port, optionally wherein the diffuser is directly attached to the second gases port for enabling the exhaled gases to be expelled out of the interface body through the second gases port and diffuser; and d) the second gases conduit is directly connected to the second gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the first gases port, optionally wherein the diffuser is directly attached to the first gases port for enabling the exhaled gases to be expelled out of the interface body through the first gases port and diffuser. [00216] In some configurations, the diffuser is a bias flow diffuser.
[00217] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[00218] In some configurations, the diffuser comprises a diffuser material.
[00219] In some configurations, the diffuser comprises clamping portions to hold the diffuser material therebetween.
[00220] In some configurations, the diffuser comprises at least one aperture.
[00221] In some configurations, the nasal interface comprises a Y-piece connector directly connected or configured to by directly connected to the first and second gases ports and first gases conduit.
[00222] In some configurations, the nasal interface comprises a 3-way adaptor configured to be interchangeably connected at its first end to an end of the first conduit distal from the interface body or a further respiratory device, and to be connected at its second end to a respiratory tubing.
[00223] In some configurations, the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient.
[00224] In some configurations, at least one flow restriction creates or contributes to the asymmetric flow.
[00225] In some configurations, at least one flow restriction is formed by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[00226] In some configurations, the interface body comprises a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00227] In some configurations, the at least one baffle has a thickness that varies along its length.
[00228] In some configurations, a middle of the at least one baffle baffles is thicker than the ends of the at least one baffle.
[00229] In some configurations, the flow area at the middle of the at least one baffle is between about 50 mm2 and about 300 mm2.
[00230] is between about 50 mm2 and about 80 mm2. [00231] In some configurations, the flow area at the middle of the at least one baffle is about 65 mm2.
[00232] In some configurations, the flow area at the middle of the at least one baffle is between about 100 mm2 and about 200 mm2.
[00233] In some configurations, the flow area at the middle of the at least one baffle is between about 150 mm2 and about 200 mm2.
[00234] In some configurations, the flow area at the middle of the at least one baffle is about 180 mm2.
[00235] In some configurations, the at least one baffle is configured to create a flow restriction in the gases flow channel.
[00236] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion creating the asymmetric flow.
[00237] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00238] In some configurations, the interface body comprises a frame portion and a cushion portion.
[00239] In some configurations, the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
[00240] In some configurations, the cushion portion and frame portion are inter- engageable to form the interface body.
[00241] In some configurations, the interface body comprises a cushion portion and a frame portion, the first gases port formed as a first cushion opening in the cushion portion and a first frame opening formed in the frame portion, and the second gases port formed as a second cushion opening in the cushion portion and a second frame opening formed in the frame portion, wherein the first cushion opening and first frame opening are inter-engageable, and wherein the second cushion opening and second frame opening are inter-engageable to attach the cushion portion to the frame portion. [00242] In some configurations, the frame portion comprises a first protrusion comprising the first frame opening and a second protrusion comprising the second frame opening, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion.
[00243] In some configurations, the cushion portion comprises a first protrusion comprising the first cushion opening and a second protrusion comprising the second cushion opening, wherein the first and second protrusions are receivable in respective first and second apertures in the frame portion.
[00244] In some configurations, the first protrusion and second protrusion are generally circular in cross-section.
[00245] In some configurations, the first aperture and second aperture are formed as a generally C-shaped opening.
[00246] In some configurations, the first protrusion and the second protrusion are formed as a bead at and edge of the cushion portion.
[00247] In some configurations, at least a portion of the first conduit and second conduit extend away from the interface body in a divergent direction.
[00248] In some configurations, the first conduit and second conduit are interchangeable with one another.
[00249] In some configurations, the first gases port and the second gases port have substantially the same sized openings.
[00250] In some configurations, same sized openings have the same cross section and/or geometry in a direction transverse to gases flow through the first and second gases ports.
[00251] In some configurations, the first gases port points substantially toward the first delivery element or first delivery element portion and the second gases port points substantially toward the second delivery element or second delivery element portion.
[00252] In some configurations, the first gases port has a first gases port connection feature for connecting to either of the first and second respiratory system component and wherein the second gases port has a second gases port connection feature for connecting to either of the first and second respiratory system component, and wherein the first gases port connection feature is substantially the same as the second gases port connection feature.
[00253] In some configurations, at least one of the first gases port connection feature and second gases port connection feature is a clip or a lip for engaging with the first and/or second respiratory component. [00254] In some configurations, the first gases port and second gases port are substantially circular.
[00255] In some configurations, the first respiratory component and second respiratory component are tethered.
[00256] In some configurations, at least one of the first respiratory component and second respiratory component are tethered to the interface body.
[00257] In some configurations, the first gases port and the second gases port are symmetrical about a midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00258] In some configurations, the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect.
[00259] In some configurations, the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
[00260] In some configurations, the angle between the first axis and the second axis is more than 15 degrees and up to about 80 degrees.
[00261] In some configurations, the angle between the first axis and the second axis is more than 30 degrees and up to about 75 degrees.
[00262] In some configurations, the angle between the first axis and the second axis is more than 40 degrees and up to about 60 degrees.
[00263] In some configurations, the angle between the first axis and the second axis is about 50 degrees.
[00264] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00265] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
[00266] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear. [00267] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[00268] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00269] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[00270] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00271] In some configurations, side arms or headgear arms comprise cheek pads.
[00272] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00273] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[00274] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00275] In some configurations, the cheek pad is formed as a hollow body.
[00276] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00277] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[00278] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[00279] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction. [00280] In some configurations, wherein the second direction is a laterally outward direction.
[00281] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising : an interface body comprising a gases flow channel, a first nasal delivery element comprising a first outlet in fluid communication with the gases flow channel and a second nasal delivery element comprising a second outlet in fluid communication with a gases flow channel, wherein the first nasal delivery element and the second nasal delivery element are each configured to seal with a respective naris of a patient to deliver gases to the respective naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel for enabling respiratory gases to be delivered into the interface body, a second gases port in the interface body and in fluid communication with the gases flow channel for enabling exhaled gases to be expelled out of the interface body, the interface body comprising a lip-contacting portion that is arranged to contact an upper lip region of the patient in use, the interface body comprising a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises a headgear connection feature to connect to a respective end of a headgear to fit the nasal interface to a patient's head, wherein the headgear connection feature is positioned at a height generally between the first and second outlets and the lip-contacting portion, such that in use the headgear pulls the body portion against the patient's face in a direction between an insertion direction of the nasal delivery elements in the patient's nares and a force applied by the user's face to the lip-contacting portion.
[00282] In some configurations, the interface body comprises a frame portion and a cushion portion, wherein the cushion portion comprises the first and second nasal delivery elements, and wherein the frame portion comprises the pair of side arms.
[00283] In some configurations, the first and second nasal delivery elements each comprise a pillow.
[00284] In some configurations, each headgear connection feature comprises a post to connect with a hook at the respective end of the headgear.
[00285] In some configurations, the gases inlet defines a first axis corresponding to a gases flow direction through the first gases port, and wherein the post of the proximal side arm is oriented at an angle of between about 90 degrees and about 135 degrees from the first axis, wherein the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, and wherein the post of the proximal side arm is oriented at an angle of between about 90 degrees and about 135 degrees from the second axis.
[00286] In some configurations, the first gases port is formed as a first cushion opening in the cushion portion and a first frame opening is formed in the frame portion, and the second gases port is formed as a second cushion opening in the cushion portion and a second frame opening is formed in the frame portion, wherein the first cushion opening and first frame opening are inter-engageable, and wherein the second cushion opening and second frame opening are inter-engageable to attach the cushion portion to the frame portion.
[00287] In some configurations, the frame portion comprises a first protrusion comprising the first frame opening and a second protrusion comprising the second frame opening, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion.
[00288] In some configurations, the cushion portion comprises a first protrusion comprising the first cushion opening and a second protrusion comprising the second cushion opening, wherein the first and second protrusions are receivable in respective first and second apertures in the frame portion.
[00289] In some configurations, the first gases port and the second gases port are symmetrical about a midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00290] In some configurations, the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect.
[00291] In some configurations, the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
[00292] In some configurations, the angle between the first axis and the second axis is more than 15 degrees and up to about 80 degrees.
[00293] In some configurations, the angle between the first axis and the second axis is more than 30 degrees and up to about 75 degrees.
[00294] In some configurations, the angle between the first axis and the second axis is more than 40 degrees and up to about 60 degrees.
[00295] In some configurations, the angle between the first axis and the second axis is about 50 degrees. [00296] In some configurations, each nasal delivery element comprises a base wall that is thicker and/or more rigid than a remainder of the nasal delivery element.
[00297] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
[00298] In some configurations, the asymmetric flow is created by or contributed to by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[00299] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[00300] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00301] In some configurations, at least one flow restriction creates or contributes to the asymmetric flow.
[00302] In some configurations, at least one flow restriction is formed by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[00303] In some configurations, the interface body comprises a plurality of spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00304] In some configurations, the at least one baffle has a thickness that varies along its length.
[00305] In some configurations, a middle of the at least one baffle is thicker than the ends of the at least one baffle.
[00306] In some configurations, the flow area at the middle of the at least one baffle is between about 50 mm2 and about 300 mm2. [00307] In some configurations, the flow area at the middle of the at least one baffle is between about 50 mm2 and about 80 mm2.
[00308] In some configurations, the flow area at the middle of the at least one baffle is about 65 mm2.
[00309] In some configurations, the flow area at the middle of the at least one baffle is between about 100 mm2 and about 200 mm2.
[00310] In some configurations, the flow area at the middle of the at least one baffle is between about 150 mm2 and about 200 mm2.
[00311] In some configurations, the flow area at the middle of the at least one baffle is about 180 mm2.
[00312] In some configurations, the at least one baffle is configured to create a flow restriction in the gases flow channel.
[00313] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00314] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
[00315] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00316] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[00317] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00318] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region. [00319] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00320] In some configurations, side arms or headgear arms comprise cheek pads.
[00321] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00322] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[00323] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00324] In some configurations, the cheek pad is formed as a hollow body.
[00325] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00326] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[00327] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[00328] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[00329] In some configurations, wherein the second direction is a laterally outward direction.
[00330] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion comprising a first outlet in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion comprising a second outlet in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port configured for connecting to a first respiratory component for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port for enabling exhaled gases to be expelled out of the interface body, the second gases port configured for connecting to a second respiratory component, wherein the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00331] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
[00332] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[00333] In some configurations, the interface body comprises a pair of side arms, said side arms being symmetrical about the first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00334] In some configurations, the side arms are symmetrical about the second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
[00335] In some configurations, the interface body comprises a frame portion and a cushion portion.
[00336] In some configurations, the frame portion comprises the first gases port and the second gases port, and the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
[00337] In some configurations, the nasal interface comprises a first outlet in the first delivery element and a second outlet in the second delivery element, wherein the shape of the shape of the first outlet and second outlet are substantially the same.
[00338] In some configurations, the nasal interface comprises a first outlet in the first delivery element and a second outlet in the second delivery element, wherein the first outlet and second outlet are circular in shape. [00339] In some configurations, the first gases port points substantially toward the first outlet and the second gases port points substantially toward the second outlet.
[00340] In some configurations, an opening of the first gases port and second gases port are substantially circular, and wherein the opening of the first gases port is concentric with first outlet and the opening of the second gases port is concentric with the second outlet.
[00341] In some configurations, the first gases port defines a first axis corresponding to the first gases port pointing substantially toward the first outlet, and the second gases port defines a second axis corresponding to the second gases port pointing substantially toward the second outlet a gases flow direction through the second gases port, wherein the first and second axes intersect.
[00342] In some configurations, the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
[00343] In some configurations, the angle between the first axis and the second axis is more than 15 degrees and up to about 80 degrees.
[00344] In some configurations, the angle between the first axis and the second axis is more than 30 degrees and up to about 75 degrees.
[00345] In some configurations, the angle between the first axis and the second axis is more than 40 degrees and up to about 60 degrees.
[00346] In some configurations, the angle between the first axis and the second axis is about 50 degrees.
[00347] In some configurations, the first gases port and the second gases port have substantially the same configuration such that the first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that the second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
[00348] In some configurations, the first respiratory system component is a first gases conduit for delivery of respiratory gases into the nasal interface, and wherein the second respiratory system component is a diffuser or a second gases conduit.
[00349] In some configurations, the diffuser is a bias flow diffuser.
[00350] In some configurations, the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port, and wherein the at least one baffle being symmetrical about the first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00351] In some configurations, the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port, and wherein the at least one baffle is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
[00352] In some configurations, the interface body comprises a plurality of spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00353] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of the patient.
[00354] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[00355] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00356] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00357] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction. [00358] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00359] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[00360] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00361] In some configurations, side arms or headgear arms comprise cheek pads.
[00362] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00363] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[00364] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00365] In some configurations, the cheek pad is formed as a hollow body.
[00366] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00367] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[00368] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[00369] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[00370] In some configurations, wherein the second direction is a laterally outward direction.
[00371] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel for enabling respiratory gases to be delivered into the interface body, a second gases port in the interface body and in fluid communication with the gases flow channel for enabling exhaled gases to be expelled out of the interface body, the interface body comprising a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00372] In some configurations, the nasal interface comprises the headgear connecting portion.
[00373] In some configurations, a headgear comprises the headgear connecting portion.
[00374] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[00375] In some configurations, the moveable connection is a rotatable connection about the ball and socket joint.
[00376] In some configurations, each side arm comprises a distal end that is distal to the interface body the ball portion or socket portion positioned at the distal end.
[00377] In some configurations, the ball portion is formed as an aperture with a ball shaped feature formed in the wall of the aperture.
[00378] In some configurations, the aperture is substantially a D-shape and the ball is formed in the straight portion of the D shape.
[00379] In some configurations, the socket portion is formed as a hooked portion.
[00380] In some configurations, the hooked portion is configured to pass through the aperture and engage at least partially around the ball portion.
[00381] In some configurations, an end of the hooked portion formed with an undercut profile to enable the ball portion to be engageable at least partially around the ball portion. [00382] In some configurations, the undercut portion is substantially a C-shape in profile to conform with the shape of the ball portion.
[00383] In some configurations, the headgear connecting portion is an elongate portion and defines a connecting portion axis between its ends.
[00384] In some configurations, the ball and socket joint is configured to allow the headgear connecting portion to rotatably twist relative to the side arms, wherein the connecting portion axis does not move.
[00385] In some configurations, the angle of twisting from a neutral position is any point between 0 and about 85 degrees in opposing directions.
[00386] In some configurations, the angle of twisting from a neutral position is any point between 0 and about 75 degrees in opposing directions.
[00387] In some configurations, the angle of twisting from a neutral position is any point between 0 and about 60 degrees in opposing directions.
[00388] In some configurations, the angle of twisting from a neutral position is any point between 0 and about 45 degrees in opposing directions.
[00389] In some configurations, the ball and socket joint is configured to allow the headgear connecting portion to rotatably move such that the connecting portion axis is angled relative to the connecting portion axis in a neutral position.
[00390] In some configurations, the connecting portion axis angle is positionable at any point between 0 and about 85 degrees.
[00391] In some configurations, the connecting portion axis angle is positionable at any point between 0 and about 75 degrees.
[00392] In some configurations, the connecting portion axis angle is positionable any point between 0 and about 60 degrees in opposing directions.
[00393] In some configurations, the connecting portion axis angle is positionable any point between 0 and about 45 degrees in opposing directions.
[00394] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at any angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[00395] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00396] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at any angle between 0 and about 85 degrees in opposing directions. [00397] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at any angle between 0 and about 75 degrees in opposing directions.
[00398] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at any angle between 0 and about 60 degrees in opposing directions.
[00399] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at any angle between 0 and about 45 degrees in opposing directions.
[00400] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00401] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
[00402] In some configurations, the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
[00403] In some configurations, the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[00404] In some configurations, the interface body comprises a plurality of spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00405] In some configurations, the interface body comprises a frame portion and a cushion portion.
[00406] In some configurations, the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion. [00407] In some configurations, the cushion portion and frame portion are inter- engageable to form the interface body.
[00408] In some configurations, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of the patient.
[00409] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[00410] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00411] In some configurations, the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[00412] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00413] In some configurations, side arms or headgear arms comprise cheek pads.
[00414] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00415] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[00416] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00417] In some configurations, the cheek pad is formed as a hollow body.
[00418] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00419] In some configurations, the hooking connection comprises slot openings for securing at least one strap. [00420] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion.
[00421] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[00422] In some configurations, wherein the second direction is a laterally outward direction.
[00423] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed, the patient interface comprising : a nasal interface, the nasal interface comprising an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel for enabling respiratory gases to be delivered into the interface body, a second gases port in the interface body and in fluid communication with the gases flow channel for enabling exhaled gases to be expelled out of the interface body, the interface body comprising a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear, and a pair of the headgear connecting portions each moveable connected to one of the side arms, each side arm comprising either the ball or socket portion and each headgear connecting portion comprising the corresponding socket or ball portion.
[00424] In some configurations, the interface body is configured to deliver gases to a first naris of the patient and to a second naris of the patient.
[00425] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element in fluid communication with the gases flow channel and configured to deliver gases to or from the first naris of the patient, a second delivery element in fluid communication with the gases flow channel and configured to deliver gases to or from the second naris of the patient, a first gases port for delivery of respiratory gases into the nasal interface, and a second gases port for expelling exhaled gases out of the nasal interface, wherein the nasal interface is configured to create a flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient, and wherein the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
[00426] In some configurations, the nasal pillow comprises an outlet distal to the interface body for the passage of gases into or out of the nasal interface, and a base proximal to the interface body, wherein a cross-sectional area of the base is larger than the outlet.
[00427] In some configurations, the outlet and base both comprise substantially circular or oval diameter cross-sections.
[00428] In some configurations, the diameter of the base is larger than the diameter of the outlet.
[00429] In some configurations, the thinned region is a narrower wall thickness.
[00430] In some configurations, wherein at least one of the nasal pillows has a plurality of thinned regions for sealing around a tube passing therethrough at different locations.
[00431] In some configurations, the first gases port is in fluid communication with the interface body to deliver the respiratory gases from the first gases port through the interface body to the first naris and/or second naris of the patient in use.
[00432] In some configurations, the second gases port is in fluid communication with the interface body to expel the exhaled gases from the first and/or second naris of the patient through the interface body to the second gases port in use.
[00433] In some configurations, the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
[00434] In some configurations, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
[00435] In some configurations, the plurality of thinned regions are symmetrical about the second midline plane of the interface body.
[00436] In some configurations, the nasal interface may be inverted and placed on a patient with the tube remaining in the same position.
[00437] In some configurations, the pillows are convex shaped.
[00438] In some configurations, the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
[00439] In some configurations, the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
[00440] In some configurations, the interface body comprises a plurality of spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00441] In some configurations, the interface body comprises a frame portion and a cushion portion.
[00442] In some configurations, the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
[00443] In some configurations, the cushion portion and frame portion are inter- engageable to form the interface body.
[00444] In some configurations, the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of the patient.
[00445] In some configurations, the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
[00446] In some configurations, the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
[00447] In some configurations, the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00448] In some configurations, the headgear connecting portion is configured to rotatably move from a central position at an angle between at least 0 degrees and about 90 degrees relative to the side arm in any direction.
[00449] In some configurations, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00450] In some configurations, the interface body comprises at least one cheek pad positioned on straps or arms connected to lateral portions of the interface body and configured to be positioned on a patient's cheek when in use.
[00451] In some configurations, side arms or headgear arms comprise cheek pads.
[00452] In some configurations, the cheek pads are formed of a flexible material to allow the cheek pads to conform to a patient's cheek.
[00453] In some configurations, the cheek pad has a bulbous or oval shape extending in a patient direction from the strap or arm.
[00454] In some configurations, the cheek pad is formed having a substantially tubular body with a lateral channel extending therethrough.
[00455] In some configurations, the cheek pad is formed as a hollow body.
[00456] In some configurations, the cheek pad comprises a pad opening configured to inter-engage with a hooking connection formed on the strap or arm for securing the cheek pad to the strap or arm.
[00457] In some configurations, the hooking connection comprises slot openings for securing at least one strap.
[00458] In some configurations, the nasal interface comprises a gases delivery elbow coupled to, or defining, the gases inlet portion. [00459] In some configurations, the gases delivery elbow comprises a gases delivery portion extending in a first direction to couple to, or defining, the gases inlet port of the interface body, and a gases receipt portion extending in a second direction and configured to receive the incoming respiratory gases from the gases supply conduit and to deliver the incoming respiratory gases to the gases delivery portion, and wherein the first direction is transverse to the second direction.
[00460] In some configurations, wherein the second direction is a laterally outward direction.
[00461] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a nasal interface is disclosed, the nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, wherein the first and the second delivery elements optionally comprise a pillow, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port directly connected to or configured to directly connect to a first respiratory component, optionally a first gases conduit, for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port directly connected to or configured to directly connect to a second respiratory component for enabling exhaled gases to be expelled out of the interface body, wherein the nasal interface is configured to create an asymmetric flow of gases, optionally pressure, at a patient's nasal airways throughout a respiratory cycle of a patient.
[00462] In some configurations, the first gases port and the second gases port have substantially the same configuration such that the first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that the second respiratory component can be selectively connected to each of the first gases port and to the second gases port, the first gases port and the second gases port optionally having substantially the same sized openings, wherein the same sized openings, optionally, have the same geometry in a direction transverse to gases flow through the first and second gases ports, the first gases port and the second gases port optionally being substantially circular. [00463] In some configurations, the first gases port has a first gases port connection feature for connecting to either of the first and second respiratory system component and wherein the second gases port has a second gases port connection feature for connecting to either of the first and second respiratory system component, wherein the first gases port connection feature is substantially the same as the second gases port connection feature and/or wherein at least one the first gases port connection feature and the second gases port connection feature is clip or a lip for engaging with the first and/or second respiratory component.
[00464] In some configurations, the second respiratory component is a second gases conduit, wherein the second gases port is directly connected to or configured to directly connect to the second gases conduit, or a diffuser, wherein the diffuser is directly connected or configured to directly connect to the second gases port and/or to an end of the second conduit distal from the interface body.
[00465] In some configurations, the nasal interface is reconfigurable between at least two of the following configurations wherein: the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body; the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body, wherein the diffuser or a filter is directly attached to an end of the second gases conduit distal to the second gases port; the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the second gases port, optionally wherein the diffuser is directly attached to the second gases port for enabling the exhaled gases to be expelled out of the interface body through the second gases port and the diffuser; and the second gases conduit is directly connected to the second gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the first gases port, optionally wherein the diffuser is directly attached to the first gases port for enabling the exhaled gases to be expelled out of the interface body through the first gases port and diffuser.
[00466] In some configurations, the diffuser is a bias flow diffuser, the diffuser optionally comprising at least one aperture and/or a diffuser material as well as optionally clamping portions to hold the diffuser material therebetween. [00467] In some configurations, wherein at least one flow restriction creates or contributes to the asymmetric flow, the at least one flow restriction optionally being formed by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port, wherein, optionally, a plurality of spaced apart baffles extend along the gases flow channel, wherein the baffles optionally extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
[00468] In some configurations, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow, the first gases port optionally pointing substantially toward the first delivery element or first delivery element portion and the second gases port optionally pointing substantially toward the second delivery element or second delivery element portion, wherein, optionally, the opening of the first gases port is concentric with a first outlet of the first delivery element or first delivery element portion and the opening of the second gases port is concentric with a second outlet of the second delivery element or second delivery element portion.
[00469] In some configurations, wherein the first gases port and the second gases port are symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use, wherein, optionally, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets, the interface body, optionally, comprising a pair of side arms, said side arms being symmetrical about the first midline plane of the interface body and/or the second midline plane of the interface body.
[00470] In some configurations, wherein the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect, wherein, optionally, the first axis and the second axis lie within the second midline plane.
[00471] In some configurations, wherein the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees, optionally more than 15 degrees and up to 80 degrees, optionally more than 30 degrees and up to about 75 degrees, optionally more than 40 degrees and up to about 60 degrees, optionally about 50 degrees.
[00472] In some configurations, wherein the interface body comprises a first side at which the first and second nasal delivery elements or delivery element portions are provided and an opposite second side at which the first and second gases ports are provided, the interface body as a whole optionally being curved and having a radial inner surface forming the first side and a radial outer surface forming the second side.
[00473] In some configurations, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear, wherein, optionally, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
[00474] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed, the patient interface comprising: the nasal interface of any configuration above and a pair of the headgear connecting portions each moveable connected to one of the side arms, each side arm comprising either the ball or socket portion and each headgear connecting portion comprising the corresponding socket or ball portion.
[00475] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising: a respiratory therapy apparatus comprising: a controller; an ambient air inlet; a gases outlet; and a nasal interface according to any of the above configurations.
[00476] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a method of changing the configuration or direction of a gases inlet of a nasal interface outlined above or herein is disclosed, the method comprising: rotating the ball portion within the socket portion of the ball and socket joint, such that nasal interface goes from a first configuration where the gases inlet is on a left side of the nasal interface to a second configuration where gases inlet is on a right side of the nasal interface, wherein rotating the ball portion in the socket portion causes the change from first configuration to second configuration.
[00477] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a patient interface is disclosed, the patient interface comprising : a nasal interface, the nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, and a second gases port in the interface body and in fluid communication with the gases flow channel, and a headgear comprising first and second ends with connectors that are configured to connect to the headgear connection features on the side arms.
[00478] In some configurations, the interface body of the nasal interface comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises a headgear connection feature to connect to a respective end of a headgear to fit the nasal interface to a patient's head.
[00479] In some configurations, the headgear is reversible so that either of the ends of the headgear can be connected to either of the headgear connection features.
[00480] In some configurations, each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
[00481] In accordance with certain features, aspects and advantages of at least one of the embodiments disclosed herein, a respiratory therapy system is disclosed, the respiratory therapy system comprising : a controller; an ambient air inlet; a gases outlet; and a nasal interface comprising : an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, and a second gases port in the interface body and in fluid communication with the gases flow channel.
[00482] In some configurations, the respiratory therapy system comprises a blood oxygen saturation sensor; an oxygen inlet; and a valve in fluid communication with the oxygen inlet to control a flow of oxygen through the oxygen inlet; wherein the controller is configured to control the valve based on at least one measurement of oxygen saturation from the blood oxygen saturation sensor.
[00483] In some configurations of any of the nasal interfaces described herein, the nasal delivery elements are configured to form a seal with the patient's nares, and the nasal interface is configured to provide pressure and asymmetrical flow at the patient's airways in use.
[00484] Features from one or more embodiments or configurations may be combined with features of one or more other embodiments or configurations. Additionally, more than one embodiment or configuration may be used together in a respiratory support system during a process of respiratory support of a patient.
[00485] As used herein the term "(s)" following a noun means the plural and/or singular form of that noun.
[00486] As used herein the term "and/or" means "and" or "or", or where the context allows both.
[00487] The term "comprising" as used in this specification means "consisting at least in part of". When interpreting each statement in this specification that includes the term "comprising", features other than that or those prefaced by the term may also be present. Related terms such as "comprise" and "comprises" are to be interpreted in the same manner.
[00488] It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range (for example, 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of rational numbers within that range (for example, 2 to 8, 1.5 to 5.5 and 3.1 to 4.7) and, therefore, all sub-ranges of all ranges expressly disclosed herein are hereby expressly disclosed. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application in a similar manner.
[00489] This disclosure may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more said parts, elements or features, and where specific integers are mentioned herein which have known equivalents in the art to which this disclosure relates, such known equivalents are deemed to be incorporated herein as if individually set forth. [00490] The disclosure consists in the foregoing and also envisages constructions of which the following gives examples only.
BRIEF DESCRIPTION OF THE DRAWINGS
[00491] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
[00492] Figure 1 is a perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface.
[00493] Figure 2 shows a top section perspective view of the nasal interface of Figure 1.
[00494] Figure 3 shows a rear section perspective view of the nasal interface of Figure 1, i.e. from the patient direction.
[00495] Figure 4 shows a top section perspective view of the nasal interface of Figure 1.
[00496] Figure 5 shows a top section perspective view of the nasal interface of Figure 1.
[00497] Figure 6 shows a plan section view of a schematic of the nasal interface of Figure 1.
[00498] Figure 7 shows a diffuser I diffuser cap for use with the nasal interface of Figure 1.
[00499] Figure 8 shows a further diffuser I diffuser cap for use with the nasal interface of Figure 1.
[00500] Figure 9 shows a front perspective view of the nasal interface of Figure 1.
[00501] Figure 10 shows a plan section view of the nasal interface of Figure 1.
[00502] Figure 11 shows a front perspective view of a frame of the nasal interface of Figure 1.
[00503] Figure 12 shows a front perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-11, and Figures 17-55.
[00504] Figure 13 shows a top section perspective view of the nasal interface of Figure 12.
[00505] Figure 14 shows a side section perspective view of the nasal interface of Figure 12. [00506] Figure 15 shows a top-rear perspective view of a frame of the nasal interface of Figure 12.
[00507] Figure 16 shows a side section schematic view of the nasal interface of Figure 12.
[00508] Figure 17 shows a front perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-16 and Figures 25-55.
[00509] Figure 18 shows a front section perspective view of the nasal interface of Figure 17.
[00510] Figure 19 shows a front section perspective view of the nasal interface of Figure 17.
[00511] Figure 20 shows a side section perspective view of the nasal interface of Figure 17.
[00512] Figure 21 shows a top section perspective view of the nasal interface of Figure 17.
[00513] Figure 22 shows a front section perspective view of an alternative configuration to the nasal interface of Figure 17.
[00514] Figure 23 shows a side section perspective view of an alternative configuration to the nasal interface of Figure 17.
[00515] Figure 24 shows a rear partially transparent perspective view of an alternative configuration to the nasal interface of Figure 17.
[00516] Figure 25 shows a perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-24, and Figures 27-55.
[00517] Figure 26 shows a top section perspective view of the nasal interface of Figure 25.
[00518] Figure 27 shows a side section view of a cap for use with the nasal interface of Figures 1-26.
[00519] Figure 28 shows a side section view of an adapter for use with the nasal interface of Figures 1-26.
[00520] Figure 29 shows a side perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-26, and Figures 33-55.
[00521] Figure 30 shows a side perspective view of the nasal interface of Figure 29.
[00522] Figure 31 shows a side perspective view of the nasal interface of Figure 29. [00523] Figure 32 shows a side perspective view of the nasal interface of Figure 29.
[00524] Figure 33 shows rear perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-32, and Figures 38-55.
[00525] Figure 34 shows a top perspective view of the nasal interface of Figure 33.
[00526] Figure 35 shows a rear-side perspective view of the nasal interface of Figure
33.
[00527] Figure 36 shows a rear perspective view of the frame of the nasal interface of Figure 33.
[00528] Figure 37 shows a rear perspective view of an alternative frame of the nasal interface of Figure 33.
[00529] Figure 38 shows top-front perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-37, and Figures 45-55.
[00530] Figure 39 shows a front perspective detailed view the side arm of the nasal interface of Figure 38.
[00531] Figure 40 shows a front perspective detailed view the side arm of the nasal interface of Figure 38.
[00532] Figure 41 shows a side perspective detailed view the side arm of the nasal interface of Figure 38.
[00533] Figure 42 shows a side perspective detailed view the side arm of the nasal interface of Figure 38.
[00534] Figure 43 shows a side perspective detailed view the side arm of the nasal interface of Figure 38.
[00535] Figure 44 shows a top plan detailed view the side arm of the nasal interface of Figure 38.
[00536] Figure 45 shows thinned regions of the interface body of the nasal interface of Figure 33.
[00537] Figure 46 shows a bottom perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-45, and Figures 48-55.
[00538] Figure 47 shows thinned regions of the interface body of the nasal interface of Figure 46. [00539] Figure 48 shows top perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-47, and Figures 49-55.
[00540] Figure 49 shows top perspective view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-48, and Figures 50-55.
[00541] Figure 50 shows top perspective sectional view of an exemplary configuration patient interface of the present disclosure comprising a nasal interface, which may also be the nasal interface of or used with any of Figures 1-49, and Figures 51-55.
[00542] Figure 50A shows the top perspective sectional view of Figure 50 with additional features relating to the arms.
[00543] Figure 51 shows a front perspective view of any of the patient interfaces of the present disclosure in a first configuration.
[00544] Figure 52 shows a front perspective view of any of the patient interfaces of the present disclosure in a second configuration.
[00545] Figure 53 shows a front perspective view of any of the patient interfaces of the present disclosure in a third configuration.
[00546] Figure 54 shows a front perspective view of any of the patient interfaces of the present disclosure in a fourth configuration.
[00547] Figure 55 shows a front perspective view of any of the patient interfaces of the present disclosure in a fifth configuration.
[00548] Figure 56 shows schematically a respiratory therapy system configured to provide a respiratory therapy to a patient.
[00549] Figure 57 shows a block diagram of a control system interacting with and/or providing control and direction to components of a respiratory therapy system.
DETAILED DESCRIPTION
[00550] Patient interfaces can be used for delivering breathing gases to airways of a patient. The patient interfaces may comprise nasal interfaces that can be used to deliver a flow of gases to a patient. In some configurations, nasal delivery elements, such as nasal prongs or pillows, are inserted into the nose of a patient to deliver the required therapy. The nasal delivery elements seal at the nose to deliver the therapy. One or more of the nasal delivery elements may comprise a nasal pillow to seal at the nose.
[00551] Disclosed is a system to deliver gases to a patient through a nasal interface. [00552] In some configurations, the system provides a pressure differential at first and second nasal delivery elements of the nasal interface, with a resulting differential gases flow at the first and second nasal delivery elements. This allows an asymmetrical or asymmetric flow to be delivered through the nasal interface to both nares. Asymmetrical flow as described herein refers to a flow that differs within the nasal interface or within the nose. In this way, a different flow may be delivered by each nasal delivery element. An asymmetrical flow also includes substantially unidirectional flow or partial unidirectional flow.
[00553] Delivery of asymmetrical flow may improve clearance of dead space in the upper airways, e.g. by flushing out CO2 built up in the airways at the end of expiration. A nasal interface as described is configured to produce such asymmetrical flow through nasal delivery elements.
[00554] Flow generated by respiratory therapy depends on flow through the nasal interface, which depends on the pressure at each nasal delivery element. If the pressure is different at each nasal delivery element, an asymmetric flow of gases will be generated. [00555] If flow, leak, or a combination of flow and leak, is asymmetrical through the nasal interface, the flow through the nose may become asymmetrical during breathing. Partial unidirectional flow may be a type of asymmetrical flow. Partial unidirectional flow may provide improved clearance of anatomical dead space as the air is flushed from the upper airways. Partial unidirectional flow may be more comfortable than total unidirectional flow. Total unidirectional flow herein includes all flow entering one naris by a nasal delivery element and exiting via the other naris via a nasal delivery element, venting to the atmosphere, due to the absence of a nasal delivery element, or the like. Partial unidirectional flow as described herein includes flow that may enter the nose via both nares and leave the nose from one naris, flow that may enter the nose through one naris and leave the nose via both nares, or different proportions of flow that may enter the nose through both nares and/or different proportions of flow that may leave the nose through both nares, and may be flow that may enter the nose via both nares and leave the nose from one or both nares and optionally via the mouth. If there is a pressure differential between the first and second nasal delivery elements, during inspiration the first nasal delivery element will receive more gases flow from a gases inlet than the second nasal delivery element. During expiration, the second nostril associated with the second nasal delivery element will expel more gases flow than the first nostril associated with the first nasal delivery element. The pressure differential between the first and second nasal delivery elements can change depending on whether the patient's breathing cycle is in an inspiration phase or expiration phase.
[00556] The asymmetrical flow assessment may be applied over a suitable period. For example, the asymmetrical flow assessment may be applied over one breath cycle of the patient or alternatively over a different number of breath cycles of the patient.
[00557] The partially unidirectional flow may reduce turbulence in the patient's nasal cavity, which could improve comfort. A reduction in turbulence can also reduce noise in the nasal cannula providing a quieter interface and improved comfort.
[00558] Figures 1-55 show an exemplary patient interface 1 that comprises a nasal interface 100 with nasal delivery elements comprising a first nasal delivery element 111 and a second nasal delivery element 112.
[00559] The nasal interface 100 provides a patient with a patient interface suitable for the delivery of pressure-controlled, optionally high humidity, gas flow to the patient's nasal cavity/nares. In some configurations, the nasal interface 100 is adapted to deliver a high flow of gases over a wide flow range (e.g. about 8 Ipm (liters per minute), or higher depending on other therapy applications, perhaps such as 10 - 50 Ipm, 20 - 40 Ipm, or higher). The flow rates may be bias flows averaged over time. In some configurations, the nasal interface 100 is adapted to deliver a lower flow of gases. The flow is dependent on pressure so it can fluctuate depending on different breathing pressures and set pressures. Wherein set pressure(s) relates to the therapy and/or patient pressure(s) which are maintained by an ancillary respiratory therapy apparatus when used in conjunction with the nasal interface of the disclosure.
[00560] In some configurations, the nasal interface 100 can be used to provide asymmetric continuous positive airway pressure (CPAP) therapy. Pressure is created in the patient's airways and controlled, but there is also asymmetric or partial unidirectional flow in the patient's airways. This provides pressure therapy with flushing.
[00561] The nasal interface 100 comprises a face mount part or interface body 110 part including a pair of hollow nasal delivery elements 111 and 112, integrally moulded with or removably attached to the interface body 110. The nasal interface 100 comprises a gases manifold 120 part or frame 120 that comprises a gases inlet 121. The gases manifold 120 may be removably attached or integrally moulded to the respiratory conduit 300.
[00562] The interface body 110 part may be connectable to or engageable with the gases manifold 120 part, or may be integrally formed or permanently engaged with the gases manifold 120 part. If the interface body 110 part is engageable with the gases manifold part 120, that engagement brings the first nasal delivery element 111 and the second nasal delivery element 112 into fluid communication with the gases inlet 121 such that the first nasal delivery element 111 is more proximal the gases inlet 121 and the second nasal delivery 112 element is more distal the gases inlet 121.
[00563] The interface body 110 may be formed from a soft, flexible material such as silicone, thermoplastic elastomers, or other polymers known in the art. The nasal delivery elements 111 and 112 may be supple and may be formed from a sufficiently thin layer of silicone or other suitable material to achieve this property. The interface body 110 and nasal delivery elements 111, 112 may, for example, be formed from an elastomeric material that is able to confirm to the geometry of a patient's nostril and/or cheek and provide an effective pneumatic seal.
[00564] The gases manifold 120 may be formed from a relatively harder material such as Polycarbonate, a High-Density Polyethylene (HDPE) or any other suitable plastics material known in the art. The interface body 110 provides a soft interfacing component to the patient for comfortably delivering the flow of gases through the nasal delivery elements 111 and 112, while the gases manifold 120 fluidly couples the respiratory conduit 300 to the nasal delivery elements 111 and 112 of the interface body 110.
[00565] The nasal delivery elements 111 and 112 are substantially hollow.
[00566] The first and second nasal delivery elements 111, 112 may have the same shape and configuration as each other, i.e. may be symmetrical. In other configurations, the first and second nasal delivery elements may have a different shape and/or configuration from each other, i.e. may be asymmetrical.
[00567] The interface body 110 is shaped to generally follow the contours of a patient's face around the upper lip area. The interface body 110 is moulded or pre-formed to be able to conform to and/or is pliable to adapt, accommodate and/or correspond with the contours of the user's face, in the region of the face where the nasal interface is to be located.
[00568] The interface body 110 comprises a base portion 118 from which the nasal delivery elements 111 and 112 extend.
[00569] The base portion 118 is arranged to locate between a patient's face and the gases manifold 120 in use. The base portion 118 may act as a cushion to avoid the gases manifold 120 from touching the patient's face.
[00570] In the configuration shown, the interface body 110 comprises two side arms 101, 102 that extend laterally from either side of the base portion 118 or the interface body 110. [00571] In the configuration shown, the side arms 101, 102 comprise wing portions extending laterally from either side of the base portion 118 or interface body 110. The wing portions are integrally formed with the base portion 118 or interface body 110 but may alternatively be separate parts.
[00572] In some configurations, the nasal delivery elements 111, 112 extend generally upwardly and rearwardly from the base portion 118 or from the interface body 110.
[00573] Adhesive pads (not shown) may be provided on each wing portion to facilitate coupling of the nasal interface 100 to the patient.
[00574] The gases manifold 120 is generally tubular in shape having a gases port 121, 122 proximal at least one side thereof, and generally extending from a front of the nasal interface 100 (Figures 1, 9 and 11). In some configurations, the gases port 121, 122 may optionally be positioned at either side thereof. At least one of the gases ports 121, 122 may be removably attachable to a respiratory conduit 300, such as via a threaded engagement but alternatively via a snap-fit or any other type of coupling known in the art. That enables the at least one of the gases ports 121, 122 to act as a gases inlet for the gases manifold 120 and thereby for the nasal interface 100. Alternatively, in some configurations, the port 121, 122 may be fixedly coupled or integrally formed with a respiratory conduit 300.
[00575] Flow enters the nasal interface 100 through the gases port 121, 122 and travels through the gases manifold 120 in a direction that a transverse to the direction the flow is intended to travel into the first and second nasal delivery elements 111, 112. [00576] The gases inlet is in fluid communication with the respiratory conduit 300.
[00577] In some configurations, the respiratory conduit 300 has an internal diameter of between about 12 mm and about 23 mm, optionally more than about 12 mm and up to about 23 mm, optionally more than about 12 mm and up to about 22 mm, optionally more than about 12 mm and up to about 21 mm, optionally more than about
12 mm and up to about 20 mm, optionally more than about 12 mm and up to about 19 mm, optionally more than about 12 mm and up to about 18 mm, optionally between about
13 mm and about 17 mm, optionally between about 14 mm and about 16 mm, optionally about 12 mm, optionally about 13 mm, optionally about 14 mm, optionally about 15 mm, optionally about 16 mm, optionally about 17 mm, optionally about 18 mm, optionally about 19 mm, optionally about 20 mm, optionally about 21 mm, optionally about 22 mm, optionally about 23 mm, or optionally any value between any two of those values. [00578] Referring to Figures 2, 4 and 6, a gases flow path is defined by a lumen or flow channel 125 in the gases manifold 120.
[00579] The flow channel 125 extends from the gases port 121 at one side of the gases manifold 120, through the gases manifold, to the gases port 122 at the other side of the gases manifold 120.
[00580] The gases manifold 120 may consist of a single part or may comprise a plurality of components that assemble together. For example, the gases manifold 120 may have a first body portion that provides the gases flow channel 125, and that optionally provides the gases ports 121, 122, and a second body portion. Alternatively, the gases manifold 120 may be a single component. In an alternative configuration, the gases manifold 120 may comprise a single outlet, and the interface body 110 may comprise a single complementary gases entry that couples with the single outlet of the gases manifold 120 and that is in fluid communication with the first and second nasal delivery elements 111, 112 to deliver the gases to the first and second nasal delivery elements 111, 112.
[00581] Referring to Figures 1-11, in some configurations a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 may be as described herein. The interface body 110 is configured to substantially form a seal with the patient's nasal airways. The interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient.
[00582] The interface body 110 comprises a gases flow channel 125. The gases flow channel 125 provides the gases flow path. In the presently described configuration, the gases flow channel 125 may be formed as part of the interface body 100. In other configurations, such as those described elsewhere herein, the gases flow channel 125 may be formed as part of a gases manifold 120.
[00583] In some configurations, the gases flow channel 125 is formed by the internal space of the nasal interface 100. In some cases, that may be defined as the interface body 110.
[00584] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00585] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or delivery element portion is configured to substantially deliver gases to or from the second naris of the patient. [00586] The first delivery element 111 may be the first nasal delivery element 111 as described herein. It may also be referred to as a first outlet 111. The second delivery element 112 may be the second nasal delivery element 112 as described herein. It may also be referred to as the second outlet 112. In some arrangements, the terms are interchangeable and the description of said features are interchangeable.
[00587] The first nasal delivery element or first outlet 111 or first outlet portion and the second nasal delivery element or second outlet 112 or second outlet portion are each configured to seal with a respective naris of a patient. The first nasal delivery element 111 is configured to seal with a first naris of the patient and the second nasal delivery element 112 is configured to seal with a second naris of the patient. It will be appreciated the configurations are not limited such that the first and second delivery element 111, 112, delivery element portions or nares are numbered in a particular order, e.g., from left or from right.
[00588] As discussed above, the nasal interface may comprise distinct nasal delivery elements 111, 112 (or outlets 1111a, 1112a as discussed below) for delivery of the respiratory gases to the respective nares of the patient the interface body 110. Alternatively, the nasal interface 110 may comprise a single outlet that defines a first outlet portion and a second outlet portion for delivery of the respiratory gases to the respective nares of the patient. Therefore, reference herein to "first (nasal) delivery element", "first outlet", "second (nasal) delivery element" and "second outlet" can instead be considered references to "first outlet portion", "first delivery element portion", "second delivery element portion" and "second outlet portion" respectively. Some of the possible exemplary configurations are described in more detail below.
[00589] In such a configuration, the interface body 110 may have a single opening for delivery of gases to or from the nares of a patient. Therefore, it may be a first portion of the opening that is for a first naris and a second portion of the opening that is for the second naris. In some configurations, the first delivery element 111 and second delivery element 112 are replaced by the first delivery element portion and a second delivery element portion.
[00590] Whilst the term 'delivery' is used in the description of the first and second delivery elements 111, 112, it will be appreciated that the delivery is not limited to a particular direction of flow, i.e. to or from the naris and may be bidirectional.
[00591] The nasal interface 100 comprises a first gases port 121 in the interface body 110 and in fluid communication with the gases flow channel 125. The first gases port 121 is configured for connecting to a first respiratory component 331 for enabling respiratory gases to be delivered into the interface body 110.
[00592] The nasal interface 100 comprises a second gases port 122 in the interface body 110 and in fluid communication with the gases flow channel 125. The second gases port 122 is configured for connecting to a second respiratory component 332 for enabling exhaled gases to be expelled out of the interface body 110.
[00593] Whilst the first gases port 121 and second gases port 122 have been described as being for delivery and expelling of gases from the interface body 110 respectively, in some configurations, the first gases port 121 may be for more expelling gases and the second gases port 122 may be for delivery of gases. Further, in some configurations, both of the first gases port and second gases port 121, 122 may be for delivery of gases and/or the expelling of gases.
[00594] The nasal interface 100 may be configured to create a flow of gases at a patient's nasal airways.
[00595] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by any number of means as described elsewhere in this disclosure.
[00596] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00597] Pressure is created at the patient's airways due to using a sealed nasal interface 100. The pressure helps to stent the patient's airways open in use.
[00598] It will be appreciated that the flow channel 125, at least in part, extends from the gases port 121, through the interface body 110 (or the gases manifold I interface frame 120 when applicable), to the gases port 122. However, in some configurations, the gases flow channel 125 between the first gases port 121 and second gases port 122 may be disrupted. This may be for the purposes of asymmetric flow as described above.
[00599] In some configurations, the first and second nasal delivery elements 111, 112 each comprise a pillow. This pillow may each seal with a respective naris of a patient. [00600] In some configurations, the interface body 110 comprises a cushion portion 129 comprising the first delivery element 111, or first delivery element portion and the second delivery element 112 or the second delivery element portion. In such a configuration, the interface body may comprise frame portion 120 comprising the first gases port 121 and the second gases port 122. [00601] The first gases port 121 and the second gases port 122 have substantially the same configuration such that the first respiratory component 331 can be selectively connected to each of the first gases port 121 and the second gases port 122, and such that the second respiratory component 332 can be selectively connected to each of the first gases port 121 and to the second gases port 122.
[00602] The substantially same configuration of the first gases port 121 and the second gases port 122 allows a respiratory component, such as a respiratory conduit 300 to be changed between the first gases port 121 and the second gases port 122 as required without any issues with ensuring the fittings or attachments correspond. It also allows for adaptability in the nasal interface 100.
[00603] The first gases port 121 and the second gases port 122 comprise respective openings 137, 138. The openings 137, 138 may be formed as a break in the surface of the interface body 110. In some configurations as illustrated in Figure 3 the first gases port 121 comprises a circular opening 137 and the second gases port 122 comprises a circular opening 138. Therefore, in some configurations the first gases port 121 and second gases port 122 are substantially circular.
[00604] In some configurations, the first gases port 121 and the second gases port 122 have substantially the same sized openings 137, 138. This is illustrated in Figures 1- 11 where a similar sized opening 137, 138 is shown. In some configurations where the first gases port 121 and the second gases port 122 comprise circular openings 137, 138, a first opening diameter 127 of the first gases port opening 137 may be the same as a second opening diameter 128 of the second gases port opening 138. This is shown in Figure 3 which illustrates a reverse view of the nasal interface 100 showing the shape of the openings 137, 138. It will be appreciated that whilst circular openings 137, 138 are illustrated, other shapes may be provided.
[00605] A substantially the same sized opening 137, 138 assists with the selective connecting of the first and second respiratory components 331, 332. In some configurations, this is for geometric requirements of the fittings and/or attachments of the first and second respiratory components 331, 332 with the first gases port 121 and the second gases port 122. Alternatively, or additionally, the substantially same sized openings 137, 138 also ensure the substantially same or similar flow characteristics for each of the first gases port 121 and the second gases port 122. As described above, the nasal interface 100 is not limited to have a delivery of gases through the first gases port 121. Therefore, in an example, the second gases port 122 may be for enabling delivery of gases to the interface body 110 and the substantially the same sized openings 137, 138 ensures a similar flow characteristic as the first gases port 121 would provide when enabled for delivery of gases.
[00606] Alternatively, in some configurations, the nasal interface 100 is configured to have different flow characteristics as a result of the first gases port 121 and the second gases port 122 being used for delivery or expelling of the flow of gases.
[00607] In some configurations, the openings 137, 138 have a substantially similar shape and configuration. In one example, the openings 137, 138 may be identical.
[00608] The same sized openings 137, 138 have the geometry in a direction transverse to a gases flow through the first and second gases ports 121, 122. Accordingly, the same sized openings 137, 138 have the same cross-section in a direction transverse to gases flow through the first and second gases ports 121, 122. The gases flow may be a resultant gases flow through the respective port 121, 122. In some configurations, such as with a first circular opening 137 or a second circular opening 138, the direction transverse to the gases flow is the radial direction of the openings 137, 138. This is also the diameter of the openings 127, 128. Figure 10 illustrates a cross sectional view through the first gases port 121 and the second gases port 122. A substantially same or similar cross-section I geometry has the benefits for the selective connecting of the first and second respiratory components 331, 332 as discussed above. It also clarifies that in some configurations, a depth of the openings 137, 138 is substantially same I similar.
[00609] In some configurations, the first gases port 121 has a first gases port connection feature 133 for connecting to the first and second respiratory component 331, 332. The second gases port 122 has a second gases port connection feature 134 for connecting to the first and second respiratory system component 331, 332. The first gases port connection feature 133 is substantially the same as the second gases port connection feature 134. In some configurations, the first gases port connection feature 133 and the second gases port connection feature 134 are identical to each other.
[00610] The substantially same or similar first gases port connection feature 133 and second gases port connection feature 134 assists with the selective connectability of each of the first gases port 121 and the second gases port 122 described herein. Such features may be additional to the substantially same shaped openings and/or substantially same cross sections I geometry. This allows the first and second respiratory component 331, 332 to be switched between the first gases port 121 and the second gases port 122 as required by having the same the first gases port connection feature 133 and second gases port connection feature 134. [00611] In some configurations, the first gases port connection feature 133 and second gases port connection feature 134 is a sealing connection to ensure that the first and second respiratory component 331, 332 are sealingly attached to the interface body 110.
[00612] The first gases port connection feature 133 and second gases port connection feature 134 allows for a removable connection to ensure the selective connectability for each of the first gases port 121 and the second gases port 122. However, in some configurations, the first and second respiratory component 331, 332 are not intended to be readily switched, such as by a patient. Therefore, a specialist tool or technique may be required to allow for the changing of first and second respiratory component 331, 332 between the first gases port 121 and the second gases port 122.
[00613] In some configurations, the first gases port connection feature 133 and second gases port connection feature 134 is a clip or a lip 135 (shown for example in Figure 6) for engaging with the first and second respiratory component 331, 332. A clip or lip 135 may be formed as part of the interface body 110 or may be formed separately and attached to the first or second gases port 121, 122 as appropriate. As described below, an interface frame 120 may be provided having such a clip or lip 135.
[00614] Whilst a clip or lip 135 is described, it will be appreciated that other connection mechanisms may be used as known to the skilled person.
[00615] In some configurations, the first respiratory component 331 is a gases conduit 300 for delivery of respiratory gases into the nasal interface 100. In some configurations the second respiratory component 332 is a bias flow restriction 340 or a gases conduit 300.
[00616] Other arrangements of respiratory components 331, 332 may be provided, such as those described with reference to Figures 25-26.
[00617] The bias flow restriction 340 may comprise or be an optional diffuser to diffuse gases flowing through the first or second gases port 121, 122. The filter may mitigate respiratory contaminants being released through the bias flow restriction 340. The bias flow restriction 340 or diffuser may comprise at least one aperture 342. The aperture 342 allows a flow of gases therethrough.
[00618] Figures 5-9 show a diffuser 340 that is configured to cover at least one first or second gases port 121, 122 to diffuse gases as they exit the interface body 110. The diffuser may comprise a diffuser material 341. The diffuser material 341 may comprise any suitable material, such as one or more of non-woven fibrous material (including polymer fibres), open cell foam, sintered polymer. Other materials include: a combination of nylon mesh with diffuser material, thin plastic sheets with holes cut into it, foaming material, a RT020 electrostatic filter, a plastic porous material (like a woven or sintered nylon), woven mesh (Nylon, polyester and polypropylene, polyethylene) or a pleated filter. Although a filter material can be used in the diffuser 340, it may be beneficial to not use a filter material to reduce or avoid liquid build-up in the diffuser 340.
[00619] The aperture 342 and diffuser material 341 may be combined in a diffuser 340 such as shown in Figures 7 and 8.
[00620] The diffuser 340 may diffuse gases exiting the bias flow restriction 340 to reduce noise.
[00621] In some configurations, the diffuser 340 may have an antimicrobial material to reduce bacteria in the exhaled air. This can be advantageous for infectious patients.
[00622] The diffuser 340 may comprises clamping portions to hold the diffuser material 341 therebetween. In some configurations, such as shown in Figures 5-9, the diffuser 340 is circular, with the diffuser material forming a center of the circular shape.
[00623] In some configurations, the diffuser 340 may have a small protrusion allowing the user to easily remove it.
[00624] The diffuser 340 may have an aperture or groove in its rim for engaging with a protrusion or lip in the gases port 121, 122. The aperture or groove may be formed in an outer frame in which a diffuser 340 sits or is attached to.
[00625] As the first respiratory component 331 and second respiratory component 332 are interchangeable and removeable as described herein, the diffuser 340 may be removed for cleaning.
[00626] In some configurations, the first respiratory component 331 and second respiratory component 332 are tethered. A tether 345 may take various forms such as material formed between each part. In some arrangements, such as shown in Figure 9, the tether 345 is attached to the first respiratory component 331 at a first end and the second respiratory component 332 at a second end.
[00627] In some configurations, the tether 345 may be a narrow piece of material that extends across a front of an interface body 110 when the first respiratory component
331 and second respiratory component 332 are connected to the interface body 110.
[00628] As the first respiratory component 331 and second respiratory component
332 are interchangeable and removeable, to ensure that the components do not go missing, they are tethered. This may be particularly advantageous for smaller components, such as a diffuser 340 which may be misplaced. [00629] In some configurations, first respiratory component 331 and/or second respiratory component 332 are tethered to the interface body 110. The tether 345 may take various forms such as material formed between each part as with the tether 345 between the first respiratory component 331 and the second respiratory component 332. Therefore, one end is connected to the interface body 110 (on an outside surface) and the other end to the first respiratory component 331 and/or second respiratory component 332.
[00630] Such an arrangement allows for adaptability of the first respiratory component 331 and second respiratory component 332 used, where they do not need to be limited by a tether 345. For instance, a smaller components such as a diffuser 340 may be tethered to the interface body 110, whilst a larger component, such as a gases conduit 300 does not need such a tether 345.
[00631] In some configurations, the tether 345 is removeable from the first respiratory component 331 and/or second respiratory component 332. This allows the tether 345 to be changed between components whilst still retaining the advantages discussed above.
[00632] In some configurations, the first gases port 121 points or is arranged such that flow therethrough is directed substantially toward the first delivery element 111 or first delivery element portion. Referring to Figure 4, the first gases port 121 is substantially aligned with the first delivery element 111 as illustrated by an arrow indicating a first port inlet gases flow 171. Where there is a circular opening 137, this may be considered as the circular opening 137 and an opening of the first delivery element 111 being concentric. Such an arrangement may be beneficial as the gases flow from the first gases port 121 is primarily directed toward a first naris of the patient via the first delivery element 111 (or in some configurations, a gases flow from the first naris to the first gases port 121). This may create or contribute to asymmetric flow, when such a flow is present, referred to above.
[00633] In some configurations, the second gases port 122 points or is arranged such that flow therethrough is directed substantially toward the second delivery element 112 or second delivery element portion. Referring to Figure 4, the second gases port 122 is substantially aligned with the second delivery element 112 as illustrated by an arrow indicating a second port outlet gases flow 172. Such an arrangement may be beneficial as an exhalation gases flow from the second naris of a patient is primarily directed toward the second gases port 122 via the second delivery element 112 (or in some configurations, a gases flow from second gases port 122 is directed to the second naris of a patient). [00634] In some configurations, whilst the first gases port 121 points substantially toward the first delivery element 111 (or first delivery element portion) and/or the second gases port 122 points substantially toward the second delivery element 112 (or second delivery element portion), the flow path may be restricted. For instance, a first port inlet gases flow 171 or the second port outlet gases flow 172 does not directly follow the arrows as indicated in Figure 4. However, in some configurations, the resultant flow may be in the direction of the arrow 171, 172 as described.
[00635] Additionally, in some configurations, there may be a bypass flow 173. The bypass flow 173 is formed by the respiratory gases (such as shown by the first port inlet gases flow 171) passing through the gases flow channel 125 and bypassing the patient's first naris. Therefore, the respiratory gases pass from the first gases port 121 toward second gases port 122.
[00636] The bypass flow 173 then may either travel into the second naris as a bypass inhalation flow 174 or may travel out of the interface body 110 through the second gases port 122 as a bypass exhaust flow 175. Alternatively, in some configurations, it is a combination of bypass inhalation flow 174 and bypass exhaust flow 175 depending on the respiratory cycle of the patient.
[00637] Additionally, in some configurations, there may be an exhalation bypass flow 176. The exhalation bypass flow 176 is formed by the exhalation gases (such as shown by the second port outlet gases flow 172) passing back through the gases flow channel 125 after being exhaled from the second naris. Therefore, the exhalation gases pass from the second delivery element 112 toward the first gases port 121.
[00638] The exhalation bypass flow 176 then may either be re-inhaled by the patient into the first naris as recirculated flow 177. However, in some configurations, the exhalation bypass flow 176 may form part of the bypass flow 173.
[00639] Whilst the first port inlet gases flow 171, second port outlet gases flow 172, bypass flow 173, bypass inhalation flow 174, bypass exhaust flow 175, exhalation bypass flow 176 and recirculated flow 177 are shown by arrows in Figure 4, it will appreciated that in some configurations, the direction of the arrows may be reversed where the respiratory gas is delivered to the second gases port 122.
[00640] Referring to Figures 1-11, the first gases port 121 is proximal to the first nasal delivery element 111 or first delivery element portion and distal from the second nasal delivery element 112 or second nasal delivery element portion. Therefore, the first gases port 121 is closer to the first nasal delivery element 111 than the second nasal delivery element 112. The result of this configuration means that flow through the first gases port 121 is closer to the naris of the patient at the first nasal delivery element 111. Therefore, a gases flow delivered to the interface body 110 may be more directed toward the first nasal delivery element 111 than the second nasal delivery element 112. Alternatively, if the first gases port 121 is for expelling gases, then exhalation gases may be more directed to first gases port 121. In either arrangement, this may create or contribute to the asymmetric flow when such a flow is present.
[00641] In some configurations, the nasal interface 100 is configured to receive incoming gases from the first gases port 121 and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use. The incoming gases also provide a second flow stream of gases from the first gases port 121 configured to be substantially provided to the second naris of the patient in use. As a result, the nasal interface 100 is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases. This creates or contributes to the asymmetric flow.
[00642] It will be appreciated, that the incoming gases may be via the second gases port 122 and more directed to the second naris.
[00643] There are various means for providing more of to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases. This may include geometry and flow directing features, such as baffles.
[00644] As shown in Figures 1-11, in some configurations, the first gases port 121 and the second gases port 122 are symmetrical. The symmetry is about a midline plane 165 of the interface body 110. The midline plane 165 is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface 100 is in use.
[00645] The symmetry of the ports 111, 112 assists with the port connection features 133, 134 being interchangeable with respiratory components 331, 332. The symmetry also ensures that any geometry requirements are reflected in the opposing port 121, 122. For example, a connected component 331, 332 such as a gases conduit 300 may be required to extend at a particular angle when connected to the interface body 110. This may be provided by one of the ports 111, 112 having its opening 137, 138 angled in a particular orientation. By the first gases port 121 and the second gases port 122 being symmetrical, that orientation is likewise symmetrical ensuring that the orientation of the component 331, 332 is likewise reflected.
[00646] A benefit of such a configuration is that it can simplify the side-swapping of the respiratory components 331, 332. That can allow non-medical staff, e.g. patients, to side-swap the components themselves. This is advantageous for, e.g. chronic patients at home.
[00647] In some configurations, as shown in Figure 10, it is the nasal interface 100 and/or interface body 110 that is symmetrical about a midline plane 165 of the interface body 110 where the midline plane 165 is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface 100 is in use.
[00648] Referring to Figure 10, the first gases port 121 defines a first axis 167. The first axis 167 corresponds to a gases flow direction through the first gases port 121. Alternatively or additionally, the first axis 167 may be perpendicular to the face of the first opening 137, or the first opening diameter 127. Similarly, the second gases port 122 defines a second axis 168. The second axis 168 corresponds to a gases flow direction through the second gases port 122. Alternatively or additionally, the second axis 168 may be perpendicular to the face of the second opening 138, or the second opening diameter 128.
[00649] In view of the above axis lines are defined and extend through the openings 137, 138 of the first and second gases ports 121, 122 respectively. It will be appreciated that if the first axis 167 and second axis 168 are parallel, then the ports 111, 112 must be aligned on the same plane as they are perpendicular to the first axis 167 and second axis 168. In the configuration shown in Figure 11, the first axis 167 and second axis 168 intersect. Therefore, the ports 111, 112 are arranged on different planes. That is, the nasal interface 100 is angled. More specifically, the nasal interface is angled about the midline plane 165.
[00650] Such an angled geometry of the nasal interface 100 allows the interface to conform with the shape of the patient's face. Such an angled geometry corresponds to the shape of the nasal passages which are generally angled toward each other in humans. Whilst an angled geometry is considered such that the first and second delivery elements 111, 112 are faced toward one another, i.e., arranged closer to one another. This may also be termed as ports of the first and second delivery elements 111, 112 are positioned closer together than base portions of the first and second nasal delivery elements 111, 112 distal from the ports of the first and second delivery elements 111, 112. In some configurations, the opposite configuration may be used.
[00651] Whilst an angled nasal interface 100 is described with reference to the first axis 167 and the second axis 168, in some configurations, the interface body 110 comprises: a first body portion 116 comprising the first gases port 121; and a second body portion 117 comprising the second gases port 122. Therefore, the first and second body portions 116, 117 may be considered sides or halves of the interface body 110. The first body portion and second body portion are angled relative to one another.
[00652] The angle 169 between the first axis 167 and the second axis 168 is more than 0 degrees. In some configurations, the angle 169 between the first axis 167 and the second axis 168 is less than 120 degrees. In some configurations, the angle 169 between the first axis 167 and the second axis 168 is between about 40 and 60 degrees. In some configurations, the angle 169 between the first axis 167 and the second axis 168 is about 50 degrees.
[00653] The angle provides increased septum spacing and allows different patients to adjust for different septum spacing, or to allow the nasal interface 100 sit more closely to their nose for more stability. It also provides a decreased footprint on the face making it easier for eating or drinking.
[00654] The headgear may be used to retain the nasal interface 100 against the patient's face. The headgear comprises a head strap 200. The head strap 200 may be a single continuous length and adapted to extend in use along the patient's cheeks, above the ears and about the back of the head, may be adjustable, and/or may extend around other portions of the patient's head.
[00655] The headgear has ends that connect to the side arms of the interface body 110.
[00656] In the exemplary configuration shown (Figures 1, 5, 6, 9, 27-30), primary end portions 201 and 202 of the strap 200 are adapted to releasably connect respective formations 101 and 102 on either side of the nasal interface 100 to hold the nasal interface 100 in position during use.
[00657] In one configuration, a clip or hook component is provided at each end portion 201, 202 capable of being received and retained within the corresponding formation 101, 102. The clip component may be coupled to the strap at the respective primary end portion. Furthermore, the head strap 200 is adjustable in length to customise the strap to the wearer's head. The strap 200 may be formed from a soft and stretchable/elastic material such as an elastic, textile material/fabric that is comfortable to the wearer. Alternatively, the strap 200 may be formed from a substantially more rigid, or less flexible, material such as a hard plastics material.
[00658] The headgear may further comprise an additional strap or other headgear component that couples the strap 200 to extend over the patient's crown in use. A crown strap or crown component can have the benefit of pulling the strap 200 up and above the patient's ears in use to improve fit and comfort. [00659] Rear portions of the strap 200 may extend through a receiver. The receiver may allow the rear portions of the strap 200 to be adjusted to adjust the size of the headgear to fit a patient's head.
[00660] Strap segments of a fixed length can be releasably connected to the main strap to extend its length.
[00661] A number of strap segments of varying predetermined lengths may be provided to provide alternative adjustment lengths. For example, one or more strap segments may be provided having a length within the range of about 1 cm to about 10 cm, or within the range of about 2 cm to about 6 cm. The strap segments have lengths of, for example, about 2 cm, about 4 cm or about 6 cm. It will be appreciated that these examples are not intended to be limiting and the length of each strap segments can be of any size as it is dependent on the user and/or application.
[00662] Furthermore, each end of each strap segment may be connectable to a respective end of another strap segment and/or to a respective secondary end portion of the main strap to thereby enable a user to combine one or more strap segments of the same or varying length to customise the overall length of the extension as desired.
[00663] The additional strap segments may be formed from a soft and stretchable/elastic material such as an elastic, textile material/fabric that are comfortable to the wearer. For example, a tubular knitted type head strap or sections of the head straps may be utilised, particular for comfort over a user's ears.
[00664] It will be appreciated that particular comfort may be achieved from a head strap which is able to provide suitable locating of the nasal interface 100 in a relatively stable position on a user's face, yet simultaneously provide for a relatively loose fit or low tension fit about the user's head.
[00665] Alternatively, the additional strap segments may be formed from a substantially rigid material such as a hard plastics material.
[00666] The patient interface 1 and/or nasal interface 100 may have any one or more of the features and functionality described in PCT publication no. WO 2014/182179 or US patent no. 10,406,311. The contents of those specifications are incorporated herein in their entireties by way of reference.
[00667] As an alternative to a headgear, the patient interface may comprise a securement system of the type described in PCT publication number WO 2012/053910 or US patent no. 10,238,828. The contents of those specifications are incorporated herein in their entirety by way of reference. [00668] The patient interface 1 and/or nasal interface may have any one or more of the features and functionality described in PCT publication no. WO 2023/067558 or US patent application no. 18/702,459. The contents of those specifications are incorporated herein in their entirety by way of reference. The features that provide or contribute to providing the asymmetric flow and parameters of the asymmetric flow may be any of the features and parameters described in those specifications.
[00669] Figures 12-16 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 as described with reference to Figures 1-11. Like reference numbers indicate like parts. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 12-16.
[00670] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 is configured to substantially form a seal with the patient's nasal airways. The interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient. The interface body 110 comprises a gases flow channel 125.
[00671] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00672] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or second delivery element portion is configured to substantially deliver gases to or from the second naris of the patient.
[00673] The features herein described may be similar to those described for Figures 1-11 and the descriptions and alternatives may be applied to the present description.
[00674] The nasal interface 100 comprises a first gases port 121. The first gases port 121 is for the delivery of respiratory gases into the nasal interface 100. The first gases port 121 is in fluid communication with the interface body 110. This allows delivery of respiratory gases from the first gases port 121, through the interface body 110 and to the first and second nares of the patient.
[00675] The nasal interface 100 comprises a second gases port 122. The second gases port 122 is for the delivery (or expelling) of exhaled gases out of the nasal interface 100. The second gases port 122 is in fluid communication with the interface body 110. This allows delivery (or expelling) of exhaled gases from the second naris of the patient to the second gases port 122, through the interface body 110.
[00676] Whilst the first gases port 121 and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first gases port 121 may be used for expelling exhalation gases and the second gases port 122 may be for delivery of respiratory gases.
[00677] Further, in some configurations, both of the first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris.
[00678] The nasal interface 100 may be configured to create a flow of gases at a patient's nasal airways.
[00679] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by means as described throughout this disclosure.
[00680] The interface body 110 comprises a cushion portion 129 and a frame portion 120.
[00681] In some configurations, such as with reference to Figures 1-11, the structure of the nasal interface 100 and the gases flow channel 125 has been described with reference to the interface body 110. However, the interface body 110 may be defined as a frame portion 120 and a cushion portion 129 that together define the structure and gases flow channel 125.
[00682] The frame portion 120 is the manifold 120 or is an alternative to the manifold 120 described herein. The frame portion 120 is illustrated without a cushion portion 129 in Figure 15 (and also Figure 11). The frame portion 120 may support the cushion portion 129. The frame portion may also support one or more other components (such as the first gases port 121, second gases port 122, headgear 200, and/or the interface body itself 110). Therefore, reference herein to "gases manifold" can instead be considered references to "frame". [00683] The cushion portion 129 may be the interface body 110 as described having a flexible material and shaped to generally follow the contours of a patient's face around the upper lip area.
[00684] Such a frame portion 120 and cushion portion 129 may apply to the other configurations described herein.
[00685] Referring to Figures 12-16, the first gases port 121 is formed as a first cushion opening 1291 in the cushion portion 129 and a first frame opening 1201 formed in the frame portion 120.
[00686] The second gases port 122 is formed as a second cushion opening 1292 in the cushion portion 129 and a second frame opening 1202 formed in the frame portion 120.
[00687] The openings 1201, 1202, 1291, 1292 are such that they are formed as apertures in frame portion 120 and cushion portion 129 respectively.
[00688] The first cushion opening 1291 and first frame opening 1201 are inter- engageable to attach the cushion portion 129 to the frame portion 120. In that way, the first cushion opening 1291 and first frame opening 1201 form the first opening 137 as described with reference to Figure 3. The second cushion opening 1292 and second frame opening 1202 are inter-engageable to attach the cushion portion 129 to the frame portion 120. In that way, the second cushion opening 1292 and first frame opening 1202 form the second opening 138 as described with reference to Figure 3.
[00689] The inter-engageability enables the frame portion 120 to be connected to the cushion portion 129 through the openings 1201, 1202, 1291, 1292. This provides the benefit of providing various ways for the frame portion 120 and cushion portion 129 to be connected without using welding, gluing or fusing means. This provides an easy attachment of the frame to the cushion. The inter-engageability also enables a removeable connection between the frame portion 120 and the cushion portion 129.
[00690] The frame portion 120 and cushion portion 129 may engaged by protrusions on one portion that engage with apertures on the corresponding portion.
[00691] In some configurations, such as illustrated in Figures 13 and 14, the cushion portion 129 comprises a first protrusion 1293 comprising the first cushion opening 1291 and a second protrusion 1294 comprising the second cushion opening 1292, wherein the first and second protrusions 1293, 1294 are receivable in respective first and second apertures 1203, 1204 in the frame portion 120.
[00692] Alternatively, in some configurations, the frame portion 120 comprises a first protrusion comprising the first frame opening 1201 and a second protrusion comprising the second frame opening 1202, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion 129.
[00693] A combination of frame protrusions and cushion protrusions may be provided in some configurations.
[00694] The protrusions 1293, 1294 may be fed through the apertures 1203, 1204 to engage within one another. Therefore, the protrusions are affixed within the apertures when engaged.
[00695] In some configurations, such as shown in Figure 13, the protrusions 1293, 1294 may be generally circular in cross-section. These are shaped to engage with a generally circular aperture 1203, 1204. Therefore, the aperture 1203, 1204 is formed as a generally C-shaped opening into which the protrusion 1293, 1294 is hooked. Whilst a circular cross-section is contemplated, other shapes may be used such as elliptical or polygon. Likewise, the aperture 1203, 1204 may have a receiving shape that is likewise shaped top conform to the shape of the protrusion 1293, 1294.
[00696] In some configurations, the protrusion 1293, 1294 is formed as a bead at and edge of the cushion portion 129. Therefore, the protrusion 1293, 1294 is a thickening in the material at the first and second frame opening 1201, 1202. In other configurations, the protrusions 1293, 1294 are formed as a separate material that is attached or otherwise fused to the cushion portion 129.
[00697] As shown in Figures 13 and 14, the frame portion 120 forms the internal part of the interface body 110 when engaged. Therefore, the cushion portion 129 is stretched over the frame portion 120 when engaged. However, in some configurations, such as shown in Figure 6, the frame portion 120 is primarily external to the cushion portion 129. This provides benefits such as allowing for easy cleaning of the frame portion 120. This is also advantageous as it allows for easy assembly and disassembly by a layperson, e.g. a chronic patient in the home.
[00698] The frame portion 120 provides the structure of the interface body 110 that faces away from the patient's face in use. Therefore, the part of the interface body that is opposite to the side with the first and second delivery elements 111, 112. This ensure that the more rigid material of the frame portion 120 is not in contact with the patient's face. This provides conform for the patient whose face is primarily in contact with the flexible material of the cushion portion 129. The front part of the frame portion 120 is shown in Figures 11 and 15.
[00699] In some configurations, the frame portion 120 comprises an outwardly extended periphery portion. [00700] Additionally, or alternatively, the frame comprises a pair of side arms on either side of the frame 120. The side arms 101, 102 may be the formations 101 and 102 on either side of the nasal interface 100 described with reference to Figures 1-13. The side arms 101, 102 are used to hold the nasal interface 100 in position during use, such as in conjunction with the head strap 200.
[00701] The side arms 101, 102 may be the outwardly extended periphery portion. [00702] In some configurations, such as shown in Figure 12 but also as seen in Figure 11, the side arms 101, 102 are angled respectively toward the proximal first delivery element 111 (or first delivery element portion) and the second delivery element 112 (or second delivery element portion).
[00703] The angling ensures a snug fit to the face and reduces the overall size of the interface body 110 across the face.
[00704] The side arms 101, 102, may be angled such that at an end that extends from the frame portion 120, the side arms 101, 102 extend in a direction toward the face (such as upper lip) of a patient in use.
[00705] The side arms 101, 102 each comprise an elongate slot 106. This is best illustrated in Figure 15 where only the frame 120 is shown. The elongate slot 106 allows each end portion 201, 202 of the strap 200 to engage with the interface body 110. The elongate nature of the slots 106 allow for adjustability on the patient's face as the end portions 201, 202 can slide within the slot 106 to provide different angles and positions.
[00706] Further, as illustrated in Figure 15, in some configurations, the elongate slot 106 is angled by virtue of being formed at the end of the angled side arms 101, 102. The angle of the slot 106 is such that it is substantially in line with the contours of the face. This is converse to the angle of the first and second gases ports 121, 122 that are angled in a relative downward direction when the nasal interface 100 is in use.
[00707] The first nasal delivery element 111 has a first outlet 1111a. The first outlet 1111a for allowing gases into and out of the interface body 110 via the first delivery element 111. The first outlet 1111a is at an end of the first delivery element 111. Likewise, the second nasal delivery element 112 has a second outlet 1112a. The second outlet 1112a for allowing gases into and out of the interface body 110 via the second delivery element 112. The second outlet 1112a is at an end of the second delivery element 112.
[00708] At the opposing end of the delivery element 111, 112 to the outlets 1111a, 1112a there are provided a first base 1111c and a second base 1112c. More specifically, the first delivery element 111 extends from the interface body 110 from the first base 1111c of the first delivery element 111. The second delivery element 112 extends from the interface body 110 from the second base 1112c of the second delivery element 112. Therefore, when applicable, a respiratory gas flow flows from the first base 1111c from the interface body 110 through the first delivery element 111 and out from the first outlet 1111a to a patient's first naris. When applicable, an exhalation gas flow flows from the patient's first naris, into the first outlet 1111a, through the first delivery element 111 then the first base 1111c into the interface body 110.
[00709] Likewise, from the second naris viewpoint, when applicable, a respiratory gas flow flows from the second base 1112c from the interface body 110 through the second delivery element 112 and out from the second outlet 1112a to a patient's second naris. When provided, an exhalation gas flow flows from the patient's second naris, into the second outlet 1112a, through the second delivery element 112 then the second base 1112c into the interface body 110.
[00710] As discussed elsewhere, when an asymmetric flow is required, the actual flow of gases to provide the asymmetric flow is a selection of the flows described above. Further, an outlet portion, may also apply to the first outlet 1111a and the second outlet 1112a as described herein. Asymmetric flow may be provided by the nasal interface 110 by more flow being directed to the first naris/first outlet 1111a than to the second naris/second outlet 1112a. That may be considered flow directionality.
[00711] The nasal interface 110 may be structured and configured to provide the flow directionality in different ways. For example, the nasal interface 110 may comprise a flow director and/or a flow splitter and/or at least partial alignment of a gases inlet with the first outlet 1111a to provide the flow directionality. Some of the possible exemplary configurations are described in more detail in the present disclosure.
[00712] As shown in Figure 16, a base 1111c, 1112c of each first 111 and second 112 nasal delivery element is thicker than an outlet 1111a, 1112a (or tip) of the first 111 and second 112 nasal delivery element.
[00713] The thickness is wall thickness. Therefore, the first nasal delivery element 111 and the second nasal delivery element 112 have a wall thickness at a base 1111c, 1112c and a wall thickness adjacent the first and second outlets 1111a, 1112a. Wherein the wall thickness at the base 1111c, 1112c is larger than the wall thickness adjacent the first and second outlets 1111a, 1112a.
[00714] In some configurations, the wall thickness at the first and second outlets 1111a, 1112a is from about 0.6 mm to about 0.9 mm. In some configurations, the wall thickness at the first and second outlets 1111a, 1112a is from about 0.7 mm to about 0.8 mm. In some configurations, the wall thickness at the first and second bases 1111c, 1112c is from about 0.9 mm to about 1.3 mm. In some configurations, the wall thickness at the first and second bases 1111c, 1112c is from about 1.0 mm to about 1.2 mm.
[00715] Generally, in some configurations, the wall thickness increases as the wall extends from the first and second outlets 1111a, 1112a in a direction toward the first and second bases 1111c, 1112c. For instance, the wall thickness increases by about 0.1 mm to 0.2 mm as the wall extends to the widest part of the first 111 and second 112 nasal delivery element. At the widest (largest diameter) point of the first 111 and second 112 nasal delivery element, the wall thickness increases further by about 0.1 mm to 0.2 mm. [00716] The wall thickness of the first 111 and second 112 nasal delivery element may change in thickness as the wall extends from the widest part of the first 111 and second 112 nasal delivery element in a direction toward the first and second bases 1111c, 1112c. In this region, the thickness of the wall may be about 0.3-1.2 mm, or about 0.4- 1.0 mm, or about 0.4-0.8 mm. The wall thickness of the first 111 and second 112 nasal delivery element then transitions in thickness from this point to the first and second bases 1111c, 1112c.
[00717] The wall thickness for the remainder of the interface body 110 (e.g. the cushion portion 129) is about 1.0 mm to about 1.6 mm. In some configurations, the wall thickness for the of the interface body 110 is from about 1.2 mm to about 1.4 mm.
[00718] The first nasal delivery element 111 and the second nasal delivery element 112 are collapsible to help with the flexible movement and sitting in the patient's nares. The thickened base 1111c, 1112c helps from over-collapsing. This may cause issues with the flow channel 125 such that gases cannot bypass the first nasal delivery element 111 and the second nasal delivery element 112.
[00719] Figures 17-24 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 with reference to Figures 1-16. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 17-24.
[00720] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 is configured to substantially form a seal with the patient's nasal airways. The interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient. The interface body 110 comprises a gases flow channel 125.
[00721] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00722] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or second delivery element portion is configured to substantially deliver gases to or from the second naris of the patient.
[00723] The features herein described may be similar to those described for Figures 1-24 and the descriptions and alternatives may be applied to the present description.
[00724] The nasal interface 100 comprises a first gases port 121 in the interface body 110. The first gases port 121 is in fluid communication with the gases flow channel 125. The first gases port 121 is directly connected or configured to be directly connected to a first conduit 300 for enabling the delivery of respiratory gases into the interface body 110. This allows delivery of respiratory gases from the first conduit 300 into the interface body 110 through the first gases port 121.
[00725] The nasal interface 100 comprises a second gases port 122 in the interface body 110. The second gases port 122 is in fluid communication with the gases flow channel 125. The second gases port 122 is directly connected or configured to be directly connected to a second conduit 302 for enabling the delivery (or expelling) of exhaled gases out of the interface body 110. This allows delivery (or expelling) of exhaled gases from the interface body 110 into the second conduit 302.
[00726] Whilst the first conduit 300 and first gases port 121, and second conduit 302 and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first conduit 300 and first gases port 121 may be used for expelling exhalation gases and the second conduit 302 and second gases port 122 may be for delivery of respiratory gases. Further, in some configurations, both of the first conduit 300, second conduit 302, first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris. In some configurations, the respiratory gases are delivered to the patient through the first delivery element 111 and the exhalation gases leave the patient via the second nasal delivery element 112. [00727] As shown in Figures 17-24, the nasal interface 100 comprises at least one baffle 180 extending along the gases flow channel from a region corresponding generally to the first gases port 121 toward a region corresponding generally to the second gases port 122.
[00728] In the configurations illustrated in Figures 17-24, the baffle 180 is an elongate planar member. The baffle 180 is arranged perpendicular to the openings 137, 138 of the first and second gases ports 121, 122.
[00729] The baffle 180 has a leading edge 181 and a trailing edge 182. Therefore, in the illustrated configuration, the leading edge 181 extends along a front width of the baffle 180 and the trailing edge 182 is arranged along the rear width of the baffle 180. The baffle 180 is arranged such that the leading edge 181 is positioned at or proximal the first and second gases ports 121, 122. The baffle 180 is arranged such that the trailing edge 182 is positioned at or proximal the first and second delivery elements 111, 112.
[00730] In some configurations, the at least one baffle 180 is arranged such that when respiratory gases are delivered into the interface body 110 through the first gases port 121, they pass along the baffle 180 to the first delivery element 111 or the first delivery element portion and along the baffle 180 to the second delivery element 112 or the second delivery element portion.
[00731] Therefore, the baffle 180 provides a directional arrangement for respiratory flow passing through the interface body 110 to a patient. In some configurations, the baffle 180 may direct the respiratory gases to a single delivery element, e.g. the first delivery element 111.
[00732] In some configurations, the at least one baffle 180 is arranged such that exhaled gases pass along the baffle 180 to the second gases port 122. Therefore, the baffle provides a directional arrangement for exhalation flow from a patient through the interface body 110.
[00733] The baffle 180 has the benefit of reducing turbulence of gases flow and also reducing noise. The ribs 180 also act to direct the flow.
[00734] The nasal interface 100 is configured to create a flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient.
[00735] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by means as described throughout this disclosure. [00736] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00737] A plurality of the baffles 180 may be provided as shown in Figures 17-24. The plurality of baffles 180 are arranged in parallel with a gap therebetween. Therefore, each baffle 180 retains a leading edge 181 closer to the first and second gases ports 121, 122 than the first and second delivery elements 111, 112.
[00738] The number of baffles 180 may be between 1 and 5, such as 1, 2, 3, 4 or 5 baffles 180. A plurality of baffles 180 increases the likelihood that gases flow will be influenced by the baffles 180. For instance, a plurality of baffles 180 minimises the space for turbulent flow. Whilst 5 baffles 180 is stated as the largest number, it could be envisaged that additional baffles 180 be provided in some situations where space allows. [00739] In some configurations, the interface body comprises a plurality of the baffles 180, wherein the baffles 180 are spaced apart from each other and extend along the gases flow channel. In some configurations, the baffles 180 extend across a cushion portion 129, a frame portion 120, or both a cushion portion 129 and a frame portion 120 of the nasal interface 100.
[00740] The baffle 180 extends substantially a full length of the gases flow channel 125 such that gases cannot pass around ends of the baffle 180. Therefore, as shown in Figures 21 and 24, each baffle 180 is attached (or in contact with) at its ends to internal surfaces of the interface body 110. When attached, the baffle 180 may be molded as part of the interface body 100, or may be affixed such as by welding or adhesive.
[00741] The baffles 180 extending the width of the interface body 110 (i.e. the length of the flow channel 125) ensures that gases flow does not pass around the edge causes turbulence and also risking an increase in sound.
[00742] In some configurations such as shown in Figures 18 and 19, the baffle 180 has a constant thickness along its length. The length refers to the extension between the sides, i.e. transverse to the direction between the leading edge 181 and the trailing edge 182. The constant thickness provides easier molding and allows for the gases flow to pass along the flow channel 125 transversely along the baffle 180.
[00743] In some configurations such as shown in Figures 22 and 24, the baffle 180 has a varying thickness along its length. The baffle 180 may be thicker at around its center. Therefore, the baffles 180 have a thickened portion 184. The baffle 180 may have the thickened portion 184 at a position between the first gases port 121 and the second gases port 122. The thickening to the thickened portion 184 may be gradual from the sides to the center of the baffle 180.
[00744] The thickening in the middle I center of the baffles 180 restricts the flow in the flow channel 125. This increases asymmetrical flow, when present, as gases flow cannot easily bypass the delivery elements 111, 112.
[00745] A thicker thickened portion 184 promotes more asymmetrical flow that may be beneficial for additional flushing. This may be adopted in hospital settings.
[00746] A thicker thickened portion 184 may result in more sound than a relatively smaller thickened portion 184. Therefore, it may be preferable to use larger thickened portions 184 in settings like hospitals where noise is less of an issue than domestic settings. The flow area at the center of the flow channel 125 in the quietest version, i.e. with the least restriction may be at least about 100 mm2 or at least about 300 mm2. In some configurations, the least restricted flow area is about 180 mm2. The flow area at the center of the flow channel 125 with the most flushing, i.e. largest thickened portion 184, may have a flow area between about 50-80 mm2. In some configurations, the restricted flow area is about 65 mm2.
[00747] In some configurations, the baffle 180 (or one of the baffles 180) is positioned at the center of the pillow outlet 1111a, 1112a. Therefore, with a circular outlet 1111a, 1112a, the baffle 180 substantially equally bisects the circle. This has the benefit of reducing any disruption in flow through the delivery element 111, 112.
[00748] As illustrated in Figures 20 and 21, the baffle 180 has a depth that does not extend to the delivery element base 1111c, 1112c. Therefore, the baffle is within the flow channel 125. This ensures that the delivery elements 111, 112 do not have reduced flexibility to ensure patient nasal comfort.
[00749] In some configurations, a support rib 185 may be provided at a center line of the interface body 110. Such a support rib 185 may be positioned transverse to the baffle 180. The support rib 185 may be formed on an edge of the internal surface of the interface body 110. Alternatively, in some configurations, the support rib 185 may be formed as a planar wall in the interface body 110. In such a configuration, the support rib 185 may have openings or perforations to allow the bypass of some flow. This also provides for asymmetric flow. Such a configuration is illustrated in Figure 21.
[00750] The nasal interface 100 may comprise a cushion portion 129 and a frame portion 120 as described in reference to Figures 12-16. In such a configuration, the baffle 180 may be formed as part of the frame portion 120 as illustrated in Figure 19 and 24. In such a configuration, the baffles 180 are rigid with fixed spacing. The frame 120 may be a molded component and the baffles 180 are molded as part of the frame 120.
[00751] In some configurations, the baffle 180 may be formed as part of the cushion portion 129 (or the interface body 110).
[00752] Figures 25-28 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 as described with reference to Figures 1-24. Like reference numbers indicate like parts. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 25-28.
[00753] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 is configured to substantially form a seal with the patient's nasal airways. The interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient. The interface body 110 comprises a gases flow channel 125.
[00754] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00755] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or second delivery element portion is configured to substantially deliver gases to or from the second naris of the patient.
[00756] The features herein described may be similar to those described for Figures 1-11 and the descriptions and alternatives may be applied to the present description.
[00757] The nasal interface 100 comprises a first gases port 121. The first gases port 121 is for the delivery of respiratory gases into the nasal interface 100. The first gases port 121 is in fluid communication with the interface body 110. This allows delivery of respiratory gases from the first gases port 121, through the interface body 110 and to the first and second nares of the patient.
[00758] The nasal interface 100 comprises a second gases port 122. The second gases port 122 is for the delivery (or expelling) of exhaled gases out of the nasal interface 100. The second gases port 122 is in fluid communication with the interface body 110. This allows delivery (or expelling) of exhaled gases from the second naris of the patient to the second gases port 122, through the interface body 110. [00759] Whilst the first gases port 121 and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first gases port 121 may be used for expelling exhalation gases and the second gases port 122 may be for delivery of respiratory gases. Further, in some configurations, both of the first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris.
[00760] The nasal interface 100 may be configured to create a flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient.
[00761] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by means as described throughout this disclosure.
[00762] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00763] In some configurations, to create or contribute to asymmetric flow when present, the first conduit 300 delivery respiratory gases to the first gases port 121 directs flow towards the first delivery element 111. This directed flow is comparatively more than the flow directed to the second delivery element 112. This results in the nasal interface 100 being configured to receive incoming gases from the first gases port 121 and to provide, from the incoming gases through the conduit 300, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases.
[00764] With reference to Figures 9, 10, and 11, the nasal interface 100 comprises a bypass restriction 130 to provide a pressure drop through the nasal interface 100 between the first nasal delivery element 111 and the second nasal delivery element 112 when gases are delivered from the first gases port 121 to the first nasal delivery element 111 and the second nasal delivery element 112 such that pressure at the first nasal delivery element 111 is higher than pressure at the second nasal delivery element 112. [00765] As used herein, a bypass restriction 130 may be any feature or geometry that provides a pressure drop through the nasal interface 100 between the first nasal delivery element 111 and the second nasal delivery element when gases are delivered from the first gases port 121 to the first nasal delivery element 111 and the second nasal delivery element 112 such that pressure at the first nasal delivery element 111 is higher than pressure at the second nasal delivery element 112. In some configurations, the bypass restriction 130 may be a physical restriction relative to an adjacent part of the gases flow channel 125, relative to the gases inlet 121, relative to the combined cross- sectional area of the first and second nasal delivery elements 111, 112, and/or relative to any other part of the nasal interface 100.
[00766] In some configurations, the bypass restriction 130 may be a flow splitter or flow director.
[00767] The pressure drop is such that gases pressure upstream of the bypass restriction will be higher than gases pressure downstream of the bypass restriction.
[00768] In some configurations, the bypass restriction 130 may be formed by the baffle 180 or support rib 185 as described with reference to Figures 17-24.
[00769] In some configurations, the interface body comprises a frame portion 120 and a cushion portion 129 as described with reference to Figures 11-16.
[00770] In the illustrated configuration, the interface body 110 is angled as described with reference to Figures 1-11. Namely, the first axis line 167 and second axis line 168 intersect. As the first conduit 300 and the second conduit 302 are connected to the first gases port 121 and second gases port 122 respectively, at least a portion of the first conduit 300 and second conduit 302 follow the axis lines 167, 168. Therefore, the first conduit 300 and second conduit 302 are angled (away) relative to one another. The first conduit 300 and second conduit 302 extend away from the interface body 110 in a divergent direction. This is opposite to the first and second delivery elements 111, 112 that are angled to converge.
[00771] In some configurations, the nasal interface 100 is angled about the midline plane 165 of the interface body 110. The midline plane 165 is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface 100 is in use.
[00772] The conduits 300, 302 being angled away from one another for comfort.
[00773] In addition to the angled arrangement of the interface body 110, the symmetrical arrangement of the interface body 110 as described in Figures 1-11 may be provided in some configurations. In such configurations, the first conduit 300 and second conduit 302 may extend in a symmetrical direction about the midline plane 165. [00774] The use of a first conduit 300 and second conduit 302 has benefits such as reducing dead space that is associated with a Y-connected attached to the first gases port 121 and second gases port 122. Therefore, such a configuration using an NIV dual limb allows the removal of the Y-piece adaptor of a dual limb circuit to attach one of the conduits to the inspiratory limb, and one to the expiratory limb. Such a configuration can be used in an NIV therapy, for example bi-level pressure therapy or CPAP therapy.
[00775] In some configurations, a diffuser (or diffuser cap) 340 may be removably connectable to the end of the conduit 302. The diffuser 340 may be as described in reference to Figures 5-8 and the same description likewise applies.
[00776] An exemplary diffuser cap 340 is shown in Figure 27 attachable to a conduit end 3005, 3006 (see Figure 25). The diffuser cap 340 is the same as the diffuser 340 which is insertable into the interface body 110. The diffuser 340 is insertable into an end cap 3015 where the end cap is generally cylindrical. As described above, the diffuser 340 has a recess around its rim for engaging with a protrusion, where the protrusion is formed in the end cap 3015. Therefore, the diffuser may be removably connectable at the end (3005, 3006 - Figure 25) of the conduit 300, 302 at the end cap 3015 or on the first or second gases port 121, 122, i.e. it is interchangeable. Referring back to Figure 27, Such an arrangement allows for a two-conduit interface 100 to be used with a single limb ventilator.
[00777] The end cap 3015 may have an internally tapered connection to engage with a conduit end 3005, 3006. The internal diameter of the tapered connection may have a diameter to match that of the conduit 300, 302 as described herein, e.g. an internal diameter of between about 12 mm and about 23 mm, optionally any value between any two of those values, and/or optionally about 22 mm.
[00778] The diffuser 340 having the same size and connection as the diffuser 340 described in reference to Figures 1-11 allows a user to remove it from the conduit 300, 302 and insert it into the interface body 110 if they no longer require a dual limb configuration with the two conduits 300, 302. To generate appropriate bias flow, the diffuser may be connected to the gases port 122 or to the second conduit 302. This removes the need for a second conduit 302 (or dual limb) remaining attached when it is no longer required.
[00779] Referring to Figure 28, a 3-way adaptor 344 is illustrated. The 3-way adaptor 344 allows for an interchangeable connection between respiratory components 331, 332. In a configuration, the 3-way adaptor 344 is generally hollow cylindrically shaped. At its first end 3441, the 3-way adaptor 344 is adapted to engage with tubing. In some configurations, the tubing may be connected to a CPAP device, humidifier, blower or other respiratory device. In some configurations, the first end 3441 opens into an internally tapered narrowing portion partially through the 3-way adaptor 344 that expands to a bulbous internal recess 3442. The bulbous recess 3442 may be attachable to a ring formed in the tubing.
[00780] The 3-way adaptor 344 has a second end 3444 that is adapted to connect to multiple connection types. In some configurations, the second end 3444 opens into an internally tapered narrowing portion partially through the 3-way adaptor 344, i.e. toward the first end 3441. The internally tapered narrowing portion from the first end 3441 and the internally tapered narrowing portion from the second end 3442 converge at a partition portion 3443 substantially in a centre portion of the 3-way adaptor 344. The partition portion 3443 is formed by at least an internal rim around the inner surface of the 3-way adaptor 344. The partition portion 3443 may comprise a collar that extends from an inner diameter of the rim. This geometry may be for connecting to a connector.
[00781] The tapered narrowing portion from the second end 3442 and the partition portion 3443 allow two different connectors to interchangeably engage with the 3-way adaptor 344. Therefore, the 3-way adaptor 344 allows the dual limb to do both NIV (pressure-controlled) and (flow-controlled) therapies such as NHF (nasal high flow) therapy or HFT (high flow therapy).
[00782] As described with reference to Figures 1-17, the nasal interface 100 has connection features 133, 134 that are substantially the same. Therefore, the first gases port connection feature 133 is substantially the same as the second gases port connection feature 134. The first conduit 300 and second conduit 302 are interchangeable with each other. Likewise, as discussed above, the diffuser 340 is interchangeable with one of the conduits 300, 302. Further any first respiratory component 331 or second respiratory component 332 is interchangeable.
[00783] In some configurations, a Y-limb connector may be provided. This may be attached to one of the first conduit 300 or second conduit 302, or both.
[00784] In some configurations, a 3-way adaptor may be provided. This may be attached to one of the first conduit 300 or second conduit 302, or both.
[00785] It will be appreciated that the nasal interface 100 may be used in a number of configurations to suit clinical requirements. In such a configuration, the first gases port 121 and second gases port 122 are removably connectable between a first gases conduit 300, a second gases conduit 302 and a diffuser 340. A filter 343 may also be provided. [00786] A filter 343 may be advantageous as this nasal interface 100 can be used on patients suffering from respiratory infections or infectious diseases like COVID 19 or other such diseases. The filter may be microbial and may filter out microbes from the exhaled air from the patient.
[00787] A non-exhaustive list of these is as follows:
[00788] In some configurations, the first gases conduit 300 is directly connected to the first gases port 121 for enabling respiratory gases to be delivered into the interface body 110. The second gases conduit 302 is directly connected to the second gases port 122 for enabling exhaled gases to be expelled out of the interface body 110. No diffuser 340 is required in such a configuration. Such a configuration is shown in Figure 54. Such a configuration may be suitable for Nasal High Flow (NHF) using two conduits 300, 302 as described below. The second gases conduit 302 may be left open to ambient air to enable the exhaled gases to travel out of the second gases conduit 302.
[00789] In a further configuration, the first gases conduit 300 is directly connected to the first gases port 121 for enabling respiratory gases to be delivered into the interface body 110. The second gases conduit 302 is directly connected to the second gases port 122 for enabling exhaled gases to be expelled out of the interface body 110. The diffuser 340 or a filter is directly attached to the end 3006 of the second gases conduit 302 distal to the second gases port 122. Therefore, the nasal interface 100 may be reconfigured by adding the diffuser 340 or filter 343 to the end 3006 of the second gases conduit 302. In some configurations, the diffuser 340 or filter 343 may be added to the end 3005 of the first gases conduit 300. In such an arrangement, the second gases conduit 302 may become the inspiratory conduit.
[00790] Such a configuration with a filter 343 (e.g. Figure 51) may be suitable for Non-Invasive Ventilation (NIV) using dual limb, as described below. The filter 343 will help prevent contamination of the breathing assistance apparatus as exhaled air is passed back to the breathing assistance apparatus. Alternatively, that configuration may be suitable for single limb NIV or NHF, with the filter 343 allowing the passage of exhaled gases to ambient air. Such a configuration with a diffuser (e.g. Figure 52) may be suitable for single limb NIV. The diffuser 340 will enable exhaled gases to pass to ambient air. A filter 343 will reduce infection transfer or contamination and makes the interface useful in hospitals and the home.
[00791] When a filter 343 is used, that will typically have a lower pressure drop than a diffuser. [00792] The filter 343 will have any suitable configuration as known in the art. For example, the filter 343 may have a filter housing comprising one or more housing parts, and one or more filter materials in the housing. Exhaled gases will pass into the filter 343 through a filter inlet port, through the filter material(s), and out of a filter outlet port. The filter materials may be any one or more of the materials described herein for example. [00793] In a further configuration, the first gases conduit 300 is directly connected to the first gases port 121 for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the second gases port 122. The second gases port 122 may be open and not connected to another component. Optionally, the diffuser 340 is directly attached to the second gases port 122 for enabling the exhaled gases to be expelled out of the interface body 110 through the second gases port 122 and diffuser 340. Therefore, the nasal interface 100 may be reconfigured by removing the second gases conduit 302 and placing the diffuser 340 in the second gases port 122. In some configurations, the diffuser 340 may be optional. Such a configuration may be suitable for changing from a dual limb NIV to a single limb (i.e., one conduit 300 remains), as described below. Such a configuration, where the diffuser 340 is optional, may be suitable for changing from a dual limb NIV to a single limb NHF, as described below. A configuration with the first gases conduit 300 directly connected to the first gases port 121 and the diffuser 340 directly connected to the second gases port 122 is shown in Figure 53. A configuration with the first gases conduit 300 directly connected to the first gases port 121 and the second gases port 122 open is shown in Figure 55.
[00794] In a further configuration, the second gases conduit 302 is directly connected to the second gases port 122 for enabling respiratory gases to be delivered into the interface body 110 and exhaled gases can be expelled out of the interface body through the first gases port 121. The first gases port 121 may be open and not connected to another component. Optionally, the diffuser 340 is directly attached to the first gases port 121 for enabling exhaled gases to be expelled out of the interface body 110 through the first gases port 121 and diffuser 340. Therefore, the nasal interface 100 may be reconfigured by swapping the inspiratory conduit to the be the second gases conduit 302. In some configurations, it may be the first gases conduit 300 that is connected to the second gases port 122 in this configuration.
[00795] A further explanation of a non-exhaustive list of the reconfigurable modes is as follows:
[00796] 1. Nasal High Flow (NHF) : [00797] NHF can be delivered to either side of the nasal interface 100, i.e. to first connection feature 133 or the second connection feature 134. The opposite side can remain open or have the second conduit 302 removed to help with the CO2 washout.
[00798] The nasal interface 100 may also be operated in a Low Aerosol NHF or High PEEP (Positive End-Expiratory Pressure) Mode.
[00799] Low Aerosol NHF: A method that filters aerosols for infection control.
[00800] High PEEP Mode: In certain situations, such as treating Acute Respiratory
Distress Syndrome (ARDS), clinicians intentionally set higher PEEP levels as part of an "Open Lung Approach." This approach aims to keep alveoli open and improve oxygen exchange.
[00801] NHF is supplied to one side of the nasal interface 100, such as through the first gases port 121. On the other side, at the second gases port 122, for instance, a respiratory filter is attached which may have the diffuser I filter material(s) discussed above. That filter may be connected to the distal end of the second conduit 302 that is attached to the second gases port 122.
[00802] This setup minimizes aerosol dispersion, enhancing infection control measures.
[00803] 2. Bubble CPAP:
[00804] Bubble CPAP moves excess liquid into a separate chamber from the main pressure-generating section, automatically ensuring that the set pressure does not change with liquid build-up. In bubble CPAP a separate chamber holds water and the expiratory limb is placed in the water. The level of water in the chamber, i.e. the amount of expiratory tube that is submerged, defines the pressure. The bubble generator includes an overflow container that can be detached to remove excess water from the system, without disrupting delivery therapy.
[00805] In this mode, NHF is supplied to one side of the interface 100 such as through the first gases port 121. The other side, i.e. the second gases port 122, connects to a Bubble CPAP line directed toward a bubbler.
[00806] 3. Non-Invasive Ventilation Dual Limb:
[00807] As discussed above, a Y-piece adaptor from a dual-limb circuit can be removed and the conduit 300 is attached to the inspiratory port, e.g. first gases port 121 and the other conduit 302 is attached to the expiratory port, e.g. the second gases port 122. This reduces the dead space normally present between the Y-piece and the interface 100, improving ventilation efficiency.
[00808] 4. Single Limb NIV: [00809] The Supply NIV 300 is attached to one port of the interface 100, e.g. the first gases port 121. The second conduit 302 is replaced with a diffuser assembly 340 or a Positive End-Expiratory Pressure (PEEP) cap is attached to the second gases port 122. The PEEP cap determines bias flow effectively. In some configurations, this may be an adapter between the second gases port 122 and the diffuser assembly 340.
[00810] 5. Low Aerosol single limb NIV:
[00811] In such a configuration, there is the addition of a RT020 electrostatic filter, a plastic porous material (like a woven or sintered nylon), woven mesh (Nylon, polyester and polypropylene, polyethylene) or pleated filter 340 on the expiratory side, i.e. the second gases port 122, to reduce aerosols. This may be connected to the distal end of the second conduit 302 that is attached to the second gases port 122.
[00812] There are also additional features, such as assisting hospitals in weaning support for NIV Patients. The nasal interface 100 supports lower pressure supply in NHF mode, facilitating smooth progression.
[00813] Advantageously, the second conduit 302 may act as a reservoir for humidified gas during brief breath cycles that exceed the supply flow momentarily.
[00814] Figures 29-32 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 as described with reference to Figures 1-28. Like reference numbers indicate like parts. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 29-32.
[00815] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 comprises a gases flow channel 125.
[00816] The interface body 110 comprises a first nasal delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first nasal delivery element 111 or first delivery element portion is configured to seal with a first naris of the patient to substantially deliver gases to or from the first naris of the patient.
[00817] The interface body 110 comprises a second nasal delivery element 112 or a second nasal delivery element portion in fluid communication with the gases flow channel 125. The second nasal delivery element 112 or second delivery element portion is configured to seal with a second naris of a patient to substantially deliver gases to or from the second naris of the patient. [00818] The first nasal delivery element 111 comprises a first outlet 1111a. the second nasal delivery element 112 comprises a second outlet 1112a.
[00819] The nasal interface 100 comprises a first gases port 121 (or gases inlet 121) in the interface body 110. The first gases port 121 is for the delivery of respiratory gases into the interface body 110. The first gases port 121 is in fluid communication with the gases flow channel 125.
[00820] The first gases port 121 allows delivery of respiratory gases through the interface body 110 and to the first and second nares of the patient via the first and second outlets 1111a, 1112a.
[00821] The nasal interface 100 comprises a second gases port 122 (or gases outlet 122) in the interface body 110. The second gases port 122 is for the delivery (or expelling) of exhaled gases out of the interface body 110. The second gases port 122 is in fluid communication with the gases flow channel 125.
[00822] The second gases port 122 allows delivery (or expelling) of exhaled gases from the second naris of the patient to the second gases port 122, through the interface body 110.
[00823] The features herein described may be similar to those described for Figures 1-28 and the descriptions and alternatives may be applied to the present description.
[00824] The interface body 110 comprises a lip-contacting portion that is arranged to contact an upper lip region of the patient in use. Therefore, the interface body 110 has a lip-contacting portion at a position approximately between the first and second gases inlets 121, 122 and the first and second nasal delivery elements 111, 112.
[00825] The interface body 110 comprises a pair of side arms 101, 102 that extend in laterally opposed outward directions.
[00826] In some configurations, the side arms 101, 102 may also be described as with reference to other configurations herein, such as in Figures 1-15. For instance, there may also be a frame 120.
[00827] The side arms 101, 102 may be used to hold the nasal interface 100 in position during use, such as in conjunction with a head strap 200.
[00828] Each side arm comprises a headgear connection feature 1001, 1002 for connecting to the respective end of the headgear or head strap 200.
[00829] The headgear connection feature 1001, 1002 is positioned at a height or position generally between the first and second outlets 1111a, 1112a and the lipcontacting portion, such that in use the headgear 200 pulls the interface body 110 against the patient's face in a direction between an insertion direction of the nasal delivery elements 111, 112 in the patient's nares and a force applied by the user's face to the lipcontacting portion.
[00830] Whilst the first gases port 121 and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first gases port 121 may be used for expelling exhalation gases and the second gases port 122 may be for delivery of respiratory gases. Further, in some configurations, both of the first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris.
[00831] The nasal interface 100 is configured to create a flow of gases at a patient's nasal airways.
[00832] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by means as described throughout this disclosure.
[00833] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00834] In some configurations, such as with reference to Figures 1-11, the structure of the nasal interface 100 and the gases flow channel 125 has been described with reference to the interface body 110. However, the interface body 110 may be defined as a frame portion 120 and a cushion portion 129 that together define the structure and gases flow channel 125.
[00835] Referring to Figure 29, the nasal interface 100 is illustrated with the forces acting thereon. The force from the nose to the first and second nasal delivery elements 111, 112 is the nose force 401. This is illustrated with an arrow that extends axially through the first outlet and second outlet 1111a, 1112a. Therefore, the nose force 401 pushes the nasal interface 100 in a substantially downward direction.
[00836] The force from the lip to the interface body 110 (i.e. the lip contacting portion 155) is the lip force 403. This is illustrated with an arrow that extends in a substantially upward direction from a lower part of the interface body 110. Therefore, the lip force 403 pushes the nasal interface 100 in a substantially upward direction. [00837] Between these is the force exerted from the headgear 200 that passes through the headgear connecting portion 1001, 1002 and the side arms 101, 102. This is the headgear force 402. The headgear force is positioned between the nose force 401 and the lip force 403. In some configurations, such as that illustrated, the headgear force 402 is equidistant between the nose force 401 and the lip force 403.
[00838] Without a lip force 403 acting on the lip contacting portion 155, the headgear force 402 would need to pull at a different angle to counteract the force and prevent the nasal interface 100 from riding up into a patient's eyes. In some configurations, such as that illustrated in Figure 30, there is no lip contacting portion. However, to redirect the headgear force, a rigid headgear connecting portion 1001, 1002 (or rigid side arms 101, 102) moves the headgear force 402 to the end of the rigid headgear connecting portions 1001, 1002. Therefore, the headgear force 402 has a similar angle as the lip force 401 of Figure 29. Such an arrangement reduces the likelihood of the nasal interface 100 to rotate into the patient's eyes.
[00839] It is highlighted that the headgear connecting portion 1001, 1002 may form part of the headgear strap 200.
[00840] Referring to Figure 31, the height 404 between the lip contact portion 155 and the nasal delivery elements 111, 112 is shown. A larger height 404 in this area provides stability. This is due to the amount of contact being maximized.
[00841] Referring to Figure 31, the length 405 between the conduit 300 (or the gases ports 121, 122) and the headgear connecting portions 1001, 1002 is shown. A larger length 405 in this area reduces the likelihood that the conduit 300 will cause the nasal interface 100 to twist. Therefore, the nasal interface 100 is less likely to leak.
[00842] In some configurations, the interface body 110 comprises a frame portion 120 and a cushion portion 129, wherein the cushion portion 129 comprises the first and second nasal delivery elements 111, 112, and wherein the frame portion 129 comprises the pair of side arms 101, 102.
[00843] The cushion portion 129 and frame portion 120 may be connectable as described with reference to Figures 1-26.
[00844] In some configurations, each headgear connection feature 1001, 1002 (or each side arm 101, 102) comprises a post 158 to connect with a hook at the respective end of the headgear 200.
[00845] In some configurations, the first gases port 121 defines a first axis corresponding to a gases flow direction through the first gases port 121, and wherein the post 158 of the proximal side arm 101 is oriented at an angle of between about 90 degrees and about 135 degrees, optionally more than 90 degrees and up to about 135 degrees, optionally between about 95 degrees and about 135 degrees, from the first axis. In some configurations, the second gases port 122 defines a second axis corresponding to a gases flow direction through the second gases port 122, and wherein the post 158 of the proximal side arm 102 is oriented at an angle of between about 90 degrees and about 135 degrees, optionally more than 90 degrees and up to about 135 degrees, optionally between about 95 degrees and about 135 degrees, from the second axis.
[00846] That is, the length of the posts 150 of the side arms may be at an angle of between about 90 degrees and 135 degrees from the nose force 401 direction, optionally more than 90 degrees and up to about 135 degrees, optionally between about 95 degrees and about 135 degrees from the nose force direction 401. As a consequence, in some configurations, the headgear force direction is between about 0 degrees and about 45 degrees, optionally more than 0 degrees and up to about 45 degrees, optionally between about 5 degrees and about 45 degrees, from the nose force 401 direction.
[00847] The angle of the posts 158 allow the headgear 200 to extend at a direction where the headgear force 402 does not cause twisting of the nasal interface 100.
[00848] The nasal interface may have substantially the same first and second gases ports 121, 122 as described with reference to Figures 1-26 to allow for interconnectivity. Further the nasal interface 100 may be symmetrical about the sagittal plane as described with reference to Figures 1-26.
[00849] In some configurations, the headgear 200 is reversible so that either of the ends of the headgear 200 can be connected to either of the headgear connection features 1001, 1002.
[00850] Figures 33-37 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 with reference to Figures 1-32. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 33-37.
[00851] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 is configured to substantially form a seal with the patient's nasal airways.
[00852] The interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient. The interface body 110 comprises a gases flow channel 125. [00853] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00854] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or second delivery element portion is configured to substantially deliver gases to or from the second naris of the patient.
[00855] The first nasal delivery element 111 comprises a first outlet 1111a. the second nasal delivery element 112 comprises a second outlet 1112a.
[00856] The features herein described may be similar to those described for Figures 1-32 and the descriptions and alternatives may be applied to the present description.
[00857] As illustrated in Figure 34, the nasal interface 100 comprises a first gases port 121 in the interface body 110. The first gases port 121 is configured for connecting to a first respiratory component (331, e.g. Figure 1) for enabling respiratory gases to be delivered into (or expiratory gases out of) the interface body 110.
[00858] The nasal interface 100 comprises a second gases port 122 in the interface body 110. The second gases port 122 is in fluid communication with the gases flow channel 125. The second gases port 122 is configured for connecting to a second respiratory component (332, e.g. Figure 1) for enabling exhaled gases to be expelled out (or respiratory gases into) of the interface body 110.
[00859] Whilst the first gases port 121, and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first gases port 121 may be used for expelling exhalation gases and the second gases port 122 may be for delivery of respiratory gases. Further, in some configurations, both first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris. In some configurations, the respiratory gases are delivered to the patient through the first nasal delivery element 111 and the exhalation gases leave the patient via the second nasal delivery element 112.
[00860] The nasal interface 100 is configured to create a flow of gases at a patient's nasal airways. [00861] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by any number of means as described elsewhere in this disclosure.
[00862] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00863] As shown in Figure 33 the interface body 110 has a midline plane 165. The midline plane 165 is a plane of the interface body 110 that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface 100 is in use. As seen from Figure 33, the midline plane 165 equally bisects the interface body 110 in a vertical direction when viewing from the rear, i.e. from the nasal delivery elements 111, 112 direction. Further as shown in Figure 34, the midline plane 165 equally bisects the interface body 110 in a front to back direction when viewing from the top, i.e. a plan view. [00864] The interface body 110 is symmetrical about the first midline plane 165. Therefore, the side of the interface body 110 comprising the first delivery element 111 and first gases port 121 is symmetrically identical to the side of the interface body 110 comprising the second delivery element 112 and the second gases port 122.
[00865] It may also be termed that the nasal interface 100 has symmetry about the first midline plane 165. The symmetrical about the first midline plane 165 allows the nasal interface 100 to be placed on a patient 'upside down', such that the first delivery element 111 is in contact with the first naris and the second delivery element 112 is in contact with the second naris, or the nasal interface 100 is flipped and the first delivery element 111 is in contact with the second naris and the second delivery element 112 is in contact with the first naris. This reduces the effort required in ensuring the orientation of the nasal interface 100. It also reduces incorrect wearing of the nasal interface 100.
[00866] Referring to Figure 33, the interface body 110 comprises a second midline plane 166. The second midline plane 166 is transverse to the first midline plane 165. The second midline plane 166 bisects the interface body 110 when viewed from the rear or front. Therefore, the second midline plane equally bisects at least one of the pair of first and second gases ports 121, 122 or the pair of first and second delivery elements 111, 112, or the pair of first and second outlets 1111a, 1112a.
[00867] The interface body 110 (or nasal interface 100) is symmetrical about the second midline plane 166. Therefore, a bottom half of the interface body 110 when viewed from the front or rear, is symmetrical with a top half of the interface body 110. [00868] As with the symmetry of the first midline plane 165, the interface body 110 being symmetrical about the second midline plane 166 allows the switching of nares to delivery elements 111, 112 and reduces the effort or errors in ensuring the orientation of wearing the nasal interface 100.
[00869] Where the first midline plane 165 and second midline plane 166 cross a line 164 is formed between the planes. This line, when viewed along the line, i.e. from a front or rear view (as seen in Figure 33) may be termed as the centrosymmetric point 164. Therefore, the nasal interface 100 is centrosymmetric about the centrosymmetric point 164 when rotated 180 degrees. This is when viewed from the front or rear in terms of the figures, e.g. Figure 33.
[00870] As will be appreciated, given the symmetry described herein, in some configurations, it will be beneficial for the first gases port 121 and second gases port 122 to be substantially the same. This will allow the exchange of respiratory components regardless of the orientation of the nasal interface 100 on the patient. In this regard, the description in reference to Figures 1-11 of the gases ports 121, 122 being substantially the same applies.
[00871] Therefore, with reference to Figures 33-35, the first gases port 121 and the second gases port 122 have substantially the same configuration such that the first respiratory component 331 can be selectively connected to each of the first gases port 121 and the second gases port 122, and such that the second respiratory component 332 can be selectively connected to each of the first gases port 121 and to the second gases port 122.
[00872] The first gases port 121 and the second gases port 122 have substantially the same sized openings 137, 138. This is illustrated in Figures 1-11 where a similar sized opening 137, 138 is shown. This likewise applies to Figures 33-35, albeit not shown in these views.
[00873] A diffuser 340, a conduit, 300, 302 or any other component described herein may likewise be connected to the first or second gases ports 121, 122.
[00874] In some configurations, the symmetrical interface body 110, is also angled with reference to the first midline plane 165 and as described with reference to Figure 10. The description likewise applies to the configurations of Figures 33-35. Namely, the nasal interface 100 is angled about the midline plane 165.
[00875] Such an angled geometry of the nasal interface 100 allows the interface to conform with the shape of the patient's face. Whilst an angled geometry is considered such that the first and second delivery elements 111, 112 are faced toward one another, i.e., arranged closer to one another. This may also be termed as ports/outlets of the first and second delivery elements 111, 112 are positioned closer together than base portions of the first and second nasal delivery elements 111, 112 distal from the ports of the first and second delivery elements 111, 112. In some configurations, the opposite configuration may be used.
[00876] Referring to Figure 34, the first axis 167 and the second axis 168 are shown which are as described with reference to Figure 10. Therefore, the first gases port 121 defines a first axis 167. The first axis 167 corresponds to a gases flow direction through the first gases port 121. Alternatively, or additionally, the first axis 167 may be perpendicular to the face of the first gases porty 121. Similarly, the second gases port 122 defines a second axis 168. The second axis 168 corresponds to a gases flow direction through the second gases port 122. Alternatively, or additionally, the second axis 168 may be perpendicular to the face of the second gases port 122. The first axis 167 and second axis 168 intersect due to the angled geometry of the nasal interface 100.
[00877] The angle 169 between the first axis 167 and the second axis 168 is more than 0 degrees. In some configurations, the angle 169 between the first axis 167 and the second axis 168 is less than 120 degrees. In some configurations, the angle 169 between the first axis 167 and the second axis 168 is between about 40 and 60 degrees. In some configurations, the angle 169 between the first axis 167 and the second axis 168 is about 50 degrees.
[00878] The angle provides increased septum spacing and allows different patients to adjust for different septum spacing, or to allow the nasal interface 100 sit more closely to their nose for more stability. It also provides a decreased footprint on the face making it easier for eating or drinking.
[00879] In some configurations, such as shown in Figure 35, the first outlet 1111a in the first delivery element 111 and the second outlet 1112a in the second delivery element 112 are shown. The first outlet 1111a and second outlet 1112a are substantially the same shape. In some configurations, such as illustrated, the first outlet 1111a and second outlet 1112a are circular in shape. Therefore, the outlet 1111a and second outlet 1112a have the same diameter 170.
[00880] As described above, the symmetry of the interface body 110 reduces errors in mask placement. Further, the first and second outlets 1111a, 1112a are referred to be similarly sized so that flow through these is not altered with such a rotation of the nasal interface 100. [00881] In some configurations, the opening of the first gases port 121 is concentric with the first outlet 1111a and the opening of the second gases port 122 is concentric with the second outlet 1112a. For the symmetry of the interface body 110, the first gases port 121 and second gases port 122 may be aligned with their respective nasal delivery elements 111, 112. This also allows for a gases flow directed along these to be directed to or from each naris of the patient.
[00882] As shown in Figures 33 to 35, in some configurations, the interface body 110 comprises a pair of side arms 101, 102. The side arms 101, 102 are as described elsewhere such as with reference to Figures 1-32.
[00883] The side arms 101, 102 are symmetrical about the first midline plane 165. Therefore, the side arms 101, 102 are not angled in a particular direction to conform with a patient's face in this plane 165.
[00884] In some configurations, the side arms 101, 102 are symmetrical about the second midline plane 166 of the interface body 110. Therefore, the side arms 101, 102 are not angled in a particular direction to conform with a patient's face in this plane 166. Therefore, the nasal interface 100 may be inverted without the headgear 200 having a resultant different position or needing further adjustment.
[00885] It is highlighted that such a symmetrical side arm 101, 102 is different to the configurations such as shown in Figures 29-32 where the side arms 101, 102 are angled relative to a patient's face. It is noted that where a frame portion 120 and a cushion portion 129 are used, as described herein, that the cushion portion 129 may have the symmetry described above with the frame portion 120 not having the symmetry.
[00886] Referring to the above, in some configurations, the interface body 110 comprises a frame portion 120 and a cushion portion 129.
[00887] As with reference elsewhere, the interface body 110 may be defined as a frame portion 120 and a cushion portion 129 that together define the structure and gases flow channel 125. Likewise, the frame portion 120 and cushion portion 129 may be attached to form the interface body 110 as described with reference to Figures 12-16.
[00888] The side arms 101, 102 may be formed as part of the frame portion 120. Further, as best seen in Figures 36-38, the frame portion 120 may comprise the baffles 180. However, the frame portion 120 (and the cushion portion 129) may be symmetrical along at least one of the first midline plane 165 and second midline plane 166.
[00889] Figures 38-45 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 as described with reference to Figures 1-37. Like reference numbers indicate like parts. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 38-45.
[00890] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 is configured to substantially form a seal with the patient's nasal airways.
[00891] The interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient. The interface body 110 comprises a gases flow channel 125.
[00892] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00893] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or second delivery element portion is configured to substantially deliver gases to or from the second naris of the patient.
[00894] The features herein described may be similar to those described for Figures 1-37 and the descriptions and alternatives may be applied to the present description.
[00895] The nasal interface 100 comprises a first gases port 121. The first gases port 121 is for the delivery of respiratory gases into the nasal interface 100.
[00896] The nasal interface 100 comprises a second gases port 122. The second gases port 122 is for the delivery (or expelling) of exhaled gases out of the nasal interface 100.
[00897] In some configurations, the first gases port 121 is in fluid communication with the interface body 110. This allows delivery of respiratory gases from the first gases port 121, through the interface body 110 and to the first and second nares of the patient. The second gases port 122 is in fluid communication with the interface body 110. This allows delivery (or expelling) of exhaled gases from the second naris of the patient to the second gases port 122, through the interface body 110.
[00898] Whilst the first gases port 121 and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first gases port 121 may be used for expelling exhalation gases and the second gases port 122 may be for delivery of respiratory gases. Further, in some configurations, both of the first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris.
[00899] The nasal interface 100 is configured to create a flow of gases at a patient's nasal airways.
[00900] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by means as described throughout this disclosure.
[00901] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00902] As illustrated in Figure 38, the interface body 110 comprises a pair of side arms 101, 102 that extend in opposed laterally outward directions. The side arms 101, 102 are as described elsewhere such as with reference to Figures 1-37. Therefore, the side arms 101, 102 may be symmetrical about the first midline plane 165 and/or second midline plane 166 in some configurations.
[00903] As with reference elsewhere, the interface body 110 may be defined as a frame portion 120 and a cushion portion 129 that together define the structure and gases flow channel 125. Likewise, the frame portion 120 and cushion portion 129 may be attached to form the interface body 110 as described with reference to Figures 12-16.
[00904] The side arms 101, 102 may be formed as part of the frame portion 120. Further, the frame portion 120 may comprise baffles 180. However, the frame portion 120 (and the cushion portion 129) may be symmetrical along at least one of the first midline plane 165 and second midline plane 166.
[00905] The nasal interface 100 comprises a headgear connecting portion 1005, 1006. The headgear connecting portion 1005, 1006 is an intermediary connector between the headgear 200 and the side arms 101, 102. Therefore, the headgear connecting portion 1005, 1006 connects at one end to the side arms 101, 102 and at its other end to the headgear end portion 201, 202. The headgear connecting portion 1005, 1006 may have a slot for the headgear end portions 201, 202 to slot around there. However, other connection means may be used. [00906] In some configurations, the headgear end portions 201, 202 may comprise end portions of headgear strap(s). In other configurations, the headgear end portions 201, 202 may comprise sleeves or other features that are connected to the headgear strap(s). [00907] The headgear connecting portion 1005, 1006 may share a number of similar features with the headgear connecting feature 1001, 1002 described with reference to Figures 29-32. Therefore, the description there applies here with the exception of the differences described below.
[00908] Further, whilst the headgear connecting portion 1005, 1006 is described as being comprised by the nasal interface 100, in some configurations, it may be comprised by the headgear 200 or be a patient interface comprising a headgear 200 and a nasal interface 100.
[00909] Each side arm 101, 102 comprises either a ball portion 1007 or a socket portion 1008 of a ball and socket joint 191. Referring to Figures 39-45, the details of the ball and socket joint 191 are shown. Whilst the headgear connecting portion 1005, 1006 is shown to comprise the socket portion 1008, in some configurations it may be the side arm 101, 102 that comprises the socket portion 1008. Likewise, in some alternative configurations, the ball and socket joint 191 may be different for each side arm 101, 102. For instance, the first side arm 101 may comprise a ball portion 1007 and the second side arm 102 may comprise the socket portion 1008.
[00910] The ball and socket joint 191 is configured to be a moveable connection. Therefore, the ball portion 1007 may move relative to the socket portion 1008 when connected or engaged.
[00911] The movement of the ball portion 1007 and the socket portion 1008 may be described as a rotatable connection as the socket portion 1008 rotates or pivots around the ball portion 1007 when connected.
[00912] The ball and socket joint 191 is a removably engageable connection, therefore, the ball portion 1007 may be removably engaged with the socket portion 1008. However, in some configurations, the ball and socket joint 191 may be permanently attached or may be attached in a manner that is not freely disconnectable, such as a tool may be required. This is to prevent accidental dislodgement of the connected ball and socket joint 191.
[00913] Referring to Figures 39 and 40 and with overall reference to Figure 38, each side arm 101, 102 comprises a distal end 1016 that is distal to the interface body 110. The ball portion 1007 positioned at the distal end 1016. Therefore, the ball portion 1007 is at a distal point from the interface body 110 that ensures that it does not interfere with the positioning of the nasal interface 100 with the nares of the patient.
[00914] In some configurations, as described above, it may be the socket portion 1008 at the distal end 1016.
[00915] The distal end 1016 comprises an aperture 1017. The ball portion 1007 is formed in a wall of the aperture 1017. that is, the ball portion 1007 is a ball-shaped (or bulbous of spherical) feature formed in the wall of the aperture 1017.
[00916] As shown in Figures 39 and 40, the aperture 1017 is substantially a D- shaped aperture 1017 and the ball portion 1007 is formed in the straight portion of the D-shape 1017. The straight portion of the D-shape 1017 forms the outer most point of the distal end 1016. Therefore, the curved part of the D-shape 1017 is proximal to the interface body 110. Referring back to Figures 29 to 32, the straight portion of the D-shape 1017 may be similar to the post 158 of that configuration.
[00917] The ball portion 1007 may be substantially central in the straight portion of the D-shape 1017. However, in some configurations, the positioning of the ball portion 1007 may be asymmetric.
[00918] Whilst a ball-shaped ball portion 1007 is described, other shapes could be contemplated that are not fully spherical.
[00919] The socket portion 1008 is formed as a hooked-shaped portion 1008. Therefore, the socket portion 1008 is shaped to have a curved portion at its distal end with an inner hook.
[00920] The hooked-shaped portion 1008 is configured to pass through the aperture 1017 and engage at least partially around the ball portion 1007. Therefore, the part of the hooked-shape 1008 passes through the aperture 1017 and around the ball portion 1007. The hooked-shape 1008 may have an outer body that conforms with the curve of the D- shape 1007 to ensure it maximizes the space whilst retaining a gap for movement.
[00921] In some configurations, such as shown in Figure 44, an end of the hooked- shape 1008 (or hooked portion) is formed with an undercut profile 1018. The undercut profile 1018 shaped to allow the hooked-shape 1008 to engage with the ball portion 1007 by having a corresponding profile to the shape of the ball portion 1007. Therefore, in some configurations, the undercut 1018 may be substantially C-shaped to reflect the shape of a ball-shaped ball portion 1007. This means the sides of the hooked-shape 1008 partially surround the ball portion 1007 to ensure a secure connection.
[00922] The ball and socket joint 191 is a moveable connection having multiple-axis or omnidirectional movement. This enables the headgear connecting portion 1005, 1006 to have a high degree of positional freedom to align the nasal interface 100 with a headgear 200 for maximum patient comfort.
[00923] The headgear connecting portion 1006, 1007 is an elongate portion and defines a connecting portion axis 1024 between its elongate ends as shown in Figures 39 and 40. Referring to Figures 39 and 41, the headgear connecting portion 1006, 1007 is shown in a neutral position, that is the connecting portion axis 1024 is in line with an axis of the side arms 101, 102. The axis of the side arms 101, 102 may sit on the same plane as the second midline plane 166 or may be parallel to it. In Figures 41-43, the ball and socket joint 191 is shown in a different orientation. Namely, the ball and socket joint 191 is shown from the side. Therefore, it is effectively along the connecting portion axis 1024 described with reference to Figures 39 and 40.
[00924] As shown in the comparison between Figures 39-43, the ball and socket joint 191 is configured to allow the headgear connecting portion 1005, 1006 to rotatably twist relative to the side arms 101, 102. That is the headgear connecting portion 1005, 1006 twists about the connecting portion axis 1024. Referring to Figure 40, 42 and 43, the connecting portion 1005, 1006 rotatably twists upwards or downwards when viewed from the front or rear. Therefore, the connecting portion 1005, 1006 has a portion that is relatively flat in a neutral position and this portion is angled relative to this neutral position when twisted.
[00925] The angle of twisting 1025 from the neutral position is any point between 0 and about 85 degrees in opposing (up or down twist) directions. Or is any point between 0 and about 75 degrees in opposing directions. Or is any point between 0 and about 60 degrees in opposing directions. Or is any point between 0 and about 45 degrees in opposing directions. It may also be at any point in between these. It will be appreciated that these are maximum points of movements. Therefore, the position required for a patient may be at any angle required therebetween.
[00926] The ball and socket joint 191 may also move such that such that the connecting portion axis 1024 is angled relative to the connecting portion axis 1024 in a neutral position. That is the headgear connecting portion 1005, 1006 may move in a rotating upward direction 1026 or a rotating downwards direction 1027 as shown by the arrows in Figure 39. Therefore, the connecting portion axis 1024 is angled.
[00927] In such a movement, the connecting portion axis angle is positionable at any point between 0 and about 85 degrees, or between 0 and about 75 degrees, or between 0 and about 60 degrees or between 0 and about 45 degrees in opposing directions (i.e., in the upward 1026 or downward 1027 directions). It may also be at any point in between these. It will be appreciated that these are maximum points of movements. Therefore, the position required for a patient may be at any angle required therebetween. [00928] Whilst two planes of movement are described, from the position described above, i.e. the neutral or central position, as the ball and socket joint 191 has freedom of movement, the headgear connecting portion 1005, 1006 is configured to rotatably move from this neutral position relative to the side arms 101, 102 at any angle between at least 0 degrees and about 90 degrees in any direction (or any point between 0 and about 75 degrees, or between 0 and about 60 degrees or between 0 and about 45 degrees). That is, the ball and socket joint 191 is a pivot point where the headgear connecting portion 1005, 1006 may pivot about in any direction with a maximum pivot angle of 90 degrees. [00929] The freedom of movement provided by the ball and socket joint 191 allows the flexibility of the fixing of the nasal interface 100 to the patient in any configuration. This accommodates a broader range of facial geometry. This may reduce leaks since the joint can move in more ways, and when it moves, it transfers less load to the nasal interface 100, which could displace it.
[00930] It will be appreciated that in some configurations, the freedom of movement provided by the ball and socket joint 191 may be useful with other parts of configurations described herein. For instance, in some configurations, the interface body 110 is symmetrical about the first midline 164 as described with reference to Figures 1-13 and 33-37. Additionally, the interface body 110 may be symmetrical about the second midline plane 166 as described with reference to Figures 33-37. Therefore, the description used there also applies here. In such a configuration, the ball and socket joint 191 of the side arms 101, 102 is symmetrical. The combination of these features allows the inversion of the nasal interface 100 without the positioning of the nasal interface 100 relative to the headgear 200 being affected as the ball and socket joint 191 will work in either orientation. [00931] As will be appreciated, the first gases port 121 and the second gases port 122 having substantially the same configuration would also be useful in some configurations. Therefore, with reference to Figures 38-45, the first gases port 121 and the second gases port 122 have substantially the same configuration such that the first respiratory component 331 can be selectively connected to each of the first gases port 121 and the second gases port 122, and such that the second respiratory component 332 can be selectively connected to each of the first gases port 121 and to the second gases port 122.
[00932] A method of side-swapping or changing the configuration or direction of a gases inlet of the nasal interface 100 may be provided by the described configuration. As described above, the nasal interface 100 may be inverted and worn in either orientation on the patient's face. The method comprises inverting the nasal interface 100. Inverting the nasal interface 100 causes the nasal interface 100 to change from a first configuration where the gases inlet (e.g. first gases port 121 and first respiratory component 331) is on a left side of the nasal interface 100 to a second configuration where gases inlet (e.g. first gases port 121 and first respiratory component 331) is on a right side of the nasal interface 100. The method comprises rotating the ball portion 1007 in the socket portion 1008 of the ball and socket joint 191.
[00933] The method may comprise rotating the ball portions 1007 in the socket portions 1008 in both sides of the nasal interface 100.
[00934] The first gases port 121 and the second gases port 122 have substantially the same sized openings 137, 138. This is illustrated in Figures 1-11 where a similar sized opening 137, 138 is shown.
[00935] A diffuser 340, a conduit 300, 302, or any other component described herein may likewise be connected to the first or second gases ports 121, 122.
[00936] In some configurations, the symmetrical interface body 110, is also angled with reference to the first midline plane 165 and as described with reference to Figure 10. The description likewise applies to the configurations of Figures 38-45. Namely, the nasal interface 100 is angled about the midline plane 165.
[00937] Referring to the above, in some configurations, the interface body 110 comprises a frame portion 120 and a cushion portion 129.
[00938] As referenced elsewhere, the interface body 110 may be defined as a frame portion 120 and a cushion portion 129 that together define the structure and gases flow channel 125. Likewise, the frame portion 120 and cushion portion 129 may be attached to form the interface body 110 as described with reference to Figures 12-16.
[00939] In some configurations, the baffles 180 as described with reference to Figures 17-24 may be provided in the present configuration.
[00940] Figures 46-50 schematically shows an alternative configuration nasal interface 100 for use in a patient interface. Unless described as being different below, the features, functionality, alternatives, and uses of the nasal interface 100 are as described for the nasal interface 100 as described with reference to Figures 1-45. Like reference numbers indicate like parts. Exemplary configurations of the nasal interface are described in more detail below with reference to Figures 46-50A. [00941] In the described configuration, a nasal interface 100 of the present disclosure comprises an interface body 110. The interface body 110 is configured to substantially form a seal with the patient's nasal airways.
[00942] In some configurations, the interface body 110 is configured to deliver gases to the first naris of the patient and to the second naris of the patient. The interface body 110 comprises a gases flow channel 125.
[00943] The interface body 110 comprises a first delivery element 111 or a first delivery element portion in fluid communication with the gases flow channel 125. The first delivery element 111 or first delivery element portion is configured to substantially deliver gases to or from the first naris of the patient.
[00944] The interface body 110 comprises a second delivery element 112 or a second delivery element portion in fluid communication with the gases flow channel 125. The second delivery element 112 or second delivery element portion is configured to substantially deliver gases to or from the second naris of the patient.
[00945] The features herein described may be similar to those described for Figures 1-44 and the descriptions and alternatives may be applied to the present description.
[00946] The nasal interface 100 comprises a first gases port 121. The first gases port 121 is for the delivery of respiratory gases into the nasal interface 100.
[00947] The nasal interface 100 comprises a second gases port 122. The second gases port 122 is for the delivery (or expelling) of exhaled gases out of the nasal interface 100.
[00948] The nasal interface 100 is configured to create a flow of gases at a patient's nasal airways.
[00949] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient. An asymmetric flow may be enabled by means as described throughout this disclosure.
[00950] In some configurations, the nasal interface 100 is configured to create an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[00951] In some configurations, the first gases port 121 is in fluid communication with the interface body 110. This allows delivery of respiratory gases from the first gases port 121, through the interface body 110 and to the first and second nares of the patient. The second gases port 122 is in fluid communication with the interface body 110. This allows delivery (or expelling) of exhaled gases from the second naris of the patient to the second gases port 122, through the interface body 110.
[00952] Whilst the first gases port 121 and second gases port 122 have been described as being for delivery and expelling of gases respectively, in some configurations, the first gases port 121 may be used for expelling exhalation gases and the second gases port 122 may be for delivery of respiratory gases. Further, in some configurations, both of the first gases port and second gases port 121, 122 may be for delivery of gases or the expelling of gases. Likewise, whilst the first naris and second naris of the patient have been described as both receiving respiratory gases, only one naris may receive respiratory gases. Further, in some configurations, whilst the second naris has been described as expelling exhalation gases, this does not preclude the first naris expelling gases on its own or in combination with the second naris.
[00953] In some configurations, the interface body 110 comprises a cushion portion comprising the first delivery element 111 (or first delivery element portion) and the second delivery element 112 (or the second delivery element portion). In such a configuration, the interface body may comprise frame portion 120 comprising the first gases port 121 and the second gases port 122.
[00954] The first and second nasal delivery elements 111, 112 each comprise a respective pillow 193, 194. Each pillow 193, 194 may seal with a respective naris of a patient. Whilst the pillows 193, 194 have not been described in detail herein, the nasal interface 100 illustrated in Figures 1-45 may comprise pillows 193, 194 for sealing with a patient's naris.
[00955] A portion of at least one of the nasal pillows 193, 194 has a thinned region for deforming around a tube 196 passing along the thinned region.
[00956] The thinned region allows for the tube 196, which may be a nasogastric (NG) tube, to be placed on the patient along with, or before, the nasal interface 100. The tube 196 will be positioned externally of the nasal interface 100, such that the exterior of the portion deforms around the tube 196. The thinned region will deform inwardly to deform around the tube. This reduces force applied to the tube 196 by the nasal interface 196, which could otherwise cause discomfort to the patient.
[00957] In some configurations, the thinned region is a result of a narrower wall thickness in the area.
[00958] In some configurations, at least one of the nasal pillows 193, 194 has a plurality of thinned regions for providing multiple locations for sealing around a tube 196 passing therethrough. Therefore, flexibility is provided in the tube 196 location. [00959] In some configurations, only one of the nasal pillows 193, 194 has the thinned region(s). In other configurations, both of the nasal pillows 193, 194 have the thinned region(s).
[00960] As shown schematically in Figure 45, the thinned region(s) may be provided in the upper portion(s) of the nasal pillow(s). The thinned regions are behind the upper shaded regions of the tubes 196. The thinned regions may include the widest portion(s) of the nasal pillow(s) and may extend from the widest portion(s) at least part way, and optionally the entire way, to the outlets 1111a, 1112a.
[00961] The lip contact portion 155 may also include thinned region(s) to reduce force applied to the tube 196 between the nasal interface 196 and the patient's lip region. Such thinned regions(s) are behind the lower shaded regions of the tubes 196 in Figure 45.
[00962] Figure 46 shows shaded regions that represent the thinned regions TRI, TR2. This configuration is for an interface body 110 that is symmetrical about the first midline plane 165.
[00963] In some configurations, a first outlet 1111a in the first delivery element 111 and a second outlet 1112a in the second delivery element 112 are substantially the same shape. This same shape may be circular such that the first outlet 1111a and second outlet 1112a are circular in shape. The thinned region therefore may be provided on mirrored locations on the pillows 193, 194 as they have the same geometry.
[00964] As described above, the symmetry of the interface body 110 reduces errors in mask placement. Further, the first and second outlets 1111a, 1112a are referred to be similarly sized so that flow through these is not altered with such a rotation of the nasal interface 100.
[00965] In some configurations, the nasal interface 100 may be centrosymmetric. Therefore, as described with reference to Figures 33-37, the interface body 110 is symmetrical about the first midline plane 165. Therefore, the side of the interface body 110 comprising the first delivery element 111 and first gases port 121 is symmetrically identical to the side of the interface body 110 comprising the second delivery element 112 and the second gases port 122. The interface body 110 (or nasal interface 100) is also optionally symmetrical about the second midline plane 166. Therefore, a bottom half of the interface body 110 when viewed from the front or rear, is symmetrical with a top half of the interface body 110.
[00966] The 'inverting' of the nasal interface 100 will require the NG tube 196 to be in the same location. Therefore, the thinned region will likewise be mirrored as part of the symmetry as shown in Figure 45 for example. In some configurations, each nasal pillow 193, 194 has two thinned regions (e.g. front and back) for a tube 196. Therefore, a nasal interface has four thinned regions. This allows a tube 196 to seal in multiple orientations of the nasal interface 100.
[00967] Figure 45 shows shaded regions that represent the thinned regions TRI, TR2, TR3, TR4. This configuration is for an interface body 110 that is symmetrical about both a first midline plane 165 and a second midline plane 166. This configuration has upper and lower thinned regions so that the nasal interface can be fitted to a patient either way up.
[00968] In some configurations, such as shown in Figures 48 and 49, the nasal pillow 193, 194 comprises an outlet 1111a, 1112a distal to the interface body 110 for the passage of gases into or out of the nasal interface 100. The outlets 1111a, 1112a are the same as the first and second outlets 1111a, 1112a described herein. The nasal pillow 193, 194 also comprises a base 1111c, 1112c proximal to the interface body 110. The base 1111c, 1112c is the same as the first and second base 1111c, 1112c described herein.
[00969] A cross-sectional area of the base 1111c, 1112c is larger than the outlet 1111a, 1112a. A pillow with a larger base radius can fit more population in terms of nose size.
[00970] For comparison, as shown in Figure 48, a superimposed image of the nasal interface 100 is shown, where a nasal interface 100b having a larger outlet cross-section relative to the base is shown in comparison to a nasal interface 100a having a smaller outlet 1111a, 1112a cross-section relative to the base 1111c, 1112c. The outlet 1111a, 1112a, in some configurations, may have a pillow tip increased by up to 2 mm. That is, the nasal interface 100a having a smaller outlet cross-section relative to the base has the tip (i.e. the outlet height) increased by 2 mm. However, in some configurations, the tip increase may be between 1 mm and 3 mm.
[00971] Additionally or alternatively, in some configurations, the pillow pivot height of the nasal interface 100a having a smaller outlet cross-section relative to the base may be increased by 2 mm. That is, the point where the pillow 193, 194 turns (i.e. the largest portion between the outlet 1111a, 1112a and the base 1111c, 1112c on the base side) is 2 mm further away from the base. However, in some configurations, the pillow pivot height may be increased between 1 mm and 3 mm.
[00972] Additionally or alternatively, in some configurations, the pillow pivot height of the nasal interface 100a having a smaller outlet cross-section relative to the base may be reduced by 1 mm. That is, the point where the pillow 193, 194 turns (i.e. the largest portion between the outlet 1111a, 1112a and the base 1111c, 1112c) is 1 mm narrower. However, in some configurations, the pillow pivot height may be increased between 0.5 mm and 2 mm. This may provide more septum spacing.
[00973] In some configurations, the outlet 1111a, 1112a and base 1111c, 1112c both comprise substantially circular or oval diameter cross-sections. Therefore, the diameter of the base 1111c, 1112c is larger than the diameter of the outlet 1111a, 1112a. [00974] Referring to Figure 49, in some configurations, the first pillow 193 and second pillow 194 are convex in shape. Such a convex shape is illustrated by comparative superimposed lines showing a broken line concave first pillow 197 and a broken line concave second pillow 198.
[00975] The convex shape is outwardly convex. That is, at least a portion of each nasal pillow 193, 194 between the widest portion of the nasal pillow and the outlet 1111a, 1112a is outwardly bowed, rather than being inwardly recessed as shown in broken lines. [00976] In some configurations, the convex shape extends around the entire periphery of the first pillow 193 and the second pillow 194. In other configurations, the convex shape extends around only part of the periphery of the first pillow 193 and the second pillow; for example, at least half of the periphery of the pillow or at least three quarters of the periphery of the pillow.
[00977] As shown in Figure 49, the concave pillow 193, 194 may be made a convex shape by lofting. The convex pillows 197, 198 has advantages such as a better seal against the patient's nose; one size fits a large percentage of the population (70%-80% of people); more movement freedom for the nasal interface; and more comfortable to the nose. In some configurations, this may be combined with the narrower outlets 1111a, 1112a.
[00978] In some configurations, such as illustrated in Figure 50, the first nasal delivery element 111 has a first outlet 1111a and the second nasal delivery element 112 has a second outlet 1112a as described above. Likewise, at the opposing end of the delivery element 111, 112 to the outlets 1111a, 1112a there are provided a first base 1111c and a second base 1112c as described.
[00979] In the configuration of Figure 50, the first delivery element comprises a first prong portion 11 lid extending from the first base 1111c. The first prong portion 11 lid extends from the interface body 110 from the first base 1111c of the first delivery element 111 in a substantially cylindrical or tubular shape. The second delivery element comprises a second prong portion 1112d extending from the second base 1112c. The second prong - I l l - portion 1112d extends from the interface body 110 from the second base 1112c of the second delivery element 112 in a substantially cylindrical or tubular shape.
[00980] The first nasal delivery element 111 comprises a first pillow 193. The first pillow 193 is a nasal pillow 193 as described elsewhere herein and may comprise any of the features of the nasal pillows 193 disclosed. The pillow 193 is positioned at an end of the first prong 111 Id opposite to the first base 1111c.
[00981] The second nasal delivery element 112 comprises a second pillow 194. The second pillow 194 is a nasal pillow 194 as described elsewhere herein and may comprise any of the features of the nasal pillows 194 disclosed. The second pillow 194 is positioned at an end of the second prong 1112d opposite to the second base 1112c.
[00982] When applicable, an inhalation gas flows from gases inlet port 121 through the interface body 110, then the first base 1111c, followed by the prong portion 11 lid, through the first pillow 193, out the first outlet 1111a into the patient's first naris. The opposite flow direction will be provided for an exhalation flow.
[00983] Likewise, an exhalation flow passes from the patient's second naris, into the second outlet 1112a, through second pillow 194, through the second prong portion 1112d, through the second base 1112c into the interface body 110, and out through the outlet gases port 122 or the diffuser 340 as illustrated in Figure 50.
[00984] The respective prong portions lllld, 1112d provide alternative geometry. This may assist with rigidity or positioning of the nasal pillows 193, 194.
[00985] The nasal interface 100 of Figure 50 comprises a structural support 2110 extending into the flow channel 125. The structural support 2110 may be formed as part of the interface body 110 extending from the inner wall of the base portion 118. The cushion portion 129 may be formed unitary with the structural support 2110. The structural support 2110 may be formed of the same material as the cushion portion 129. The structural support 2110 provides structural resistance to the collapse of the interface body 110. The structural support 2110 helps the interface body 110 maintain its shape in resistance to forces applied thereupon. The structural support 2110 helps maintain that the flow channel 125 is not closed or obstructed. The structural support 2110 maintains a gasp between the structural support and the frame 120. In some optional arrangements, the structural support 2110 may be used to provide a restriction in the flow channel 125 such as to direct flow. The structural support 2110 is formed in the shape of a cuboid. However, other shapes, such as a dome or semi-disc shape.
[00986] The cushion portion 129 may comprise at least one lateral tab 2116. The lateral tab 2116 extends outwardly at the lateral portions of the interface body 110. The lateral tabs 2116 provide area to grip or hold when assembling or disassembling the attachment of the cushion portion 129 to the frame 120.
[00987] The nasal interface 100 comprises a groove 124 formed in the periphery of the frame 120. The groove 124 extends around a portion or the entirety of the perimeter of the frame 120. A portion of the interface body 110 is received in the groove 124. The groove 124 is generally U-shaped. The interaction between the cushion portion 129 in the groove 124 secures the cushion portion 129 to the frame portion 120 to form the interface body 110.
[00988] The portion of the cushion portion 129 received in the groove 124 is formed as a circumferential lip. The circumferential lip is arranged circumferentially around the face of the cushion portion 129 that corresponds to the frame portion 120. Multiple openings may each comprise a circumferential lip. The circumferential lip forms a partial face of the cushion portion 129 on the side facing away from the patient (in use).
[00989] The circumferential lip is sized to be received in the groove 124. The circumferential lip corresponds to the groove 124. In some arrangements, the circumferential lip forms a sealing connection with the groove 124.
[00990] In some configurations, such as the one illustrated in Figure 50, the size of the groove 124 varies around the edges of the frame portion 120. At least a portion of the groove 124 comprises a deeper and/or thicker channel relative to a further portion of the groove 124.
[00991] A deeper portion of the groove 124 may extend between 1.5 times to 4 times the depth of the remainder of the groove 124.
[00992] The deeper portion of the groove 124 may have a greater thickness than the remainder of the groove 124. The deeper portion of the groove may extend further in a front to back direction relative nasal interface 100 in use. The deeper portion of the groove may extend further in a substantially sagittal plane direction of the patient in use. The deeper portion of the groove may extend between 1.2 times to 3 times the width of the remainder of the groove 124.
[00993] The circumferential lip is sized to be received in the groove 124 such that it has a portion that is sized to correspond to the deeper portion of the groove 124.
[00994] The groove 124 and circumferential lip are orientated such that the deeper portion of the groove 124 is positioned to be receive a correspondingly sized portion of the circumferential lip when the frame 120 and cushion portion 129 are in the desired orientation. [00995] The deeper portion of the groove 124 may be positioned on the edge at or near the outlet gases port 122 I diffuser 340. Such a position ensures that the deeper portion of the groove 124 does not interfere or overlap with the inlet gases port 121.
[00996] Optionally, in some configurations, the diffuser 340 may be positioned more distal to the edge where the deeper portion of the groove 124 is positioned than the inlet gases port 121 is relative to its proximal edge.
[00997] The groove 124 and circumferential lip comprising a varied corresponding size ensures that the cushion portion 129 may only be positioned or connected to the frame 120 in a single orientation. Given the symmetrical or very similar mirrored features of the nasal interface 100, there is a risk that the frame 120 and cushion portion 129 be orientated incorrectly or in an undesired orientation. The varied size of the groove 124 and corresponding lip provides a key or polarisation to the connection.
[00998] Whilst the deeper portion of the groove 124 is illustrated as being positioned on one edge of the nasal interface 100 with the three remaining edges having a standard sized groove and lip in some optional arrangements, the deeper portion of the groove 124 may be positioned on any of the edges and may be positioned on more than one edge.
[00999] Referring to Figure 50A, a schematical view of the nasal interface 100 of Figure 50 is shown. However, the figure shows more details to describe the features of a cheek pad. The illustrations omit reference numerals for some features described in reference to Figure 50, and omits some features for explanation such as the headgear. Otherwise, the description provided in reference to figures elsewhere applies for like- features. As will be clear, the nasal interface 100 of the presently described figures may be applied to any arrangement described herein.
[OO1OOO] The nasal interface 100 comprises cheek pads 210. In the illustrated configuration, the cheek pad 210 forms part of the side arms 101, 102 of the frame 120. However, in some arrangements, the cheek pads 210 may be present on the headgear or intermediary elements such as extension arms or headgear connecting portions. Any of these features may comprise the cheek pads 210. In some configurations, the cheek pads 210 are present on headgear arms.
[001001] The cheek pads 210 are present on each side arm 101, 102 of the frame 120 relative to the nasal interface 100. The cheek pads 210 are positioned at or near the lateral edges of the interface body 110 to ensure they are in positioned proximal to a patient's cheek when in use.
[001002] The cheek pads 210 have a bulbous shape extending from the patient facing side of the straps of the side arms 101, 102. The cheek pads 210 are enclosed such that they do not have an opening. The cheek pads 210 are shaped to have its greatest height at or near the patient interface 100 side of the cheek pad 210 and its lowest height at the opposing end. The cheek pad 210 has a smooth transition between the greatest and lowest heights.
[001003] The cheek pad 210 is formed having an outer wall. A pad opening 222 in the outer wall is formed on the surface that faces the side arm 101, 102.
[001004] The side arm 101, 102 comprises a hook portion 1334. The hook portion 1334 is engageable with the pad opening 222 for securing the cheek pad 210 to the side arm 101, 102.
[001005] The hook portion 1334 comprises a peripheral groove 1336 for engaging with the walls of the pad opening 222.
[001006] The peripheral groove 1336 may be eccentric such that it engages with a larger portion of the wall of the pad opening 222. This may increase the securement of the cheek pad 210 to the side arm 101, 102.
[001007] Further referring to Figure 50A, in some arrangements, the connector is a gases delivery elbow 351. The gases delivery elbow 351 forms an angled interface between the conduit 300 (not shown) and the gases inlet port 121. Therefore, the gases delivery elbow 351 comprises a first end defining a gases delivery portion 352. The gases delivery portion 352 couples to the gases inlet port 121. In some arrangements, the gases delivery portion 352 defines the gases inlet port 121. At its opposing end, the gases delivery elbow 351 comprises a gases receipt portion 353. The gases receipt portion 353 is coupled to the conduit 300 and is configured to receive respiratory gases therethrough. [001008] The gases delivery elbow 351 enables the directing of the conduit 300 or the directing of gases flowing from the conduit into the interface body 110.
[001009] The gases delivery portion 352 extends in a first direction, and the gases receipt portion 353 extends in a second direction. In the illustrated arrangement, the gases delivery elbow 351 forms an approximately right-angled bend. Therefore, in some arrangements, the first direction is approximately 90 degrees to the second direction. The gases delivery elbow 351 directs the conduit 300 laterally from the side of the frame 120. This arrangement reduces conduit interference with the patient mouth to allow for functions such as talking, eating or drinking. The gases delivery elbow 351 may also contribute to reducing turbulent flow, this may be in part due to the angle formed.
[001010] The gases delivery elbow 351 may be formed as part of the frame 120, or may be formed as a separate part. The gases delivery elbow 351 may be removably or permanently connected to the frame 120 and/or conduit 300. The gases delivery elbow 351 may be formed to snap-in, or screw into the frame 120. The gases delivery elbow 351 may be swivelable to allow different orientations.
[OO1O11] As clarified above, the features of the configurations illustrated in Figures 46-50A may be combined with any other feature disclosed herein. For instance, in some configurations, the interface body 110 is symmetrical about the first midline 164 as described with reference to Figures 1-13 and 33-37. Additionally, the interface body 110 may be symmetrical about the second midline plane 166 as described with reference to Figures 33-37. Therefore, the description used there also applies here. Further, the ball and socket joint 191 of the side arms 101, 102 as described with reference to Figures 38- 45 may be combined.
[001012] As will be appreciated, the first gases port 121 and the second gases port 122 having substantially the same configuration would also be useful in some configurations of Figures 46-50A.
[001013] Referring to the above, in some configurations, the interface body 110 comprises a frame portion 120 and a cushion portion 129. Likewise, the frame portion 120 and cushion portion 129 may be attached to and from the interface body 110 as described with reference to Figures 12-16.
[001014] In some configurations, the baffles 180 as described with reference to Figures 17-24 may be provided in any of the described configurations.
[001015] The nasal interface 100 provides an asymmetric flow in some configurations. In use of the nasal interface in such configurations, there is a net flow from the first naris of the patient to the second naris of the patient throughout a respiratory or breath cycle when flow or pressure therapy is delivered to the patient, such as CPAP or BiPAP.
[001016] In some configurations, the patient may be spontaneously breathing.
[001017] The breath cycle could be described to have an inspiration phase, an inflection phase where the patient is neither inspiring or expiring (this phase could also be known as a breathing holding phase), and an expiration phase. The inflection phase may occur over a significantly shorter time period than the inspiration and/or expiration phase. [001018] Patient interfaces with nasal interfaces 100 according to the configurations described herein may be employed in a method of delivering gas to the airway of a patient in need thereof, improving the ventilation of a patient in need thereof, reducing the volume of anatomical dead space within the volume of the airway of a patient in need thereof, and/or treating a respiratory condition in a patient in need thereof, as described above. [001019] The patient population that can most benefit from the use of the nasal interfaces 100 and patient interfaces 30 of the present disclosure are COPD patients, in particular patients suffering from overlap syndrome of OSA and COPD
[001020] The nasal interfaces 100 and patient interfaces 30 are advantageous as they can provide pressure and asymmetric flow to flush airways. Additionally the nasal interfaces 100 and patient interfaces provide a more comfortable and easier to use interface.
[001021] Usability advantages are provided by the nasal interfaces 100 and patient interfaces 30 having the ball and socket configurations for connecting the headgear to the nasal interface 100, the nasal interfaces 100 having a general symmetrical shape that allows easy side swapping of the gases inlet and/or the respiratory components, and the coupling between the frame and cushion where a portion of the frame is inserted into the cushion or vice versa, which enables easy assembly and disassembly for cleaning. Each of those features will be advantageous for patients with overlap syndrome who may have reduced physical dexterity and in some instances reduced cognitive capability.
[001022] Patient interfaces comprising nasal interfaces 100 of the type disclosed herein may be used in a respiratory therapy system for delivering gases to a patient.
[001023] Because the patient interfaces can comprise any of the nasal interfaces (or nasal interface components such as the interface bodies 110 and interface frames 120) of the type disclosed herein, references herein and below to nasal interface 100 can instead be considered references to any of the other nasal interfaces 100.
[001024] In some configurations, the respiratory therapy system 1000 comprises a respiratory therapy apparatus 1100 and a patient interface comprising a nasal interface 100.
[001025] A schematic representation of an example respiratory therapy system 1000 is provided by Figure 56. The respiratory therapy system 1000 may comprise at least a breathing assistance apparatus 10, supply conduit 20, and the patient interface with the nasal interface 100. Other modules or elements may be present in the system. Hereinafter, the apparatus comprising a flow generator 11 and a humidifier 12 will be referred to as a "breathing assistance apparatus", whereas the system comprising the flow generator 11, humidifier 12, supply conduit 20, and patient interface 1 will be referred to as a "respiratory therapy system", but these terms should not be considered limiting. The respiratory therapy system 1000 may omit the patient interface 1 in some circumstances. [001026] An exemplary breathing assistance apparatus will now be described, with reference to Figures 56 and 57. This is intended as a non-limiting example of a breathing assistance apparatus that can be supported on a support stand in accordance with this disclosure.
[001027] Breathing assistance apparatus 10 is configured or operable to provide respiratory therapy via the supply conduit 20 and the patient interface 1.
[001028] It will be appreciated that the components, methods and processes described herein may be applied to other breathing assistance apparatus and/or to other modes of operation and/or modes of therapy delivered by such apparatus. For example, the breathing assistance apparatus 10 may additionally or alternatively be configured or operable to provide pressure-based therapies such as continuous positive airway pressure (CPAP) therapy and/or bi-level positive airway pressure (bi-level) therapy. The patient interface used is a sealed interface, such as nasal pillows, a nasal mask, under-nose mask, or full-face mask.
[001029] The breathing assistance apparatus 10 may be an integrated apparatus comprising a plurality of key components in a single housing, or a discrete componentbased arrangement where the key components are separate but connected together.
[001030] With reference to Figure 56, the breathing assistance apparatus 10 comprises at least a flow generator 11 and a humidifier 12. In some configurations, the flow generator 11 and humidifier 12 are part of an integrated breathing assistance apparatus 10, sharing a common housing 16. In other configurations, the breathing assistance apparatus 10 could be a modular arrangement of discrete components, with the flow generator 11 and humidifier 12 being separate modules that can be connected together.
[001031] The breathing assistance apparatus 10 comprises an inlet module 1010 for providing a gas or gases such as air, oxygen (O2), air blended with oxygen, or a mix of air and/or oxygen and one or more other supplemental gases to the flow generator 11. The inlet module 1010 may comprise one or more inlets for receiving flows of (or drawing in) ambient and/or pressurised air, oxygen, and/or other gases. For example, with reference to Figure 56, in some embodiments the inlet module 110 may comprise an ambient air inlet 1101, low-pressure gas inlet 1102, and/or high-pressure gas inlet 1103. A greater or lesser number of inlets may be provided in other embodiments. Some or all of the inlets may comprise connectors (such ports, terminals, couplers, and the like) for establishing fluid or pneumatic connections to the sources of said gases. The inlet module 110 may be considered to form part of the flow generator 11, the breathing assistance apparatus 10, or it may be a separate, modular component, depending on the context. [001032] With reference to Figure 56, a filter or multiple filters may be provided as part of the inlet module 1010, at or immediately downstream of the ambient air intake 1101, the low-pressure gas inlet 1102, and/or the high-pressure gas inlet 1103. There may be a single filter 1106 positioned at the inlet or inlets to blower 1111 to filter particulates and pathogens carried with the incoming gases before they reach the blower 1111. Additionally, or alternatively, there may be individual filters positioned at each of the inlets or intakes 1101, 1102, 1103. In an exemplary embodiment, a filter 1104 is provided between the high-pressure gas inlet 1103, at or upstream of a valve 1105 which be a proportional valve 1105, in addition to a filter 1106 positioned at the inlet or inlets to the blower 1111, downstream of the proportional valve 1105 and the intake 1101 and inlet 1102.
[001033] The valve 1105 will be in fluid communication with the high pressure gas (e.g. oxygen) inlet 1103 to control a flow of high pressure gas through the high pressure gas inlet.
[001034] According to the above and depending on the configuration (some components may be optional), the respiratory therapy system 1000 can include a combination of components or modules selected from the following:
• a flow generator 11, comprising an inlet module 1010, comprising one or more gas source inlets and their respective connectors (if applicable), a filter or filter module 1106, and a blower/sensor module 1114,
• non-return valve 1122,
• a humidifier 12 for humidifying the gases flow,
• a supply conduit 20, and/or
• a patient interface 1.
[001035] The respiratory therapy system 1000 and breathing assistance apparatus 10 will now be described in more detail.
[001036] The gas sources connected to the inlet module 1010 or inlets of the inlet module may include an in-wall ("piped") supply of supplementary gas (e.g., oxygen) or mixture of gases, a tank of said supplementary gases, and/or a gas flow source such as an oxygen concentrator. The aforementioned gas sources may provide the respective gas or gases at low or high pressures and/or low or high flow rates. In some configurations, one or more of the gas sources may include a shut-off valve and/or regulator or other flow or pressure control means which may be manually adjustable by a user. For example, one of the gas sources may be pressurised gas cylinder connected to the high-pressure gas inlet 1103 via a regulator and shut-off valve. [001037] The flow generator 11 comprises a blower/sensor module 1114 that least comprises a blower 1111 that controls flows delivered to a patient via the supply conduit 20 and patient interface 1. The blower 1111 may be a centrifugal blower, comprising at least a motor and impeller or fan that is driver by the motor. Other types of blowers may be employed, such as axial blowers. The flow rate and/or pressure of flows of gases being output by the flow generator 11 can be controlled by varying the output of the blower
1111, for example by varying the rotational speed of the motor driving the impeller or fan. The flow generator may be configured to provide flows of gases at high flow rates. Examples of high flow rates are provided later.
[001038] The blower/sensor module 1114 may further comprise a sensor module
1112. With reference to Figure 56, in some embodiments the sensor module 1112 may be positioned "after" or downstream of the blower 1111 (i.e., an inlet of the sensor module 1112 may be fluidically/pneumatically connected to the outlet of the blower 1111) but may instead be positioned upstream of the blower in other embodiments. The sensor module 1112 may be located prior to humidifier 12.
[001039] One or more sensors (for example, Hall Effect sensors) may be used to measure a motor speed of the blower motor.
[001040] Positioning sensors (e.g., flow rate, pressure, oxygen fraction, and/or other types of sensors in the sensor module 1112) downstream of the blower 1111 can increase accuracy of measurements, such as the measurement of fractional gas concentrations, including oxygen fraction, over systems that position the sensors upstream of the blower and/or a mixer. Positioning these sensors at a location further along the flow pathway, after the flow of gases has been more mixed (and may therefore be more homogeneous), may yield more consistent and/or repeatable measurements.
[001041] In some embodiments of the breathing assistance apparatus 10, a nonreturn valve (NRV) 1122 may be located downstream of the blower 1111 or blower/sensor module 1114 but prior to the flow generator outlet 113 and/or the inlet to humidification chamber 1205. The NRV 1122 may be positioned within the flow generator outlet 113. The non-return valve 1122 may serve to prevent any backflow of gases, aerosols, and/or liquids into the flow generator 11 via the humidifier 12. During the provision of respiratory therapy, some flows of gases expired by patients may travel down the supply conduit 20, back into the humidifier 12 and potentially reaching the flow generator or displacing other gases that then travel into the humidifier and/or flow generator; these flows of gases may carry pathogens which could contaminate the flow generator. In addition, the flows of gases may transport significant quantities of water vapour (especially if returning via the humidifier 12) which, over time, may damage the internal hardware of the flow generator if backflow is allowed to occur. Hence, a non-return valve may be included in the breathing assistance apparatus.
[001042] The patient interface 1 is a sealing patient respiratory interface. Such sealing interfaces may be a full or under-nose face mask, or nasal masks and nasal pillows, where the nares of a patient are completely sealed off from the outside environment, in contrast to non-sealing nasal prongs which allow for some movement of gases between the outside environment and the nasal passageways. However, in the present disclosure, sealing pillows (or nasal elements) are used.
[001043] A humidifier 12 is provided between the flow generator 11 and the apparatus outlet 13 and/or supply conduit 20 to humidify the flow of gases being output by the flow generator 11. Humidification is particularly useful when providing high flow therapy (where high flow rates of otherwise dry gases are delivered to the patient's airways) as it improves the tolerability and comfortability of the therapy. Increasing the humidity of the gases to or closer to the natural levels in a healthy patient's airways (e.g., 37°C dew point) may help to maintain the condition of the airways, reducing or preventing drying-out or other effects which may cause discomfort and adverse health outcomes. In some configurations the humidifier 12 may be optional, in which case the breathing assistance apparatus 10 may provide non-humidified gases from the flow generator 11 to the patient.
[001044] The humidifier 12 may be a heated humidifier, wherein the humidifier comprises at least one heating element. The humidifier 12 may be a heated pass-over humidifier. A heated pass-over humidifier typically comprises at least a heater plate 1216, a heating element 1226 arranged and configured to heat the heater plate 1216, and a humidification chamber 1205 comprising a heat-conductive base that is in close contact with the heater plate 1216 when in use. The humidification chamber 1205 will be at least partially filled with water when in use; the heat-conductive base will transfer heat from the heater plate to the water, thereby causing controlled evaporation of the water to increase the humidity of a gases flow travelling through the chamber.
Sensors
[001045] Various sensors configured to detect or measure properties or parameters of the respiratory therapy system 1000 and/or the flow of gases may be disposed at one or more locations throughout the system.
[001046] In an exemplary embodiment of the respiratory therapy system 1000, at least the following sensors may be provided : • Sensor 1107 at the ambient air inlet 1101 (e.g., a pressure, flow, temperature, and/or humidity (relative and/or absolute) sensor);
• Sensor 1108 at or optionally downstream of the high-pressure gas inlet 1103 (e.g., a pressure and/or a flow sensor);
• Sensor 1109 downstream of the proportional valve 1105 (e.g., a pressure and/or a flow sensor);
• Sensor 1113 at the blower 1111, optionally proximal to the stator windings of the motor driving the blower (e.g., a temperature and/or a motor speed sensor);
• Sensor 123 at the heating element 1226, or proximal to the heater plate 1216 (e.g., a temperature sensor);
• Sensor 130 downstream of the apparatus outlet 13 (e.g., a temperature sensor);
• Sensor 21 at a patient end of the supply conduit 20 (e.g., a temperature sensor or a blood oxygen saturation sensor).
[001047] Sensors 1107, 1108, 1109, 1113, 123, 130, and/or 21 may comprise multiple sensors. The multiple sensors may be part of a single package or separate, discrete sensors, or a combination of integrated sensor modules and discrete components. [001048] Additional sensors may be provided as part of or within the sensor module 1112. The sensor module 1112 may be configured and arranged to measure properties of the gases flow travelling from the blower 1111 through to flow generator outlet 113 and beyond. For example, the sensor module may comprise a sensor or sensors to detect the flow rate, oxygen concentration fraction (FdCh), pressure, temperature, and/or humidity of the flow of gases.
[001049] In addition to the sensors described above, various other sensors may be provided in and throughout the respiratory therapy system 1000. The sensors may be configured to detect, measure, and/or determine flow rate, pressure, temperature, humidity (e.g., relative and/or absolute humidity), oxygen concentration/fraction, and/or motor speed. Other sensors can be placed throughout the system and/or at, on or near the patient — for example, a pulse oximetry sensor may be attached to the patient and coupled to the controller 14 via a pulse oximeter. Alternatively, or additionally, sensors from which the above parameters can be derived could be used.
[001050] Some or all of the sensors listed above may be electrically and/or communicatively connected to a controller 14, as mentioned above. The connection may be direct or indirect — e.g., via signal conditioning circuits, driver circuits, another controller, and/or other types of circuit. The connection(s) may be wired or wireless.
[001051] The controller 14 may be a microprocessor, a microcontroller, a programmable logic device (such as a CPLD or FPGA), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), or other suitable form of device, and may not necessarily be implemented in a single monolithic integrated circuit (IC) but may include additional discrete electrical and/or electronic components. The controller 14 may comprise a single device or multiple devices and components. For example, the controller 14 may comprise multiple microprocessors or microcontrollers. Overall, it will be appreciated by persons of skill in the art that various types of devices and components may be employed as or in controllers such as controller 14.
[001052] The controller can include programming instructions for detection of input conditions and control of output conditions. The programming instructions can be stored in memory of or associated with the controller 14. The programming instructions can correspond to the methods, processes and functions described herein. The programming instructions can be executed by one or more processors of the controller 14. The programming instructions can be implemented in C, C+ + , Java, or any other suitable programming languages or combinations thereof. Some or all of the portions of the programming instructions can be implemented in application specific circuitry such as ASICs and FPGAs.
[001053] In some configurations, the outputs from at least some or all of the sensors described above are sent to the controller 14 to assist the control of the respiratory system 1 and its constituent components or modules (e.g., the blower 1111, heating element 1226, supply conduit 20, display and input/output (I/O) 142, and other modules). The controller 14 may be coupled to at least one or more of: the proportional valve 1105, blower 1111, humidifier heating element 1226, and/or the heated breathing tube of supply conduit 20. In some configurations, the controller 14 controls at least these and other parts of the respiratory system 1 as described herein. "Control" as referred to herein may involve direct control of components (i.e., by signals output from the controller 14) or control via signal conditioning circuits, drivers/driving circuits (such as MOSFET gate drivers or motor drivers, for example). [001054] In some examples, the controller can operate the blower 1111 and/or the proportional valve 1105 to provide a flow of gas at a desired flow rate. The controller 14 may also receive user input from a user interface aspect of the display and I/O 142. The user input may include a target flow rate, pressure, oxygen fraction (i.e., FdOz (fraction of delivered oxygen) or FiOz (fraction of inspired oxygen)), therapy mode (high flow therapy, CPAP, etc.), alarm thresholds, and/or other parameters. The user can be a patient, healthcare professional, or others.
[001055] In some configurations, the controller 14 is configured to control the valve 1105 based on at least one measurement of oxygen saturation from the blood oxygen saturation sensor.
[001056] The controller 14 may output information to a display and I/O peripheral 142. The display and I/O peripheral 142 can display warnings and/or other alerts. The display and I/O peripheral 142 can be configured to display characteristics of sensed gases in real time or otherwise. The controller 14 can also receive user inputs via a user interface aspect of the display and I/O peripheral 142. The user interface can include virtual and/or physical button(s) and/or dial(s). The user interface can comprise a touch-sensitive screen.
[001057] The breathing assistance apparatus 10 may include one or more communications modules 141 which can enable data communications with one or more external devices or servers over a data or communication link or data network, whether wired, wireless or a combination thereof. In one configuration, for example, the breathing assistance apparatus 10 can include a wireless data transmitter, receiver, and/or transceiver to enable the controller 14 to send and receive data signals in a wireless manner to/from external devices, including sensors (e.g., sensors affixed to a patient), patient monitoring systems, mobile phones or other devices, and/or remote servers. In one example, the one or more communications modules 141 may comprise cellular (e.g., 3G, 4G, and/or 5G), Bluetooth, and/or Wi-Fi modules. The one or more communications modules 141 may comprise a singular module configured to perform communication using cellular, Bluetooth, and Wi-Fi technologies and protocols.
[001058] The one or more communications modules 141 can deliver data to a remote patient management system (for example, implemented or located on a remote server) and/or enable remote control of the breathing assistance apparatus 10 or respiratory system 1. The remote patient management system may comprise a single server, multiple servers, or multiple computing devices implemented in a cloud computing network. The communication may be two-way (bidirectional) communication between the breathing assistance apparatus 10 and the remote patient management system, and/or another remote system.
[001059] The one or more communications modules may allow the controller 14 to wirelessly send information to another local device such as, for example, a user or patient's mobile phone, tablet, smartwatch, etc. The breathing assistance apparatus 10 may additionally, or alternatively, comprise a Near Field Communication (NFC) module to allow for local data transfer and/or data communication. In some examples, the breathing assistance apparatus 10 may transmit data over a wired or wireless connection to the local user or patient device, for example via USB, Wi-Fi, Bluetooth, or NFC, and the user or patient device may then wirelessly transmit data to a remote server, such as the remote patient management system (for example, via the Internet).
[001060] As mentioned above, estimated, measured, or determined respiratory parameters that are generated or received by the breathing assistance apparatus 10 may be transmitted via the one or more communications modules 141 to a remote server. In addition, usage information and selected therapy parameters may also be transmitted. Therapy parameters — e.g., flow rate, humidity level and other respiratory parameters such as respiratory rate, occurrences of apnoeas, pulse oximetry data (e.g., SpCh) — may be transmitted together. In some examples, the breathing assistance apparatus 10 or the user or patient device may generate an index (for example, a respiratory oxygenation (ROX) index) that contains, comprises, or is based on therapy parameters — e.g., patient SpO2, device FdCh or FiCh, flow rate, humidity level, and other determined or estimated respiratory parameters — and is transmitted by the breathing assistance apparatus 10 or the user or patient device to a remote server.
[001061] The remote patient management system may be implemented on a single server or a network of servers or a cloud computing system or other suitable architecture for operating a remote patient management system. The remote patient management system may further include memory for storing received data and various software applications or services that can be executed to perform multiple functions. Then, for example, the remote patient management system may communicate information or instructions to the breathing assistance apparatus 10 at least in part dependent on the data received. For example, the nature of the data received may trigger the remote server (or a software application running on the remote server) to communicate an alert, alarm, or notification to the breathing assistance apparatus 10. The remote patient management system may further store the received data for access by an authorized party such as a clinician, or the patient, or another authorized party. The remote patient management system may further be configured to generate reports in response to a request from an authorized party, and respiratory or selected therapy parameters may be included in the generated reports. The reports may comprise other data or patient breathing or respiratory parameters, e.g., respiratory rate, SpC>2, and/or device parameters such as flow rate(s), pressure(s), temperature(s), and/or humidity level(s).
[001062] Figure 57 illustrates a block diagram 301 of an example control system 310 (which can be implemented on, by, or at least partially on or by the controller 14 (and any other controllers or circuits described herein) that can detect patient and/or system conditions and control operation of the respiratory therapy system 1000, including any gases source(s). The control system 310 can determine and generate the output control signals 322-326 based on one or more received inputs 311-321. The inputs 311-321 can correspond to sensor measurements received automatically by the controller 14 and/or user inputs. The control system 310 can receive, including but not limited to, pressure sensor(s) input(s) 311, temperature sensor(s) input(s) 312, flow rate sensor(s) input(s) 313, motor speed sensor(s) input(s) 31, gas fraction/concentration sensor(s) input(s) 315, humidity sensor(s) input(s) 316, pulse oximetry sensor(s) input(s) 317 (for example, SpO2 and/or heart rate), stored or user parameter(s) input(s) 318, duty cycle or pulse width modulation (PWM) input(s) 319, voltage(s) input(s) 320, current(s) input(s) 3211. [001063] With continued reference to Figure 56, a supply conduit 20 can be coupled to an apparatus outlet 13 formed in or as part of the housing 16 of the breathing assistance apparatus 10 at one end, and to a patient interface 1 at another end.
[001064] The gases flow generated by the flow generator 11 may be humidified before being delivered to the patient via the supply conduit 20 and the patient respiratory interface 30, as explained previously. The controller 14 can control the flow generator 11 to generate a gases flow of a desired flow rate, and/or one or more valves (such as proportional valve 1105) to control the mixing of air and oxygen and/or other supplemental gases by the blower 1111. The controller 14 can control a heating element 1226 in or associated with the humidifier 12, if present, to heat the gases flow to a desired temperature that achieves a desired level of temperature and/or humidity for delivery to the patient. The supply conduit 20 may be a heated conduit, comprising one or more conductors (i.e., heating elements) embedded within the walls of the supply conduit, which may be supplied with electrical current in order to heat the internal passageway(s) of the conduit. Alternatively, the heating element(s) may be attached to the interior surface of the supply conduit 20, or even float within the interior of conduit. The power supplied to the heating elements can be controlled by the controller 14. [001065] The respiratory therapy system may have any one or more of the features and functionality described in PCT publication no. WO 2021/048744 and U.S. provisional application numbers 62/897,899 and 63/025,151 and/or in PCT publication no. WO 2021/049954 and U.S. provisional application no. 62/898,464. The contents of those specifications are incorporated herein in their entireties by way of reference.
[001066] The patient interface 1 and nasal interface 100 used in the respiratory therapy system 1000 may have any one or more of the features and/or functionality described herein for nasal interface 100 or any of the other nasal interfaces disclosed herein.
[001067] In some configurations, the nasal interface 100, patient interface 1, and/or respiratory therapy system 1000 may be used in a method of providing respiratory support to a patient.
[001068] In some configurations, the method of providing respiratory support to a patient comprises: providing a respiratory therapy system 1000 comprising: a gases source 1011 for respiratory gases and configured to provide pressure controlled respiratory gases; a breathing tube 16 to receive the pressure controlled respiratory gases; and a nasal interface 100 having a gases inlet 121 in fluid communication with the breathing tube 16 to deliver the respiratory gases to a patient, the nasal interface 100 comprising a first nasal delivery element 111 and a second nasal delivery element 112; sealing each of the first nasal delivery element 111 and the second nasal delivery element 112 with a respective naris of a patient; operating the respiratory therapy apparatus 1000 to provide a flow of gases to the nasal interface 100; and delivering a flow of gases from the respiratory therapy apparatus 1000 through the first nasal delivery element 111 and the second nasal delivery element 112 at a patient's nares.
[001069] In some configurations, the method of providing respiratory support to a patient comprises: providing a respiratory therapy system 1000 comprising: a gases source for respiratory gases and configured to provide pressure controlled respiratory gases; a breathing tube 300 to receive the pressure controlled respiratory gases; and a nasal interface 100 in fluid communication with the breathing tube 16 to deliver the respiratory gases to a patient; sealing the nasal interface 100 with a patient's nasal airways; operating the respiratory therapy apparatus 10 to provide a flow of gases to the nasal interface 100; and receiving incoming gases at a gases inlet 121 of the nasal interface and creating a flow of gases at a patient's nasal airways.
[001070] In some configurations of the above paragraphs, the method may comprise delivering an asymmetric flow of gases at the patient's nares to create an asymmetric flow of gases at a patient's nasal airways.
[001071] In some configurations of the above paragraphs, the method may comprise delivering an asymmetric flow of gases and pressure at a patient's airways throughout a respiratory cycle of a patient.
[001072] The asymmetric flow of gases at the patient's nasal airways may be created during an inhalation phase of the respiratory cycle. Additionally, this may also occur during an exhalation phase of the respiratory cycle. The inhalation phase and exhalation phase may define a respiratory cycle. As such, an asymmetric flow may be provided at the nasal airways of the patient by the nasal interface 100 throughout a respiratory cycle of a patient.
[001073] The nasal interface may be any one of the nasal interfaces 100, disclosed herein.
[001074] The patient interface 1 and nasal interface 100 used in the method may have any one or more of the features and/or functionality described herein for the herein described nasal interfaces 100.
[001075] The respiratory therapy system 1000 used in the method may have any one or more of the features and/or functionality described herein for the respiratory therapy system 1000.
[001076] In use of the patient interface 1 and nasal interface 100 of the present disclosure for a CPAP-style therapy, compared to a high flow therapy the CPAP-style therapy may provide one or more of: a quieter therapy, increased therapy pressure, easy detection of breath rate, nasal interface removal, and/or reduced leaking (due to control of pressure). [001077] The nasal interfaces 100 disclosed herein could be used in a medical care facility, home environment, emergency vehicle, or any other suitable environment. Therefore, references herein to "patient" should be interpreted to be any suitable subject that the nasal interfaces are used for or by.
[001078] Although the present disclosure has been described in terms of certain embodiments, other embodiments apparent to those of ordinary skill in the art also are within the scope of this disclosure. Thus, various changes and modifications may be made without departing from the spirit and scope of the disclosure. For instance, various components may be repositioned as desired. Features from any of the described embodiments may be combined with each other and/or an apparatus may comprise one, more, or all of the features of the above-described embodiments. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present disclosure. Accordingly, the scope of the present disclosure is intended to be defined only by the claims that follow.

Claims

CLAIMS:
1. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port configured for connecting to a first respiratory component for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port for enabling exhaled gases to be expelled out of the interface body, the second gases port configured for connecting to a second respiratory component, wherein the first gases port and the second gases port have substantially the same configuration such that the first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that the second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
2. The nasal interface according to claim 1, wherein the first gases port and the second gases port have substantially the same sized openings.
3. The nasal interface according to claim 2, wherein the same sized openings have the same geometry in a direction transverse to gases flow through the first and second gases ports.
4. The nasal interface according to any one of claims 1 to 3, wherein the first gases port points substantially toward the first delivery element or first delivery element portion, and wherein the second gases port points substantially toward the second delivery element or second delivery element portion.
5. The nasal interface according to any one of claims 1 to 4, wherein the first gases port has a first gases port connection feature for connecting to either of the first and second respiratory system component and wherein the second gases port has a second gases port connection feature for connecting to either of the first and second respiratory system component, and wherein the first gases port connection feature is substantially the same as the second gases port connection feature.
6. The nasal interface according to claim 5, wherein at least one of the first gases port connection feature and second gases port connection feature is a clip or a lip for engaging with the first and/or second respiratory component.
7. The nasal interface according to any one of claims 1 to 6, wherein the first gases port and second gases port are substantially circular.
8. The nasal interface according to any one of claims 1 to 7, wherein the first respiratory system component is a first gases conduit for delivery of respiratory gases into the nasal interface, and wherein the second respiratory system component is a diffuser or a second gases conduit.
9. The nasal interface according to claim 8, wherein the diffuser is a bias flow diffuser.
10. The nasal interface according to claim 8 or claim 9, wherein the diffuser comprises diffuser material.
11. The nasal interface according to claim 10, wherein the diffuser comprises clamping portions to hold the diffuser material therebetween.
12. The nasal interface according to any one of claims 8 to 11, wherein the diffuser comprises at least one aperture.
13. The nasal interface according to any one of claims 1 to 12, wherein the first respiratory component and second respiratory component are tethered.
14. The nasal interface according to claim 13, wherein at least one of the first respiratory component and second respiratory component are tethered to the interface body.
15. The nasal interface according to one of claims 1 to 14, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
16. The nasal interface according to claim 15, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
17. The nasal interface according to claim 15 or claim 16, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases to create or contribute to the asymmetric flow.
18. The nasal interface according to any one of claims 1 to 17, wherein the first gases port and the second gases port are symmetrical about a midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
19. The nasal interface according to any one of claims 1 to 18, wherein the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect.
20. The nasal interface according to claim 19, wherein the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
21. The nasal interface according to any one of claims 1 to 20, wherein the interface body comprises: a first body portion comprising the first gases port; and a second body portion comprising the second gases port, and wherein the first body portion and second body portion are angled relative to one another.
22. The nasal interface according to any one of claims 1 to 21, wherein the interface body comprises a frame portion and a cushion portion.
23. The nasal interface according to claim 22, wherein the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
24. The nasal interface according to any one of claims 1 to 23, comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
25. The nasal interface according to claim 24, comprising a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
26. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, and a first gases port for delivery of respiratory gases into the nasal interface, wherein the first gases port is in fluid communication with the interface body to deliver the respiratory gases from the first gases port through the interface body to the first naris and second naris of the patient in use, and a second gases port for expelling exhaled gases out of the nasal interface, wherein the second gases port is in fluid communication with the interface body to expel the exhaled gases substantially from the second naris of the patient through the interface body to the second gases port in use, wherein the interface body comprises a cushion portion and a frame portion, the first gases port formed as a first cushion opening in the cushion portion and a first frame opening formed in the frame portion, and the second gases port formed as a second cushion opening in the cushion portion and a second frame opening formed in the frame portion, wherein the first cushion opening and first frame opening are inter-engageable, and wherein the second cushion opening and second frame opening are inter-engageable to attach the cushion portion to the frame portion.
27. The nasal interface according to claim 26, wherein the frame portion comprises a first protrusion comprising the first frame opening and a second protrusion comprising the second frame opening, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion.
28. The nasal interface according to claim 27, wherein the cushion portion comprises a first protrusion comprising the first cushion opening and a second protrusion comprising the second cushion opening, wherein the first and second protrusions are receivable in respective first and second apertures in the frame portion.
29. The nasal interface according to claim 27 or claim 28, wherein the first protrusion and second protrusion are generally circular in cross-section.
30. The nasal interface according to any one of claims 27 to 29, wherein the first aperture and second aperture is formed as a generally C-shaped opening.
31. The nasal interface according to any one of claims 27 to 30, wherein the first protrusion and the second protrusion is formed as a bead at an edge of the cushion portion.
32. The nasal interface according to any one of claims 27 to 31, wherein the frame portion comprises an outwardly extended periphery portion.
33. The nasal interface according to any one of claims 7 to 32, wherein the frame portion comprises a pair of side arms on either side of the interface body.
34. The nasal interface according to claim 33, wherein the side arms are each angled respectively toward the proximal first delivery element or first delivery element portion and the second delivery element or second delivery element portion.
35. The nasal interface according to claim 33 or claim 34, wherein the side arms each comprise an elongate slot for engaging with a strap.
36. The nasal interface according to any one of claims 26 to 35, comprising a first outlet in the first delivery element and a second outlet in the second delivery element.
37. The nasal interface according to claim 36, wherein a base of each first and second delivery element is thicker than a tip of the first and second delivery element, wherein the first outlet and second outlet is located at the respective tip of the first and second delivery element.
38. The nasal interface according to claim 26, wherein the first delivery element and the second delivery element each have a wall thickness at the base and a wall thickness adjacent the first and second outlets, and wherein the wall thickness at the base is larger than the wall thickness adjacent the first and second outlets.
39. The nasal interface according to one of claims 26 to 38, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of the patient.
40. The nasal interface according to claim 39, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
41. The nasal interface according to claim 39 or claim 40, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
42. The nasal interface according to any one of claims 26 to 41, comprising at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
43. The nasal interface according to claim 42, comprising a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across the cushion portion, the frame portion, or both the cushion portion and the frame portion of the nasal interface.
44. The nasal interface according to any one of claims 26 to 43, wherein the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
45. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port for delivery of respiratory gases into the nasal interface, wherein the first gases port is in fluid communication with the gases flow channel, and a second gases port for expelling exhaled gases out of the nasal interface, wherein the second gases port is in fluid communication with the gases flow channel, and at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
46. The nasal interface according to claim 45, wherein the at least one baffle is arranged such that when respiratory gases are delivered into the interface body through the first gases port, they pass along the baffle to the first delivery element or the first delivery element portion and along the baffle to the second delivery element or the second delivery element portion, and such that exhaled gases substantially pass along the baffle to the second gases port.
47. The nasal interface according to claim 45 or 46, comprising a plurality of the baffles.
48. The nasal interface according to claim 47, wherein the baffles extend substantially parallel to one another.
49. The nasal interface according to claim 47 or claim 48, comprising between 2 and 5 baffles.
50. The nasal interface according to any one of claims 47 to 49, wherein each baffle is equally spaced from one another.
51. The nasal interface according to any one of claims 47 to 50, wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
52. The nasal interface according to any one of claims 45 to 51, wherein the at least one baffle extends substantially a full length of the gases flow channel such that gases cannot pass around ends of the at least one baffle.
53. The nasal interface according to any one of claims 45 to 52, wherein the at least one baffle has a depth that terminates before the first and second delivery elements.
54. The nasal interface according to any one of claims 45 to 53, wherein the at least one baffle has a constant thickness along its length.
55. The nasal interface according to any one of claims 45 to 54, wherein the at least one baffle has a thickness that varies along its length.
56. The nasal interface according to claim 55, wherein a middle of the at least one baffle baffles is thicker than the ends of the at least one baffle.
57. The nasal interface according to claim 56, wherein the flow area at the middle of the at least one baffle is between about 50 mm2 and about 300 mm2.
58. The nasal interface according to any one of claims 45 to 57, wherein the at least one baffle is configured to create a flow restriction in the gases flow channel.
59. The nasal interface according to any one of claims 45 to 58, wherein the interface body comprises a frame portion and a cushion portion.
60. The nasal interface of claim 59, wherein the at least one baffle is formed as part of the frame portion or the cushion portion.
61. The nasal interface according to any one of claims 45 to 60, wherein the at least one baffle is formed as a separate part to the interface body and is inserted therein.
62. The nasal interface according to any one of claims 45 to 61, comprising a support rib, the support rib positioned transverse to the at least one baffle in the interface body and configured to support the at least one baffle.
63. The nasal interface according to any one of claims 45 to 62, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
64. The nasal interface according to claim 63, wherein the at least one baffle creates or contributes to the asymmetric flow.
65. The nasal interface according to claim 63 or claim 64, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
66. The nasal interface according to any one of claims 63 to 65, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
67. The nasal interface according to any one of claims 45 to 66, wherein the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
68. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port directly connected to or configured to directly connect to a first gases conduit for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port directly connected to or configured to directly connect to a second gases conduit for enabling exhaled gases to be expelled out of the interface body, wherein the nasal interface is configured to create an asymmetric flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient.
69. The nasal interface of claim 68, comprising a diffuser, wherein the diffuser is directly connected or configured to directly connect to the second gases port of an end of the second conduit distal from the interface body.
70. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, and a second gases port in the interface body and in fluid communication with the gases flow channel, wherein the first gases port and second gases port are removably attachable between a first gases conduit, a second gases conduit and a diffuser, and wherein the nasal interface is reconfigurable between at least two of the following configurations wherein: a) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body; b) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body, wherein the diffuser or a filter is directly attached to an end of the second gases conduit distal to the second gases port; c) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the second gases port, optionally wherein the diffuser is directly attached to the second gases port for enabling the exhaled gases to be expelled out of the interface body through the second gases port and diffuser; and d) the second gases conduit is directly connected to the second gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the first gases port, optionally wherein the diffuser is directly attached to the first gases port for enabling the exhaled gases to be expelled out of the interface body through the first gases port and diffuser.
71. The nasal interface according to claim 69 or 70, wherein the diffuser is a bias flow diffuser.
72. The nasal interface according to claim 69 to 71, wherein the diffuser comprises a diffuser material.
73. The nasal interface according to claim 72, wherein the diffuser comprises clamping portions to hold the diffuser material therebetween.
74. The nasal interface according to any one of claims 69 to 73, wherein the diffuser comprises at least one aperture.
75. The nasal interface according to any one of claims 69 to 74, comprising a Y-piece connector directly connected or configured to be directly connected to the first and second gases ports and first gases conduit.
76. The nasal interface according to any one of claims 69 to 75, comprising a 3-way adaptor configured to be interchangeably connected at its first end to an end of the first conduit distal from the interface body or a further respiratory device, and to be connected at its second end to a respiratory tubing.
77. The nasal interface according to any one of claims 68 to 76, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of the patient.
78. The nasal interface according to any one of claims 68, 69, or 77, wherein at least one flow restriction creates or contributes to the asymmetric flow.
79. The nasal interface according to claims 78, wherein at least one flow restriction is formed by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
80. The nasal interface according to claim 79, comprising a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
81. The nasal interface according to claim 68, 69, or any one of claims 77 to 80, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
82. The nasal interface according to claim 68, 69, or any one of claims 77 to 81, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
83. The nasal interface according to any one of claims 68 to 82, wherein the interface body comprises a frame portion and a cushion portion.
84. The nasal interface according to claim 83, wherein the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
85. The nasal interface of claim 83 or claim 84, wherein the cushion portion and frame portion are inter-engageable to form the interface body.
86. The nasal interface of any one of claims 68 to 85, wherein at least a portion of the first conduit and second conduit extend away from the interface body in a divergent direction.
87. The nasal interface of any one of claims 68 to 86, wherein the first conduit and second conduit are interchangeable with one another.
88. A nasal interface comprising : an interface body comprising a gases flow channel, a first nasal delivery element comprising a first outlet in fluid communication with the gases flow channel and a second nasal delivery element comprising a second outlet in fluid communication with a gases flow channel, wherein the first nasal delivery element and the second nasal delivery element are each configured to seal with a respective naris of a patient to deliver gases to the respective naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel for enabling respiratory gases to be delivered into the interface body, a second gases port in the interface body and in fluid communication with the gases flow channel for enabling exhaled gases to be expelled out of the interface body, the interface body comprising a lip-contacting portion that is arranged to contact an upper lip region of the patient in use, the interface body comprising a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises a headgear connection feature to connect to a respective end of a headgear to fit the nasal interface to a patient's head, wherein the headgear connection feature is positioned at a height generally between the first and second outlets and the lipcontacting portion, such that in use the headgear pulls the body portion against the patient's face in a direction between an insertion direction of the nasal delivery elements in the patient's nares and a force applied by the user's face to the lip-contacting portion.
89. The nasal interface of claim 88, wherein the interface body comprises a frame portion and a cushion portion, wherein the cushion portion comprises the first and second nasal delivery elements, and wherein the frame portion comprises the pair of side arms.
90. The nasal interface according to claim 89, wherein the first and second nasal delivery elements each comprise a pillow.
91. The nasal interface according to claim any one of claims 88 to 90, wherein each headgear connection feature comprises a post to connect with a hook at the respective end of the headgear.
92. The nasal interface according to claim 91, wherein the gases inlet defines a first axis corresponding to a gases flow direction through the first gases port, and wherein the post of the proximal side arm is oriented at an angle of between about 90 degrees and about 135 degrees from the first axis, wherein the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, and wherein the post of the proximal side arm is oriented at an angle of between about 9 degrees and about 135 degrees from the second axis.
93. The nasal interface according to any one of claims 88 to 92, wherein the first gases port is formed as a first cushion opening in the cushion portion and a first frame opening is formed in the frame portion, and the second gases port is formed as a second cushion opening in the cushion portion and a second frame opening is formed in the frame portion, wherein the first cushion opening and first frame opening are inter-engageable, and wherein the second cushion opening and second frame opening are inter-engageable to attach the cushion portion to the frame portion.
94. The nasal interface according to claim 93, wherein the frame portion comprises a first protrusion comprising the first frame opening and a second protrusion comprising the second frame opening, wherein the first and second protrusions are receivable in respective first and second apertures in the cushion portion.
95. The nasal interface according to claim 93, wherein the cushion portion comprises a first protrusion comprising the first cushion opening and a second protrusion comprising the second cushion opening, wherein the first and second protrusions are receivable in respective first and second apertures in the frame portion.
96. The nasal interface according to any one of claims 88 to 95, wherein the first gases port and the second gases port are symmetrical about a midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
97. The nasal interface according to any one of claims 88 to 96, wherein the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect.
98. The nasal interface according to claim 97, wherein the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
99. The nasal interface according to any one of claims 88 to 98, wherein each nasal delivery element comprises a base wall that is thicker and/or more rigid than a remainder of the nasal delivery element.
100. The nasal interface according to any one of claims 88 to 99, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
101. The nasal interface according to claims 100, wherein the asymmetric flow is created by or contributed to by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
102. The nasal interface according to claim 100 or claim 101, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
103. The nasal interface according to claim 100, 101, or 102, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
104. The nasal interface according to any one of claims 88 to 103, comprising a plurality of spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
105. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion comprising a first outlet in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion comprising a second outlet in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port configured for connecting to a first respiratory component for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port for enabling exhaled gases to be expelled out of the interface body, the second gases port configured for connecting to a second respiratory component, wherein the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
106. The nasal interface according to claim 105, wherein the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
107. The nasal interface according to claim 105 or claim 106, wherein the interface body comprises a pair of side arms, said side arms being symmetrical about the first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
108. The nasal interface according to claim 107, wherein the side arms are symmetrical about the second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
109. The nasal interface according to any one of claims 105 to 108, wherein the interface body comprises a frame portion and a cushion portion.
110. The nasal interface according to claim 109, wherein the frame portion comprises the first gases port and the second gases port, and the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
111. The nasal interface according to any one of claims 105 to 110, wherein the shape of the first outlet and second outlet are substantially the same.
112. The nasal interface according to any one of claims 105 to 111, wherein the first outlet and second outlet are circular in shape.
113. The nasal interface according to claim 105 or claim 112, wherein the first gases port points substantially toward the first outlet and the second gases port points substantially toward the second outlet.
114. The nasal interface according to claim 113, wherein an opening of the first gases port and second gases port are substantially circular, and wherein the opening of the first gases port is concentric with first outlet and the opening of the second gases port is concentric with the second outlet.
115. The nasal interface according to claims 113 or 114, wherein first gases port defines a first axis corresponding to the first gases port pointing substantially toward the first outlet, and the second gases port defines a second axis corresponding to the second gases port pointing substantially toward the second outlet a gases flow direction through the second gases port, wherein the first and second axes intersect.
116. The nasal interface according to claim 115, wherein the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees.
117. The nasal interface according to any one of claims 105 to 116, wherein the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
118. The nasal interface according to any one of claims 105 to 117, wherein the first respiratory component is a first gases conduit for delivery of respiratory gases into the nasal interface, and wherein the second respiratory component is a diffuser or a second gases conduit.
119. The nasal interface according to claim 118, wherein the diffuser is a bias flow diffuser.
120. The nasal interface according to any one of claims 105 to 119, wherein the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port, and wherein the at least one baffle being symmetrical about the first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
121. The nasal interface according to claim 120, wherein the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port, and wherein the at least one baffle is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets.
122. The nasal interface according to claim 120 or 121, comprising a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
123. The nasal interface according to one of claims 105 to 122, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of the patient.
124. The nasal interface according to claim 123, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
125. The nasal interface according to claim 123 or claim 124, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
126. The nasal interface according to any one of claims 105 to 125, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
127. The nasal interface according to claim 126, wherein the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
128. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, a first gases port in the interface body and in fluid communication with the gases flow channel for enabling respiratory gases to be delivered into the interface body, a second gases port in the interface body and in fluid communication with the gases flow channel for enabling exhaled gases to be expelled out of the interface body, the interface body comprising a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
129. The nasal interface according to claim 128, wherein the moveable connection is a rotatable connection about the ball and socket joint.
130. The nasal interface according to claim 128 or claim 129, wherein each side arm comprises a distal end that is distal to the interface body the ball portion or socket portion positioned at the distal end.
131. The nasal interface according to any one of claims 128 to 130, wherein the ball portion is formed as an aperture with a ball shaped feature formed in the wall of the aperture.
132. The nasal interface according to claim 131, wherein the aperture is substantially a D-shape and the ball is formed in the straight portion of the D shape.
133. The nasal interface according to claim 131 or claim 132, wherein the socket portion is formed as a hooked portion.
134. The nasal interface according to claim 133, wherein the hooked portion is configured to pass through the aperture and engage at least partially around the ball portion.
135. The nasal interface according to claim 134, wherein an end of the hooked portion formed with an undercut profile to enable the ball portion to be engageable at least partially around the ball portion.
136. The nasal interface according to claim 135, wherein the undercut portion is substantially a C-shape in profile to conform with the shape of the ball portion.
137. The nasal interface according to any one of claims 128 to 136, wherein the headgear connecting portion is an elongate portion and defines a connecting portion axis between its ends.
138. The nasal interface according to claim 137, wherein the ball and socket joint is configured to allow the headgear connecting portion to rotatably twist relative to the side arms, wherein the connecting portion axis does not move.
139. The nasal interface according to claim 138 wherein the angle of twisting from a neutral position is any point between 0 and about 85 degrees in opposing directions.
140. The nasal interface according to any one of claims 137 to 139, wherein the ball and socket joint is configured to allow the headgear connecting portion to rotatably move such that the connecting portion axis is angled relative to the connecting portion axis in a neutral position.
141. The nasal interface according to claim 140, wherein the connecting portion axis angle is positionable at any point between 0 and about 85 degrees.
142. The nasal interface according to any one of claims 128 to 141, wherein the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
143. The nasal interface according to any one of claims 128 to 142, wherein the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
144. The nasal interface according to claim 143, wherein, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
145. The nasal interface according to any one of claims 128 to 144, wherein the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
146. The nasal interface according to any one of claims 128 to 146, wherein the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
147. The nasal interface according to claim 146, comprising a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
148. The nasal interface according to any one of claims 128 to 147, wherein the interface body comprises a frame portion and a cushion portion.
149. The nasal interface according to claim 148, wherein the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
150. The nasal interface of claim 148 or claim 149, wherein the cushion portion and frame portion are inter-engageable to form the interface body.
151. The nasal interface according to one of claims 128 to 150, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
152. The nasal interface according to claim 151, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
153. The nasal interface according to claim 151 or claim 152, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
154. A patient interface comprising the nasal interface of any one of claims 128 to 153 and a pair of the headgear connecting portions each moveable connected to one of the side arms, each side arm comprising either the ball or socket portion and each headgear connecting portion comprising the corresponding socket or ball portion.
155. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element in fluid communication with the gases flow channel and configured to deliver gases to or from the first naris of the patient, a second delivery element in fluid communication with the gases flow channel and configured to deliver gases to or from the second naris of the patient, a first gases port for delivery of respiratory gases into the nasal interface, and a second gases port for expelling exhaled gases out of the nasal interface, wherein the nasal interface is configured to create a flow of gases at a patient's nasal airways throughout a respiratory cycle of a patient, and wherein the first delivery element and second delivery element each comprise a nasal pillow configured to form the seal with the patient's nasal airways, and wherein a portion of at least one of the nasal pillows has a thinned region for deforming around a tube passing along the thinned region.
156. The nasal interface according to claim 155, wherein the nasal pillow comprises an outlet distal to the interface body for the passage of gases into or out of the nasal interface, and a base proximal to the interface body, wherein a cross-sectional area of the base is larger than the outlet.
157. The nasal interface according to claim 156, wherein the outlet and base both comprise substantially circular or oval diameter cross-sections.
158. The nasal interface according to claim 157, wherein the diameter of the base is larger than the diameter of the outlet.
159. The nasal interface according to any one of claims 155 to 158, wherein the thinned region is a narrower wall thickness.
160. The nasal interface according to any one of claims 156 to 159, wherein at least one of the nasal pillows has a plurality of thinned regions for deforming around a tube passing along the thinned regions.
161. The nasal interface according to any one of claims 156 to 160, wherein the first gases port is in fluid communication with the interface body to deliver the respiratory gases from the first gases port through the interface body to the first naris and/or second naris of the patient in use.
162. The nasal interface according to any one of claims 156 to 161, wherein the second gases port is in fluid communication with the interface body to expel the exhaled gases from the first and/or second naris of the patient through the interface body to the second gases port in use.
163. The nasal interface according to any one of claims 156 to 162, wherein the interface body is symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use.
164. The nasal interface according to claim 163, wherein, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second delivery elements.
165. The nasal interface according to claim 164 when dependent on claim 160, wherein the plurality of thinned regions are symmetrical about the second midline plane of the interface body.
166. The nasal interface according to any one of claims 156 to 165, wherein the first gases port and the second gases port have substantially the same configuration such that a first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that a second respiratory component can be selectively connected to each of the first gases port and to the second gases port.
167. The nasal interface according to any one of claims 156 to 166, wherein the interface body comprises at least one baffle extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port.
168. The nasal interface according to claim 167, comprising a plurality of the spaced apart baffles extending along the gases flow channel, optionally wherein the baffles extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
169. The nasal interface according to any one of claims 156 to 168, wherein the interface body comprises a frame portion and a cushion portion.
170. The nasal interface according to claim 169, wherein the frame portion comprises the first gases port and the second gases port, and wherein the cushion portion comprises the first delivery element or first delivery element portion and the second delivery element or the second delivery element portion.
171. The nasal interface of claim 169 or claim 170, wherein the cushion portion and frame portion are inter-engageable to form the interface body.
172. The nasal interface according to one of claims 156 to 171, wherein the nasal interface is configured to create an asymmetric flow of gases and pressure at a patient's nasal airways throughout a respiratory cycle of a patient.
173. The nasal interface according to claim 172 wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow.
174. The nasal interface according to claim 172 or claim 173, wherein the nasal interface is configured to receive incoming gases from the first gases port and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use, and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create or contribute to the asymmetric flow.
175. A patient interface comprising the nasal interface of any one of claims 156 to 174 and a pair of the headgear connecting portions each moveable connected to one of the side arms, each side arm comprising either the ball or socket portion and each headgear connecting portion comprising the corresponding socket or ball portion.
176. A method of changing the configuration or direction of a gases inlet of a nasal interface according to any one of claims 128 to 154, the method comprising rotating the ball portion within the socket portion of the ball and socket joint, such that nasal interface goes from a first configuration where the gases inlet is on a left side of the nasal interface to a second configuration where gases inlet is on a right side of the nasal interface, wherein rotating the ball portion in the socket portion causes the change from first configuration to second configuration.
177. A patient interface comprising a nasal interface according to any one of claims 88 to 104, and a headgear comprising first and second ends with connectors that are configured to connect to the headgear connection features on the side arms.
178. A patient interface comprising a nasal interface according to any one of claims 128 to 154, and a headgear comprising first and second ends that are connectable to the headgear connecting portions.
179. A patient interface comprising : a nasal interface according to any one of claims 1 to 87, 105 to 127, and 155 to 174, the interface body of the nasal interface comprising a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises a headgear connection feature to connect to a respective end of a headgear to fit the nasal interface to a patient's head, and a headgear comprising first and second ends with connectors that are configured to connect to the headgear connection features on the side arms.
180. The patient interface according to any one of claims 177 to 179, wherein the headgear is reversible so that either of the ends of the headgear can be connected to either of the headgear connection features.
181. The patient interface according to any one of claims 178 to 180, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear.
182. A respiratory therapy system comprising: a respiratory therapy apparatus comprising: a controller; an ambient air inlet; a gases outlet; and a nasal interface according to any one of claims 1 to 174.
183. A respiratory therapy system according to claim 182, comprising: a blood oxygen saturation sensor; an oxygen inlet; and a valve in fluid communication with the oxygen inlet to control a flow of oxygen through the oxygen inlet; wherein the controller is configured to control the valve based on at least one measurement of oxygen saturation from the blood oxygen saturation sensor.
184. A nasal interface comprising: an interface body configured to substantially form a seal with a patient's nasal airways, the interface body comprising a gases flow channel, a first delivery element or a first delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the first naris of the patient, a second delivery element or a second delivery element portion in fluid communication with the gases flow channel and configured to substantially deliver gases to or from the second naris of the patient, wherein the first and the second delivery elements optionally comprise a pillow, a first gases port in the interface body and in fluid communication with the gases flow channel, the first gases port directly connected to or configured to directly connect to a first respiratory component, optionally a first gases conduit, for enabling respiratory gases to be delivered into the interface body, and a second gases port in the interface body and in fluid communication with the gases flow channel, the second gases port directly connected to or configured to directly connect to a second respiratory component for enabling exhaled gases to be expelled out of the interface body, wherein the nasal interface is configured to create an asymmetric flow of gases, optionally pressure, at a patient's nasal airways throughout a respiratory cycle of a patient.
185. The nasal interface of claim 184, wherein the first gases port and the second gases port have substantially the same configuration such that the first respiratory component can be selectively connected to each of the first gases port and the second gases port, and such that the second respiratory component can be selectively connected to each of the first gases port and to the second gases port, the first gases port and the second gases port optionally having substantially the same sized openings, wherein the same sized openings, optionally, have the same geometry in a direction transverse to gases flow through the first and second gases ports, the first gases port and the second gases port optionally being substantially circular.
186. The nasal interface of claim 184 or 185, wherein the first gases port has a first gases port connection feature for connecting to either of the first and second respiratory system component and wherein the second gases port has a second gases port connection feature for connecting to either of the first and second respiratory system component, wherein the first gases port connection feature is substantially the same as the second gases port connection feature and/or wherein at least one the first gases port connection feature and the second gases port connection feature is clip or a lip for engaging with the first and/or second respiratory component.
187. The nasal interface of any one of claims 184 to 186, wherein the second respiratory component is a second gases conduit, wherein the second gases port is directly connected to or configured to directly connect to the second gases conduit, or a diffuser, wherein the diffuser is directly connected or configured to directly connect to the second gases port and/or to an end of the second conduit distal from the interface body.
188. The nasal interface of claim 187, wherein the nasal interface is reconfigurable between at least two of the following configurations wherein : a) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body; b) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body, and the second gases conduit is directly connected to the second gases port for enabling exhaled gases to be expelled out of the interface body, wherein the diffuser or a filter is directly attached to an end of the second gases conduit distal to the second gases port; c) the first gases conduit is directly connected to the first gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the second gases port, optionally wherein the diffuser is directly attached to the second gases port for enabling the exhaled gases to be expelled out of the interface body through the second gases port and the diffuser; and d) the second gases conduit is directly connected to the second gases port for enabling respiratory gases to be delivered into the interface body and exhaled gases can be expelled out of the interface body through the first gases port, optionally wherein the diffuser is directly attached to the first gases port for enabling the exhaled gases to be expelled out of the interface body through the first gases port and diffuser.
189. The nasal interface of claim 187 or 188, wherein the diffuser is a bias flow diffuser, the diffuser optionally comprising at least one aperture and/or a diffuser material as well as optionally clamping portions to hold the diffuser material therebetween.
190. The nasal interface of any one of claims 184 to 189, wherein at least one flow restriction creates or contributes to the asymmetric flow, the at least one flow restriction optionally being formed by at least one baffle in the interface body extending along the gases flow channel from a region corresponding generally to the first gases port toward a region corresponding generally to the second gases port, wherein, optionally, a plurality of spaced apart baffles extend along the gases flow channel, wherein the baffles optionally extend across a cushion portion, a frame portion, or both a cushion portion and a frame portion of the nasal interface.
191. The nasal interface according to any one of claims 184 to 190, wherein the first gases port is proximal to the first delivery element or first delivery element portion and distal from the second delivery element or second delivery element portion to create or contribute to the asymmetric flow, the first gases port optionally pointing substantially toward the first delivery element or first delivery element portion and the second gases port optionally pointing substantially toward the second delivery element or second delivery element portion, wherein, optionally, the opening of the first gases port is concentric with a first outlet of the first delivery element or first delivery element portion and the opening of the second gases port is concentric with a second outlet of the second delivery element or second delivery element portion.
192. The nasal interface according to any one of claims 184 to 191, wherein the first gases port and the second gases port are symmetrical about a first midline plane of the interface body that is arranged to be parallel to or coplanar with the sagittal plane of a patient when the nasal interface is in use, wherein, optionally, the interface body is symmetrical about a second midline plane of the interface body that is transverse to the first midline plane and bisects at least one of the pair of first and second gases ports or the pair of first and second outlets, the interface body, optionally, comprising a pair of side arms, said side arms being symmetrical about the first midline plane of the interface body and/or the second midline plane of the interface body.
193. The nasal interface according to any one of claims 184 to 192, wherein the first gases port defines a first axis corresponding to a gases flow direction through the first gases port, and the second gases port defines a second axis corresponding to a gases flow direction through the second gases port, wherein the first and second axes intersect, wherein, optionally, the first axis and the second axis lie within the second midline plane.
194. The nasal interface according to claim 193, wherein the angle between the first axis and the second axis is more than 0 degrees and up to about 120 degrees, optionally more than 15 degrees and up to 80 degrees, optionally more than 30 degrees and up to about 75 degrees, optionally more than 40 degrees and up to about 60 degrees, optionally about 50 degrees.
195. The nasal interface according to any one of claims 184 to 194, wherein the interface body comprises a first side at which the first and second nasal delivery elements or delivery element portions are provided and an opposite second side at which the first and second gases ports are provided, the interface body as a whole optionally being curved and having a radial inner surface forming the first side and a radial outer surface forming the second side.
196. The nasal interface according to any one of claims 184 to 195, wherein the interface body comprises a pair of side arms that extend in opposed laterally outward directions, wherein each side arm comprises either a ball portion or a socket portion of a ball and socket joint configured to moveably connect to a corresponding ball or socket portion on a headgear connecting portion for connecting a headgear end portion of a headgear, wherein, optionally, the ball and socket joint is a pivot point that the headgear connecting portion pivots about in any direction with a maximum pivot angle of 90 degrees relative to the side arm.
197. A patient interface comprising the nasal interface of claim 196 and a pair of the headgear connecting portions each moveable connected to one of the side arms, each side arm comprising either the ball or socket portion and each headgear connecting portion comprising the corresponding socket or ball portion.
198. A respiratory therapy system comprising: a respiratory therapy apparatus comprising: a controller; an ambient air inlet; a gases outlet; and a nasal interface according to any one of claims 184 to 197.
EP25811515.3A 2024-08-23 2025-08-22 Patient interface Pending EP4724128A1 (en)

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